Breast implants and possible association with ALCL: A retrospective study including a histological analysis of 296 explanted breast tissues and current literature.

PubMed

Kuehlmann, Britta; Prantl, Lukas

2016-10-05

To identify a possible connection between anaplastic large cell lymphoma and different types of breast implants. We conducted a retrospective evaluation of 296 breast tissues of 227 women with different breast implant types undergoing surgical revision or explantation between January 2000 and June 2015. Histological and selected immunohistochemical analyses of CD30-&ALK-1-markers of the breast capsules were performed. The womens' average age was 42.91±12.66 years (median: 43.83 years) during implantation and 51.40±11.40 years (median: 52.37 years) during revision or explantation of the implants. Average implant residing time was 8.49±8.90 years (median: 5.83 years). In 51% implantation was for reconstructive, in 48% for aesthetic reasons, in 1% for other reasons. At 59% the main reason for explantation or removal was capsular fibrosis (n = 173). In 296 breast capsules we could not find pathological lymphoma cells according to ALCL, retrospectively. In our study we detected high incidences of various cells in relationship to the implant's type and residing time, which will be published in further articles. We could not find ALCL-cells in breast capsules of explanted or revised breast implants during 2000-2015, retrospectively.There should be a heightened awareness of a possible relationship between the development of cancer and breast implants. To date there are case reports about a possible association between the development of ALCL and breast implants. The number of cases are few and our knowledge of the pathogenesis is little. Further investigation is needed to understand the possible link between breast implants and ALCL found in the breast.

A guide to breast implants for the non-breast specialist

PubMed Central

Harvey, Kate L.; Clark, Sarah E.

2016-01-01

Breast augmentation is an increasingly popular cosmetic surgery procedure, and breast implants can also be used in reconstructive surgery following mastectomy. Problematic breast implants can present to any discipline of medicine, most frequently to primary care or acute service such as emergency medicine. This guide aims to inform the non-breast specialist in how to assess and treat common problems and when referral to specialist services is necessary. PMID:29334026

Breast cancer detection and survival among women with cosmetic breast implants: systematic review and meta-analysis of observational studies.

PubMed

Lavigne, Eric; Holowaty, Eric J; Pan, Sai Yi; Villeneuve, Paul J; Johnson, Kenneth C; Fergusson, Dean A; Morrison, Howard; Brisson, Jacques

2013-04-29

To evaluate whether the stage distribution among women diagnosed as having breast cancer differs between those who have received breast implants for cosmetic purposes and those with no implants and to evaluate whether cosmetic breast augmentation before the detection of breast cancer is a predictor of post-diagnosis survival. Systematic review of observational studies with two meta-analyses. Systematic search of the literature published before September 2012 conducted in Medline, Embase, Global health, CINAHL, IPAB, and PsycINFO. Eligible publications were those that included women diagnosed as having breast cancer and who had had augmentation mammaplasty for cosmetic purposes. The overall odds ratio of the first meta-analysis based on 12 studies was 1.26 (95% confidence interval 0.99 to 1.60; P=0.058; I(2)=35.6%) for a non-localized stage of breast cancer at diagnosis comparing women with implants who had breast cancer and women without implants who had breast cancer. The second meta-analysis, based on five studies, evaluated the relation between cosmetic breast implantation and survival. This meta-analysis showed reduced survival after breast cancer among women who had implants compared with those who did not (overall hazard ratio for breast cancer specific mortality 1.38, 95% confidence interval 1.08 to 1.75). The research published to date suggests that cosmetic breast augmentation adversely affects the survival of women who are subsequently diagnosed as having breast cancer. These findings should be interpreted with caution, as some studies included in the meta-analysis on survival did not adjust for potential confounders. Further investigations are warranted regarding diagnosis and prognosis of breast cancer among women with breast implants.

A population-based analysis of secondary malignancies in breast cancer patients receiving breast reconstruction.

PubMed

Warschkow, Rene; Cerny, Thomas; Schmied, Bruno M; Güller, Ulrich; Thuerlimann, Beat; Joerger, Markus

2016-06-28

There is an ongoing debate about the relationship between breast implants and secondary malignancies. Breast cancer patients undergoing surgical reconstruction after mastectomy by either implants or autologous flap were identified in the Surveillance, Epidemiology and End Results registry between 1998 and 2002. The occurrence of secondary malignancies at least 1 year after diagnosis was compared between breast reconstruction with implants vs autologous flap. Of 7955 women, 3727 underwent reconstruction using implants and 4228 using autologous flap. The incidence of secondary tumours was similar in both the groups (hazards ratio (HR)=1.02, 95% confidence interval (CI): 0.82-1.26, P=0.880). For lung cancer, a significantly increased risk for implants (HR=2.51, 95% CI: 1.28-4.95, P=0.005) was observed. Except for lung cancer, no association between implants and secondary malignancies including lymphomas was observed.

Lymphomas Associated with Breast Implants: A Review of the Literature.

PubMed

Rupani, Asha; Frame, James D; Kamel, Dia

2015-07-01

Recently there have been concerns raised about anaplastic large cell lymphoma (ALCL) associated with breast implants. The main aim of this article was to review and analyze the published literature specifically for hematopoietic malignancies associated with breast implants and postulate a hypothesis for their etiology and pathogenesis. The PubMed database was searched using key words "lymphoma" and "breast implants" for published papers and abstracts on implant-associated hematopoietic malignancies. The authors found 83 published cases reported of lymphomas associated with breast implants in the medical literature. The reported cases involved various subtypes of lymphomas and the majority were ALCL, of which 66 were confirmed as ALK negative; however there was no association with any particular type of implant. The more aggressive cases and reported low death rate appeared to be related to the presence of breast masses at the time of presentation rather than effusion. The remaining reports were occasional case reports of T-cell lymphoma, follicular lymphoma, marginal zone B-cell lymphoma, primary effusion lymphoma and lymphoplasmacytic lymphoma. Considering the many thousands of women that have breast implants every year; the compiled data show that there is a very small risk of developing lymphoma. Increased awareness of association between implants and ALCL is needed globally and prospective patients considering breast implants should be fully informed of the risk. As the behavior of ALCL in these cases was indolent as compared with other primary breast lymphomas, it could suggest an abnormal reactive process. 3 © 2015 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

PIP breast implants: rupture rate and correlation with breast cancer

PubMed Central

MOSCHETTA, M.; TELEGRAFO, M.; CORNACCHIA, I.; VINCENTI, L.; RANIERI, V.; CIRILLI, A.; RELLA, L.; IANORA, A.A. STABILE; ANGELELLI, G.

2014-01-01

Aim To evaluate the incidence of Poly Implant Prosthése (PIP) rupture as assessed by magnetic resonance imaging (MRI), the prevalence of the detected signs and the potential correlation with breast carcinoma. Patients and methods 67 patients with silicone breast implants and clinical indications for breast MRI were evaluated for a total of 125 implants: 40 (32%) PIP in 21 patients and 85 non-PIP in 46 patients (68%), the latest considered as control group. A 1.5-T MR imaging device was used in order to assess implant integrity with dedicated sequences and in 6 cases a dynamic study was performed for characterizing breast lesions. Two radiologists with more than 5 years’ experience in the field of MRI evaluated in consensus all MR images searching for the presence of clear signs of intra or extra-capsular implant rupture. Results 20/40 (50%) PIP implants presented signs of intra-capsular rupture: linguine sign in 20 cases (100%), tear-drop sign in 6 (30%). In 12/20 cases (60%), MRI signs of extra-capsular rupture were detected. In the control group, an intra-capsular rupture was diagnosed in 12/85 cases (14%) associated with extra-capsular one in 5/12 cases (42%). Among the six cases with suspected breast lesions, in 2/21 patients with PIP implants (10%) a breast carcinoma was diagnosed (mucinous carcinoma, n=1; invasive ductal carcinoma, n=1). In 4/46 patients (9%) with non-PIP implants, an invasive ductal carcinoma was diagnosed. Conclusion The rupture rate of PIP breast implants is significantly higher than non-PIP (50% vs 14%). MRI represents the most accurate imaging tool for evaluating breast prostheses and the linguine sign is the most common MRI sign to be searched. The incidence of breast carcinoma does not significantly differ between the PIP and non-PIP implants and a direct correlation with breast cancer can not been demonstrated. PMID:25644728

PIP breast implants: rupture rate and correlation with breast cancer.

PubMed

Moschetta, M; Telegrafo, M; Cornacchia, I; Vincenti, L; Ranieri, V; Cirili, A; Rella, L; Stabile Ianora, A A; Angelelli, G

2014-01-01

To evaluate the incidence of Poly Implant Prosthése (PIP) rupture as assessed by magnetic resonance imaging (MRI), the prevalence of the detected signs and the potential correlation with breast carcinoma. 67 patients with silicone breast implants and clinical indications for breast MRI were evaluated for a total of 125 implants: 40 (32%) PIP in 21 patients and 85 non-PIP in 46 patients (68%), the latest considered as control group. A 1.5-T MR imaging device was used in order to assess implant integrity with dedicated sequences and in 6 cases a dynamic study was performed for characterizing breast lesions. Two radiologists with more than 5 years' experience in the field of MRI evaluated in consensus all MR images searching for the presence of clear signs of intra or extra-capsular implant rupture. 20/40 (50%) PIP implants presented signs of intra-capsular rupture: linguine sign in 20 cases (100%), tear-drop sign in 6 (30%). In 12/20 cases (60%), MRI signs of extra-capsular rupture were detected. In the control group, an intra-capsular rupture was diagnosed in 12/85 cases (14%) associated with extra-capsular one in 5/12 cases (42%). Among the six cases with suspected breast lesions, in 2/21 patients with PIP implants (10%) a breast carcinoma was diagnosed (mucinous carcinoma, n=1; invasive ductal carcinoma, n=1). In 4/46 patients (9%) with non-PIP implants, an invasive ductal carcinoma was diagnosed. The rupture rate of PIP breast implants is significantly higher than non-PIP (50% vs 14%). MRI represents the most accurate imaging tool for evaluating breast prostheses and the linguine sign is the most common MRI sign to be searched. The incidence of breast carcinoma does not significantly differ between the PIP and non-PIP implants and a direct correlation with breast cancer can not been demonstrated.

The socially constructed breast: breast implants and the medical construction of need.

PubMed Central

Jacobson, N

1998-01-01

When silicone gel breast implants became the subject of a public health controversy in the early 1990s, the most pressing concern was safety. This paper looks at another, less publicized issue: the need for implants. Using a symbolic interactionist approach, the author explores the social construction of the need for implants by tracing the history of the 3 surgical procedures for which implants were used. Stakeholders in this history constructed need as legitimized individual desire, the form of which shifted with changes in the technological and social context. PMID:9702166

PIP breast implant removal: a study of 828 cases.

PubMed

Oulharj, S; Pauchot, J; Tropet, Y

2014-03-01

In March, 2010, the French Health Products Safety Agency suspended the sale of prefilled silicone breast implants manufactured by Poly Implants Prosthèse Prothese (PIP) because of a high failure rate and the use of an inappropriate silicone gel that did not comply with CE marking. These findings led to an international medical crisis. In France, 30,000 female patients had PIP implants. In our Department, 1150 PIP breast implants had been implanted in 630 patients since 2001. A retrospective study was conducted to define the rupture rate of these implants and the complications that arise. The women included in the study underwent implant removal from May 2010 to September 2012 for preventive or curative reasons. Data were collected from medical records that included: results of clinical examination, breast ultrasound before removal, rates of implant rupture, results of biopsy of periprosthetic capsule and pericapsule tissue and postoperative complications. A total of 828 PIP breast implants were removed in 455 patients. The rate of ruptured implants was 7.73% (64/828), corresponding to 11.6% of patients. A periprosthetic effusion was associated with rupture in 44% of cases. Breast ultrasound indicated a rupture for 87 implants; 32% were true positives and 3% were false negatives. Periprosthetic capsule biopsy demonstrated the presence of a foreign body, which seemed to be silicone, in 26% of cases and the presence of inflammation in 13% of cases. No siliconoma-type lesion was identified in the pericapsular tissue at biopsy. A total of 14 implants presented perspiration at removal. A statistically significant difference was found between the rates of rupture for texturised implants as compared to the smooth-surfaced implants. There were eight post-revisional-surgery complications (1%) and three cases of breast adenocarcinoma. The preventive explantation of PIP breast implants is justified given the high failure rate (7.73%) and given patients' exposure to silicone gel that did not comply with CE standards in the absence of rupture, through the early perspiration of implants. Copyright © 2013 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Prospective Analysis of Primary Breast Augmentation on Body Image Using the BREAST-Q: Results from a Nationwide Study

PubMed Central

Pusic, Andrea; Murphy, Diane K.

2016-01-01

Background: The Breast Implant Follow-up Study is a large, ongoing observational study of women who received Natrelle round silicone-filled or saline-filled breast implants. This analysis describes patient-reported outcomes in the cohort who underwent breast augmentation. Methods: Subjects prospectively completed two validated scales of the BREAST-Q (satisfaction with breasts and psychosocial well-being) preoperatively and at 1 and 4 years postoperatively. Effect size and z tests were used to compare differences between preoperative versus postoperative scores; multivariate mixed models were used to compare differences in scores between silicone-filled and saline-filled implants. Results: Of 17,899 subjects completing the BREAST-Q preoperatively, 14,514 (81.1 percent) completed the postoperative questionnaire (12,726 received silicone-filled implants and 1788 received saline-filled implants). Overall, satisfaction with breasts and psychosocial well-being increased significantly at postoperative year 1 (p < 0.0001 for both), and the improvement was sustained at year 4 (p < 0.0001 for both). Large effect sizes were observed for satisfaction with breasts (2.0 at year 1; 1.8 at year 4) and psychosocial well-being (1.2 at year 1; 1.0 at year 4). In the multivariate model, silicone-filled implants were associated with significantly greater improvement compared with saline-filled implants for satisfaction with breasts and psychosocial well-being at year 1 (p < 0.0001 for both) and year 4 (p < 0.0001 and p < 0.0019, respectively). Conclusions: Breast implants are effective in improving women’s quality of life. The authors found significant and sustained improvements in satisfaction and psychosocial well-being in women undergoing breast augmentation with Natrelle silicone-filled or saline-filled implants. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV. PMID:27219264

Enhancing surface properties of breast implants by using electrospun silk fibroin.

PubMed

Valencia-Lazcano, A A; Román-Doval, R; De La Cruz-Burelo, E; Millán-Casarrubias, E J; Rodríguez-Ortega, A

2017-08-24

In the present study, a new electrospun silk fibroin coating of silicone breast implants with improved biocompatibility and mechanical properties was obtained. Fibrous scaffolds were produced by electrospinning a solution containing silk fibroin, derived from Bombyx mori cocoons, and polyethylene oxide (PEO) to be used as a coating of breast implants. A randomly oriented structure of fibroin/PEO was electrospun on implants as assessed by SEM analysis, roughness measurements and ATR-FTIR spectroscopy. The scaffold showed 0.25 µm diameter fibres, 0.76 µm size superficial pores, arithmetic roughness of 0.632 ± 0.12 µm and texture aspect ratio of 0.893 ± 0.04. ATR-FTIR spectroscopy demonstrates the presence of PEO and fibroin in the coating. The mechanical characterisation of the implants before and after being coated with fibroin/PEO demonstrated that the fibroin/PEO scaffold contributes to the increase in the elastic modulus from 0.392 ± 0.02 to 0.560 ± 0.03 MPa and to a more elastic behaviour of the breast implants. Using the fibroin/PEO coating, human fibroblasts seeded on this matrix increased viability up to 30% compared to conventional breast implants. Electrospun silk fibroin could represent a clinically compatible, viable form to coat breast implants. Low cytotoxicity by the fibroin coating and its physico-chemical and mechanical properties may find application in improving breast implants biocompatibility. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2017. © 2017 Wiley Periodicals, Inc.

The effect of silicone implants on the diagnosis, prognosis, and treatment of breast cancer.

PubMed

Handel, Neal

2007-12-01

Because of the prevalence of breast cancer, many augmented women eventually will develop the disease. This article reviews what is known about the effect of implants on the detection, prognosis, and treatment of carcinoma of the breast. Observations were made on 4082 breast cancer patients (3953 nonaugmented and 129 augmented) treated over a 23-year time span. Findings in the two groups were compared and differences analyzed statistically. Mammograms of all women with palpable lesions were reviewed to assess mammographic sensitivity in patients with and without implants. Cosmetic outcomes in augmented patients treated with breast conservation therapy were reviewed. Augmented patients presented more frequently with palpable lesions, invasive tumors, axillary nodal metastases, and false-negative mammograms. However, there was no significant difference in stage of disease, tumor size, recurrence rates, or survival between the two groups. Augmented patients treated with breast conservation therapy often experienced poor cosmetic results and frequently required reoperation. Despite the diminished sensitivity of mammography in women with implants, augmented and nonaugmented patients are diagnosed at a similar stage of disease and have a comparable prognosis. Implants may impair mammography but appear to facilitate tumor detection on physical examination. Magnetic resonance imaging and breast ultrasound may be useful adjuncts, but conventional mammography remains the most reliable tool for diagnosing early breast cancer in augmented patients. Breast implants do not interfere with mastectomy or breast reconstruction but may compromise the outcome of breast conservation therapy.

Do textured breast implants decrease the rate of capsular contracture compared to smooth implants?

PubMed

Cifuentes, Ignacio; Dagnino, Bruno; Rada, Gabriel

2017-08-31

The use of breast implants for aesthetic and reconstructive purposes has become one of the most common procedures performed by plastic surgeons. Several breast implants models exist. They differ in their size, filling, shape and characteristic of the shell, which can be smooth or textured. Capsular contracture is one of the main complications of breast implants. It has been suggested that the use of textured implants could reduce the incidence of capsular contracture. To answer this question, we used Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others. We identified 15 studies overall, of which 13 were randomized trials relevant for the question of interest. We extracted data from the systematic reviews, reanalyzed data of primary studies, conducted a meta-analysis and generated a summary of findings table using the GRADE approach. We concluded the use of textured breast implants probably decreases the risk of capsular contracture, however, they might be associated to an increased risk of anaplastic large cell lymphoma.

Patient satisfaction with postmastectomy breast reconstruction: a comparison of saline and silicone implants.

PubMed

McCarthy, Colleen M; Klassen, Anne F; Cano, Stefan J; Scott, Amie; Vanlaeken, Nancy; Lennox, Peter A; Alderman, Amy K; Mehrara, Babak J; Disa, Joseph J; Cordeiro, Peter G; Pusic, Andrea L

2010-12-15

At a time when the safety and effectiveness of breast implants remains under close scrutiny, it is important to provide reliable and valid evidence regarding patient outcomes. In the setting of postmastectomy reconstruction, patient satisfaction and quality of life may be the most significant outcome variables when evaluating surgical success. The objective of the current study was to identify predictors of patient satisfaction with breast appearance, including implant type, in a large sample of women who underwent breast reconstruction surgery using implants. A multicenter, cross-sectional study design was used. A total of 672 women who had completed postmastectomy, implant-based reconstruction at 1 of 3 centers in North America were asked to complete the BREAST-Q (Reconstruction Module). Multivariate linear regression modeling was performed. Completed questionnaire data were available for 482 of the 672 patients. In 176 women, silicone implants were placed and in 306, saline implants were used. The multivariate model confirmed that patients' satisfaction with their breasts was significantly higher in patients with silicone implants (P = .016). The receipt of postmastectomy radiotherapy was found to have a significant, negative effect on breast satisfaction (P<.000) in both silicone and saline implant recipients. In addition, for women who received either silicone or saline implants, satisfaction diminished over time (P = .017). In the setting of postmastectomy reconstruction, patients who received silicone breast implants reported significantly higher satisfaction with the results of reconstruction than those who received saline implants. This information can be used to optimize shared medical decision-making by providing patients with realistic postoperative expectations. Copyright © 2010 American Cancer Society.

Anaplastic large cell lymphoma and breast implants: five Australian cases.

PubMed

Taylor, Kim O; Webster, Howard R; Prince, H Miles

2012-04-01

There has never been a convincing association between breast implants and breast malignancy. A total of 42 cases of non-Hodgkin's lymphoma of the breast associated with implant capsules have been reported. The majority of the patients have anaplastic large cell lymphoma of T-cell origin. These lymphoma types have less frequently been observed in women without implants. The senior author (H.R.W.) diagnosed and treated two women with anaplastic large cell lymphoma in a short period of time. After this, the authors were contacted by other surgeons in Australia who had treated similar cases. The authors report five new cases of anaplastic large cell lymphoma associated with breast implants. There is an apparent spectrum of disease, with some cases pursuing an aggressive clinical course, although most have experienced a good prognosis. Both saline and silicone implants are implicated. All implant shells were textured. Textured surface implants only became widely used in the 1990s and therefore were not significantly represented in the large cohort studies of breast implant safety undertaken in the early 1990s. The diagnosis of anaplastic large cell lymphoma in the breast needs to be considered in patients, particularly those presenting with a periprosthetic seroma 6 months or more after breast implant insertion. Risk, V.

ALK-1-negative anaplastic large cell lymphoma associated with breast implants: a new clinical entity.

PubMed

Lazzeri, Davide; Agostini, Tommaso; Bocci, Guido; Giannotti, Giordano; Fanelli, Giovanni; Naccarato, Antonio Giuseppe; Danesi, Romano; Tuccori, Marco; Pantaloni, Marcello; D'Aniello, Carlo

2011-10-01

Concerns have been raised recently regarding the increasing number of reports of non-Hodgkin lymphoma (NHL) that developed in close proximity to silicone or saline breast implants. In particular, an increased risk of anaplastic large cell lymphoma (ALCL) in patients with breast prostheses has been proposed. We reviewed clinical and pathologic findings in 40 women who received a diagnosis of breast NHL arising in association with breast implants and of 27 patients who had a diagnosis of ALCL with breast involvement reported in the published literature. Among the 40 reported cases of prosthesis-associated breast lymphomas, 28 were anaplastic lymphoma kinase-1-negative (ALK-1(-)) ALCLs, whereas of 27 ALCLs in patients without implants found in the literature, only 10 were ALK-1(-). The finding of 28 cases of breast ALK-1(-) ALCL occurring in patients with implants compared with 10 cases in women without implants is in favor of an association between silicone breast prostheses and ALK-1(-) ALCL. Although the incidence of this type of lymphoma remains remarkably low given that breast prostheses have been widely used for decades, clinical and pathologic evidence for a causative role is becoming dramatically strong. The histologic, phenomenologic, and clinical similarities of the majority of implant-related ALK-1(-) ALCLs suggest a common mechanism, especially when compared with the counterpart of patients without implants in which very few and highly dishomogeneous cases of the same malignancy were detected. There is convincing evidence that primary implant-related ALK-1(-) ALCL represents a distinct clinicopathologic entity that has been inappropriately fitted into the category of systemic ALK-1(-) ALCL. Thus it should be recognized as a separate category and classified on its own. Copyright © 2011 Elsevier Inc. All rights reserved.

Cancer risk among Danish women with cosmetic breast implants.

PubMed

Friis, Søren; Hölmich, Lisbet R; McLaughlin, Joseph K; Kjøller, Kim; Fryzek, Jon P; Henriksen, Trine F; Olsen, Jørgen H

2006-02-15

The available epidemiologic evidence does not support a carcinogenic effect of silicone breast implants on breast or other cancers. Data on cancer risk other than breast cancer are limited and few studies have assessed cancer risk beyond 10-15 years after breast implantation. We extended follow-up of our earlier cohort study of Danish women with cosmetic breast implants by 7 years, yielding 30 years of follow-up for women with longest implant duration. The study population consisted of women who underwent cosmetic breast implant surgery at private clinics of plastic surgery (n = 1,653) or public hospitals (n = 1,110), and a control group of women who attended private clinics for other plastic surgery (n = 1,736), between 1973-95. Cancer incidence through 2002 was ascertained using the Danish Cancer Registry. Risk evaluation was based on computation of standardized incidence ratios (SIR) and Cox proportional hazards models, adjusting for age, calendar period and reproductive history. We observed 163 cancers among women with breast implants compared to 136.7 expected based on general population rates (SIR = 1.2; 95% confidence interval [CI] = 1.0-1.4), during a mean follow-up period of 14.4 years (range = 0-30 years). Women with breast implants experienced a reduced risk of breast cancer (SIR = 0.7; 95% CI = 0.5-1.0), and an increased risk of non-melanoma skin cancer (SIR = 2.1; 95% CI = 1.5-2.7). Stratification by age at implantation, calendar year at implantation and time since implantation showed no clear trends, however, the statistical precision was limited in these analyses. When excluding non-melanoma skin cancer, the SIR for cancer overall was 1.0 (95% CI = 0.8-1.2). With respect to other site-specific cancers, no significantly increased or decreased SIR were observed. Similar results were found when directly comparing women who had implants at private clinics with women who attended private clinics for other plastic surgery, with rate ratios for cancer overall, breast cancer and non-melanoma skin cancer of 1.1 (95% CI = 0.8-1.6), 0.7 (95% CI = 0.4-1.3) and 1.5 (95% CI = 0.8-2.7), respectively. In conclusion, our study lends further support to the accumulating evidence that silicone breast implants are not carcinogenic. Reasons for the consistently reported deficit of breast cancer among women with breast implants remain unclear, whereas increased exposure to sunlight may explain the excess occurrence of non-melanoma skin cancer. We found no indication of delayed diagnosis of breast cancer due to the presence of breast implants.

The clinical implications of poly implant prothèse breast implants: an overview.

PubMed

Wazir, Umar; Kasem, Abdul; Mokbel, Kefah

2015-01-01

Mammary implants marketed by Poly Implant Prothèse (PIP) were found to contain industrial grade silicone and this caused heightened anxiety and extensive publicity regarding their safety in humans. These implants were used in a large number of patients worldwide for augmentation or breast reconstruction. We reviewed articles identified by searches of Medline, PubMed, Embase, and Google Scholar databases up to May 2014 using the terms: "PIP", "Poly Implant Prothèse", "breast implants" and "augmentation mammoplasty" "siloxanes" or "silicone". In addition the websites of regulating bodies in Europe, USA, and Australia were searched for reports related to PIP mammary implants. PIP mammary implants are more likely to rupture than other implants and can cause adverse effects in the short to the medium term related to the symptoms of rupture such as pain, lumps in the breast and axilla and anxiety. Based on peer-reviewed published studies we have calculated an overall rupture rate of 14.5% (383/2,635) for PIP implants. However, there is no evidence that PIP implant rupture causes long-term adverse health effects in humans so far. Silicone lymphadenopathy represents a foreign body reaction and should be treated conservatively. The long-term adverse effects usually arise from inappropriate extensive surgery, such as axillary lymph node dissection or extensive resection of breast tissue due to silicone leakage.

Public health implications of differences in U.S. and European Union regulatory policies for breast implants.

PubMed

Zuckerman, Diana; Booker, Nyedra; Nagda, Sonia

2012-12-01

The recall of tens of thousands of defective breast implants in Europe in 2011-12 as well as new data on risks have raised questions about regulatory standards for these and other medical implants in the United States (U.S.) and European Union (EU). In the U.S., breast implants are regulated as high-risk medical devices that must be proven reasonably safe and effective in clinical trials and subject to government inspection before they can be sold. In contrast, clinical trials and inspections have not been required for breast implants or other implanted devices in the EU; approval is based on other information. As a result of these differing standards, the PIP breast implants that were recalled across Europe had been removed from the market years earlier in the U.S. than in the EU, a decision U.S. government health agencies can point to with pride. Nevertheless, the FDA track record on post-marketing breast implant research indicates poorly implemented studies and little meaningful enforcement to ensure that studies have been conducted correctly or findings reported accurately or acted upon. In sum, neither the EU nor the US has used their regulatory authority to ensure the long-term safety of breast implants. However, in 2012 the EU announced regulatory changes that could improve that situation. Copyright © 2012 Reproductive Health Matters. Published by Elsevier Ltd. All rights reserved.

The evolution of FDA policy on silicone breast implants: a case study of politics, bureaucracy, and business in the process of decision-making.

PubMed

Palley, H A

1995-01-01

The central issue facing federal regulation of breast implants is that while such devices are not functionally necessary or needed for survival, the side effects may be harmful and have not been proven unharmful. The Medical Device Amendments of 1976 appear to require such evidence prior to the FDA permitting the unrestricted marketing of these devices. However, only recently have such requirements been imposed by the FDA. The author examines the FDA's decision-making process, particularly as applied to silicone breast implants, and the factors that appears to have affected such decisions. In pursuing this study, the activities of a number of interest-group actors, as well as congressional responses and the role of federal bureaucratic actors, were examined. In 1992, the FDA established a regulatory protocol that effectively withdrew most silicone breast implants from the market for the purpose of breast augmentation and allows for the monitoring of the impact of new implants on women's health. This increase concern for determining the safety of breast implants is due to a number of factors, which are examined in this article.

Mammograms

MedlinePlus

... mammography facility know about breast implants when scheduling a mammogram. The technologist and radiologist must be experienced in performing mammography on women who have breast implants. If the technologist ...

The natural history of Becker expandable breast implants: a single-center 10-year experience.

PubMed

Sindali, Katia; Davis, Marcus; Mughal, Maleeha; Orkar, Kusu S

2013-09-01

Use of Becker expandable breast implants in single-stage breast surgery is a well-established technique; however, replacement with fixed-volume implants is common. The authors sought to analyze the long-term natural history of these implants over a wide range of surgical indications. A retrospective review of 330 consecutive patients who underwent 384 Becker expander breast reconstructions over a 10-year period in a dedicated plastic surgery unit was undertaken. Implant indication, Becker type, volume and site, complications, expander lifespan, and explant reasons were assessed. Two hundred twenty-eight patients (267 implants) and 102 patients (117 implants) underwent implantation for congenital deformities and breast cancer reconstruction, respectively. One hundred eighty-seven (48 percent) were explanted at a median period of 13.0 months (range, 9.0 to 26.0 months), 149 (39 percent) for aesthetic reasons and 38 (10 percent) for complications. Complication rates were higher in breast cancer reconstruction compared with congenital patients (19.6 percent versus 7.9 percent; p = 0.002), driven by an increased rate of wound complications (13.7 percent versus 4.4 percent; p = 0.003). Cancer-related surgery and advancing age were the only predictors of complication risk. The overall Becker expander retention rate was 24.9 percent and 46.8 percent at 150 months in the cancer reconstruction and congenital groups, respectively. Forty-seven percent of Becker implants were retained long term after congenital corrective surgery; only 25 percent were retained after postmastectomy reconstruction. Poor aesthetics was driving the exchange for fixed-volume implants, indicating that after breast cancer reconstruction, Becker expanders were being used as part of a two-stage reconstructive strategy.

Do Breast Implants Influence Breastfeeding? A Meta-Analysis of Comparative Studies.

PubMed

Cheng, Fengrui; Dai, Shuiping; Wang, Chiyi; Zeng, Shaoxue; Chen, Junjie; Cen, Ying

2018-06-01

Aesthetic breast implant augmentation surgery is the most popular plastic surgery worldwide. Many women choose to receive breast implants during their reproductive ages, although the long-term effects are still controversial. Research aim: We conducted a meta-analysis to assess the influence of aesthetic breast augmentation on breastfeeding. We also compared the exclusive breastfeeding rates of periareolar versus inframammary incision. A systematic search for comparative studies about breast implants and breastfeeding was performed in PubMed, MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, ScienceDirect, Scopus, and Web of Science through May 2018. Meta-analysis was conducted with a random-effects model (or fixed effects, if heterogeneity was absent). Four cohorts and one cross-sectional study were included. There was a significant reduction in the exclusive breastfeeding rate for women with breast implants compared with women without implants, pooled relative risk = 0.63, 95% confidence interval [0.46, 0.86], as well as the breastfeeding rate, pooled relative risk = 0.88, 95% confidence interval [0.81, 0.95]. There was no evidence that periareolar incision was associated with a reduction in the exclusive breastfeeding rate, pooled relative risk = 0.84, 95% confidence interval [0.45, 1.58]. Participants with breast implants are less likely to establish breastfeeding, especially exclusive breastfeeding. Periareolar incision does not appear to reduce the exclusive breastfeeding rate.

Lightweight Breast Implants: A Novel Solution for Breast Augmentation and Reconstruction Mammaplasty

PubMed Central

Govrin-Yehudain, Jacky; Dvir, Haim; Preise, Dina; Govrin-Yehudain, Orel; Govreen-Segal, Dael

2015-01-01

Breast augmentation and reconstruction mammaplasty have been in practice for decades and are highly prevalent surgeries performed worldwide. While overall patient satisfaction is high, common long-term effects include breast tissue atrophy, accelerated ptosis and inframammary fold breakdown. Increasing evidence attributes these events to the durative loading and compressive forces introduced by the breast implants. Mechanical challenges exceeding the elastic capacity of the breast tissue components, eventually lead to irreversible tissue stretching, directly proportional to the introduced mass. Thus, it is suggested that, contrary to long-standing dogmas, implant weight, rather than its volume, stands at the basis of future tissue compromise and deformation. A novel lightweight implant has been developed to address the drawbacks of traditional breast implants, which demonstrate equivalence between their size and weight. The B-Lite® breast implant (G&G Biotechnology Ltd., Haifa, Israel) design allows for a reduction in implant weight of up to 30%, while maintaining the size, form, and function of traditional breast implants. The CE-marked device can be effectively implanted using standard of care procedures and has been established safe for human use. Implantation of the B-Lite® breast implant is projected to significantly reduce the inherent strains imposed by standard implants, thereby conserving tissue stability and integrity over time. In summary, this novel, lightweight breast implant promises to reduce breast tissue compromise and deformation and subsequent reoperation, further improving patient safety and satisfaction. PMID:26333989

Intra-prosthetic breast MR virtual navigation: a preliminary study for a new evaluation of silicone breast implants.

PubMed

Moschetta, Marco; Telegrafo, Michele; Capuano, Giulia; Rella, Leonarda; Scardapane, Arnaldo; Angelelli, Giuseppe; Stabile Ianora, Amato Antonio

2013-10-01

To assess the contribute of intra-prosthetic MRI virtual navigation for evaluating breast implants and detecting implant ruptures. Forty-five breast implants were evaluated by MR examination. Only patients with a clinical indication were assessed. A 1.5-T device equipped with a 4-channel breast coil was used by performing axial TSE-T2, axial silicone-only, axial silicone suppression and sagittal STIR images. The obtained dicom files were also analyzed by using virtual navigation software. Two blinded radiologists evaluated all MR and virtual images. Eight patients for a total of 13 implants underwent surgical replacement. Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) were calculated for both imaging strategies. Intra-capsular rupture was diagnosed in 13 out of 45 (29%) implants by using MRI. Basing on virtual navigation, 9 (20%) cases of intra-capsular rupture were diagnosed. Sensitivity, specificity, accuracy, PPV and NPV values of 100%, 86%, 89%, 62% and 100%, respectively, were found for MRI. Virtual navigation increased the previous values up to 100%, 97%, 98%, 89% and 100%. Intra-prosthetic breast MR virtual navigation can represent an additional promising tool for the evaluation of breast implants being able to reduce false positives and to provide a more accurate detection of intra-capsular implant rupture signs. Copyright © 2013 Elsevier Inc. All rights reserved.

Breast implants and anaplastic large-cell lymphoma: a danish population-based cohort study.

PubMed

Vase, Maja Ølholm; Friis, Søren; Bautz, Andrea; Bendix, Knud; Sørensen, Henrik Toft; d'Amore, Francesco

2013-11-01

A potential link between breast implants and anaplastic large-cell lymphoma (ALCL) has been suggested. We examined lymphoma occurrence in a nationwide cohort of 19,885 Danish women who underwent breast implant surgery during 1973-2010. Standardized incidence ratios (SIR), with 95% confidence intervals (CI), for ALCL and lymphoma overall associated with breast implantation were calculated. During 179,246 person-years of follow-up, we observed 31 cases of lymphoma among cohort members. No cases of ALCL were identified. SIRs for ALCL and lymphoma overall were zero (95% CI, 0-10.3) and 1.20 (95% CI, 0.82-1.70), respectively. In our nationwide cohort study, we did not find an increased risk of lymphoma in general, or ALCL in particular, among Danish women who underwent breast implantation. However, our evaluation of ALCL risk was limited by the rarity of the disease. Our results do not support an association between breast implants and ALCL and are consistent with other studies on cancer risk and breast implants. ©2013 AACR.

Risk of lymphoma in women with breast implants: analysis of clinical studies.

PubMed

Largent, Joan; Oefelein, Michael; Kaplan, Hilton M; Okerson, Ted; Boyle, Peter

2012-05-01

Large studies suggest that the overall rate of lymphoma in women with breast implants is no greater than in the general population; clinical reports suggest an association between breast implants and the rare non-Hodgkin lymphoma, anaplastic large cell lymphoma (ALCL). Observed cases of lymphoma reported in Allergan-sponsored breast implant clinical studies were compared with expected cases on the basis of the incidence of lymphoma among women in the National Cancer Institute's Surveillance Epidemiology and End Results program, using standardized incidence ratios (SIRs) and 95% confidence intervals (CIs). In clinical studies, there were 28 observed cases of lymphoma among 89 382 patients and 204 682 person-years of follow-up compared with 43 expected cases [SIR: 28/43=0.65 (95% CI: 0.43-0.94), P=0.02]. SIRs were calculated stratifying by baseline cancer history: women without prior cancer [SIR: 17/24=0.70 (95% CI: 0.41-1.13), P=0.17] and women with prior cancer [SIR: 11/14=0.79 (95% CI: 0.39-1.41), P=0.52]. SIRs were calculated by implant shell type: textured shell implants [SIR: 16/23=0.70 (95% CI: 0.40-1.13), P=0.16] and smooth shell implants [SIR: 12/19=0.63 (95% CI: 0.33-1.10), P=0.12]. Surveillance Epidemiology and End Results reported 12 cases of primary breast ALCL in women between 1996 and 2007 without a history of cancer, for an average annual incidence of 4.28 (95% CI: 3.51-5.05)/100 million women in the US - these women may or may not have breast implants. In clinical studies, three ALCL cases were reported in women with breast implants and a history of breast cancer, yielding a crude incidence rate of 1.46 (95% CI: 0.30-4.3)/100 000 person-years. Large clinical studies, based on over 200 000 person-years of follow-up, suggest no evidence of an increased risk of lymphoma among women who have received breast implants.

The Clinical Implications of Poly Implant Prothèse Breast Implants: An Overview

PubMed Central

Wazir, Umar; Kasem, Abdul

2015-01-01

Mammary implants marketed by Poly Implant Prothèse (PIP) were found to contain industrial grade silicone and this caused heightened anxiety and extensive publicity regarding their safety in humans. These implants were used in a large number of patients worldwide for augmentation or breast reconstruction. We reviewed articles identified by searches of Medline, PubMed, Embase, and Google Scholar databases up to May 2014 using the terms: "PIP", "Poly Implant Prothèse", "breast implants" and "augmentation mammoplasty" "siloxanes" or "silicone". In addition the websites of regulating bodies in Europe, USA, and Australia were searched for reports related to PIP mammary implants. PIP mammary implants are more likely to rupture than other implants and can cause adverse effects in the short to the medium term related to the symptoms of rupture such as pain, lumps in the breast and axilla and anxiety. Based on peer-reviewed published studies we have calculated an overall rupture rate of 14.5% (383/2,635) for PIP implants. However, there is no evidence that PIP implant rupture causes long-term adverse health effects in humans so far. Silicone lymphadenopathy represents a foreign body reaction and should be treated conservatively. The long-term adverse effects usually arise from inappropriate extensive surgery, such as axillary lymph node dissection or extensive resection of breast tissue due to silicone leakage. PMID:25606483

The Subfascial Approach to Primary and Secondary Breast Augmentation with Autologous Fat Grafting and Form-Stable Implants.

PubMed

Sampaio Goes, João Carlos; Munhoz, Alexandre Mendonça; Gemperli, Rolf

2015-10-01

This article presents an overview of the subfascial approach to primary and secondary breast augmentation with form-stable implants associated with autologous fat grafting. Although breast augmentation is a well-studied procedure, there are few previous reports concerning the subfascial technique and, especially, this technique associated with lipofilling. Consequently, the authors present their experience with a form-stable, anatomically shaped silicone gel breast implant, which has recently been approved in the United States following FDA clinical trials. Primary and secondary breast augmentations using form-stable implants resulted in satisfactory outcomes. Copyright © 2015 Elsevier Inc. All rights reserved.

Transition from Round to Shaped Implants in Immediate Breast Reconstruction: Our Preferred Approach and Clinical Outcomes.

PubMed

Imahiyerobo, Thomas A; Small, Kevin H; Sackeyfio, Robyn; Hoffman, Hannah; Talmor, Mia

2017-04-01

Smooth, round, silicone implants predominate device-based breast reconstruction in the USA; despite their prevalence, complications can include bottoming out, superior contour deformity, rippling, and/or lateral malposition. This complication profile increases the need for revision surgery and subsequent patient dissatisfaction. With the resurgence of shaped, textured, silicone implants in the USA, we report the senior author's success with these devices and outline a strategy to optimize outcomes in breast reconstruction surgery. A retrospective chart review was conducted on a prospectively collected IRB-approved database of nipple-sparing mastectomies (NSMs) with immediate breast reconstruction with smooth, round, silicone implants (Group A) in 2011 in comparison to textured, shaped, silicone implants (Group B) in 2012. Changes in operative technique were highlighted and extrapolated. Outcomes were reviewed. In Group A, 128 NSMs were performed in 76 patients. In Group B, 109 NSMs were performed in 59 patients. Thirteen percent of patients in Group A had direct to implant reconstruction as compared with 21% in Group B. Patients with textured, shaped implants were more likely to have acellular dermal matrix (61 vs 34%, p < 0.0001) than those with smooth, round implants. Patients who had smooth, round implants were more likely to have postoperative nipple malposition (18 vs 0%, p < 0.0001,) and rippling (29 vs 0%, p < 0.0001.) Patients with textured, shaped implants had fewer operative revision reconstructions as compared with those with smooth, round implants (36.71 vs 12.8%, p < 0.0001) Based on these results, our technique has evolved and has eight key technical modifications. With a few adaptations in surgical technique, the transition to textured, shaped, silicone devices for breast reconstruction can be seamless with superior breast contour and reduced complications/revision rates. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

A Retrospective Analysis of Ruptured Breast Implants

PubMed Central

Baek, Woo Yeol; Lew, Dae Hyun

2014-01-01

Background Rupture is an important complication of breast implants. Before cohesive gel silicone implants, rupture rates of both saline and silicone breast implants were over 10%. Through an analysis of ruptured implants, we can determine the various factors related to ruptured implants. Methods We performed a retrospective review of 72 implants that were removed for implant rupture between 2005 and 2014 at a single institution. The following data were collected: type of implants (saline or silicone), duration of implantation, type of implant shell, degree of capsular contracture, associated symptoms, cause of rupture, diagnostic tools, and management. Results Forty-five Saline implants and 27 silicone implants were used. Rupture was diagnosed at a mean of 5.6 and 12 years after insertion of saline and silicone implants, respectively. There was no association between shell type and risk of rupture. Spontaneous was the most common reason for the rupture. Rupture management was implant change (39 case), microfat graft (2 case), removal only (14 case), and follow-up loss (17 case). Conclusions Saline implants have a shorter average duration of rupture, but diagnosis is easier and safer, leading to fewer complications. Previous-generation silicone implants required frequent follow-up observation, and it is recommended that they be changed to a cohesive gel implant before hidden rupture occurs. PMID:25396188

[Radiological trap and oncological precautions in a patient who has undergone a permanent withdrawal of PIP breast implants].

PubMed

Koutsomanis, A; Bruant-Rodier, C; Roedlich, M-N; Bretz-Grenier, M-F; Perrot, P; Bodin, F

2015-12-01

We report the case of a 57-year-old patient who presented radiological images similar to ruptured breast implants one year after the supposed withdrawal of the latter. This woman had benefited for the first time from cosmetic PIP breast implants in 2000. Early in 2014, she requested the removal of the implants without renewal because she was feeling pain and functional discomfort. A few months after the operation, she consulted for breast swelling in the upper pole of the breast. Radiological assessment showed liquid formations compatible with the presence of implants. At our request, the rereading of the MRI by the radiologist definitively concluded on a bilateral seroma within the persistent fibrous capsule. In the absence of symptoms, clinical monitoring had been decided. But at the recrudescence of anaplastic large cell lymphoma cases associated with breast implants, a cytological sampling was intended. In case of cytological abnormality or recurrence of the seroma, a surgical procedure should be performed. In conclusion, the removal of a breast implant without capsulectomy may result in the formation of a seroma whose images resemble those of an implant. It is always worthwhile to provide precise clinical data to the radiologist in order to help him to make informed interpretations. Every serous effusion in a breast lodge having contained a silicone implant must evoke the diagnosis of anaplastic large cell lymphoma. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Immediate direct-to-implant breast reconstruction using anatomical implants.

PubMed

Kim, Sung-Eun; Jung, Dong-Woo; Chung, Kyu-Jin; Lee, Jun Ho; Kim, Tae Gon; Kim, Yong-Ha; Lee, Soo Jung; Kang, Su Hwan; Choi, Jung Eun

2014-09-01

In 2012, a new anatomic breast implant of form-stable silicone gel was introduced onto the Korean market. The intended use of this implant is in the area of aesthetic breast surgery, and many reports are promising. Thus far, however, there have been no reports on the use of this implant for breast reconstruction in Korea. We used this breast implant in breast reconstruction surgery and report our early experience. From November 2012 to April 2013, the Natrelle Style 410 form-stable anatomically shaped cohesive silicone gel-filled breast implant was used in 31 breasts of 30 patients for implant breast reconstruction with an acellular dermal matrix. Patients were treated with skin-sparing mastectomies followed by immediate breast reconstruction. The mean breast resection volume was 240 mL (range, 83-540 mL). The mean size of the breast implants was 217 mL (range, 125-395 mL). Breast shape outcomes were considered acceptable. Infection and skin thinning occurred in one patient each, and hematoma and seroma did not occur. Three cases of wound dehiscence occurred, one requiring surgical intervention, while the others healed with conservative treatment in one month. Rippling did not occur. So far, complications such as capsular contracture and malrotation of breast implant have not yet arisen. By using anatomic breast implants in breast reconstruction, we achieved satisfactory results with aesthetics better than those obtained with round breast implants. Therefore, we concluded that the anatomical implant is suitable for breast reconstruction.

Recall management of patients with Rofil Medical breast implants.

PubMed

Schott, Sarah; Bruckner, Thomas; Golatta, Michael; Wallwiener, Markus; Küffner, Livia; Mayer, Christine; Paringer, Carmen; Domschke, Christoph; Blumenstein, Maria; Schütz, Florian; Sohn, Christof; Heil, Joerg

2014-07-01

Some Rofil Medical breast implants are relabelled Poly Implant Prothèse (PIP) implants, and it is recommended that Rofil implants be managed in the same way as PIP implants. We report the results of a systematic recall of patients who had received Rofil implants. All patients who received Rofil implants at our centre were identified and invited for specialist consultation. In patients who opted for explantation, preoperative and intraoperative work-up was performed in accordance with national guidelines and analysed. In cases suspicious for rupture, an MRI scan was performed. Two-hundred and twenty-five patients (average age 56; range 28-80) received a total of 321 Rofil implants an average of 5.8 (range 1-11) years previously, 225/321 (70%) implants were used for reconstruction after breast cancer. A total of 43 implants were removed prior to 2011, mainly due to capsular contracture (CC). A total of 188 patients were still affected at the time of recall. Of the 188 patients, 115 (61%) attended for specialist consultation, of which 50 (44%) requested immediate implant removal. To date, 72 of 115 (63%) women attending consultation (38% of all affected) have chosen explantation, 66 of 72 (92%) opting for new implants. Of the 108 explanted implants, 25 (23%) had capsular rupture and 57 (53%) had implant bleeding. Preoperative clinical assessment was unreliable for predicting CC or rupture. The majority of patients attended for consultation and requested explantation. The quality of the explanted Rofil implants was comparable to PIP implants, with a higher rupture prevalence compared with other, non-affected implants. Nevertheless, the acceptance of breast implants for reimplantation remained high. Copyright © 2014 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Complex radial folds versus subtle signs of intracapsular rupture of breast implants: MR findings with surgical correlation.

PubMed

Soo, M S; Kornguth, P J; Walsh, R; Elenberger, C D; Georgiade, G S

1996-06-01

Detection of intracapsular rupture of silicone breast prostheses using MR imaging is often performed by identifying the "linguine sign" [1]. The linguine sign is easily differentiated from simple radial folds that are seen in intact implants. However, more subtle signs of intracapsular rupture, including undulating subcapsular lines and the "teardrop sign," are less often recognized [2-5] and may prove difficult for the less experienced radiologist to differentiate from complex radial folds of intact implants. In this essay, we illustrate the MR imaging findings of complex radial folds in intact implants and compare them with findings of incomplete shell collapse in ruptured implants in a surgically confirmed series of explanted silicone breast prostheses.

Evaluation of Aesthetic and Quality-of-Life Results after Immediate Breast Reconstruction with Definitive Form-Stable Anatomical Implants.

PubMed

Kuroda, Flavia; Urban, Cicero; Zucca-Matthes, Gustavo; de Oliveira, Vilmar Marques; Arana, Gabriel Hubner; Iera, Marco; Rietjens, Mario; Santos, Gabriela; Spagnol, Caroline; de Lima, Rubens Silveira

2016-02-01

Although there are many reports on different techniques in breast reconstruction, there are few data regarding immediate breast reconstruction with definitive form-stable anatomical implants in terms of aesthetics and quality-of-life outcomes. Ninety-four patients underwent mastectomy with immediate breast reconstruction using anatomical implants and contralateral symmetrization. Aesthetic results were evaluated by three different methods: the patient's self-report, the assessment of four independent specialists (two breast surgeons and two plastic surgeons from different institutions), and the BCCT.core software. Quality of life was evaluated by means of the BREAST-Q instrument. Average age ± SD was 52.1 ± 11.6 years. Most of patients had medium size breasts and T1 tumors. Patients had evaluated their aesthetic results better than did software and specialists. There was no significant difference in the comparison between software and specialist's evaluation. Multifactorial analysis showed that age older than 70 years and radiotherapy were significant risk factors for poor aesthetic outcomes after immediate breast reconstruction with implants. Considering quality of life, most of the patients were satisfied with their outcome and psychosocial and sexual well-being. Immediate breast reconstruction with implants and contralateral symmetrization had a positive impact on the quality of life and showed satisfactory outcomes when evaluated by subjective and objective methods.

The impact of cosmetic breast implants on breastfeeding: a systematic review and meta-analysis

PubMed Central

2014-01-01

Background Cosmetic breast augmentation (breast implants) is one of the most common plastic surgery procedures worldwide and uptake in high income countries has increased in the last two decades. Women need information about all associated outcomes in order to make an informed decision regarding whether to undergo cosmetic breast surgery. We conducted a systematic review to assess breastfeeding outcomes among women with breast implants compared to women without. Methods A systematic literature search of Medline, Pubmed, CINAHL and Embase databases was conducted using the earliest inclusive dates through December 2013. Eligible studies included comparative studies that reported breastfeeding outcomes (any breastfeeding, and among women who breastfed, exclusive breastfeeding) for women with and without breast implants. Pairs of reviewers extracted descriptive data, study quality, and outcomes. Rate ratios (RR) and 95% confidence intervals (CI) were pooled across studies using the random-effects model. The Newcastle-Ottawa scale (NOS) was used to critically appraise study quality, and the National Health and Medical Research Council Level of Evidence Scale to rank the level of the evidence. This systematic review has been registered with the international prospective register of systematic reviews (PROSPERO): CRD42014009074. Results Three small, observational studies met the inclusion criteria. The quality of the studies was fair (NOS 4-6) and the level of evidence was low (III-2 - III-3). There was no significant difference in attempted breastfeeding (one study, RR 0.94, 95% CI 0.76, 1.17). However, among women who breastfed, all three studies reported a reduced likelihood of exclusive breastfeeding amongst women with breast implants with a pooled rate ratio of 0.60 (95% CI 0.40, 0.90). Conclusions This systematic review and meta-analysis suggests that women with breast implants who breastfeed were less likely to exclusively feed their infants with breast milk compared to women without breast implants. PMID:25332722

Comparison of the Explantation Rate of Poly Implant Prothèse, Allergan, and Pérouse Silicone Breast Implants within the First Four Years after Reconstructive Surgery before the Poly Implant Prothèse Alert by the French Regulatory Authority.

PubMed

Leduey, Alexandre; Mazouni, Chafika; Leymarie, Nicolas; Alkhashnam, Heba; Sarfati, Benjamin; Garbay, Jean-Rémi; Gaudin, Amélie; Kolb, Frédéric; Rimareix, Françoise

2015-01-01

Background. In March 2010, ANSM (Agence Nationale de Sécurité du Medicament), the French Medical Regulatory Authority, withdrew Poly Implant Prothèse (PIP) breast implants from the market due to the use of non-medical-grade silicone gel. The aim of this study was to compare the removal rate (and reasons thereof) of breast implants produced by different manufacturers before the ANSM alert. Materials and Methods. From October 2006 to January 2010, 652 women received 944 implants after breast cancer surgery at the Gustave Roussy Comprehensive Cancer Center, Paris (France). The complications and removal rates of the different implant brands used (PIP, Allergan, and Pérouse) were evaluated and compared. Results. PIP implants represented 50.6% of the used implants, Allergan 33.4%, and Pérouse 16%. The main reasons for implant removal were patient dissatisfaction due to aesthetic problems (43.2%), infection (22.2%), and capsular contracture (13.6%). Two years after implantation, 82% of Pérouse implants, 79% of PIP, and 79% of Allergan were still in situ. There was no difference in removal rate among implant brands. Conclusion. Before the ANSM alert concerning the higher rupture rate of PIP breast implants, our implant removal rate did not predict PIP implant failure related to the use of nonapproved silicone gel.

Comparison of the Explantation Rate of Poly Implant Prothèse, Allergan, and Pérouse Silicone Breast Implants within the First Four Years after Reconstructive Surgery before the Poly Implant Prothèse Alert by the French Regulatory Authority

PubMed Central

Leduey, Alexandre; Mazouni, Chafika; Leymarie, Nicolas; Alkhashnam, Heba; Sarfati, Benjamin; Garbay, Jean-Rémi; Gaudin, Amélie; Kolb, Frédéric; Rimareix, Françoise

2015-01-01

Background. In March 2010, ANSM (Agence Nationale de Sécurité du Medicament), the French Medical Regulatory Authority, withdrew Poly Implant Prothèse (PIP) breast implants from the market due to the use of non-medical-grade silicone gel. The aim of this study was to compare the removal rate (and reasons thereof) of breast implants produced by different manufacturers before the ANSM alert. Materials and Methods. From October 2006 to January 2010, 652 women received 944 implants after breast cancer surgery at the Gustave Roussy Comprehensive Cancer Center, Paris (France). The complications and removal rates of the different implant brands used (PIP, Allergan, and Pérouse) were evaluated and compared. Results. PIP implants represented 50.6% of the used implants, Allergan 33.4%, and Pérouse 16%. The main reasons for implant removal were patient dissatisfaction due to aesthetic problems (43.2%), infection (22.2%), and capsular contracture (13.6%). Two years after implantation, 82% of Pérouse implants, 79% of PIP, and 79% of Allergan were still in situ. There was no difference in removal rate among implant brands. Conclusion. Before the ANSM alert concerning the higher rupture rate of PIP breast implants, our implant removal rate did not predict PIP implant failure related to the use of nonapproved silicone gel. PMID:26543648

Long-Term Health Outcomes in Women With Silicone Gel Breast Implants: A Systematic Review.

PubMed

Balk, Ethan M; Earley, Amy; Avendano, Esther A; Raman, Gowri

2016-02-02

Silicone gel breast implants were removed from the U.S. market for cosmetic use in 1992 owing to safety concerns. They were reintroduced in 2006, with a call for improved surveillance of clinical outcomes. To systematically review the literature regarding specific long-term health outcomes in women with silicone gel breast implants, including cancer; connective tissue, rheumatologic, and autoimmune diseases; neurologic diseases; reproductive issues, including lactation; offspring issues; and mental health issues (depression and suicide). MEDLINE, EMBASE, and Ovid Healthstar (inception through 30 June 2015), and the Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews (through the first quarter of 2015). 4 researchers double-screened articles for longitudinal studies that compared women with and without breast implants and reported long-term health outcomes of interest. 4 researchers extracted data on participant and implant characteristics, analytic methods, and results. 32 studies (in 58 publications) met eligibility criteria. Random-effects model meta-analyses of effect sizes were conducted when feasible. For most outcomes, there was at most only a single adequately adjusted study, which usually found no significant associations. There were possible associations with decreased risk for primary breast and endometrial cancers and increased risks for lung cancer, rheumatoid arthritis, Sjögren syndrome, and Raynaud syndrome. Evidence on breast implants and other outcomes either was limited or did not exist. The evidence was most frequently not specific to silicone gel implants, and studies were rarely adequately adjusted for potential confounders. The evidence remains inconclusive about any association between silicone gel implants and long-term health outcomes. Better evidence is needed from existing large studies, which can be reanalyzed to clarify the strength of associations between silicone gel implants and health outcomes. The Plastic Surgery Foundation.

Magnetic resonance imaging of breast implants.

PubMed

Shah, Mala; Tanna, Neil; Margolies, Laurie

2014-12-01

Silicone breast implants have significantly evolved since their introduction half a century ago, yet implant rupture remains a common and expected complication, especially in patients with earlier-generation implants. Magnetic resonance imaging is the primary modality for assessing the integrity of silicone implants and has excellent sensitivity and specificity, and the Food and Drug Administration currently recommends periodic magnetic resonance imaging screening for silent silicone breast implant rupture. Familiarity with the types of silicone implants and potential complications is essential for the radiologist. Signs of intracapsular rupture include the noose, droplet, subcapsular line, and linguine signs. Signs of extracapsular rupture include herniation of silicone with a capsular defect and extruded silicone material. Specific sequences including water and silicone suppression are essential for distinguishing rupture from other pathologies and artifacts. Magnetic resonance imaging provides valuable information about the integrity of silicone implants and associated complications.

Weight Measurement and Volumetric Displacement of Breast Implants and Tissue Expanders: Why Port and Shell Volumes Matter in Breast Reconstruction, Augmentation, and Revision.

PubMed

Wenzel, Chad G; Wacholtz, William F; Janssen, David A; Bengtson, Bradley P

2015-10-01

There are significant differences in weight and volumetric characteristics between silicone and saline breast implants of which most plastic surgeons are unaware. Phase I of this study was a weight measurement focused on recording differences in the weight of saline volumes instilled versus recorded weights of saline implants and expanders. Phase II compared displaced volume differences of tissue expanders with instilled volumes. As a result of this study, surgeons should now be able to precisely calculate the volume created for breast pocket development, allowing for accurate matching of expander and final breast implant. Copyright © 2015 Elsevier Inc. All rights reserved.

Characterization of Breast Implant Surfaces, Shapes, and Biomechanics: A Comparison of High Cohesive Anatomically Shaped Textured Silicone, Breast Implants from Three Different Manufacturers.

PubMed

Atlan, Michael; Bigerelle, Maxence; Larreta-garde, Véronique; Hindié, Mathilde; Hedén, Per

2016-02-01

Several companies offer anatomically shaped breast implants but differences among manufacturers are often misunderstood. The shell texture is a crucial parameter for anatomically shaped implants to prevent rotation and to decrease the risk of capsular contracture, even though concerns have recently been raised concerning the complications associated with textured breast implants. The aim of this study was to characterize differences in terms of texture, cell adhesion, shape, and stiffness between some commonly used anatomically shaped implants from three different manufacturers. Five commercially available anatomically shaped breast implants from 3 different manufacturers (Allergan, Mentor, and Sebbin) were used. Scanning electron microscopy, X-ray microtomography, and scanning mechanical microscopy were used to characterize the shell texture. Human fibroblast adhesion onto the shells was evaluated. 3D models of the implants were obtained using CT-scan acquisitions to analyze their shape. Implant stiffness was evaluated using a tractiometer. Major differences were observed in the topography of the textures of the shells, but this was not conveyed by a statistically significant fibroblast adhesion difference. However, fibroblasts adhered better on anatomically shaped textured implants than on smooth implants (p < 0.01). Our work pointed out differences in the Biocell® texture in comparison with older studies. The 3D analysis showed significant shape differences between the anatomically shaped implants of the 3 companies, despite similar dimensions. Implant stiffness was comparable among the 3 brands. Each texture had its specific topography, and this work is the first description of Sebbin anatomic breast implant texturation. Moreover, major discrepancies were found in the analysis of the Biocell® texture when comparing our results with previous reports. These differences may have clinical implications and are discussed. This study also highlighted major shape differences among breast implants from different manufacturers, which is quite counterintuitive. The clinical impact of these differences however needs further investigation. This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Scanning electron microscope fractography of induced fatigue-damaged saline breast implants.

PubMed

Brandon, H J; Jerina, K L; Savoy, T L; Wolf, C J

2006-01-01

Breast implant strength and durability is presently an important topic in biomaterials science. Research studies are being conducted to determine the mechanisms and rates of failure in order to assess the in vivo performance of breast implants. Fatigue life is a measure of breast implant durability since fatigue failure is a potential in vivo failure mechanism. This study describes the characterization of the fracture surface morphology of breast implant shell regions that have failed due to cyclic fatigue. Saline breast implants were fatigue tested to failure using a laboratory apparatus in which flat plates cyclically compressed the implants. The implants were unimplanted control devices of both textured and smooth saline implants. The failure surfaces of the fatigued shells were examined using scanning electron microscopy (SEM). The morphological features of the failure surfaces are described for implants with short and long fatigue lifetimes. The details of both the inside and outside surfaces of the shell at the failure location are described. Two different modes of failure were observed in both the textured and smooth shells. These modes depend on the magnitude of the cyclic load and corresponding number of fatigue cycles at failure. The first mode is a tear in the shell of about 18 mm in length, and the second mode is a pinhole approximately 1 mm in diameter. Details of the surface morphology for these two types of failure modes and shell thickness data are presented herein. There was no significant change in the crosslink density of the shell as a result of fatigue.

Breast implants and breast cancer: a review of incidence, detection, mortality, and survival.

PubMed

Deapen, Dennis

2007-12-01

Soon after breast implants were commercially introduced over 30 years ago, questions about potential carcinogenicity were raised. Animal experiments dating back to the mid-twentieth century demonstrated that foreign body implantation of many materials, including silicone, can induce sarcomas. Indeed, female breast cancer incidence rates in the United States have increased substantially over that period. Of the several published studies from various countries that have formally investigated the risk of breast cancer among augmentation mammaplasty patients, none show any evidence of increased risk. In fact, most find lower than expected risk, some with statistically significant reductions. Similarly, breast cancer mortality among these patients is generally found to be below that expected of other similar women. Delayed detection of breast cancer is a concern for these patients because implants can interfere with mammography. However, using indicators such as stage at diagnosis and tumor size, current research shows that augmentation patients do not experience delayed detection. Furthermore, several comparisons of post-breast cancer survival of augmented versus nonaugmented patients have found no significant differences. In summary, breast implants are not associated with an increased risk of breast cancer incidence or death, and these patients do not experience delayed detection or poorer post-breast cancer survival.

Evaluation of anatomical and round breast implant aesthetics and preferences in Dutch young lay and plastic surgeon cohort.

PubMed

Bletsis, Patrick P; Bouwer, Lesley R; Ultee, Klaas H; Cromheecke, Michel; van der Lei, Berend

2018-04-16

Literature remains inconclusive on the attractiveness and natural aspect of anatomical breast implants, and thus far, studies have failed to demonstrate the visible difference in implants that are in practice compared to those that are round. This study was undertaken to evaluate (1) whether lay and professional participants can distinguish between breasts augmented with either round or anatomical breast implants and (2) their opinion with regard to naturalness and attractiveness of these augmented breasts. Twenty breast augmentations (10 anatomical and 10 round implants), each depicted by two postoperative pictures, were scored by 100 lay participants and 15 plastic surgeons. Implant volume ranged from 275 to 400 g. Ptotic or malformed breasts were excluded. Finally, they had to score the most natural, unnatural, attractive, and unattractive breast shapes on a schematic depiction of breast types with varying upper poles. The rate of correct implant identifications was 74.0% (1480/2000 observations, p < 0.001) in the lay and 67.3% (202/300 observations, p < 0.001) in the surgeon cohort. Breasts with anatomical implants were rated as significantly more natural (3.3 ± 1.0 vs. 2.6 ± 1.0, p < 0.001 and 3.3 ± 1.0 vs. 2.2 ± 0.9, p < 0.001, respectively) and more attractive (3.1 ± 1.0 vs. 2.6 ± 1.0, p < 0.001 and 3.6 ± 0.9 vs. 2.7 ± 0.9, p < 0.001, respectively) versus round implants by both lay participants and surgeons. Participants preferred breasts with a neutral or slightly negative upper pole contour. Participants were able to distinguish between the results achieved with either anatomical or round textured Allergan breast implants and found augmented breasts with the anatomical implants more natural and attractive. Copyright © 2018 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Intraoperative Comparison of Anatomical versus Round Implants in Breast Augmentation: A Randomized Controlled Trial.

PubMed

Hidalgo, David A; Weinstein, Andrew L

2017-03-01

The purpose of this randomized controlled trial was to determine whether anatomical implants are aesthetically superior to round implants in breast augmentation. Seventy-five patients undergoing primary breast augmentation had a round silicone implant of optimal volume, projection, and diameter placed in one breast and an anatomical silicone device of similar volume and optimal shape placed in the other. After intraoperative photographs were taken, the anatomical device was replaced by a round implant to complete the procedure. A survey designed to measure breast aesthetics was administered to 10 plastic surgeon and 10 lay reviewers for blind evaluation of the 75 cases. No observable difference in breast aesthetics between anatomical and round implants was reported by plastic surgeons in 43.6 percent or by lay individuals in 29.2 percent of cases. When a difference was perceived, neither plastic surgeons nor lay individuals preferred the anatomical side more often than the round side. Plastic surgeons judged the anatomical side superior in 51.1 percent of cases and the round side superior in 48.9 percent of cases (p = 0.496). Lay individuals judged the anatomical side superior in 46.7 percent of cases and the round side superior in 53.3 percent (p = 0.140). Plastic surgeons identified implant shape correctly in only 26.5 percent of cases. This study provides high-level evidence supporting no aesthetic superiority of anatomical over round implants. Given that anatomical implants have important and unique disadvantages, a lack of proven aesthetic superiority argues against their continued use in breast augmentation. Therapeutic, I.

Cancer among Scandinavian women with cosmetic breast implants: a pooled long-term follow-up study.

PubMed

Lipworth, Loren; Tarone, Robert E; Friis, Søren; Ye, Weimin; Olsen, Jørgen H; Nyren, Olof; McLaughlin, Joseph K

2009-01-15

No increased risks of specific types of cancer following breast implantation have been consistently reported, but data on risk beyond 15 years are limited. We have pooled the results of 2 nationwide cohort studies of 3,486 Swedish and 2,736 Danish women who underwent cosmetic breast implantation between 1965 and 1993. Cancer incidence through 2002 was ascertained through nationwide cancer registries. Standardized incidence ratios (SIRs) and 95% confidence intervals (CIs) were calculated to compare cancer incidence among women with implants with women in the general population. Mean duration of follow up was 16.6 years (range 0.1-37.8 years). Over 50% of women were followed for 15 years or more after breast implantation and 13.3% for at least 25 years. There was a reduced incidence of breast cancer (SIR=0.73; 95% CI 0.58-0.90), whereas lung cancer was above expectation (SIR=1.64; 95% CI 1.10-2.36). The increased risk of lung cancer is expected due to the high prevalence of smoking among the women with implants in our study. With respect to other site-specific cancers, no significantly increased or decreased SIR was observed. This study, which includes women followed for almost 4 decades, represents the longest follow up of women with cosmetic breast implants to date. The results provide no evidence of an association between breast implants and any type of cancer. Copyright (c) 2008 Wiley-Liss, Inc.

Breast Implants

MedlinePlus

... sale in the United States: saline-filled and silicone gel-filled. Both types have a silicone outer shell. They vary in size, shell thickness, ... implant them. Provide information on saline-filled and silicone gel-filled breast implants, including data supporting a ...

Breast Reconstruction with Implants

MedlinePlus

... implants is a complex procedure performed by a plastic surgeon. The breast reconstruction process can start at ... doctor may recommend that you meet with a plastic surgeon. Consult a plastic surgeon who's board certified ...

Single- and double- lumen silicone breast implant integrity: prospective evaluation of MR and US criteria.

PubMed

Berg, W A; Caskey, C I; Hamper, U M; Kuhlman, J E; Anderson, N D; Chang, B W; Sheth, S; Zerhouni, E A

1995-10-01

To evaluate the accuracy of magnetic resonance (MR) and ultrasound (US) criteria for breast implant integrity. One hundred twenty-two single-lumen silicone breast implants and 22 bilumen implants were evaluated with surface coil MR imaging and US and surgically removed. MR criteria for implant failure were a collapsed implant shell ("linguine sign"), foci of silicone outside the shell ("noose sign"), and extracapsular gel, US criteria were collapsed shell, low-level echoes within the gel, and "snowstorm" echoes of extracapsular silicone. Among single-lumen implants, MR imaging depicted 39 of 40 ruptures, 14 of 28 with minimal leakage; 49 of 54 intact implants were correctly interpreted. US depicted 26 of 40 ruptured implants, four of 28 with minimal leakage, and 30 of 54 intact implants. Among bilumen implants, MR imaging depicted four of five implants with rupture of both lumina and nine of 10 as intact; US depicted one rupture and helped identify two of 10 as intact. Mammography accurately depicted the status of 29 of 30 bilumen implants with MR imaging correlation. MR imaging depicts implant integrity more accurately than US; neither method reliably depicts minimal leakage with shell collapse. Mammography is useful in screening bilumen implant integrity.

Polyurethane Implants in 2-Stage Breast Reconstruction: 9-Year Clinical Experience.

PubMed

Pompei, Stefano; Arelli, Floriana; Labardi, Lara; Marcasciano, Fabio; Evangelidou, Dora; Ferrante, Gianluigi

2017-02-01

Capsular contracture (CC) is a major complication of breast surgery with smooth and textured implants. Polyurethane (PU) foam-coated breast implants were developed to decrease the incidence of CC. The authors determined the incidence of CC following 2-stage breast reconstruction using PU foam-covered implants, with and without radiation therapy. The records of 92 patients who received 115 PU implants were retrospectively reviewed. The rates of CC over time were compared for irradiated and nonirradiated groups with a Kaplan-Meier analysis and log-rank test. CC rates also were analyzed with respect to age. The median follow-up time for patients was 103.3 months. Nine patients experienced unilateral Baker grade III or IV fibrous CC, including 6 patients from the irradiated group and 3 patients from the nonirradiated group. The overall cumulative incidence of CC at 9 years was 8.1%. In the irradiated and nonirradiated groups, the 9-year cumulative incidence was 10.7% and 5.5%, respectively. CC occurred within 3 years in the irradiated group and within 7 years in the nonirradiated group. The incidence of CC appeared to be higher among younger patients. Radiation therapy increases the risk of high-grade CC with textured or smooth implants. PU implants are associated with a much lower cumulative incidence of CC following 2-stage breast reconstruction, even when radiotherapy is performed. LEVEL OF EVIDENCE 3. © 2016 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

Understanding rare adverse sequelae of breast implants: anaplastic large-cell lymphoma, late seromas, and double capsules.

PubMed

Clemens, Mark W; Nava, Maurizio Bruno; Rocco, Nicola; Miranda, Roberto N

2017-04-01

Breast implant-associated anaplastic large cell lymphoma (BI-ALCL) is a distinct type of T-cell lymphoma arising around breast implants. The United States FDA recently updated the 2011 safety communication, warning that women with breast implants may have a very low risk of developing ALCL adjacent to a breast implant. According to the World Health Organization, BI-LCL is not a breast cancer or cancer of the breast tissue; it is a lymphoma, a cancer of immune cells. BI-ALCL is highly curable in the majority of patients. Informed consent should include the risk of BI-ALCL with breast implant patients. Women with breast implants are encouraged to contact their plastic surgeon if they notice swelling, fluid collections, or unexpected changes in breast shape. Physicians are encouraged to send suspicious peri-prosthetic fluid for CD30 immunohistochemistry, cell block cytology, and culture in symptomatic patients. An observation from reported cases indicates a predominance of textured device involvement. More information is needed to fully understand risk factors and etiology. The association of bacteria and biofilm with ALCL is currently being investigated and one theory is that biofilm may play a role in this disease process stressing the importance of best practice techniques intraoperatively. Recent studies have reported clinical presentation, prognosis, and treatment outcomes with long term followup demonstrating the critical role for surgical management.

Silicone-specific blood lymphocyte response in women with silicone breast implants.

PubMed Central

Ojo-Amaize, E A; Conte, V; Lin, H C; Brucker, R F; Agopian, M S; Peter, J B

1994-01-01

A blinded cross-sectional study was carried out with 99 women, 44 of whom had silicone breast implants. Group I consisted of 55 healthy volunteer women without breast implants; group II comprised 13 volunteer women with breast implants or explants who felt healthy; group III comprised 21 volunteer women with breast implants who had chronic fatigue, musculoskeletal symptoms, and skin disorders; and group IV comprised 10 women who had their prostheses explanted but still presented with clinical symptoms similar to those of the women in group III. Proliferative responses of peripheral blood mononuclear cells from all 99 women were measured by [3H]thymidine uptake after exposure to SiO2 silicon, or silicone gel. The levels of proliferative responses were expressed as stimulation indices, which were obtained by dividing the counts per minute of stimulated cells by the counts per minute of unstimulated cells. Abnormal responses to SiO2, silicon, or silicone gel were defined as a stimulation index of > 2.8, > 2.1, or > 2.4, respectively. Abnormal responses were observed in 0% of group I, 15% of group II, 29% of group III, and 30% of group IV (P < 0.0005 for group I versus groups II and IV). Thirty-one percent of symptomatic women with silicone gel breast implants had elevated serum silicon levels ( > 0.18 mg/liter); however, there was no significant correlation between abnormal cellular responses and silicon levels in blood serum, type of implant, time since first implantation, prosthesis explantation, number of implants, or report of implant leakage or rupture.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:8556522

Understanding rare adverse sequelae of breast implants: anaplastic large-cell lymphoma, late seromas, and double capsules

PubMed Central

Nava, Maurizio Bruno; Rocco, Nicola

2017-01-01

Breast implant-associated anaplastic large cell lymphoma (BI-ALCL) is a distinct type of T-cell lymphoma arising around breast implants. The United States FDA recently updated the 2011 safety communication, warning that women with breast implants may have a very low risk of developing ALCL adjacent to a breast implant. According to the World Health Organization, BI-LCL is not a breast cancer or cancer of the breast tissue; it is a lymphoma, a cancer of immune cells. BI-ALCL is highly curable in the majority of patients. Informed consent should include the risk of BI-ALCL with breast implant patients. Women with breast implants are encouraged to contact their plastic surgeon if they notice swelling, fluid collections, or unexpected changes in breast shape. Physicians are encouraged to send suspicious peri-prosthetic fluid for CD30 immunohistochemistry, cell block cytology, and culture in symptomatic patients. An observation from reported cases indicates a predominance of textured device involvement. More information is needed to fully understand risk factors and etiology. The association of bacteria and biofilm with ALCL is currently being investigated and one theory is that biofilm may play a role in this disease process stressing the importance of best practice techniques intraoperatively. Recent studies have reported clinical presentation, prognosis, and treatment outcomes with long term followup demonstrating the critical role for surgical management. PMID:28497021

"Not all breast implants are equal: a 13-year review of implant longevity and reasons for explantation".

PubMed

Van Slyke, Aaron C; Carr, Michael; Carr, Nicholas J

2018-06-04

Augmentation mammoplasty is the most common aesthetic procedure. Textured implants control implant position and have improved capsular contracture rates; however, the impact of texturing on longevity and clinical findings at explantation is unclear. All cases of explantation between January 2005 - April 2017 from an aesthetic practice were reviewed retrospectively. Patient demographics, implant characteristics, time-to-explantation, and clinical presentation and intraoperative findings at explantation were analyzed. 539 breast implants were explanted during the study period: 249 saline, 147 smooth gel, 123 Biocell, and 20 other nonaggressively textured breast implants. Average time from placement to explantation was 7.5 years, 5.6 years, 4.9 years, and 4.0 years for saline, other textured, smooth gel, and Biocell implants, respectively (p-value = 3.25e-08). The percentage of implants removed associated with implant performance failure was 50.3%, 57.5%, 75.0%, and 85.4% for smooth gel, saline, other textured, and Biocell implants, respectively (p-value = 7.25e-09). 21.1% of Biocell implants versus 1.5% of all other implants presented with pain (p-value = 2.71e-15). 45 Biocell implants had double capsules; this phenomenon was not observed with any other implant type (p-value = 5.85e-37). Seven Biocell implants had late seromas, compared to three late seromas with any other implant type (p-value = 0.0013). Here, we provide evidence that Biocell implants have the shortest time-to-explantation and the highest proportion of implants associated with implant performance failure. This information should complement the informed consent process when selecting an appropriate implant.

Mastectomy - discharge

MedlinePlus

... Elsevier Saunders; 2015:chap 109. Read More Breast cancer Breast lump removal Breast reconstruction - implants Breast reconstruction - natural tissue Mastectomy Patient Instructions Cosmetic breast surgery - discharge Mastectomy and breast ...

Breast implant capsule-associated squamous cell carcinoma: a report of 2 cases.

PubMed

Olsen, Daniel L; Keeney, Gary L; Chen, Beiyun; Visscher, Daniel W; Carter, Jodi M

2017-09-01

The use of prosthetic implants for breast augmentation has become commonplace. Although implants do not increase the risk of conventional mammary carcinoma, they are rarely associated with anaplastic large cell lymphoma. We report 2 cases of breast implant capsule-associated squamous cell carcinoma with poor clinical outcomes. Both patients (56-year-old woman and 81-year-old woman) had long-standing implants (>25 years) and presented with acute unilateral breast enlargement. In both cases, squamous cell carcinoma arose in (focally dysplastic) squamous epithelium-lined breast implant capsules and widely invaded surrounding breast parenchyma or chest wall. Neither patient had evidence of a primary mammary carcinoma or squamous cell carcinoma at any other anatomic site. Within 1 year, one patient developed extensive, treatment-refractory, locoregional soft tissue metastasis, and the second patient developed hepatic and soft tissue metastases and died of disease. There are 2 prior reported cases of implant-associated squamous cell carcinoma in the plastic surgery literature; one provides no pathologic staging or outcome information, and the second case was a capsule-confined squamous cell carcinoma. Together, all 4 cases share notable commonalities: the patients had long-standing breast implants and presented with acute unilateral breast pain and enlargement secondary to tumors arising on the posterior aspect of squamous epithelialized implant capsules. Because of both its rarity and its unusual clinical presentation, implant capsule-associated squamous cell carcinoma may be underrecognized. The aggressive behavior of the tumors in this series underscores the importance of excluding malignancy in patients with long-standing breast implants who present with acute unilateral breast pain and enlargement. Copyright © 2017 Elsevier Inc. All rights reserved.

The relationship of silicone breast implants and cancer at other sites.

PubMed

Brinton, Louise A

2007-12-01

Although most attention regarding the effects of silicone breast implants on cancer risk has focused on breast cancer, there have also been concerns regarding effects on other cancers. This includes malignancies that could occur as a result of foreign-body carcinogenesis (sarcomas) or immune alterations (hematopoietic malignancies), or cancers suggested as possibly elevated on the basis of previous epidemiologic studies (cancers of the cervix, vulva, lung, and brain). Searches of the English language literature on the topic of silicone breast implants and cancer risk were conducted and reviewed to determine relationships that might have etiologic relevance. Epidemiologic studies provide no support for an increased risk of either sarcoma or multiple myeloma among breast implant recipients, disputing clinical and laboratory findings suggesting such a link. Although a number of epidemiologic studies have demonstrated elevated risks of cervical, vulvar, and lung cancers among breast implant patients, it is likely that these excesses relate more to lifestyle characteristics (e.g., cigarette smoking, sexual behavior) than to the effects of the implants. Brain cancer excesses, suggested in one study, have not been confirmed in either an update of the mortality experience in this study or on the basis of other investigations. At present, there is no convincing evidence that breast implants alter the risk of nonbreast malignancies. Breast implant patients should continue to be monitored for longer term risks and to assess whether cancer risk is influenced by various patient and implant characteristics.

Imaging of idle breast implants with ultrasound-strain elastography- A first experimental study to establish criteria for accurate imaging of idle implants via ultrasound-strain elastography.

PubMed

Kuehlmann, Britta; Prantl, Lukas; Michael Jung, Ernst

2016-01-01

To investigate whether there are fundamental sonographic and elastographic criteria to precisely assess different surfaces and fillings of idle breast implants and to determine their most distinctive parameters. This was a comparative study of different unused breast implant materials, neighter in animals nor in humans. This knowledge should be transferred in vivo to develop an objective measurement tool. Nine idle breast implants-silicone and polyurethane (PU)-were examined in an experimental study by using ultrasound B-mode with tissue harmonic imaging (THI), speckle reduction imaging (SRI, level 0-4), cross-beam (CB, low, medium, high), photopic and the colour coded ultrasound-strain elastography with a multifrequency probe (9-15 MHz).Using a standardised protocol the implants' centre as well as the edge were analysed by one experienced examiner. Two independent readers performed analysis and evaluation. For image interpretation a score was created (score 0:inadequate image, score 5:best image quality). The highest score result for the centre was achieved by using ultrasound with B-mode in addition with CB level medium, SRI level 2, THI and photopic (mean:3.22±SD:1.56), but without any statistic significant difference (t-value = 0.71). With elastography the implants' edge in general was represented without disruptive artefacts (3.89±0.60) with statistic significant difference (t-value = 5.29). Implants filled with inner cohesive silicone gel II° showed best imaging conditions for their centre via ultrasound (5±0) as well as for their edge via elastography (4.50±0.71). Ultrasound-strain elastography and high resolution ultrasound represent a valuable measurement tool to evaluate different properties of idle breast implants. These modified ultrasound examinations could be an additional help for clinical investigations and be correlated with Baker's Classification.

Benefits and Limitations of Macrotextured Breast Implants and Consensus Recommendations for Optimizing Their Effectiveness.

PubMed

Maxwell, G Patrick; Scheflan, Michael; Spear, Scott; Nava, Maurizio B; Hedén, Per

2014-08-01

Implant texture is an important factor influencing implant selection for breast augmentation. Natrelle Biocell implants are characterized by macrotextured shell surfaces containing irregularly arranged concavities with large open-pore diameters and depths. These properties facilitate adhesion of the implant to the surrounding tissue, thereby promoting implant immobilization. Relative to implants with other surfaces, macrotextured implants offer low rates of capsular contracture; low rates of malposition, rotation, and rippling; and high rates of patient satisfaction. However, macrotextured implants are associated with a slightly higher risk of double capsule and late seroma. The surgeon can minimize these risks with straightforward techniques that encourage tissue adhesion. This report presents experience-based recommendations to optimize the effectiveness of Biocell anatomic implants. The authors discuss the application of best practices to all aspects of the breast implantation process, from implant selection and surgical planning to operative technique and postoperative management. LEVEL OF EVIDENCE 3. © 2014 The American Society for Aesthetic Plastic Surgery, Inc.

Presence of Biofilms on Polyurethane-Coated Breast Implants: Preliminary Results.

PubMed

Rieger, Ulrich M; Djedovic, Gabriel; Pattiss, Alexander; Raschke, Gregor F; Frei, Reno; Pierer, Gerhard; Trampuz, Andrej

2016-01-01

Polyurethane-coated breast implants seem to be associated with lower medium- and long-term capsular contracture rates in comparison to textured or smooth implant surfaces. Although the etiology of capsular contracture is uncertain, bacterial biofilms have been suggested to trigger chronic peri-implant inflammation, eventually leading to capsular contracture. It is unknown whether polyurethane-coated implants are less prone to biofilm colonization than other implant surfaces. We extracted data from patient records included in a prospective cohort between 2008 and 2011. All patients who underwent removal of polyurethane-coated implants were included in this current study and screened for presence of biofilms by sonication. In addition, implant- and patient-related data were analyzed. Of the ten included polyurethane-coated breast implants, six had been inserted for reconstructive purposes and four for aesthetic reasons. The median implant indwelling time was 28.3 mo. Overall, sonication cultures were positive in 50% of implants. Propionibacterium acnes and coagulase-negative staphylococci were the predominant pathogens isolated from biofilm cultures. Like other implant surfaces, polyurethane-coated implants are prone to biofilm colonization. Further investigations are needed to determine why capsular contracture rates seem to be lower in polyurethane implants than in other implant surfaces. Notably, in this study, 40% of the implants were explanted from breasts with severe capsular contracture.

Shaped versus Round Implants in Breast Reconstruction: A Multi-Institutional Comparison of Surgical and Patient-Reported Outcomes.

PubMed

Khavanin, Nima; Clemens, Mark W; Pusic, Andrea L; Fine, Neil A; Hamill, Jennifer B; Kim, H Myra; Qi, Ji; Wilkins, Edwin G; Kim, John Y S

2017-05-01

Since the 2012 approval of shaped implants, their use in breast reconstruction has increased in the United States. However, large-scale comparisons of complications and patient-reported outcomes are lacking. The authors endeavored to compare surgical and patient-reported outcomes across implant types. The Mastectomy Reconstruction Outcomes Consortium database was queried for expander/implant reconstructions with at least 1-year postexchange follow-up (mean, 18.5 months). Outcomes of interest included postoperative complications, 1-year revisions, and patient-reported outcomes. Bivariate and mixed-effects regression analyses evaluated the effect of implant type on patient outcomes. Overall, 822 patients (73.5 percent) received round and 297 patients (26.5 percent) received shaped implants. Patients undergoing unilateral reconstructions with round implants underwent more contralateral symmetry procedures, including augmentations (round, 18.7 percent; shaped, 6.8 percent; p = 0.003) and reductions (round, 32.2 percent; shaped, 20.5 percent; p = 0.019). Shaped implants were associated with higher rates of infection (shaped, 6.1 percent; round, 2.3 percent; p = 0.002), that remained significant after multivariable adjustment. Other complication rates did not differ significantly between cohorts. Round and shaped implants experienced similar 2-year patient-reported outcome scores. This prospective, multicenter study is the largest evaluating outcomes of shaped versus round implants in breast reconstruction. Although recipients of round implants demonstrated lower infection rates compared with shaped implants, these patients were more likely to undergo contralateral symmetry procedures. Both implant types yielded comparable patient-reported outcome scores. With appropriate patient selection, both shaped and round implants can provide acceptable outcomes in breast reconstruction. Therapeutic, III.

Long-term outcome of accelerated partial breast irradiation using a multilumen balloon applicator in a patient with existing breast implants.

PubMed

Akhtari, Mani; Nitsch, Paige L; Bass, Barbara L; Teh, Bin S

2015-01-01

Accelerated partial breast irradiation is now an accepted component of breast-conserving therapy. However, data regarding long-term outcomes of patients treated with multilumen catheter systems who have existing breast implants are limited. We report the treatment and outcome of our patient who had existing bilateral silicone subpectoral implants at the time of presentation. Ultrasound-guided core needle biopsy of the right breast showed infiltrating mucinous carcinoma. Right breast lumpectomy revealed an 8 mm area of infiltrating ductal carcinoma with mucinous features and nuclear grade 1. A 4-5 cm Contura (Bard Biopsy Systems, Tempe, AZ) device was placed, and she was treated over the course of 5 days twice daily to a dose of 34 Gy using a high-dose-rate iridium-192 source. The planning target volume for evaluation was 73.9 cc. The percentage of the planning target volume for evaluation receiving 90%, 95%, and 100% of the prescribed dose was 99.9%, 99.3%, and 97.8%, respectively. The total implant volume was 234.5 cc and received a mean dose of 15.4 Gy and a maximum dose of 72.8 Gy. The percentage of implant volume receiving 50%, 75%, 100%, and 200% of the prescribed dose was 31.1%, 16.5%, 8.6%, 2.0%, and 0%, respectively. Maximum skin dose was 97% of the prescribed dose. With a followup of nearly 5 years, she continues to be cancer free with minimal late toxicities and good to excellent cosmetic outcome. Accelerated partial breast irradiation using a multilumen balloon applicator in patients with existing breast implants can safely be performed with excellent long-term cosmetic outcome. Further studies are needed to establish the absolute dosimetric tolerance of breast implants. Copyright © 2015 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.

The Relationship of Bacterial Biofilms and Capsular Contracture in Breast Implants

PubMed Central

Ajdic, Dragana; Zoghbi, Yasmina; Gerth, David; Panthaki, Zubin J.; Thaller, Seth

2016-01-01

Capsular contracture is a common sequelae of implant-based breast augmentation. Despite its prevalence, the etiology of capsular contracture remains controversial. Numerous studies have identified microbial biofilms on various implantable materials, including breast implants. Furthermore, biofilms have been implicated in subclinical infections associated with other surgical implants. In this review, we discuss microbial biofilms as a potential etiology of capsular contracture. The review also outlines the key diagnostic modalities available to identify the possible infectious agents found in biofilm, as well as available preventative and treatment measures. PMID:26843099

Women with silicone breast implants and autoimmune inflammatory syndrome induced by adjuvants: description of three patients and a critical review of the literature.

PubMed

Pavlov-Dolijanovic, Slavica; Vujasinovic Stupar, Nada

2017-08-01

Silicone has been widely used in the manufacture of medical implants. It is well tolerated in most cases. However, in this paper we report the cases of three women who developed autoimmune/inflammatory syndrome induced by adjuvants (ASIA syndrome), namely with silicone breast implants. The symptoms in these cases include arthralgia, arthritis, myalgia, sleep disturbances, the appearance of autoantibodies, miscarriage, Raynaud's phenomenon, and involvement of autoimmune diseases (scleroderma and undifferentiated connective tissue diseases). In one patient, breast implants were removed, but no improvement was seen after the removal. The remaining two patients received the updated information about their condition, and they decided not to remove the implants. In conclusion, earlier reports that silicone is biologically relatively inert have recently been challenged with the description of ASIA syndrome.

Cancer risk among Los Angeles women with cosmetic breast implants.

PubMed

Deapen, Dennis M; Hirsch, Elliot M; Brody, Garry S

2007-06-01

As the first generation of women who received cosmetic breast implants ages, questions remain about cancer risk. This study is an update of the Los Angeles Augmentation Mammaplasty Study and examines cancer risk among women with long-term exposure to breast implants. The authors conducted a record linkage cohort study of patients with cosmetic breast implants by abstracting from records of the private practices of 35 board-certified plastic surgeons in Los Angeles County, California. They included 3139 Caucasian women who received cosmetic breast implants between 1953 and 1980. Spanish-surnamed women, nonresidents of Los Angeles County, and patients with prior subcutaneous mastectomy or breast cancer were excluded. Cancer outcomes through 1994 were ascertained through record linkage with the Los Angeles County Cancer Surveillance Program. With a mean follow-up period of 15.5 years, 43 cases of breast cancer were observed, compared with 62.6 expected, based on Los Angeles County population-based incidence rates (standardized incidence ratio, 0.69; 95% CI, 0.50 to 0.93). Significant increases were observed for cancer of the lung and bronchus (standardized incidence ratio, 2.14; 95% CI, 1.42 to 3.09) and vulvar cancer (standardized incidence ratio, 3.47; 95% CI, 1.39 to 7.16). The breast cancer results of this study are consistent with the previous reports of the Los Angeles study as well as with several other long-term cohort studies. Lung cancer has previously been found to be increased in this cohort and also in some, but not most, other studies. The increased risk of vulva cancer has previously been observed in this cohort and just one other.

Different types of implants for reconstructive breast surgery.

PubMed

Rocco, Nicola; Rispoli, Corrado; Moja, Lorenzo; Amato, Bruno; Iannone, Loredana; Testa, Serena; Spano, Andrea; Catanuto, Giuseppe; Accurso, Antonello; Nava, Maurizio B

2016-05-16

Breast cancer is the most common cancer in women worldwide, and is a leading cause of cancer death among women. Prophylactic or curative mastectomy is often followed by breast reconstruction for which there are several surgical approaches that use breast implants with which surgeons can restore the natural feel, size and shape of the breast. To assess the effects of different types of breast implants on capsular contracture, surgical short- and long-term complications, postoperative satisfaction level and quality of life in women who have undergone reconstructive breast surgery after mastectomy. We searched the Cochrane Breast Cancer Group's Specialised Register on 20 July 2015, MEDLINE (1985 to 20 July 2015), EMBASE (1985 to 20 July 2015) and the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 8, 2015). We also searched the World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov on 16 July 2015. We included randomised controlled trials (RCTs) and quasi-RCTs that compared different types of breast implants for reconstructive surgery. We considered the following types of intervention: implant envelope surfaces - texturised versus smooth; implant filler material - silicone versus saline, PVP-Hydrogel versus saline; implant shape - anatomical versus round; implant volume - variable versus fixed; brands - different implant manufacturing companies and implant generation (fifth versus previous generations). Two review authors independently assessed methodological quality and extracted data. We used standard Cochrane methodological procedures. The quality of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. Five RCTs with 202 participants met the inclusion criteria. The women participants were typically in their 50s, and the majority of them (about 82%) received reconstructive surgery following breast cancer, while the others had reconstructive surgery after prophylactic mastectomy. The studies were heterogenous in terms of implant comparisons, which prevented us from pooling the data.The studies were judged as being at an unclear risk of bias for most risk of bias items owing to poor quality of reporting in the trial publications. Three of the five RCTs were judged to be at high risk of attrition bias, and one at high risk of detection bias.Textured silicone versus smooth silicone implants: textured implants were associated with worse outcomes when compared to smooth implants (capsular contracture: risk ratio (RR) 0.82, 95% CI 0.14 to 4.71; 1 study, 20 participants; very low quality evidence; reintervention: RR 0.82, 95% CI 0.14 to 4.71; 1 study, 20 participants; very low quality evidence). No results in this comparison were statistically significant.Silicone versus saline implants: saline-filled implants performed better than silicone-filled implants for some outcomes; specifically, they produced less severe capsular contracture (RR 3.25, 95% CI 1.24 to 8.51; 1 study, 60 participants; very low quality evidence) and increased patient satisfaction (RR 0.60, 95% CI 0.41 to 0.88; 1 study, 58 participants; very low quality evidence). However reintervention was significantly more frequent in the saline-filled implant group than in the silicone-filled group (OR 0.08, 95% CI 0.01 to 0.43; 1 study, 60 participants; very low quality evidence).Poly(N-vinyl-2-pyrrolidone) hydrogel-filled (PVP-hydrogel) versus saline-filled implants: PVP-hydrogel-filled implants were associated with worse outcomes when compared to saline-filled implants (capsular contracture: RR 3.50, 95% CI 0.83 to 14.83; 1 study, 40 participants; very low quality evidence; short-term complications: RR 2.10, 95% CI 0.21 to 21.39; 1 study, 41 participants; very low quality evidence).Anatomical versus round implants: anatomical implants were associated with worse outcomes than round implants (capsular contracture: RR 2.00, 95% CI 0.20 to 20.15; 1 study, 36 participants; very low quality evidence; short-term complications: RR 2.00, 95% CI 0.42 to 9.58; 1 study, 36 participants; very low quality evidence; reintervention: RR 1.50, 95% CI 0.51 to 4.43; 1 study, 36 participants; very low quality evidence). No results in this comparison were statistically significant.Variable-volume versus fixed-volume implants: data about one-stage reconstruction using variable-volume implants were compared with data about fixed-volume implants positioned during the second surgical procedure of two-stage reconstructions. Fixed-volume implant reconstructions were possibly associated with a greater number of women reporting that their reconstruction corresponded with expected results (RR 0.25, 95% CI 0.10 to 0.62; 1 study, 40 participants; very low quality evidence) and fewer reinterventions (RR 7.00, 95% CI 1.82 to 26.89; 1 study, 40 participants; very low quality evidence) when compared to variable-volume implants. A higher patient satisfaction level (rated from 1 to 6, with 1 being very bad and 6 being very good) was found with the fixed-volume implants for overall aesthetic result (mean difference (MD) -1.10, 95% CI -1.59 to -0.61; 1 study, 40 participants; very low quality evidence).There were no studies that examined the effects of recent (fifth) generation silicone implants versus previous generations or different implant manufacturing companies. Despite the central role of breast reconstruction in women with breast cancer, the best implants to use in reconstructive surgery have been studied rarely in the context of RCTs. Furthermore the quality of these studies and the overall evidence they provide is largely unsatisfactory. Some of our results can be interpreted as early evidence of potentially large differences between different surgical approaches, which should be confirmed in new high-quality RCTs that include a larger number of women. These days - even after a few million women have had breasts reconstructed - surgeons cannot inform women about the risks and complications of different implant-based breast reconstructive options on the basis of results derived from RCTs.

Five-Year Safety Data for More than 55,000 Subjects following Breast Implantation: Comparison of Rare Adverse Event Rates with Silicone Implants versus National Norms and Saline Implants.

PubMed

Singh, Navin; Picha, George J; Hardas, Bhushan; Schumacher, Andrew; Murphy, Diane K

2017-10-01

The U.S. Food and Drug Administration has required postapproval studies of silicone breast implants to evaluate the incidence of rare adverse events over 10 years after implantation. The Breast Implant Follow-Up Study is a large 10-year study (>1000 U.S. sites) evaluating long-term safety following primary augmentation, revision-augmentation, primary reconstruction, or revision-reconstruction with Natrelle round silicone breast implants compared with national norms and outcomes with saline implants. Targeted adverse events in subjects followed for 5 to 8 years included connective tissue diseases, neurologic diseases, cancer, and suicide. The safety population comprised 55,279 women (primary augmentation, n = 42,873; revision-augmentation, n = 6837; primary reconstruction, n = 4828; and revision-reconstruction, n = 741). No targeted adverse events occurred at significantly greater rates in silicone implant groups versus national norms across all indications. The standardized incidence rate (observed/national norm) for all indications combined was 1.4 for cervical/vulvar cancer, 0.8 for brain cancer, 0.3 for multiple sclerosis, and 0.1 for lupus/lupus-like syndrome. Silicone implants did not significantly increase the risk for any targeted adverse events compared with saline implants. The risk of death was similar with silicone versus saline implants across all indications. The suicide rate (10.6 events per 100,000 person-years) was not significantly higher than the national norm. No implant-related deaths occurred. Results from 5 to 8 years of follow-up for a large number of subjects confirmed the safety of Natrelle round silicone implants, with no increased risk of systemic disease or suicide versus national norms or saline implants. Therapeutic, II.

The In Vivo Pericapsular Tissue Response to Modern Polyurethane Breast Implants.

PubMed

Frame, James; Kamel, Dia; Olivan, Marcelo; Cintra, Henrique

2015-10-01

Polyurethane breast implants were first introduced by Ashley (Plast Reconstr Surg 45:421-424, 1970), with the intention of trying to reduce the high incidence of capsular contracture associated with smooth shelled, high gel bleed, silicone breast implants. The sterilization of the polyurethane foam in the early days was questionable. More recently, ethylene oxide (ETO)-sterilized polyurethane has been used in the manufacturing process and this has been shown to reduce the incidence of biofilm. The improved method of attachment of polyurethane onto the underlying high cohesive gel, barrier shell layered, silicone breast implants also encourages bio-integration. Polyurethane covered, cohesive gel, silicone implants have also been shown to reduce the incidence of other problems commonly associated with smooth or textured silicone implants, especially with reference to displacement, capsular contracture, seroma, reoperation, biofilm and implant rupture. Since the introduction of the conical polyurethane implant (Silimed, Brazil) into the United Kingdom in 2009 (Eurosurgical, UK), we have had the opportunity to review histology taken from the capsules of polyurethane implants in three women ranging from a few months to over 3 years after implantation. All implants had been inserted into virgin subfascial, extra-pectoral planes. The results add to the important previously described histological findings of Bassetto et al. (Aesthet Plast Surg 34:481-485, 2010). Five distinct layers are identified and reasons for the development of each layer are discussed. Breast capsule around polyurethane implants, in situ for fifteen and 20 years, has recently been obtained and analysed in Brazil, and the histology has been incorporated into this study. After 20 years, the polyurethane is almost undetectable and capsular contracture may appear. These findings contribute to our understanding of polyurethane implant safety, and give reasoning for a significant reduction in clinical capsular contracture rate, up to 10 years after implantation, compared to contemporary silicone implants. A more permanent matrix equivalent to polyurethane may be the solution for reducing long-term capsular contracture. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Nine-Year Core Study Data for Sientra's FDA-Approved Round and Shaped Implants with High-Strength Cohesive Silicone Gel.

PubMed

Stevens, W Grant; Calobrace, M Bradley; Harrington, Jennifer; Alizadeh, Kaveh; Zeidler, Kamakshi R; d'Incelli, Rosalyn C

2016-04-01

Since approval in March 2012, data on Sientra's (Santa Barbara, CA) silicone gel implants have been updated and published regularly to provide immediate visibility to the continued safety and performance of these devices. The 9 year follow-up data support the previously published data confirming the ongoing safety and efficacy of Sientra silicone gel breast implants. The authors provide updated 9 year study data for Sientra's round and shaped silicone gel breast implants. The Core Study is an ongoing 10 year study that enrolled 1788 patients with 3506 Sientra implants across four indications (primary augmentation, revision-augmentation, primary reconstruction, and revision-reconstruction). For the safety analysis, Kaplan-Meier risk rates were calculated to evaluate postoperative complications, including all breast implant-related adverse effects. For the effectiveness analyses, results were presented through 8 years as patient satisfaction scores were assessed at even years. Through 9 years, the overall risk of capsular contracture was 12.6%. Smooth devices (16.6%, 95% CI, 14.2%, 19.5%) had a statistically significantly higher rate of capsular contracture compared to textured devices (8.0%, 95% CI, 6.2%, 10.4%). Out of the 610 reoperations in 477 patients, over half of all reoperations were due to cosmetic reasons (n = 315; 51.6%). Patient satisfaction remains high through 8 years, with 90% of primary augmentation patients indicating their breast implants look natural and feel soft. The 9-year follow-up data from the ongoing Core Study of the Sientra portfolio of HSC and HSC+ silicone gel breast implants reaffirm the very strong safety profile as well as continued patient satisfaction. 2 Therapeutic. © 2016 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

Dosimetric intercomparison of permanent Ho-166 seed's implants and HDR Ir-192 brachytherapy in breast cancer.

PubMed

de Campos, Tarcisio Passos Ribeiro; Nogueira, Luciana Batista; Trindade, Bruno; Cuperschmid, Ethel Mizrahy

2016-01-01

To provide a comparative dosimetric analysis of permanent implants of Ho(166)-seeds and temporary HDR Ir(192)-brachytherapy through computational simulation. Brachytherapy with Ir(192)-HDR or LDR based on temporary wires or permanent radioactive seed implants can be used as dose reinforcement for breast radiation therapy. Permanent breast implants have not been a practical clinical routine; although, I(125) and Pd(103)-seeds have already been reported. Biodegradable Ho(166)-ceramic-seeds have been addressed recently. Simulations of implants of nine Ho(166)-seeds and equivalent with HDR Ir(192)-brachytherapy were elaborated in MCNP5, shaped in a computational multivoxel simulator which reproduced a female thorax phantom. Spatial dose rate distributions and dose-volume histograms were generated. Protocol's analysis involving exposure time, seed's activities and dose were performed. Permanent Ho(166)-seed implants presented a maximum dose rate per unit of contained activity (MDR) of 1.1601 μGy h(-1) Bq(-1); and, a normalized MDR in standard points (8 mm, equidistant to 03-seeds - SP1, 10 mm - SP2) of 1.0% (SP1) and 0.5% (SP2), respectively. Ir(192)-brachytherapy presented MDR of 4.3945 × 10(-3) μGy h(-1) Bq(-1); and, 30% (SP1), and 20% (SP2). Therefore, seed's implant activities of 333 MBq (Ho(166)) and 259 GBq (Ir(192)) produced prescribed doses of 58 Gy (SP1; 5d) and 56 Gy (SP1, 5 fractions, 6 min), respectively. Breast Ho(166)-implants of 37-111 MBq are attractive due to the high dose rate near 6-10 mm from seeds, equivalent to Ir(192)-brachytherapy of 259 GBq (3 fractions, 6 min) providing similar dose in standard points at a week; however, with spatial dose distribution better confined. The seed positioning can be adjusted for controlling the breast tumor, in stages I and II, in flat and deep tumors, without any breast volumetric limitation.

Reduced Pain and Accelerated Recovery Following Primary Breast Augmentation With Lightweight Breast Implants.

PubMed

Govrin-Yehudain, Orel; Matanis, Yossef; Govrin-Yehudain, Jacky

2018-03-22

The postoperative pain associated with breast augmentation is a top concern of most patients and can affect the decision on surgery. This study aimed to compare the postoperative pain and recovery times of patients undergoing primary breast augmentation with lightweight versus full-mass implants of similar volumes. We hypothesized that the reduced mechanical strain applied by lightweight implants elicits less pain. In this retrospective, observational study, 100 women who had undergone primary breast augmentation with either a lightweight breast implant (LWBI; B-Lite®, G&G Biotechnology Ltd., Haifa, Israel; n=50) or a traditional full-mass silicone implant (n=50), were contacted by phone and asked about their postoperative experiences and overall satisfaction with the outcome. All women were treated by the same surgical team and the two groups were matched by date of surgery. The majority of patients in the two cohorts had a self-reported preoperative B cup size and relatively high tolerance to pain. On average, LWBI patients were 6 years older than those undergoing full-mass implantation (32.4 ± 8.7 vs. 26.2 ± 8.0; p=0.0004) and more had experienced at least one pregnancy (61.2% vs. 24%, p=0.0002). LWBI patients opted for implants 39 ± 28.4 cc larger than patients in the control group. Subglandular placement was selected in the majority of cases (LWBI: 83.7% and full-mass: 90.0%). Mean postoperative pain was lower in the LWBI cohort (5.5 ± 2.4 vs. 6.5 ± 2.4) and required a shorter duration of analgesics use (3.87 ± 1.77 days vs. 5.26 ± 2.94 days; p=0.009). Age- and parity-adjusted measures demonstrated a respective 2-day and 5-day shorter recovery period and return to normal activities interval in the LWBI versus full-mass implant cohorts (p=0.04 and p=0.002, respectively). As compared to traditional silicone filled full-mass implants, breast augmentations with B-Lite lightweight breast implants, elicit less postoperative pain and require less down-time, ultimately, meeting patients' quest for desired breast shape at minimal discomfort.

Cohort Study to Assess the Impact of Breast Implants on Breastfeeding.

PubMed

Filiciani, Sandra; Siemienczuk, Guillermo F; Nardín, Juan M; Cappio, Bárbara; Albertengo, Andrés C; Nozzi, Guillermo; Caggioli, Matías

2016-12-01

The objective of this study was to evaluate the impact of breast implant surgery and its approaches on lactation by comparing women with and without breast implants at the time of childbirth. Between April of 2013 and July of 2014, in Rosario (Sanatorio de la Mujer and Centro Quirúrgico Rosario), Argentina, a prospective cohort study of women with and without breast implants was performed. Of a total of 3950 births that occurred during this period, 200 patients with similar anthropometric characteristics (maternal and newborn) were selected. Breastfeeding (exclusive or mixed) was compared with artificial feeding at 24 and 48 hours and 30 days in both groups, and the type of incision was also compared. Breastfeeding at 30 days showed a nonsignificant trend favoring the control group (OR, 7.39; 95 percent CI, 0.92 to 339.2). The percentage of women with implants who succeeded in establishing breastfeeding (exclusive or mixed) was very high (93 percent). In the control group, 99 percent of the women were breastfeeding at 30 days. In a comparison of the submammary and areola incision, breastfeeding showed odds ratios of 0.78 (95 percent CI, 0.33 to 1.87) at 24 hours, 1.10 (95 percent CI, 0.48 to 2.56) at 48 hours, and 0.18 (95 percent CI, 0.36 to 1.82) at 30 days. This study shows that most patients with breast implants were able to establish breastfeeding. However, there is a higher number of women without implants that established exclusive breastfeeding. No significant difference was found between the different surgical approaches. Therapeutic, II.

Cost-effectiveness analysis of implants versus autologous perforator flaps using the BREAST-Q.

PubMed

Matros, Evan; Albornoz, Claudia R; Razdan, Shantanu N; Mehrara, Babak J; Macadam, Sheina A; Ro, Teresa; McCarthy, Colleen M; Disa, Joseph J; Cordeiro, Peter G; Pusic, Andrea L

2015-04-01

Reimbursement has been recognized as a physician barrier to autologous reconstruction. Autologous reconstructions are more expensive than prosthetic reconstructions, but provide greater health-related quality of life. The authors' hypothesis is that autologous tissue reconstructions are cost-effective compared with prosthetic techniques when considering health-related quality of life and patient satisfaction. A cost-effectiveness analysis from the payer perspective, including patient input, was performed for unilateral and bilateral reconstructions with deep inferior epigastric perforator (DIEP) flaps and implants. The effectiveness measure was derived using the BREAST-Q and interpreted as the cost for obtaining 1 year of perfect breast health-related quality-adjusted life-year. Costs were obtained from the 2010 Nationwide Inpatient Sample. The incremental cost-effectiveness ratio was generated. A sensitivity analysis for age and stage at diagnosis was performed. BREAST-Q scores from 309 patients with implants and 217 DIEP flap reconstructions were included. The additional cost for obtaining 1 year of perfect breast-related health for a unilateral DIEP flap compared with implant reconstruction was $11,941. For bilateral DIEP flaps compared with implant reconstructions, the cost for an additional breast health-related quality-adjusted life-year was $28,017. The sensitivity analysis demonstrated that the cost for an additional breast health-related quality-adjusted life-year for DIEP flaps compared with implants was less for younger patients and earlier stage breast cancer. DIEP flaps are cost-effective compared with implants, especially for unilateral reconstructions. Cost-effectiveness of autologous techniques is maximized in women with longer life expectancy. Patient-reported outcomes findings can be incorporated into cost-effectiveness analyses to demonstrate the relative value of reconstructive procedures.

Anaplastic large cell lymphoma (ALCL) and breast implants: breaking down the evidence.

PubMed

Ye, Xuan; Shokrollahi, Kayvan; Rozen, Warren M; Conyers, Rachel; Wright, Penny; Kenner, Lukas; Turner, Suzanne D; Whitaker, Iain S

2014-01-01

Systemic anaplastic large cell lymphoma (ALCL) is a distinct disease classification provisionally sub-divided into ALCL, Anaplastic Lymphoma Kinase (ALK)(+) and ALCL, ALK(-) entities. More recently, another category of ALCL has been increasingly reported in the literature and is associated with the presence of breast implants. A comprehensive review of the 71 reported cases of breast implant associated ALCL (iALCL) is presented indicating the apparent risk factors and main characteristics of this rare cancer. The average patient is 50 years of age and most cases present in the capsule surrounding the implant as part of the periprosthetic fluid or the capsule itself on average at 10 years post-surgery suggesting that iALCL is a late complication. The absolute risk is low ranging from 1:500,000 to 1:3,000,000 patients with breast implants per year. The majority of cases are ALK-negative, yet are associated with silicone-coated implants suggestive of the mechanism of tumorigenesis which is discussed in relation to chronic inflammation, immunogenicity of the implants and sub-clinical infection. In particular, capsulotomy alone seems to be sufficient for the treatment of many cases suggesting the implants provide the biological stimulus whereas others require further treatment including chemo- and radiotherapy although reported cases remain too low to recommend a therapeutic approach. However, CD30-based therapeutics might be a future option. Copyright © 2014 Elsevier B.V. All rights reserved.

[Application of serratus anterior muscle flap combined with breast implants for breast reconstruction after modified radical mastectomy].

PubMed

Chai, Lijun; Zhang, Xuehui

2017-09-01

To investigate effectiveness of the combination of serratus anterior muscle flap and breast implants for breast reconstruction after modified radical mastectomy. Between January 2015 and December 2015, 25 female patients with breast cancer were enrolled, aged 24-62 years (mean, 40.6 years). The tumor located at left side in 9 cases and right side in 16 cases; 14 cases were in the left upper quadrant, 4 cases were in the left lower quadrant, 7 cases were on the top of the breast. All cases were invasive ductal carcinoma. According to TNM staging, 14 cases were at stageⅠand 11 cases were at stageⅡA. The diameter of lumps were all less than 3 cm. All those lumps were solitary and without distant metastasis. The sentinel nodes were all negative. After modified radical mastectomy, the breasts were reconstructed by serratus anterior muscle flap and breast implants. The nipples were spared in 22 cases. The operation time was 113-148 minutes (mean, 136 minutes). All breasts survived and incisions healed at stageⅠ. There was no complication such as hematoma, infection, etc . All patients were followed up 6-18 months (mean, 15 months). Except 1 case, the others were evaluated according to the criteria of the reconstructed breast at 12 months after operation. Among them, 23 cases were evaluated as good and 1 case as fair. There was no tumor recurrence during the follow-up period. The combination of serratus anterior muscle flap and breast implants after the modified radical mastectomy is a handy approach of breast reconstruction which is less harmful with few postoperative complications. It also gains a high degree of satisfaction from patients for good breast shape.

Eight-year follow-up data from the U.S. clinical trial for Sientra's FDA-approved round and shaped implants with high-strength cohesive silicone gel.

PubMed

Stevens, W Grant; Harrington, Jennifer; Alizadeh, Kaveh; Broadway, David; Zeidler, Kamakshi; Godinez, Tess B

2015-05-01

On March 9, 2012, the Food and Drug Administration (FDA) approved Sientra's premarket approval application for its portfolio of silicone gel breast implants based on their review of Sientra's 3-year study data from the largest pivotal silicone gel breast implant study to date. This included the first approval of shaped breast implants in the United States. The authors provide an update to the 8-year safety and effectiveness of the Sientra High-Strength silicone gel breast implants. The Sientra Core study is an ongoing 10 year open-label, prospective, multi-center clinical study, which includes 1788 patients implanted with 3506 Sientra implants across four indications (Primary Augmentation, Revision Augmentation, Primary Reconstruction, and Revision Reconstruction). For the safety analysis, the incidence of post-operative complications, including all breast implant-related adverse effects (eg, infection, asymmetry), was estimated based on Kaplan-Meier risk rates. The effectiveness analyses include surgeon and patient satisfaction and changes in bra/cup size. Through 8 years, the overall risk of rupture was 4.6%, the risk of capsular contracture was 11.8% (rates were lower when using True Texture™), and the risk of reoperation was 28.3%. Out of the 580 reoperations in 456 patients, over half of all reoperations were due to cosmetic reasons (n = 299). The most common reasons for reoperation were capsular contracture (19.0%), style and/or size change (18.4%), and asymmetry (8.8%). Patient satisfaction remains high through 8 years, with 87% indicating that their breast implants make them feel more feminine than prior to enrollment. Safety data from the FDA Core study continues to support a comprehensive safety and effectiveness profile of Sientra's portfolio of round and shaped implants through 8 years. 3 Therapeutic. © 2015 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

Dosimetric considerations and early clinical experience of accelerated partial breast irradiation using multi-lumen applicators in the setting of breast augmentation.

PubMed

Akhtari, Mani; Pino, Ramiro; Scarboro, Sarah B; Bass, Barbara L; Miltenburg, Darlene M; Butler, E Brian; Teh, Bin S

2015-12-01

Accelerated partial breast irradiation (APBI) is an accepted treatment option in breast-conserving therapy for early stage breast cancer. However, data regarding outcomes of patients treated with multi-lumen catheter systems who have existing breast implants is limited. The purpose of this study was to report treatment parameters, outcomes, and possible dosimetric correlation with cosmetic outcome for this population of patients at our institution. We report the treatment and outcome of seven consecutive patients with existing breast implants and early stage breast cancer who were treated between 2009 and 2013 using APBI following lumpectomy. All patients were treated twice per day for five days to a total dose of 34 Gy using a high-dose-rate (192)Ir source. Cosmetic outcomes were evaluated using the Harvard breast cosmesis scale, and late toxicities were reported using the Radiation Therapy Oncology Group (RTOG) late radiation morbidity schema. After a mean follow-up of 32 months, all patients have remained cancer free. Six out of seven patients had an excellent or good cosmetic outcome. There were no grade 3 or 4 late toxicities. The average total breast implant volume was 279.3 cc, received an average mean dose of 12.1 Gy, and a maximum dose of 234.1 Gy. The average percentage of breast implant volume receiving 50%, 75%, 100%, 150%, and 200% of the prescribed dose was 15.6%, 7.03%, 4.6%, 1.58%, and 0.46%, respectively. Absolute volume of breast implants receiving more than 50% of prescribed dose correlated with worse cosmetic outcomes. Accelerated partial breast irradiation using a multi-lumen applicator in patients with existing breast implants can safely be performed with promising early clinical results. The presence of the implant did not compromise the ability to achieve dosimetric criteria; however, dose to the implant and the irradiated implant volume may be related with worse cosmetic outcomes.

Dosimetric considerations and early clinical experience of accelerated partial breast irradiation using multi-lumen applicators in the setting of breast augmentation

PubMed Central

Akhtari, Mani; Pino, Ramiro; Scarboro, Sarah B.; Bass, Barbara L.; Miltenburg, Darlene M.; Butler, E. Brian

2015-01-01

Purpose Accelerated partial breast irradiation (APBI) is an accepted treatment option in breast-conserving therapy for early stage breast cancer. However, data regarding outcomes of patients treated with multi-lumen catheter systems who have existing breast implants is limited. The purpose of this study was to report treatment parameters, outcomes, and possible dosimetric correlation with cosmetic outcome for this population of patients at our institution. Material and methods We report the treatment and outcome of seven consecutive patients with existing breast implants and early stage breast cancer who were treated between 2009 and 2013 using APBI following lumpectomy. All patients were treated twice per day for five days to a total dose of 34 Gy using a high-dose-rate 192Ir source. Cosmetic outcomes were evaluated using the Harvard breast cosmesis scale, and late toxicities were reported using the Radiation Therapy Oncology Group (RTOG) late radiation morbidity schema. Results After a mean follow-up of 32 months, all patients have remained cancer free. Six out of seven patients had an excellent or good cosmetic outcome. There were no grade 3 or 4 late toxicities. The average total breast implant volume was 279.3 cc, received an average mean dose of 12.1 Gy, and a maximum dose of 234.1 Gy. The average percentage of breast implant volume receiving 50%, 75%, 100%, 150%, and 200% of the prescribed dose was 15.6%, 7.03%, 4.6%, 1.58%, and 0.46%, respectively. Absolute volume of breast implants receiving more than 50% of prescribed dose correlated with worse cosmetic outcomes. Conclusions Accelerated partial breast irradiation using a multi-lumen applicator in patients with existing breast implants can safely be performed with promising early clinical results. The presence of the implant did not compromise the ability to achieve dosimetric criteria; however, dose to the implant and the irradiated implant volume may be related with worse cosmetic outcomes. PMID:26816499

Serious Illnesses and Breastfeeding

MedlinePlus

... concerns about the safety of breastfeeding after breast enlargement with breast implants. But there is no evidence ... have been cut. In certain cases of breast enlargement, the women had underdeveloped breast tissue, which was ...

Evaluation of dental implants as a risk factor for the development of bisphosphonate-related osteonecrosis of the jaw in breast cancer patients.

PubMed

Matsuo, Akira; Hamada, Hayato; Takahashi, Hidetoshi; Okamoto, Ayako; Kaise, Hiroshi; Chikazu, Daichi

2016-09-01

It remains unclear whether dental implants are a risk factor for the development of bisphosphonate-related osteonecrosis of the jaw (BRONJ). We retrospectively evaluated the status of dental implants in patients given intravenous bisphosphonates (BPs) in a breast cancer cohort to elucidate the risk for BRONJ at the implant site. We established a BRONJ oral monitoring program for 247 breast cancer patients given intravenous BP in our institution. The 3-year cumulative incidence rate was determined. The systemic and local risk factors of 44 patients who completed comprehensive oral examinations were evaluated by logistic regression analysis. The 3-year cumulative incidence rate of the 247 patients was 0.074 % (8/247, 95 % CI 0.0081-0.014). In the 44 orally examined patients, 6 (13.6 %: 6/44) had dental implants. Of these 6 patients, 1 developed BRONJ at the implant site. There were no significant differences in the age, total BP treatment period, number of residual teeth, time of regular oral monitoring, oral hygiene level, or dental implant insertion. Although a case of ONJ was identified, dental implants which were inserted before intravenous BP administration were not a risk factor for the development of ONJ in breast cancer patients.

Correlation between MRI results and intraoperative findings in patients with silicone breast implants.

PubMed

Lindenblatt, Nicole; El-Rabadi, Karem; Helbich, Thomas H; Czembirek, Heinrich; Deutinger, Maria; Benditte-Klepetko, Heike

2014-01-01

Silicone gel breast implants may silently rupture without detection. This has been the main reason for magnetic resonance imaging (MRI) of the augmented or reconstructed breast. The aim of the present study was to investigate the accuracy of MRI for implant rupture. Fifty consecutive patients with 85 silicone gel implants were included in the study. The mean age of the patients was 51 (range 21-72) years, with a mean duration of implantation of 3.8 (range 1-28) years. All patients underwent clinical examination and breast MRI. Intraoperative implant rupture was diagnosed by the operating surgeon. Nineteen of the 50 patients suffered from clinical symptoms. An implant rupture was diagnosed by MRI in 22 of 85 implants (26%). In seven of 17 removed implants (41%), the intraoperative diagnosis corresponded with the positive MRI result. However, only 57% of these patients were symptomatic. Ultrasound imaging of the harvested implants showed signs of interrupted inner layers of the implant despite integrity of the outer shell. By microsurgical separation of the different layers of the implant shell, we were able to reproduce this phenomenon and to produce signs of implant rupture on MRI. Our results show that rupture of only the inner layers of the implant shell with integrity of the outer shell leads to a misdiagnosis on MRI. Correlation with clinical symptoms and the specific wishes of the patient should guide the indication for implant removal.

The response of breast cancer cells to mesenchymal stem cells: a possible role of inflammation by breast implants.

PubMed

Orciani, Monia; Lazzarini, Raffaella; Scartozzi, Mario; Bolletta, Elisa; Mattioli-Belmonte, Monica; Scalise, Alessandro; Di Benedetto, Giovanni; Di Primio, Roberto

2013-12-01

Breast implants are widely used and at times might cause inflammation as a foreign body, followed by fibrous capsule formation around the implant. In cancer, the inflamed stroma is essential for preservation of the tumor. Mesenchymal stem cells can be recruited to sites of inflammation, and their role in cancer development is debated. The authors assessed the effects of inflammation caused by breast implants' effects on tumor. Mesenchymal stem cells were isolated from the fibrous capsules of women who underwent a second operation after 1 year (presenting inflammation) or after 20 years (not presenting inflammation) since initial surgery. After characterization, cells were co-cultured with MCF7, a breast cancer cell line. The expression of genes involved in oncogenesis, proliferation, and epithelial-to-mesenchymal transition was investigated, followed by Western blot analyses. After co-culture with mesenchymal stem cells from the inflamed capsule, MCF7 induced a dose- and time-dependent increase in proliferation. Polymerase chain reaction analyses revealed a dysregulation of genes involved in oncogenesis, proliferation, and epithelial-to-mesenchymal transition. The subsequent evaluation by Western blot did not confirm these results, showing only a modest decrease in the expression of E-cadherin after co-culture with mesenchymal stem cells (both derived from inflamed or control capsules). These data indicate that inflammation caused by breast implants partially affects proliferation of MCF7 but does not influence key mechanisms of tumor development.

Distant Migration of Multiple Siliconomas in Lower Extremities following Breast Implant Rupture: Case Report

PubMed Central

Oh, Joo Hyun; Song, Seung Yong; Lew, Dae Hyun

2016-01-01

Summary: Siliconoma from ruptured breast implants has been reported in multiple body sites, including but not limited to the breast parenchyma, axillary lymph nodes, upper arm, and even lower leg. In this regard, we report a rare case of distant silicone migration to the lower extremities after traumatic breast implant rupture. A 55-year-old Asian woman who received bilateral augmentation mammoplasty 20 years ago presented with ruptured breast implants from a car accident 2 years earlier. Magnetic resonance imaging confirmed intracapsular and extracapsular rupture of the right breast implant, showing “linguine sign.” We removed the bilateral breast implants and performed capsulectomy and bilateral reduction mammoplasty using inverted-T incisions. The implant was confirmed as a smooth, silicone gel–filled mammary implant of 125 cm3 by a Japanese manufacturer, Koken. During her regular follow-up outpatient visits, physical examination revealed 2.5- × 1.5-cm ill-defined, tender, subcutaneous nodules on both knees and 8.5- × 3.0-cm inflammatory changes in the inguinal area with persistent pain. Computed tomography showed no definite mass, but rather infiltrative, nonenhancing soft-tissue densities in the subcutaneous layers of the bilateral inguinal and knee areas. Surgical excision was performed, and pathologic findings confirmed variable vacuoles with foreign body reaction and fibrosis, consistent with siliconoma. It is important to acknowledge that siliconomas can be encountered in patients with ruptured breast implants, especially those manufactured decades ago. Our patient with masses as remote as the inguinal and knee areas is a prime example of how far siliconomas can migrate. PMID:27826457

Systematic review of the effectiveness of polyurethane-coated compared with textured silicone implants in breast surgery.

PubMed

Duxbury, Paula J; Harvey, James R

2016-04-01

Silicone gel implants are used worldwide for breast augmentation and breast reconstruction. Textured silicone implants are the most commonly placed implant, but polyurethane-coated implants are increasingly being used in an attempt to ameliorate the long-term complications associated with implant insertion. This systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Electronic searches of MEDLINE, EMBASE, the Cochrane Library and www.ClinicalTrials.gov were undertaken in March 2014 using keywords. Following data extraction, 18 studies were included in the review, including four core studies of textured silicone implants and five studies reporting outcomes for polyurethane-coated silicone implants. There are no clear data reporting revision rates in patients treated with polyurethane implants. In the primary reconstructive setting, capsular contracture rates with silicone implants are 10-15% at 6 years, whilst studies of polyurethane implants report rates of 1.8-3.4%. In the primary augmentation setting, core studies show a capsular contracture rate of 2-15% at 6 years compared with 0.4-1% in polyurethane-coated implants; however, the polyurethane studies are limited by their design and poor follow-up. The use of polyurethane implants should be considered a safe alternative to textured silicone implants. It is likely that an implant surface does influence short- and long-term outcomes; however, the extent of any benefit cannot be determined from the available evidence base. Future implant studies should target the short- and long-term benefits of implant surfacing by procedure with defined outcome measures; a head-to-head comparison would help clarify outcomes. Copyright © 2016 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Surface and mechanical analysis of explanted Poly Implant Prosthèse silicone breast implants.

PubMed

Yildirimer, L; Seifalian, A M; Butler, P E

2013-05-01

The recent events surrounding Poly Implant Prosthèse (PIP) breast implants have renewed the debate about the safety profile of silicone implants. The intentional use of industrial-grade instead of certified medical-grade silicone is thought to be responsible for reportedly higher frequencies of implant rupture in vivo. The differences in mechanical and viscoelastic properties between PIP and medical-grade silicone implant shells were investigated. Surface characterization of shells and gels was carried out to determine structural changes occurring after implantation. Breast implants were obtained from women at the Royal Free Hospital (London, UK). PIP implants were compared with medical-grade control silicone implants. Tensile strength, tear resistance and elongation at break were assessed using a tensile tester. Surfaces were analysed using attenuated total reflectance-Fourier transform infrared (ATR-FTIR) spectroscopy. Spearman correlation analyses and Kruskal-Wallis one-way statistical tests were performed for mechanical data. There were 18 PIP and four medical-grade silicone implants. PIP silicone shells had significantly weaker mechanical strength than control shells (P < 0·009). There were negative correlations between mechanical properties of PIP shells and implantation times, indicative of deterioration of PIP shells over time in vivo (r(s) = -0·75, P = 0·009 for tensile strength; r(s) = -0·76, P = 0·001 for maximal strain). Comparison of ATR-FTIR spectra of PIP and control silicones demonstrated changes in material characteristics during the period of implantation suggestive of time-dependent bond breakage and degradation of the material. This study demonstrated an increased weakness of PIP shells with time and therefore supports the argument for prophylactic removal of PIP breast implants. © 2013 British Journal of Surgery Society Ltd. Published by John Wiley & Sons Ltd.

Correlation between MRI results and intraoperative findings in patients with silicone breast implants

PubMed Central

Lindenblatt, Nicole; El-Rabadi, Karem; Helbich, Thomas H; Czembirek, Heinrich; Deutinger, Maria; Benditte-Klepetko, Heike

2014-01-01

Background Silicone gel breast implants may silently rupture without detection. This has been the main reason for magnetic resonance imaging (MRI) of the augmented or reconstructed breast. The aim of the present study was to investigate the accuracy of MRI for implant rupture. Methods Fifty consecutive patients with 85 silicone gel implants were included in the study. The mean age of the patients was 51 (range 21–72) years, with a mean duration of implantation of 3.8 (range 1–28) years. All patients underwent clinical examination and breast MRI. Intraoperative implant rupture was diagnosed by the operating surgeon. Results Nineteen of the 50 patients suffered from clinical symptoms. An implant rupture was diagnosed by MRI in 22 of 85 implants (26%). In seven of 17 removed implants (41%), the intraoperative diagnosis corresponded with the positive MRI result. However, only 57% of these patients were symptomatic. Ultrasound imaging of the harvested implants showed signs of interrupted inner layers of the implant despite integrity of the outer shell. By microsurgical separation of the different layers of the implant shell, we were able to reproduce this phenomenon and to produce signs of implant rupture on MRI. Conclusion Our results show that rupture of only the inner layers of the implant shell with integrity of the outer shell leads to a misdiagnosis on MRI. Correlation with clinical symptoms and the specific wishes of the patient should guide the indication for implant removal. PMID:25114595

Study of breast implant rupture: MRI versus surgical findings.

PubMed

Vestito, A; Mangieri, F F; Ancona, A; Minervini, C; Perchinunno, V; Rinaldi, S

2012-09-01

This study evaluated the role of breast magnetic resonance (MR) imaging in the selective study breast implant integrity. We retrospectively analysed the signs of breast implant rupture observed at breast MR examinations of 157 implants and determined the sensitivity and specificity of the technique in diagnosing implant rupture by comparing MR data with findings at surgical explantation. The linguine and the salad-oil signs were statistically the most significant signs for diagnosing intracapsular rupture; the presence of siliconomas/seromas outside the capsule and/or in the axillary lymph nodes calls for immediate explantation. In agreement with previous reports, we found a close correlation between imaging signs and findings at explantation. Breast MR imaging can be considered the gold standard in the study of breast implants.

Distant Migration of Multiple Siliconomas in Lower Extremities following Breast Implant Rupture: Case Report.

PubMed

Oh, Joo Hyun; Song, Seung Yong; Lew, Dae Hyun; Lee, Dong Won

2016-10-01

Siliconoma from ruptured breast implants has been reported in multiple body sites, including but not limited to the breast parenchyma, axillary lymph nodes, upper arm, and even lower leg. In this regard, we report a rare case of distant silicone migration to the lower extremities after traumatic breast implant rupture. A 55-year-old Asian woman who received bilateral augmentation mammoplasty 20 years ago presented with ruptured breast implants from a car accident 2 years earlier. Magnetic resonance imaging confirmed intracapsular and extracapsular rupture of the right breast implant, showing "linguine sign." We removed the bilateral breast implants and performed capsulectomy and bilateral reduction mammoplasty using inverted-T incisions. The implant was confirmed as a smooth, silicone gel-filled mammary implant of 125 cm 3 by a Japanese manufacturer, Koken. During her regular follow-up outpatient visits, physical examination revealed 2.5- × 1.5-cm ill-defined, tender, subcutaneous nodules on both knees and 8.5- × 3.0-cm inflammatory changes in the inguinal area with persistent pain. Computed tomography showed no definite mass, but rather infiltrative, nonenhancing soft-tissue densities in the subcutaneous layers of the bilateral inguinal and knee areas. Surgical excision was performed, and pathologic findings confirmed variable vacuoles with foreign body reaction and fibrosis, consistent with siliconoma. It is important to acknowledge that siliconomas can be encountered in patients with ruptured breast implants, especially those manufactured decades ago. Our patient with masses as remote as the inguinal and knee areas is a prime example of how far siliconomas can migrate.

Silicone granuloma from ruptured breast implants as a cause of cervical lymphadenopathy

PubMed Central

Gallagher, G; Skelly, BL

2016-01-01

A 56-year-old woman with a 10-year history of bilateral silicone breast implants presented to the ear, nose and throat outpatient clinic with a 2-month history of a right-sided neck lump. She was found to have a 1.3cm supraclavicular lymph node that gave the clinical impression of being reactive. Ultrasonography guided fine needle aspiration was inconclusive and initial review of subsequent computed tomography failed to identify a cause. This was followed by excisional biopsy of the lymph node, which revealed a silicone granuloma that was linked to a ruptured right-sided breast implant placed ten years previously. This case highlights the importance for otolaryngologists to consider silicone granuloma among the differential diagnoses of cervical lymphadenopathy in patients with a history of silicone breast implants. Recognising this differential diagnosis could avoid undue anxiety for patient and clinician regarding more serious pathology. PMID:27167311

Breast implants and the risk of breast cancer: a meta-analysis of cohort studies.

PubMed

Noels, Eline C; Lapid, Oren; Lindeman, Jan H N; Bastiaannet, Esther

2015-01-01

The popularity of cosmetic breast augmentation and the incidence of breast cancer have been increasing worldwide. It has been hypothesized that the risk of breast cancer may be greater among patients who have undergone cosmetic breast implantation. The authors performed a meta-analysis of the available literature on the risk of breast cancer among women with cosmetic breast implants. The study was designed as a meta-analysis of observational studies. A systematic search of the English literature (published by August 28, 2013) was conducted in PubMed and EMBASE. Eligible reports were those that included relative risk (RR; the increased or decreased risk of breast cancer associated with breast implants) or the standardized incidence ratio (SIR) of the observed number of cases of breast cancer to the expected number of cases among patients that previously underwent cosmetic breast augmentation. Seventeen studies representing 7 cohorts were selected. Some of these were follow-up reports of previously published studies; in such cases, only the most recent reports were included in the meta-analysis. Summary SIR and RR rates and the corresponding 95% confidence intervals (CIs) were calculated with a random-effects (SIR) or fixed-effects (RR) model. The overall SIR estimate was 0.69 (95% CI, 0.56-0.85), and the overall RR, based on 4 studies, was 0.63 (95% CI, 0.56-0.71). Finding of this meta-analysis suggest that women who have undergone cosmetic breast implantation do not have an increased risk of breast cancer. © 2015 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

Incidence of breast implant rupture in a 12-year retrospective cohort: Evidence of quality discrepancy depending on the range.

PubMed

Seigle-Murandi, Frédéric; Lefebvre, François; Bruant-Rodier, Catherine; Bodin, Frédéric

2017-01-01

The majority of studies assessing the rupture rate of breast implants were performed by the breast implant manufacturing industry with questionable independence. After repetitive removals of ruptured implants from the same model, our team decided to assess the rupture rate and the estimated risk thereof for most of the silicone gel-filled implants we have used since they regained market approval in France in 2001. Our study is a retrospective cohort of 809 patients operated in our University Hospital from 2001 to 2013 for cosmetic or reconstructive goals. We could track 1561 implants, 90% of them from the same manufacturer, Allergan (Irvine, CA, USA). For each of those, we gathered their exact reference, date of implantation, surgical approach, status, last follow-up visit or the eventual date, and cause of removal. Of 225 explanted devices, only 27 were ruptured, all from the Allergan brand. Risks of removal for rupture were estimated: 0.5% at 1000 days, 6% at 2000 days, and 14% at 3000 days. Risks were significantly different between the models from this same manufacturer. One of the range of macro-textured round implants showed risks of removal for rupture of 33% at 3000 days compared to 6% for the anatomically shaped range. These results suggest a qualitative discrepancy among the different ranges of breast implants of a single manufacturer within the same timeframe of implantation. To determine the in vivo lifespan of the implants that we use more precisely and sooner, we suggest that each removed implant should be analyzed for wear and tear, independently from the industry. Copyright © 2016 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

A comparison of outcomes involving highly cohesive, form-stable breast implants from two manufacturers in patients undergoing primary breast augmentation.

PubMed

Jewell, Mark L; Jewell, James L

2010-01-01

Although there have been reports of single-surgeon outcomes with highly cohesive, form-stable silicone gel implants in women undergoing primary breast augmentation, there has been only one study published that compares the outcomes between the Allergan 410 and the Mentor CPG devices. The goal of the study is to compare outcomes in each cohort and to determine if quality systems and processes would have an impact on lowering the surgical revision rate, as compared to published reports for round gel implants and form-stable implants. Patients selected for the study were required to meet predefined inclusion criteria and general indications for breast augmentation. All subjects were treated uniformly with extensive informed consent prior to surgery. The entire process of breast augmentation (patient assessment, informed consent, the surgical procedure itself and postoperative instructions) was identical between the two groups. Patients were not randomized, as the studies did not start at the same time. The process for management of each patient was based on adaptation of the Toyota Production System and Lean Manufacturing, with emphasis on achieving operational excellence in the use of planning templates for surgery, including accurate management of patient expectations regarding size outcome. Outcomes data included physical breast measurements, quality of life metrics, and patient/surgeon satisfaction assessment. Adverse events were compared against published data for breast implants. Follow-up ranged between 20-77 months (Allergan 410) and 16-77 months (Mentor CPG). The outcome data indicate that these devices produce natural-appearing breasts with extremely low aggregate reoperation rate (4.2%). Only 0.8% of the reoperations were attributable to surgeon-related factors. There were no reoperations to correct mismanaged size expectations during the course of each study. There were 13 pregnancies and no difficulties with lactation were reported. Rippling (lateral/medial, palpable and/or visible) was encountered in both cohorts. The Mentor CPG cohort had a fivefold greater incidence of rippling (37.3% versus 7.6% in Allergan 410 cohort). This was highly statistically significant (P < .001). Provided that there is adherence to core principles and avoidance of errors in planning, patient expectations, and surgery, highly cohesive, form-stable breast implants can deliver excellent long term outcomes in primary breast augmentation in a diverse patient population. The impact of quality processes such as Toyota Production System and Lean Manufacturing was substantive in delivering operational excellence in primary breast augmentation.

Numb chin syndrome as a manifestation of possible breast cancer metastasis around dental implants.

PubMed

Orhan, Kaan; Bayndr, Hakan; Aksoy, Seçil; Seker, Basak Kusakci; Berberoğlu, Atilla; Ozan, Oğuz

2011-05-01

Numb chin syndrome, sometimes called numb lip syndrome, is an uncommon but well-recognized symptom in medical oncology. It may be a metastatic neurologic manifestation of malignancy, often with no clinically visible pathologic finding. The authors report a numb chin syndrome as a manifestation possible breast cancer metastasis around dental implants in a 69-year-old woman. The patient was presented with complaint of numbness in the lower jaw. Medical anamnesis revealed a metastatic breast carcinoma (CA). Radiographic imaging with conventional panoramic radiography and cone beam computed tomographic examination, revealed a moth-eaten shape, radiolucent, and radiopaque mixed appearance around the dental implants that was related with possible metastasis of the breast cancer. Numb chin syndrome is almost unknown within the dental and oral and maxillofacial community, despite being well reported in the medical literature. General dentists, oral medicine specialists, and oral and maxillofacial surgeons must be aware of this condition to consider metastatic cancer in patients with unexplained facial hypoesthesia. Moreover, although the development of metastatic lesions around implants is an uncommon pathologic finding, the examination of peri-implant lesion should be performed carefully considering the entire pathologic situations.

Intracapsular implant rupture: MR findings of incomplete shell collapse.

PubMed

Soo, M S; Kornguth, P J; Walsh, R; Elenberger, C; Georgiade, G S; DeLong, D; Spritzer, C E

1997-01-01

The objective of this study was to determine the frequency and significance of the MR findings of incomplete shell collapse for detecting implant rupture in a series of surgically removed breast prostheses. MR images of 86 breast implants in 44 patients were studied retrospectively and correlated with surgical findings at explantation. MR findings included (a) complete shell collapse (linguine sign), 21 implants; (b) incomplete shell collapse (subcapsular line sign, teardrop sign, and keyhole sign), 33 implants; (c) radial folds, 31 implants; and (d) normal, 1 implant. The subcapsular line sign was seen in 26 implants, the teardrop sign was seen in 27 implants, and the keyhole sign was seen in 23 implants. At surgery, 48 implants were found to be ruptured and 38 were intact. The MR findings of ruptured implants showed signs of incomplete collapse in 52% (n = 25), linguine sign in 44% (n = 21), and radial folds in 4% (n = 2). The linguine sign perfectly predicted implant rupture, but sensitivity was low. Findings of incomplete shell collapse improved sensitivity and negative predictive values, and the subcapsular line sign produced a significant incremental increase in predictive ability. MRI signs of incomplete shell collapse were more common than the linguine sign in ruptured implants and are significant contributors to the high sensitivity and negative predictive values of MRI for evaluating implant integrity.

Sustained Release Talazoparib Implants for Localized Treatment of BRCA1-deficient Breast Cancer

PubMed Central

Belz, Jodi E.; Kumar, Rajiv; Baldwin, Paige; Ojo, Noelle Castilla; Leal, Ana S.; Royce, Darlene B.; Zhang, Di; van de Ven, Anne L.; Liby, Karen T.; Sridhar, Srinivas

2017-01-01

Talazoparib, a potent PARP inhibitor, has shown promising clinical and pre-clinical activity by inducing synthetic lethality in cancers with germline Brca1/2 mutations. Conventional oral delivery of Talazoparib is associated with significant off-target effects, therefore we sought to develop new delivery systems in the form of an implant loaded with Talazoparib for localized, slow and sustained release of the drug at the tumor site in Brca1-deficient breast cancer. Poly(lactic-co-glycolic acid) (PLGA) implants (0.8 mm diameter) loaded with subclinical dose (25 or 50 µg) Talazoparib were fabricated and characterized. In vitro studies with Brca1-deficient W780 and W0069 breast cancer cells were conducted to test sensitivity to PARP inhibition. The in vivo therapeutic efficacy of Talazoparib implants was assessed following a one-time intratumoral injection in Brca1Co/Co;MMTV-Cre;p53+/- mice and compared to drug-free implants and oral gavage. Immunohistochemistry studies were performed on tumor sections using PCNA and γ-H2AX staining. Sustained release of Talazoparib was observed over 28 days in vitro. Mice treated with Talazoparib implants showed statistically significant tumor growth inhibition compared to those receiving drug-free implants or free Talazoparib orally. Talazoparib implants were well-tolerated at both drug doses and resulted in less weight loss than oral gavage. PARP inhibition in mice treated with Talazoparib implants significantly increased double-stranded DNA damage and decreased tumor cell proliferation as shown by PCNA and γ-H2AX staining as compared to controls. These results demonstrate that localized and sustained delivery of Talazoparib via implants has potential to provide superior treatment outcomes at sub-clinical doses with minimal toxicity in patients with BRCA1 deficient tumors. PMID:29158830

Sustained Release Talazoparib Implants for Localized Treatment of BRCA1-deficient Breast Cancer.

PubMed

Belz, Jodi E; Kumar, Rajiv; Baldwin, Paige; Ojo, Noelle Castilla; Leal, Ana S; Royce, Darlene B; Zhang, Di; van de Ven, Anne L; Liby, Karen T; Sridhar, Srinivas

2017-01-01

Talazoparib, a potent PARP inhibitor, has shown promising clinical and pre-clinical activity by inducing synthetic lethality in cancers with germline Brca1/2 mutations. Conventional oral delivery of Talazoparib is associated with significant off-target effects, therefore we sought to develop new delivery systems in the form of an implant loaded with Talazoparib for localized, slow and sustained release of the drug at the tumor site in Brca1 -deficient breast cancer. Poly(lactic-co-glycolic acid) (PLGA) implants (0.8 mm diameter) loaded with subclinical dose (25 or 50 µg) Talazoparib were fabricated and characterized. In vitro studies with Brca1 -deficient W780 and W0069 breast cancer cells were conducted to test sensitivity to PARP inhibition. The in vivo therapeutic efficacy of Talazoparib implants was assessed following a one-time intratumoral injection in Brca1 Co/Co ;MMTV-Cre;p53 +/- mice and compared to drug-free implants and oral gavage. Immunohistochemistry studies were performed on tumor sections using PCNA and γ-H2AX staining. Sustained release of Talazoparib was observed over 28 days in vitro . Mice treated with Talazoparib implants showed statistically significant tumor growth inhibition compared to those receiving drug-free implants or free Talazoparib orally. Talazoparib implants were well-tolerated at both drug doses and resulted in less weight loss than oral gavage. PARP inhibition in mice treated with Talazoparib implants significantly increased double-stranded DNA damage and decreased tumor cell proliferation as shown by PCNA and γ-H2AX staining as compared to controls. These results demonstrate that localized and sustained delivery of Talazoparib via implants has potential to provide superior treatment outcomes at sub-clinical doses with minimal toxicity in patients with BRCA1 deficient tumors.

Breast Implant-Associated Anaplastic Large Cell Lymphoma: Case Report and Review of the Literature.

PubMed

Berlin, Eva; Singh, Kunwar; Mills, Christopher; Shapira, Ilan; Bakst, Richard L; Chadha, Manjeet

2018-01-01

We are reporting the case of a 58-year-old woman with history of bilateral silicone breast implants for cosmetic augmentation. At 2-year interval from receiving the breast implants, she presented with swelling of the right breast with associated chest wall mass, effusion around the implant, and axillary lymphadenopathy. Pathology confirmed breast implant-associated anaplastic large cell lymphoma (stage III, T4N2M0, using BIA-ALCL TNM staging and stage IIAE, using Ann-Arbor staging). The patient underwent bilateral capsulectomy and right partial mastectomy with excision of the right breast mass and received adjuvant CHOP chemotherapy and radiation to the right breast and regional nodes. Since completion of multimodality therapy, the patient has sustained remission on both clinical exam and PET/CT scan. We report this case and review of the literature on this rare form of lymphoma.

Breast Implant-Associated Anaplastic Large Cell Lymphoma: Case Report and Review of the Literature

PubMed Central

Singh, Kunwar; Mills, Christopher; Shapira, Ilan

2018-01-01

We are reporting the case of a 58-year-old woman with history of bilateral silicone breast implants for cosmetic augmentation. At 2-year interval from receiving the breast implants, she presented with swelling of the right breast with associated chest wall mass, effusion around the implant, and axillary lymphadenopathy. Pathology confirmed breast implant-associated anaplastic large cell lymphoma (stage III, T4N2M0, using BIA-ALCL TNM staging and stage IIAE, using Ann-Arbor staging). The patient underwent bilateral capsulectomy and right partial mastectomy with excision of the right breast mass and received adjuvant CHOP chemotherapy and radiation to the right breast and regional nodes. Since completion of multimodality therapy, the patient has sustained remission on both clinical exam and PET/CT scan. We report this case and review of the literature on this rare form of lymphoma. PMID:29607225

Immunopathologic effects of silicone breast implants.

PubMed Central

Teuber, S S; Yoshida, S H; Gershwin, M E

1995-01-01

Silicone-gel breast implants have been associated with a myriad of autoimmune and connective tissue disorders by anecdotal reports and small observational series. To date, no prospective epidemiologic studies have been done to substantiate these observations, but an increasing body of literature is being developed and older studies are being recognized that point to immunotoxic or inflammatory effects of these breast implant components. The development of disease due to implants would depend on the interaction of genetic host factors so that only a few patients would potentially be at risk. Based on the example of other chemically mediated disorders, such as scleroderma in association with silica exposure, latency periods of more than 30 years before disease develops may be possible. Herein we review studies on silicone and immunity. PMID:7785255

Does the presence of an implant including expander with internal port alter radiation dose? An ex vivo model.

PubMed

Strang, Barbara; Murphy, Kyla; Seal, Shane; Cin, Arianna Dal

2013-01-01

There is a lack of literature examining the dosimetric implications of irradiating breast implants and expanders with internal ports inserted at the time of mastectomy. To determine whether the presence of breast expanders with port in saline or silicone implants affect the dose uniformity across the breast when irradiated with various photon and electron energies. One tissue-equivalent torso phantom with overlying tissue expanders in saline or silicone implants were irradiated using tangential fields with 6 MV and 18 MV photons and 9 MeV and 12 MeV electrons. All dose measurements were performed using thermoluminescent dosimeters (TLDs). The TLDs were arranged around the port and the perimeters of either the expander, or saline or silicone implant. Comparisons of measured radiation doses, and between the expected and measured doses of radiation from the TLDs on each prosthesis, were performed. Data were analyzed using two-tailed t tests. There were no differences in TLD measurements between the expander and the saline implant for all energy modalities, and for the expected versus actual measurements for the saline implant. Higher than anticipated measurements were recorded for a significant number of TLD positions around the silicone implants. Radiation doses around saline implants or expanders with internal port were unaltered, whereas dose recordings for silicone implants were higher than predicted in the present laboratory/ex vivo study.

Comparative silicone breast implant evaluation using mammography, sonography, and magnetic resonance imaging: experience with 59 implants.

PubMed

Ahn, C Y; DeBruhl, N D; Gorczyca, D P; Shaw, W W; Bassett, L W

1994-10-01

With the current controversy regarding the safety of silicone implants, the detection and evaluation of implant rupture are causing concern for both plastic surgeons and patients. Our study obtained comparative value analysis of mammography, sonography, and magnetic resonance imaging (MRI) in the detection of silicone implant rupture. Twenty-nine symptomatic patients (total of 59 silicone implants) were entered into the study. Intraoperative findings revealed 21 ruptured implants (36 percent). During physical examination, a positive "squeeze test" was highly suggestive of implant rupture. Mammograms were obtained of 51 implants (sensitivity 11 percent, specificity 89 percent). Sonography was performed on 57 implants (sensitivity 70 percent, specificity 92 percent). MRI was performed on 55 implants (sensitivity 81 percent, specificity 92 percent). Sonographically, implant rupture is demonstrated by the "stepladder sign." Double-lumen implants may appear as false-positive results for rupture on sonography. On MRI, the "linguine sign" represents disrupted fragments of a ruptured implant. The most reliable imaging modality for implant rupture detection is MRI, followed by sonogram. Mammogram is the least reliable. Our study supports the clinical indication and diagnostic value of sonogram and MRI in the evaluation of symptomatic breast implant patients.

MRI evaluation of post-mastectomy irradiated breast implants: prevalence and analysis of complications.

PubMed

Rella, L; Telegrafo, M; Nardone, A; Milella, A; Stabile Ianora, A A; Lioce, M; Angelelli, G; Moschetta, M

2015-09-01

To evaluate the effect of post-mastectomy radiation therapy (RT) on breast implants as detected by magnetic resonance imaging (MRI) searching for short-term complications. One hundred and forty patients (total of 144 implants) were evaluated by MRI; 80 (group 1) had undergone RT, whereas the remaining 60 patients (group 2) underwent mastectomy with implant reconstruction without RT. Two radiologists evaluated MRI images searching for implant rupture signs, sub-capsular seromas, capsular contracture, soft-tissue oedema, peri-implant fluid collections. Implant ruptures were classified as severe complications; seromas and capsular contractures as moderate complications; oedema and fluid collections as mild complications. The prevalence of MRI findings in the two groups was calculated and compared by unpaired t-test. Cohen's kappa statistics was used to assess interobserver agreement. Sixty-nine out of 144 (48%) implants presented pathological findings at MRI with complication rates of 47.5 and 48.4 for groups 1 and 2, respectively. Two (5%) severe complications, 10 (26%) moderate complications, and 26 (69%) mild complications occurred in group 1 and surgical treatment was performed in 10 cases. Two (6%) severe complications, seven (23%) moderate complications, and 22 (71%) mild complications occurred in group 2 and surgical treatment was performed in eight cases. No significant difference between the two groups was found (p>0.1). Almost perfect agreement between the two radiologists was found for MRI image detection (k=0.86). RT does not seem to cause a significant effect on breast implants in terms of complication rate in patients undergoing implant-based breast reconstruction. One-stage immediate implant-based breast reconstruction performed at the same time as mastectomy could be proposed. Copyright © 2015 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

Cognitive and emotional factors associated with elective breast augmentation among young women.

PubMed

Moser, Stephanie E; Aiken, Leona S

2011-01-01

The purpose of this research was to propose and evaluate a psychosocial model of young women's intentions to obtain breast implants and the preparatory steps taken towards having breast implant surgery. The model integrated anticipated regret, descriptive norms and image norms from the media into the theory of planned behaviour (TPB). Focus groups (n = 58) informed development of measures of outcome expectancies, preparatory steps and normative influence. The model was tested and replicated among two samples of young women who had ever considered getting breast implants (n = 200, n = 152). Intentions and preparatory steps served as outcomes. Model constructs and outcomes were initially assessed; outcomes were re-assessed 11 weeks later. Evaluative attitudes and anticipated regret predicted intentions; in turn, intentions, along with descriptive norms, predicted subsequent preparatory steps. Perceived risk (susceptibility, severity) of negative medical consequences of breast implants predicted anticipated regret, which predicted evaluative attitudes. Intentions and preparatory steps exhibited interplay over time. This research provides the first comprehensive model predicting intentions and preparatory steps towards breast augmentation surgery. It supports the addition of anticipated regret to the TPB and suggests mutual influence between intentions and preparatory steps towards a final behavioural outcome.

A Ballistics Examination of Firearm Injuries Involving Breast Implants.

PubMed

Pannucci, Christopher J; Cyr, Adam J; Moores, Neal G; Young, Jason B; Szegedi, Martin

2018-03-01

This ballistics study examines whether saline breast implants can decrease tissue penetration in firearm injuries. We hypothesize that the fluid column within a saline breast implant can alter bullet velocity and/or bullet pattern of mushrooming. The two experimental groups included saline implants with 7.4 cm projection and a no implant group. The experimental design allowed the bullet to pass-through an implant and into ballistics gel (n = 10) or into ballistics gel without passage through an implant (n = 11). Shots that passed through an implant had 20.6% decreased penetration distance when compared to shots that did not pass-through an implant; this difference was statistically significant (31.9 cm vs. 40.2 cm, p < 0.001). Implant group bullets mushroomed prior to gel entry, but the no implant group mushroomed within the gel. Bullet passage through a saline breast implant results in direct bullet velocity reduction and earlier bullet mushrooming; this causes significantly decreased ballistics gel penetration. © 2017 American Academy of Forensic Sciences.

Prosthetic breast reconstruction: indications and update

PubMed Central

Quinn, Tam T.; Miller, George S.; Rostek, Marie; Cabalag, Miguel S.; Rozen, Warren M.

2016-01-01

Background Despite 82% of patients reporting psychosocial improvement following breast reconstruction, only 33% patients choose to undergo surgery. Implant reconstruction outnumbers autologous reconstruction in many centres. Methods A systematic review of the literature was undertaken. Inclusion required: (I) Meta-analyses or review articles; (II) adult patients aged 18 years or over undergoing alloplastic breast reconstruction; (III) studies including outcome measures; (IV) case series with more than 10 patients; (V) English language; and (VI) publication after 1st January, 2000. Results After full text review, analysis and data extraction was conducted for a total of 63 articles. Definitive reconstruction with an implant can be immediate or delayed. Older patients have similar or even lower complication rates to younger patients. Complications include capsular contracture, hematoma and infection. Obesity, smoking, large breasts, diabetes and higher grade tumors are associated with increased risk of wound problems and reconstructive failure. Silicone implant patients have higher capsular contracture rates but have higher physical and psychosocial function. There were no associations made between silicone implants and cancer or systemic disease. There were no differences in outcomes or complications between round and shaped implants. Textured implants have a lower risk of capsular contracture than smooth implants. Smooth implants are more likely to be displaced as well as having higher rates of infection. Immediate breast reconstruction (IBR) gives the best aesthetic outcome if radiotherapy is not required but has a higher rate of capsular contracture and implant failure. Delayed-immediate reconstruction patients can achieve similar aesthetic results to IBR whilst preserving the breast skin if radiotherapy is required. Delayed breast reconstruction (DBR) patients have fewer complications than IBR patients. Conclusions Implant reconstruction is a safe and popular mode of post-mastectomy reconstruction. Evidence exists for the settings in which complications are more likely, and we can now more reliably predict outcomes of reconstruction on an individual basis and assess patient suitability. PMID:27047785

Silicone gel breast implants: science and testing.

PubMed

Kinney, Brian M; Jeffers, Lynn L C; Ratliff, Gregory E; Carlisle, Dan A

2014-07-01

Since the first generation of breast implants, major design innovations, including consistency of the gel, palpability and thickness of the shell, and barrier materials in the shell, have been introduced. Surgeons have not had metrics to assess and compare available implants. Research at independent laboratories included 4 tests: gel elasticity (the gel's ability to retain its shape), gel compression fracture (the resistance to permanent gel deformation), gel-shell peel (the integration of the gel with shell as a cohesive unit), and morphological analysis. Sientra's round High-Strength Cohesive (HSC) experienced the least gel elasticity (5.805 mm), whereas Allergan's round implants experienced the most (7.465 mm). Among shaped implants, Allergan 410 experienced the least gel elasticity (3.242 mm), whereas the Sientra HSC+ implant experienced the most (4.270 mm). Sientra's round (36.32 lbf) and shaped (44.16 lbf) implants demonstrated the highest resistance to gel fracture, with Allergan's implants demonstrating the least among round (23.06 lbf) implants and Mentor Contour Profile Gel (CPG) among shaped (30.45 lbf) implants. For the gel-shell peel test, Sientra's implant required over 26% greater force than Allergan's implant and over 35% greater force than Mentor's implant. Sientra's shaped implants required more than double the peel force than Allergan 410 (119% greater) and Mentor CPG (130% greater). Morphological results showed Sientra's implants preserved structural integrity (-1.10% change). The initial findings show that these implant characteristics are individual factors to be considered separately and are not necessarily correlative. Further study of implants using these and other testing techniques will help clinicians choose between implants.

Polyurethane-Coated Breast Implants Revisited: A 30-Year Follow-Up

PubMed Central

Castel, Nikki; Soon-Sutton, Taylor; Deptula, Peter; Flaherty, Anna

2015-01-01

Background Polyurethane coating of breast implants has been shown to reduce capsular contracture in short-term follow-up studies. This 30-year study is the longest examination of the use of polyurethane-coated implants and their correlation with capsular contracture. Methods This study evaluates the senior surgeon's (F.D.P.) experience with the use of polyurethane-coated implants in aesthetic breast augmentation in 382 patients over 30 years. Follow-up evaluations were conducted for six months after surgery. After the six-month follow-up period, 76 patients returned for reoperation. The gross findings, histology, and associated capsular contracture were noted at the time of explantation. Results No patient during the six-month follow-up period demonstrated capsular contracture. For those who underwent reoperation for capsular contracture, Baker II/III contractures were noted nine to 10 years after surgery and Baker IV contractures were noted 12 to 21 years after surgery. None of the explanted implants had macroscopic evidence of polyurethane, which was only found during the first five years after surgery. The microscopic presence of polyurethane was noted in all capsules up to 30 years after the original operation. Conclusions An inverse correlation was found between the amount of polyurethane coating on the implant and the occurrence of capsular contracture. Increasingly severe capsular contracture was associated with a decreased amount of polyurethane coating on the surface of the implants. No contracture occurred in patients whose implants showed incomplete biodegradation of polyurethane, as indicated by the visible presence of polyurethane coating. We recommend research to find a non-toxic, non-biodegradable synthetic material as an alternative to polyurethane. PMID:25798390

Does the presence of an implant including expander with internal port alter radiation dose? An ex vivo model

PubMed Central

Strang, Barbara; Murphy, Kyla; Seal, Shane; Cin, Arianna Dal

2013-01-01

BACKGROUND: There is a lack of literature examining the dosimetric implications of irradiating breast implants and expanders with internal ports inserted at the time of mastectomy. OBJECTIVE: To determine whether the presence of breast expanders with port in saline or silicone implants affect the dose uniformity across the breast when irradiated with various photon and electron energies. METHODS: One tissue-equivalent torso phantom with overlying tissue expanders in saline or silicone implants were irradiated using tangential fields with 6 MV and 18 MV photons and 9 MeV and 12 MeV electrons. All dose measurements were performed using thermoluminescent dosimeters (TLDs). The TLDs were arranged around the port and the perimeters of either the expander, or saline or silicone implant. Comparisons of measured radiation doses, and between the expected and measured doses of radiation from the TLDs on each prosthesis, were performed. Data were analyzed using two-tailed t tests. RESULTS: There were no differences in TLD measurements between the expander and the saline implant for all energy modalities, and for the expected versus actual measurements for the saline implant. Higher than anticipated measurements were recorded for a significant number of TLD positions around the silicone implants. CONCLUSIONS: Radiation doses around saline implants or expanders with internal port were unaltered, whereas dose recordings for silicone implants were higher than predicted in the present laboratory/ex vivo study. PMID:24431935

Rupture of poly implant prothèse silicone breast implants: an implant retrieval study.

PubMed

Swarts, Eric; Kop, Alan M; Nilasaroya, Anastasia; Keogh, Catherine V; Cooper, Timothy

2013-04-01

Poly Implant Prothèse implants were recalled in Australia in April of 2010 following concerns of higher than expected rupture rates and the use of unauthorized industrial grade silicone as a filler material. Although subsequent investigations found that the gel filler material does not pose a threat to human health, the important question of what caused a relatively modern breast implant to have such a poor outcome compared with contemporary silicone breast implants is yet to be addressed. From a cohort of 27 patients, 19 ruptured Poly Implant Prothèse breast implants were subjected to a range of mechanical tests and microscopic/macroscopic investigations to evaluate possible changes in properties as a result of implantation. New Poly Implant Prothèse implants were used as controls. All samples, explanted and controls, complied with the requirements for shell integrity as specified in the International Organization for Standardization 14607. Compression testing revealed rupture rates similar to those reported in the literature. Shell thickness was highly variable, with most shells having regions below the minimum thickness of 0.57 mm that was specified by the manufacturer. Potential regions of stress concentration were observed on the smooth inner surfaces and outer textured surfaces. The high incidence of Poly Implant Prothèse shell rupture is most likely a result of inadequate quality control, with contributory factors being shell thickness variation and manufacturing defects on both inner and outer surfaces of the shell. No evidence of shell degradation with implantation time was determined.

Ten-Year Results From the Natrelle 410 Anatomical Form-Stable Silicone Breast Implant Core Study

PubMed Central

Maxwell, G. Patrick; Van Natta, Bruce W.; Bengtson, Bradley P.; Murphy, Diane K.

2015-01-01

Background Silicone breast implants have long been used for breast augmentation and reconstruction. During this time, these medical devices have gone through a number of modifications to improve their safety, quality, and clinical outcome performance. Objectives The authors conducted a 10-year study to determine the safety and effectiveness of Natrelle 410 silicone breast implants. Methods This prospective, multicenter study enrolled 941 subjects who were undergoing either augmentation, augmentation revision, reconstruction, or reconstruction revision. Data on complications, reoperations, explantations, and subject satisfaction were collected at annual clinic visits, and one-third of subjects underwent biennial magnetic resonance imaging (MRI) to screen for implant rupture. The authors used the Kaplan-Meier estimator to calculate risk rates for local complications, reoperations, and explantations. Results Capsular contracture rates increased approximately 1% per year from the previously reported 6-year rates. The rates were significantly lower than those from the Natrelle round gel core study. The overall rate of confirmed ruptured implants in subjects who underwent MRI was 5.7%. Eleven late seromas were reported. The most common reason for explantation was a subject requesting a size or style change. Satisfaction rates remained high through 10 years, with most subjects saying they were somewhat or definitely satisfied with their implants. Conclusions This 10-year prospective trial demonstrated the long-term safety and effectiveness of Natrelle 410 anatomical form-stable implants. The complication rates were low and the satisfaction rates were high. Level of Evidence: 1 Therapeutic PMID:25717116

Objective Comparison of Commercially Available Breast Implant Devices.

PubMed

Henderson, Peter W; Nash, David; Laskowski, Marta; Grant, Robert T

2015-10-01

Breast implants are frequently used for both cosmetic breast augmentation and breast reconstruction after mastectomy. Three companies currently offer FDA-approved breast implants (Allergan, Mentor, and Sientra), but their product offerings-including permanent breast implants, breast tissue expanders, sizers, and post-operative warranty-can be difficult to compare because of brand names and company-specific jargon. The ability to have a brand-agnostic understanding of all available options is important for both the surgical trainee as well as the surgeon in clinical practice. After a brief review of the history of breast implant devices, this review utilizes a unique conceptual framework based on variables such as fill material, shape, relative dimensions, and surface coating to facilitate a better understanding of the similarities and differences between the different company's offerings. Specifically, we identify which types of devices are offered by all three companies, those that are offered by only one company, those that have very limited product offerings, and those combinations that are not available at all. Finally, clinical implications are drawn from this framework that can be used by both cosmetic and reconstructive surgeons to counsel patients about all available options. Importantly, this project is entirely independent of any company's funding, support, or input. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

[Criteria of life quality after reconstructive breast cancer surgery].

PubMed

Strittmatter, H J; Neises, M; Blecken, S R

2006-08-01

The aim of this study was to evaluate the quality of life of women after a breast cancer surgery. The question was if women which had reconstructive breast cancer surgery experience a higher quality of life than women who, for various distinct reasons, had not undergone reconstruction. The participants of this study were women who had either received a mastectomy or those who at the same time underwent a breast reconstruction using implants during the time period from 1/1/2000 until 31/10/2003 at the University Hospital for Women of Heidelberg and Mannheim. With the help of three standardised questionnaires, the women could describe their post-surgical physical and psychological condition as well as the perceived quality of life. The study included 33 patients who had received breast implants and 31 patients without reconstruction. Women who had breast cancer surgery with reconstruction through implants had less problems and restrictions concerning their physical condition as well as their functional status. Moreover, compared to those participants with no reconstruction, their cognitive and emotional burdens were not as pronounced and they also they were able to better cope with the disease. Thus, their overall quality of life was superior than that of the other women. Breast reconstruction after primary and secondary mastectomy is an important contribution in order to improve the self-esteem and quality of a patient's life. Furthermore, it plays an essential role in coping with the psychological effects of breast cancer.

Aesthetic remodeling of the healthy breast in breast reconstruction using expanders and implants.

PubMed

Mayo, Federico; Vecino, Maria González

2009-03-01

Breast reconstruction using expanders and implants still is the most common surgical procedure in many hospitals. The most important factor in obtaining a satisfactory aesthetic result for both the patient and the surgeon is to achieve the greatest symmetry possible between the healthy breast and the reconstructed breast. To get a good result, it is necessary to make an exhaustive preoperative examination that facilitates selection of the most suitable technique for remodeling the healthy breast and to choose the most suitable expander for placement on the side to be reconstructed. A retrospective study investigated 60 patients submitted to breast reconstruction between October 2005 and January 2008. The study analyzed the characteristics of the healthy breast (e.g., volume, ptosis), which is treated in the first part of the first operation. These characteristics are used later as a model for reconstructing the mastectomy side. The most adequate technique for remodeling the healthy breast based on its characteristics is indicated, as well as techniques not recommended for obtaining the desired symmetry. This study aimed to determine the basis for selecting the most appropriate technique to use in managing the healthy breast and obtaining the most aesthetic result in breast reconstruction. The healthy breast analysis allows an algorithm of indications to be elaborated based on the volume and degree of ptosis exhibited by the healthy breast. The healthy breast should resemble the reconstructed breast with its anatomic implant. In this study, the technique used most often to remodel the healthy breast was reduction surgery with a superomedial pedicle, and glandular flap (autoimplant) (30%). The results were highly satisfactory for both the patient and the surgeon. Aesthetic remodeling of the healthy breast is the first surgical treatment in breast reconstruction in two stages using expanders and implants. The expander for reconstruction of the other breast then is selected according to the measurements of the healthy modified breast. This reproducible and simple model of breast reconstruction, with its detailed preoperative plan, allows clinicians to obtain a good aesthetic result for breast reconstruction patients.

The double capsules in macro-textured breast implants.

PubMed

Giot, Jean-Philippe; Paek, Laurence S; Nizard, Nathanael; El-Diwany, Mostafa; Gaboury, Louis A; Nelea, Monica; Bou-Merhi, Joseph S; Harris, Patrick G; Danino, Michel A

2015-10-01

Breast implants are amongst the most widely used types of permanent implants in modern medicine and have both aesthetic and reconstructive applications with excellent biocompatibility. The double capsule is a complication associated with textured prostheses that leads to implant displacement; however, its etiology has yet to be elucidated. In this study, 10 double capsules were sampled from breast expander implants for in-depth analysis; histologically, the inner capsular layer demonstrated highly organized collagen in sheets with delamination of fibers. At the prosthesis interface (PI) where the implant shell contacts the inner capsular layer, scanning electron microscopy (SEM) revealed a thin layer which mirrored the three-dimensional characteristics of the implant texture; the external surface of the inner capsular layer facing the intercapsular space (ICS) was flat. SEM examination of the inner capsule layer revealed both a large bacterial presence as well as biofilm deposition at the PI; a significantly lower quantity of bacteria and biofilm were found at the ICS interface. These findings suggest that the double capsule phenomenon's etiopathogenesis is of mechanical origin. Delamination of the periprosthetic capsule leads to the creation of the ICS; the maintained separation of the 2 layers subsequently alters the biostability of the macro-textured breast implant. Copyright © 2015 Elsevier Ltd. All rights reserved.

A prospective study comparing endoscopic subcutaneous mastectomy plus immediate reconstruction with implants and breast conserving surgery for breast cancer.

PubMed

Fan, Lin-Jun; Jiang, Jun; Yang, Xin-Hua; Zhang, Yi; Li, Xing-Gang; Chen, Xian-Chun; Zhong, Ling

2009-12-20

Breast conserving surgery (BCS) has been the standard surgical procedure for the treatment of early breast cancer. Endoscopic subcutaneous mastectomy (ESM) plus immediate reconstruction with implants is an emerging procedure. The objective of this prospective study was to evaluate the clinical outcomes of these two surgical procedures in our clinical setting. From March 2004 to October 2007, 43 patients with breast cancer underwent ESM plus axillary lymph node dissection and immediate reconstruction with implants, while 54 patients underwent BCS. The clinical and pathological characteristics, surgical safety, and therapeutic effects were compared between the two groups. There were no significant differences in the age, clinical stage, histopathologic type of tumor, operative blood loss, postoperative drainage time, and postoperative complications between the two groups (P > 0.05). The postoperative complications were partial necrosis of the nipple and superficial skin flap in the ESM patients, and hydrops in the axilla and residual cavity in the BCS patients. There was no significant difference in the rate of satisfactory postoperative cosmetic outcomes between the ESM (88.4%, 38/43) and BCS (92.6%, 50/54) patients (P > 0.05). During follow-up of 6 months to 4 years, all patients treated with ESM were disease-free, but 3 patients who underwent BCS had metastasis or recurrence -one of these patients died of multiple organ metastasis. After considering the wide indications for use, high surgical safety, and favorable cosmetic outcomes, we conclude that ESM plus axillary lymph node dissection and immediate reconstruction with implants - the new surgery of choice for breast cancer - warrants serious consideration as the prospective next standard surgical procedure.

Analysis of periprosthetic capsular tissue from women with silicone breast implants by magic-angle spinning NMR.

PubMed

Garrido, L; Young, V L

1999-09-01

The amount of silicone (polydimethylsiloxane [PDMS]) in capsular tissue surgically removed from women with breast implants was measured by using (29)Si and (1)H magic-angle spinning solid-state NMR spectroscopy. Twelve women having smooth surface silicone gel-filled implants, including a subject with "low-bleed" double-lumen implants, had detectable levels of PDMS ranging from 0. 05 to 9.8% silicon in wet tissue (w/w). No silicon-containing compounds other than PDMS were detected. No correlation was found between the amount of PDMS measured in the capsular tissue and the length of implantation time (Pearson correlation coefficient, r = 0. 22). The results showed no relationship between higher amounts of PDMS and capsular contracture (p = 0.74) or other symptoms (p = 0. 53). Magn Reson Med 42:436-441, 1999. Copyright 1999 Wiley-Liss, Inc.

Natrelle round silicone breast implants: Core Study results at 10 years.

PubMed

Spear, Scott L; Murphy, Diane K

2014-06-01

Allergan's Natrelle round silicone-filled breast implants were approved by the U.S. Food and Drug Administration in 2006 based on interim results from the Core Study; final 10-year study results are now available. Seven hundred fifteen subjects were implanted with smooth and Biocell textured Natrelle round silicone implants and attended clinic visits at 0 to 4 weeks, 6 months, 1 year, and annually through 10 years. Approximately one-third of subjects underwent magnetic resonance imaging at years 1, 3, 5, 7, and 9 to assess rupture. Complication rates showed modest increases over the previously published 6-year rates. The Kaplan-Meier capsular contracture rate was 18.9 percent for augmentation, 28.7 percent for revision-augmentation, and 24.6 percent for reconstruction. Among augmentation subjects, capsular contracture was significantly lower (p = 0.023) for submuscular (15.7 percent) versus subglandular (26.3 percent) placement. The overall rupture rate in the magnetic resonance imaging cohort was 13.0 percent for subjects and 7.7 percent for implants. By the end of the study, 81.8 percent of augmentation subjects still had an original implant in place. Using a five-point scale, 94.2 percent of augmentation, 83.8 percent of revision-augmentation, and 90.7 percent of reconstruction subjects reported being satisfied or definitely satisfied with their implants. Significant improvement over baseline was also seen in overall breast satisfaction and satisfaction with breast size, shape, feel, and how well they matched. The 10-year data from the Natrelle Core Study, which can guide surgeons and patients in decision-making, demonstrate safety and high levels of patient satisfaction. Therapeutic, III.

Magnetic resonance imaging screening results compared with explantation results in poly implant prothèse silicone breast implants, recalled from the European market in 2010.

PubMed

Maijers, Maria C; Niessen, Francisus B; Veldhuizen, Jacob F H; Ritt, Marco J P F; Manoliu, Radu A

2014-02-01

In a prospective cohort study, the authors followed 112 women whose Poly Implant Prothèse silicone breast implants were recalled. Magnetic resonance imaging results and clinical consequences were previously published. The authors compared magnetic resonance imaging screening with explantation results to study the diagnostic value of magnetic resonance imaging in this unique unselected and nonbiased group. women with 224 proven Poly Implant Prothèse implants after a mean implantation time of 10 years were enrolled in 2011. All women underwent magnetic resonance imaging screening and were offered explantation. The explantation details of 107 women could be compared with magnetic resonance imaging results. Of 107 women, 29 (27 percent) had at least one ruptured implant at explantation, and 44 of 214 explanted implants (21 percent) were ruptured. The magnetic resonance imaging results correctly diagnosed 154 intact and 35 ruptured implants. Sensitivity and specificity were 80 percent and 91 percent, respectively. The positive predictive value was 69 percent, and the negative predictive value was 95 percent. The accuracy of magnetic resonance imaging is comparable to previously published data from other manufacturers of modern silicone implants but lower than that of some recent validation studies in selected symptomatic women. The authors believe that this study is representative of common daily practice as they followed normal day-to-day magnetic resonance imaging protocol without using multiple independent readers. The authors hope that this study will contribute to the ongoing discussion to screen asymptomatic women with modern silicone breast implants. Diagnostic, II.

Evolution and update on current devices for prosthetic breast reconstruction

PubMed Central

2015-01-01

Over the past decade, the leading breast reconstruction modality has shifted from autologous tissue to implants. This trend reversal is multi-factorial but includes increasing bilateral mastectomies and the more widespread acceptance of implants due to stringent quality and safety regulatory surveillance by the US Food and Drug Administration (FDA). Since 2012, the US FDA has approved several new implant styles, shapes and textures, increasing the choices for patients and surgeons. Predictable, superior aesthetic results after prosthetic breast reconstruction are attainable, but require thoughtful planning, precise surgical technique and appropriate device selection based on several different patient and surgeon parameters, such as patient desires, body mass index, breast shape, mastectomy flap quality and tissue based bio-dimensional assessment. This article briefly reviews historic devices used in prosthetic breast reconstruction beginning in the 1960s through the modern generation devices used today. We reflect on the rigorous hurdles endured over the last several decades leading to the approval of silicone gel devices, along with their well-established safety and efficacy. The various implant characteristics can affect feel and performance of the device. The many different styles and features of implants and expanders are described emphasizing surgical indications, advantages and disadvantages of each device. PMID:26005642

Long-Term Safety of Textured and Smooth Breast Implants.

PubMed

Calobrace, M Bradley; Schwartz, Michael R; Zeidler, Kamakshi R; Pittman, Troy A; Cohen, Robert; Stevens, W Grant

2017-12-13

In this review, the authors provide a 20-year review and comparison of implant options and describe the evolution of breast implant surface textures; compare available implant surfaces; present long-term safety data from the 10-year US-based Core clinical studies; list the key benefits and risks associated with smooth and textured implants; and provide perspectives on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The authors explore the key benefits and risks associated with all available devices so that optimal and safe patient outcomes can be achieved. © 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

Breast-implant texturing associated with delamination of capsular layers: A histological analysis of the double capsule phenomenon.

PubMed

Efanov, J I; Giot, J P; Fernandez, J; Danino, M A

2017-06-01

Macro-texturing of breast implants was developed with the double goal of improving implant stabilization within the breast cavity and decreasing the rate of capsular contractures. However, recent evidence suggests that double capsular formation, a potentially worrisome phenomenon associated with late seromas and biofilms, occurs with preponderance in macro-textured implants. Our objective was to analyze histologically different regions of double capsules to determine if they are more prone to mechanical movements. A prospective analysis including patients undergoing second-stage expander to definitive breast-implant reconstruction post-mastectomy was conducted after intraoperative identification of the double capsule phenomenon. Two samples were collected from each capsules around the implant, located centrally and laterally. The specimens were sent for histological analysis by the institution's pathologist. In total, 10 patients were identified intraoperatively with partial double capsule phenomenon. Among samples retrieved from the lateral aspect of the breast implant, all were associated with delamination and fractures in the collagen matrix of the double capsules. This phenomenon was not observed in any sample from the dome of the breast. Breast-implant macro-texturing plays an important role on delamination of capsules on lateral portions of the breast, which may have an etiologic role in double capsule formation. Manufacturing implants with macro-texturing on one side and smooth surface on the other could diminish mechanical shear forces responsible for these findings. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

MR imaging of silicone breast implants: evaluation of prospective and retrospective interpretations and interobserver agreement.

PubMed

Quinn, S F; Neubauer, N M; Sheley, R C; Demlow, T A; Szumowski, J

1996-01-01

MR imaging was used to evaluate the integrity of silicone breast implants in 54 women with 108 implants. MR images were interpreted by relatively inexperienced readers who tried to reproduce the experiences reported in the literature. The study examines the interobserver agreement using different diagnostic signs and the influence of experience on interpretation errors. Prospective and retrospective interpretations were compared with surgical findings at the time of explanation. Diagnostic indicators, including the linguine sign, the inverted tear drop sign, the C sign, water droplets mixed with silicone, and extracapsular globules of silicone, were evaluated for diagnostic efficacy and interobserver agreement. The prospective sensitivity and specificity were 87% and 78%, respectively. With the retrospective interpretations, the sensitivity and specificity increased to 93% and 92%, respectively. Most of the prospective false-positive interpretations were due to misinterpreting radial folds as signs of implant rupture. Six implants interpreted retrospectively as false positives had gross amounts of silicone around the implants at surgery but there were no obvious rents in the implant shells. There was fair to excellent interobserver agreement with the individual diagnostic signs except for extracapsular globules of silicone. All of the signs had specificities of greater than 90%. The sensitivities of the individual signs were less than the overall retrospective sensitivity. With experience, the sensitivity improved from 87% to 93% and the specificity improved from 78% to 92%. This study helps substantiate the use of diagnostic signs used by other authors to detect silicone loss from breast implants by MR imaging; however, questions remain as to the clinical role of MR imaging in evaluating implants for silicone loss.

One-step breast reconstruction with polyurethane-covered implants after skin-sparing mastectomy.

PubMed

Rancati, Alberto; Soderini, Alejandro; Dorr, Julio; Gercovich, Gustavo; Tessari, Luciano; Gonzalez, Eduardo

2013-12-01

Skin-sparing mastectomy (SSM) and immediate one-step breast reconstruction with implants has become an increasingly popular, effective treatment for selected patients with breast carcinoma. However, it is associated with high complication rates. Breast augmentation with polyurethane-covered implants (PCIs) has consistently had optimal short-term and long-term results with low rates of capsular contracture. The aim of this study was to evaluate the clinical and aesthetic outcomes of immediate one-step breast reconstruction with PCI after SSM in early breast cancer patients at a single institution. We reviewed the records of 221 consecutive breast cancer patients who underwent one-stage immediate reconstruction with PCI after SSM from 1995 through 2005. Patient and tumour characteristics, type of reconstruction, postoperative complications, aesthetic results and recurrence rate were analysed. The mean age of the patients was 52±11 years (range, 30-76; standard deviation (SD), 11). The American Joint Committee on Cancer (AJCC) pathologic stages were 0 (10%), I (63.3%) and II (26.7%). Thirty-nine (17.65%; confidence interval (CI)=13.04-23.1) of the 221 patients had complications; seven had prosthesis extrusion requiring an implant (five due to skin necrosis, one due to infection and one due to late haematoma). In six of these seven cases, the procedure was indicated for local recurrence after conservative breast surgery with adjunctive radiation therapy (rescue procedure). Thirty-two (14.4%) patients had minor complications: 12 had cutaneous rash, four had malpositioned implants and 16 had inadequate implant projection. At long-term follow-up, four (1.8%) patients had developed grade IV capsular contracture associated with postoperative radiation therapy. At a median follow-up of 98 months (range, 36-156), 14 (6.3%) patients had tumour recurrence and 12.2% had distant metastasis. Nineteen patients had died of cancer, and 192 (86.8%) remained disease free. One-stage immediate breast reconstruction with PCI after SSM appears to be oncologically safe and provides a high level of patient satisfaction. Copyright © 2013 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Back to the future: a 15-year experience with polyurethane foam-covered breast implants using the partial-subfascial technique.

PubMed

de la Peña-Salcedo, Jose Abel; Soto-Miranda, Miguel Angel; Lopez-Salguero, Jose Fernando

2012-04-01

Implants with a polyurethane foam cover have been used by plastic surgeons since Ashley described them in 1970. Overwhelming evidence confirms the benefits of these implants, especially the extremely low incidence of capsular contracture (grades 3 and 4, Baker classification). On the other hand, except for a transient and self-limited rash, there is no evidence that polyurethane implants present more complications than texturized or smooth gel implants. Due to concerns of polyurethane-induced cancer, these implants were withdrawn in United States after approximately 110,000 American women had received them. This fact, together with the probability that these implants will be reintroduced in the United States, suggests that continued monitoring of their long-term safety and effectiveness is mandatory. A retrospective study analyzed the outcomes of 996 implants inserted during a period of 15 years. The incidence of early and late complications was analyzed as well as the aesthetic outcome. The complications evaluated included hematoma (0.6%), infection (0.4%), seroma (0.8%), rash (4.3%), wound dehiscence (0%), capsular contracture (0.4%), implant malposition (0.8%), need for revisional surgery (1.2%), implant rupture (0.7%), rippling (1.8%), and polyurethane-related cancer (0%). Regarding the aesthetic outcome, 95% of the patients expressed satisfaction with their final result. The polyurethane foam-covered implants have been proven safe for use in breast surgery. They provide the lowest rate of capsular contracture (0.4% in the current study) and excellent aesthetic results.

Multiple autoantibodies in patients with silicone breast implants.

PubMed

Bar-Meir, E; Teuber, S S; Lin, H C; Alosacie, I; Goddard, G; Terybery, J; Barka, N; Shen, B; Peter, J B; Blank, M

1995-04-01

Diverse immunologic abnormalities have been described in women who received silicone breast implants. However, most studies have focused on either a limited number of patients or a small panel of autoantibodies. We report the analysis of 20 autoantibodies in 116 women with implants and 134 controls. The patients ranged from 26- to 66-years-old, with a mean of 45.7 +/- 8.3 years; breast prostheses were in place for a mean of 15 +/- 5.6 years, with a range of 4 to 30, the chief complaints of the 116 patients included polyarthralgias, fatigue, myalgias, morning stiffness, and decreased memory. All 250 sera were tested blindly using a panel of 20 autoantigens including SS-A, SS-B, RNP, cardiolipin (CL), collagen types I, II and IV, phosphatidylserine (PS), myeloperoxidase (MPO), sulfatides (sulf), thyroglobulin (TG), gangliosides (GDIa;GM2), proteinase-3 (PR3), Jo-1, Sm, HPRPP-ribosomal phosphate, histones (H2AH2B), Scl-70 and glomerular basement membrane (NC-1). Values from individual patients were considered positive only when greater than 3 SD above the control mean. There was a statistically significant greater frequency of autoantibodies in women with implants for 15 of the 20 autoantigens; these were particularly striking for anti-H2AH2B, HPRPP, SS-A, SS-B, Scl-70, CL, PS, GM2, and NC-1. Many patients harbored several autoantibodies; 20% had four autoantibodies; 8% had six autoantibodies. The association of autoantibodies and implants suggests an adjuvant action of silicon/silicone byproducts.

Polyurethane-covered mammary implants: a 12-year experience.

PubMed

Gasperoni, C; Salgarello, M; Gargani, G

1992-10-01

Polyurethane-covered mammary implants are the implants of choice in aesthetic and reconstructive mammary surgery. These implants give very good results in regard to breast contour and consistency, and have a very low complication rate. We present our 12-year experience using polyurethane-covered prostheses. We place the implant mostly in the subglandular or subcutaneous site, and their capsular contracture rate is extremely low (3.3%). Based on our experience, we also review the other complications and side effects occurring with polyurethane prostheses and discuss them in detail.

Form-stable silicone gel breast implants.

PubMed

Jewell, Mark

2009-01-01

This article addresses the question of what is the optimal shape for a breast implant. It is oriented toward processes, system engineering, and operational excellence versus being a treatise on the author's personal technique.

Breast MRI scan

MedlinePlus

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Platinum concentration in silicone breast implant material and capsular tissue by ICP-MS.

PubMed

Maharaj, S V M

2004-09-01

Inductively coupled plasma-mass spectrometry (ICP-MS) was used to determine the concentration of platinum (Pt) in silicone breast implant gel (range, 0.26-48.90 microg g(-1) Pt; n=15), elastomer (range, 3.05-28.78 microg g(-1) Pt; n=7), double lumen (range, 5.79-125.27 microg g(-1) Pt; n=7), foam (range, 5.79-8.36 microg g(-1) Pt; n=2), and capsular tissue (range, 0.003-0.272 microg g(-1) Pt; n=15). The results show that very high levels of Pt are present in the encasing elastomer, double lumen, and foam envelope materials. Silicone breast implants can be a source of significant Pt exposure for individuals with these implants.

Breast Massage, Implant Displacement, and Prevention of Capsular Contracture After Breast Augmentation With Implants: A Review of the Literature.

PubMed

Sood, Aditya; Xue, Erica Y; Sangiovanni, Christopher; Therattil, Paul J; Lee, Edward S

2017-01-01

Objective: Capsular contracture, the most common complication following breast augmentation with implants, is a complex inflammatory reaction that ultimately leads to fibrosis at the contact site between the implant and tissue. A number of peri-, pre-, and postoperative techniques have been postulated and implemented by many surgeons to reduce the incidence of capsular contracture. Breast massage and implant displacement technique is a commonly recommended practice that has not been well studied in regard to capsular contracture prevention. The authors present a review of the literature addressing methods and efficacy of massage and implant displacement techniques after breast augmentation. Methods: A literature review was performed using PubMed and the Cochrane Collaboration Library for primary research articles on breast massage or implant displacement after breast augmentation with implants for breast contracture prevention between January 1975 and March 2017. Exclusion criteria were studies that were focused on the treatment rather than prevention of breast contracture, addressed other strategies of preventing contracture as the main focus, or did not report the number of patients studied. Information related to massage technique and capsular contracture outcomes was extracted. Results: The literature search yielded 4 relevant studies, with a total of 587 patients. Outcomes evaluated included massage technique, onset of massage, frequency of massage, and incidence of capsular contracture. Breast massage was introduced between 2 days and 2 weeks postoperatively, performed twice daily, and lasted from 2 to 5 minutes for each breast. Final postoperative follow-up concluded between 6 and 36 months. The average capsular contracture rate was similar, 31% (range, 0-35) in the massage group versus 40% (range, 30-90) in the nonmassage group. Conclusions: While multiple techniques have been proposed and practiced in the prevention of capsular contracture, breast massage and implant displacement techniques remain controversial. While there is a method to measure adequacy of breast massage pressure, it is not widely utilized. The available data do not support breast massage to prevent capsular contracture; more studies with standardized techniques are needed to better assess the efficacy of breast massage in preventing capsular contracture.

Poly Implant Prothèse (PIP) incidence of rupture: a retrospective MR analysis in 64 patients.

PubMed

Scotto di Santolo, Mariella; Cusati, Bianca; Ragozzino, Alfonso; Dell'Aprovitola, Nicoletta; Acquaviva, Alessandra; Altiero, Michele; Accurso, Antonello; Riccardi, Albina; Imbriaco, Massimo

2014-12-01

The purpose of this retrospective study was to describe the magnetic resonance imaging (MRI) features of Poly Implant Prothèse (PIP) hydrogel implants in a group of 64 patients and to assess the incidence of rupture, compared to other clinical trials. In this double-center study, we retrospectively reviewed the data sets of 64 consecutive patients (mean age, 43±9 years, age range, 27-65 years), who underwent breast MRI examinations, between January 2008 and October 2013, with suspected implant rupture on the basis of clinical assessment or after conventional imaging examination (either mammography or ultrasound). All patients had undergone breast operation with bilateral textured cohesive gel PIP implant insertion for aesthetic reasons. The mean time after operation was 8 years (range, 6-14 years). No patients reported history of direct trauma to their implants. At the time of clinical examination, 41 patients were asymptomatic, 16 complained of breast tenderness and 7 had clinical evidence of rupture. Normal findings were observed in 15 patients. In 26 patients there were signs of mild collapse, with associated not significant peri-capsular fluid collections and no evidence of implant rupture; in 23 patients there was suggestion of implant rupture, according to breast MRI leading to an indication for surgery. In particular, 14 patients showed intra-capsular rupture, with associated evidence of the linguine sign in all cases; the keyhole sign and the droplet signs were observed in 6 cases. In 9 patients there was evidence of extra-capsular rupture, with presence of axillary collections (siliconomas) in 7 cases and peri-prosthetic and mediastinal cavity siliconomas, in 5 cases. The results of this double center retrospective study, confirm the higher incidence (36%) of prosthesis rupture observed with the PIP implants, compared to other breast implants.

Breast prosthesis: Management of patients after plastic surgery

PubMed Central

Bassetti, E.; Pediconi, F.; Luciani, M.L.; Santucci, E.; Miglio, E.; Candreva, R.

2011-01-01

Breast augmentation and breast reconstruction are increasingly common operations. All radiologists need to be able to recognize the normal appearances of the more commonly used implants on various imaging modalities and breast radiologists in particular are facing new challenges when imaging the women involved. This work aims to review the normal and abnormal findings in women undergoing breast implant surgery using ultrasonography, mammography, and magnetic resonance imaging. PMID:23396957

The Economics of Prepectoral Breast Reconstruction.

PubMed

Glasberg, Scot Bradley

2017-12-01

The world of breast reconstruction over the last several years has seen a dramatic shift in focus to discussion and the application of placing tissue expanders and implants back into the prepectoral space. Although this technique failed during the early advent of breast reconstruction, newer technologies such as advances in fat grafting, improved acellular dermal matrices, better methods of assessing breast flap viability, and enhanced implants appear to have set the stage for the resurgence and positive early results seen with this technique. The main benefits of a switch to prepectoral breast reconstruction clinically appears to be less associated pain, lower incidence of animation deformities, and its associated symptoms as well as presumably better aesthetics. Early data suggest that the results are extremely promising and early adopters have attempted to define the ideal patients for prepectoral breast reconstruction. As with any new operative procedure, an assessment of finances and costs are crucial to its successful implementation. Although current data are minimal, this article attempts to build the fundamentals of an economic model that exhibits and displays potential savings through the use of prepectoral breast reconstruction.

Three-dimensional imaging, an important factor of decision in breast augmentation.

PubMed

de Runz, A; Boccara, D; Bertheuil, N; Claudot, F; Brix, M; Simon, E

2018-04-01

Since the beginning of the 21st century, three-dimensional imaging systems have been used more often in plastic surgery, especially during preoperative planning for breast surgery and to simulate the postoperative appearance of the implant in the patient's body. The main objective of this study is to assess the patients' attitudes regarding 3D simulation for breast augmentation. A study was conducted, which included women who were operated on for primary breast augmentation. During the consultation, a three-dimensional simulation with Crisalix was done and different sized implants were fitted in the bra. Thirty-eight women were included. The median age was 29.4, and the median prosthesis volume was 310mL. The median rank given regarding the final result was 9 (IQR: 8-9). Ninety percent of patients agreed (66% absolutely agreed, and 24% partially agreed) that the final product after breast augmentations was similar to the Crisalix simulation. Ninety-three percent of the patients believed that the three-dimensional simulation helped them choose their prosthesis (61% a lot and 32% a little). After envisaging a breast enlargement, patients estimated that the Crisalix system was absolutely necessary (21%), very useful (32%), useful (45%), or unnecessary (3%). Regarding prosthesis choice, an equal number of women preferred the 3D simulation (19 patients) as preferred using different sizes of implants in the bra (19 patients). The present study demonstrated that 3D simulation is actually useful for patients in order to envisage a breast augmentation. But it should be used as a complement to the classic method of trying different sized breast implants in the bra. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Development, fabrication and evaluation of a novel biomimetic human breast tissue derived breast implant surface.

PubMed

Barr, S; Hill, E W; Bayat, A

2017-02-01

Breast implant use has tripled in the last decade with over 320,000 breast implant based reconstructions and augmentations performed in the US per annum. Unfortunately a considerable number of women will experience capsular contracture, the irrepressible and disfiguring, tightening and hardening of the fibrous capsule that envelops the implant. Functionalising implant surfaces with biocompatible tissue-specific textures may improve in vivo performance. A novel biomimetic breast implant is presented here with anti-inflammatory in vitro abilities. Topographical assessment of native breast tissue facilitated the development of a statistical model of adipose tissue. 3D grayscale photolithography and ion etching were combined to successfully replicate a surface modelled upon the statistics of breast tissue. Pro-inflammatory genes ILβ1, TNFα, and IL6 were downregulated (p<0.001) and anti-inflammatory gene IL-10 were upregulated on the novel surface. Pro-inflammatory cytokines Gro-Alpha, TNFα and neutrophil chemoattractant IL8 were produced in lower quantities and anti-inflammatory IL-10 in higher quantities in culture with the novel surface (p<0.01). Immunocytochemistry and SEM demonstrated favourable fibroblast and macrophage responses to these novel surfaces. This study describes the first biomimetic breast tissue derived breast implant surface. Our findings attest to its potential translational ability to reduce the inflammatory phase of the implant driven foreign body reaction. Breast implants are still manufactured using outdated techniques and have changed little since their inception in the 1960's. Breast implants can cause a medical condition, capsular contracture which often results in disfigurement, pain, implant removal and further surgery. This condition is due to the body's reaction to these breast implants. This article describes the successful development and testing of a novel breast implant surface inspired by the native shapes present in breast tissue. Results show that this novel implant surface is capable of reducing the negative reaction of human cells to these surfaces which may help reduce capsular contracture formation. This work represents the first steps in producing a biocompatible breast implant. Copyright © 2016 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

Outcome of 122 delayed breast reconstruction following post-mastectomy radiotherapy: The scarless latissimus dorsi flap with tissue expansion technique.

PubMed

de Runz, A; Boccara, D; Bekara, F; Chaouat, M; Mimoun, M

2017-02-01

Delayed breast reconstruction with tissue expansion may be risky after radiotherapy, due to the poor skin quality. To permit the use of the tissue expansion procedure, we propose a scarless latissimus dorsi flap to bring tissue trophicity, by a healthy vascularized muscular interface with no donor scar and no patch effect. The objective of this study is to assess the outcome of the tissue expansion technique with scarless latissimus dorsi flap after post-mastectomy radiotherapy. All the patients who had benefited of a delayed breast reconstruction after radiotherapy using tissue expansion technique with scarless latissimus dorsi flap, between January 2000 and January 2013, were reviewed. The exclusion criteria were: prior breast reconstruction, or interruption of breast reconstruction procedure due to active metastatic disease requiring ongoing oncological treatment. The complications were identified: failures of reconstruction, implant exposure, wound dehiscence, capsular contracture, deflation of implant, hematoma, infection, and skin necrosis. One hundred and twenty-two breasts were reviewed. The average time between the flap and the expander intervention was: 194±114 SD (28-1051) days. The mean volume of inserted expander was 633±111 SD (350-1100) mL and the mean inflation volume was 578±190 SD (170-1160) mL. The average time between insertion of the expander and insertion of the permanent implant was 132±76 SD (49-683) days. The mean inflation of the implant volume was 368±105 SD (130-620) mL. Forty patients developed at least one complication. The most common complication was the appearance of a capsular contracture requiring a capsulectomy: 11 (9.2%) with permanent implants and 6 (4.9%) with expander. Deflation of implants occurred with six permanent implants and with one expander. There were 3 breast reconstructions failures (two infections and one exposure of implants). This procedure offers the advantages that there is no unattractive scar, and that there are low rates of exposure or failed reconstruction. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Patients’ satisfaction with anatomic polyurethane implants

PubMed Central

2017-01-01

This paper presents patients satisfaction using anatomical polyurethane breast implants. We performed surgery on 525 patients, 370 of which were primary and 155 were secondary to various causes such as capsular contracture, ruptured implants, volume changes, and incorrect positioning of the implant. The advantages of silicone polyurethane covers shown high level of patient satisfaction, low incidence of capsular contracture, and absence of implant rotation, and late seroma. PMID:28497022

Versatility of Capsular Flaps in the Salvage of Exposed Breast Implants

PubMed Central

Tenna, Stefania; Cagli, Barbara; Pallara, Tiziano; Campa, Stefano; Persichetti, Paolo

2015-01-01

Summary: Breast implant exposure due to poor tissue coverage or previous irradiation represents a surgical challenge both in the reconstructive and aesthetic plastic surgery practice. In case of implant extrusion or incipient exposure, the commonly suggested strategies, such as targeted antibiotic therapy, drainage and lavage of the cavity, fistulectomy, and primary closure, may be ineffective leading the surgeon to an unwanted implant removal or to adopt more invasive flap coverage procedures. Breast implant capsule, in its physiological clinical behavior, can be considered as a new reliable source of tissue, which can be used in a wide range of clinical situations. In our hands, capsular flaps proved to be a versatile solution not only to treat breast contour deformities or inframammary fold malpositions but also to salvage exposed breast implants. In this scenario, the use of more invasive surgical techniques can be avoided or simply saved and delayed for future recurrences.(Plast Reconstr Surg Glob Open 2015;3:e340; doi:10.1097/GOX.0000000000000307; Published online 30 March 2015.) PMID:26034647

Comparison among the levels of patients' satisfaction according to the surgical technique used in breast reconstruction after mastectomy.

PubMed

Gómez-Escolar Larrañaga, Lucía; Delgado Martínez, Julio; Miguelena Bobadilla, José María

2017-12-01

It has been proved that a breast reconstruction after a mastectomy has a great psycho-social impact on patients. For this reason, it is increasingly done in a greater percentage of cases. There are two major groups of reconstructive techniques: a reconstruction with implants and a reconstruction with autologous tissue of the patient. In order to make a more objective assessment of the results, it is important to know how satisfied these patients are with the results. Therefore, we performed a study using Q-BREAST, the aim of which is to analyze the satisfaction of mastectomized patients according to the different surgical reconstruction techniques. A retrospective, descriptive and observational study of patients reconstructed in our service from 2008 to 2011 was carried out. Patient satisfaction levels were compared according to the surgical technique used in breast reconstruction using the Q-BREAST test, which was mailed to them. There are no statistical differences in the levels of satisfaction in terms of age, type of mastectomy done, coadjutant treatment or existence of complications. Higher levels of satisfaction are observed in patients reconstructed with autologous tissue versus implants (P=.028). Patients reconstructed with autologous tissue have higher levels of satisfaction than those reconstructed with implants. Copyright © 2017 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

Current Trends in the Oncologic and Surgical Managements of Breast Cancer in Women with Implants: Incidence, Diagnosis, and Treatment.

PubMed

Veronesi, Paolo; De Lorenzi, Francesca; Loschi, Pietro; Rietjens, Mario; Veronesi, Umberto

2016-04-01

Breast augmentation is the most common cosmetic surgery in the United States, and thousands of augmented patients develop breast cancer each year. The possible effects of implants on cancer incidence, diagnosis, and treatment usually generate a disarming confusion. The present paper represents an update of the more recent oncologic and surgical strategies, aiming to support plastic and general surgeons in such challenging aspects. Several aspects of breast cancer management in augmented women are investigated, including (1) risk estimation and cancer characteristics, stage at diagnosis, and prognosis; (2) cancer diagnosis with clinical examination, mammography, ultrasound, and magnetic resonance imaging; (3) cancer treatment including breast conservation, intraoperative radiotherapy, sentinel node biopsy and mastectomy, and reconstruction. A brief resume of recommendations and conclusions is suggested, elucidating correct trends in the oncologic management of augmented patients and refusing well-established misconceptions: (1) breast augmentation does not increase the risk of breast cancer incidence, and it does not influence the prognosis; (2) possible risks exist in cancer detection due to technical difficulties; (3) sentinel lymph node detection is feasible; (4) intraoperative radiotherapy represents a good chance for conserving treatment; (5) immediate reconstruction with submuscular-subfascial implants is the most common procedure after mastectomy, and biological substitutes could support this procedure. Breast clinicians should be alerted because of high expectations of this subgroup of patients, accustomed to emphasize the aesthetic result. This journal requires that the authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Natrelle Silicone Breast Implant Follow-Up Study: Demographics, Lifestyle, and Surgical Characteristics of More Than 50,000 Augmentation Subjects

PubMed Central

Picha, George J.; Murphy, Diane K.

2016-01-01

Background: A large, multicenter, 10-year observational study is being conducted to compare the long-term safety and effectiveness of Natrelle silicone breast implants with saline implants or national norms. Study baseline data and surgical characteristics are reported here. Methods: Women seeking primary augmentation, revision-augmentation, primary reconstruction, or revision-reconstruction participated. Eligible subjects had completed surgery and received one implant or matching implants. Baseline demographics, health, lifestyle, and surgical characteristics were recorded. Data are presented here for subjects (≥22 years old) who underwent primary augmentation or revision-augmentation. Results: Of 50,979 subjects who underwent augmentation procedures, 35,756 received silicone implants and 15,223 received saline implants. Of these, 86.3 percent underwent primary augmentation, and 13.7 percent underwent revision-augmentation; nearly all subjects (99.3 percent) received bilateral implants. In the primary augmentation group, 67.6 percent of subjects received silicone implants versus 86.1 percent in the revision-augmentation group. Median age was lower in the primary augmentation group compared with the revision-augmentation group (33 versus 42 years old, respectively). Most subjects were white nonsmokers and had attended college. Hispanic subjects and subjects with a body mass index of 25 kg/m2 or greater were more likely to receive saline versus silicone implants. Across groups, the most common characteristics by procedure or implant type included inframammary incision site (54.6 percent), partial (58.2 percent) or complete (31.9 percent) submuscular placement, smooth surface implants (93.1 percent), and implant size of 300 to 399 cc. Incision size was larger for silicone versus saline implants. Conclusion: These data add to the body of knowledge on women undergoing augmentation procedures by providing an unprecedented look at a large number of subjects. PMID:26710009

Nanotechnology, nanosurfaces and silicone gel breast implants: current aspects

PubMed Central

Mendonça Munhoz, Alexandre; Santanelli di Pompeo, Fabio; De Mezerville, Roberto

2017-01-01

Abstract Nanotechnology is defined as the design of products that interact with biological systems on the nanoscopic scale. Creating a controlled nanotexture and understanding the ways in which surface properties impact inflammatory response is of the utmost significance in designing implants that can provide satisfactory outcomes. PMID:29250575

Testosterone and breast cancer prevention.

PubMed

Glaser, R; Dimitrakakis, C

2015-11-01

Testosterone (T) is the most abundant biologically active hormone in women. Androgen receptors (AR) are located throughout the body including the breast where T decreases tissue proliferation. However, T can be aromatized to estradiol (E2), which increases proliferation and hence, breast cancer (BCA) risk. Increased aromatase expression and an imbalance in the ratio of stimulatory estrogens to protective androgens impacts breast homeostasis. Recent clinical data supports a role for T in BCA prevention. Women with symptoms of hormone deficiency treated with pharmacological doses of T alone or in combination with anastrozole (A), delivered by subcutaneous implants, had a reduced incidence of BCA. In addition, T combined with A effectively treated symptoms of hormone deficiency in BCA survivors and was not associated with recurrent disease. Most notably, T+A implants placed in breast tissue surrounding malignant tumors significantly reduced BCA tumor size, further supporting T direct antiproliferative, protective and therapeutic effect. Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Comparison of Reconstructive Outcomes in Breast Cancer Patients With Preexisting Subpectoral Implants: Implant-Sparing Mastectomy With Delayed Implant Exchange Versus Immediate Tissue Expander Reconstruction.

PubMed

Parabkaharan, Sangeetha; Melody, Megan; Trotta, Rose; Lleshi, Amina; Sun, Weihong; Smith, Paul D; Khakpour, Nazanin; Dayicioglu, Deniz

2016-06-01

Women who have undergone prior augmentation mammoplasty represent a unique subset of breast cancer patients with several options available for breast reconstruction. We performed a single institution review of surgical outcomes of breast reconstruction performed in patients with breast cancer with prior history of subpectoral breast augmentation. Institutional review board-approved retrospective review was conducted among patients with previously mentioned criteria treated at our institution between 2000 and 2014. Reconstructions were grouped into 2 categories as follows: (1) removal of preexisting subpectoral implant during mastectomy with immediate tissue expander placement and (2) implant-sparing mastectomy followed by delayed exchange to a larger implant. We reviewed demographics, tumor features, and reconstruction outcomes of these groups. Fifty-three patients had preexisting subpectoral implants. Of the 63 breast reconstructions performed, 18 (28.6%) had immediate tissue expander placed and 45 (71.4%) had implant-sparing mastectomy followed by delayed implant exchange. The groups were comparable based on age, body mass index, cancer type, tumor grade, TNM stage at presentation, and hormonal receptor status. No significant difference was noted between tumor margins or subsequent recurrence, mastectomy specimen weight, removed implant volume, volume of implant placed during reconstruction, or time from mastectomy to final implant placement. Rates of complications were significantly higher in the tissue expander group compared to the implant-sparing mastectomy group 7 (38.9%) versus 4 (8.9%) (P = 0.005). Implant-sparing mastectomy with delayed implant exchange in patients with preexisting subpectoral implants is safe and has fewer complications compared to tissue expander placement. There was no difference noted in the final volume of implant placed, time interval for final implant placement, or tumor margins.

Multimodality Imaging-based Evaluation of Single-Lumen Silicone Breast Implants for Rupture.

PubMed

Seiler, Stephen J; Sharma, Pooja B; Hayes, Jody C; Ganti, Ramapriya; Mootz, Ann R; Eads, Emily D; Teotia, Sumeet S; Evans, W Phil

2017-01-01

Breast implants are frequently encountered on breast imaging studies, and it is essential for any radiologist interpreting these studies to be able to correctly assess implant integrity. Ruptures of silicone gel-filled implants often occur without becoming clinically obvious and are incidentally detected at imaging. Early diagnosis of implant rupture is important because surgical removal of extracapsular silicone in the breast parenchyma and lymphatics is difficult. Conversely, misdiagnosis of rupture may prompt a patient to undergo unnecessary additional surgery to remove the implant. Mammography is the most common breast imaging examination performed and can readily depict extracapsular free silicone, although it is insensitive for detection of intracapsular implant rupture. Ultrasonography (US) can be used to assess the internal structure of the implant and may provide an economical method for initial implant assessment. Common US signs of intracapsular rupture include the "keyhole" or "noose" sign, subcapsular line sign, and "stepladder" sign; extracapsular silicone has a distinctive "snowstorm" or echogenic noise appearance. Magnetic resonance (MR) imaging is the most accurate and reliable means for assessment of implant rupture and is highly sensitive for detection of both intracapsular and extracapsular rupture. MR imaging findings of intracapsular rupture include the keyhole or noose sign, subcapsular line sign, and "linguine" sign, and silicone-selective MR imaging sequences are highly sensitive to small amounts of extracapsular silicone. © RSNA, 2017.

The clinical and diagnostic consequences of Poly Implant Prothèse silicone breast implants, recalled from the European market in 2010.

PubMed

Maijers, Maria C; Niessen, Francisus B

2013-03-01

Recently, Poly Implant Prothèse silicone breast implants were recalled from the European market. The authors studied 112 women and previously published data on rupture prevalence. Women are presenting with symptoms they feel may be a result of ruptured implants. The authors' aim was to study the clinical consequences of Poly Implant Prothèse implants. One hundred twelve women with 224 proven Poly Implant Prothèse implants after 10 years of implantation were enrolled in this study. All women underwent physical examination and magnetic resonance imaging and were interviewed regarding symptoms. Details of the explantations of 35 women with at least one ruptured implant were documented. Tissue from 10 women was sent for pathologic investigation. Of 112 women, 34 (30.4 percent) had symptoms attributable to their implants. Physical examination showed that 12 of the 121 women (10.7 percent) had findings suggestive of rupture, most commonly pain. Three had lymphadenopathy that seemed to correlate with implant rupture or excessive "gel bleed." Pathologic findings showed no malignancies. Eight women who underwent explantation had no implant rupture. Excessive gel bleed was documented in half of them. Clinical consequences of women with Poly Implant Prothèse implants are comparable to those reported in the literature of other manufacturers. Neither complaints nor findings at physical examination had a significant correlation with implant rupture at explantation. Magnetic resonance imaging is still the preferred method compared with physical examination for diagnosing rupture. The low specificity was probably caused by the difficulty in differentiating between rupture and excessive gel bleed in these implants.

Localized morphea after breast implant for breast cancer: A case report.

PubMed

Moretti, A; Bianchi, F; Abbate, I V; Gherardi, G; Bonavita, M; Passoni, E; Nazzaro, G; Bramati, A; Dazzani, M C; Piva, S; Paternò, E; Frungillo, N; Farina, G; La Verde, N

2018-03-01

Early breast cancer follow-up guidelines for patients who underwent surgery suggest a regular and accurate clinical examination of the breast area, for an early identification of cutaneous or subcutaneous breast cancer relapse. Nonetheless, breast skin lesions arising in patients treated with mastectomy for breast cancer can be caused by several diseases. A series of diagnostic hypotheses should be considered, not only focusing on cutaneous metastasis, but also on dermatologic and systemic diseases. In February 2015, a 37-year-old patient underwent a right subcutaneous mastectomy for stage IIA breast cancer. Five months after beginning adjuvant chemotherapy, she noted hyperpigmentation and thickening of the skin on the right breast. Differential diagnosis included local relapse, skin infection, lymphoma, or primary cutaneous disease, and a skin biopsy was performed. The histopathologic specimen showed full-thickness sclerosis, with features of localized morphea. Therapy with clobetasol was prescribed, with progressive resolution of the thickness. The collaboration between many professionals in a multidisciplinary team (oncologist, dermatologist, plastic surgeon, and pathologist) was crucial to achieving the diagnosis. In the literature, some articles describe correlation between connective tissue diseases and silicone breast implants, but the pathogenetic mechanisms are unknown. We report a rare case of breast morphea after positioning a silicone implant in a patient who had undergone mastectomy. This clinical report represents an interesting model of multidisciplinary management of a patient with breast cancer who developed an uncommon dermatologic disease. Further studies are needed to clarify the association between silicone implants and breast morphea.

The Effect of Postmastectomy Radiation Therapy on Breast Implants: Material Analysis on Silicone and Polyurethane Prosthesis.

PubMed

Lo Torto, Federico; Relucenti, Michela; Familiari, Giuseppe; Vaia, Nicola; Casella, Donato; Matassa, Roberto; Miglietta, Selenia; Marinozzi, Franco; Bini, Fabiano; Fratoddi, Ilaria; Sciubba, Fabio; Cassese, Raffaele; Tombolini, Vincenzo; Ribuffo, Diego

2018-05-17

The pathogenic mechanism underlying capsular contracture is still unknown. It is certainly a multifactorial process, resulting from human body reaction, biofilm activation, bacteremic seeding, or silicone exposure. The scope of the present article is to investigate the effect of hypofractionated radiotherapy protocol (2.66 Gy × 16 sessions) both on silicone and polyurethane breast implants. Silicone implants and polyurethane underwent irradiation according to a hypofractionated radiotherapy protocol for the treatment of breast cancer. After irradiation implant shells underwent mechanical, chemical, and microstructural evaluation by means of tensile testing, infrared spectra in attenuated total reflectance mode, nuclear magnetic resonance, and field emission scanning electron microscopy. At superficial analysis, irradiated silicone samples show several visible secondary and tertiary blebs. Polyurethane implants showed an open cell structure, which closely resembles a sponge. Morphological observation of struts from treated polyurethane sample shows a more compact structure, with significantly shorter and thicker struts compared with untreated sample. The infrared spectra in attenuated total reflectance mode spectra of irradiated and control samples were compared either for silicon and polyurethane samples. In the case of silicone-based membranes, treated and control specimens showed similar bands, with little differences in the treated one. Nuclear magnetic resonance spectra on the fraction soluble in CDCl3 support these observations. Tensile tests on silicone samples showed a softer behavior of the treated ones. Tensile tests on Polyurethane samples showed no significant differences. Polyurethane implants seem to be more resistant to radiotherapy damage, whereas silicone prosthesis showed more structural, mechanical, and chemical modifications.

What's really behind the attack on silicone breast implants.

PubMed

Angell, M

1996-09-09

Millions of dollars are being awarded by injuries and a major company has been forced into bankruptcy because of litigation over silicone breast implants. Yet scientific research hasn't established a link between the implants and disease, notes Marcia Angell, executive editor of the New England Journal of Medicine. When she began studying the issue, this self-described feminist and liberal Democrat expected to uncover iniquities of big business and the implant manufacturers. Instead, she's written an indictment of the tort system, junk science, and the gullibility of the news media. Attorneys have twisted facts and played on the emotions of juries, with the consent of judges and often to the cheers of the press. Angell worries that it's now become politically correct to bash the scientific method in the name of diversity, multiculturalism, and feminism.

Risk Factors Associated With Complication Rates of Becker-Type Expander Implants in Relation to Implant Survival: Review of 314 Implants in 237 Patients.

PubMed

Taboada-Suarez, Antonio; Brea-García, Beatriz; Magán-Muñoz, Fernando; Couto-González, Iván; González-Álvarez, Eduardo

2015-12-01

Although autologous tissue reconstruction is the best option for breast reconstruction, using implants is still a reliable and simple method, offering acceptable aesthetic results. Becker-type implants are permanent implants that offer a 1-stage reconstructive option. A retrospective study was carried out in our center reviewing the clinical reports of 237 patients, in whom a total of 314 Becker-type prostheses were implanted. Overall survival was calculated using a Kaplan-Meier estimate. Cox proportional hazard models were used to calculate adjusted hazard ratios. At the end of the study, 214 expanders (68.15%) presented no complications, 40 (12.47%) developed significant capsular contracture, in 27 (8.60%) infection occurred, 24 (7.64%) suffered minor complications, and 9 (2.87%) ruptured. The mean survival time of the expanders was 120.41 months (95% CI: 109.62, 131.19). Radiotherapy, chemotherapy, high Molecular Immunology Borstel, age, mastectomy performed previously to the implant, ductal carcinoma, advanced tumoral stage, experience of the surgeon, and Becker 35-type implants were significantly related to a high number of complications in relation to the survival of the implants. Cox regression analysis revealed that the main risk factors for the survival of expander implants included radiotherapy and surgeon experience. The complication hazard ratio or relative risk caused by these 2 factors was 1.976 and 1.680, respectively. One-stage reconstruction using Becker-type expanders is an appropriate, simple, and reliable option in delayed breast reconstruction in patients who have not received radiotherapy and as long as the procedure is carried out by surgeons skilled in the technique.

[Breast augmentation by implants: a review of surgical practices. A study among French plastic surgeons].

PubMed

Chekaroua, K; Delay, E

2005-10-01

In the framework of the 2005 report on mammary implants prepared by the Société française de chirurgie plastique reconstructrice et esthétique (SOF.CPRE), we conducted a survey among french plastic surgeons involved in the field. We elaborated a questionnaire that we distributed twice to the 600 members of the society; a total of 261 responded. Analysis of the data collected provides information on the socioprofessional characteristics of the responding surgeons, and on the devices, products and techniques they use. Finally, the survey has permitted to identify their qualitative perception of breast implant products currently available. Ranking these items by order of frequency provides a snapshot of the current procedures and practices in use for breast augmentation surgery in France.

Pure pectus carinatum (not associated with pectus excavatum) solved by MIRPC (minimally invasive repair of pectus carinatum) associated with bilateral mamarian hypoplasia solved by bilateral breast implants.

PubMed

Ciurea, M; Ulmeanu, D; Popa, D; Mercuţ, R; Enache, M; Vânvu, A L; Demetrian, A

2014-01-01

We present the case of a young 24-year-old woman with an important but symmetrical pectus carinatum, not associated with pectus excavatum, without cardiorespiratory symptoms but with significant psychosocial implications for the patient, solved by the minimally invasive technique described by Abramson(reversed Nuss procedure) - MIRPC (Minimally invasive Repair of Pectus carinatum). The sternal malformation was associated with bilateral mammary hypoplasia, solved by bilateral breast implants 10 months later. The evolution was favorable and the aesthetic result was satisfactory for the patient. Celsius.

Local infiltrative anesthesia for transaxillary subpectoral breast implants.

PubMed

Mottura, A A

1995-01-01

Breast augmentations using a transaxillary subpectoral approach are usually performed under general anesthesia. This article describes a technique that uses local infiltrative anesthesia in breast augmentation, adenomastectomies with immediate breast reconstruction, and when placing breast expansors. Large anesthetic solutions with vasoconstrictor and long-acting effects are prepared. The axila, the subpectoral space, and a surrounding area of 3 cm outside the demarcation limits are infiltrated. Minimal bleeding, long-lasting effects, and a considerable postoperative analgesic effect are some of the advantages of this procedure.

Poly Implant Prothèse (PIP) incidence of rupture: a retrospective MR analysis in 64 patients

PubMed Central

Scotto di Santolo, Mariella; Cusati, Bianca; Ragozzino, Alfonso; Dell’Aprovitola, Nicoletta; Acquaviva, Alessandra; Altiero, Michele; Accurso, Antonello; Riccardi, Albina

2014-01-01

Aim of the study The purpose of this retrospective study was to describe the magnetic resonance imaging (MRI) features of Poly Implant Prothèse (PIP) hydrogel implants in a group of 64 patients and to assess the incidence of rupture, compared to other clinical trials. Material and methods In this double-center study, we retrospectively reviewed the data sets of 64 consecutive patients (mean age, 43±9 years, age range, 27-65 years), who underwent breast MRI examinations, between January 2008 and October 2013, with suspected implant rupture on the basis of clinical assessment or after conventional imaging examination (either mammography or ultrasound). All patients had undergone breast operation with bilateral textured cohesive gel PIP implant insertion for aesthetic reasons. The mean time after operation was 8 years (range, 6-14 years). No patients reported history of direct trauma to their implants. Results At the time of clinical examination, 41 patients were asymptomatic, 16 complained of breast tenderness and 7 had clinical evidence of rupture. Normal findings were observed in 15 patients. In 26 patients there were signs of mild collapse, with associated not significant peri-capsular fluid collections and no evidence of implant rupture; in 23 patients there was suggestion of implant rupture, according to breast MRI leading to an indication for surgery. In particular, 14 patients showed intra-capsular rupture, with associated evidence of the linguine sign in all cases; the keyhole sign and the droplet signs were observed in 6 cases. In 9 patients there was evidence of extra-capsular rupture, with presence of axillary collections (siliconomas) in 7 cases and peri-prosthetic and mediastinal cavity siliconomas, in 5 cases. Conclusions The results of this double center retrospective study, confirm the higher incidence (36%) of prosthesis rupture observed with the PIP implants, compared to other breast implants. PMID:25525578

Use of antibiotic beads to salvage infected breast implants.

PubMed

Sherif, Rami D; Ingargiola, Michael; Sanati-Mehrizy, Paymon; Torina, Philip J; Harmaty, Marco A

2017-10-01

When an implant becomes infected, implant salvage is often performed where the implant is removed, capsulectomy is performed, and a new implant is inserted. The patient is discharged with a PICC line and 6-8 weeks of intravenous (IV) antibiotics. This method has variable success and subjects the patient to long-term systemic antibiotics. In the 1960s, the use of antibiotic-impregnated beads for the treatment of chronic osteomyelitis was described. These beads deliver antibiotic directly to the site of the infection, thereby eliminating the complications of systemic IV antibiotics. This study aimed to present a case series illustrating the use of STIMULAN calcium sulfate beads loaded with vancomycin and tobramycin to increase the rate of salvage of the infected implant and forgo IV antibiotics. A retrospective analysis was performed of patients who were treated at Mount Sinai Hospital for implant infection with salvage and antibiotic beads. Twelve patients were identified, 10 of whom had breast cancer. Comorbidities included hypertension, smoking, and immunocompromised status. Infections were noted anywhere from 5 days to 8 years postoperatively. Salvage was successful in 9 out of the 12 infected implants using antibiotic bead therapy without home IV antibiotics. The use of antibiotic beads is promising for salvaging infected breast implants without IV antibiotics. Seventy-five percent of the implants were successfully salvaged. Of the three patients who had unsalvageable implants, one was infected with antibiotic-resistant Rhodococcus that was refractory to bead therapy and one was noncompliant with postoperative instructions. Copyright © 2017 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Breast Cancer after Augmentation: Oncologic and Reconstructive Considerations among Women Undergoing Mastectomy.

PubMed

Cho, Eugenia H; Shammas, Ronnie L; Phillips, Brett T; Greenup, Rachel A; Hwang, E Shelley; Hollenbeck, Scott T

2017-06-01

Breast augmentation with subglandular versus subpectoral implants may differentially impact the early detection of breast cancer and treatment recommendations. The authors assessed the impact of prior augmentation on the diagnosis and management of breast cancer in women undergoing mastectomy. Breast cancer diagnosis and management were retrospectively analyzed in all women with prior augmentation undergoing therapeutic mastectomy at the authors' institution from 1993 to 2014. Comparison was made to all women with no prior augmentation undergoing mastectomy in 2010. Subanalyses were performed according to prior implant placement. A total of 260 women with (n = 89) and without (n = 171) prior augmentation underwent mastectomy for 95 and 179 breast cancers, respectively. Prior implant placement was subglandular (n = 27) or subpectoral (n = 63) (For five breasts, the placement was unknown). Breast cancer stage at diagnosis (p = 0.19) and detection method (p = 0.48) did not differ for women with and without prior augmentation. Compared to subpectoral augmentation, subglandular augmentation was associated with the diagnosis of invasive breast cancer rather than ductal carcinoma in situ (p = 0.01) and detection by self-palpation rather than screening mammography (p = 0.03). Immediate two-stage implant reconstruction was the preferred reconstructive method in women with augmentation (p < 0.01). Breast cancer stage at diagnosis was similar for women with and without prior augmentation. Among women with augmentation, however, subglandular implants were associated with more advanced breast tumors commonly detected on palpation rather than mammography. Increased vigilance in breast cancer screening is recommended among women with subglandular augmentation. Therapeutic, III.

Breast reconstruction with anatomical implants: A review of indications and techniques based on current literature.

PubMed

Gardani, Marco; Bertozzi, Nicolò; Grieco, Michele Pio; Pesce, Marianna; Simonacci, Francesco; Santi, PierLuigi; Raposio, Edoardo

2017-09-01

One important modality of breast cancer therapy is surgical treatment, which has become increasingly less mutilating over the last century. Breast reconstruction has become an integrated part of breast cancer treatment due to long-term psychosexual health factors and its importance for breast cancer survivors. Both autogenous tissue-based and implant-based reconstruction provides satisfactory reconstructive options due to better surgeon awareness of "the ideal breast size", although each has its own advantages and disadvantages. An overview of the current options in breast reconstruction is presented in this article.

Combined usage of intercostal nerve block and tumescent anaesthesia: an effective anaesthesia technique for breast augmentation.

PubMed

Shimizu, Yusuke; Nagasao, Tomohisa; Taneda, Hiroko; Sakamoto, Yoshiaki; Asou, Toru; Imanishi, Nobuyuki; Kishi, Kazuo

2014-02-01

Patients are occasionally unhappy with the size, shape, and positioning of breast implants. An option to improve their satisfaction with breast augmentation includes directly involving them in the process with awake surgery done under nerve block and tumescence. This study describes the resultsof using such an awake anaesthesia technique in 35 patients. After the intercostal nerves dominating the Th3 to Th6 regions were anaesthetized using 0.5% bupivacaine, a tumescent solution consisting of lidocaine, epinephrine, and saline was injected around the mammary gland, and breast augmentation was conducted using silicon implants. The majority of patients (31/35) reported no pain during the procedure and all patients were able to choose and confirm their final implant size and positioning. In all cases, blood loss was less than 10 ml. No patient experienced pneumothorax or toxicity of local anaesthetics. Combined usage of the intercostal nerve block and tumescent anaesthesia effectively reduces pain during breast augmentation. Keeping patient conscious enables meeting their requests during operation, contributing to increased satisfaction. For these advantages, combined usage of the intercostal nerve block and tumescent anaesthesia is recommended as a useful anaesthetic technique for breast augmentation.

Subcutaneous testosterone-letrozole therapy before and concurrent with neoadjuvant breast chemotherapy: clinical response and therapeutic implications.

PubMed

Glaser, Rebecca L; York, Anne E; Dimitrakakis, Constantine

2017-07-01

Hormone receptor-positive breast cancers respond favorably to subcutaneous testosterone combined with an aromatase inhibitor. However, the effect of testosterone combined with an aromatase inhibitor on tumor response to chemotherapy was unknown. This study investigated the effect of testosterone-letrozole implants on breast cancer tumor response before and during neoadjuvant chemotherapy. A 51-year-old woman on testosterone replacement therapy was diagnosed with hormone receptor-positive invasive breast cancer. Six weeks before starting neoadjuvant chemotherapy, the patient was treated with subcutaneous testosterone-letrozole implants and instructed to follow a low-glycemic diet. Clinical status was followed. Tumor response to "testosterone-letrozole" and subsequently, "testosterone-letrozole with chemotherapy" was monitored using serial ultrasounds and calculating tumor volume. Response to therapy was determined by change in tumor volume. Cost of therapy was evaluated. There was a 43% reduction in tumor volume 41 days after the insertion of testosterone-letrozole implants, before starting chemotherapy. After the initiation of concurrent chemotherapy, the tumor responded at an increased rate, resulting in a complete pathologic response. Chemotherapy was tolerated. Blood counts and weight remained stable. There were no neurologic or cardiac complications from the chemotherapy. Cost of therapy is reported. Subcutaneous testosterone-letrozole was an effective treatment for this patient's breast cancer and did not interfere with chemotherapy. This novel combination implant has the potential to prevent side effects from chemotherapy, improve quality of life, and warrants further investigation.

Patient-reported outcomes measured by BREAST-Q after implant-based breast reconstruction: A cross-sectional controlled study in Brazilian patients.

PubMed

Aguiar, Isabella de Carvalho; Veiga, Daniela Francescato; Marques, Thaline Figueiredo; Novo, Neil Ferreira; Sabino Neto, Miguel; Ferreira, Lydia Masako

2017-02-01

The purpose of this study was to assess patient-reported outcomes of breast reconstruction with implants, using the BREAST-Q, in the late postoperative period. A total of 114 women previously operated due to breast cancer, in the late postoperative period (range 6-24 months) were enrolled in this cross-sectional study, and were allocated to either the mastectomy group (MG, n = 57) or reconstruction group (RG, n = 57). Patients in MG and RG, respectively, completed the Brazilian versions of Mastectomy and Reconstruction Modules of the BREAST-Q. The mean age of patients was 46.6 and 44.3 years in MG and RG, respectively. All patients underwent chemotherapy and 6% and 11% of patients underwent radiotherapy in MG and RG, respectively. Patients in the RG reported higher satisfaction with surgical outcome (P < 0.0001). However, no significant between-group differences were found in physical and sexual well-being, or satisfaction with the plastic surgeon, medical team, and office staff. Breast reconstruction with implants increased patient satisfaction with the surgical outcome, but did not influence patients' physical and sexual well-being or their satisfaction with the treatment received. Copyright © 2016 Elsevier Ltd. All rights reserved.

PIP silicone breast implants: rupture rates based on the explantation of 676 implants in a single surgeon series.

PubMed

Quaba, Omar; Quaba, Awf

2013-09-01

To determine the true rupture rates of PIP implants from a large single surgeon cohort and to assess whether rupture rates varied depending on time of implant insertion. In addition, the efficacy of ultra sound scanning (USS) in determining rupture is examined. Predominantly prospectively based analysis of patient records, investigations and surgical findings. 338 patients (676 implants) were included in the study and they all had removal of their implants. The senior author operated on all patients at some stage of their treatment. 160 patients were imaged pre-operatively with USS. Patients had implants inserted between 1999 and 2007 for cosmetic breast augmentation. A total of 144 ruptured implants were removed from 119 patients, giving a rupture rate of 35.2% per patient and 21.3% per implant over a mean implantation period of 7.8 years. A statistical difference (P < 0.001) in rupture rates between implants inserted prior to 2003 and those inserted from 2003 was demonstrated, with higher failure rates in the latter group. There was a significant difference in rupture rates depending on pocket placement of the implants. The sensitivity and specificity of USS at detecting rupture was 90.6% and 98.3% respectively. A proportion of patients (29.4%) demonstrated loco-regional spread of silicone to the axilla on scanning. Our paper has confirmed high rates of PIP implant failure in the largest published series to date. The significant difference in rupture rates between implants inserted prior to 2003 and those after this time supports the view that industrial silicone was used in the devices after 2003. Implants are more likely to rupture if inserted in the sub muscular plane compared to the sub glandular plane. USS is highly effective at detecting rupture in PIP implants and loco-regional spread is high compared to other devices. We believe this paper provides hard data enabling more informed decision making for patients, clinicians and providers in what remains an active issue affecting thousands of women. Copyright © 2013 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

One-Step Salvage of Infected Prosthetic Breast Reconstructions Using Antibiotic-Impregnated Polymethylmethacrylate Plates and Concurrent Tissue Expander Exchange.

PubMed

Albright, Steven B; Xue, Amy S; McKnight, Aisha; Wolfswinkel, Erik M; Hollier, Larry H; Brown, Rodger H; Bullocks, Jamal M; Izaddoost, Shayan A

2016-09-01

Periprosthetic infection represents a major complication in breast reconstruction, frequently leading to expander-implant loss. Recent studies report variable success in the salvage of infected breast prostheses through systemic antibiotic therapy and surgical intervention. There is currently no consensus regarding a management algorithm for attempted salvage. The purpose of this pilot study was to evaluate the early outcomes of a protocol using antibiotic-impregnated polymethylmethacrylate (PMMA) implant placement with expander device exchange. A retrospective database was queried to identify all patients with infected implant-based breast reconstruction who were treated by the study authors and who underwent attempted salvage under the study protocol. All patients received intravenous antibiotics followed by surgical debridement of the infected pocket, insertion of antibiotic-impregnated PMMA plates and/or beads, device exchange, and postoperative antibiotics. After clinical resolution of infection, tissue expansion was performed with the PMMA implants remaining in situ until exchanged to permanent implants. All patients with infected prosthetic breast reconstructions achieved implant pocket sterilization using this method. At a mean follow-up of 8.2 months (range, 1-19 months), none of these patients have required reoperation for capsular contracture. One patient, while under treatment with prednisone for a rash, developed recurrent infection, which led to explantation of her implant. Two patients underwent radiation therapy while an antibiotic plate and tissue expander were in place, with no observed exposure or infection recurrence. Sustained local antibiotic delivery using PMMA implants and expander device exchange can successfully salvage an infected breast implant. Perceived benefits include shorter time to completed reconstruction, preserved skin envelope integrity, and possibly improved long-term aesthetic outcomes.

The new opt-out Dutch National Breast Implant Registry - Lessons learnt from the road to implementation.

PubMed

Rakhorst, Hinne A; Mureau, Marc A M; Cooter, Rodney D; McNeil, John; van Hooff, Miranda; van der Hulst, René; Hommes, Juliette; Hoornweg, Marije; Moojen-Zaal, Laura; Liem, Patricia; Mathijssen, Irene M J

2017-10-01

An estimated 1-3% of all women in the Netherlands carry breast implants. Since the introduction five decades ago, problems with a variety of breast implants have emerged with direct consequences for the patients' health. Plastic surgeons worldwide reacted through campaigning for auditing on long-term implant quality, surgeon performance, and institutional outcomes in implant registries. Especially, the PIP implant scandal of 2010 demonstrated the paucity of epidemiological data and uncovered a weakness in our ability to even 'track and trace' patients. In addition, a recent report of the Dutch Institute of National Health showed a lack of compliance of 100% of breast implant producers to CE requirements. These arguments stress the need for an independent implant registry. Insufficient capture rates or dependence from the implant producers made the variety of national and international patient registries unreliable. The Dutch Breast Implant Registry (DBIR) is unique because it is an opt-out registry without the need for informed consent and thus a high capture rate. Furthermore, an estimated 95% of breast implants are implanted by board-certified plastic surgeons. Funding was received from a non-governmental organisation to increase the quality of health care in the Netherlands, and maintenance is gathered by 25 euros per implant inserted. This article describes the way the Dutch have set up their system, with special attention to the well-known hurdles of starting a patient registry. Examples include: funding, medical ethical issues, opt out system, benchmarking, quality assurance as well as governance and collaboration. The Dutch consider their experience and data shareware for others to be used globally to the benefit of patient safety and quality improvement. Copyright © 2017 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

[Breast reconstruction: autologous tissue versus implant].

PubMed

Plogmeier, K; Handstein, S; Schneider, W

1998-01-01

Modified radical mastectomy remains the standard for treatment of breast cancer. Women faced with the diagnosis of breast cancer often find it difficult to cope with the arousing emotions. Fear of death or cancer recurrence and a perceived loss of femininity often coexists with the desire for a return to normality and wholeness. For women seeking breast reconstruction various techniques have been developed. Two different ways for breast reconstruction have become a standard. One way is the reconstruction by tissue expansion or transposing locally available tissue with the use of implants. The other way is the reconstruction of the breast without using any implants with the Latissimus dorsi flap or the TRAM flap. We performed 291 breast reconstructions. In 125 women available tissue and an implant was used. The Latissimus dorsi flap was used in 57 cases and 109 TRAM flaps either pedicled or as a microvascular flap were performed. Using expanders we found a perforation of the device in 2 cases. After using implants there were capsular contracture in 2 cases and in 1 case we had an infection. Using autologous tissue we had 2 partial flap necrosis, 4 hematomas, and 4 prolonged healings. There was no complete flap necrosis. Breast reconstruction using autologous tissue i.e. the TRAM flap is supposed to be a standard technique. Microsurgical transplantation of the TRAM flap shows almost no morbidity of the donor site area. Autologous tissue follows the changes of the body like weight gain or reduction to a certain extend and shows neither capsular contracture nor other implant associated side effects. Women get the impression that the TRAM flap is like soft tissue to the touch and not like a foreign body. The aesthetic results were in all cases superior sometimes needing minor secondary correction and mostly shaping of the nippel-areola complex. All patients were pleased with the result.

Inflammation by Breast Implants and Adenocarcinoma: Not Always a Bad Company.

PubMed

Orciani, Monia; Sorgentoni, Giulia; Olivieri, Fabiola; Mattioli-Belmonte, Monica; Di Benedetto, Giovanni; Di Primio, Roberto

2017-07-01

Inflammation and tumor are now an inseparable binomial. Inflammation may also derive by the use of breast implants followed by the formation of a periprosthetic capsule. It is known that tumor cells, in an inflamed microenvironment, can profit by the paracrine effect exerted also by mesenchymal stem cells (MSCs). Here we evaluated the role of inflammation on the immunobiology of MSCs before and after cocultures with cells derived from breast adenocarcinoma. MSCs derived from both inflamed (I-MSCs) and control (C-MSCs) tissues were isolated and cocultured with MCF7 cells derived from breast adenocarcinoma. Before and after cocultures, the proliferation rate of MCF7 cells and the expression/secretion of cytokines related to inflammation were tested. Before cocultures, higher levels of cytokine related to chronic inflammation were detected in I-MSCs than in C-MSCs. After cocultures with MCF7, C- and I-MSCs show a variation in cytokine production. In detail, IL-2, IL-4, IL-5, IL-10, IL-13, TGF-β and G-CSF were decreased, whereas IL-6, IL-12, IFN-γ, and IL-17 were oversecreted. Proliferation of MCF7 was significantly increased after cocultures with I-MSCs. Inflammation at the site of origin of MSCs affects their immunobiology. Even if tumor cells increased their proliferation rate after cocultures with I-MSCs, the analysis of the cytokines, known to play a role in the interference of tumor cells with the host immune system, absolves completely the breast implants from the insult to enforce the risk of adenocarcinoma. Copyright © 2017 Elsevier Inc. All rights reserved.

Rupture rate and patterns of shell failure with the McGhan Style 153 double-lumen breast implant.

PubMed

Neaman, Keith C; Albert, Mark; Hammond, Dennis C

2011-01-01

In 2005, the McGhan Style 153 double-lumen breast implant was removed from the market secondary to a higher rupture rate when contrasted with other implants in the Core Study group. The high rupture rate was attributed to the development of a posterior tear in the shell where the inner implant is bonded to the posterior wall of the device. The purpose of this study was to report the existing rupture rate and describe the apparent mechanism of failure in the Style 153 double-lumen breast implant. Ninety-seven patients (157 implants) who received the McGhan Style 153 double-lumen breast implant by the senior author were reviewed. Intraoperative observations and photographic images of ruptured implants were reviewed and characterized based on severity and location of implant rupture. With a mean length of follow-up of greater than 6 years (82 months), the rupture rate was 19.1 percent per implant. Physical examination (60 percent) was the most common method of rupture detection. Ruptures tended to occur in the marginal aspect (63 percent) of the implant. Only three ruptures occurred secondary to a disruption of the inner bladder from the posterior portion of the implant. The rupture rate of the Style 153 double-lumen breast implant is higher than previously thought, with a rate of 19.1 percent. A majority of ruptures occurred in the peripheral aspects of the implant. It is postulated that these ruptures were likely secondary to fold flaws that led to failure of the implant shell.

In vivo contaminant partitioning to silicone implants: Implications for use in biomonitoring and body burden.

PubMed

O'Connell, Steven G; Kerkvliet, Nancy I; Carozza, Susan; Rohlman, Diana; Pennington, Jamie; Anderson, Kim A

2015-12-01

Silicone polymers are used for a wide array of applications from passive samplers in environmental studies, to implants used in human augmentation and reconstruction. If silicone sequesters toxicants throughout implantation, it may represent a history of exposure and potentially reduce the body burden of toxicants influencing the risk of adverse health outcomes such as breast cancer. Objectives of this research included identifying a wide variety of toxicants in human silicone implants, and measuring the in vivo absorption of contaminants into silicone and surrounding tissue in an animal model. In the first study, eight human breast implants were analyzed for over 1400 organic contaminants including consumer products, chemicals in commerce, and pesticides. A total of 14 compounds including pesticides such as trans-nonachlor (1.2-5.9ng/g) and p,p'-DDE (1.2-34ng/g) were identified in human implants, 13 of which have not been previously reported in silicone prostheses. In the second project, female ICR mice were implanted with silicone and dosed with p,p'-DDE and PCB118 by intraperitoneal injection. After nine days, silicone and adipose samples were collected, and all implants in dosed mice had p,p'-DDE and PCB118 present. Distribution ratios from silicone and surrounding tissue in mice compare well with similar studies, and were used to predict adipose concentrations in human tissue. Similarities between predicted and measured chemical concentrations in mice and humans suggest that silicone may be a reliable surrogate measure of persistent toxicants. More research is needed to identify the potential of silicone implants to refine the predictive quality of chemicals found in silicone implants. Copyright © 2015 Elsevier Ltd. All rights reserved.

Quantifying shape changes of silicone breast implants in a murine model using in vivo micro-CT.

PubMed

Anderson, Emily E; Perilli, Egon; Carati, Colin J; Reynolds, Karen J

2017-08-01

A major complication of silicone breast implants is the formation of a capsule around the implant known as capsular contracture which results in the distortion of the implant. Recently, a mouse model for studying capsular contracture was examined using micro-computed tomography (micro-CT), however, only qualitative changes were reported. The aim of this study was to develop a quantitative method for comparing the shape changes of silicone implants using in vivo micro-CT. Mice were bilaterally implanted with silicone implants and underwent ionizing radiation to induce capsular contracture. On day 28 post-surgery mice were examined in vivo using micro-CT. The reconstructed cross-section images were visually inspected to identify distortion. Measurements were taken in 2D and 3D to quantify the shape of the implants in the normal (n = 11) and distorted (n = 5) groups. The degree of anisotropy was significantly higher in the distorted implants in the transaxial view (0.99 vs. 1.19, p = 0.002) and the y-axis lengths were significantly shorter in the sagittal (9.27 mm vs. 8.55 mm, p = 0.015) and coronal (9.24 mm vs. 8.76 mm, p = 0.031) views, indicating a deviation from the circular cross-section and shortening of the long axis. The 3D analysis revealed a significantly lower average thickness (sphere-fitting method) in distorted implants (6.86 mm vs. 5.49 mm, p = 0.002), whereas the volume and surface area did not show significant changes. Statistically significant differences between normal and distorted implants were found in 2D and 3D using distance measurements performed via micro-CT. This objective analysis method can be useful for a range of studies involving deformable implants using in vivo micro-CT. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 1447-1452, 2017. © 2016 Wiley Periodicals, Inc.

Disseminated Pleural Siliconoma Mimicking Malignant Pleural Mesothelioma.

PubMed

Tanaka, Toshiki; Tao, Hiroyuki; Hayashi, Tatsuro; Yoshiyama, Koichi; Furukawa, Masashi; Yoshida, Kumiko; Okabe, Kazunori

2015-12-01

A 48-year-old woman with a 3-month history of back pain was admitted for further examination of multiple left pleural nodules. She had undergone bilateral breast augmentation with silicone implants 10 years previously. Nine years after the operation, both ruptured implants were removed, and autologous fat was injected. Computed tomography revealed multiple pleural nodules suggestive of malignant pleural mesothelioma. Thoracoscopic exploration revealed multiple pleural nodules with massive pleural adhesions. The nodules were filled with viscous liquid and were histologically determined to be siliconomas. Disseminated pleural siliconoma should be recognized as a late adverse event of silicone breast implantation. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Nummular Eczema of Breast: A Potential Dermatologic Complication after Mastectomy and Subsequent Breast Reconstruction

PubMed Central

Iwahira, Yoshiko; Nagasao, Tomohisa; Shimizu, Yusuke; Kuwata, Kumiko; Tanaka, Yoshio

2015-01-01

Purposes. The present paper reports clinical cases where nummular eczema developed during the course of breast reconstruction by means of implantation and evaluates the occurrence patterns and ratios of this complication. Methods. 1662 patients undergoing breast reconstruction were reviewed. Patients who developed nummular eczema during the treatment were selected, and a survey was conducted on these patients regarding three items: (1) the stage of the treatment at which nummular eczema developed; (2) time required for the lesion to heal; (3) location of the lesion on the reconstructed breast(s). Furthermore, histopathological examination was conducted to elucidate the etiology of the lesion. Results. 48 patients (2.89%) developed nummular eczema. The timing of onset varied among these patients, with lesions developing after the placement of tissue expanders for 22 patients (45.8%); after the tissue expanders were replaced with silicone implants for 12 patients (25%); and after nipple-areola complex reconstruction for 14 patients (29.2%). Nummular eczema developed both in periwound regions (20 cases: 41.7%) and in nonperiwound regions (32 cases: 66.7%). Histopathological examination showed epidermal acanthosis, psoriasiform patterns, and reduction of sebaceous glands. Conclusions. Surgeons should recognize that nummular eczema is a potential complication of breast reconstruction with tissue expanders and silicone implants. PMID:26380109

Transumbilical breast augmentation (TUBA): patient selection, technique, and clinical experience.

PubMed

Pound, E C; Pound, E C

2001-07-01

The TUBA procedure offers another approach to placing inflatable breast implants in the subglandular or submuscular position. It is an easy procedure to learn and to perform, using only a few relatively inexpensive specialized instruments. It also can be modified to use preexisting scars on the abdomen as the access point. The authors believe that complications seem to occur less with TUBA patients than with patients having breast augmentation by other approaches, an observation shared by other plastic surgeons offering the TUBA procedure. Limitations include the fact that only inflatable implants can be used. Also, with increasing distance from the breast, there is less control over manipulation of the pocket. Fortunately, the authors have not found this to be a problem in achieving symmetry. Furthermore, bleeding tends to be minimal with this approach. Nevertheless, should technical difficulties arise, conversion to a standard breast incision is an easy back-up option and should be discussed with the patient before surgery. Interest in the TUBA approach to breast augmentation continues to grow. Patients appreciate the lack of scarring on the breast and the short recovery that allows them to resume their normal lifestyle quickly. The authors' caseload has increased considerably over the past 8 years through word-of-mouth advertising from satisfied patients. Other plastic surgeons who offer this approach agree that patient demand for this operation continues to grow dramatically in their practices.

Air Travel Safety in Postoperative Breast Cancer Patients: A Systematic Review.

PubMed

Co, Michael; Ng, Judy; Kwong, Ava

2018-05-17

Air travel has long been a dilemma in post-breast cancer surgery patients. Anecdotal reports have described adverse outcomes on surgical wound, implants, and lymphedema during air travel. This review aims to evaluate the best evidence from the literature concerning the air travel safety in breast cancer patients. A comprehensive review was performed of the Medline, Embase, CINAHL, and Cochrane databases using a predefined strategy. Retrieved studies were independently screened and rated for relevance. Data were extracted by 2 researchers. We reviewed the best evidence on air travel safety in postoperative breast cancer patients. Evidence was limited in the current literature to suggest adverse effects on postoperative mastectomy wounds and drains by high-altitude travel. Similarly, adverse effects on breast implants were limited to case reports and ex vivo experiments. A systematic review of 12 studies concluded that air travel is not associated with upper limb lymphedema after breast cancer surgery. Deep-vein thrombosis (DVT) is a known complication after air travel; in addition, malignancy itself is a known risk factor for DVT. Evidence of safety to continue tamoxifen during the period of air travel is lacking in the literature. Evidence to support the use of systemic DVT prophylaxis in general postoperative breast cancer patients is also limited. Best evidence from a large retrospective study suggested that mechanical antiembolism devices and early mobilization are the only measures required. Air travel is generally safe in patients after breast cancer surgery. Copyright © 2018. Published by Elsevier Inc.

Radiological assessment of the breast following enhancement with Macrolane: Managing the challenges.

PubMed

Scaperrotta, Gianfranco; Satchithananda, Keshtra; Tengvar, Magnus; Post, Karin; Lim, Adrian K; Panizza, Pietro; Wesolowska, Ewa; Inglefield, Christopher J

2017-01-01

Macrolane VRF ® , a biodegradable, stabilized hyaluronic acid gel, was used for breast enhancement 2008-2012. Similar to permanent implants, the presence of Macrolane gel may interfere with interpretation of mammography. This short communication aims to provide a guide to the appearance of Macrolane on radiology examination (including mammography, ultrasound and magnetic resonance imaging) and aid selection of the most appropriate imaging modality to facilitate breast examination in women who have undergone Macrolane breast enhancement. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Breast augmentation with extra-projected and high-cohesive Dual-Gel Prosthesis 510: a prospective study of 75 consecutive cases for a new method (the Zenith system).

PubMed

Riggio, Egidio

2012-08-01

Extra-projected Natrelle 510 belongs to a new generation of silicone breast implants. A single-surgeon prospective study set out to investigate the device's features, outcomes, and complications, and devise a proper measurement method based on the zenith system. From December 2004 to June 2010, 75 subjects (150 implants) were enrolled in four cohorts: primary augmentation (66.7%), primary mastopexy augmentation (17.3%), secondary implant exchange (9.3%), and secondary implant exchange+pexy (6.7%). The system used to select the implant correlated the point of maximal projection (vertex-zenith) and nipple position. The surgical approach included (1) narrow pocket, preferably dual-plane; (2) device vertex 1-2.5 cm beneath nipple (zenith range=12°-23°) related to a nipple-inframammary fold distance of 7-7.5 cm at maximal stretch and a nipple-sternum/lower-pole line distance of 4-5 cm; (3) inframammary fold lowered minimally; (4) vertex at ±1 cm from the midbreast meridian crossing the nipple; and (5) maximizing the biomechanical effects between soft-tissue dynamics, firmer gel pressure, and pectoralis major counterpressure to expand the lower skin (dynamic tension). Mean follow-up was 26.5 months (range=6-72); in 20 subjects; follow-up was over 3 years (average=50 months) with a 90.8% patient satisfaction rate. This rate was lower in patients with preoperative ptosis. There was inframammary preservation with 60% of the implants and modification in 40% (0.80±0.45 cm). The overall complication rate per implant was 16.6% and included wound healing/scarring (7%), malrotation (2.6%, only 1% after primary augmentation), rippling (2%), capsular contracture (1.3%), and bottoming-out (0.6%). The revision rate was 6%, of which 3.3% were pocket revisions. Greater skills are required through the learning curve, patient education, case selection, planning using the nipple-vertex relationship (the zenith system), and improved surgical manipulation. Indications and contraindications were analyzed. Cosmetic results were compliant with different breast shapes, and excellent for the breast with poor projection, in thin subjects, and those with low BMI. Ptotic breast should require a larger amount of pexy, 510 did not lift the breast enough. Based on vertex-nipple distance, dynamic tension, and skin extensibility, this new approach gives guidelines and methods to perform breast augmentation with extra-projected implants. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors at www.springer.com/00266.

Implementation of an Integrated Biodimensional Method of Breast Augmentation with Anatomic, Highly Cohesive Silicone Gel Implants: Short-Term Results With the First 620 Consecutive Cases.

PubMed

Montemurro, Paolo; Agko, Mouchammed; Quattrini Li, Alessandro; Avvedimento, Stefano; Hedén, Per

2017-07-01

The previously described Akademikliniken (AK) method is a comprehensive approach to breast augmentation with form stable implants that has been shown to afford favorable outcomes when applied by experienced surgeons. To evaluate outcomes of a surgeon newly adopting this method at the beginning of his career. A retrospective review of patients undergoing dual plane subpectoral augmentation with Style 410 implants between April 2009 and December 2014 was undertaken. The review was performed one year after the last operation. The first author (P.M.) performed all operations. Complications and reoperation rates were analyzed and correlated with patient and implant characteristics using the chi-square or Fisher's exact test, as appropriate. A total of 620 consecutive patients met the inclusion criteria with a mean follow up of 8 months (range, 1 week-60 months). Complications occurred in 14.8% of the patients: request for larger size (3.3%), rotation (3%), and Baker III/IV capsular contracture (2.2%) were the most common ones. Low implant projection was a statistically significant risk factor (P < 0.05) for the most common complication - request for a larger size. The overall reoperation rate was 8.7%. The most common indication for reoperation was request for larger size (2.2%) followed by rotation (2.2%) and capsular contracture (2%). Breast augmentation with form stable anatomical implants requires a considerably different process. By implementing a systematic approach such as the AK method, novices in this terrain can expect to achieve reasonable outcomes. 4. © 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com

Economic Analysis of Screening Strategies for Rupture of Silicone Gel Breast Implants

PubMed Central

Chung, Kevin C.; Malay, Sunitha; Shauver, Melissa J.; Kim, H. Myra

2012-01-01

Background In 2006, the U.S. Food and Drug Administration (FDA) recommended screening of all women with silicone gel breast implants with magnetic resonance imaging (MRI) three years after implantation and every two years thereafter to assess their integrity. The cost for these serial examinations over the lifetime of the breast implants is an added burden to insurance payers and to women. We perform an economic analysis to determine the most optimal screening strategies by considering the diagnostic accuracy of the screening tests, the costs of the tests and subsequent implant removal. Methods We determined aggregate/pooled values for sensitivity and specificity of the screening tests ultrasound (US) and MRI in detecting silicone breast implant ruptures from the data obtained from published literature. We compiled costs, based on Medicare reimbursements for 2011, for the following elements: imaging modalities, anesthesia and 3 surgical treatment options for detected ruptures. We used decision tree to compare three alternate screening strategies of US only, MRI only and US followed by MRI in asymptomatic and symptomatic women. Results The cost per rupture of screening and management of rupture with US in asymptomatic women was $1,090, whereas in symptomatic women it was $1,622. Similar cost for MRI in asymptomatic women was $2,067, whereas in symptomatic women it was $2,143. Similar cost for US followed by MRI in asymptomatic women was $637, whereas in symptomatic women it was $2,908. Conclusion Screening with US followed by MRI was optimal for asymptomatic women and screening with US was optimal for symptomatic women. PMID:22743887

[Etiopathogenesis and treatment of breast capsular contracture].

PubMed

Pereira Leite, Luis; Correia Sá, Inês; Marques, Marisa

2013-01-01

Capsular contracture is a chronic and the most frequent complication of augmentation mammoplasty with breast implants and the main cause of patient's and surgeon's dissatisfaction. The mammary capsule consists of a fibrous tissue that surrounds the implant that may contract, changing the shape and consistency of the breast. In its advanced stage is accompanied by pronounced deformity, hardness and pain, being indicated for surgical treatment. All the articles indexed on PubMed through the search 'capsular contracture' (2000 - January 2012) were reviewed and were included the articles of greater interest in terms of etiology, prophylaxis and treatment. Articles referred in relevant publications were also examined. Everything indicates that its etiology is multifactorial; the etiopathology of breast capsular contracture continues being subject of multiple pre-clinical investigations. There are many studies performed in order to prevent the onset of capsular contracture but, although promising results, little is set for its application on clinical practice. The capsulectomy/capsulotomy continues being the gold standard treatment although the future may undergo non invasive techniques, at least in mild stages of disease. Although the surgical techniques and the quality of breast implants have been improving drastically in recent years, capsular contracture remains a real complication with great incidence and that continues affecting thousands of women all over the world.

SU-F-T-314: Estimation of Dose Distributions with Different Types of Breast Implants in Various Radiation Treatment Techniques for Breast Cancer

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lee, M; Lee, S; Suh, T

Purpose: This study investigates the effects of different kinds and designs of commercialized breast implants on the dose distributions in breast cancer radiotherapy under a variety of conditions. Methods: The dose for the clinical conventional tangential irradiation, Intensity Modulated Radiation Therapy (IMRT), volumetric modulated arc therapy (VMAT) breast plans was measured using radiochromic films and stimulated luminescence dosimeter (OSLD). The radiochromic film was used as an integrating dosimeter, while the OSLDs were used for real-time dosimetry to isolate the contribution of dose from individual segment. The films were placed at various slices in the Rando phantom and between the bodymore » and breast surface OSLDs were used to measure skin dose at 18 positions spaced on the two (right/left) breast. The implant breast was placed on the left side and the phantom breast was remained on the right side. Each treatment technique was performed on different size of the breasts and different shape of the breast implant. The PTV dose was prescribed 50.4 Gy and V47.88≥95%. Results: In different shapes of the breast implant, because of the shadow formed extensive around the breast implant, dose variation was relatively higher that of prescribed dose. As the PTV was delineated on the whole breast, maximum 5% dose error and average 3% difference was observed averagely. VMAT techniques largely decrease the contiguous hot spot in the skin by an average of 25% compared with IMRT. The both IMRT and VMAT techniques resulted in lower doses to normal critical structures than tangential plans for nearly all dose analyzation. Conclusion: Compared to the other technique, IMRT reduced radiation dose exposure to normal tissues and maintained reasonable target homogeneity and for the same target coverage, VMAT can reduce the skin dose in all the regions of the body.« less

Public Interest in Breast Augmentation: Analysis and Implications of Google Trends Data.

PubMed

Wilson, Stelios C; Daar, David A; Sinno, Sammy; Levine, Steven M

2018-06-01

Breast augmentation is the most common aesthetic surgery performed in the United States (US) annually. Analysis of Google Trends (GT) data may give plastic surgeons useful information regarding worldwide, national, and regional interest for breast augmentation and other commonly performed aesthetic surgeries. Data were collected using GT for breast augmentation and associated search terms from January 2004 to May 2017. Case volume was obtained from the American Society of Plastic Surgeons (ASPS) annual reports for the calendar year 2005-2016. Trend analysis showed that total search term volume for breast augmentation and breast implants gradually decreased worldwide and in the US over the study period while the search term boob job slowly increased. Univariate linear regression demonstrated a statistically significant positive correlation between average annual Google search volume of "breast augmentation" and the annual volume of breast augmentations performed in the US according to ASPS data (R 2  = 0.44, p = 0.018). There was no significant correlation between national volume of breast augmentations performed and search volume using the terms "breast implants" or "boob job" over time (p = 0.84 and p = 0.07, respectively). In addition, there appears to be country specific variation in interest based on time of year and peaks in interest following specific policies. To our knowledge, this is the first and only analysis of GT data in the plastic surgery literature to date. To that end, this study highlights this large and potentially powerful data set for plastic surgeons both in the US and around the world. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Users’ guide to the surgical literature: how to assess an article about harm in surgery

PubMed Central

Thoma, Achilleas; Kaur, Manraj Nirmal; Farrokhyar, Forough; Waltho, Daniel; Levis, Carolyn; Lovrics, Peter; Goldsmith, Charlie H.

2016-01-01

Clinical scenario You are a new plastic surgeon in the community and you are referred a patient interested in breast reconstruction. The patient is a 35-year-old female school teacher who had a bilateral prophylactic mastectomy 2 years earlier, as she was a BRCA gene carrier. Since she is of a petite build with very little subcutaneous tissue or extra skin in the lower abdomen, you decide that she is not a suitable candidate for an abdomen-based autologous tissue reconstruction. You recommend the technique of tissue expansion and silicone gel implants. She is concerned, however, about the possibility of anaplastic large cell lymphoma (ALCL) developing in her breasts. She read in a magazine recently that ALCL, an unusual form of breast cancer, has been occurring in patients who have breast implants. She is very concerned that she might be at risk and asks for your opinion as to whether she should proceed with the procedure or not. PMID:27668334

Comparison of the artifacts caused by metallic implants in breast MRI using dual-echo dixon versus conventional fat-suppression techniques.

PubMed

Le, Yuan; Kipfer, Hal D; Majidi, Shadie S; Holz, Stephanie; Lin, Chen

2014-09-01

The purpose of this article is to evaluate and compare the artifacts caused by metal implants in breast MR images acquired with dual-echo Dixon and two conventional fat-suppression techniques. Two types of biopsy markers were embedded into a uniform fat-water emulsion. T1-weighted gradient-echo images were acquired on a clinical 3-T MRI scanner with three different fat-suppression techniques-conventional or quick fat saturation, spectrally selective adiabatic inversion recovery (SPAIR), and dual-echo Dixon-and the 3D volumes of artifacts were measured. Among the subjects of a clinical breast MRI study using the same scanner, five patients were found to have one or more metal implants. The artifacts in Dixon and SPAIR fat-suppressed images were evaluated by three radiologists, and the results were compared with those of the phantom study. In the phantom study, the artifacts appeared as interleaved bright and dark rings on SPAIR and quick-fat-saturation images, whereas they appeared as dark regions with a thin bright rim on Dixon images. The artifacts imaged with the Dixon technique had the smallest total volume. However, the reviewers found larger artifact diameters on patient images using the Dixon sequence because only the central region was recognized as an artifact on the SPAIR images. Metal implants introduce artifacts of different types and sizes, according to the different fat-suppression techniques used. The dual-echo Dixon technique produces a larger central void, allowing the implant to be easily identified, but presents a smaller overall artifact volume by obscuring less area in the image, according to a quantitative phantom study.

Immediate breast reconstruction with anatomical implants following mastectomy: The radiation perspective

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ben-David, Merav, E-mail: Merav.ben-david@sheba.health.gov.il; Sackler School of Medicine, Tel Aviv University, Tel Aviv; Granot, Hila

2016-07-01

Immediate implant-based breast reconstruction followed by postmastectomy radiation therapy (PMRT) is controversial because of the risk of compromised treatment plans and concerns regarding cosmetic outcomes. We evaluated the effects of immediate direct-to-implant breast reconstruction with anatomical implants on the quality of PMRT delivered by 3-dimensional conformal radiotherapy (3D-CRT). In this retrospective, single-institution study, patients who had undergone reconstruction with direct anatomic implant, performed by a single surgeon, received 3D-CRT between 2008 and 2013. For each patient, 2 plans (including or excluding internal mammary nodes [IMN]) were created and calculated. The primary end point was the dose distribution among reconstructed breasts,more » heart, lungs, and IMNs, and between right and left breasts. Of 29 consecutive patients, 11 received right-sided and 18 received left-sided PMRT to a total dose of 50 Gy. For plans excluding IMN coverage, mean D{sub mean} for right and left reconstructed breasts was 49.09 Gy (98.2% of the prescribed dose) and 48.51 Gy (97.0%), respectively. For plans including IMNs, mean D{sub mean} was 49.15 Gy (98.3%) for right and 48.46 Gy (96.9%) for left reconstructed breasts; the mean IMN D{sub mean} was 47.27 Gy (right) and 47.89 Gy (left). Heart D{sub mean} was below 1.56 Gy for all plans. Mean total lung volume receiving a dose of ≥ 20 Gy was 13.80% to 19.47%. PMRT can be delivered effectively and safely by 3D-CRT after direct-to-implant breast reconstruction with anatomical implants, even if patients require IMN treatment.« less

Polyurethane foam-covered breast implants: a justified choice?

PubMed

Scarpa, C; Borso, G F; Vindigni, V; Bassetto, F

2015-01-01

Even if the safety of the polyurethane prosthesis has been the subject of many studies and professional and public controversies. Nowadays, polyurethane covered implants are very popular in plastic surgery for the treatment of capsular contracture. We have identified 41 papers (1 is a communication of the FDA) by using search browsers such as Pubmed, Medline, and eMedicine. Eleven manuscripts have been used for an introduction, and the remaining thirty have been subdivided into three tables whose results have been summarized in three main chapters: (1) capsular formation and contracture, (2) complications, (3) biodegradation and cancer risk. (1) The polyurethanic capsule is a well defined foreign body reaction characterized by synovial metaplasia, a thin layer of disarranged collagen fibers and a high vascularization. These features make possible a "young" capsule and a low occurrence of capsular contracture even over a long period (10 years); (2) the polyurethane implants may be difficult to remove but there is no evidence that they cause an increase in the other complications; (3) there is no evidence of polyurethane related cancer in long-term studies (after 5 years). Polyurethane foam covered breast implants remain a valid choice for the treatment of capsular contracture even if it would be very useful to verify the ease of removal of the prosthesis and to continue investigations on biodegradation products.

Immediate reconstruction with implants in women with invasive breast cancer does not affect oncological safety in a matched cohort study.

PubMed

Eriksen, C; Frisell, J; Wickman, M; Lidbrink, E; Krawiec, K; Sandelin, K

2011-06-01

Physicians are still concerned about the oncological safety regarding immediate breast reconstruction (IBR) in breast cancer patients. This study aimed to evaluate possible differences between local, regional, and distant recurrences between women having implant-based reconstruction versus women operated with mastectomy alone. Secondary aims were to evaluate time to oncological treatment as well as disease-free and breast-cancer-specific survival. In a retrospective cohort designed study, 300 reconstructed patients with invasive breast cancer were matched with 300 patients from the population-based Regional Breast Cancer Register of the Stockholm-Gotland health-care region operated with mastectomy alone. They were matched for age, tumor size, nodal stage, and year of operation. Also included were patients treated with neoadjuvant chemotherapy and postoperative radiotherapy. The median follow-up for both the groups was 11.5 years (range 2-20). There were no significant differences in the local recurrence rate, 8.2% in the IBR group and 9.0% in the control group or in the regional recurrence rate, 8.2% versus 9.7%. Distant metastases occurred more frequently in the control group (27.1%) when compared to the IBR group (20.3%). There were no significant differences in time to treatment or in complications rate. Breast cancer mortality was 17% for the IBR group and 23% in the control group during follow-up. This long-term follow-up survey with a well-matched control group demonstrates that IBR with implants is safe to offer patients with invasive breast cancer without any negative effect on the oncological safety.

Users' guide to the surgical literature: how to assess an article about harm in surgery.

PubMed

Thoma, Achilleas; Kaur, Manraj Nirmal; Farrokhyar, Forough; Waltho, Daniel; Levis, Carolyn; Lovrics, Peter; Goldsmith, Charlie H

2016-09-01

You are a new plastic surgeon in the community and you are referred a patient interested in breast reconstruction. The patient is a 35-year-old female school teacher who had a bilateral prophylactic mastectomy 2 years earlier, as she was a BRCA gene carrier. Since she is of a petite build with very little subcutaneous tissue or extra skin in the lower abdomen, you decide that she is not a suitable candidate for an abdomen-based autologous tissue reconstruction. You recommend the technique of tissue expansion and silicone gel implants. She is concerned, however, about the possibility of anaplastic large cell lymphoma (ALCL) developing in her breasts. She read in a magazine recently that ALCL, an unusual form of breast cancer, has been occurring in patients who have breast implants. She is very concerned that she might be at risk and asks for your opinion as to whether she should proceed with the procedure or not.

Risks of Breast Implants

MedlinePlus

... wall or underlying rib cage appears deformed. Deflation Leakage of the saltwater (saline) solution from a saline- ... do not cause symptoms (“silent ruptures”). For early detection of silent rupture, the FDA recommends that women ...

Fluorodeoxyglucose--positive internal mammary lymph node in breast cancer patients with silicone implants: is it always metastatic cancer?

PubMed

Soudack, Michalle; Yelin, Alon; Simansky, David; Ben-Nun, Alon

2013-07-01

Patients with breast cancer following mastectomy and silicone implant reconstruction may have enlarged internal mammary lymph nodes with pathological uptake on positron emission tomography with (18)F-fluorodeoxyglucose. This lymphadenopathy is usually considered as metastatic in nature, but has also been reported to be related to other conditions, including silicon migration. The purpose of this study was to determine the rate of metastatic disease in this unique group of patients. A retrospective comparative study of 12 female patients with breast cancer with silicone implants referred for biopsy due to isolated internal mammary lymph node fluorodeoxyglucose uptake on positron emission tomography. Five patients (41.6%) had histological findings related to silicone (n = 4) or non-specific inflammation (n = 1). The remaining 7 (58.3%) had histological evidence of cancer recurrence. There was no significant difference in the fluorodeoxyglucose-standardized uptake value between the two groups. Fluorodeoxyglucose-positive mammary lymph nodes in patients with breast cancer following silicone implant reconstruction may be due to metastatic deposits, non-specific inflammation or silicone migration. Clinical and imaging characteristics are insufficient in differentiating between these conditions. Biopsy is recommended prior to initiation of further treatment.

Five-year follow-up data from the U.S. clinical trial for Sientra's U.S. Food and Drug Administration-approved Silimed® brand round and shaped implants with high-strength silicone gel.

PubMed

Stevens, W Grant; Harrington, Jennifer; Alizadeh, Kaveh; Berger, Lewis; Broadway, David; Hester, T Roderick; Kress, Donald; dʼIncelli, Rosalyn; Kuhne, JoAnn; Beckstrand, Maggi

2012-11-01

In March of 2012, the U.S. Food and Drug Administration approved Sientra's application for premarket approval for its Silimed brand silicone gel implants, based on data from the largest silicone gel breast implant study to date. This was the first approval for shaped silicone gel breast implants. This article presents the results of Sientra's study through 5 years. Sientra's study is an ongoing, 10-year, open-label, prospective, multicenter clinical study designed to assess the safety and effectiveness of Sientra's implants in patients undergoing augmentation and reconstruction. A total of 1788 subjects were implanted with 3506 implants, including 1116 primary augmentation, 363 revision-augmentation, 225 primary reconstruction, and 84 revision-reconstruction subjects. Physical evaluations and complications were recorded at each visit. Effectiveness was measured by postimplantation bra cup size and assessment of subject satisfaction and quality of life. Of the 1788 subjects, 571 underwent magnetic resonance imaging to assess silent rupture. Safety endpoints were analyzed using the Kaplan-Meier method. Across all cohorts, the risk of rupture was 1.8 percent (95 percent CI, 1.2 to 2.6 percent), the risk of capsular contracture (Baker grade III/IV) was 9.0 percent (95 percent CI, 7.6 to 10.6 percent), and the risk of reoperation was 23.8 percent (95 percent CI, 21.8 to 26.0 percent). Over 99 percent of surgeons reported satisfaction with the postoperative results, and subject satisfaction remained high 5 years after implantation. The 5-year results of Sientra's study continue to provide a comprehensive safety and effectiveness profile of Sientra's portfolio of Silimed brand shaped and round implants. Therapeutic, IV.

Bilateral Breast Reconstruction with Extended Thoracodorsal Artery Perforator Propeller Flaps and Implants

PubMed Central

Gunnarsson, Gudjon L.; Børsen-Koch, Mikkel; Nielsen, Henrik T.; Salzberg, Andrew

2015-01-01

Summary: We present our experience of bilateral total breast reconstruction using a double-sided extended thoracodorsal artery perforator propeller flap in a case series of 10 patients. Reconstruction was successfully achieved in all cases with few complications. The median time for surgery was 275 minutes (200–330), and the average implant size used was 350 cm3 (195–650). We demonstrate how the extended thoracodorsal artery perforator propeller flap allows for a swift and reliable direct to implant bilateral total breast reconstruction in a simple setting and is a valuable adjunct to our armamentarium of techniques for single-stage bilateral breast reconstruction. PMID:26180736

Appearance of low signal intensity lines in MRI of silicone breast implants.

PubMed

Stroman, P W; Rolland, C; Dufour, M; Grondin, P; Guidoin, R G

1996-05-01

Magnetic resonance (MR) images of five explanted mammary prostheses were obtained with a 1.5 T GE Signa system using a conventional spin-echo pulse sequence, in order to investigate the low-intensity curvilinear lines which may be observed in MR images of silicone gel-filled breast implants under pressure from fibrous capsules. MR images showed ellipsoid prostheses, often containing multiple low-intensity curvilinear lines which in some cases presented an appearance very similar to that of the linguine sign. Upon opening the fibrous capsules, however, all of the prostheses were found to be completely intact demonstrating that the appearance of multiple low signal intensity curvilinear lines in MR images of silicone gel-filled prostheses is not necessarily a sign of prosthesis rupture. The MR image features which are specific to the linguine sign must be more precisely defined.

Reconstruction of the Irradiated Breast: A National Claims-Based Assessment of Postoperative Morbidity.

PubMed

Chetta, Matthew D; Aliu, Oluseyi; Zhong, Lin; Sears, Erika D; Waljee, Jennifer F; Chung, Kevin C; Momoh, Adeyiza O

2017-04-01

Implant-based reconstruction rates have risen among irradiation-treated breast cancer patients in the United States. This study aims to assess the morbidity associated with various breast reconstruction techniques in irradiated patients. From the MarketScan Commercial Claims and Encounters database, the authors selected breast cancer patients who had undergone mastectomy, irradiation, and breast reconstruction from 2009 to 2012. Demographic and clinical treatment data, including data on the timing of irradiation relative to breast reconstruction were recorded. Complications and failures after implant and autologous reconstruction were also recorded. A multivariable logistic regression model was developed with postoperative complications as the dependent variable and patient demographic and clinical variables as independent variables. Four thousand seven hundred eighty-one irradiated patients who met the inclusion criteria were selected. A majority of the patients [n = 3846 (80 percent)] underwent reconstruction with implants. Overall complication rates were 45.3 percent and 30.8 percent for patients with implant and autologous reconstruction, respectively. Failure of reconstruction occurred in 29.4 percent of patients with implant reconstruction compared with 4.3 percent of patients with autologous reconstruction. In multivariable logistic regression, irradiated patients with implant reconstruction had two times the odds of having any complication and 11 times the odds of failure relative to patients with autologous reconstruction. Implant-based breast reconstruction in the irradiated patient, although popular, is associated with significant morbidity. Failures of reconstruction with implants in these patients approach 30 percent in the short term, suggesting a need for careful shared decision-making, with full disclosure of the potential morbidity. Therapeutic, III.

Laser-Raman microprobe identification of inclusions in capsules associated with silicone gel breast implants.

PubMed

Centeno, J A; Mullick, F G; Panos, R G; Miller, F W; Valenzuela-Espinoza, A

1999-07-01

Raman spectroscopy (the analysis of scattered photons after excitation with a monochromatic light source) provides a nondestructive method for identifying organic and inorganic materials on the basis of the molecule's characteristic spectrum of vibrational frequencies. Although the technique has been predominantly applied in sciences other than pathology, the recent advent of high-quality microscope optics coupled to optical Raman spectrometers (a variation known as a Raman microprobe) rendered this technique amenable to applications in human pathology. In the Raman microprobe, a laser beam is focused on a spot approximately 1 microm in diameter on the surface of the sample, e.g., tissue, and the scattered light is collected and analyzed. In this investigation, we used the Raman microprobe for the identification of foreign materials in breast implant capsular tissues. The characteristic silicone group frequencies associated with the silicon-oxygen stretch, the silicone-carbon stretch, the silicon-methyl and the methyl carbon-hydrogen stretch frequencies were used to identify polydimethylsiloxane and to define chemical differences among the various other implant-related inclusions. All of the inclusions were positively identified in a series of 44 capsules from silicone gel-filled implants: polydimethylsiloxane was found in 44 of 44 capsules surrounding silicone gel-filled implants; polyurethane was seen in 4 of 4 capsules around polyurethane foam-coated gel-filled implants; 4 of 4 capsules enveloping Dacron patch gel-filled implants revealed Dacron; and talc was identified in 8 of these 44 capsules. Raman microspectroscopy provides a rapid, accurate, and sensitive method for identifying inclusions associated with silicone and other implant materials in tissue.

Metastatic Breast Cancer in Medication-Related Osteonecrosis Around Mandibular Implants.

PubMed

Favia, Gianfranco; Tempesta, Angela; Limongelli, Luisa; Crincoli, Vito; Piattelli, Adriano; Maiorano, Eugenio

2015-09-15

Many authors have considered dental implants to be unrelated to increased risk of medication-related osteonecrosis of the jaw (MRONJ). Nevertheless, more recently, more cases of peri-implant MRONJ (PI-MRONJ) have been described, thus becoming a challenging health problem. Also, metastatic cancer deposits are not infrequently found at peri-implant sites and this may represent an additional complication for such treatments. We present the case of a breast cancer patient with PI-MRONJ, presenting a clinically and radiologically undetected metastasis within the necrotic bone, and highlight the necessity of an accurate histopathological analysis. A 66-year-old female patient, who had received intravenous bisphosphonates for bone breast cancer metastases, came to our attention for a non-implant surgery-triggered PI-MRONJ. After surgical resection of the necrotic bone, conventional and immunohistochemical examinations were performed, which showed breast cancer deposits within the necrotic bone. Cancer patients with metastatic disease, who are undergoing bisphosphonate treatment, may develop unusual complications, including MRONJ, which is a site at risk for hosting additional metastatic deposits that may be clinically and radiologically overlooked. Such risk is increased by previous or concomitant implant procedures. Consequently, clinicians should be prudent when performing implant surgery in cancer patients with advanced-stage disease and consider the possible occurrence of peri-implant metastases while planning adequate treatments in such patients.

Liquid- and solid-state high-resolution NMR methods for the investigation of aging processes of silicone breast implants.

PubMed

Birkefeld, Anja Britta; Bertermann, Rüdiger; Eckert, Hellmut; Pfleiderer, Bettina

2003-01-01

To investigate aging processes of silicone gel breast implants, which may include migration of free unreacted material from the gel and rubber to local (e.g. connective tissue capsule) or distant sites in the body, chemical alteration of the polymer and infiltration of body compounds, various approaches of multinuclear nuclear magnetic resonance (NMR) experiments (29Si, 13C, 1H) were evaluated. While 29Si, 13C, and 1H solid-state magic angle spinning (MAS) NMR techniques performed on virgin and explanted envelopes of silicone prostheses provided only limited information, high-resolution liquid-state NMR techniques of CDCl(3) extracts were highly sensitive analytical tools for the detection of aging related changes in the materials. Using 2D 1H, 1H correlation spectroscopy (COSY) and 29Si, 1H heteronuclear multiple bond coherence (HMBC) experiments with gradient selection, it was possible to detect lipids (mainly phospholipids) as well as silicone oligomer species in explanted envelopes and gels. Silicone oligomers were also found in connective tissue capsules, indicating that cyclic polysiloxanes can migrate from intact implants to adjacent and distant sites. Furthermore, lipids can permeate the implant and modify its chemical composition. Copyright 2002 Elsevier Science Ltd.

Darunavir

MedlinePlus

... HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex ... while taking darunavir, call your doctor. Do not breast-feed if you are ... rings, injections, or implants). Talk to your doctor about other ways to ...

Complications After Mastectomy and Immediate Breast Reconstruction for Breast Cancer: A Claims-Based Analysis

PubMed Central

Jagsi, Reshma; Jiang, Jing; Momoh, Adeyiza O.; Alderman, Amy; Giordano, Sharon H.; Buchholz, Thomas A.; Pierce, Lori J.; Kronowitz, Steven J.; Smith, Benjamin D.

2016-01-01

Objective To evaluate complications after post-mastectomy breast reconstruction, particularly in the setting of adjuvant radiotherapy. Summary-Background Data Most studies of complications after breast reconstruction have been conducted at centers of excellence; relatively little is known about complication rates in radiated patients treated in the broader community. This information is relevant for breast cancer patients' decision-making. Methods Using the claims-based MarketScan database, we described complications in 14,894 women undergoing mastectomy for breast cancer from 1998-2007 who received immediate autologous reconstruction (n=2637), immediate implant-based reconstruction (n=3007), or no reconstruction within the first two postoperative years (n=9250). We used a generalized estimating equation to evaluate associations between complications and radiotherapy over time. Results Wound complications were diagnosed within the first two postoperative years in 2.3% of patients without reconstruction, 4.4% with implants, and 9.5% with autologous reconstruction (p<0.001). Infection was diagnosed within the first two postoperative years in 12.7% of patients without reconstruction, 20.5% with implants, and 20.7% with autologous reconstruction (p<0.001). 5219 (35%) women received radiation. Radiation was not associated with infection in any surgical group within the first six months but was associated with an increased risk of infection in months 7-24 in all three groups (each p<0.001). In months 7-24, radiation was associated with higher odds of implant removal in patients with implant reconstruction (OR 1.48, p<0.001) and fat necrosis in those with autologous reconstruction (OR=1.55; P=0.01). Conclusions Complication risks after immediate breast reconstruction differ by approach. Radiation therapy appears to modestly increase certain risks, including infection and implant removal. PMID:25876011

Rapid response of breast cancer to neoadjuvant intramammary testosterone-anastrozole therapy: neoadjuvant hormone therapy in breast cancer.

PubMed

Glaser, Rebecca L; Dimitrakakis, Constantine

2014-06-01

Experimental and clinical data support the inhibitory effect of testosterone on breast tissue and breast cancer. However, testosterone is aromatized to estradiol, which exerts the opposite effect. The aim of this study was to determine the effect of testosterone, combined with the aromatase inhibitor anastrozole, on a hormone receptor positive, infiltrating ductal carcinoma in the neoadjuvant setting. To determine clinical response, we obtained serial ultrasonic measurements and mammograms before and after therapy. Three combination implants-each containing 60 mg of testosterone and 4 mg of anastrozole-were placed anterior, superior, and inferior to a 2.4-cm tumor in the left breast. Three additional testosterone-anastrozole implants were again placed peritumorally 48 days later. By day 46, there was a sevenfold reduction in tumor volume, as measured on ultrasound. By week 13, we documented a 12-fold reduction in tumor volume, demonstrating a rapid logarithmic response to intramammary testosterone-anastrozole implant therapy, equating to a daily response rate of 2.78% and a tumor half-life of 23 days. Therapeutic systemic levels of testosterone were achieved without elevation of estradiol, further demonstrating the efficacy of anastrozole combined with testosterone. This novel therapy, delivered in the neoadjuvant setting, has the potential to identify early responders and to evaluate the effectiveness of therapy in vivo. This may prove to be a new approach to both local and systemic therapies for breast cancer in subgroups of patients. In addition, it can be used to reduce tumor volume, allowing for less surgical intervention and better cosmetic oncoplastic results.

Development and Optimization of a Dedicated, Hybrid Dual-Modality SPECT-CmT System for Improved Breast Lesion Diagnosis

DTIC Science & Technology

2009-01-01

breast are radiotracer uptake by heart and liver. Glandular Tissue Implant Biopsy Clip Streak Artifact Adipose Tissue FIGURE 10: CmT reconstructed... adipose tissue and implants. The cylindrical artifact is due to the offset geometry (further explanation in Task 2(a)). The second patient was...and Image Reconstruction Our emission tomography system is composed of a compact 16x20cm2 field of view cadmium zinc telluride (CZT) LumaGEM

76 FR 39882 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-07

... meeting is regarding the discussion of different innovative methodological approaches to the conduct of postmarket studies regarding silicone gel breast implants. Additionally, the panel will discuss key long-term...

Optimizing and Evaluating an Integrated SPECT-CmT System Dedicated to Improved 3-D Breast Cancer Imaging

DTIC Science & Technology

2009-05-01

sagittal slices of a breast cancer patient (42yrs, 68kg) with implant and biopsy clip and various identified tissues . Glandular Adipose Implant...Biopsy Clip 13 volumetric imaging to effectively differentiate between normal glandular, adipose tissue and the artificial implants. It is...impacting the lowered head section. A. SPECT Sub-System The main component of the SPECT sub-system is a compact 16x20cm2 field of view Cadmium - Zinc

[Surgery of the breast on transgender persons].

PubMed

Karhunen-Enckell, Ulla; Kolehmainen, Maija; Kääriäinen, Minna; Suominen, Sinikka

2015-01-01

For a female-to-male transgender person, mastectomy is the most important procedure making the social interaction easier. Along with the size of the breasts, the quantity and quality of skin will influence the selection of surgical technique. Although complications are rare, corrective surgery is performed for as many as 40% of the patients. Of male-to-female transsexual persons, 60 to 70% opt for breast enlargement. Breast enlargement can be carried out by using either silicone implants or fat transplantation. Since the surgical procedures on breasts are irreversible, their implementation requires confirmation of the diagnosis of transsexualism by a multidisciplinary team.

The Supra-Inframammary Fold Approach to Breast Augmentation: Avoiding a Double Bubble

PubMed Central

2017-01-01

Background: The inframammary incision for breast augmentation is commonly made at or below the existing inframammary fold (IMF) in an effort to keep the scar in the crease. In recent studies, surgeons inferiorly relocate the IMF, center the implant at nipple level, and attempt to secure the new IMF with sutures. The fascial attachments (also called ligaments) holding the IMF are released, risking a bottoming-out deformity or a double bubble. Methods: This retrospective study evaluated 160 consecutive women undergoing primary subpectoral breast augmentation. An incision was made 0.5–1.0 cm above the IMF. Dissection proceeded directly to the pectoralis margin, preserving IMF fascial attachments. The pectoralis origin was released from the lower sternum. Surveys were administered to obtain patient-reported outcome data. Ninety-eight patients (61%) participated. Results: Implants often appear high on the chest at early follow-up appointments but gradually settle. One patient (0.6%) developed a double bubble. No reoperations were needed for implant malposition. One patient had a mild animation deformity. There were no cases of symmastia. The mean result rating was 9.1/10. Four percent of surveyed patients found their implants too high; 8% found them too low. Ninety-two patients (94%) reported that their scars were well-hidden. Ninety-six women (98%) said that they would redo the surgery. Conclusions: A supra-IMF approach anticipates the normal descent of implants after augmentation. Scars remain hidden both in standing and supine positions. This method reduces the short-term risk of reoperation for implant malposition or a double bubble. PMID:28831352

[The breast of the adolescent girl].

PubMed

Bruant-Rodier, C; Dissaux, C; Baratte, A; Francois Fiquet, C; Bodin, F

2016-10-01

During adolescence, psychological and physical changes occur and breast takes a major place in the young woman body image. Except rare malign tumors, breast pathologies at this age are mainly benign or malformative. Malformative issues are revealed during breast growth, as isolated asymmetry or associated to other regional anomalies, with abnormal shape or volume of the breast, or even supernumerary breast. Therapeutic solutions will not differ from the ones used for adults. Breast lipofilling, recently admitted by plastic surgery community is an interesting tool that can be used on young women. Choosing the right technic depends on the initial problem. It comes at an early stage to offset hypoplasia resulting in a problem of asymmetry. It waits for breast stability in case of hypertrophy and for legal majority in case of breast augmentation using implants. Psychological impairment stays however a central issue and forces the surgeon to adapt to the individual and to his body change over time. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

ASPS clinical practice guideline summary on breast reconstruction with expanders and implants.

PubMed

Alderman, Amy; Gutowski, Karol; Ahuja, Amy; Gray, Diedra

2014-10-01

After reading this article, participants should be able to: 1. Understand the evidence regarding the timing of expander/implant breast reconstruction in the setting of radiation therapy. 2. Discuss the implications of a patient's risk factors for possible outcomes and complications of expander/implant breast reconstruction. 3. Implement proper prophylactic antibiotic protocols. 4. Use the guidelines to improve their own clinical outcomes and reduce complications. In March of 2013, the Executive Committee of the American Society of Plastic Surgeons approved an evidence-based guideline on breast reconstruction with expanders and implants, as developed by a guideline-specific work group commissioned by the society's Health Policy Committee. The guideline addresses ten clinical questions: patient education, immediate versus delayed reconstruction, risk factors, radiation therapy, chemotherapy, hormonal therapy, antibiotic prophylaxis, acellular dermal matrix, monitoring for cancer recurrence, and oncologic outcomes associated with implant-based reconstruction. The evidence indicates that patients undergoing mastectomy should be offered a preoperative referral to a plastic surgeon. Evidence varies regarding the association between postoperative complications and timing of postmastectomy expander/implant breast reconstruction. Evidence is limited regarding the optimal timing of expand/implant reconstruction in the setting of radiation therapy but suggests that irradiation to the expander or implant is associated with an increased risk of postoperative complications. Evidence also varies regarding the association between acellular dermal matrix and surgical complications in the setting of postmastectomy expander/implant reconstruction. Data support the use of an appropriate preoperative antibiotic, but antibiotics should be discontinued within 24 hours of the procedure, unless a surgical drain is present. Furthermore, postmastectomy expander/implant breast reconstruction does not adversely affect oncologic outcomes.

Anaplastic Large Cell Lymphoma Associated With Breast Implants

PubMed Central

Ravi-Kumar, Shalini; Sanaei, Omid; Vasef, Mohammad; Rabinowitz, Ian; Fekrazad, Mohammad Houman

2012-01-01

A forty two years old woman with a history of bilateral breast augmentation for cosmetic reasons was presented for poor healing of the surgical site. Tissue and periprosthetic fluid were removed from the wound site revealing an atypical lymphoid infiltrate. Subsequently the patient developed axillary lymph adenopathy. Excisional biopsy was performed. Flow cytometry was non-diagnostic. She continued to heal poorly and eventually had removal of implant during a simple mastectomy. A nodular area in the breast specimen showed ALK negative anaplastic large cell lymphoma (ALCL). The patient was treated in the private section, with only a pathology consultation being done at our institution (Figures 1-3). PMID:25734041

Explicating perceived barriers to mammography for the USCREEN project: concerns about breast implants, faith violations, and perceived recommendations.

PubMed

Jensen, Jakob D; Ratcliff, Chelsea; Weaver, Jeremy; Krakow, Melinda M; Payton, William; Loewen, Sherrie

2015-11-01

In line with the health belief model, perceived barriers have proven to be a key determinant of intentions to screen for breast cancer. The standard measure of perceived barriers to breast cancer screening is an 11 item scale developed by Victoria Champion. However, perceived barriers emerge and change over time, and Champion's perceived barriers scale was last revised in 1999. Moreover, the original scale did not address barriers which may be more pronounced in particular populations, such as congruity of action with faith. As part of the Utah Screening Project, a sample of women 40-74 (N = 341, Mage = 51.19, SD = 8.11) were recruited from four Utah counties in 2014 to complete a survey. The results revealed that the four new perceived barrier items explained 6.4 % of intentions to screen, above and beyond other predictors. In addition to barriers identified in past research, the current study identified several novel barriers including (a) concerns about negative effects to breast implants, (b) perceived conflict with faith, and the (c) perception that mammography is no longer recommended. The new perceived barriers items are useful to researchers interested in exploring barriers not addressed by the original instrument. The barriers also suggest potential belief-based targets and channels (e.g., plastic surgery clinics, faith-based interventions) for delivering mammography interventions.

A prospective study on silicone breast implants and the silicone-related symptom complex.

PubMed

Contant, C M E; Swaak, A J G; Obdeijn, A I M; van der Holt, B; Tjong Joe Wai, R; van Geel, A N; Eggermont, A M M

2002-06-01

This cohort study prospectively evaluated the prevalence of the silicone-related symptom complex (SRSC) in relation to antinuclear antibodies (ANA) and magnetic resonance imaging (MRI) of silicone breast implants (SBI) 1 year after implantation. A total of 57 women undergoing mastectomy followed by immediate breast reconstruction (IBR) and SBI between March 1995 and March 1997 at the University Hospital Rotterdam/Daniel den Hoed Cancer Centre, were prospectively evaluated. Just before and 1 year after IBR the sera of these women were tested for the presence of ANA and they were screened for the prevalence of SRSC-related symptoms by questionnaire. All prostheses were evaluated by MRI 1 month and 1 year after IBR. Just before operation 11% of the women had a Sjögren score of more than 2, whereas 30% had such a score 1 year after IBR ( P = 0.01). One year postoperatively women had significantly more RA/Raynaud-related complaints: 21% preoperatively versus 40% 1 year after IBR ( P = 0.03). Within the undefined complaints-related group 19% had a score of 2 or more preoperatively and 33% 1 year after IBR ( P = 0.09). There were no new cases of ANA positivity 1 year after IBR. The linguine sign was seen by MRI in three implants: one 1 month after IBR and two 1 year after IBR. There was no relation to changes in SRSC expression and these MRI findings. In conclusion, 1 year after SBI implantation women had more SRSC-related complaints, especially Sjögren's and RA/Raynaud's. Moreover there was no correlation between elevated SRSC expression and changes in the presence of ANA or changes in MRI of the SBI 1 year after IBR.

Lumbar herniation following extended autologous latissimus dorsi breast reconstruction.

PubMed

Fraser, Sheila Margaret; Fatayer, Hiba; Achuthan, Rajgopal

2013-05-30

Reconstructive breast surgery is now recognized to be an important part of the treatment for breast cancer. Surgical reconstruction options consist of implants, autologous tissue transfer or a combination of the two. The latissimus dorsi flap is a pedicled musculocutaneous flap and is an established method of autologous breast reconstruction.Lumbar hernias are an unusual type of hernia, the majority occurring after surgery or trauma in this area. The reported incidence of a lumbar hernia subsequent to a latissimus dorsi reconstruction is very low. We present the unusual case of lumbar herniation after an extended autologous latissimus dorsi flap for breast reconstruction following a mastectomy. The lumbar hernia was confirmed on CT scanning and the patient underwent an open mesh repair of the hernia through the previous latissimus dorsi scar. Lumbar hernias are a rare complication that can occur following latissimus dorsi breast reconstruction. It should be considered in all patients presenting with persistent pain or swelling in the lumbar region.

Breast implant-associated anaplastic large cell lymphoma: a case report and literature review.

PubMed

Hwang, Mei-Ju; Brown, Hamish; Murrin, Richard; Momtahan, Navid; Sterne, Guy D

2015-06-01

Breast implant-associated anaplastic large cell lymphoma (ALCL) is a rare new clinical entity. The incidence is 0.3 % per 100,000 women per year. Patients present with non-specific implant-related complications resulting in delayed diagnosis. We present such a case to raise awareness and discuss management. A 48-year-old female presented with a 3-month history of left breast pain and swelling. She had undergone multiple bilateral augmentations 8 years previously. Triple assessment revealed a seroma, and a magnetic resonance imaging scan excluded implant rupture. Cytology showed a typical cells with mitotic activity which lead to removal of implants and a left capsulectomy. Final histology revealed an anaplastic lymphoma kinase (ALK) negative ALCL confined to the capsule. A computerised tomography scan and bone marrow biopsy excluded systemic disease, but due to later identified B symptoms, she received CHOP chemotherapy under the care of the haematologists. ALK-negative ALCL is associated with breast implants, and any persistent late onset seroma or breast symptoms should raise the suspicion of ALK-negative ALCL as a differential diagnosis. The recommended treatment is surgical removal of the implant including a full capsulectomy, highlighting the suspicion of ALCL to the pathologist. Exclusion of systematic disease is also recommended in all patients, and the need for adjuvant therapy should be addressed on an individual case basis. For disease confined to the capsule, adjuvant chemoradiotherapy is not needed. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors http://www.springer.com/00266 .

Magnetic resonance imaging (MRI) evaluation of residual breast tissue following mastectomy and reconstruction with silicone implants.

PubMed

Zippel, Douglas; Tsehmaister-Abitbol, Vered; Rundstein, Arie; Shalmon, Anat; Zbar, Andrew; Nardini, Gil; Novikov, Ilya; Sklair-Levy, Miri

2015-01-01

We present our use of magnetic resonance (MR) measurement to determine the amount of residual breast tissue (RBT) following total mastectomy with reconstruction. Breast MR images of 45 women who underwent surgery between January and November 2011 were reviewed. The cohort included therapeutic and prophylactic mastectomies. RBT was evaluated at four points with a digital caliper assessing T2-weighted and T1-weighted images. Patients undergoing mastectomy for carcinoma tended to have less RBT than in prophylactic surgery. Greater age and recent surgery both correlated with larger RBT. Variable thickness of RBT is demonstrable following mastectomy and implant reconstruction using MR imaging. Copyright © 2015 Elsevier Inc. All rights reserved.

Image segmentation and 3D visualization for MRI mammography

NASA Astrophysics Data System (ADS)

Li, Lihua; Chu, Yong; Salem, Angela F.; Clark, Robert A.

2002-05-01

MRI mammography has a number of advantages, including the tomographic, and therefore three-dimensional (3-D) nature, of the images. It allows the application of MRI mammography to breasts with dense tissue, post operative scarring, and silicon implants. However, due to the vast quantity of images and subtlety of difference in MR sequence, there is a need for reliable computer diagnosis to reduce the radiologist's workload. The purpose of this work was to develop automatic breast/tissue segmentation and visualization algorithms to aid physicians in detecting and observing abnormalities in breast. Two segmentation algorithms were developed: one for breast segmentation, the other for glandular tissue segmentation. In breast segmentation, the MRI image is first segmented using an adaptive growing clustering method. Two tracing algorithms were then developed to refine the breast air and chest wall boundaries of breast. The glandular tissue segmentation was performed using an adaptive thresholding method, in which the threshold value was spatially adaptive using a sliding window. The 3D visualization of the segmented 2D slices of MRI mammography was implemented under IDL environment. The breast and glandular tissue rendering, slicing and animation were displayed.

Is mammary reconstruction with the anatomical Becker expander a simple procedure? Complications and hidden problems leading to secondary surgical procedures: a follow-up study.

PubMed

Farace, Francesco; Faenza, Mario; Bulla, Antonio; Rubino, Corrado; Campus, Gian Vittorio

2013-06-01

Debate over the role of Becker expander implants (BEIs) in breast reconstruction is still ongoing. There are no clear indications for BEI use. The main indications for BEI use are one-stage breast reconstruction procedure and congenital breast deformities correction, due to the postoperative ability to vary BEI volume. Recent studies showed that BEIs were removed 5 years after mammary reconstruction in 68% of operated patients. This entails a further surgical procedure. BEIs should not, therefore, be regarded as one-stage prostheses. We performed a case-series study of breast reconstructions with anatomically shaped Becker-35™ implants, in order to highlight complications and to flag unseen problems, which might entail a second surgical procedure. A total of 229 patients, reconstructed from 2005 to 2010, were enrolled in this study. Data relating to implant type, volume, mean operative time and complications were recorded. All the patients underwent the same surgical procedure. The minimum follow-up period was 18 months. During a 5-year follow-up, 99 patients required secondary surgery to correct their complications or sequelae; 46 of them underwent BEI removal within 2 years of implantation, 56 within 3 years, 65 within 4 years and 74 within 5 years. Our findings show that two different sorts of complications can arise with these devices, leading to premature implant removal, one common to any breast implant and one peculiar to BEIs. The Becker implant is a permanent expander. Surgeons must, therefore, be aware that, once positioned, the Becker expander cannot be adjusted at a later date, as in two-stage expander/prosthesis reconstructions for instance. Surgeons must have a clear understanding of possible BEI complications in order to be able to discuss these with their patients. Therefore, only surgeons experienced in breast reconstruction should use BEIs. Copyright © 2013 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Multisite Infection with Mycobacterium abscessus after Replacement of Breast Implants and Gluteal Lipofilling

PubMed Central

Rüegg, Eva; Cheretakis, Alexandre; Modarressi, Ali; Harbarth, Stephan; Pittet-Cuénod, Brigitte

2015-01-01

Introduction. Medical tourism for aesthetic surgery is popular. Nontuberculous mycobacteria (NTM) occasionally cause surgical-site infections. As NTM grow in biofilms, implantations of foreign bodies are at risk. Due to late manifestation, infections occur when patients are back home, where they must be managed properly. Case Report. A 39-year-old healthy female was referred for acute infection of the right gluteal area. Five months before, she had breast implants replacement, abdominal liposuction, and gluteal lipofilling in Mexico. Three months postoperatively, implants were removed for NTM-infection in Switzerland. Adequate antibiotic treatment was stopped after seven days for drug-related hepatitis. At entrance, gluteal puncture for bacterial analysis was performed. MRI showed large subcutaneous collection. Debridement under general anaesthesia was followed by open wound management. Total antibiotic treatment was 20 weeks. Methods. Bacterial analysis of periprosthetic and gluteal liquids included Gram-stain plus acid-fast stain, and aerobic, anaerobic and mycobacterial cultures.  Results. In periprosthetic fluid, Mycobacterium abscessus, Propionibacterium, and Staphylococcus epidermidis were identified. The same M. abscessus strain was found gluteally. The gluteal wound healed within six weeks. At ten months' follow-up, gluteal asymmetry persists for deep scarring. Conclusion. This case presents major complications of multisite aesthetic surgery. Surgical-site infections in context of medical tourism need appropriate bacteriological investigations, considering potential NTM-infections. PMID:25893122

Propeller thoracodorsal artery perforator flap for breast reconstruction.

PubMed

Angrigiani, Claudio; Rancati, Alberto; Escudero, Ezequiel; Artero, Guillermo; Gercovich, Gustavo; Deza, Ernesto Gil

2014-08-01

The thoracodorsal artery perforator (TDAP) flap has been described for breast reconstruction. This flap requires intramuscular dissection of the pedicle. A modification of the conventional TDAP surgical technique for breast reconstruction is described, utilizing instead a propeller TDAP flap. The authors present their clinical experience with the propeller TDAP flap in breast reconstruction alone or in combination with expanders or permanent implants. From January 2009 to February 2013, sixteen patients had breast reconstruction utilizing a propeller TDAP flap. Retrospective analysis of patient characteristics, clinical indications, procedure and outcomes were performed. The follow-up period ranged from 4 to 48 months. Sixteen patients had breast reconstruction using a TDAP flap with or without simultaneous insertion of an expander or implant. All flaps survived, while two cases required minimal resection due to distal flap necrosis, healing by second intention. There were not donor-site seromas, while minimal wound dehiscence was detected in two cases. The propeller TDAP flap appears to be safe and effective for breast reconstruction, resulting in minimal donor site morbidity. The use of this propeller flap emerges as a true alternative to the traditional TDAP flap.

Release of low molecular weight silicones and platinum from silicone breast implants.

PubMed

Lykissa, E D; Kala, S V; Hurley, J B; Lebovitz, R M

1997-12-01

We have conducted a series of studies addressing the chemical composition of silicone gels from breast implants as well as the diffusion of low molecular weight silicones (LM-silicones) and heavy metals from intact implants into various surrounding media, namely, lipid-rich medium (soy oil), aqueous tissue culture medium (modified Dulbecco's medium, DMEM), or an emulsion consisting of DMEM plus 10% soy oil. LM-silicones in both implants and surrounding media were detected and quantitated using gas chromatography (GC) coupled with atomic emission (GC-AED) as well as mass spectrometric (GC/MS) detectors, which can detect silicones in the nanogram range. Platinum, a catalyst used in the preparation of silicone gels, was detected and quantitated using inductive argon-coupled plasma/mass spectrometry (ICP-MS), which can detect platinum in the parts per trillion range. Our results indicate that GC-detectable low molecular weight silicones contribute approximately 1-2% to the total gel mass and consist predominantly of cyclic and linear poly-(dimethylsiloxanes) ranging from 3 to 20 siloxane [(CH3)2-Si-O] units (molecular weight 200-1500). Platinum can be detected in implant gels at levels of approximately 700 micrograms/kg by ICP-MS. The major component of implant gels appears to be high molecular weight silicone polymers (HM-silicones) too large to be detected by GC. However, these HM-silicones can be converted almost quantitatively (80% by mass) to LM-silicones by heating implant gels at 150-180 degrees C for several hours. We also studied the rates at which LM-silicones and platinum leak through the intact implant outer shell into the surrounding media under a variety of conditions. Leakage of silicones was greatest when the surrounding medium was lipid-rich, and up to 10 mg/day LM-silicones was observed to diffuse into a lipid-rich medium per 250 g of implant at 37 degrees C. This rate of leakage was maintained over a 7-day experimental period. Similarly, platinum was also observed to leak through intact implants into lipid-containing media at rates of approximately 20-25 micrograms/day/250 g of implant at 37 degrees C. The rates at which both LM-silicones and platinum have been observed to leak from intact implants could lead to significant accumulation within lipid-rich tissues and should be investigated more fully in vivo.

Sientra portfolio of Silimed brand shaped implants with high-strength silicone gel: a 5-year primary augmentation clinical study experience and a postapproval experience-results from a single-surgeon 108-patient series.

PubMed

Haws, Melinda J; Schwartz, Michael R; Berger, Lewis H; Daulton, Kimber L

2014-07-01

The Sientra portfolio of silicone gel breast implants was approved by the Food and Drug Administration on March 9, 2012, and included the first approved shaped implants in the United States. The 5-year results from Sientra's Core Gel and Continued Access Study and the results of a single surgeon are presented. This analysis used the data of 640 shaped implants in 321 primary augmentation patients implanted by 16 study surgeons through 5 years. The Kaplan-Meier method was used to analyze safety endpoints. In addition, analysis is presented for a single surgeon's results of 213 shaped implants in 108 postapproval patients through up to 16 months of follow-up (9-month mean) using a separate frequency analysis. The overall risk of rupture for primary augmentation patients through 5 years was 0.4%, the risk of infection was 1.4%, and the risk of capsular contracture (Baker grade III/IV) was 3.9%. Reported surgeon satisfaction was 100%, and patient satisfaction remained high. In the separate single-surgeon analysis, after 16 months, 4 of the 108 patients experienced a complication (3.7%) and 3 underwent a reoperation (2.8%). Complications included infection, ptosis (0.9%, each), and capsular contracture (1.9%). The results of Sientra's large clinical study and the postapproval data from a single surgeon demonstrate the safety and effectiveness of Sientra's shaped implants. The review of the data and author's experience illustrate the ease of incorporating shaped implants into any surgical practice.

Breast implant-associated anaplastic large cell lymphoma: a systematic review of the literature and mini-meta analysis.

PubMed

Thompson, Philip A; Prince, H Miles

2013-09-01

Breast implant-associated ALCL (BIA-ALCL) is a rare, but likely under-reported entity, which most commonly presents with an effusion developing between the breast implant and the host fibrous capsule that surrounds it. It has been described in association with breast implants used for post-cancer reconstructive surgery and when implanted for purely cosmetic reasons. Two different presentations are seen; presentation with an effusion alone +/- co-existing capsular contracture, without an associated mass, and presentation with a mass lesion +/- an effusion. These two presentations are associated with very different outcomes, with women presenting with effusion alone having an excellent long-term survival, even in the absence of specific therapy other than implant removal. In these women, no further therapy other than implant removal is likely necessary. In contrast, women presenting with a mass lesion have a higher rate of relapse and may require more aggressive therapy.

[Autoimmune/infl ammatory syndrome induced by adjuvants, ASIA].

PubMed

Stolarczyk, Jędrzej; Kubiś, Marek; Brzosko, Marek

There have been many cases of the appearance of autoantibodies and symptoms of disease after exposure to adjuvants, not only after breast augmentation with silicone implants, but also as a very rare vaccination side effect, such as Gulf war syndrome or macrophagic myofasciitis syndrome. Diseases whose symptoms developed after such adjuvant exposure are called autoimmune/ inlammatory syndrome induced by adjuvants (ASIA). The group of adjuvants includes not only silicone implants, silica, squalen and aluminium, but also ink components used for making tattoos. Analyzing the available reports on the inluence of adjuvants on the development of autoimmune diseases, the conclusion is that apart from long -term silicone exposure, the coexistence of other factors such as genetic or environmental is also necessary. Metaanalyses clearly do not conirm an increased risk of developing autoimmune disease after breast augmentation with silicone implants, or tattooing, but it seems that among these patients there is a group that is more predestined to develop disease symptoms. In the general population the beneits of vaccination are obvious, and the risk of severe adverse events following immunisation is incomparably lower than the risk of developing a speciic disease and its complications, also for patients with diagnosed autoimmune diseases. Because of data heterogeneity in previous studies and dificulties in diagnosing ASIA it seems necessary to conduct further analyses of adjuvants’ inluence on autoimmune disease development, and to reine ASIA diagnostic criteria, which now allow too easy a diagnosis of this syndrome.

Volumetric Evaluation of the Mammary Gland and Pectoralis Major Muscle following Subglandular and Submuscular Breast Augmentation.

PubMed

Roxo, Ana Claudia Weck; Nahas, Fabio Xerfan; Salin, Renan; de Castro, Claudio Cardoso; Aboudib, Jose Horacio; Marques, Ruy Garcia

2016-01-01

Besides being a procedure with high level of patient satisfaction, one of the main causes for reoperation after breast augmentation is related to contour deformities and changes in breast volume. Few objective data are available on postoperative volumetric analysis following breast augmentation. The aim of this study was to evaluate volume changes in the breast parenchyma and pectoralis major muscle after breast augmentation with the placement of silicone implants in the subglandular and submuscular planes. Fifty-eight women were randomly allocated either to the subglandular group (n = 24) or submuscular group (n = 24) and underwent breast augmentation in the subglandular or submuscular plane, respectively, or to a control group (n = 10) and received no intervention. Volumetric magnetic resonance imaging was performed at inclusion in all participants and either after 6 and 12 months in the control group or at 6 and 12 months after surgery in the intervention groups. Twelve months after breast augmentation, only the subglandular group had a significant reduction in glandular volume (mean, 22.8 percent), while patients in the submuscular group were the only ones showing significant reduction in muscle volume (mean, 49.80 percent). Atrophy of the breast parenchyma occurred after subglandular breast augmentation, but not following submuscular breast augmentation. In contrast, submuscular breast augmentation caused atrophy of the pectoralis major muscle. Therapeutic, II.

Breast augmentation, antibiotic prophylaxis, and infection: comparative analysis of 1,628 primary augmentation mammoplasties assessing the role and efficacy of antibiotics prophylaxis duration.

PubMed

Khan, Umar Daraz

2010-02-01

Infections after augmentation mammoplasty are not uncommon, and prophylactic antibiotics are routinely administered to minimize infection. However, there is paucity of information on the relationship between the length of prophylaxis cover and its benefits in primary augmentation mammoplasty. A retrospective analysis of different antibiotic cover regimens, their effectiveness in preventing infections, and the management of infection in established cases is reviewed. A retrospective chart analysis of periprosthetic infections in primary augmentation mammoplasties performed over the past 10 years was conducted. Periprosthetic infection was determined by the presence of pain, swelling, redness, and discharge. Each breast was taken as an individual unit in 1,628 patients, and data for 3,256 breasts were analyzed. The patients had their augmentation in the partial submuscular plane (214 breasts in 107 patients), the subglandular plane (1,548 breasts in 774 patients), and the muscle-splitting biplane (1,494 breasts in 747 patients). All the patients had soft round cohesive gel silicone implants. Of the 3,256 implants, 3,218 were textured, and 38 were smooth surfaced. The patients received antibiotics as a single intravenous dose of cephalosporin (474 breasts in 237 patients), a single intravenous dose plus an oral dose for 24 h (344 breasts in 172 patients), or a single intravenous dose plus an oral course for 5 days (2,438 breasts in 1,219 patients). Infection was recorded as superficial (e.g., wound breakdown, stitch extrusion, stitch abscess) or deep (periprosthetic). The patients with established periprosthetic infections, determined clinically by the presence of pain, discharge, swelling, and redness of the breasts, were managed either conservatively using antibiotics, passive wound drainage, and healing of the wound with secondary intention or by explantation and replacement after 3 to 4 months. In selected cases of periprosthetic infection, the implants were removed after a course of antibiotics and negative swab cultures. The cavity was washed thoroughly with betadine and saline, and new implants were simultaneously reimplanted. The incidence of infection was lowest with a single perioperative dose of intravenous antibiotic compared with a combination of intravenous and oral antibiotics. Superficial infection was seen in 38 breasts (all unilateral), with an incidence of 1.2%, and periprosthetic infection was observed in 17 breasts (13 unilateral and 2 bilateral), giving an infection incidence of 0.52% (p = 0.002). In patients with a single intravenous dose of antibiotic, superficial and periprosthetic infection was seen in four breasts (0.8%) and no breasts, respectively. The difference was not significant (p = 0.13). The patients receiving a single intravenous antibiotic and a 24-h oral antibiotic had superficial and periprosthetic infection rates of 2.3% (8 breasts) and 0.3% (1 breast), respectively, and the difference between the two sub-groups was significantly higher (p = 0.04). The patients receiving an intravenous antibiotic and 5 days of oral antibiotics had superficial and periprosthetic infection rates of 1.1% (26 breasts) and 0.65% (14 breasts), respectively. The difference between the two subgroups was not significant (p = 0.09). Of the 17 periprosthetic infections in 15 patients (13 unilateral and 2 bilateral), 11 breasts (1 bilateral and 9 unilateral) were treated conservatively using antibiotics, passive drainage, and wound healing with secondary intention. Capsular contracture developed in two of the conservatively treated breasts, requiring capsulotomies with change of implants. Of the six periprosthetic infections in six patients, requiring surgical intervention, two implants were treated using explantation with immediate replacement after a course of antibiotics and a negative culture, and two implants were explanted followed by reimplantation later. One patient had both implants removed after unilateral infection, and no reimplantation was performed. One patient had a bilateral infection. In this case, one implant was explanted and the other was treated conservatively. The patient had bilateral reimplantion 6 months later, and bilateral Baker 4 capsular contracture developed in both breasts within 6 months. No other complications were seen in the patients who underwent surgery. A single dose of intravenous antibiotic is adequate for prophylaxis in breast augmentation surgery, and the extra duration of antibiotic cover does not result in reduced superficial or periprosthetic infections. Infection can be managed in more than one way depending on the nature, degree, and extent of infection.

Diagnosis of anaplastic large cell lymphoma on late peri-implant breast seroma: Management of cytological sample by an integrated approach.

PubMed

Ronchi, A; Montella, M; Argenzio, V; Lucia, A; De Renzo, A; Alfano, R; Franco, R; Cozzolino, I

2018-04-06

Peri-implant breast seroma is a late clinical presentation of reconstructive surgery or augmentation mammoplasty with breast implants. Pre-operative cytological evaluation of the peri-implant breast seroma is a common clinical approach, showing mainly an inflammatory reaction or more rarely a breast implant-associated anaplastic large cell lymphoma. Herein, we reported the role of cytology in the evaluation of peri-implant breast seroma and its critical pre-operative implications. Eight cases of peri-implant breast seroma from files at Luigi Vanvitelli University were identified between January and December 2017. In all cases, seroma was aspirated; cytospins were performed and stained by Papanicolaou stain; finally, in all cases, a cell block was obtained for immunocytochemical evaluation and, in one case, for FISH to detect ALK1-gene translocation. The median age of patients was 48 years and the mean time between the implant placement and the occurrence of peri-implant breast seroma was 18 months. Microscopic examination showed breast implant-associated anaplastic large cell lymphoma in one case, aspecific inflammatory reaction in six cases and silicon-associated reaction in one case. Peri-implant breast seroma may be caused by several pathological conditions with different clinical behaviour. A proper cytological approach to peri-implant breast seroma allows a correct differential diagnosis between inflammatory conditions and breast implant-associated anaplastic large cell lymphoma and an appropriate management of the patient. © 2018 John Wiley & Sons Ltd.

Incidence of Internal Mammary Lymph Nodes with Silicone Breast Implants at MR Imaging after Oncoplastic Surgery.

PubMed

Sutton, Elizabeth J; Watson, Elizabeth J; Gibbons, Girard; Goldman, Debra A; Moskowitz, Chaya S; Jochelson, Maxine S; Dershaw, D David; Morris, Elizabeth A

2015-11-01

To assess the incidence of benign and malignant internal mammary lymph nodes (IMLNs) at magnetic resonance (MR) imaging among women with a history of treated breast cancer and silicone implant reconstruction. The institutional review board approved this HIPAA-compliant retrospective study and waived informed consent. Women were identified who (a) had breast cancer, (b) underwent silicone implant oncoplastic surgery, and (c) underwent postoperative implant-protocol MR imaging with or without positron emission tomography (PET)/computed tomography (CT) between 2000 and 2013. The largest IMLNs were measured. A benign IMLN was pathologically proven or defined as showing 1 year of imaging stability and/or no clinical evidence of disease. Malignant IMLNs were pathologically proven. Incidence of IMLN and positive predictive value (PPV) were calculated on a per-patient level by using proportions and exact 95% confidence intervals (CIs). The Wilcoxon rank sum test was used to assess the difference in axis size. In total, 923 women with breast cancer and silicone implants were included (median age, 46 years; range, 22-89 years). The median time between reconstructive surgery and first MR imaging examination was 49 months (range, 5-513 months). Of the 923 women, 347 (37.6%) had IMLNs at MR imaging. Median short- and long-axis measurements were 0.40 cm (range, 0.20-1.70 cm) and 0.70 cm (range, 0.30-1.90 cm), respectively. Two hundred seven of 923 patients (22.4%) had adequate follow-up; only one of the 207 IMLNs was malignant, with a PPV of 0.005 (95% CI: 0.000, 0.027). Fifty-eight of 923 patients (6.3%) had undergone PET/CT; of these, 39 (67.2%) had IMLN at MR imaging. Twelve of the 58 patients (20.7%) with adequate follow-up had fluorine 18 fluorodeoxyglucose-avid IMLN, with a median standardized uptake value of 2.30 (range, 1.20-6.10). Only one of the 12 of the fluorodeoxyglucose-avid IMLNs was malignant, with a PPV of 0.083 (95% CI: 0.002, 0.385). IMLNs identified at implant-protocol breast MR imaging after oncoplastic surgery for breast cancer are overwhelmingly more likely to be benign than malignant. Imaging follow-up instead of immediate metastatic work-up may be warranted. © RSNA, 2015

Breast reconstruction following mastectomy: an update.

PubMed

Elliott, L F; Beegle, P H; Hartrampf, C R; Bennett, G K

1991-11-01

Breast reconstruction today is a realistic and vital part of total breast cancer treatment. All physicians should be well informed on current methods of reconstruction so that they can present the facts to their patients in an encouraging, yet realistic manner. Recent developments in breast reconstruction after mastectomy have included the increase utilization of immediate breast reconstruction at the time of mastectomy, the improvement and refinement of the TRAM flap, the increased use of the "free" flap transfer of the TRAM flap which increases blood supply to the flap, texturing of implants which appears to increase their stability on the chest wall and reduce the incidence of capsular contracture or firmness, and the introduction of the newer autogenous tissue methods including the LTTF, gluteal, and latissimus dorsi flaps. Plastic surgeons are charged with the task of becoming proficient in breast reconstruction procedures in order to offer the mastectomy patient a safe, realistic facsimile breast that will be trouble free. Fortunately, there are several good options for restoring the breast after mastectomy. The method of reconstruction should be chosen by matching the desires of informed patients with the indications and contraindications in each case. In general, silicone reconstruction is expedient and satisfactory in most patients. However, it cannot compete with autogenous tissue transfer for severe chest wall defects, covering irradiated areas, creating a large, ptotic breast, or providing a natural appearing, soft breast mount.

Predictors for contralateral prophylactic mastectomy in breast cancer patients

PubMed Central

Fu, Yun; Zhuang, Zhigang; Dewing, Michelle; Apple, Sophia; Chang, Helena

2015-01-01

Background: In recent years, radical breast cancer surgery has been largely replaced by breast conservation treatment, due to early diagnosis and more effective adjuvant treatment. While breast conservation is mostly preferred, the trend of bilateral mastectomy has risen in the United States. The aim of this study is to determine factors influencing patients’ choice for having contralateral prophylactic mastectomy (CPM). Methods: This is a retrospective study of 373 patients diagnosed with primary invasive breast cancer who were treated by bilateral or unilateral mastectomy (BM or UM) at the Revlon/UCLA Breast Center between Jan. 2002 and Dec. 2010. In the BM group, only those with unilateral breast cancer who chose CPM were included in the analysis. Results: When compared with the UM group, the following factors were found to be associated with BM: younger age, pre-menopausal, a family history of breast/ovarian cancer, BRCA mutation, more breast biopsies, history of breast augmentation, having MRI study within 6 months before the surgery, more likely to have reconstruction and sentinel lymph node biopsy (SLNB) and fewer had neoadjuvant/adjuvant chemotherapy/radiation. When patients with bilateral breast cancer were excluded, multivariate logistic regression analysis indicated younger patients with negative nodes, SLNB as the only nodal surgery and positive family history were significant factors predicting CPM and immediate reconstruction using tissue expanders or implants. Conclusion: Younger age, lower TN stage, requiring only SLNB and high risk family history predict contralateral prophylactic mastectomy. Tissue expander/implant-based reconstructions were more frequently chosen by patients with BM. PMID:26097557

Oncoplastic Surgery for Upper/Upper Inner Quadrant Breast Cancer.

PubMed

Lin, Joseph; Chen, Dar-Ren; Wang, Yu-Fen; Lai, Hung-Wen

2016-01-01

Tumors located in the upper/upper inner quadrant of the breast warrant more attention. A small lesion relative to the size of breast in this location may be resolved by performing a level I oncoplastic technique. However, a wide excision may significantly reduce the overall quality of the breast shape by distorting the visible breast line. From June 2012 to April 2015, 36 patients with breast cancer located in the upper/upper inner quadrant underwent breast-conservation surgery with matrix rotation mammoplasty. According to the size and location of the tumor relative to the nipple-areola complex, 11 patients underwent matrix rotation with periareolar de-epithelialization (donut group) and the other 25 underwent matrix rotation only (non-donut group). The cosmetic results were self-assessed by questionnaires. The average weights of the excised breast lumps in the donut and non-donut groups were 104.1 and 84.5 g, respectively. During the 3-year follow-up period, local recurrence was observed in one case and was managed with nipple-sparing mastectomy followed by breast reconstruction with prosthetic implants. In total, 31 patients (88.6%) ranked their postoperative result as either acceptable or satisfactory. The treated breasts were also self-evaluated by 27 patients (77.1%) to be nearly identical to or just slightly different from the untreated side. Matrix rotation is an easy breast-preserving technique for treating breast cancer located in the upper/upper inner quadrant of the breast that requires a relatively wide excision. With this technique, a larger breast tumor could be removed without compromising the breast appearance.

Dosimetry in x-ray-based breast imaging

PubMed Central

Dance, David R; Sechopoulos, Ioannis

2016-01-01

The estimation of the mean glandular dose to the breast (MGD) for x-ray based imaging modalities forms an essential part of quality control and is needed for risk estimation and for system design and optimisation. This review considers the development of methods for estimating the MGD for mammography, digital breast tomosynthesis (DBT) and dedicated breast CT (DBCT). Almost all of the methodology used employs Monte Carlo calculated conversion factors to relate the measurable quantity, generally the incident air kerma, to the MGD. After a review of the size and composition of the female breast, the various mathematical models used are discussed, with particular emphasis on models for mammography. These range from simple geometrical shapes, to the more recent complex models based on patient DBCT examinations. The possibility of patient-specific dose estimates is considered as well as special diagnostic views and the effect of breast implants. Calculations using the complex models show that the MGD for mammography is overestimated by about 30% when the simple models are used. The design and uses of breast-simulating test phantoms for measuring incident air kerma are outlined and comparisons made between patient and phantom-based dose estimates. The most widely used national and international dosimetry protocols for mammography are based on different simple geometrical models of the breast, and harmonisation of these protocols using more complex breast models is desirable. PMID:27617767

Polymeric composite devices for localized treatment of early-stage breast cancer

PubMed Central

Kan-Dapaah, Kwabena; Soboyejo, Wole

2017-01-01

For early-stage breast cancers mastectomy is an aggressive form of treatment. Therefore, there is a need for new treatment strategies that can enhance the use of lumpectomy by eliminating residual cancer cells with limited side effects to reduce local recurrence. Although, various radiotherapy-based methods have been developed, residual cells are found in 20–55% of the time at the first operation. Furthermore, some current treatment methods result in poor cosmesis. For the last decade, the authors have been exploring the use of polymeric composite materials in single and multi-modal implantable biomedical devices for post-operative treatment of breast cancer. In this paper, the concept and working principles of the devices, as well as selected results from experimental and numerical investigations, are presented. The results show the potential of the biomedical implants for cancer treatment. PMID:28245288

[Hurt eczematiforme column (chronicle) of the breast after implementation of a surgical clip].

PubMed

Motton, S; Gardinal, I; Soulé-Tholy, M; Viraben, R; Hoff, J; Leguevaque, P

2011-04-01

We report a case of atopic dermatitis in relation with a surgical titanium clip. Such a complication has only been reported once in the literature. We advocate to ask the patients about query atopic manifestations especially contact dermatitis to metal before any procedure involving metallic implants. Copyright © 2010 Elsevier Masson SAS. All rights reserved.

Dosimetry in x-ray-based breast imaging

NASA Astrophysics Data System (ADS)

Dance, David R.; Sechopoulos, Ioannis

2016-10-01

The estimation of the mean glandular dose to the breast (MGD) for x-ray based imaging modalities forms an essential part of quality control and is needed for risk estimation and for system design and optimisation. This review considers the development of methods for estimating the MGD for mammography, digital breast tomosynthesis (DBT) and dedicated breast CT (DBCT). Almost all of the methodology used employs Monte Carlo calculated conversion factors to relate the measurable quantity, generally the incident air kerma, to the MGD. After a review of the size and composition of the female breast, the various mathematical models used are discussed, with particular emphasis on models for mammography. These range from simple geometrical shapes, to the more recent complex models based on patient DBCT examinations. The possibility of patient-specific dose estimates is considered as well as special diagnostic views and the effect of breast implants. Calculations using the complex models show that the MGD for mammography is overestimated by about 30% when the simple models are used. The design and uses of breast-simulating test phantoms for measuring incident air kerma are outlined and comparisons made between patient and phantom-based dose estimates. The most widely used national and international dosimetry protocols for mammography are based on different simple geometrical models of the breast, and harmonisation of these protocols using more complex breast models is desirable.

An Investigation and Analysis of the Vestibulo-Ocular Reflex (VOR) in a Vibration Environment

DTIC Science & Technology

2013-03-01

could not have had breast implants. Participants with corrective vision through LASIK , PRK or soft contacts were qualified but individuals requiring...corrective lenses (glasses/contact lenses)? YES/NO Have you had corrective eye surgery ( PRK / LASIK )? YES/NO Have you been diagnosed or...Figure 6. Relative Intensity vs . Forward Current for Everlight 5mm Infrared LED ........ 30 Figure 7. IR LED Circuit

'Use what God has given me': difference and disparity in breast reconstruction.

PubMed

Rubin, Lisa R; Chavez, Jessica; Alderman, Amy; Pusic, Andrea L

2013-01-01

African-American women are significantly less likely to undergo postmastectomy breast reconstruction compared to white women in the USA. These observed differences have been interpreted as evidence of a healthcare disparity. The current study examines breast reconstruction decision-making among African-American women, locating reconstruction decisions in a context of culture, racial inequality and biomedicalisation. Semi-structured interviews were conducted with 27 African-American women who underwent mastectomy for breast cancer to add patient-centred perspectives to existing conceptualisations of racial/ethnic differences in reconstruction. Participants were socio-demographically diverse, and resided in the New York metropolitan area. Data analysis was informed by grounded theory. Spiritually and culturally informed body ethics often guided surgery decisions. Participants expressed reservations about breast implants, preferring autologous procedures that use 'what God has given'. For some, breast reconstruction restored a sense of normalcy after cancer; others challenged an imperative to reconstruct. Several participants redirected our focus on access to reconstruction toward access to alternatives, noting the low reimbursement for prostheses, or their unavailability in patients' skin tones. We suggest that a framework of 'stratified biomedicalization' better addresses the complexities of race, class and gender that inform preference, access and recommendations for breast reconstruction, and focuses attention on access to high and low-tech interventions.

New Language and Old Problems in Breast Cancer Radiotherapy.

PubMed

Chiricuţă, Ion Christian

2017-01-01

New developments in breast cancer radiotherapy make possible new standards in treatment recommandations based on international guidelines. Developments in radiotherapy irradiation techniques from 2D to 3D-Conformal RT and to IMRT (Intensity Modulated Arc Therapy) make possible to reduce the usual side effects on the organs at risk as: skin, lung, miocard, bone, esophagus and brahial plexus. Dispite of all these progresses acute and late side effects are present. Side effects are as old as the radiotherapy was used. New solutions are available now by improving irradiation techniques. New techniques as sentinel node procedure (SNP) or partial breast irradiation (PBRT) and immediate breast reconstruction with silicon implants (IBRIS) make necessary new considerations regarding the target volume delineations. A new language for definition of gross tumor volume (GTV), clinical target volume (CTV) based on the new diagnostic methods as PET/CT,nonaparticle MRI will have real impact on target delineation and irradiation techniques. "The new common language in breast cancer therapy" would be the first step to improve the endresults and finally the quality of life of the patients. Celsius.

MR imaging of breast implants.

PubMed

Gorczyca, D P

1994-11-01

MR imaging has proved to be an excellent imaging modality in locating free silicone and evaluating an implant for rupture, with a sensitivity of approximately 94% and specificity of 97%. Silicone has a unique MR resonance frequency and long T1 and T2 relaxation times, which allows several MR sequences to provide excellent diagnostic images. The most commonly used sequences include T2-weighted, STIR, and chemical shift imaging (Figs. 3, 13, and 14). The T2-weighted and STIR sequences are often used in conjunction with chemical water suppression. The most reliable findings on MR images for detection of implant rupture include identification of the collapsed implant shell (linguine sign) and free silicone within the breast parenchyma.

Informed consent in Italy-traditional versus the law: a gordian knot.

PubMed

Turillazzi, Emanuela; Neri, Margherita; Riezzo, Irene; Frati, Paola; Fineschi, Vittorio

2014-08-01

Italian law no. 86 of 5 June 2012, which establishes a set of rules on the matter of breast implants, came into effect in July 2012. The law is at the center of a widespread and animated cultural debate that in recent years has been taking place in Italy. The fundamental prohibition imposed by the law concerns the age limit. Breast implants for exclusively aesthetic purposes are allowed only if the legal age (18 years) has been reached. This prohibition does not apply in cases of severe congenital malformations certified by a physician operating within the National Health Service or by a public health care institution. The legal imposition of an age limit raises a number of perplexities: one at a bioethical level and one that is strictly juridical. In fact, it is impossible to deal with this issue unless the wider debate concerning the self-determination and autonomy of underage patients in biomedical matters is considered. It appears, then, that the issue is again exclusively related to the peculiarity of cosmetic surgery, which when aimed at correcting "only" the pathologic experiences of self-image, does not acquire the dignity of therapy. If, however, the improvement of self-image serves to achieve a better psycho-emotional balance and favors the development of social relations undermined by evident physical defects, age restrictions can be disregarded. The authors believe the real risk is that the law imposed by the Italian state is based on assumptions and preformed value judgments. Furthermore, in the understanding of needs, legislation often is biased toward objective biophysical problems without attaching due importance to subjective psychological and social problems. While acknowledging the seriousness of the issue, the authors do not agree with the legislature's rigidity. However, plastic surgeons must form a plan for addressing the concerns about breast implants and evaluating whether they are appropriate for adolescents, taking into account the unique psychological and developmental considerations of adolescent cosmetic surgery patients. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Proceedings of the Annual Meeting of the Association for Education in Journalism and Mass Communication (81st, Baltimore, Maryland, August 5-8, 1998). Commission on the Status of Women.

ERIC Educational Resources Information Center

Association for Education in Journalism and Mass Communication.

The Commission on the Status of Women section of the Proceedings contains the following 12 papers: "Framing Women's Health with a Sense-making Approach: Magazine Coverage of Breast Cancer and Implants" (Julie L. Andsager and Angela Powers); "Gender Roles in 'Rumplestiltskin': The Effect of Fantasy Portrayals on Real-Life…

Axillary silicone lymphadenopathy presenting with a lump and altered sensation in the breast: a case report

PubMed Central

2009-01-01

Introduction Silicone lymphadenopathy is a rare but recognised complication of procedures involving the use of silicone. It has a poorly understood mechanism but is thought to occur following the transportation of silicone particles from silicone-containing prostheses to lymph nodes by macrophages. Case presentation We report of a case involving a 35-year-old woman who presented to the breast clinic with a breast lump and altered sensation below her left nipple 5 years after bilateral cosmetic breast augmentations. A small lump was detected inferior to the nipple but clinical examination and initial ultrasound investigation showed both implants to be intact. However, mammography and magnetic resonance imaging of both breasts revealed both intracapsular and extracapsular rupture of the left breast prosthesis. The patient went on to develop a flu-like illness and tender lumps in the left axilla and right mastoid regions. An excision biopsy of the left axillary lesion and replacement of the ruptured implant was performed. Subsequent histological analysis showed that the axillary lump was a lymph node containing large amounts of silicone. Conclusion The exclusion of malignancy remains the priority when dealing with lumps in the breast or axilla. Silicone lymphadenopathy should however be considered as a differential diagnosis in patients in whom silicone prostheses are present. PMID:19830102

Breast augmentation and reconstructive surgery: MR imaging of implant rupture and malignancy.

PubMed

Herborn, Christoph U; Marincek, Borut; Erfmann, Daniel; Meuli-Simmen, Claudia; Wedler, Volker; Bode-Lesniewska, Beate; Kubik-Huch, Rahel A

2002-09-01

The purpose of this study was to assess the diagnostic accuracy of MRI in detecting prosthesis integrity and malignancy after breast augmentation and reconstruction. Forty-one implants in 25 patients were analyzed by MRI before surgical removal. Imaging results were compared with ex vivo findings. Magnetic resonance imaging of the breast was performed on a 1.5-T system using a dedicated surface breast coil. Axial and sagittal T2-weighted fast spin-echo as well as dynamic contrast-enhanced T1-weighted gradient-recalled-echo sequences were acquired. The linguine sign indicating collapse of the silicone shell or siliconomas indicating free silicone proved implant rupture, whereas early focal contrast enhancement of a lesion was suspicious for malignancy. The sensitivity for detection of implant rupture was 86.7% with a specificity of 88.5%. The positive and negative predictive values were 81.3 and 92.0%, respectively. The linguine sign as a predictor of intracapsular implant rupture had a sensitivity of 80% with a specificity of 96.2%. Magnetic resonance imaging revealed two lesions with suspicious contrast enhancement (one carcinoma, one extra-abdominal fibromatosis). Magnetic resonance imaging is a reliable and reproducible technique for diagnosing both implant rupture and malignant lesions in women after breast augmentation and reconstruction.

Prosthetic metal implants and airport metal detectors.

PubMed

Ismail, A; Dancey, A; Titley, O G

2013-04-01

Metal detectors have been present in airports and points of departure for some time. With the introduction of heightened security measures in response to fears of an increased threat of terrorism, they may become more prevalent in other public locations. The aim of this study was to ascertain which prosthetic devices activated metal detector devices used for security purposes. A range of prosthetic devices used commonly in orthopaedic and plastic surgery procedures were passed through an arch metal detector at Birmingham Airport in the UK. Additionally, each item was passed under a wand detector. Items tested included expandable breast prostheses, plates used in wrist and hand surgery, screws, K-wires, Autosuture™ ligation clips and staples. No prostheses were detected by the arch detector. The expandable implants and wrist plates were the only devices detected by passing the wand directly over them. No device was detected by the wand when it was under cover of the axillary soft tissue. Screws, K-wires, Autosuture™ clips and staples were not detected under any of the study conditions. Although unlikely to trigger a detector, it is possible that an expandable breast prosthesis or larger plate may do so. It is therefore best to warn patients of this so they can anticipate detection and further examination.

Prosthetic metal implants and airport metal detectors

PubMed Central

Dancey, A; Titley, OG

2013-01-01

Introduction Metal detectors have been present in airports and points of departure for some time. With the introduction of heightened security measures in response to fears of an increased threat of terrorism, they may become more prevalent in other public locations. The aim of this study was to ascertain which prosthetic devices activated metal detector devices used for security purposes. Methods A range of prosthetic devices used commonly in orthopaedic and plastic surgery procedures were passed through an arch metal detector at Birmingham Airport in the UK. Additionally, each item was passed under a wand detector. Items tested included expandable breast prostheses, plates used in wrist and hand surgery, screws, K-wires, Autosuture™ ligation clips and staples. Results No prostheses were detected by the arch detector. The expandable implants and wrist plates were the only devices detected by passing the wand directly over them. No device was detected by the wand when it was under cover of the axillary soft tissue. Screws, K-wires, Autosuture™ clips and staples were not detected under any of the study conditions. Conclusions Although unlikely to trigger a detector, it is possible that an expandable breast prosthesis or larger plate may do so. It is therefore best to warn patients of this so they can anticipate detection and further examination. PMID:23827294

Stereoscopic Analysis of Silicone Breast Implant Shells Damaged by Surgical Instruments.

PubMed

Rapp, Derek A; Neaman, Keith C; Hammond, Dennis C

2015-07-01

Iatrogenic shell injury during the implantation and explantation of silicone gel breast implants may lead to eventual device failure. Identification of the patterns of injury caused by surgical instruments is important when attempting to characterize the cause of shell rupture. Understanding the true causes of device failure may help with its prevention. The purpose of this study was to microscopically characterize patterns of shell injury induced by various surgical instruments. Textured and smooth silicone gel implants were intentionally damaged with a variety of surgical instruments. Various scalpels and surgical scissors ranging in fineness were used to create full-thickness injuries in the implant shell. Optical microscopy and scanning electron microscopy were then used to image the injured area to determine patterns of injury. Full-thickness striations across the thickness of the shell could be seen with damage caused by scissors. The density of these striations correlated directly with the fineness of scissors used. No striations were seen with injuries caused by scalpels. Striations were only observed in injuries caused by scissors and suture needles. Striation density correlated with the coarseness of the cutting edge. No such striations were seen in shells damaged by a scalpel even when the angle of approach was changed. This difference can be of assistance in distinguishing between scissors versus scalpel injury of an implant shell.

Latissimus dorsi flap for total autologous immediate breast reconstruction without implants.

PubMed

Santanelli di Pompeo, Fabio; Laporta, Rosaria; Sorotos, Michail; Pagnoni, Marco; Falesiedi, Federica; Longo, Benedetto

2014-12-01

The latissimus dorsi flap provides suitable recipient tissue for fat transfer, with a good blood supply and a reasonable volume of host tissue to inject into. The authors present their experience with use of the pedicled latissimus dorsi flap for fat grafting in total autologous immediate breast reconstruction without implants. From 2010 to 2013, 23 patients underwent breast reconstruction with primary fat augmented latissimus dorsi flaps (21 unilateral procedures and two bilateral procedures). Mean patient age was 52.3 years (range, 39 to 68 years); mean body mass index was 24.77 kg/m2 (range, 21.5 to 28.7 kg/m2). Fat was harvested using the Coleman technique with 10-ml syringes and injected into the adipose layer and muscle fascia of the latissimus dorsi flap skin paddle with 1-ml syringes. The mean size of the harvested skin paddle was 19.7 × 11.04 cm (range, 18 × 10 cm to 21 × 12 cm). Mean operative time was 2.62 hours (range, 2.10 to 3.20 hours) and 4.12 hours (range, 4.10 to 4.15 hours) for unilateral and bilateral reconstructions, respectively. Mean harvested fat volume was 126 ml (range, 90 to 180 ml), and mean injected fat volume was 101 ml (range, 60 to 150 ml). All flaps healed uneventfully, no seroma occurred at the flap donor-site, and no fat grafting-related complications were observed. To the best of the authors' knowledge, this is the first report in which fat transfer was used to achieve immediate latissimus dorsi flap volume augmentation as an alternative for total autologous reconstruction, avoiding implant-related complications.

Influence of dressing application time after breast augmentation on cutaneous colonization: A randomized clinical trial.

PubMed

Mendes, D A; Veiga, D F; Veiga-Filho, J; Loyola, A B A T; Paiva, L F; Novo, N F; Sabino-Neto, M; Ferreira, L M

2018-06-01

Concepts regarding the best way to treat a surgical wound vary, in literature, ranging from no dressing use to dressing maintenance for 24 to 48 hours or until suture removal. This study aimed to evaluate the influence of the length of dressing maintenance after breast augmentation with implants on cutaneous colonization and surgical site infection. This is a two-arm, parallel group, randomized clinical trial. Eighty patients who were candidates for augmentation mammoplasty with silicone implants were randomly allocated to two groups, in which the dressing was removed on postoperative day 1 (group A, n = 40) or postoperative day 6 (group B, n = 40). Cutaneous colonization was examined by culturing samples collected before and after dressing removal. The criteria defined by the Centers for Disease Control and Prevention were used to assess surgical site infection. No significant difference regarding cutaneous colonization was observed between groups before dressing application. On postoperative day 6, significantly more bacterial growth was observed in group A (p = 0.01). No surgical site infection occurred. We concluded that maintaining the dressing for 6 days led to a lower cutaneous colonization but did not influence surgical site infection rates. Copyright © 2018 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

The influence of the Product Liability Act, governmental regulation, and medical economics on medical devices and their clinical applications.

PubMed

Hirose, T T

1996-12-01

The advancement of medical technology constantly demands the introduction of safer and more efficient medical instruments and devices. Recent litigation and rulings against the manufacturers of breast implants and the subsequent refusal of major plastic companies to supply materials to them are seriously threatening the production and development of other permanent implants such as ventricular assist devices and even disposable catheters. In addition, government overregulation also discourages and hinders production and clinical applications of new instruments. Current trends such as cost effectiveness measures and economic restraints imposed by government agencies and managed care systems are endangering investments from the medical and industrial communities to exploit more expensive and sophisticated instrument technologies. The resultant lack of grant money and pressure from animal rights advocates also suppress experimentation on primates and domestic laboratory animals.

An Analysis of Eye Movements with Helmet Mounted Displays

DTIC Science & Technology

2014-03-27

YES/NO Have you had corrective eye surgery ( PRK / LASIK )? YES/NO Have you been diagnosed or treated for any eye injuries or disease(s)? YES...without the use of any type of corrective lenses (glasses or contacts). Those with corrective vision through LASIK or PRK are qualified. Additionally...breast implants? YES/NO Do you wear corrective lenses (glasses/contact lenses)? YES/NO Have you had corrective eye surgery ( PRK / LASIK

Patient-Reported Outcomes following Breast Conservation Therapy and Barriers to Referral for Partial Breast Reconstruction.

PubMed

Vrouwe, Sebastian Q; Somogyi, Ron B; Snell, Laura; McMillan, Catherine; Vesprini, Danny; Lipa, Joan E

2018-01-01

The purpose of this study was to evaluate the self-reported aesthetic outcome of breast conservation therapy in a generalized sample of patients, and to describe potential barriers to referral for partial breast reconstruction. Consecutive breast conservation therapy patients completing radiotherapy over a 1-year period at a regional cancer center were identified. Eligible patients were contacted by means of mail/e-mail and invited to participate. Participants completed the BREAST-Q breast conservation therapy module along with a questionnaire examining feelings about breast reconstruction. Multiple regression analysis was performed using the satisfaction with breasts scale as the dependent variable. Surveys were completed by 185 of 592 eligible participants (response rate, 31.3 percent; mean age, 61 years) an average of 38 months after lumpectomy. The mean score for the BREAST-Q satisfaction with breasts scale was 59 of 100. Younger age (p = 0.038), lumpectomy reexcision (p = 0.018), and lumpectomy at a nonacademic center (p = 0.026) were significantly associated with lower satisfaction. Bra size, months from lumpectomy, and tumor quadrant/size were not significantly associated with satisfaction (p > 0.05). The most common statements regarding reconstruction were "I don't feel the need for it" (60.0 percent), "I don't like the thought of having breast implants" (22.7 percent), and "I don't want any more surgeon/doctor visits" (22.2 percent). Before lumpectomy, only 1.6 percent had a consultation for reconstruction, and only 22.7 percent were aware of this option. If offered, 33.1 percent of patients would have attended this consultation. There is an unmet demand for partial breast reconstruction, with an opportunity to advocate and increase awareness on behalf of patients undergoing breast conservation therapy.

Design for Natural Breast Augmentation: The ICE Principle.

PubMed

Mallucci, Patrick; Branford, Olivier Alexandre

2016-06-01

The authors' published studies have helped define breast beauty in outlining key parameters that contribute to breast attractiveness. The "ICE" principle puts design into practice. It is a simplified formula for inframammary fold incision planning as part of the process for determining implant selection and placement to reproduce the 45:55 ratio previously described as fundamental to natural breast appearance. The formula is as follows: implant dimensions (I) - capacity of the breast (C) = excess tissue required (E). The aim of this study was to test the accuracy of the ICE principle for producing consistent natural beautiful results in breast augmentation. A prospective analysis of 50 consecutive women undergoing primary breast augmentation by means of an inframammary fold incision with anatomical or round implants was performed. The ICE principle was applied to all cases to determine implant selection, placement, and incision position. Changes in parameters between preoperative and postoperative digital clinical photographs were analyzed. The mean upper pole-to-lower pole ratio changed from 52:48 preoperatively to 45:55 postoperatively (p < 0.0001). Mean nipple angulation was also statistically significantly elevated from 11 degrees to 19 degrees skyward (p ≤ 0.0005). Accuracy of incision placement in the fold was 99.7 percent on the right and 99.6 percent on the left, with a standard error of only 0.2 percent. There was a reduction in variability for all key parameters. The authors have shown using the simple ICE principle for surgical planning in breast augmentation that attractive natural breasts may be achieved consistently and with precision. Therapeutic, IV.

Increased COX-2 expression in epithelial and stromal cells of high mammographic density tissues and in a xenograft model of mammographic density.

PubMed

Chew, G L; Huo, C W; Huang, D; Hill, P; Cawson, J; Frazer, H; Hopper, J L; Haviv, I; Henderson, M A; Britt, K; Thompson, E W

2015-08-01

Mammographic density (MD) adjusted for age and body mass index is one of the strongest known risk factors for breast cancer. Given the high attributable risk of MD for breast cancer, chemoprevention with a safe and available agent that reduces MD and breast cancer risk would be beneficial. Cox-2 has been implicated in MD-related breast cancer risk, and was increased in stromal cells in high MD tissues in one study. Our study assessed differential Cox-2 expression in epithelial and stromal cells in paired samples of high and low MD human breast tissue, and in a validated xenograft biochamber model of MD. We also examined the effects of endocrine treatment upon Cox-2 expression in high and low MD tissues in the MD xenograft model. Paired high and low MD human breast tissue samples were immunostained for Cox-2, then assessed for differential expression and staining intensity in epithelial and stromal cells. High and low MD human breast tissues were separately maintained in biochambers in mice treated with Tamoxifen, oestrogen or placebo implants, then assessed for percentage Cox-2 staining in epithelial and stromal cells. Percentage Cox-2 staining was greater for both epithelial (p = 0.01) and stromal cells (p < 0.0001) of high compared with low MD breast tissues. In high MD biochamber tissues, percentage Cox-2 staining was greater in stromal cells of oestrogen-treated versus placebo-treated tissues (p = 0.05).

Feasibility study of contralateral risk-reducing mastectomy with breast reconstruction for breast cancer patients with BRCA mutations in Japan.

PubMed

Yoshimura, Akiyo; Okumura, Seiko; Sawaki, Masataka; Hattori, Masaya; Ishiguro, Junko; Adachi, Yayoi; Kotani, Haruru; Gondo, Naomi; Kataoka, Ayumi; Iwase, Madoka; Onishi, Sakura; Sugino, Kayoko; Terada, Mitsuo; Horisawa, Nanae; Mori, Makiko; Takaiso, Nobue; Hyodo, Ikuo; Iwata, Hiroji

2018-03-08

Contralateral risk-reducing mastectomy (CRRM) for breast cancer patients with BRCA mutations has been reported to not only reduce breast cancer incidence but also to improve survival. The National Comprehensive Cancer Network guidelines recommend providing CRRM to women with BRCA mutations who desire CRRM after risk-reduction counseling. However, in Japan, CRRM cannot be performed generally because it is not covered by health insurance. Thus, we conducted a feasibility study to confirm the safety of CRRM. CRRM with bilateral breast reconstructions were performed for breast cancer patients with BRCA mutations. The primary endpoint was early adverse events within 3 months, and secondary endpoints were late adverse events. Between August 2014 and November 2016, ten patients were enrolled. The median age was 37.5 years, and five of the patients had the BRCA1 mutation while five had the BRCA2 mutation. Six patients received neoadjuvant chemotherapy. Eight patients selected silicone breast implants, and two patients selected transverse rectus abdominis myocutaneous flap reconstruction. Pathological findings showed no evidence of occult breast cancers in any of the patients. At a median of 25.5 months follow-up time, CRRM-related early adverse events were hematoma (subsequently removed by re-operation; grade 2, n = 1), wound infection (grade 2, n = 1), skin ulceration (grade 1, n = 2) and wound pain (grade 1, n = 1). Overall, there were no grade 3 or more severe adverse events. Our results confirm that CRRM with reconstruction could be performed safely.

Axillary silicone lymphadenopathy secondary to augmentation mammaplasty

PubMed Central

Dragoumis, Dimitrios M.; Assimaki, Anthoula S.; Vrizas, Triantafyllos I.; Tsiftsoglou, Aris P.

2010-01-01

We report a case involving a 45-year-old woman, who presented with an axillary mass 10 years after bilateral cosmetic augmentation mammaplasty. A lump was detected in the left axilla, and subsequent mammography and magnetic resonance imaging demonstrated intracapsular rupture of the left breast prosthesis. An excisional biopsy of the left axillary lesion and replacement of the ruptured implant was performed. Histological analysis showed that the axillary lump was lymph nodes containing large amounts of silicone. Silicone lymphadenopathy is an obscure complication of procedures involving the use of silicone. It is thought to occur following the transit of silicone droplets from breast implants to lymph nodes by macrophages and should always be considered as a differential diagnosis in patients in whom silicone prostheses are present. PMID:21217983

Staphylococcus aureus and Staphylococcus epidermidis infections on implants.

PubMed

Oliveira, W F; Silva, P M S; Silva, R C S; Silva, G M M; Machado, G; Coelho, L C B B; Correia, M T S

2018-02-01

Infections are one of the main reasons for removal of implants from patients, and usually need difficult and expensive treatments. Staphylococcus aureus and Staphylococcus epidermidis are the most frequently detected pathogens. We reviewed the epidemiology and pathogenesis of implant-related infections. Relevant studies were identified by electronic searching of the following databases: PubMed, ScienceDirect, Academic Google, and CAPES Journal Portal. This review reports epidemiological studies of implant infections caused by S. aureus and S. epidermidis. We discuss some methodologies used in the search for new compounds with antibiofilm activity and the main strategies for biomaterial surface modifications to avoid bacterial plaque formation and consequent infection. S. aureus and S. epidermidis are frequently involved in infections in catheters and orthopaedic/breast implants. Different methodologies have been used to test the potential antibiofilm properties of compounds; for example, crystal violet dye is widely used for in-vitro biofilm quantification due to its low cost and good reproducibility. Changes in the surface biomaterials are necessary to prevent biofilm formation. Some studies have investigated the immobilization of antibiotics on the surfaces of materials used in implants. Other approaches have been used as a way to avoid the spread of bacterial resistance to antimicrobials, such as the functionalization of these surfaces with silver and natural compounds, as well as the electrical treatment of these substrates. Copyright © 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

The PIP mammary prosthesis: a product recall study.

PubMed

Berry, M G; Stanek, Jan J

2012-06-01

Concerns about the durability of silicone breast implants manufactured by Poly Implant Prothèse (PIP) have been expressed for several years prior to their formal withdrawal from the market in March 2010. Although precise details of what elements were at fault remain unclear, concerns have been raised about both the elastomer and the filler gel. Media speculation has focussed on device safety, longevity and, recently, a possible association with lymphoma, specifically anaplastic large cell lymphoma (ALCL). There is however, no actual data concerning these implants with which to guide and inform when concerned patients seek advice. PIP mammary prostheses were used by the senior author for both primary and revision breast augmentation (BA) during the period January 2000-August 2005. A database of patients was constructed and attempts made to contact each patient offering a free consultation and referral for ultrasound scan (USS). Chief outcome measures included secondary surgery, the implant rupture rate and time to rupture. 453 consecutive patients with PIP devices were identified. Of this number 30 had already undergone implant exchange for a variety of reasons. 180 (39.7%) could not be contacted and 19 had undergone explantation elsewhere, including the NHS. Of those who could be contacted, 47 declined consultation as they had no concerns. 97 had neither clinical signs nor radiographic evidence of implant rupture and elected to remain under regular review. At the time of writing, 38 have undergone implant exchange after ultrasonographic indication of rupture and the overall patient rupture rate for the PIP implant is 15.9-33.8%. This cohort correlates reduced implant longevity with each successive year from 2000 and no cases of ALCL have been diagnosed. Long-term studies such as this are difficult to undertake for a number of reasons as they place a significant additional burden of resources on a practice. They are, however, essential from an industry perspective both for the provision of information and supporting audit and professional standing. Being only a single-handed practice, this initial study is the tip of an iceberg that may affect 40,000 women in the UK with PIP implants, but it does provide some hard data with which to guide our patients. It is also believed to be the first independent product recall study in aesthetic breast surgery. Copyright © 2012 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Breast reconstruction using permanent Becker expander implants: an 18 year experience.

PubMed

Goh, S C J; Thorne, A L; Williams, G; Laws, S A M; Rainsbury, R M

2012-12-01

Single-stage reconstruction using permanent expander implants is an established technique following mastectomy. Short and long-term outcome data following breast reconstruction using Becker tissue expanders is limited. A retrospective case note review of patients undergoing expander-based procedures between 1989 and 2007 was undertaken. Data recorded included postoperative symptoms and complications, the use of radiotherapy, revisional surgery, and device failure. Three hundred and thirteen expanders were used in 276 patients with a mean age of 48.3 (17-78) years, over the 18 year study period. The mean follow up period was 64.6 (1-199) months. 256 Becker expanders were used during 175 latissimus dorsi (LD) and 52 subpectoral (SP) reconstructions, 13 contralateral augmentations and 16 implant replacements. The postoperative infection rate was 5.8%, leading to an expander loss rate of 3.8%. The use of prophylactic antibiotics was associated with an increased postoperative infection rate (p = 0.046). Six haematomas (2.5%) and 12 cases of skin envelope necrosis (5.0%) required unscheduled intervention. Symptoms of pain, distortion and hardness were experienced by 21.3% of patients, and radiotherapy was associated with a significantly higher risk of adverse symptoms (p < 0.0001). No patient developed symptomatic implant rupture or silicone granuloma but 17.9% of reconstructions underwent revisional surgery, the rate being highest following SP reconstruction (p = 0.029). Nine patients developed injection port complications (3.8%), and the overall device failure rate was 1.3%. The original expander has been retained by 74.2% of women. The Becker permanent expander is a reliable implant associated with a low complication rate and a high retention rate when used during breast reconstruction. Copyright © 2012 Elsevier Ltd. All rights reserved.

Cyclic volatile methylsiloxanes in human blood as markers for ruptured silicone gel-filled breast implants.

PubMed

Rosendahl, Pia; Hippler, Joerg; Schmitz, Oliver J; Hoffmann, Oliver; Rusch, Peter

2016-05-01

The replacement of medical-grade silicone with industrial-grade silicone material in some silicone gel-filled breast implants (SBI) manufactured by Poly Implant Prothèse and Rofil Medical Nederland B.V., reported in 2010, which resulted in a higher rupture tendency of these SBI, demonstrates the need for non-invasive, sensitive monitoring and screening methods. Therefore a sensitive method based on large volume injection-gas chromatography coupled to mass spectrometry (LVI-GC/MS) was developed to determine octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5), and dodecamethylcyclo-hexasiloxane (D6) in blood samples from women with intact (n = 13) and ruptured SBI (n = 11). With dichloromethane extraction, sample cooling during preparation, and analysis extraction efficiencies up to 100 % and limits of detection of 0.03-0.05 ng D4-D6/g blood were achieved. Blood samples from women with SBI were investigated. In contrast to women with intact SBI, in blood from women with ruptured SBI higher D4 and D6 concentrations up to 0.57 ng D4/g blood and 0.16 ng D6/g blood were detected. With concentrations above 0.18 D4 ng/blood and 0.10 ng D6/g blood as significant criteria for ruptured SBI, this developed analytical preoperative diagnostic method shows a significant increase of the recognition rate. Finally a higher precision (error rate 17%) than the commonly used clinical diagnostic method, mamma sonography (error rate 46%), was achieved.

The influence of external ultrasound on the histologic architecture of the organic capsule around smooth silicone implants: experimental study in rats.

PubMed

Mendes, F H; Viterbo, F; DeLucca, L

2008-05-01

Capsular contracture is the main complication related to breast silicone implants, and its prevention remains a medical challenge. The authors present experimental research examining the effect of external ultrasound on the formation and contracture of peri-implant capsules. In this study, 42 male Wistar rats had a 2-mm smooth surface implant placed in a dorsal submuscular pocket. They then were separated into "ultrasound" and "control" groups that received repeated external applications either with or without the ultrasound power on. Ultrasound applications were given three times a week for a period of 90 days. After that, both groups were housed under the same conditions with no application scheduled. Five animals of each group, killed at 30, 60, 90, and 180 days, had their implants removed along with the capsule, which received a special histologic preparation via annular sectioning that provided wide circumferential observation of the capsular tissue. Sections were stained with hematoxylin/eosin stain, Masson's trichrome stain, and Pricrosirius Red stain for regular microscopic evaluation under normal and polarized light. Histologic data showed that capsules from the ultrasound and control groups had statistically significant differences. Ultrasound application developed a capsular architecture similar to that shown within textured silicone implants, and its effect had an early definition with subsequent stabilization. The authors conclude that early and repeated external ultrasound application enhances the thickness, cellular count, and vascularity of smooth silicone capsular tissue, whereas it diminishes the pattern of parallel orientation of collagen fibers.

The Type of Breast Reconstruction May Not Influence Patient Satisfaction in the Chinese Population: A Single Institutional Experience

PubMed Central

Chen, Jiaying; Chen, Ying; Hu, Zhen; Liu, Guangyu; Shen, Zhenzhou; Shao, Zhimin; Wu, Jiong

2015-01-01

Background The goal of this study was to evaluate patient satisfaction with four common types of breast reconstruction performed at our institution: latissimus dorsi myocutaneous (LDM) flap reconstruction with or without implants, pedicled transverse rectus abdominis musculocutaneous (TRAM) flap reconstruction, and free deep inferior epigastric perforator (DIEP) flap reconstruction. Methods A custom survey consisting of questions that assessed general and aesthetic satisfaction was sent to patients who had undergone breast reconstruction in the last 5 years. The clinical data and details of the surgery were also collected from the patients who returned the surveys. We compared satisfaction rates across the four breast reconstruction types and analyzed the effects of various factors on overall general and aesthetic satisfaction rates using a binary logistic regression model. Result A total of 207 (72%) patients completed the questionnaires. Overall, significant differences in general and aesthetic satisfaction among the four procedures were not observed. A multivariate analysis revealed that the factor “complications” (p = 0.001) played a significant role in general satisfaction and that the factors “> 2 years since reconstruction” (p = 0.043) and “age > 35 years” (p = 0.05) played significant roles in overall aesthetic satisfaction. Conclusion The present study demonstrated that the type of breast reconstruction might not influence satisfaction in Chinese patients. PMID:26562294

A Translational Approach to Validate In Vivo Anti-Tumor Effects of Chloroquine on Breast Cancer Risk

DTIC Science & Technology

2015-07-01

Type of Cancer Drop Down Number/DK Drop Down   29 Birth   Control     The next section is about the use of birth control pills and... birth control pills or other hormonal contraceptives for at least one month for any reason? These include pills, injections, implants, and patches...Question 50. r Refuse to answer Skip to Question 50. 48. How old were you when you started taking birth control pills/hormonal contraceptives

Immediate breast reconstruction using autologous skin graft associated with breast implant.

PubMed

Dutra, A K; Andrade, W P; Carvalho, S M T; Makdissi, F B A; Yoshimatsu, E K; Domingues, M C; Maciel, M S

2012-02-01

Immediate breast reconstruction with skin graft is still little mentioned in the literature. Follow-up studies regarding the technique aspects are particularly scarce. The objective was to detail immediate breast reconstruction using autologous skin graft. Patients (n = 49) who underwent mastectomies and autologous immediate breast reconstruction with skin graft associated with a breast implant at A. C. Camargo Hospital (São Paulo, Brazil) between January 2007 and July 2010 were included. Information on clinical data, technique details and clinical outcome were prospectively collected. Following mastectomy, the autologous full-thickness skin graft was obtained through an inframammary fold incision along the contralateral breast in most patients. The skin graft was placed on the surface of the pectoralis major muscle after adjustments to conform to the mastectomy defect. A minimum of 10-month follow-up period was established. Patients' age ranged from 35 to 55 years and all received a silicone gel textured surface implant to obtain the necessary breast mound. The mean surgical time was 45 min, and the mean amount of skin resection was 4.5 cm in the largest diameter. Follow-up ranged from 10 to 35 months (median 23). All patients had silicone-gel textured surface implants to perform the breast mound reconstruction. No complications were observed in 87.8% of reconstructions. Forty-six patients (94%) had no complaints about the donor-site aesthetics. The result was a breast mound with a central ellipse of healed skin graft. Three (6%) poor results were observed. Thirty-six patients (67%) reported the results as good or very good. Our results lead us to conclude that autologous skin graft provided a reliable option in immediate breast reconstruction to skin-sparing mastectomy defects. The technique accomplished a single-stage implant breast reconstruction when there is inadequate skin coverage. Copyright © 2011 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Fast patient-specific Monte Carlo brachytherapy dose calculations via the correlated sampling variance reduction technique

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sampson, Andrew; Le Yi; Williamson, Jeffrey F.

2012-02-15

Purpose: To demonstrate potential of correlated sampling Monte Carlo (CMC) simulation to improve the calculation efficiency for permanent seed brachytherapy (PSB) implants without loss of accuracy. Methods: CMC was implemented within an in-house MC code family (PTRAN) and used to compute 3D dose distributions for two patient cases: a clinical PSB postimplant prostate CT imaging study and a simulated post lumpectomy breast PSB implant planned on a screening dedicated breast cone-beam CT patient exam. CMC tallies the dose difference, {Delta}D, between highly correlated histories in homogeneous and heterogeneous geometries. The heterogeneous geometry histories were derived from photon collisions sampled inmore » a geometrically identical but purely homogeneous medium geometry, by altering their particle weights to correct for bias. The prostate case consisted of 78 Model-6711 {sup 125}I seeds. The breast case consisted of 87 Model-200 {sup 103}Pd seeds embedded around a simulated lumpectomy cavity. Systematic and random errors in CMC were unfolded using low-uncertainty uncorrelated MC (UMC) as the benchmark. CMC efficiency gains, relative to UMC, were computed for all voxels, and the mean was classified in regions that received minimum doses greater than 20%, 50%, and 90% of D{sub 90}, as well as for various anatomical regions. Results: Systematic errors in CMC relative to UMC were less than 0.6% for 99% of the voxels and 0.04% for 100% of the voxels for the prostate and breast cases, respectively. For a 1 x 1 x 1 mm{sup 3} dose grid, efficiency gains were realized in all structures with 38.1- and 59.8-fold average gains within the prostate and breast clinical target volumes (CTVs), respectively. Greater than 99% of the voxels within the prostate and breast CTVs experienced an efficiency gain. Additionally, it was shown that efficiency losses were confined to low dose regions while the largest gains were located where little difference exists between the homogeneous and heterogeneous doses. On an AMD 1090T processor, computing times of 38 and 21 sec were required to achieve an average statistical uncertainty of 2% within the prostate (1 x 1 x 1 mm{sup 3}) and breast (0.67 x 0.67 x 0.8 mm{sup 3}) CTVs, respectively. Conclusions: CMC supports an additional average 38-60 fold improvement in average efficiency relative to conventional uncorrelated MC techniques, although some voxels experience no gain or even efficiency losses. However, for the two investigated case studies, the maximum variance within clinically significant structures was always reduced (on average by a factor of 6) in the therapeutic dose range generally. CMC takes only seconds to produce an accurate, high-resolution, low-uncertainly dose distribution for the low-energy PSB implants investigated in this study.« less

A Qualitative Study of Breast Reconstruction Decision-Making among Asian Immigrant Women Living in the United States.

PubMed

Fu, Rose; Chang, Michelle Milee; Chen, Margaret; Rohde, Christine Hsu

2017-02-01

Despite research supporting improved psychosocial well-being, quality of life, and survival for patients undergoing postmastectomy breast reconstruction, Asian patients remain one-fifth as likely as Caucasians to choose reconstruction. This study investigates cultural factors, values, and perceptions held by Asian women that might impact breast reconstruction rates. The authors conducted semistructured interviews of immigrant East Asian women treated for breast cancer in the New York metropolitan area, investigating social structure, culture, attitudes toward surgery, and body image. Three investigators independently coded transcribed interviews, and then collectively evaluated them through axial coding of recurring themes. Thirty-five immigrant East Asian women who underwent surgical treatment for breast cancer were interviewed. Emerging themes include functionality, age, perceptions of plastic surgery, inconvenience, community/family, fear of implants, language, and information. Patients spoke about breasts as a function of their roles as a wife or mother, eliminating the need for breasts when these roles were fulfilled. Many addressed the fear of multiple operations. Quality and quantity of information, and communication with practitioners, impacted perceptions about treatment. Reconstructive surgery was often viewed as cosmetic. Community and family played a significant role in decision-making. Asian women are statistically less likely than Caucasians to pursue breast reconstruction. This is the first study to investigate culture-specific perceptions of breast reconstruction. Results from this study can be used to improve cultural competency in addressing patient concerns. Improving access to information regarding treatment options and surgical outcomes may improve informed decision-making among immigrant Asian women.

Current applications and future direction of MR mammography.

PubMed

Kneeshaw, P J; Turnbull, L W; Drew, P J

2003-01-13

Compared with triple assessment for symptomatic and occult breast disease, magnetic resonance mammography (MRM) offers higher sensitivity for the detection of multifocal cancer, which is important in selecting patients appropriately for breast-conserving surgery. It is an ideal tool for the screening of patients with a high risk of breast cancer or where there is axillary disease or nipple discharge and conventional imaging has not revealed the primary focus. Techniques are now available to biopsy lesions only apparent on MRM. MRM can differentiate scar tissue from tumour; therefore, it is useful in patients in which there is possible recurrent disease. Clinical and X-ray mammographic assessment of response to neoadjuvant chemotherapy may be unreliable because of replacement of the tumour with scar tissue. MRM can identify responders and nonresponders with more accuracy. It is the modality of choice for the assessment of breast implants for rupture with accuracy higher than X-ray mammography and ultrasound. Advances in both spatial and temporal resolutions, the imaging sequences employed, pharmacokinetic modelling of contrast uptake, the use of dedicated and now phased-array breast coils, and gadolinium-based contrast agents have all played their part in the advancement of this imaging technique. Despite the limitations of patient compliance, scan-time and cost, this review describes how MRM has become a valuable tool in breast disease, especially in cases of diagnostic uncertainty. However, MRM must make the transition from research institutions into routine clinical practice.

Who Should Bear the Cost of Convenience? A Cost-effectiveness Analysis Comparing External Beam and Brachytherapy Radiotherapy Techniques for Early Stage Breast Cancer.

PubMed

McGuffin, M; Merino, T; Keller, B; Pignol, J-P

2017-03-01

Standard treatment for early breast cancer includes whole breast irradiation (WBI) after breast-conserving surgery. Recently, accelerated partial breast irradiation (APBI) has been proposed for well-selected patients. A cost and cost-effectiveness analysis was carried out comparing WBI with two APBI techniques. An activity-based costing method was used to determine the treatment cost from a societal perspective of WBI, high dose rate brachytherapy (HDR) and permanent breast seed implants (PBSI). A Markov model comparing the three techniques was developed with downstream costs, utilities and probabilities adapted from the literature. Sensitivity analyses were carried out for a wide range of variables, including treatment costs, patient costs, utilities and probability of developing recurrences. Overall, HDR was the most expensive ($14 400), followed by PBSI ($8700), with WBI proving the least expensive ($6200). The least costly method to the health care system was WBI, whereas PBSI and HDR were less costly for the patient. Under cost-effectiveness analyses, downstream costs added about $10 000 to the total societal cost of the treatment. As the outcomes are very similar between techniques, WBI dominated under cost-effectiveness analyses. WBI was found to be the most cost-effective radiotherapy technique for early breast cancer. However, both APBI techniques were less costly to the patient. Although innovation may increase costs for the health care system it can provide cost savings for the patient in addition to convenience. Copyright © 2016 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

Anaplastic large cell lymphoma of the breast arising around mammary implant capsule: an Italian report.

PubMed

Farace, Francesco; Bulla, Antonio; Marongiu, Francesco; Campus, Gian Vittorio; Tanda, Francesco; Lissia, Amelia; Cossu, Antonio; Fozza, Claudio; Rubino, Corrado

2013-06-01

Anaplastic large cell lymphoma (ALCL) of the breast is a very rare nonepithelial neoplasm. In the literature, this tumor has sometimes been described in proximity of breast implants (60 implant-related ALCL reported). In 2010, a patient who had undergone a right mastectomy and tissue expander/implant reconstruction for a "ductal" carcinoma 10 years before was referred to our unit for evaluation. On examination, an enlarged reconstructed right breast was found. The reconstructed breast did not show tenderness or signs of infection, ulceration, or breakdown. Mammograms and ultrasound scan did not suggest the presence of recurrent cancer, infection, deflation of the implant, or severe capsule contracture. The patient underwent mammary implant replacement. About 3 weeks after surgery, the patient came back to our unit for a new mild enlargement of the operated breast and the implant was removed. Three months later, the patient returned with a skin lesion in the right parasternal region. A radical excisional biopsy was performed under local anesthesia and the diagnosis of ALK-1-negative ALCL was finally made. The clinical and histological diagnosis of this disease is difficult as it can often be mistaken for a simple seroma (breast enlargement), an infection, or an unspecific reaction to silicone (redness and/or tension of the skin, itching, and fever). We strongly suggest considering ALCL in any patient with a spontaneous breast seroma lasting more than 6 months after mammary prosthesis implantation. The suspicion of ALCL must be suggested to the pathologist immediately. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Immediate Implant-based Prepectoral Breast Reconstruction Using a Vertical Incision

PubMed Central

Lind, Jeffrey G.; Hopkins, Elizabeth G.

2015-01-01

Background: Ideally, breast reconstruction is performed at the time of mastectomy in a single stage with minimal scarring. However, postoperative complications with direct-to-implant subpectoral reconstruction remain significant. These include asymmetry, flap necrosis, animation deformity, and discomfort. We report on a series of patients who have undergone immediate single-stage prepectoral, implant-based breast reconstruction with a smooth, adjustable saline implant covered with mesh/acellular dermal matrix for support using a vertical mastectomy incision. This technique, when combined with an adjustable implant, addresses the complications related to subpectoral implant placement of traditional expanders. Our follow-up time, 4.6 years (55 months), shows a low risk of implant loss and elimination of animation deformity while also providing patients with a safe and aesthetically pleasing result. Methods: All patients who underwent immediate implant-based prepectoral breast reconstruction using a vertical mastectomy incision as a single-staged procedure were included. Charts were reviewed retrospectively. Adjustable smooth round saline implants and mesh/acellular dermal matrix were used for fixation in all cases. Results: Thirty-one patients (62 breasts) underwent single-staged implant-based prepectoral breast reconstruction using a vertical mastectomy incision. Postoperative complications occurred in 9 patients, 6 of which were resolved with postoperative intervention while only 2 cases resulted in implant loss. Conclusions: There can be significant morbidity associated with traditional subpectoral implant-based breast reconstruction. As an alternative, the results of this study show that an immediate single-stage prepectoral breast reconstruction with a smooth saline adjustable implant, using a vertical incision, in conjunction with mesh/matrix support can be performed with excellent aesthetic outcomes and minimal complications. PMID:26180713

Survival signals and targets for therapy in breast implant-associated ALK--anaplastic large cell lymphoma.

PubMed

Lechner, Melissa G; Megiel, Carolina; Church, Connor H; Angell, Trevor E; Russell, Sarah M; Sevell, Rikki B; Jang, Julie K; Brody, Garry S; Epstein, Alan L

2012-09-01

Anaplastic lymphoma kinase (ALK)-negative, T-cell, anaplastic, non-Hodgkin lymphoma (T-ALCL) in patients with textured saline and silicone breast implants is a recently recognized clinical entity for which the etiology and optimal treatment remain unknown. Using three newly established model cell lines from patient biopsy specimens, designated T-cell breast lymphoma (TLBR)-1 to -3, we characterized the phenotype and function of these tumors to identify mechanisms of cell survival and potential therapeutic targets. Cytogenetics revealed chromosomal atypia with partial or complete trisomy and absence of the NPM-ALK (2;5) translocation. Phenotypic characterization showed strong positivity for CD30, CD71, T-cell CD2/5/7, and antigen presentation (HLA-DR, CD80, CD86) markers, and interleukin (IL)-2 (CD25, CD122) and IL-6 receptors. Studies of these model cell lines showed strong activation of STAT3 signaling, likely related to autocrine production of IL-6 and decreased SHP-1. STAT3 inhibition, directly or by recovery of SHP-1, and cyclophosphamide-Adriamycin-vincristine-prednisone (CHOP) chemotherapy reagents, effectively kill cells of all three TLBR models in vitro and may be pursued as therapies for patients with breast implant-associated T-ALCLs. The TLBR cell lines closely resemble the primary breast implant-associated lymphomas from which they were derived and as such provide valuable preclinical models to study their unique biology. ©2012 AACR.

Radiographic evaluation of vessel count and density with quantitative magnetic resonance imaging during external breast expansion in Asian women: A prospective clinical trial.

PubMed

Myung, Yujin; Kwon, Heeyeon; Pak, Changsik; Lee, Hobin; Jeong, Jae Hoon; Heo, Chan Yeong

2016-12-01

Breast augmentation with fat transfer does not bear the risks associated with silicone implantation. The method can potentially be especially useful in Asian women, who often reject augmentation mammoplasty with implants. This prospective clinical trial evaluated the effects of external breast expansion on breast density and vessel count using magnetic resonance imaging. Thirty-four enrolled patients were instructed to apply one of two devices, the conventional BRAVA device (used in the AESTES trial) or a novel external expansion device (EVERA) designed for Asian women, continuously for 8 h per day for 12 weeks. For external expansion, the pressure was set to 25 mmHg. Follow-up examinations were performed for 4 weeks after completion of the expansion. The ratio between the fibroglandular and adipose tissues of the breast was measured using T1-weighted MRI, and the number of vessels in the breast tissue was determined before and after the treatment by contrast MRI. Additionally, the volume of the breast was measured by laser scanning before, during, and after the device application. The obtained measurements were compared within and between the groups at different time points. Six patients dropped out, while 28 completed the trial without major side effects or adverse events. External expansion significantly increased breast vessel count in both the EVERA and AESTES groups (p = 0.019, p = 0.022). However, it did not significantly change breast density in either group (p = 0.186, p = 0.638). No significant intergroup differences were noted in vessel count (p = 0.874) or density (p = 0.482). Breast volume increases after 12 weeks of application were statistically significant in both groups, with mean changes of 81 ± 22 cc (AESTES) and 98 ± 30 cc (EVERA) (p < 0.001 in both cases). External expansion resulted in a marked increase in breast vessel count but did not affect breast density. The observed increase in breast volume can be considered substantial for Asian women. Level II, therapeutic study. Copyright © 2016 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Sensitivity after bilateral prophylactic mastectomy and immediate reconstruction.

PubMed

Gahm, Jessica; Jurell, Göran; Wickman, Marie; Hansson, Per

2007-01-01

The purpose of this retrospective study was to evaluate the cutaneous somatosensory function and patients' subjective experience after bilateral prophylactic mastectomy and immediate reconstruction with implants. Twenty-four patients treated during an eight-year period were included. Somatosensory examination was made at least two years after the latest surgery to study perception thresholds to touch, warmth, cold, and heat pain, using quantitative techniques. Patients also completed a questionnaire about subjective sensitivity. Sixteen women who had had no previous breast surgery were used as a control group. Most patients reported decreased sensitivity in the breasts, which was confirmed by the results from the quantitative somatosensory examination. The results also showed that the ability to experience sexual feelings in the breast is usually lost after this type of operation, and as many as 14 patients reported spontaneous or stimulus-evoked discomfort in the breasts.

Comparative study between ultrasound-guided fine needle aspiration cytology of axillary lymph nodes and sentinel lymph node histopathology in early-stage breast cancer

PubMed Central

Cardoso-Coelho, Lívio Portela; Borges, Rafael Soares; Alencar, Airlane Pereira; Cardoso-Campos-Verdes, Larysse Maira; da Silva-Sampaio, João Paulo; Borges, Umbelina Soares; Gebrim, Luiz Henrique; da Silva, Benedito Borges

2017-01-01

The replacement of sentinel lymph node biopsy (SNB) by ultrasound-guided fine-needle aspiration (US-guided FNA) cytology of axillary lymph nodes is controversial, despite the simplicity and reduced cost of the latter. In the present study, US-guided FNA was performed in 27 patients with early-stage breast cancer for comparison with SNB. Data were analyzed by calculation of sample proportions. Tumor subtypes included invasive ductal carcinoma (85%), invasive lobular carcinoma (7%), and tubular and metaplastic carcinoma (4%). FNA had a sensitivity of 45%, specificity of 100%, positive predictive value of 100% and a negative predictive value of 73%. Axillary lymph node cytology obtained by US guided-FNA in patients with breast cancer had a specificity similar to that of sentinel lymph node histopathology in the presence of axillary node metastases. However, when lymph node cytology is negative, it does not exclude the existence of metastatic implants, due to its low sensitivity in comparison to sentinel lymph node histopathology. PMID:28521436

Technique of after-loading interstitial implants.

PubMed

Syed, A M; Feder, B H

1977-01-01

Interstitial implants are either removable or permanent (and occasionally a combination of both). Permanent implants are generally utilized where tumors are not accessible enough to permit easy removal of sources or where accurate source distribution is less critical. They are useful for cancers of the lung, pancreas, prostate, bladder, lymph nodes, etc. Radon and gold-198 have been largely replaced by iodine-125. Our major interests are in the removable after-loading iridium-192 implant techniques. Template (steel guide) and non-template (plastic tube) techniques are utilized. Templates are preferred where the tumor volume can only be approached from one side and where accurate positioning of sources would otherwise be difficult. They are useful for cancers of the cervix, vagina, urethra, and rectum. Non-template (plastic tube) techniques are preferred where the tumor volume can be approached from at least two sides and where templates are either not feasible or not essential for accurate positioning of sources. The single needle non-template approach is useful for cancers of lip, nodes, and breast (plastic button) and for cancers of the oral cavity and oropharynx (gold button). The paired needle non-template approach is useful for cancers of the gum, retromolar trigone, and base of tongue (loop technique) and for cancers of the palate (arch technique). Procedures for each technique are described in detail.

The difference of scoring dose to water or tissues in Monte Carlo dose calculations for low energy brachytherapy photon sources.

PubMed

Landry, Guillaume; Reniers, Brigitte; Pignol, Jean-Philippe; Beaulieu, Luc; Verhaegen, Frank

2011-03-01

The goal of this work is to compare D(m,m) (radiation transported in medium; dose scored in medium) and D(w,m) (radiation transported in medium; dose scored in water) obtained from Monte Carlo (MC) simulations for a subset of human tissues of interest in low energy photon brachytherapy. Using low dose rate seeds and an electronic brachytherapy source (EBS), the authors quantify the large cavity theory conversion factors required. The authors also assess whether ap plying large cavity theory utilizing the sources' initial photon spectra and average photon energy induces errors related to spatial spectral variations. First, ideal spherical geometries were investigated, followed by clinical brachytherapy LDR seed implants for breast and prostate cancer patients. Two types of dose calculations are performed with the GEANT4 MC code. (1) For several human tissues, dose profiles are obtained in spherical geometries centered on four types of low energy brachytherapy sources: 125I, 103Pd, and 131Cs seeds, as well as an EBS operating at 50 kV. Ratios of D(w,m) over D(m,m) are evaluated in the 0-6 cm range. In addition to mean tissue composition, compositions corresponding to one standard deviation from the mean are also studied. (2) Four clinical breast (using 103Pd) and prostate (using 125I) brachytherapy seed implants are considered. MC dose calculations are performed based on postimplant CT scans using prostate and breast tissue compositions. PTV D90 values are compared for D(w,m) and D(m,m). (1) Differences (D(w,m)/D(m,m)-1) of -3% to 70% are observed for the investigated tissues. For a given tissue, D(w,m)/D(m,m) is similar for all sources within 4% and does not vary more than 2% with distance due to very moderate spectral shifts. Variations of tissue composition about the assumed mean composition influence the conversion factors up to 38%. (2) The ratio of D90(w,m) over D90(m,m) for clinical implants matches D(w,m)/D(m,m) at 1 cm from the single point sources, Given the small variation with distance, using conversion factors based on the emitted photon spectrum (or its mean energy) of a given source introduces minimal error. The large differences observed between scoring schemes underline the need for guidelines on choice of media for dose reporting. Providing such guidelines is beyond the scope of this work.

Trends and Variation in Use of Breast Reconstruction in Patients With Breast Cancer Undergoing Mastectomy in the United States

PubMed Central

Jagsi, Reshma; Jiang, Jing; Momoh, Adeyiza O.; Alderman, Amy; Giordano, Sharon H.; Buchholz, Thomas A.; Kronowitz, Steven J.; Smith, Benjamin D.

2014-01-01

Purpose Concerns exist regarding breast cancer patients' access to breast reconstruction, which provides important psychosocial benefits. Patients and Methods Using the MarketScan database, a claims-based data set of US patients with employment-based insurance, we identified 20,560 women undergoing mastectomy for breast cancer from 1998 to 2007. We evaluated time trends using the Cochran-Armitage test and correlated reconstruction use with plastic-surgery workforce density and other treatments using multivariable regression. Results Median age of our sample was 51 years. Reconstruction use increased from 46% in 1998 to 63% in 2007 (P < .001), with increased use of implants and decreased use of autologous techniques over time (P < .001). Receipt of bilateral mastectomy also increased: from 3% in 1998 to 18% in 2007 (P < .001). Patients receiving bilateral mastectomy were more likely to receive reconstruction (odds ratio [OR], 2.3; P < .001) and patients receiving radiation were less likely to receive reconstruction (OR, 0.44; P < .001). Rates of reconstruction receipt varied dramatically by geographic region, with associations with plastic surgeon density in each state and county-level income. Autologous techniques were more often used in patients who received both reconstruction and radiation (OR, 1.8; P < .001) and less frequently used in patients with capitated insurance (OR, 0.7; P < .001), patients undergoing bilateral mastectomy (OR, 0.5; P < .001), or patients in the highest income quartile (OR, 0.7; P = .006). Delayed reconstruction was performed in 21% of patients who underwent reconstruction. Conclusion Breast reconstruction has increased over time, but it has wide geographic variability. Receipt of other treatments correlates with the use of and approaches toward reconstruction. Further research and interventions are needed to ensure equitable access to this important component of multidisciplinary treatment of breast cancer. PMID:24550418

Exeresis and Brachytherapy as Salvage Treatment for Local Recurrence After Conservative Treatment for Breast Cancer: Results of a Ten-Year Pilot Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Guix, Benjamin, E-mail: bguix@imor.or; Lejarcegui, Jose Antonio; Tello, Jose Ignacio

2010-11-01

Purpose: To analyze the long-term results of a pilot study assessing excision and brachytherapy as salvage treatment for local recurrence after conservative treatment of breast cancer. Methods and Materials: Between December 1990 and March 2001, 36 patients with breast-only recurrence less than 3 cm in diameter after conservative treatment for Stage I or II breast carcinoma were treated with local excision followed by high-dose rate brachytherapy implants (30 Gy in 12 fractions over a period of 5 days). No patient was lost to follow-up. Special attention was paid to local, regional, or distant recurrences; survival; cosmesis; and early and latemore » side effects. Results: All patients completed treatment. During follow-up (range, 1-13 years), 8 patients presented metastases (2 regional and 6 distant) as their first site of failure, 1 had a differed local recurrence, and 1 died of the disease. Actuarial results at 10 years were as follows: local control, 89.4%; disease-free survival, 64.4%; and survival, 96.7%. Cosmetic results were satisfactory in 90.4%. No patient had Grade 3 or 4 early or late complications. Of the 11 patients followed up for at least 10 years, all but 1 still had their breast in place at the 10-year stage. Conclusions: High-dose rate brachytherapy is a safe, effective treatment for small-size, low-risk local recurrence after local excision in conservatively treated patients. The dose of 30 Gy of high-dose rate brachytherapy (12 fractions over a period of 5 days twice daily) was well tolerated. The excellent results support the use of breast preservation as salvage treatment in selected patients with local recurrence after conservative treatment for breast cancer.« less

Immediate breast reconstruction-impact on radiation management.

PubMed Central

Shankar, Ravi A.; Nibhanupudy, J. Rao; Sridhar, Rajagopalan; Ashton, Cori; Goldson, Alfred L.

2003-01-01

Breast reconstruction is an option for women undergoing modified radical mastectomy due to a diagnosis of breast cancer. In certain patients, breast reconstruction is performed by insertion of a temporary tissue expander prior to the placement of permanent breast implants. Some of these patients, following mastectomy, may require chest wall irradiation to prevent loco regional relapse. The compatibility of radiation and tissue expanders placed in the chest wall is of major concern to the radiation oncologist. Clinically undetectable changes can occur in the tissue expander during the course of radiation therapy. This can lead to radiation treatment set-up changes, variation in tissue expansion resulting in unwanted cosmesis, and deviation from the prescribed radiation dose leading to over and/or under dosing of tumor burden. At Howard University hospital, a CT scan was utilized to evaluate the status of the temporary tissue expander during radiation treatment to enable us to prevent radiation treatment related complications resulting from dosimetric discrepancies. CT images of the tissue expander were obtained through the course of treatment. To avoid a 'geographic miss' the amount of fluid injected into the tissue expander was kept constant following patient's satisfaction with the size of the breast mound. The CT scans allowed better visualization of the prosthesis and its relation to the surrounding tumor bed. This technique ensured that anatomical changes occurring during radiation treatment, if any, were minimized. Repeated dosimetry evaluations showed no changes to the prescribed dose distribution. A CT of the reconstructed breast provides an important quality control. Further studies with greater number of patients are required for confirming this impact on radiation treatment. Images Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 PMID:12749619

Do metallic ports in tissue expanders affect postmastectomy radiation delivery?

PubMed

Damast, Shari; Beal, Kathryn; Ballangrud, Ase; Losasso, Thomas J; Cordeiro, Peter G; Disa, Joseph J; Hong, Linda; McCormick, Beryl L

2006-09-01

Postmastectomy radiation therapy (PMRT) is often delivered to patients with permanent breast implants. On occasion, patients are irradiated with a tissue expander (TE) in place before their permanent implant exchange. Because of concern of potential under-dosing in these patients, we examined the dosimetric effects of the Magna-Site (Santa Barbara, CA) metallic port that is present in certain TEs. We performed ex vivo film dosimetry with single 6-MV and 15-MV photon beams on a water phantom containing a Magna-Site disc in two orientations. Additionally, using in vivo films, we measured the exit dose from 1 patient's TE-reconstructed breast during chest wall treatment with 15-MV tangent beams. Finally, we placed thermoluminescent dosimeters (TLDs) on 6 patients with TEs who received PMRT delivered with 15-MV tangent beams. Phantom film dosimetry revealed decreased transmission in the region of the Magna-Site, particularly with the magnet in the parallel orientation (at 22 mm: 78% transmission with 6 MV, 84% transmission with 15 MV). The transmission measured by in vivo films during single beam treatment concurred with ex vivo results. TLD data showed acceptable variation in median dose to the skin (86-101% prescription dose). Because of potential dosimetric effects of the Magna-Site, it is preferable to treat PMRT patients with permanent implants. However, it is not unreasonable to treat with a TE because the volume of tissue affected by attenuation from the Magna-Site is small. In this scenario, we recommend using 15 MV photons with compensating bolus.

Clinical utility of scintimammography: From the Anger-camera to new dedicated devices

NASA Astrophysics Data System (ADS)

Schillaci, Orazio; Danieli, Roberta; Romano, Pasquale; Cossu, Elsa; Simonetti, Giovanni

2006-12-01

Scintimammography is a functional imaging technique which uses a radiation detection camera to detect radionuclide tracers in the patient's breasts. Tracers are designed to accumulate in tumours more than in healthy tissue: the most used are Tc-99 m sestamibi and Tc-99 m tetrofosmin. Scintimammography is useful in some clinical indications as an adjunct to mammography: it is recommended for those lesions where additional information is required to reach a definitive diagnosis. Patients with dubious mammograms may benefit from this test, as well as women with dense breasts or with implants. Scintimammography is a valuable diagnostic tool also in patients with locally advanced breast cancer for monitoring and predicting response to neoadjuvant chemotherapy. Nevertheless, using an Anger-camera this technique shows a high sensitivity only for cancers >1 cm. Since other modalities are increasingly employed for the early identification of small abnormalities, the issue of detecting small cancers is critical for the future development and clinical utility of breast imaging with radiopharmaceuticals. The use of high-resolution cameras dedicated for breast imaging is the best option to improve the detection of small cancers: they allow higher flexibility in patient positioning, and the availability of mammography-like projections. Moreover, the detector can be placed directly in contact with the breast allowing a mild compression with reduction of the breast's thickness, thus increasing the target-to-background ratio and the sensitivity. These new devices have the potential of increasing the total number of breast scintigraphies performed thereby enhancing the role of nuclear medicine in breast cancer imaging.

Titanium wire implants with nanotube arrays: A study model for localized cancer treatment.

PubMed

Kaur, Gagandeep; Willsmore, Tamsyn; Gulati, Karan; Zinonos, Irene; Wang, Ye; Kurian, Mima; Hay, Shelley; Losic, Dusan; Evdokiou, Andreas

2016-09-01

Adverse complications associated with systemic administration of anti-cancer drugs are a major problem in cancer therapy in current clinical practice. To increase effectiveness and reduce side effects, localized drug delivery to tumour sites requiring therapy is essential. Direct delivery of potent anti-cancer drugs locally to the cancer site based on nanotechnology has been recognised as a promising alternative approach. Previously, we reported the design and fabrication of nano-engineered 3D titanium wire based implants with titania (TiO2) nanotube arrays (Ti-TNTs) for applications such as bone integration by using in-vitro culture systems. The aim of present study is to demonstrate the feasibility of using such Ti-TNTs loaded with anti-cancer agent for localized cancer therapy using pre-clinical cancer models and to test local drug delivery efficiency and anti-tumour efficacy within the tumour environment. TNF-related apoptosis-inducing ligand (TRAIL) which has proven anti-cancer properties was selected as the model drug for therapeutic delivery by Ti-TNTs. Our in-vitro 2D and 3D cell culture studies demonstrated a significant decrease in breast cancer cell viability upon incubation with TRAIL loaded Ti-TNT implants (TRAIL-TNTs). Subcutaneous tumour xenografts were established to test TRAIL-TNTs implant performance in the tumour environment by monitoring the changes in tumour burden over a selected time course. TRAIL-TNTs showed a significant regression in tumour burden within the first three days of implant insertion at the tumour site. Based on current experimental findings these Ti-TNTs wire implants have shown promising capacity to load and deliver anti-cancer agents maintaining their efficacy for cancer treatment. Copyright © 2016 Elsevier Ltd. All rights reserved.

Identification of complications in mastectomy with immediate reconstruction using tissue expanders and permanent implants for breast cancer patients.

PubMed

Ota, Daisuke; Fukuuchi, Atsushi; Iwahira, Yoshiko; Kato, Takao; Takeuchi, Masashi; Okamoto, Joji; Nishi, Tsunehiro

2016-05-01

Since complications of postmastectomy breast reconstruction may reduce patient satisfaction, we investigated complications of reconstruction with tissue expanders (TEs), particularly surgical site infections requiring TE/permanent implant (PI) removal. A retrospective review was performed of 234 primary breast cancer patients undergoing 239 postmastectomy breast reconstructions with TEs/PIs from 1997 to 2009. Clinicopathological findings and postoperative complications, particularly infections, were analyzed. Data were analyzed by the Chi-square test and a multivariate logistic regression model. TE infection risk factors considered for model inclusion were excisional biopsy, (neo) adjuvant chemotherapy, lymph node resection, body mass index (BMI), simultaneous bilateral reconstructions, and seroma aspiration. Removal of TEs/PIs was observed in 15.5% (37/239) of reconstructions, and 18/37 underwent re-reconstructions. Of the 19/37 reconstructions that were not achieved completely, the most frequent reason was TE infection (11 reconstructions). The completion rate was 92% (220/239 reconstructions) and it was significantly higher in reconstructions without TE infection than with infection (96 vs. 54%, p < 0.0001). Patients with BMI ≥ 25 kg/m² and seroma aspiration were more likely to develop TE infections (p = 0.0019, p < 0.001, respectively). By multivariate logistic regression analysis, seroma aspiration was a significant independent risk factor for TE infection (odds ratio 28.75, 95% confidence interval 5.71-40.03, p < 0.0001). To improve completion rates of breast reconstruction, prevention of TE infection plays a key role. We should reduce unnecessary seroma aspirations and delay elevation/exercise of the ipsilateral arm.

MemoryShape: impact of clinical trials, global medical economics, and the future.

PubMed

Cunningham, Bruce L; Suszynski, Thomas; Sieber, David A

2014-09-01

The global breast implant business was invented and configured by American plastic surgeons. In 2012, the first shaped silicone implants were approved in the United States by the Food and Drug Administration. It is the peculiar historical course of implant usage in America that has deprived US plastic surgeons of the opportunity to become experts in the use of this device. Most studies indicate significant safety benefits to using shaped devices, despite the technical challenges involved in their use. Upon approval, adoption of the devices has been slow in the United States, running the risk that American plastic surgery may lose the intellectual and clinical practice hegemony it has enjoyed for over 50 years in this area of the specialty. To continue to maintain leadership in the field of breast surgery, US surgeons should evaluate this new modality and either join the global trend or present data to contradict it.

Efficacy and Safety of the Collagenase of the Bacterium Clostridium Histolyticum for the Treatment of Capsular Contracture after Silicone Implants: Ex-Vivo Study on Human Tissue.

PubMed

Fischer, Sebastian; Hirche, Christoph; Diehm, Yannick; Nuutila, Kristo; Kiefer, Jurij; Gazyakan, Emre; Bueno, Ericka M; Kremer, Thomas; Kneser, Ulrich; Pomahac, Bohdan

2016-01-01

The fibrotic capsule that surrounds silicone implants consists mainly of collagen. The FDA-approved collagenase of the bacterium clostridium histolyticum provides a reasonable treatment option. Safety and efficacy at the female breast site must be evaluated before clinical utilization. We incubated 20 samples of fibrotic capsule as well as 12 full thickness skin grafts harvested from the female breast site for 24 hours with different doses of collagenase. Outcome measures involved histological assessment of thickness and density of the capsule tissue as well as the skin grafts. Furthermore, we performed a collagen assay and immunohistochemistry staining for collagen subtypes. Collagenase treatment was able to degrade human capsule contracture tissue ex-vivo. The remaining collagen subtype after degradation was type 4 only. 0.3 mg/ml of collagenase was most effective in reducing capsule thickness when compared with higher concentrations. Of note, effectiveness was inversely related to capsule density, such that there was less reduction in thickness with higher capsule densities and vice versa. Furthermore, the application of 0.3mg/ml collagenase did not lead to thinning or perforation of full thickness skin grafts. Adjustment of collagenase dose will depend on thickness and density of the contracted capsule. A concentration of 0.3mg/ml seems to be safe and effective in an ex-vivo setting. The remaining collagen subtype 4 is suitable to serve as a neo-capsule/acellular tissue matrix. Collagenase treatment for capsular contracture may soon become a clinical reality.

Dual Coverage of the Inferior Pole with Conjoined Fascial Flap and Acellular Dermal Matrix for Immediate One-Stage Breast Reconstruction with a Prosthetic Implant.

PubMed

Lee, Seo H; Chun, Yong S; Park, Heung K; Kim, Yang W; Cheon, Young W

2018-04-17

Elevation of a conjoined fascial flap composed of the pectoralis major, serratus anterior, and external oblique fascia is a type of surgical technique using autologous tissue to cover the lower pole after immediate one-stage direct-to-implant (DTI) breast reconstruction. However, volumetric breast implants hinder use of this technique alone. For better structural stability and more aesthetically favorable breast contour in large breasts, we have devised a technique involving dual coverage of the lower pole by a conjoined fascial flap and acellular dermal matrix (ADM). Twenty Asian patients underwent DTI breast reconstruction from March 2013 to May 2014. ADM was used to cover the inferomedial quadrant of the breast, and a conjoined fascial flap was elevated to cover the remaining inferolateral quadrant. Both patient- and plastic surgeon-reported outcome measures were assessed using questionnaires. For every domain of the patient- and plastic surgeon-reported questionnaires, the mean scores were between satisfied and very satisfied. Two patients developed a seroma and one patient developed partial skin flap necrosis. Both seromas resolved after a series of aspirations. The necrotic skin flap was revised under local anesthesia 3 weeks after the reconstructive surgery. The use of dual coverage of the inferior pole with a conjoined fascial flap and ADM for immediate DTI among patients with large breasts is supported by high scores in both patient- and plastic surgeon-reported outcome measures, as well as low complication rates. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

The Effect of Radiation on Complication Rates and Patient Satisfaction in Breast Reconstruction using Temporary Tissue Expanders and Permanent Implants.

PubMed

Anker, Christopher J; Hymas, Richard V; Ahluwalia, Ravinder; Kokeny, Kristine E; Avizonis, Vilija; Boucher, Kenneth M; Neumayer, Leigh A; Agarwal, Jayant P

2015-01-01

The optimal method of reconstruction following mastectomy for breast cancer patients receiving radiation therapy (RT) is controversial. This study evaluated patient satisfaction and complication rates among patients who received implant-based breast reconstruction. The specific treatment algorithm analyzed included patients receiving mastectomy and immediate temporary tissue expander (TE), followed by placement of a permanent breast implant (PI). If indicated, RT was delivered to the fully expanded TE. Records of 218 consecutive patients with 222 invasive (85%) or in situ (15%) breast lesions from the Salt Lake City region treated between 1998 and 2009 were retrospectively reviewed, 28% of whom received RT. Median RT dose was 50.4 Gy, and 41% received a scar boost at a median dose of 10 Gy. Kaplan-Meier analyses were performed to evaluate the cumulative incidence of surgical complications, including permanent PI removal. Risk factors associated with surgical events were analyzed. To evaluate cosmetic results and patient satisfaction, an anonymous survey was administered. Mean follow-up was 44 months (range 6-144). Actuarial 5-year PI removal rates for non-RT and RT patients were 4% and 22%, respectively. On multivariate analysis (MVA), the only factor associated with PI removal was RT (p = 0.009). Surveys were returned describing the outcomes of 149 breasts. For the non-RT and RT groups, those who rated their breast appearance as good or better were 63% versus 62%, respectively. Under 1/3 of each group was dissatisfied with their reconstruction. RT did not significantly affect patient satisfaction scores, but on MVA RT was the only factor associated with increased PI removal. This reconstruction technique may be considered an acceptable option even if RT is needed, but the increased complication risk with RT must be recognized. © 2015 Wiley Periodicals, Inc.

Bioavailability of octamethylcyclotetrasiloxane (D(4)) after exposure to silicones by inhalation and implantation.

PubMed Central

Luu, H M; Hutter, J C

2001-01-01

We developed a physiologically based pharmacokinetic (PBPK) model to predict the target organ doses of octamethylcyclotetrasiloxane (D(4)) after intravenous (IV), inhalation, or implantation exposures. The model used (14)C-D(4) IV disposition data in rats to estimate tissue distribution coefficients, metabolism, and excretion parameters. We validated the model by comparing the predicted blood and tissues concentrations of D(4) after inhalation to experimental results in both rats and humans. We then used the model to simulate D(4) kinetics after single and/or repeated D(4) exposures in rats and humans. The model predicted bioaccumulation of D(4) in fatty tissues (e.g., breast), especially in women. Because of its high lipid solubility (Log P(oct/water) = 5.1), D(4) persisted in fat with a half life of 11.1 days after inhalation and 18.2 days after breast implant exposure. Metabolism and excretion remained constant with repeated exposures, larger doses, and/or different routes of exposure. The accumulation of D(4) in fatty tissues should play an important role in the risk assessment of D(4) especially in women exposed daily to multiple personal care products and silicone breast implants. PMID:11712992

Is it safe to combine abdominoplasty with elective breast surgery? A review of 151 consecutive cases.

PubMed

Stevens, W Grant; Cohen, Robert; Vath, Steven D; Stoker, David A; Hirsch, Elliot M

2006-07-01

This study was designed to evaluate and compare the complication rates of patients having abdominoplasty without breast surgery with the rates of those having abdominoplasty with various types of elective breast surgery, including breast augmentation, breast reduction, mastopexy, and mastopexy combined with simultaneous augmentation. The data collected represent a retrospective chart review of consecutive abdominoplasty procedures performed at a single outpatient facility by the senior surgeon (W.G.S.) over a 15-year period (1989 to 2004). Two groups were compared: patients who underwent abdominoplasty without breast surgery and those who had abdominoplasty with breast surgery. The second group was subdivided by the various types of breast procedures noted above. The minor complications assessed included seromas, hematomas, infections, and small (<5 cm) wound breakdowns. Major complications evaluated included large (>5 cm) flap necrosis, need for blood transfusion, deep vein thrombosis, pulmonary embolus, myocardial infarction, and death. Additional data compiled included age, sex, tobacco use, body mass index, past medical history, American Society of Anesthesiologists physical status level, and operative times. Of the 415 abdominoplasty procedures, 264 (group 1) did not include simultaneous breast surgery. One hundred fifty-one procedures (group 2) involved simultaneous breast surgery, representing 36 percent of the total. Group 2 was further subdivided into those who had breast augmentation surgery (group 2A, n = 50), those who had breast reduction surgery (group 2B, n = 31), those who had mastopexy surgery (group 2C, n = 28), and those who had simultaneous mastopexy and breast augmentation surgery (group 2D, n = 42). Removal and replacement of implants and capsulectomy/capsulotomy procedures were included in the augmentation group (group 2A). There were no major complications, including flap necrosis (open wound >5 cm), blood transfusions, deep vein thrombosis, pulmonary embolus, myocardial infarction, or death. No patients required hospitalization. No statistically significant associations with complications were noted between groups 1 and 2 (chi-square, 0.0045; p > 0.95, not significant). Furthermore, when subdivided by type of breast surgery, no statistically significant associations were noted among subgroups: group 1 versus 2A (chi-square, 0.96; p > 0.05, not significant), group 1 versus 2B (chi-square, 0.032; p > 0.9, not significant), group 1 versus 2C (chi-square, 0.003; p > 0.975, not significant), and group 1 versus 2D (chi-square, 0.83; p > 0.5, not significant). The results of this retrospective review indicate that combining elective breast surgery with abdominoplasty does not appear to significantly increase the number of major or minor complications.

Spontaneous Regression and Resolution of Breast Implant-Associated Anaplastic Large Cell Lymphoma: Implications for Research, Diagnosis and Clinical Management.

PubMed

Fleming, Daniel; Stone, Jason; Tansley, Patrick

2018-06-01

First described in 1997, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) was recognised by the World Health Organisation in 2016 as a specific disease. It typically presents as a late seroma-containing atypical, monoclonal T cells which are CD30+ and anaplastic lymphoma kinase negative. Until recently, it was thought that the disease was very rare. However, it is being diagnosed increasingly frequently with 56 cases confirmed in Australia by September 2017 and the estimated incidence revised from 1 in 300,000 to between 1 in 1000 and 1 in 10,000 patients with bilateral implants. There is debate about the spectrum of BIA-ALCL. According to the current WHO classification, BIA-ALCL is a cancer in all cases. Treatment guidelines require that it is treated urgently with a minimum of bilateral removal of implants and capsulectomies. Whilst acknowledging the disease has been under diagnosed in the past, with some notable exceptions the BIA-ALCL literature has given scant attention to the epidemiological evidence. Now that it is known that the disease may occur in up to 1 in 1000 patients with a median of 7.5 years from implantation to diagnosis, understanding it in its epidemiological context is imperative. The epidemiology of cancer and lymphoma in women with breast implants strongly suggests that most patients do not have a cancer that will inevitably progress without treatment but instead a self-limiting lympho-proliferative disorder. Although the possibility of spontaneous regression has been raised and the observation made that treatment delay did not seem to increase the risk of spread, the main objection to the lympho-proliferative hypothesis has been the lack of documented cases of spontaneous regression or resolution. Because all cases currently are considered malignant and treated urgently, only case report evidence, interpreted in the proper epidemiological context, is likely to be available to challenge this thinking. New observations and interpretation of the epidemiology of BIA-ALCL are made. These are supported by the presentation of two cases, which to the best of our knowledge comprise the first documented evidence of spontaneous regression and spontaneous resolution of confirmed BIA-ALCL. The epidemiology of the disease strongly suggests that the vast majority of cases are not a cancer that will inevitably progress without treatment. The findings presented in the manuscript provide supportive clinical evidence. Consequently, an alternative view of BIA-ALCL with implications for research, diagnosis and clinical management needs to be considered. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Comparing five alternative methods of breast reconstruction surgery: a cost-effectiveness analysis.

PubMed

Grover, Ritwik; Padula, William V; Van Vliet, Michael; Ridgway, Emily B

2013-11-01

The purpose of this study was to assess the cost-effectiveness of five standardized procedures for breast reconstruction to delineate the best reconstructive approach in postmastectomy patients in the settings of nonirradiated and irradiated chest walls. A decision tree was used to model five breast reconstruction procedures from the provider perspective to evaluate cost-effectiveness. Procedures included autologous flaps with pedicled tissue, autologous flaps with free tissue, latissimus dorsi flaps with breast implants, expanders with implant exchange, and immediate implant placement. All methods were compared with a "do-nothing" alternative. Data for model parameters were collected through a systematic review, and patient health utilities were calculated from an ad hoc survey of reconstructive surgeons. Results were measured in cost (2011 U.S. dollars) per quality-adjusted life-year. Univariate sensitivity analyses and Bayesian multivariate probabilistic sensitivity analysis were conducted. Pedicled autologous tissue and free autologous tissue reconstruction were cost-effective compared with the do-nothing alternative. Pedicled autologous tissue was the slightly more cost-effective of the two. The other procedures were not found to be cost-effective. The results were robust to a number of sensitivity analyses, although the margin between pedicled and free autologous tissue reconstruction is small and affected by some parameter values. Autologous pedicled tissue was slightly more cost-effective than free tissue reconstruction in irradiated and nonirradiated patients. Implant-based techniques were not cost-effective. This is in agreement with the growing trend at academic institutions to encourage autologous tissue reconstruction because of its natural recreation of the breast contour, suppleness, and resiliency in the setting of irradiated recipient beds.

Human Breast Cancer Cells Are Redirected to Mammary Epithelial Cells upon Interaction with the Regenerating Mammary Gland Microenvironment In-Vivo

PubMed Central

Bussard, Karen M.; Smith, Gilbert H.

2012-01-01

Breast cancer is the second leading cause of cancer deaths in the United States. At present, the etiology of breast cancer is unknown; however the possibility of a distinct cell of origin, i.e. a cancer stem cell, is a heavily investigated area of research. Influencing signals from the tissue niche are known to affect stem cells. Literature has shown that cancer cells lose their tumorigenic potential and display ‘normal’ behavior when placed into ‘normal’ ontogenic environments. Therefore, it may be the case that the tissue microenvironment is able to generate signals to redirect cancer cell fate. Previously, we showed that pluripotent human embryonal carcinoma cells could be redirected by the regenerating mammary gland microenvironment to contribute epithelial progeny for ‘normal’ gland development in-vivo. Here, we show that that human metastatic, non-metastatic, and metastasis-suppressed breast cancer cells proliferate and contribute to normal mammary gland development in-vivo without tumor formation. Immunochemistry for human-specific mitochondria, keratin 8 and 14, as well as human-specific milk proteins (alpha-lactalbumin, impregnated transplant hosts) confirmed the presence of human cell progeny. Features consistent with normal mammary gland development as seen in intact hosts (duct, lumen formation, development of secretory acini) were recapitulated in both primary and secondary outgrowths from chimeric implants. These results suggest the dominance of the tissue microenvironment over cancer cell fate. This work demonstrates that cultured human breast cancer cells (metastatic and non-metastatic) respond developmentally to signals generated by the mouse mammary gland microenvironment during gland regeneration in-vivo. PMID:23155468

Double breast contour in primary aesthetic breast augmentation: incidence, prevention and treatment.

PubMed

Médard de Chardon, Victor; Balaguer, Thierry; Chignon-Sicard, Bérengère; Lebreton, Elisabeth

2010-04-01

The goal of this study was to define the incidence of double breast contour in primary aesthetic breast augmentation and to analyze its risk factors. An independent plastic surgeon analyzed the data of 200 patients who had a primary aesthetic breast augmentation with silicone gel implant and with a minimum 12-month follow-up. All patients had pre and postoperative standardized photography. Mastopexy-augmentations, breast reconstructions, breast malformations (tuberous breasts and Poland syndrome), and patients with incomplete data were excluded from the study. Assessment was achieved using an original standardized evaluation form (preoperative breast morphology, surgical options, postoperative aesthetic results). Patients were also asked to complete an exhaustive satisfaction form. A double breast contour was assessed clinically using Massiha's classification. The mean follow-up was 36 months. The double breast contour incidence was 7%. All of them were type I (the so called waterfall deformity). There was no type II (double inframammary crease). They were minor for 6.5% and major for 0.5%. They were related to a preoperative breast ptosis, subpectoral placement, and implant upper malposition. The rate of the type I was 10.5% of submuscular augmentation and 15% of preoperative breast ptosis. A double breast contour was primitive for 6% and secondary for 1% (pregnancy and breast-feeding postaugmentation). It was bilateral for 4.5% (3 cases of upper malposition, 1 case of medial malposition, 2 cases of pregnancy with breast-feeding postaugmentation and 1 patient refused a mastopexy-augmentation). It was unilateral for 2.5% related to a preoperative breast asymmetry with ptosis asymmetry and skin quality asymmetry. The satisfaction rate in the group "double contour" (14 patients) was 85.7% (vs. 91.9%). One patient had revision surgery (upper malposition). These types of deformities are fundamentally different with consideration on their clinical aspects, physiopathogeny, prevention and treatment. Type I major risk factor is subpectoral augmentation of ptotic breasts (with medium to bad skin quality and loses muscle to gland attachments). The muscle at the inferior pole of the breast is a "brake" preventing implant to fill the envelope. This risk is increased with implant malposition, constitutional ptosis asymmetry with symmetrical implant placement and selection of an insufficient implant projection or dimensions. This deformity can be avoided with selection of a subglandular or dual plane (type II or III) placement, a sufficient implant volume or projection and anatomic prosthesis. Type II is related to a lowering of a well-defined submammary fold more commonly in constricted and dens glandular breasts. This deformity can be avoided with respecting the inframammary fold, radial incisions on the gland's posterior surface, and selection of anatomic implants.

Definitive diagnosis of breast implant rupture using magnetic resonance imaging.

PubMed

Ahn, C Y; Shaw, W W; Narayanan, K; Gorczyca, D P; Sinha, S; Debruhl, N D; Bassett, L W

1993-09-01

Breast implant rupture is an important complication of augmented and reconstructed breasts. Although several techniques such as mammography, xeromammography, ultrasound, thermography, and computed tomographic (CT) scanning have been proven to be useful to detect implant rupture, they have several disadvantages and lack specificity. In the current study, we have established magnetic resonance imaging (MRI) as a definitive, reliable, and reproducible technique to diagnose both intracapsular and extracapsular ruptures. The study was conducted in 100 symptomatic patients. Our imaging parameters were able to identify ruptures in implants with silicone shells. All the ruptures showed the presence of wavy lines, free-floating silicone shell within the gel ("free-floating loose-thread sign" or "linguine sign"). We had a 3.75 percent incidence of false-positive and false-negative results. The sensitivity for detection of silicone implant rupture was 76 percent, with a specificity of 97 percent. In addition, we also were able to identify the artifacts that may interfere with the definitive diagnosis of implant rupture.

Modified round block mastopexy versus traditional round block mastopexy.

PubMed

Sterodimas, A; Nicaretta, B; Boriani, F

2015-01-01

Breast ptosis may be caused by several factors, including significant weight loss, pregnancy, long breastfeeding periods, and involution of the postmenopausal breast tissue. The authors performed a prospective study to evaluate patient satisfaction and the rate of complications after modified round block mastopexy versus traditional round block mastopexy. Forty-four patients fulfilled the inclusion criteria for undergoing round block mastopexy in a prospective randomized controlled study performed from 2007 to 2008. All the patients received polyurethane silicone implants. Group A included patients who underwent the traditional round block technique described by Benelli. Group B included patients who underwent the traditional round block and 4 cardinal glando-glandular permanent sutures. The overall satisfaction with body appearance after breast mastopexy was rated on a scale of 1 (poor), 2 (fair), 3 (good), 4 (very good), and 5 (excellent). Group A patient ages ranged from 28 to 52 years and in Group B ranged from 29 to 49 years. The mean implant volume was 215 cc in both Groups. The complication and satisfaction rates for both Groups are reported. The combination of the cardinal glandulo-glandular sutures along with the traditional round block appears to be key to preventing the areolar enlargement and persistent breast ptosis. The satisfaction rates in patients who underwent the modified round mastopexy appear superior when compared to the traditional round block mastopexy. Furhter long-term follow-up need to be performed in order to confirm the favorable results seen in this series of cases.

Formononetin induces cell cycle arrest of human breast cancer cells via IGF1/PI3K/Akt pathways in vitro and in vivo.

PubMed

Chen, J; Zeng, J; Xin, M; Huang, W; Chen, X

2011-09-01

Formononetin is one of the main components of red clover plants, and is considered as a typical phytoestrogen. This study further investigated that formononetin inactivated IGF1/IGF1R-PI3K/Akt pathways and decreased cyclin D1 mRNA and protein expression in human breast cancer cells in vitro and in vivo. MCF-7 cells were treated with different concentrations of formononetin. The proliferation of the cells treated with formononetin was tested by MTT assay. The cell cycle in the treated cells was examined by flow cytometry. The levels of p-IGF-1 R, p-Akt, and cyclin D1 protein expression and cyclin D1 mRNA expression in the treated cells were determined by Western blot and RT-PCR, respectively. In addition, the antitumor activity of formononetin was evaluated in nude mice bearing orthotopic tumor implants. Compared with the control, formononetin inhibited the proliferation of MCF-7 cells and effectively induced cell cycle arrest. The levels of p-IGF-1 R, p-Akt, cyclin D1 protein expression, and cyclin D1 mRNA expression were also downregulated. On the other hand, formononetin also prevented the tumor growth of human breast cancer cells in nude mouse xenografts. These results show that formononetin causes cell cycle arrest at the G0/G1 phase by inactivating IGF1/IGF1R-PI3K/Akt pathways and decreasing cyclin D1 mRNA and protein expression, indicating the use of formononetin in the prevention of breast cancer carcinogenesis. Georg Thieme Verlag KG Stuttgart · New York.

Breast implant-associated anaplastic large-cell lymphoma: long-term follow-up of 60 patients.

PubMed

Miranda, Roberto N; Aladily, Tariq N; Prince, H Miles; Kanagal-Shamanna, Rashmi; de Jong, Daphne; Fayad, Luis E; Amin, Mitual B; Haideri, Nisreen; Bhagat, Govind; Brooks, Glen S; Shifrin, David A; O'Malley, Dennis P; Cheah, Chan Y; Bacchi, Carlos E; Gualco, Gabriela; Li, Shiyong; Keech, John A; Hochberg, Ephram P; Carty, Matthew J; Hanson, Summer E; Mustafa, Eid; Sanchez, Steven; Manning, John T; Xu-Monette, Zijun Y; Miranda, Alonso R; Fox, Patricia; Bassett, Roland L; Castillo, Jorge J; Beltran, Brady E; de Boer, Jan Paul; Chakhachiro, Zaher; Ye, Dongjiu; Clark, Douglas; Young, Ken H; Medeiros, L Jeffrey

2014-01-10

Breast implant-associated anaplastic large-cell lymphoma (ALCL) is a recently described clinicopathologic entity that usually presents as an effusion-associated fibrous capsule surrounding an implant. Less frequently, it presents as a mass. The natural history of this disease and long-term outcomes are unknown. We reviewed the literature for all published cases of breast implant-associated ALCL from 1997 to December 2012 and contacted corresponding authors to update clinical follow-up. The median overall survival (OS) for 60 patients was 12 years (median follow-up, 2 years; range, 0-14 years). Capsulectomy and implant removal was performed on 56 of 60 patients (93%). Therapeutic data were available for 55 patients: 39 patients (78%) received systemic chemotherapy, and of the 16 patients (28%) who did not receive chemotherapy, 12 patients opted for watchful waiting and four patients received radiation therapy alone. Thirty-nine (93%) of 42 patients with disease confined by the fibrous capsule achieved complete remission, compared with complete remission in 13 (72%) of 18 patients with a tumor mass. Patients with a breast mass had worse OS and progression-free survival (PFS; P = .052 and P = .03, respectively). The OS or PFS were similar between patients who received and did not receive chemotherapy (P = .44 and P = .28, respectively). Most patients with breast implant-associated ALCL who had disease confined within the fibrous capsule achieved complete remission. Proper management for these patients may be limited to capsulectomy and implant removal. Patients who present with a mass have a more aggressive clinical course that may be fatal, justifying cytotoxic chemotherapy in addition to removal of implants.

Breast Implant–Associated Anaplastic Large-Cell Lymphoma: Long-Term Follow-Up of 60 Patients

PubMed Central

Miranda, Roberto N.; Aladily, Tariq N.; Prince, H. Miles; Kanagal-Shamanna, Rashmi; de Jong, Daphne; Fayad, Luis E.; Amin, Mitual B.; Haideri, Nisreen; Bhagat, Govind; Brooks, Glen S.; Shifrin, David A.; O'Malley, Dennis P.; Cheah, Chan Y.; Bacchi, Carlos E.; Gualco, Gabriela; Li, Shiyong; Keech, John A.; Hochberg, Ephram P.; Carty, Matthew J.; Hanson, Summer E.; Mustafa, Eid; Sanchez, Steven; Manning, John T.; Xu-Monette, Zijun Y.; Miranda, Alonso R.; Fox, Patricia; Bassett, Roland L.; Castillo, Jorge J.; Beltran, Brady E.; de Boer, Jan Paul; Chakhachiro, Zaher; Ye, Dongjiu; Clark, Douglas; Young, Ken H.; Medeiros, L. Jeffrey

2014-01-01

Purpose Breast implant–associated anaplastic large-cell lymphoma (ALCL) is a recently described clinicopathologic entity that usually presents as an effusion-associated fibrous capsule surrounding an implant. Less frequently, it presents as a mass. The natural history of this disease and long-term outcomes are unknown. Patients and Methods We reviewed the literature for all published cases of breast implant–associated ALCL from 1997 to December 2012 and contacted corresponding authors to update clinical follow-up. Results The median overall survival (OS) for 60 patients was 12 years (median follow-up, 2 years; range, 0-14 years). Capsulectomy and implant removal was performed on 56 of 60 patients (93%). Therapeutic data were available for 55 patients: 39 patients (78%) received systemic chemotherapy, and of the 16 patients (28%) who did not receive chemotherapy, 12 patients opted for watchful waiting and four patients received radiation therapy alone. Thirty-nine (93%) of 42 patients with disease confined by the fibrous capsule achieved complete remission, compared with complete remission in 13 (72%) of 18 patients with a tumor mass. Patients with a breast mass had worse OS and progression-free survival (PFS; P = .052 and P = .03, respectively). The OS or PFS were similar between patients who received and did not receive chemotherapy (P = .44 and P = .28, respectively). Conclusion Most patients with breast implant–associated ALCL who had disease confined within the fibrous capsule achieved complete remission. Proper management for these patients may be limited to capsulectomy and implant removal. Patients who present with a mass have a more aggressive clinical course that may be fatal, justifying cytotoxic chemotherapy in addition to removal of implants. PMID:24323027

The Effect of Study Design Biases on the Diagnostic Accuracy of Magnetic Resonance Imaging to Detect Silicone Breast Implant Ruptures: A Meta-Analysis

PubMed Central

Song, Jae W.; Kim, Hyungjin Myra; Bellfi, Lillian T.; Chung, Kevin C.

2010-01-01

Background All silicone breast implant recipients are recommended by the US Food and Drug Administration to undergo serial screening to detect implant rupture with magnetic resonance imaging (MRI). We performed a systematic review of the literature to assess the quality of diagnostic accuracy studies utilizing MRI or ultrasound to detect silicone breast implant rupture and conducted a meta-analysis to examine the effect of study design biases on the estimation of MRI diagnostic accuracy measures. Method Studies investigating the diagnostic accuracy of MRI and ultrasound in evaluating ruptured silicone breast implants were identified using MEDLINE, EMBASE, ISI Web of Science, and Cochrane library databases. Two reviewers independently screened potential studies for inclusion and extracted data. Study design biases were assessed using the QUADAS tool and the STARDS checklist. Meta-analyses estimated the influence of biases on diagnostic odds ratios. Results Among 1175 identified articles, 21 met the inclusion criteria. Most studies using MRI (n= 10 of 16) and ultrasound (n=10 of 13) examined symptomatic subjects. Meta-analyses revealed that MRI studies evaluating symptomatic subjects had 14-fold higher diagnostic accuracy estimates compared to studies using an asymptomatic sample (RDOR 13.8; 95% CI 1.83–104.6) and 2-fold higher diagnostic accuracy estimates compared to studies using a screening sample (RDOR 1.89; 95% CI 0.05–75.7). Conclusion Many of the published studies utilizing MRI or ultrasound to detect silicone breast implant rupture are flawed with methodological biases. These methodological shortcomings may result in overestimated MRI diagnostic accuracy measures and should be interpreted with caution when applying the data to a screening population. PMID:21364405

Potential costs of breast augmentation mammaplasty.

PubMed

Schmitt, William P; Eichhorn, Mitchell G; Ford, Ronald D

2016-01-01

Augmentation mammaplasty is one of the most common surgical procedures performed by plastic surgeons. The aim of this study was to estimate the cost of the initial procedure and its subsequent complications, as well as project the cost of Food and Drug Administration (FDA)-recommended surveillance imaging. The potential costs to the individual patient and society were calculated. Local plastic surgeons provided billing data for the initial primary silicone augmentation and reoperative procedures. Complication rates used for the cost analysis were obtained from the Allergen Core study on silicone implants. Imaging surveillance costs were considered in the estimations. The average baseline initial cost of silicone augmentation mammaplasty was calculated at $6335. The average total cost of primary breast augmentation over the first decade for an individual patient, including complications requiring reoperation and other ancillary costs, was calculated at $8226. Each decade thereafter cost an additional $1891. Costs may exceed $15,000 over an averaged lifetime, and the recommended implant surveillance could cost an additional $33,750. The potential cost of a breast augmentation, which includes the costs of complications and imaging, is significantly higher than the initial cost of the procedure. Level III, economic and decision analysis study. Copyright © 2015 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

[A scanning electron microscopy study of the surface of porous-textured breast implants and their capsules. Description of the "velcro" effect of porous-textured breast prostheses].

PubMed

Danino, A; Rocher, F; Blanchet-Bardon, C; Revol, M; Servant, J M

2001-02-01

The efficacy of breast prosthesis texturing in the prevention of capsular contracture has been established for about 20 years. This successful procedure has led to the development and marketing of a number of different models. In the present study, four porous-textured breast prostheses have been examined: the Arion monoblock implant, the CUI (McGahn), the Biocell (Mcgahn), and the Sebbin LS21. Scanning electron microscopic (SEM) investigation of the implant surfaces of the different prostheses was carried out on new samples received from the manufacturers. During a prospective study on eight patients, capsule samples corresponding to the four above-mentioned prostheses were taken to determine whether a secondary intervention was necessary for correction of asymmetry or malpositioning. These samples were analyzed by SEM to investigate whether there could be a correlation between prosthesis texturing and the aspect of the corresponding capsules. Significant ultrastructural differences were found between the various prostheses examined: the results showed that only the CUI and Biocell prostheses presented a mirror image of the capsule texturing, with a correspondence between the depressions on the prosthesis and the contacts on the capsule. This finding seems to be linked to the existence of a critical size for the pores that constitute the implant surface. This observation led to the hypothesis of an adhesive "velcro" effect between the prosthesis and its capsule. Although the latter may not be directly linked to the prevention of capsular contracture it can, however, have a major effect on implant stabilization in cases of primary breast reconstruction and in possible secondary adjustments of asymmetry and malpositioning.

Achieving a predictable 24-hour return to normal activities after breast augmentation: Part II. Patient preparation, refined surgical techniques, and instrumentation.

PubMed

Tebbetts, John B

2002-01-01

The goal of this study was to develop practices that would allow patients undergoing subpectoral augmentation to predictably return to full normal activities within 24 hours after the operation, free of postoperative adjuncts. Part I of this study used motion and time study principles to reduce operative times, medication dosages, perioperative morbidity, and recovery times in augmentation mammaplasty. Part II of the study focuses on details of patient education, preoperative planning, instrumentation, and surgical technique modifications that were identified, modified, and implemented to achieve the results reported in part I. Two groups of 16 patients each (groups 1 and 2) were studied retrospectively for comparison to a third group of 627 patients (group 3) studied prospectively. Patients in group 1 had axillary partial retropectoral breast augmentations in 1982-1983, using dissociative anesthesia, blunt instrument implant pocket dissection, and Dow Corning, double-lumen implants containing 20 mg of methylprednisolone and 20 cc of saline in the outer lumen of the implants. Patients in group 2 (1990) had inframammary, retromammary augmentations by using a combination of blunt and electrocautery dissection, Surgitek Replicon polyurethane-covered, silicone gel-filled implants, and general endotracheal anesthesia. Patients in group 3 (1998 to 2001, n = 627) had inframammary partial retropectoral, inframammary retromammary, and axillary partial retropectoral augmentations under general endotracheal anesthesia. Refined practices and surgical techniques from studies of groups 1 and 2 were applied in group 3. Videotapes from operative procedures of groups 1 and 2 were analyzed with macromotion and micromotion study principles, and tables of events were formulated for each move during the operation for all personnel in the operating room. Extensive details of surgical technique were examined and reexamined in 13 different stages by using principles of motion and time studies described in part I of this study to maximize efficiency without any change in quality. Unnecessary or unproductive motions and techniques were progressively eliminated, and essential, productive techniques were streamlined to eliminate wasted time and motion. Instrumentation and surgical techniques were evaluated in detail and modified to minimize bleeding and tissue trauma. Detailed data were presented in part I of this study that document shorter operative times, recovery times, time to discharge home, and time to return to normal activities. This part focuses on the patient education, preoperative planning, instrumentation, and surgical technique changes that were implemented on the basis of the findings in part I of the study. More extensive patient information integrated with staged informed consent resulted in a more informed and confident patient. Applying motion and time study principles to analysis and refinement of instrumentation and surgical techniques resulted in a substantial reduction in perioperative morbidity and a simpler, shorter 24-hour return to full normal activity for 96 percent of the patients undergoing breast augmentation in group 3 compared with groups 1 and 2. More than 96 percent of patients in group 3 were able to return to normal activities, lift their arms above their heads, lift normal-weight objects, and drive their car within 24 hours after their partial retropectoral breast augmentation. Patient education, preoperative planning, instrumentation, and surgical technique modifications based on motion and time study video analyses reduced surgical trauma and bleeding, reduced perioperative morbidity, and allowed 96 percent of 627 breast augmentation patients in group 3 a predictable return to full, normal activity in 24 hours or less. Specific surgical factors that contributed to these results included (1) prospective hemostasis techniques with a zero tolerance for even the smallest amount of bleeding, (2) strict "no-touch" techniques for periosteum and perichondrium, (3) eliminating all blunt dissection, (4) performing all dissection under direct vision, (5) modified and simplified instrumentation, and (6) optimal use of muscle relaxants during subpectoral dissection.

Analysis of 30 breast implant rupture cases.

PubMed

Tark, Kwan Chul; Jeong, Hii Sun; Roh, Tae Suk; Choi, Jong Woo

2005-01-01

Breast implants used for augmentation mammoplasty or breast reconstruction could rupture from various causes such as trauma or spontaneous failure. The objectives of this study were to investigate the relationships between the causes of implant rupture and the degree of capsular contracture, and then to evaluate the relative efficacies of specific signs on magnetic resonance imaging (MRI) known to be beneficial for diagnosing the rupture. A retrospective review identified patients with prosthetic implant rupture or impending rupture treated by the senior author. The 30 cases of implant rupture available for review were classified into two groups: intracapsular and extracapsular ruptures. The 30 cases of breast implant ruptures were analyzed with respect to the clinical symptoms and signs, the causes of rupture, the degree of capsular contracture, and therapeutic plans. Among the 30 cases, 14 patients who had undergone MRI during the diagnostic period were analyzed with respect to the relationships between MRI readings and operative findings. Spontaneous rupture of membranes was most common (80%), followed by failure because of trauma (7%) and valve or implant base (4%). The symptoms during implant rupture were contour deformity, palpated mass-like lesions, pain, and focal inflammation. According to the analysis of specific MRI signs, the sensitivity and specificity of the linguine sign were 87% and 100%, respectively, for intracapsular rupture. For extracapsular rupture, the sensitivity and specificity of the linguine sign were, respectively, 67% and 75%. The sensitivity and specificity of the rat-tail sign and tear drop sign were 14% and 50%, respectively. Breast implant rupture was correlated with the degree of capsular contracture in our study. Among the various specific MRI signs used in diagnosing the rupture, the linguine sign was reliable and had a high sensitivity and specificity, especially in cases of intracapsular rupture. On the other hand, the rat-tail and tear drop signs were nonspecific signs for diagnosing the rupture of breast implant.

Achieving a predictable 24-hour return to normal activities after breast augmentation: part II. Patient preparation, refined surgical techniques, and instrumentation.

PubMed

Tebbetts, John B

2006-12-01

The goal of this study was to develop practices that would allow patients undergoing subpectoral augmentation to predictably return to full normal activities within 24 hours after the operation, free of postoperative adjuncts. Part I of this study used motion and time study principles to reduce operative times, medication dosages, perioperative morbidity, and recovery times in augmentation mammaplasty. Part II of the study focuses on details of patient education, preoperative planning, instrumentation, and surgical technique modifications that were identified, modified, and implemented to achieve the results reported in part I. Two groups of 16 patients each (groups 1 and 2) were studied retrospectively for comparison to a third group of 627 patients (group 3) studied prospectively. Patients in group 1 had axillary partial retropectoral breast augmentations in 1982-1983, using dissociative anesthesia, blunt instrument implant pocket dissection, and Dow Corning, double-lumen implants containing 20 mg of methylprednisolone and 20 cc of saline in the outer lumen of the implants. Patients in group 2 (1990) had inframammary, retromammary augmentations by using a combination of blunt and electrocautery dissection, Surgitek Replicon polyurethane-covered, silicone gel-filled implants, and general endotracheal anesthesia. Patients in group 3 (1998 to 2001, n = 627) had inframammary partial retropectoral, inframammary retromammary, and axillary partial retropectoral augmentations under general endotracheal anesthesia. Refined practices and surgical techniques from studies of groups 1 and 2 were applied in group 3. Videotapes from operative procedures of groups 1 and 2 were analyzed with macromotion and micromotion study principles, and tables of events were formulated for each move during the operation for all personnel in the operating room. Extensive details of surgical technique were examined and reexamined in 13 different stages by using principles of motion and time studies described in part I of this study to maximize efficiency without any change in quality. Unnecessary or unproductive motions and techniques were progressively eliminated, and essential, productive techniques were streamlined to eliminate wasted time and motion. Instrumentation and surgical techniques were evaluated in detail and modified to minimize bleeding and tissue trauma. Detailed data were presented in part I of this study that document shorter operative times, recovery times, time to discharge home, and time to return to normal activities. This part focuses on the patient education, preoperative planning, instrumentation, and surgical technique changes that were implemented on the basis of the findings in part I of the study. More extensive patient information integrated with staged informed consent resulted in a more in formed and confident patient. Applying motion and time study principles to analysis and refinement of instrumentation and surgical techniques resulted in a substantial reduction in perioperative morbidity and a simpler, shorter 24-hour return to full normal activity for 96 percent of the patients undergoing breast augmentation in group 3 compared with groups 1 and 2. More than 96 percent of patients in group 3 were able to return to normal activities, lift their arms above their heads, lift normal-weight objects, and drive their car within 24 hours after their partial retropectoral breast augmentation. Patient education, preoperative planning, instrumentation, and surgical technique modifications based on motion and time study video analyses reduced surgical trauma and bleeding, reduced perioperative morbidity, and allowed 96 percent of 627 breast augmentation patients in group 3 a predictable return to full, normal activity in 24 hours or less. Specific surgical factors that contributed to these results included (1) prospective hemostasis techniques with a zero tolerance for even the smallest amount of bleeding, (2) strict "no-touch" techniques for periosteum and perichondrium, (3) eliminating all blunt dissection, (4) performing all dissection under direct vision, (5) modified and simplified instrumentation, and (6) optimal use of muscle relaxants during subpectoral dissection.

Role of fluconazole in the long-term suppressive therapy of fungal infections in patients with artificial implants.

PubMed

Penk, A; Pittrow, L

1999-12-01

With the increased use of artificial implants the management of related infections has become an important challenge. Normally an infected implant would be removed. In many cases this might be contraindicated and drug treatment remains as the only alternative. As microbiological eradication is often impossible, especially in fungal infections at artificial implants (FIAI) long-term suppressive therapy might be required. The objective of this study was to determine the therapeutic value of fluconazole (F) in the management of FIAI. Clinical data of 56 patients (pts) with proven or suspected fungal infections and artificial implants (FIAI) subsequently treated with F were analyzed retrospectively. FIAI caused by species with intrinsic resistance to F have been excluded from the study. The following implants were involved: prosthetic valve endocarditis (PVE) 25 pts (44.6%), intraocular lenses (IL) 9 pts (16.1%), ventriculoperitoneal shunts (VPS) 6 pts (10.7%), knee prostheses (KP) 5 pts (8.9%), biliary stents (BS) 4 pts (7.1 %), venous access devices (VAS) 3 pts (5.4%), urinary stents (US) 2 pts (3.6%), breast implant and pacemaker 1 patient (1.8%) each. Underlying diseases were valve insufficiency (in PVE), cataract surgery (in IL), prematurity in newborns (in VPS), arthrosis (in KP), biliary obstruction (in BS), cystic fibrosis (in VAS), and obstructive renal calculi (in US). Candida species (C. spp.) were the most frequently detected causative agents with C. parapsilosis as the leading cause (n = 19; 33.9%). Furthermore C. albicans (n = 15; 26.8%), C. spp. and fungi not further specified (n = 8; 14.3%), C. tropicalis (n = 3; 5.4%), C. glabrata (n = 3; 5.4%), and C. lusitaniae (n = 1; 1.8%) were identified. Acremonium kiliense has been detected in 4 pts (7.1%), Cryptococcus neoformans in 2 pts (3.6 %). Histoplasma capsulatum was identified in 1 patient (1.8%). The maximum duration of treatment with F was lifelong with a maximum recorded duration of 4,5 years. The maximum dosage used was 750 mg/d or 50 mg/kg BW in premature infants. No major adverse events were observed. In conclusion, especially the excellent safety profile as well as the documented therapeutic experience justify the use of F as long-term suppressive therapy in FIAI. Higher dosages and even life-long treatment may be needed. 1999 Blackwell Science Ltd.

Effects of flaxseed lignan and oil on bone health of breast-tumor-bearing mice treated with or without tamoxifen.

PubMed

Chen, Jianmin; Saggar, Jasdeep K; Ward, Wendy E; Thompson, Lilian U

2011-01-01

Previous studies showed that flaxseed lignan (secoisolariciresinol diglucoside, SDG) and oil (FO) inhibit established breast tumor growth in athymic mice with or without tamoxifen (TAM) treatment. TAM was found to increase bone mineral content (BMC) and density (BMD) in breast cancer patients. It is not known whether SDG or FO alone or combined with TAM affects bone health. Hence, the effects of SDG and FO, alone or in combination, on BMC, BMD, and biomechanical bone strength in ovariectomized athymic mice with established human breast tumors (MCF-7) treated with or without TAM were studied. In a factorial design, mice were divided into four non-TAM and four TAM groups. Each group consisted of mice fed a basal diet (BD), SDG (1 g/kg), FO (38.5 g/kg) or SDG + FO (combination) diets. The TAM group had TAM implants that provide a 5-mg TAM dose released over 60 d. TAM exerted an overall significant effect in increasing BMC, BMD, and biomechanical strength in femurs and lumbar vertebra. Without TAM treatment, SDG produced significant lower femur BMD (6%) while FO produced lower vertebrae BMC (8%) and BMD (6%). With TAM treatment, SDG and FO did not exert an effect on BMC and BMD at the femur or vertebra. SDG and FO produced no marked effect on biomechanical bone strength with or without TAM treatment. In conclusion, FS components did not significantly attenuate the positive effects on bone induced by TAM in this model system, indicating no apparent adverse effects on bone health.

Dose specification and quality assurance of RTOG protocol 95-17; a cooperative group study of 192Ir breast implants as sole therapy

PubMed Central

Ibbott, Geoffrey S.; Hanson, W.F.; Martin, Elizabeth; Kuske, Robert R.; Arthur, Douglas; Rabinovitch, Rachel; White, Julia; Wilenzick, Raymond M.; Harris, Irene; Tailor, Ramesh C.

2007-01-01

Purpose RTOG protocol 95-17 was a phase I/II trial to evaluate multi-catheter brachytherapy as the sole method of adjuvant breast radiotherapy for stage I/II breast carcinoma following breast conserving surgery. Low or high dose rate sources were allowed. Dose prescription and treatment evaluation were based on recommendations in ICRU Report 58, and included the parameters mean central dose (MCD), average peripheral dose, dose homogeneity index (DHI), and the dimensions of the low and high dose regions. Methods and Materials Three levels of quality assurance were implemented: (1) Credentialing of institutions was required prior to entering patients onto the study. (2) Rapid review of each treatment plan was conducted prior to treatment, and (3) Retrospective review was performed by the Radiological Physics Center in conjunction with the study chairman and RTOG dosimetry staff. Results Credentialing focused on the accuracy of dose calculation algorithm and compliance with protocol guidelines. Rapid review was designed to identify and correct deviations from the protocol prior to treatment. The retrospective review involved recalculation of dosimetry parameters and review of dose distributions to evaluate the treatment. Specifying both central and peripheral doses resulted in uniform dose distributions, with a mean dose homogeneity index of 0.83 ±0.06. Conclusions Vigorous quality assurance resulted in a high-quality study with few deviations; only 4 of 100 patients were judged as minor variations from protocol and no patient was judged a major deviation. This study should be considered a model for quality assurance of future trials. PMID:18035213

Bilateral prophylactic mastectomy in women with inherited risk of breast cancer--prevalence of pain and discomfort, impact on sexuality, quality of life and feelings of regret two years after surgery.

PubMed

Gahm, Jessica; Wickman, Marie; Brandberg, Yvonne

2010-12-01

Mastectomy due to breast cancer is associated with chronic pain and a negative impact on sexuality. The purposes of the study were to analyze the prevalence of pain and discomfort in the breasts, impact on sexuality, quality of life, and feelings of regret after bilateral prophylactic mastectomy and immediate reconstruction with implants. Fifty-nine women operated 2004-2006 were included. A questionnaire was sent out two years after the procedure. Complications and re-operations were recorded. Mean follow-up time was 29 months. 93% of patients answered the questionnaire. 69% reported pain and 71% discomfort in the breasts. Lost or much reduced sexual sensations were reported by 85% and enjoyment of sex was negatively impacted for 75% of patients. Quality of life was not affected and feelings of regret were almost non-existent. It is important to inform women approaching this prophylactic procedure about the risk of having unwanted secondary effects. Copyright © 2010 Elsevier Ltd. All rights reserved.

Registration of 3D ultrasound computer tomography and MRI for evaluation of tissue correspondences

NASA Astrophysics Data System (ADS)

Hopp, T.; Dapp, R.; Zapf, M.; Kretzek, E.; Gemmeke, H.; Ruiter, N. V.

2015-03-01

3D Ultrasound Computer Tomography (USCT) is a new imaging method for breast cancer diagnosis. In the current state of development it is essential to correlate USCT with a known imaging modality like MRI to evaluate how different tissue types are depicted. Due to different imaging conditions, e.g. with the breast subject to buoyancy in USCT, a direct correlation is demanding. We present a 3D image registration method to reduce positioning differences and allow direct side-by-side comparison of USCT and MRI volumes. It is based on a two-step approach including a buoyancy simulation with a biomechanical model and free form deformations using cubic B-Splines for a surface refinement. Simulation parameters are optimized patient-specifically in a simulated annealing scheme. The method was evaluated with in-vivo datasets resulting in an average registration error below 5mm. Correlating tissue structures can thereby be located in the same or nearby slices in both modalities and three-dimensional non-linear deformations due to the buoyancy are reduced. Image fusion of MRI volumes and USCT sound speed volumes was performed for intuitive display. By applying the registration to data of our first in-vivo study with the KIT 3D USCT, we could correlate several tissue structures in MRI and USCT images and learn how connective tissue, carcinomas and breast implants observed in the MRI are depicted in the USCT imaging modes.

Complete Surgical Excision Is Essential for the Management of Patients With Breast Implant-Associated Anaplastic Large-Cell Lymphoma.

PubMed

Clemens, Mark W; Medeiros, L Jeffrey; Butler, Charles E; Hunt, Kelly K; Fanale, Michelle A; Horwitz, Steven; Weisenburger, Dennis D; Liu, Jun; Morgan, Elizabeth A; Kanagal-Shamanna, Rashmi; Parkash, Vinita; Ning, Jing; Sohani, Aliyah R; Ferry, Judith A; Mehta-Shah, Neha; Dogan, Ahmed; Liu, Hui; Thormann, Nora; Di Napoli, Arianna; DiNapoli, Arianna; Lade, Stephen; Piccolini, Jorge; Reyes, Ruben; Williams, Travis; McCarthy, Colleen M; Hanson, Summer E; Nastoupil, Loretta J; Gaur, Rakesh; Oki, Yasuhiro; Young, Ken H; Miranda, Roberto N

2016-01-10

Breast implant-associated anaplastic large-cell lymphoma (BI-ALCL) is a rare type of T-cell lymphoma that arises around breast implants. The optimal management of this disease has not been established. The goal of this study is to evaluate the efficacy of different therapies used in patients with BI-ALCL to determine an optimal treatment approach. In this study, we applied strict criteria to pathologic findings, assessed therapies used, and conducted a clinical follow-up of 87 patients with BI-ALCL, including 50 previously reported in the literature and 37 unreported. A Prentice, Williams, and Peterson model was used to assess the rate of events for each therapeutic intervention. The median and mean follow-up times were 45 and 30 months, respectively (range, 3 to 217 months). The median overall survival (OS) time after diagnosis of BI-ALCL was 13 years, and the OS rate was 93% and 89% at 3 and 5 years, respectively. Patients with lymphoma confined by the fibrous capsule surrounding the implant had better event-free survival (EFS) and OS than did patients with lymphoma that had spread beyond the capsule (P = .03). Patients who underwent a complete surgical excision that consisted of total capsulectomy with breast implant removal had better OS (P = .022) and EFS (P = .014) than did patients who received partial capsulectomy, systemic chemotherapy, or radiation therapy. Surgical management with complete surgical excision is essential to achieve optimal EFS in patients with BI-ALCL. © 2015 by American Society of Clinical Oncology.

Complete Surgical Excision Is Essential for the Management of Patients With Breast Implant–Associated Anaplastic Large-Cell Lymphoma

PubMed Central

Clemens, Mark W.; Medeiros, L. Jeffrey; Butler, Charles E.; Hunt, Kelly K.; Fanale, Michelle A.; Horwitz, Steven; Weisenburger, Dennis D.; Liu, Jun; Morgan, Elizabeth A.; Kanagal-Shamanna, Rashmi; Parkash, Vinita; Ning, Jing; Sohani, Aliyah R.; Ferry, Judith A.; Mehta-Shah, Neha; Dogan, Ahmed; Liu, Hui; Thormann, Nora; Di Napoli, Arianna; Lade, Stephen; Piccolini, Jorge; Reyes, Ruben; Williams, Travis; McCarthy, Colleen M.; Hanson, Summer E.; Nastoupil, Loretta J.; Gaur, Rakesh; Oki, Yasuhiro; Young, Ken H.

2016-01-01

Purpose Breast implant–associated anaplastic large-cell lymphoma (BI-ALCL) is a rare type of T-cell lymphoma that arises around breast implants. The optimal management of this disease has not been established. The goal of this study is to evaluate the efficacy of different therapies used in patients with BI-ALCL to determine an optimal treatment approach. Patients and Methods In this study, we applied strict criteria to pathologic findings, assessed therapies used, and conducted a clinical follow-up of 87 patients with BI-ALCL, including 50 previously reported in the literature and 37 unreported. A Prentice, Williams, and Peterson model was used to assess the rate of events for each therapeutic intervention. Results The median and mean follow-up times were 45 and 30 months, respectively (range, 3 to 217 months). The median overall survival (OS) time after diagnosis of BI-ALCL was 13 years, and the OS rate was 93% and 89% at 3 and 5 years, respectively. Patients with lymphoma confined by the fibrous capsule surrounding the implant had better event-free survival (EFS) and OS than did patients with lymphoma that had spread beyond the capsule (P = .03). Patients who underwent a complete surgical excision that consisted of total capsulectomy with breast implant removal had better OS (P = .022) and EFS (P = .014) than did patients who received partial capsulectomy, systemic chemotherapy, or radiation therapy. Conclusion Surgical management with complete surgical excision is essential to achieve optimal EFS in patients with BI-ALCL. PMID:26628470

Axillary Silicone Granulomas in Patients With Melanoma.

PubMed

Fernández Canedo, M I; Blázquez Sánchez, N; Valdés Solís, P; de Troya Martín, M

2016-05-01

Subcutaneous lesions may be detected during follow-up of patients with melanoma. The main entities that should be contemplated in the differential diagnosis in such cases are in-transit and regional lymph node metastases. We describe 2 cases of women with breast implants who developed palpable subcutaneous lesions in the axillary region during follow-up of melanoma. In both cases, the ultrasound study showed diffuse hyperechoic signals forming the characteristic snowstorm sign in the subcutaneous tissue. Ultrasound proved to be a key diagnostic tool for ruling out melanoma-related disease, such as in-transit metastases and regional lymph node metastases. Copyright © 2015 Elsevier España, S.L.U. y AEDV. All rights reserved.

Is Latin America Ready to Identify Anaplastic Large Cell Lymphoma in Breast Implants Patients? Regional Encounter During the National Plastic Surgery Meeting in Cancun, Mexico.

PubMed

Ramos-Gallardo, Guillermo; Cuenca-Pardo, Jesus; Cardenas-Camarena, Lazaro; Duran-Vega, Hector; Rodríguez-Olivares, Eugenio; Bayter-Marin, Jorge Enrique; Levelier De Doig Alvear, Gerardo; Vazquez, Guillermo; Fontbona-Torres, Montserrat; Galán-Suárez, Ricardo; Guzman-Stein, Gabriela; Guzmán-Padilla, Sergio; Echeverría-Roldán, Guillermo; Silva-Gavarrete, Jose Fernando; Vallarta-Rodríguez, Alfonso; Contreras-Bulnes, Livia; Oaxaca-Escobar, Carlos Guillemro; Caravantes-Cortes, Isabel; Flores, María Eugenia; Cowes-McGowen, Jorge; Maciel-Sosa, María Liz; Delgado-Binasco, Ricardo; Rincón-Rubio, Linda

2018-05-16

Anaplastic large cell lymphoma associated with breast implants is receiving increased attention. Most cases have been reported in Europe, North America (USA and Canada), Australia and New Zealand. Fewer cases have been reported in Latin America (including Mexico), Africa and Asia. This report was delivered during our national plastic surgery meeting in Cancun in May 2017. Before the meeting, two participants reviewed the literature. The review was performed using the following information sources: PubMed, Embase, Cochrane, Fisterra, Google Scholar and LILACS, with entries from 1980 to August 2015 in several languages (English, Spanish, French and Portuguese). The results were revealed during the meeting to the other participants. The consensus was divided into two parts. The first part included an open-ended question regarding the incidence and prevalence of the problem. The second part included clinical scenarios with different items that were rated by the participants. After this activity, accordance among the responses was evaluated. Seven cases were reported during the meeting (3 from Mexico, 3 from Chile and 1 from Argentina). Fifty percent of the participants reported consulting with guidelines and clinical centers to help with potential cases. Most agreed that further studies must be done in cases of chronic seroma where the capsule plays an important role. A current debate exists about the incidence of this problem in Latin America because we did not report the same number of cases as Europe, Australia or North America. More studies are required to determine the differences among reports in Latin America. Most representatives agreed that further studies must be done. Concern is increasing, and the problem is known. Other factors involved may be considered, and the problem must not be ignored. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Effect on Bone Architecture of Marginal Grooves in Dental Implants Under Occlusal Loaded Conditions in Beagle Dogs.

PubMed

Kato, Hatsumi; Kuroshima, Shinichiro; Inaba, Nao; Uto, Yusuke; Sawase, Takashi

2018-02-01

The aim of this study was to clarify whether marginal grooves on dental implants affect osseointegration, bone structure, and the alignment of collagen fibers to determine bone quality under loaded conditions. Anodized Ti-6Al-4V alloy dental implants, with and without marginal grooves (test and control implants, respectively), were used (3.7 × 8.0 mm). Fourth premolars and first molars of 6 beagle mandibles were extracted. Two control and test implants were placed in randomly selected healed sites at 12 weeks after tooth extraction. Screw-retained single crowns for first molars were fabricated. Euthanasia was performed at 8 weeks after the application of occlusal forces. Implant marginal bone level, bone to implant contact (BIC), bone structure around dental implants, and the alignment of collagen fibers determining bone quality were analyzed. The marginal bone level in test implants was significantly higher than that in control implants. Occlusal forces significantly increased BIC in test implants ( P = .007), whereas BIC did not change in control implants, irrespective of occlusal forces ( P = .303). Moreover, occlusal forces significantly increased BIC in test implants compared with control implants ( P = .032). Additionally, occlusal forces preferentially aligned collagen fibers in test implants, but not control implants. Hence, marginal grooves on dental implants have positive effects on increased osseointegration and adapted bone quality based on the preferential alignment of collagen fibers around dental implants under loaded conditions.

Destiny rides again: the reappearance of silicone gel-filled breast implant toxicity.

PubMed

Brawer, A E

2017-09-01

Background Twenty-five years ago attorneys representing ailing women in class action litigation against silicone breast implant manufacturers made the procedural error of defining silicone-induced toxicity in the courtroom before it was properly studied in the exam room. This aberrant methodology perverted the proper research process, rendered verification of any real disease elusive, and cemented the groundwork for a repeat public health crisis potentially affecting two million women in the USA who possess new silicone gel devices inserted over the past 10 years. Patients and methods Six women, previously well, aged 27 to 53 (mean 42), were recipients of the new generations of cohesive silicone gel-filled breast implants approved for general use by the Food and Drug Administration (FDA) since December of 2006. They averaged seven years of total implantation time, and none experienced implant rupture. Results All six became ill on average 3.5 years from the time of implantation. By seven years the women manifested multiple types of skin rashes, polyarthritis, fatigue, protracted AM stiffness, myalgias, headaches, photosensitivity, hair loss, paresthesias, tinnitus, lymphadenopathy, chest pain, cognitive dysfunction, dry eyes, skin pigment changes, itching, muscle twitching, dizziness, nausea, easy bruising, and odor and smell sensitivity. Three of the four who were explanted noted improvement and/or resolution of at least 50% of their total disease manifestations. Conclusions These six women are representative of over 70,000 other breast implant recipients who, over the past three years, have had their new silicone devices permanently removed because of alleged gel-induced toxicity. The recurrence of this public health crisis has been fueled by manufacturers' research fraud, FDA ineptness, faulty informed consent, patient abandonment, proprietary manufacturing secrecy, misleading advertising, physician indifference, aberrant research methodology, and lax Congressional oversight.

Epidemiological evidence in forensic pharmacovigilance.

PubMed

Persaud, Nav; Healy, David

2012-01-01

Until recently epidemiological evidence was not regarded as helpful in determining cause and effect. It generated associations that then had to be explained in terms of bio-mechanisms and applied to individual patients. A series of legal cases surrounding possible birth defects triggered by doxylamine (Bendectin) and connective tissue disorders linked to breast implants made it clear that in some instances epidemiological evidence might have a more important role, but the pendulum swung too far so that epidemiological evidence has in recent decades been given an unwarranted primacy, partly perhaps because it suits the interests of certain stakeholders. Older and more recent epidemiological studies on doxylamine and other antihistamines are reviewed to bring out the ambiguities and pitfalls of an undue reliance on epidemiological studies.

Oral rehabilitation with tilted dental implants: A metaanalysis

PubMed Central

Peñarrocha-Oltra, David; Candel-Marti, Eugenia; Peñarrocha-Diago, Maria

2012-01-01

Objective: To compare the course of patients treated with tilted implants versus those treated conventionally with axial implants, analyzing the success rate and marginal bone loss. Material and Methods: A PubMed search was made using the key words “tilted implants”, “angled implants”, “angulated implants”, “inclined implants” and “maxillary atrophy.” A review was made of the articles published between 1999-2010. The inclusion criteria were the use of tilted implants, clinical series involving at least 10 patients, and a minimum follow-up of 12 months after prosthetic loading. The exclusion criteria were isolated clinical cases, studies with missing data, and publications in languages other than English or Spanish. The metaanalysis finally included 13 articles: 7 retrospective studies and 6 prospective studies. Results: On analyzing the success rate in the retrospective studies, two reported a higher success rate with tilted implants; one a higher success rate with axial implants; and two reported similar success rates with both implants. On analyzing the success rate in the prospective studies, two reported a higher success rate with tilted implants; two a higher success rate with axial implants; and two reported similar success rates with both implants. On examining marginal bone loss, three studies reported greater bone loss with axial implants and one with tilted implants. Conclusions: There was no evidence of differences in success rate between tilted and axial implants in either the prospective or retrospective studies subjected to review. The marginal bone loss observed with the tilted and axial implants likewise proved very similar. It thus can be deduced that tilted implants exhibit the same evolutive behavior as axial implants. Key words:Axial implants, tilted implants, maxillary atrophy, tilted implants. PMID:22322494

Short dental implants versus standard dental implants placed in the posterior jaws: A systematic review and meta-analysis.

PubMed

Lemos, Cleidiel Aparecido Araujo; Ferro-Alves, Marcio Luiz; Okamoto, Roberta; Mendonça, Marcos Rogério; Pellizzer, Eduardo Piza

2016-04-01

The purpose of the present systematic review and meta-analysis was to compare short implants (equal or less than 8mm) versus standard implants (larger than 8mm) placed in posterior regions of maxilla and mandible, evaluating survival rates of implants, marginal bone loss, complications and prosthesis failures. This review has been registered at PROSPERO under the number CRD42015016588. Main search terms were used in combination: dental implant, short implant, short dental implants, short dental implants posterior, short dental implants maxilla, and short dental implants mandible. An electronic search for data published up until September/2015 was undertaken using the PubMed/Medline, Embase and The Cochrane Library databases. Eligibility criteria included clinical human studies, randomized controlled trials and/or prospective studies, which evaluated short implants in comparison to standard implants in the same study. The search identified 1460 references, after inclusion criteria 13 studies were assessed for eligibility. A total of 1269 patients, who had received a total of 2631 dental implants. The results showed that there was no significant difference of implants survival (P=.24; RR:1.35; CI: 0.82-2.22), marginal bone loss (P=.06; MD: -0.20; CI: -0.41 to 0.00), complications (P=.08; RR:0.54; CI: 0.27-1.09) and prosthesis failures (P=.92; RR:0.96; CI: 0.44-2.09). Short implants are considered a predictable treatment for posterior jaws. However, short implants with length less than 8 mm (4-7 mm) should be used with caution because they present greater risks to failures compared to standard implants. Short implants are frequently placed in the posterior area in order to avoid complementary surgical procedures. However, clinicians need to be aware that short implants with length less than 8mm present greater risk of failures. Copyright © 2016. Published by Elsevier Ltd.

SU-E-T-18: A Comparison of Planning Techniques for Bilateral Reconstructed Chest Wall Patients Undergoing Whole Breast Irradiation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Volpe, T; Margiasso, R; Saleh, Z

2015-06-15

Purpose: As we continuously see more bilateral reconstructed chest wall cases, new challenges are being presented to deliver left-sided breast irradiation. We herein compare three Deep Inspiration Breath Hold (DIBH) planning techniques (tangents, VMAT, and IMRT) and two free breathing techniques (VMAT and IMRT). Methods: Three left-sided chest wall patients with bilateral implants were studied. Tangents, VMAT, and IMRT plans were created for DIBH scans. VMAT and IMRT plans were created for free breathing scans. All plans were normalized so that 95% of the prescription dose was delivered to 95% of the planning target volume (PTV). The maximum point dosemore » was constrained to less than 120% of the prescription dose. Since the success of DIBH delivery largely depends on patient’s ability to perform consistent breath hold during beam on time, smaller number of Monitor Units (MU) is in general desired. For each patient, the following information was collected to compare the planning techniques: heart mean dose, left and right lung V20 Gy, contra-lateral (right) breast mean dose, cord max dose, and MU. Results: The average heart mean dose over all patients are 1561, 692, 985, 1245, and 1121 cGy, for DIBH tangents, VMAT, IMRT, free breathing VMAT and IMRT, respectively. For left lung V20 are 60%, 28%, 26%, 30%, and 29%. For contra-lateral breast mean dose are 244, 687, 616, 783, 438 cGy. MU are 253, 853, 2048, 1035, and 1874 MUs. Conclusion: In the setting of bilateral chest wall reconstruction, opposed tangent beams cannot consistently achieve desired heart and left lung sparing. DIBH consistently achieves better healthy tissue sparing. VMAT appears to be preferential to IMRT for planning and delivering radiation to patients with bilaterally reconstructed chest walls being treated with DIBH.« less

Advances in prevention of radiation damage to visceral and solid organs in patients requiring radiation therapy of the trunk.

PubMed

Ritter, E F; Lee, C G; Tyler, D; Ferraro, F; Whiddon, C; Rudner, A M; Scully, S

1997-02-01

As a part of multimodality therapy, many patients with tumors of the trunk receive radiation therapy. The major morbidity of this therapy is often secondary to incidental radiation damage to tissues adjacent to treatment areas. We detail our use of saline breast implants placed in polyglycolic acid mesh sheets to displace visceral and solid organs away from the radiation field. Analysis of CT scans and dose volume histograms reveal that this technique successfully displaces uninvolved organs away from the radiation fields, thereby minimizing the radiation dose to such organs and tissues. We believe this is a safe and efficacious method to prevent radiation damage to visceral and solid organs adjacent to trunk tumor sites.

Survival of dental implants placed in sites of previously failed implants.

PubMed

Chrcanovic, Bruno R; Kisch, Jenö; Albrektsson, Tomas; Wennerberg, Ann

2017-11-01

To assess the survival of dental implants placed in sites of previously failed implants and to explore the possible factors that might affect the outcome of this reimplantation procedure. Patients that had failed dental implants, which were replaced with the same implant type at the same site, were included. Descriptive statistics were used to describe the patients and implants; survival analysis was also performed. The effect of systemic, environmental, and local factors on the survival of the reoperated implants was evaluated. 175 of 10,096 implants in 98 patients were replaced by another implant at the same location (159, 14, and 2 implants at second, third, and fourth surgeries, respectively). Newly replaced implants were generally of similar diameter but of shorter length compared to the previously placed fixtures. A statistically significant greater percentage of lost implants were placed in sites with low bone quantity. There was a statistically significant difference (P = 0.032) in the survival rates between implants that were inserted for the first time (94%) and implants that replaced the ones lost (73%). There was a statistically higher failure rate of the reoperated implants for patients taking antidepressants and antithrombotic agents. Dental implants replacing failed implants had lower survival rates than the rates reported for the previous attempts of implant placement. It is suggested that a site-specific negative effect may possibly be associated with this phenomenon, as well as the intake of antidepressants and antithrombotic agents. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Infection rates of rifampin/gentamicin-coated Titan Coloplast penile implants. Comparison with Inhibizone-impregnated AMS penile implants.

PubMed

Dhabuwala, Chirpriya; Sheth, Sheila; Zamzow, Brent

2011-01-01

It is a common practice to soak Titan(®) Coloplast penile implants in antibiotic solution prior to implantation. Experience with Inhibizone impregnation suggests that rifampin coating significantly reduces infection rates of penile implant surgery. In this article we describe the results of coating Titan Coloplast penile implants with rifampin/gentamicin solution. To compare infection rates of Titan(®) Coloplast penile implants coated with vancomycin/gentamycin, rifampin/gentamicin, and Inhibizone-impregnated American Medical Systems (AMS) penile implants. Chart review was done for all Mentor/Coloplast and AMS implant surgeries performed at our center between the dates January 1, 2002 and February 8, 2010. Infection rates for Titan(®) Coloplast penile implants coated with vancomycin/gentamycin, rifampin/gentamicin, and Inhibizone-impregnated (AMS) penile implants were compared. Infection rates for penile implants coated with different antibiotics. Infection rates for Titan(®) Coloplast penile implants coated with vancomycin/gentamycin and Inhibizone-impregnated (AMS) penile implants was 4.4% and 1.3%, respectively (P = 0.05). None of the rifampin/gentamicin-coated Titan(®) Coloplast penile implants have developed infection. Rifampin is the common antibiotic both in rifampin/gentamicin-coated Coloplast implants and Inhibizone(®) . The infection rate in this combined rifampin/gentamicin-coated Titan Coloplast implants and Inhibizone-coated AMS implants group was 0.63% (P = 0.03). Both rifampin/gentamicin-coated Titan(®) Coloplast penile implants and Inhibizone-impregnated (AMS) penile implants appear to have lower infection rates compared with vancomycin/gentamycin-coated Titan(®) Coloplast penile implants The present study does not suggest superiority of rifampin/gentamicin-coated Titan(®) Coloplast penile implants or Inhibizone-impregnated (AMS) penile implants but we strongly suggest that all Titan(®) Coloplast penile implants should be coated with rifampin/gentamicin solution. © 2010 International Society for Sexual Medicine.

Peri-implant bone formation and surface characteristics of rough surface zirconia implants manufactured by powder injection molding technique in rabbit tibiae.

PubMed

Park, Young-Seok; Chung, Shin-Hye; Shon, Won-Jun

2013-05-01

To evaluate osseointegration in rabbit tibiae and to investigate surface characteristics of novel zirconia implants made by powder injection molding (PIM) technique, using molds with and without roughened inner surfaces. A total of 20 rabbits received three types of external hex implants with identical geometry on the tibiae: machined titanium implants, PIM zirconia implants without mold etching, and PIM zirconia implants with mold etching. Surface characteristics of the three types of implant were evaluated. Removal torque tests and histomorphometric analyses were performed. The roughness of PIM zirconia implants was higher than that of machined titanium implants. The PIM zirconia implants exhibited significantly higher bone-implant contact and removal torque values than the machined titanium implants (P < 0.001). The PIM zirconia implants using roughened mold showed significantly higher removal torque values than PIM zirconia implants without using roughened mold (P < 0.001). It is concluded that the osseointegration of PIM zirconia implant is promising and PIM using roughened mold etching technique can produce substantially rough surfaces on zirconia implants. © 2012 John Wiley & Sons A/S.

Evaluation of single-tooth implants in the second molar region: a 5-year life-table analysis of a retrospective study.

PubMed

Koo, Ki-Tae; Wikesjö, Ulf M E; Park, Jang-Yeol; Kim, Tae-Il; Seol, Yang-Jo; Ku, Young; Rhyu, In-Chul; Chung, Chong-Pyoung; Lee, Yong-Moo

2010-09-01

To our knowledge, no study has evaluated the success or survival rate of single-tooth implants that replaced missing maxillary and mandibular second molars. The purpose of the present study was to evaluate the 1- to 5-year cumulative survival rate (CSR) for single-tooth implants placed in the second molar region and the effects of associated factors. Four hundred eighty-nine patients (298 males and 191 females; age range: 23 to 91 years; mean age: 47 years) who were admitted to the Seoul National University Dental Hospital between March 2003 and July 2008 and treated with single-tooth implants in the second molar region (227 maxillary implants and 294 mandibular implants; total: 521 implants) were included in the study. Thirty-two subjects received two implants each. A 1- to 5-year CSR was calculated using a life-table analysis. A comparison of CSRs between maxillary versus mandibular implants, one-stage versus two-stage implants, short (10 mm) implants, and standard-diameter (or=5.0 mm) implants was performed using Wilcoxon (Gehan) statistics. P <0.05 was considered significant. Fifteen of the 521 implants were lost between insertion and the follow-up examinations. The 1- to 5-year CSR was 95.1%. There were no statistically significant differences in CSRs between implants placed in maxillas and mandibles (96.3% versus 94.9%, respectively; P = 0.084), one- and two-stage implants (95.6% versus 94.7%, respectively; P = 0.267), short and long implants (100% versus 95.1%, respectively; P = 0.582), and standard- and wide-diameter implants (93.8% versus 96.8%, respectively; P = 0.065). Within the limitations of the study, the placement of single-tooth implants in the second molar region was an effective and reliable treatment modality. Also, associated factors such as implant diameter, length, and location (the maxilla versus the mandible) may not have an impact on the long-term success of implants.

Evaluation of possible prognostic factors for the success, survival, and failure of dental implants.

PubMed

Geckili, Onur; Bilhan, Hakan; Geckili, Esma; Cilingir, Altug; Mumcu, Emre; Bural, Canan

2014-02-01

To analyze the prognostic factors that are associated with the success, survival, and failure rates of dental implants. Data including implant sizes, insertion time, implant location, and prosthetic treatment of 1656 implants have been collected, and the association of these factors with success, survival, and failure of implants was analyzed. The success rate was lower for short and maxillary implants. The failure rate of maxillary implants exceeded that of mandibular implants, and the failure rate of implants that were placed in the maxillary anterior region was significantly higher than other regions. The failure rates of implants that were placed 5 years ago or more were higher than those that were placed later. Anterior maxilla is more critical for implant loss than other sites. Implants in the anterior mandible show better success compared with other locations, and longer implants show better success rates. The learning curve of the clinician influences survival and success rates of dental implants.

Finite element analysis of different loading conditions for implant-supported overdentures supported by conventional or mini implants.

PubMed

Solberg, K; Heinemann, F; Pellikaan, P; Keilig, L; Stark, H; Bourauel, C; Hasan, I

2017-05-01

The effect of implants' number on overdenture stability and stress distribution in edentulous mandible, implants and overdenture was numerically investigated for implant-supported overdentures. Three models were constructed. Overdentures were connected to implants by means of ball head abutments and rubber ring. In model 1, the overdenture was retained by two conventional implants; in model 2, by four conventional implants; and in model 3, by five mini implants. The overdenture was subjected to a symmetrical load at an angle of 20 degrees to the overdenture at the canine regions and vertically at the first molars. Four different loading conditions with two total forces (120, 300 N) were considered for the numerical analysis. The overdenture displacement was about 2.2 times higher when five mini implants were used rather than four conventional implants. The lowest stress in bone bed was observed with four conventional implants. Stresses in bone were reduced by 61% in model 2 and by 6% in model 3 in comparison to model 1. The highest stress was observed with five mini implants. Stresses in implants were reduced by 76% in model 2 and 89% increased in model 3 compared to model 1. The highest implant displacement was observed with five mini implants. Implant displacements were reduced by 29% in model 2, and increased by 273% in model 3 compared to model 1. Conventional implants proved better stability for overdenture than mini implants. Regardless the type and number of implants, the stress within the bone and implants are below the critical limits.

Short Implants Versus Standard Implants: Midterm Outcomes of a Clinical Study.

PubMed

Benlidayi, M Emre; Ucar, Yurdanur; Tatli, Ufuk; Ekren, Orhun; Evlice, Burcu; Kisa, Halil Ibrahim; Baksi, Uygar

2018-02-01

The aim of this study was to evaluate the midterm survival rate, marginal bone resorption (MBR), and stability of short implants and to compare the results with standard length implants. A total of 38 patients were included. In total, 147 implants (Nucleoss Implants, Izmir, Turkey) were placed (86 short implants and 61 standard implants). Cement-retained metal-ceramic prostheses were fabricated. MBR was evaluated on periapical radiographs taken at implant placement, at the time of crown insertion and annually thereafter. The stability of the implants was evaluated by resonance frequency analysis. The 3- and 5-year cumulative survival rates for standard implants was 98.4% and for short implants was 96.5% (P = 0.644). The MBR of the short implants was significantly lower than that of the standard implants after 1, 2, and 3 years of loading (P < 0.05). No significant differences were found between 2 groups after 6 and 12 months of loading in terms of implant stability (implant stability quotient values) (P > 0.05). Within the limits of this study, it is concluded that short implants achieved similar results as standard implants after 3 to 5 years of loading.

Agile Development of Advanced Prototypes

DTIC Science & Technology

2014-11-01

prostheses: retinal implants, cochlear implants, and neuroprosthetics (EEG controlled artificial limbs); an interactive, virtual experience...demonstrations allowing users to experience, from a patient’s perspective life with three different prostheses: retinal implants, cochlear implants...three experiences were researched and developed. The applications are interactive demonstrations of retinal implants, cochlear implants, and

EAO Supplement Working Group 4 - EAO CC 2015 Short implants versus sinus lifting with longer implants to restore the posterior maxilla: a systematic review.

PubMed

Thoma, D S; Zeltner, M; Hüsler, J; Hämmerle, C H F; Jung, R E

2015-09-01

To compare short implants in the posterior maxilla to longer implants placed after or simultaneously with sinus floor elevation procedures. The focused question was as follows: Are short implants superior to longer implants in the augmented sinus in terms of survival and complication rates of implants and reconstructions, patient-reported outcome measures (PROMs) and costs? A MEDLINE search (1990-2014) was performed for randomized controlled clinical studies comparing short implants (≤8 mm) to longer implants (>8 mm) in augmented sinus. The search was complimented by an additional hand search of the selected papers and reviews published between 2011 and 2014. Eligible studies were selected based on the inclusion criteria, and quality assessments were conducted. Descriptive statistics were applied for a number of outcome measures. Survival rates of dental implants were pooled simply in case of comparable studies. Eight randomized controlled clinical trials (RCTs) comparing short implants versus longer implants in the augmented sinus derived from an initial search count of 851 titles were selected and data extracted. In general, all studies were well conducted with a low risk of bias for the majority of the analyzed parameters. Based on the pooled analyses of longer follow-ups (5 studies, 16-18 months), the survival rate of longer implants amounted to 99.5% (95% CI: 97.6-99.98%) and for shorter implants to 99.0% (95% CI: 96.4-99.8%). For shorter follow-ups (3 studies, 8-9 months), the survival rates of longer implants are 100% (95% CI: 97.1-100%) and for shorter implants 98.2% (95% CI: 93.9-99.7%). Complications were predominantly of biological origin, mainly occurred intraoperatively as membrane perforations, and were almost three times as higher for longer implant in the augmented sinus compared to shorter implants. PROMs, morbidity, surgical time and costs were generally in favor of shorter dental implants. All studies were performed by surgeons in specialized clinical settings. The outcomes of the survey analyses demonstrated predictably high implant survival rates for short implants and longer implants placed in augmented sinus and their respective reconstructions. Given the higher number of biological complications, increased morbidity, costs and surgical time of longer dental implants in the augmented sinus, shorter dental implants may represent the preferred treatment alternative. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Three-dimensional finite element analysis of stress distribution on different bony ridges with different lengths of morse taper implants and prosthesis dimensions.

PubMed

Toniollo, Marcelo Bighetti; Macedo, Ana Paula; Rodrigues, Renata Cristina Silveira; Ribeiro, Ricardo Faria; de Mattos, Maria da Gloria Chiarello

2012-11-01

This finite element analysis (FEA) compared stress distribution on different bony ridges rehabilitated with different lengths of morse taper implants, varying dimensions of metal-ceramic crowns to maintain the occlusal alignment. Three-dimensional FE models were designed representing a posterior left side segment of the mandible: group control, 3 implants of 11 mm length; group 1, implants of 13 mm, 11 mm and 5 mm length; group 2, 1 implant of 11 mm and 2 implants of 5 mm length; and group 3, 3 implants of 5 mm length. The abutments heights were 3.5 mm for 13- and 11-mm implants (regular), and 0.8 mm for 5-mm implants (short). Evaluation was performed on Ansys software, oblique loads of 365N for molars and 200N for premolars. There was 50% higher stress on cortical bone for the short implants than regular implants. There was 80% higher stress on trabecular bone for the short implants than regular implants. There was higher stress concentration on the bone region of the short implants neck. However, these implants were capable of dissipating the stress to the bones, given the applied loads, but achieving near the threshold between elastic and plastic deformation to the trabecular bone. Distal implants and/or with biggest occlusal table generated greatest stress regions on the surrounding bone. It was concluded that patients requiring short implants associated with increased proportions implant prostheses need careful evaluation and occlusal adjustment, as a possible overload in these short implants, and even in regular ones, can generate stress beyond the physiological threshold of the surrounding bone, compromising the whole system.

The Poly Implant Prothèse breast prostheses scandal: Embodied risk and social suffering.

PubMed

Greco, Cinzia

2015-12-01

This article examines the 2010 scandal surrounding the use and subsequent recall of adulterated Poly Implant Prothèse (PIP) silicone breast prostheses in France. It uses a mixed method approach that includes 12 interviews with French PIP prosthesis recipients, analyses of medical literature, policy documents of French and EU regulatory agencies, and an online forum for PIP recipients. These data are used to explain how the definition of "acceptable risk" in the silicone implants controversy of the 1990s in the US influenced the PIP scandal later on in France. Additionally, PIP recipients had an embodied experience of risk that clashed with the definition of risk used by authorities and some surgeons. The coverage of re-implantation was also defined at different policy levels, leading to variation in patients' suffering. The combination of fraud and lack of recognition from part of the medical system constitutes an example of social suffering for the patients involved. The PIP scandal is a useful case for analyzing the interconnection of embodied experience and professional and public policy definitions of medical risk through the concepts of moral economy and biological citizenship. Copyright © 2015 Elsevier Ltd. All rights reserved.

The proliferation of normal human breast tissue implanted into athymic nude mice is stimulated by estrogen but not progesterone.

PubMed

Laidlaw, I J; Clarke, R B; Howell, A; Owen, A W; Potten, C S; Anderson, E

1995-01-01

In order to resolve the question of which ovarian steroid stimulates normal human mammary epithelial cell proliferation, we have implanted pieces of normal human breast tissue subcutaneously into athymic nude mice. These mice were then treated with slow-release pellets containing estradiol (E2) or progesterone (P) such that serum levels of E2 and P were increased to those seen in normal women. The proliferative activity of the tissue implants was assessed by uptake of tritiated thymidine and steroid receptor expression was measured immunocytochemically. Insertion of a 2 mg E2 pellet 14 days after tissue implantation increased the thymidine labeling index (TLI) from a median of 0.4% (n = 34) to a median of 2.1% after 7 days (n = 43; P < 0.001 by Mann Whitney U test). In contrast, treatment with a P pellet (4 mg) had no effect upon the TLI whereas P (4 mg) in combination with E2 (2 mg) had no effect over and above that of E2 alone. There was a significant correlation between the increase in TLI and either the E2 content of the pellets (P < 0.001 by linear regression) or the serum E2 levels achieved (P < 0.001). Expression of the P receptor was increased 15- to 20-fold by E2 treatment. We conclude that E2 is sufficient to stimulate human breast epithelial cell proliferation at physiologically relevant concentrations and that P does not affect proliferation either alone or after E2 priming.

Comparison of peri-implant bone formation around injection-molded and machined surface zirconia implants in rabbit tibiae

PubMed Central

Kim, Hong-Kyun; Woo, Kyung mi; Shon, Won-Jun; Ahn, Jin-Soo; Cha, Seunghee; Park, Young-Seok

2017-01-01

The aim of this study was to compare osseointegration and surface characteristics of zirconia implants made by the powder injection molding (PIM) technique and made by the conventional milling procedure in rabbit tibiae. Surface characteristics of 2 types of implant were evaluated. Sixteeen rabbits received 2 types of external hex implants with similar geometry, machined zirconia implants and PIM zirconia implants, in the tibiae. Removal torque tests and histomorphometric analyses were performed. The roughness of PIM zirconia implants was higher than that of machined zirconia implants. The PIM zirconia implants exhibited significantly higher bone-implant contact and removal torque values than the machined zirconia implants (P < 0.001). The osseointegration of the PIM zirconia implant is promising, and PIM, using the roughened mold etching technique, can produce substantially rough surfaces on zirconia implants. PMID:26235717

Stability of tapered and parallel-walled dental implants: A systematic review and meta-analysis.

PubMed

Atieh, Momen A; Alsabeeha, Nabeel; Duncan, Warwick J

2018-05-15

Clinical trials have suggested that dental implants with a tapered configuration have improved stability at placement, allowing immediate placement and/or loading. The aim of this systematic review and meta-analysis was to evaluate the implant stability of tapered dental implants compared to standard parallel-walled dental implants. Applying the guidelines of Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement, randomized controlled trials (RCTs) were searched for in electronic databases and complemented by hand searching. The risk of bias was assessed using the Cochrane Collaboration's Risk of Bias tool and data were analyzed using statistical software. A total of 1199 studies were identified, of which, five trials were included with 336 dental implants in 303 participants. Overall meta-analysis showed that tapered dental implants had higher implant stability values than parallel-walled dental implants at insertion and 8 weeks but the difference was not statistically significant. Tapered dental implants had significantly less marginal bone loss compared to parallel-walled dental implants. No significant differences in implant failure rate were found between tapered and parallel-walled dental implants. There is limited evidence to demonstrate the effectiveness of tapered dental implants in achieving greater implant stability compared to parallel-walled dental implants. Superior short-term results in maintaining peri-implant marginal bone with tapered dental implants are possible. Further properly designed RCTs are required to endorse the supposed advantages of tapered dental implants in immediate loading protocol and other complex clinical scenarios. © 2018 Wiley Periodicals, Inc.

Maxillary "All-On-Four" treatment using zygomatic implants. A mechanical analysis.

PubMed

de Moraes, P H; Olate, S; Nóbilo, M de Arruda; Asprino, L; de Moraes, M; Barbosa, J de Albergaría

2016-04-01

Zygomatic implants may be used for dental rehabilitation in atrophic maxillae. The aim of this study was to establish experimentally the areas of stress distribution using 2 kinds of "All-On-Four" maxillary procedures. The best position to insert the implants was selected using polyurethane craniomaxillary models and surgical guides were made. Group 1 was designed with two posterior zygomatic implants and two conventional anterior implants, and group 2 with two posterior zygomatic implants and two anterior zygomatic implants. A titanium bar was built to link the 4 implants in both groups. Photoelastic replicas of these models were made and the implants were inserted using the surgical guides. An Instrom 4411 testing machine was used to perform a unilateral compressive loading at the level of the right first molar until 2mm of displacement was obtained. Group 1 showed a high strain concentration in the right lateral orbital region at the level of the apex of the zygomatic implant. Less strain was noticed at the apical levels of the conventional implants in the anterior sector and of the contralateral zygomatic implant. Group 2 showed high strains in the lateral inferior orbital area. The load was low in the alveolar bone sector. Zygomatic bone and paranasal structures are loaded at high levels when zygomatic implants are used to stabilize a full maxillary prosthodontic rehabilitation on 4 implants. The use of 4 zygomatic implants loads the alveolar bone to a lower extent and seems better suited from a mechanical point of view than the use of 2 zygomatic implants. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Predictability of short implants (< 10 mm) as a treatment option for the rehabilitation of atrophic maxillae. A systematic review

PubMed Central

García-Sala-Bonmatí, Fernando; Martínez-González, Amparo; García-Dalmau, Carlos; Mañes-Ferrer, José-Félix; Brotons-Oliver, Alejandro

2016-01-01

Background Short implants (< 10 mm) are one of the treatment options available in cases of limited vertical bone. A purpose of this paper is to evaluate the predictability of short implants as an alternative to technically molthough such implants are now widely used, there is controversy regarding their clinical reliability. There complex treatments in patients with atrophic maxillae, based on a systematic review of the literature and the analysis of the implant survival rates, changes in peri-implant bone level, and associated complications. It is postulated that short implants offer clinical results similar to those of longer implants. Material and Methods A Medline-PubMed search was made covering the period between January 2004 and December 2014 (both included). Studies in English published in indexed journals, involving at least 20 implants and with a follow-up period of at least 12 months were considered. A manual search in four high impact journals was also conducted. Results A total of 37 studies meeting the inclusion criteria were included in this review. 9792 implants placed in over 5000 patients were analyzed. Conclusions Based on the results of this review, short implants are seen to offer clinical results in terms of survival, bone loss and complications similar to those of longer implants. Key words:Survival rate, clinical results, dental implants, oral implants, short implants, short lengt PMID:26946199

Effect of implant design and bioactive glass coating on biomechanical properties of fiber-reinforced composite implants.

PubMed

Ballo, Ahmed M; Akca, Eralp; Ozen, Tuncer; Moritz, Niko; Lassila, Lippo; Vallittu, Pekka; Närhi, Timo

2014-08-01

This study aimed to evaluate the influence of implant design and bioactive glass (BAG) coating on the response of bone to fiber-reinforced composite (FRC) implants. Three different FRC implant types were manufactured for the study: non-threaded implants with a BAG coating; threaded implants with a BAG coating; and threaded implants with a grit-blasted surface. Thirty-six implants (six implants for each group per time point) were installed in the tibiae of six pigs. After an implantation period of 4 and 12 wk, the implants were retrieved and prepared for micro-computed tomography (micro-CT), push-out testing, and scanning electron microscopy analysis. Micro-CT demonstrated that the screw-threads and implant structure remained undamaged during the installation. The threaded FRC/BAG implants had the highest bone volume after 12 wk of implantation. The push-out strengths of the threaded FRC/BAG implants after 4 and 12 wk (463°N and 676°N, respectively) were significantly higher than those of the threaded FRC implants (416°N and 549°N, respectively) and the nonthreaded FRC/BAG implants (219°N and 430°N, respectively). Statistically significant correlation was found between bone volume and push-out strength values. This study showed that osseointegrated FRC implants can withstand the static loading up to failure without fracture, and that the addition of BAG significantly improves the push-out strength of FRC implants. © 2014 Eur J Oral Sci.

Retrospective Analysis on Survival Rate, Template-Related Complications, and Prevalence of Peri-implantitis of 694 Anodized Implants Placed Using Computer-Guided Surgery: Results Between 1 and 10 Years of Follow-Up.

PubMed

Tallarico, Marco; Meloni, Silvio Mario

To report survival rate, early surgical template-related complications, and prevalence of peri-implantitis of dental implants placed in private practices using computer-guided, template-assisted surgery and followed between 1 and 10 years. The present retrospective multicenter study evaluated data collected from fully or partially edentulous patients, with anodized-surface implants placed using computer-guided, template-assisted surgery between January 2006 and December 2015. The outcome measures were implant cumulative survival rate (CSR), early surgical complications involving the surgical template, and prevalence of peri-implantitis. A total of 694 implants were placed in 141 patients. Ten patients (7.1%) with 48 implants (6.9%) dropped out during the study period. One hundred seventeen patients, who received 121 surgical and prosthetic procedures, were treated according to a double-scan protocol, while the remaining 24 patients were treated by using the integrated treatment workflow. Most of the implants were immediately loaded (528 implants, 76.1%; 112 patients, 79.4%). Overall, 107 complete full-arch restorations (supported by four to eight implants each) were delivered in 103 patients (73%) with 595 implants (85.7%), while 13 single and 30 partial restorations (two to five implants each) were delivered in 38 patients (27%) with 99 implants (14.3%). Patients were followed for up to 10 years (mean: 58.2 months, range: 12 to 120 months). Implant- and patient-level CSR (Kaplan-Meier estimation) at the 10-year follow-up was 97.4% (95% CI: 1.0309 to 0.9161) and 92.1% (95% CI: 1.1575 to 0.6836), respectively. All failed implants were lost before definitive prosthesis delivery (early failure). Ten (7.1%) minor template-related complications were experienced and resolved chairside. Over the entire follow-up period, four patients (2.8%) with 12 implants (1.7%) showed signs of peri-implantitis at the 1- (four implants), 2- (four implants), and 4-year (four implants) visits. High long-term survival rates and low complications and prevalence of peri-implantitis were observed for a large cohort of anodized-surface implants placed in private practices. Further studies are needed to confirm these preliminary results.

Distribution of bacterial morphotypes around natural teeth and titanium implants ad modum Brånemark.

PubMed

Quirynen, M; Listgarten, M A

1990-12-01

The subgingival plaque around both teeth and implants was analysed by means of differential phase-contrast microscopy. It was noted that, in comparison to natural teeth, the subgingival samples from implants were more frequently too small to provide adequate bacterial counts. In 24 partially edentulous patients (with implants and teeth in the same jaw), no significant differences in the distribution of bacterial morphotypes could be found between implants and natural teeth. The %s of coccoid cells, motile rods, spirochetes and other bacteria were 65.8, 2.3, 2.1, and 29.8 for implants and 55.6, 4.9, 3.6, and 34.9 for teeth, respectively. However, when the plaque composition on the implants of fully edentulous patients was compared with those of teeth or implants of partially edentulous patients (with teeth and implants in the same and/or opposite jaw), significant differences appeared. In fully edentulous patients, more coccoid cells (71.3%) and significant fewer motile rods (0.4%) and spirochetes (0.0) were found around the implants. The results suggest that teeth may serve as a reservoir for the bacterial colonisation of titanium implants in the same mouth.

Nanostructured severe plastic deformation processed titanium for orthodontic mini-implants.

PubMed

Serra, Glaucio; Morais, Liliane; Elias, Carlos Nelson; Semenova, Irina P; Valiev, Ruslan; Salimgareeva, Gulnaz; Pithon, Matheus; Lacerda, Rogério

2013-10-01

Titanium mini-implants have been successfully used as anchorage devices in Orthodontics. Commercially pure titanium (cpTi) was recently replaced by Ti-6Al-4V alloy as the mini-implant material base due to the higher strength properties of the alloy. However, the lower corrosion resistance and the lower biocompatibility have been lowering the success rate of Ti-6Al-4V mini-implants. Nanostructured titanium (nTi) is commercially pure titanium that was nanostructured by a specific technique of severe plastic deformation. It is bioinert, does not contain potentially toxic or allergic additives, and has higher specific strength properties than any other titanium applied in medical implants. The higher strength properties associated to the higher biocompatibility make nTi potentially useful for orthodontic mini-implant applications, theoretically overcoming cpTi and Ti-6Al-4V mini-implants. The purposes of the this work were to process nTi, to mechanically compare cpTi, Ti-6Al-4V, and nTi mini-implants by torque test, and to evaluate both the surface morphology and the fracture surface characteristics of them by SEM. Torque test results showed significant increase in the maximum torque resistance of nTi mini-implants when compared to cpTi mini-implants, and no statistical difference between Ti-6Al-4V and nTi mini-implants. SEM analysis demonstrated smooth surface morphology and transgranular fracture aspect for nTi mini-implants. Since nanostructured titanium mini-implants have mechanical properties comparable to titanium alloy mini-implants, and biocompatibility comparable to commercially pure titanium mini-implants, it is suggestive that nanostructured titanium can replace Ti-6Al-4V alloy as the material base for mini-implants. Copyright © 2013 Elsevier B.V. All rights reserved.

Rehabilitation of postrior atrophic edentulous jaws: prostheses supported by 5 mm short implants or by longer implants in augmented bone? One-year results from a pilot randomised clinical trial.

PubMed

Esposito, Marco; Pellegrino, Gerardo; Pistilli, Roberto; Felice, Pietro

2011-01-01

To evaluate whether 5 mm short dental implants could be an alternative to augmentation with anorganic bovine bone and placement of at least 10 mm long implants in posterior atrophic jaws. Fifteen patients with bilateral atrophic mandibles (5-7 mm bone height above the mandibular canal), and 15 patients with bilateral atrophic maxillae (4-6 mm bone height below the maxillary sinus) and bone thickness of at least 8 mm, were randomised according to a splitmouth design to receive one to three 5 mm short implants or at least 10 mm long implants in augmented bone. Mandibles were vertically augmented with interpositional bone blocks and maxillary sinuses with particulated bone via a lateral window. Implants were placed after 4 months, submerged and loaded, after 4 months, with provisional prostheses. Four months later, definitive provisionally cemented prostheses were delivered. Outcome measures were: prosthesis and implant failures, any complication and peri-implant marginal bone level changes. In 5 augmented mandibles, the planned 10 mm long implants could not be placed and shorter implants (7 and 8.5 mm) had to be used instead. One year after loading no patient dropped out. Two long (8.5 mm in the mandible and 13 mm in the maxilla) implants and one 5 mm short maxillary implant failed. There were no statistically significant differences in failures or complications. Patients with short implants lost on average 1 mm of peri-implant bone and patients with longer implants lost 1.2 mm. This difference was statistically significant. This pilot study suggests that 1 year after loading, 5 mm short implants achieve similar if not better results than longer implants placed in augmented bone. Short implants might be a preferable choice to bone augmentation since the treatment is faster, cheaper and associated with less morbidity, however their long-term prognosis is unknown.

Fortifying the Bone-Implant Interface Part 2: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants

PubMed Central

Lindsey, Derek P.; Woods, Shane A.; Lalor, Peggy A.; Gundanna, Mukund I.; Yerby, Scott A.

2017-01-01

Background Minimally invasive surgical fusion of the sacroiliac (SI) joint using machined solid triangular titanium plasma spray (TPS) coated implants has demonstrated positive clinical outcomes in SI joint pain patients. Additive manufactured (AM), i.e. 3D-printed, fenestrated triangular titanium implants with porous surfaces and bioactive agents, such as nanocrystalline hydroxyapatite (HA) or autograft, may further optimize bony fixation and subsequent biomechanical stability. Methods A bilateral ovine distal femoral defect model was used to evaluate the cancellous bone-implant interfaces of TPS-coated and AM implants. Four implant groups (n=6/group/time-point) were included: 1)TPS-coated, 2)AM, 3)AM+HA, and 4)AM+Autograft. The bone-implant interfaces of 6- and 12-week specimens were investigated via radiographic, biomechanical, and histomorphometric methods. Results Imaging showed peri-implant bone formation around all implants. Push-out testing demonstrated forces greater than 2500 N, with no significant differences among groups. While TPS implants failed primarily at the bone-implant interface, AM groups failed within bone ~2-3mm away from implant surfaces. All implants exhibited bone ongrowth, with no significant differences among groups. AM implants had significantly more bone ingrowth into their porous surfaces than TPS-coated implants (p<0.0001). Of the three AM groups, AM+Auto implants had the greatest bone ingrowth into the porous surface and through their core (p<0.002). Conclusions Both TPS and AM implants exhibited substantial bone ongrowth and ingrowth, with additional bone through growth into the AM implants’ core. Overall, AM implants experienced significantly more bone infiltration compared to TPS implants. While HA-coating did not further enhance results, the addition of autograft fostered greater osteointegration for AM implants. Clinical Relevance Additive manufactured implants with a porous surface provide a highly interconnected porous surface that has comparatively greater surface area for bony integration. Results suggest this may prove advantageous toward promoting enhanced biomechanical stability compared to TPS-coated implants for SI joint fusion procedures. PMID:28765800

Biomechanical evaluation of one-piece and two-piece small-diameter dental implants: In-vitro experimental and three-dimensional finite element analyses.

PubMed

Wu, Aaron Yu-Jen; Hsu, Jui-Ting; Chee, Winston; Lin, Yun-Te; Fuh, Lih-Jyh; Huang, Heng-Li

2016-09-01

Small-diameter dental implants are associated with a higher risk of implant failure. This study used both three-dimensional finite-element (FE) simulations and in-vitro experimental tests to analyze the stresses and strains in both the implant and the surrounding bone when using one-piece (NobelDirect) and two-piece (NobelReplace) small-diameter implants, with the aim of understanding the underlying biomechanical mechanisms. Six experimental artificial jawbone models and two FE models were prepared for one-piece and two-piece 3.5-mm diameter implants. Rosette strain gauges were used for in-vitro tests, with peak values of the principal bone strain recorded with a data acquisition system. Implant stability as quantified by Periotest values (PTV) were also recorded for both types of implants. Experimental data were analyzed statistically using Wilcoxon's rank-sum test. In FE simulations, the peak value and distribution of von-Mises stresses in the implant and bone were selected for evaluation. In in-vitro tests, the peak bone strain was 42% lower for two-piece implants than for one-piece implants. The PTV was slightly lower for one-piece implants (PTV = -6) than for two-piece implants (PTV = -5). In FE simulations, the stresses in the bone and implant were about 23% higher and 12% lower, respectively, for one-piece implants than those for two-piece implants. Due to the higher peri-implant bone stresses and strains, one-piece implants (NobelDirect) might be not suitable for use as small-diameter implants. Copyright © 2016. Published by Elsevier B.V.

Immediate loading of subcrestally placed dental implants in anterior and premolar sites.

PubMed

Henningsen, Anders; Smeets, Ralf; Köppen, Kai; Sehner, Susanne; Kornmann, Frank; Gröbe, Alexander; Heiland, Max; Gerlach, Till

2017-11-01

Immediate loading of dental implants has been evolving into an appropriate procedure for the treatment of partially edentulous jaws. The purpose of this study was to evaluate the clinical success and radiological outcome of immediately and delayed loaded dental implants in anterior and premolar sites. In this retrospective study, data of 163 individuals requiring tooth removal with subsequent implant placement in anterior and premolar sites were analyzed. Implants were immediately loaded by provisional acrylic resin bridges or loaded with delay. Implants were followed up annually for up to 9 years including intraoral radiographs. A total of 285 implants in 163 patients were placed. 218 implants were immediately loaded and 67 implants with delay. Fifteen implants failed during the follow-up period resulting in survival rates of 94.5% for immediate loading and 95.5% for delayed loading. After an initial decrease of 0.3 mm in the first 12 months the marginal bone level remained stable. No statistically significant differences were found in marginal bone loss between immediately and delayed loaded implants (P = 0.518, 95% CI). Within the limits of this study, immediate loading of immediately subcrestally placed dental implants in anterior and premolar sites is a reliable treatment option for dental rehabilitation. Copyright © 2017 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Osteointegration of PLGA implants with nanostructured or microsized β-TCP particles in a minipig model.

PubMed

Kulkova, Julia; Moritz, Niko; Suokas, Esa O; Strandberg, Niko; Leino, Kari A; Laitio, Timo T; Aro, Hannu T

2014-12-01

Bioresorbable suture anchors and interference screws have certain benefits over equivalent titanium-alloy implants. However, there is a need for compositional improvement of currently used bioresorbable implants. We hypothesized that implants made of poly(l-lactide-co-glycolide) (PLGA) compounded with nanostructured particles of beta-tricalcium phosphate (β-TCP) would induce stronger osteointegration than implants made of PLGA compounded with microsized β-TCP particles. The experimental nanostructured self-reinforced PLGA (85L:15G)/β-TCP composite was made by high-energy ball-milling. Self-reinforced microsized PLGA (95L:5G)/β-TCP composite was prepared by melt-compounding. The composites were characterized by gas chromatography, Ubbelohde viscometry, scanning electron microscopy, laser diffractometry, and standard mechanical tests. Four groups of implants were prepared for the controlled laboratory study employing a minipig animal model. Implants in the first two groups were prepared from nanostructured and microsized PLGA/β-TCP composites respectively. Microroughened titanium-alloy (Ti6Al4V) implants served as positive intra-animal control, and pure PLGA implants as negative control. Cone-shaped implants were inserted in a random order unilaterally in the anterior cortex of the femoral shaft. Eight weeks after surgery, the mechanical strength of osteointegration of the implants was measured by a push-out test. The quality of new bone surrounding the implant was assessed by microcomputed tomography and histology. Implants made of nanostructured PLGA/β-TCP composite did not show improved mechanical osteointegration compared with the implants made of microsized PLGA/β-TCP composite. In the intra-animal comparison, the push-out force of two PLGA/β-TCP composites was 35-60% of that obtained with Ti6Al4V implants. The implant materials did not result in distinct differences in quality of new bone surrounding the implant. Copyright © 2014 Elsevier Ltd. All rights reserved.

Enhanced antitumor efficacy of poly(D,L-lactide-co-glycolide)-based methotrexate-loaded implants on sarcoma 180 tumor-bearing mice

PubMed Central

Gao, Li; Xia, Lunyang; Zhang, Ruhui; Duan, Dandan; Liu, Xiuxiu; Xu, Jianjian; Luo, Lan

2017-01-01

Purpose Methotrexate is widely used in chemotherapy for a variety of malignancies. However, severe toxicity, poor pharmacokinetics, and narrow safety margin of methotrexate limit its clinical application. The aim of this study was to develop sustained-release methotrexate-loaded implants and evaluate antitumor activity of the implants after intratumoral implantation. Materials and methods We prepared the implants containing methotrexate, poly(D,L-lactide-co-glycolide), and polyethylene glycol 4000 with the melt-molding technique. The implants were characterized with regards to drug content, morphology, in vitro, and in vivo release profiles. Differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy (FTIR) were carried out to investigate the physicochemical properties of the implants. Furthermore, the antitumor activity of the implants was tested in a sarcoma 180 mouse model. Results The implants were prepared as solid rods. Scanning electron microscopy images showed a smooth surface of the implant, suggesting that methotrexate was homogeneously dispersed in the polymeric matrix. The results of DSC and FTIR indicated that no significant interaction between methotrexate and the polymer was observed in the implants. Both in vitro and in vivo release profiles of the implants were characterized by burst release followed by sustained release of methotrexate. Intratumoral implantation of methotrexate-loaded implants could efficiently delay tumor growth. Moreover, an increase in the dose of implants led to a higher tumor suppression rate without additional systemic toxicity. Conclusion These results demonstrate that methotrexate-loaded implants had significant antitumor efficacy in a sarcoma 180 mouse model without dose-limiting side effects, and suggest that the implants could be potentially applied as an intratumoral delivery system to treat cancer. PMID:29118572

Comparison of mechanical and biological properties of zirconia and titanium alloy orthodontic micro-implants.

PubMed

Choi, Hae Won; Park, Young Seok; Chung, Shin Hye; Jung, Min Ho; Moon, Won; Rhee, Sang Hoon

2017-07-01

The aim of this study was to compare the initial stability as insertion and removal torque and the clinical applicability of novel orthodontic zirconia micro-implants made using a powder injection molding (PIM) technique with those parameters in conventional titanium micro-implants. Sixty zirconia and 60 titanium micro-implants of similar design (diameter, 1.6 mm; length, 8.0 mm) were inserted perpendicularly in solid polyurethane foam with varying densities of 20 pounds per cubic foot (pcf), 30 pcf, and 40 pcf. Primary stability was measured as maximum insertion torque (MIT) and maximum removal torque (MRT). To investigate clinical applicability, compressive and tensile forces were recorded at 0.01, 0.02, and 0.03 mm displacement of the implants at angles of 0°, 10°, 20°, 30°, and 40°. The biocompatibility of zirconia micro-implants was assessed via an experimental animal study. There were no statistically significant differences between zirconia micro-implants and titanium alloy implants with regard to MIT, MRT, or the amount of movement in the angulated lateral displacement test. As angulation increased, the mean compressive and tensile forces required to displace both types of micro-implants increased substantially at all distances. The average bone-to-implant contact ratio of prototype zirconia micro-implants was 56.88 ± 6.72%. Zirconia micro-implants showed initial stability and clinical applicability for diverse orthodontic treatments comparable to that of titanium micro-implants under compressive and tensile forces.

Calfplasty.

PubMed

Felício, Y

2000-01-01

The author describes a method of calf augmentation by a silicone prosthesis implant for correction of asymmetrical legs or aesthetic problems. Preference is given to the placement of soft silicone implants (Glitzentein implants); they are more natural looking than hard implants. The implants are placed over both heads of the gastrocnemius muscle or beneath the fascia cruris superficialis. Operations were performed from November 1985 to August 1999. One hundred patients were studied: 95 female and 5 male. Two hundred calf implants were performed: 188 soft implants (Glitzenstein), 6 hard implants (Aiache), and 6 together on the same leg (Glitzenstein and Aiache implants). No infection problems, prosthesis rupture, or hematomas occurred. There were four seromas, but they disappeared in 15 days. Four prostheses were removed in two patients who did not like the final result. One prosthesis changed place, to the upper part of the calf. The operation is performed under sedative and local anesthesia, with an incision of approximately 4 to 5 cm in the popliteal pleat, at the same height as the fascia cruris. To date, no functional problem or muscular dysfunction has been provoked by silicone prosthesis implants. The patient walks 8 h after the surgery. We selected 500 patients who received implants in the legs with calf prostheses, fat implants, and prosthesis and fat implant together, during 14 years of follow-up, but the focus of this paper is a calf implant with prosthesis in 100 patients with 200 calf prosthesis implants.

Tilted orthodontic micro implants: a photoelastic stress analysis.

PubMed

Çehreli, Seçil; Özçırpıcı, Ayça Arman; Yılmaz, Alev

2013-10-01

The aim of this study was to examine peri-implant stresses around orthodontic micro implants upon torque-tightening and static load application by quasi-three-dimensional photoelastic stress analysis. Self-tapping orthodontic micro implants were progressively inserted into photoelastic models at 30, 45, 70, and 90 degrees and insertion torques were measured. Stress patterns (isochromatic fringe orders) were recorded by the quasi-three-dimensional photoelastic method using a circular polariscope after insertion and 250 g static force application. Torque-tightening of implants generated peri-implant stresses. Upon insertion, 90 degree placed implants displayed the lowest and homogeneous stress distribution followed by 30, 70, and 45 degree tilted implants. Static loading did not dramatically alter stress fields around the implants tested. The highest alteration in stress distribution was observed for the 90 degree placed implant, while 70 degree tilted implant had the lowest stresses among tilted implants. Torque-tightening of orthodontic micro implants creates a stress field that is not dramatically altered after application of static lateral moderate orthodontic loads, particularly at the cervical region of tilted implants.

Current status of grafts and implants in rhinoplasty: Part II. Homologous grafts and allogenic implants.

PubMed

Sajjadian, Ali; Naghshineh, Nima; Rubinstein, Roee

2010-03-01

After reading this article, the participant should be able to: 1. Understand the challenges in restoring volume and structural integrity in rhinoplasty. 2. Identify the appropriate uses of various homologous grafts and allogenic implants in reconstruction, including: (a) freeze-dried acellular allogenic cadaveric dermis grafts, (b) irradiated cartilage grafts, (c) hydroxyapatite mineral matrix, (d) silicone implants, (e) high-density polyethylene implants, (f) polytetrafluoroethylene implants, and (g) injectable filler materials. 3. Identify the advantages and disadvantages of each of these biomaterials. 4. Understand the specific techniques that may aid in the use these grafts or implants. This review specifically addresses the use of homologous grafts and allogenic implants in rhinoplasty. It is important to stress that autologous materials remain the preferred graft material for use in rhinoplasty, owing to their high biocompatibility and low risk of infection and extrusion. However, concerns of donor-site morbidity, graft availability, and graft resorption have motivated the development and use of homologous and allogenic implants.

Fortifying the Bone-Implant Interface Part 2: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants.

PubMed

MacBarb, Regina F; Lindsey, Derek P; Woods, Shane A; Lalor, Peggy A; Gundanna, Mukund I; Yerby, Scott A

2017-01-01

Minimally invasive surgical fusion of the sacroiliac (SI) joint using machined solid triangular titanium plasma spray (TPS) coated implants has demonstrated positive clinical outcomes in SI joint pain patients. Additive manufactured (AM), i.e. 3D-printed, fenestrated triangular titanium implants with porous surfaces and bioactive agents, such as nanocrystalline hydroxyapatite (HA) or autograft, may further optimize bony fixation and subsequent biomechanical stability. A bilateral ovine distal femoral defect model was used to evaluate the cancellous bone-implant interfaces of TPS-coated and AM implants. Four implant groups (n=6/group/time-point) were included: 1)TPS-coated, 2)AM, 3)AM+HA, and 4)AM+Autograft. The bone-implant interfaces of 6- and 12-week specimens were investigated via radiographic, biomechanical, and histomorphometric methods. Imaging showed peri-implant bone formation around all implants. Push-out testing demonstrated forces greater than 2500 N, with no significant differences among groups. While TPS implants failed primarily at the bone-implant interface, AM groups failed within bone ~2-3mm away from implant surfaces. All implants exhibited bone ongrowth, with no significant differences among groups. AM implants had significantly more bone ingrowth into their porous surfaces than TPS-coated implants ( p <0.0001). Of the three AM groups, AM+Auto implants had the greatest bone ingrowth into the porous surface and through their core ( p <0.002). Both TPS and AM implants exhibited substantial bone ongrowth and ingrowth, with additional bone through growth into the AM implants' core. Overall, AM implants experienced significantly more bone infiltration compared to TPS implants. While HA-coating did not further enhance results, the addition of autograft fostered greater osteointegration for AM implants. Additive manufactured implants with a porous surface provide a highly interconnected porous surface that has comparatively greater surface area for bony integration. Results suggest this may prove advantageous toward promoting enhanced biomechanical stability compared to TPS-coated implants for SI joint fusion procedures.

Autologous breast reconstruction using the immediately lipofilled extended latissimus dorsi flap.

PubMed

Johns, N; Fairbairn, N; Trail, M; Ewing, A; Yong, L; Raine, C; Dixon, J M

2018-02-01

The latissimus dorsi flap is a popular choice for autologous breast reconstruction. To dramatically improve volume, we report our experience of using the immediately lipofilled extended latissimus dorsi (ELD) flap and show it as a valid option for autologous breast reconstruction. Patients undergoing the procedure between December 2013 and June 2016 were included. Demographic, clinical and operative factors were analysed, together with in-hospital morbidity and duration of postoperative hospital stay. A total of 71 ELD flaps with immediate lipofilling were performed. Forty-five reconstructions were immediate and the remaining 26 delayed. Median (range) volume of autologous fat injected immediately was 171 ml (40-630 ml). Contralateral reductions were performed in 25 patients with the median reduction volume 185 g (89-683 g). Median duration of admission was 6.5 (3-18) days and patients were followed up for 12 months (1-37). Three total flap failures occurred and had to be excised (4%). One haematoma occurred requiring drainage (1%). Signs of infection requiring intravenous antibiotics occurred in five patients (7%). In 5 patients wound dehiscence occurred, and only two of these required resuturing (3%). In total, 7 patients developed a seroma requiring repeated drainage (10%). Three reconstructions experienced mild mastectomy flap necrosis with no needing reoperation (4%). Our experience represents the largest series to date and shows that in carefully selected patients the technique is safe, can avoid the requirement for implants, and has the potential to streamline the reconstructive journey. Copyright © 2017 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Low-energy BF2, BCl2, and BBr2 implants for ultrashallow P+-N junctions

NASA Astrophysics Data System (ADS)

Nandan, S. R.; Agarwal, Vikas; Banerjee, Sanjay K.

1997-08-01

We have examined low energy BCl2 and BBr2 implants as a means of fabricating ultra-shallow P+-N junctions. Five keV and 9 keV BCl2 implants and 18 keV BBr2 implants have been compared to 5 keV BF2 implants to study the benefits of using these species. BCl2 and BBr2, being heavier species, have a lower projected range and produce more damage. The greater damage restricts channeling, resulting in shallower as-implanted profiles. The increased damage amorphizes the substrate at low implant doses which results in reduced transient enhanced diffusion (TED) during the post-implant anneal. Post-anneal SIMS profiles indicate a junction depth reduction of over 10 nm (at 5 X 1017 cm-3 background doping) for 5 keV BCl2 implants as compared to 5 keV BF2 implants. Annealed junctions as shallow as 10 nm have been obtained from the 18 keV BBr2 implants. The increased damage degrades the electrical properties of these junctions by enhancing the leakage current densities. BCl2 implanted junctions have leakage current densities of approximately 1 (mu) A/cm2 as compared to 10 nA/cm2 for the BF2 implants. BBr2 implants have a lower leakage density of approximately 50 nA/cm2. Low energy BBr2 implants offer an exciting alternative for fabricating low leakage, ultra-shallow P+-N junctions.

Assessment of a polyelectrolyte multilayer film coating loaded with BMP-2 on titanium and PEEK implants in the rabbit femoral condyle

PubMed Central

Guillot, R.; Pignot-Paintrand, I.; Lavaud, J.; Decambron, A.; Bourgeois, E.; Josserand, V.; Logeart-Avramoglou, D.; Viguier, E.; Picart, C.

2016-01-01

The aim of this study was to evaluate the osseointegration of titanium implants (Ti-6Al-4V, noted here TA6V) and poly(etheretherketone) PEEK implants induced by a BMP-2-delivering surface coating made of polyelectrolyte multilayer films. The in vitro bioactivity of the polyelectrolyte film-coated implants was assessed using the alkaline phosphatase assay. BMP-2-coated TA6V and PEEK implants with a total dose of 9.3 µg of BMP-2 were inserted into the femoral condyles of New Zealand white rabbits and compared to uncoated implants. Rabbits were sacrificed 4 and 8 weeks after implantation. Histomorphometric analyses on TA6V and PEEK implants and microcomputed tomography on PEEK implants revealed that the bone-to-implant contact and bone area around the implants were significantly lower for the BMP-2-coated implants than for the bare implants. This was confirmed by scanning electron microscopy imaging. This difference was more pronounced at 4 weeks in comparison to the 8-week time point. However, bone growth inside the hexagonal upper hollow cavity of the screws was higher in the case of the BMP-2 coated implants. Overall, this study shows that a high dose of BMP-2 leads to localized and temporary bone impairment, and that the dose of BMP-2 delivered at the surface of an implant needs to be carefully optimized. PMID:26965394

Effect of surface chemistry on the rate of osseointegration of sintered porous-surfaced Ti-6Al-4V implants.

PubMed

Taché, Alex; Gan, Lu; Deporter, Douglas; Pilliar, Robert M

2004-01-01

The effect of adding a thin sol-gel-formed calcium phosphate (CaP) coating to sintered porous-surfaced titanium alloy (Ti-6Al-4V) implants on rates of initial bone ingrowth was investigated. Control implants (as manufactured) and similar implants with sol-gel CaP coatings were randomly placed in distal femoral rabbit condyles (1 implant/leg). After healing for 6, 9, 12, and 16 days, 8 of 10 rabbits in each time group were assessed for maximum implant pullout force (N) and interface stiffness (N/mm). Selected extracted implants also were examined by secondary electron imaging to characterize affected surfaces. The implants of the remaining 2 rabbits in each group were examined by backscattered scanning electron microscopy (BSEM). Significantly greater pullout forces and interface stiffness were found for CaP-coated implants at 6 and 9 days. At 6 days, BSEM revealed bone ingrowth on CaP-coated implants but not on control implants. Secondary electron imaging and BSEM observations also suggested greater bone ingrowth with CaP-coated porous implants at 9, 12, and 16 days. Sol-gel-formed CaP surface films significantly enhance rates of bone ingrowth into sintered porous-surfaced implants. This surface treatment may have a number of clinical benefits, including shortening the period prior to functional loading of such implants and improving treatment outcomes in situations of poor bone quality and/or quantity. (More than 50 references).

Comparison of surface modified zirconia implants with commercially available zirconium and titanium implants: a histological study in pigs.

PubMed

Gredes, Tomasz; Kubasiewicz-Ross, Pawel; Gedrange, Tomasz; Dominiak, Marzena; Kunert-Keil, Christiane

2014-08-01

New biomaterials and their various surface modifications should undergo in vitro and in vivo evaluation before clinical trials. The objective of our in vivo study was to evaluate the biocompatibility of newly created zirconium implant surfaces after implantation in the lower jaw of pigs and compare the osseointegration of these dental implants with commercially available zirconium and titanium implants. After a healing period of 12 weeks, a histological analysis of the soft and hard tissues and a histomorphometric analysis of the bone-implant contact (BIC) were performed. The implant surfaces showed an intimate connection to the adjacent bone for all tested implants. The 3 newly created zirconium implant surfaces achieved a BIC of 45% on average in comparison with a BIC of 56% from the reference zirconium implants and 35% from titanium implants. Furthermore, the new zirconium implants had a better attachment to gingival and bone tissues in the range of implant necks as compared with the reference implants. The results suggest that the new implants comparably osseointegrate within the healing period, and they have a good in vivo biocompatibility.

Comparative Clinical Study of Conventional Dental Implants and Mini Dental Implants for Mandibular Overdentures: A Randomized Clinical Trial.

PubMed

Aunmeungtong, Weerapan; Kumchai, Thongnard; Strietzel, Frank P; Reichart, Peter A; Khongkhunthian, Pathawee

2017-04-01

Dental implant-retained overdentures have been chosen as the treatment of choice for complete mandibular removable dentures. Dental implants, such as mini dental implants, and components for retaining overdentures, are commercially available. However, comparative clinical studies comparing mini dental implants and conventional dental implants using different attachment for implant-retained overdentures have not been well documented. To compare the clinical outcomes of using two mini dental implants with Equator ® attachments, four mini dental implants with Equator attachments, or two conventional dental implants with ball attachments, by means of a randomized clinical trial. Sixty patients received implant-retained mandibular overdentures in the interforaminal region. The patients were divided into three groups. In Groups 1 and 2, two and four mini dental implants, respectively, were placed and immediately loaded by overdentures, using Equator ® attachments. In Group 3, conventional implants were placed. After osseointegration, the implants were loaded by overdentures, using ball attachments. The study distribution was randomized and double-blinded. Outcome measures included changes in radiological peri-implant bone level from surgery to 12 months postinsertion, prosthodontic complications and patient satisfaction. The cumulative survival rate in the three clinical groups after one year was 100%. There was no significant difference (p < 0.05) in clinical results regarding the number (two or four) of mini dental implants with Equator attachments. However, there was a significant difference in marginal bone loss and patient satisfaction between those receiving mini dental implants with Equator attachments and conventional dental implants with ball attachments. The marginal bone resorption in Group 3 was significantly higher than in Groups 1 and 2 (p < 0.05); there were no significant differences between Groups 1 and 2. There was no significant difference in patient satisfaction between Groups 1 and 2 but it was significantly higher than that in Group3 (p < 0.05). Two and four mini dental implants can be immediately used successfully for retaining lower complete dentures, as shown after a 1-year follow up. © 2016 Wiley Periodicals, Inc.

The true incidence of near-term postoperative complications in prosthetic breast reconstruction utilizing human acellular dermal matrices: a meta-analysis.

PubMed

Newman, Martin I; Swartz, Kimberly A; Samson, Michel C; Mahoney, Chris Brown; Diab, Khaled

2011-02-01

The use of human acellular dermal matrix (HADM) materials in prosthetic-based breast reconstruction has gained popularity in recent years. Questions remain, however, regarding the nature and incidence of postoperative complications associated with this technique. The results reported in the available literature vary widely. This meta-analysis examines this question further with a broad review of the available literature in an effort to better define the true nature and incidence of near-term complications associated with the use of HADM in prosthetic-based breast reconstruction. It does not aim to compare this method of reconstruction to others. A review of the available literature was performed in July 2009. The goal was to identify all previous works describing the placement of HADM at prosthetic-based breast reconstruction. Included were studies that documented the use of HADM for coverage of tissue expanders or permanent implants following therapeutic or prophylactic mastectomy. Excluded were studies that reported on the use of HADM in cosmetic breast surgery or studies that included the use of xenografts. Data collected included demographics as well as the nature and incidence of complications, with separate categories assigned for seroma, infection, flap necrosis, and "other." Data were analyzed using Comprehensive Meta-Analysis(®) software (Biostat, Englewood, NJ). Raw proportions, fixed-effect models, and random-effect models were used to assess the complication rates across studies. Eleven published articles and one abstract that was later published as an article were identified. Within these 12 studies, a total of 789 breasts were identified that had undergone reconstruction with HADM. The mean follow-up was 13.7 months. Under the random-effects model, the total complication rate was 12.0%. The most common complications were flap necrosis (3.3%), seroma (3.3%), and infection (5.6%). All complications not included in these categories were set apart in a separate category, "Other," and totaled 3.0% The true incidence of postoperative complications in the near term utilizing HADM in prosthetic-based breast reconstruction appears to be approximately 12%. The incidence of long-term complications such as capsular contracture remains unknown. However, as surgical experience with HADM grows, operative techniques designed at reducing risks will mature, strategies for managing complications will advance, and more advanced products designed to reduce the incidence of complications are likely to become available.

Macro design effects on stress distribution around implants: a photoelastic stress analysis.

PubMed

Ozkir, Serhat Emre; Terzioglu, Hakan

2012-01-01

Biomechanics is one of the main factors for achieving long-term success of implant supported prostheses. Long-term failures mostly depend on biomechanical complications. It is important to distinguish the effects of macro design of the implants. In this study, the photoelastic response of four different types of implants that were inserted with different angulations were comparatively analyzed. The implant types investigated were screw cylinder (ITI, Straumann AG, Basel, Switzerland), stepped cylinder (Frialit2, Friadent GmbH, Manheim, Germany), root form (Camlog Rootline, Alatatec, Wilshelm, Germany), and cylindrical implant, with micro-threads on the implant neck (Astra, AstraTech, Mölndal, Sweden). In the test models, one of the implants was inserted straight, while the other one was aligned mesially with 15° angles. The superstructures were prepared as single crowns. A 150N loading was applied to the restorations throughout the test. A comparison of the implant designs showed that there were no significant differences between the straight implants; however, between the inclined implants, the most favorable stress distribution was seen with the stepped cylinder implants. The least favorable stress concentration was observed around the root formed implants. Microthreads around the implant neck appeared to be effective in a homogenous stress distribution. Observations showed that misaligned implants caused less stress than straight implants, but the stress concentrations were not homogenous. As there were observable differences between the implant types, straight placed cylindrical implants showed better stress distribution characteristics, while inclined tapering implants had better stress distribution characteristics.

Long-Term Retrospective Clinical and Radiographic Follow-up of 205 Brånemark System Mk III TiUnite Implants Submitted to Either Immediate or Delayed Loading.

PubMed

Imburgia, Mario; Del Fabbro, Massimo

2015-10-01

Studies are needed to evaluate long-term performance of immediately loaded implants with moderately rough surface. This retrospective study evaluated long-term survival and periimplant soft and hard tissue conditions in patients treated with TiUnite implants. Forty-one consecutive patients (mean age, 52.6 years) received 205 Brånemark System Mk III TiUnite implants (145 maxillary, 60 mandibular). The indication was single tooth (n = 7 implants), partial (n = 94), or full arches (n = 104). One hundred thirteen implants were immediately loaded. Cumulative survival rate (CSR) of implants was assessed. Long-term marginal bone remodeling, probing pocket depth (PPD), and periimplant mucosa conditions were assessed. Follow-up averaged 8.8 years (range, 6.6-10.6 years). Eight implants in 5 patients failed. CSR was 96.1% (implant basis) and 87.8% (patient basis) up to 10 years. At the longest follow-up, bone loss averaged 0.43 ± 1.15 mm (n = 173), PPD averaged 3.64 ± 0.74 mm, and periimplant mucosa was healthy in 74.6% of cases. Furthermore, 50.3% and 35.5% of implants scored negative for plaque and bleeding, respectively. No significant difference in CSR and hard and soft tissue conditions was found in the long term between immediately and delayed loaded implants. Implants with TiUnite surface demonstrated excellent long-term survival, marginal bone response, and soft tissue conditions, despite a nonoptimal level of oral hygiene.

Poly-ε-caprolactone Coated and Functionalized Porous Titanium and Magnesium Implants for Enhancing Angiogenesis in Critically Sized Bone Defects.

PubMed

Roland, Laura; Grau, Michael; Matena, Julia; Teske, Michael; Gieseke, Matthias; Kampmann, Andreas; Beyerbach, Martin; Murua Escobar, Hugo; Haferkamp, Heinz; Gellrich, Nils-Claudius; Nolte, Ingo

2015-12-22

For healing of critically sized bone defects, biocompatible and angiogenesis supporting implants are favorable. Murine osteoblasts showed equal proliferation behavior on the polymers poly-ε-caprolactone (PCL) and poly-(3-hydroxybutyrate)/poly-(4-hydroxybutyrate) (P(3HB)/P(4HB)). As vitality was significantly better for PCL, it was chosen as a suitable coating material for further experiments. Titanium implants with 600 µm pore size were evaluated and found to be a good implant material for bone, as primary osteoblasts showed a vitality and proliferation onto the implants comparable to well bottom (WB). Pure porous titanium implants and PCL coated porous titanium implants were compared using Live Cell Imaging (LCI) with Green fluorescent protein (GFP)-osteoblasts. Cell count and cell covered area did not differ between the implants after seven days. To improve ingrowth of blood vessels into porous implants, proangiogenic factors like Vascular Endothelial Growth Factor (VEGF) and High Mobility Group Box 1 (HMGB1) were incorporated into PCL coated, porous titanium and magnesium implants. An angiogenesis assay was performed to establish an in vitro method for evaluating the impact of metallic implants on angiogenesis to reduce and refine animal experiments in future. Incorporated concentrations of proangiogenic factors were probably too low, as they did not lead to any effect. Magnesium implants did not yield evaluable results, as they led to pH increase and subsequent cell death.

The Prevalence of Dental Implants and Related Factors in Patients with Sjögren Syndrome: Results from a Cohort Study.

PubMed

Albrecht, Katinka; Callhoff, Johanna; Westhoff, Gisela; Dietrich, Thomas; Dörner, Thomas; Zink, Angela

2016-07-01

To investigate prevalence and patient-reported outcomes of dental implants in patients with Sjögren syndrome (SS). A total of 205 female patients from an observational cohort study answered oral health questionnaires about periodontal signs and symptoms, dentures, dental implants, comorbidities, and therapies that may interfere with bone remodeling. Data were compared with the reports of 87 female healthy controls. The patients were older than the controls (58 ± 12 and 54 ± 14 yrs, respectively) and differed substantially in the prevalence of self-reported gingivitis (60% and 35%), self-reported periodontitis (19% and 8%), and in the numbers of remaining teeth (21 ± 7 and 24 ± 5). Patients more frequently had removable prostheses (36% compared with 23%) and dental implants (16% compared with 7%). The 32 patients with SS with dental implants had a mean number of 3.1 ± 2.0 implants. Notably, for patients with implants, their oldest existing implant survived for a mean period of 4.9 ± 5.4 years. A total of 5 of 104 (4.8%) implants in the patients and none of the 14 implants in the controls had to be removed. A total of 75% of the patients were highly satisfied with the implants and 97% would recommend them to other patients with SS. A substantial portion of patients with SS have dental complications and require subsequent implants. The majority were satisfied with the implants and would recommend them to other patients. The high implant survival rate may encourage patients, rheumatologists, and dentists to consider dental implants for the treatment of patients with SS.

Further studies on the effects of magnetic resonance imaging fields on middle ear implants.

PubMed

Applebaum, E L; Valvassori, G E

1990-10-01

We investigated the effects of magnetic resonance imaging (MRI) fields on 21 stapedectomy prostheses and other middle ear implants and two different receiver-stimulator modules from 22-channel cochlear implants. None of the middle ear implants was displaced by the magnetic field, except for one platinum-stainless steel stapedectomy piston. Magnetism was not induced in any of the middle ear implants subjected to prolonged exposure in the MRI scanner. We conclude that MRI could pose a hazard to patients who have had stapedectomy using certain platinum-stainless steel piston prostheses and to patients with cochlear implants. Magnetic resonance imaging should pose no hazard to patients who have had the other middle ear implants reported on in this and our previous investigation.

The effect of microgeometry, implant thickness and polyurethane chemistry on the foreign body response to subcutaneous implants.

PubMed

Ward, W Kenneth; Slobodzian, Emily P; Tiekotter, Kenneth L; Wood, Michael D

2002-11-01

We addressed the effect of implant thickness, implant porosity, and polyurethane (PU) chemistry on angiogenesis and on the foreign body response in rats. The following materials were implanted subcutaneously for 7 weeks then excised for histologic analysis: a solid PU; a solid polyurethane with silicone and polyethylene oxide (PU-S-PEO); porous expanded polytetrafluoroethylene (ePTFE); and porous polyvinyl alcohol sponge (PVA). Two thicknesses of PU-S-PEO were compared: 300 microns (thin) and 2000 microns (thick). Foreign body capsule (FBC) thickness was much less in PU-S-PEO implants than in PU implants. In addition, FBC were thinner in thin implants than in thick implants. FBC was much more dense in solid implants than in porous implants. As compared with solid implants, porous implants (PVA and ePTFE) led to a marked increase in the number of microvessels that developed adjacent to the implant, as observed both with hematoxylin/eosin staining and with an immunohistochemical anti-endothelial stain. We conclude that the polyethylene oxide and silicone moieties in PU reduce the thickness of the subsequent FBC. In addition, thin implants lead to a thin FBC. Porous implants (PVA and ePTFE) cause more angiogenesis than solid implants. These results may have implications for the measurement of blood-derived analytes by biosensors.

In vivo response of laser processed porous titanium implants for load-bearing implants

PubMed Central

Bandyopadhyay, Amit; Shivaram, Anish; Tarafder, Solaiman; Sahasrabudhe, Himanshu; Banerjee, Dishary; Bose, Susmita

2016-01-01

Applications of porous metallic implants to enhance osseointegration of load-bearing implants are increasing. In this work, porous titanium implants, with 25 volume% porosity, were manufactured using Laser Engineered Net Shaping (LENS™) to measure the influence of porosity towards bone tissue integration in vivo. Surfaces of the LENS™ processed porous Ti implants were further modified with TiO2 nanotubes to improve cytocompatibility of these implants. We hypothesized that interconnected porosity created via additive manufacturing will enhance bone tissue integration in vivo. To test our hypothesis, in vivo experiments using a distal femur model of male Sprague-Dawley rats were performed for a period of 4 and 10 weeks. In vivo samples were characterized via micro-computed tomography (CT), histological imaging, scanning electron microscopy, and mechanical push-out tests. Our results indicate that porosity played an important role to establish early stage osseointegration forming strong interfacial bonding between the porous implants and the surrounding tissue, with or without surface modification, compared to dense Ti implants used as a control. PMID:27307009

Effect of Macrogeometry on the Surface Topography of Dental Implants.

PubMed

Naves, Marina Melo; Menezes, Helder Henrique Machado; Magalhães, Denildo; Ferreira, Jessica Afonso; Ribeiro, Sara Ferreira; de Mello, José Daniel Biasoli; Costa, Henara Lillian

2015-01-01

Because the microtopography of titanium implants influences the biomaterial-tissue interaction, surface microtexturing treatments are frequently used for dental implants. However, surface treatment alone may not determine the final microtopography of a dental implant, which can also be influenced by the implant macrogeometry. This work analyzed the effects on surface roughness parameters of the same treatment applied by the same manufacturer to implants with differing macro-designs. Three groups of titanium implants with different macro-designs were investigated using laser interferometry and scanning electron microscopy. Relevant surface roughness parameters were calculated for different regions of each implant. Two flat disks (treated and untreated) were also investigated for comparison. The tops of the threads and the nonthreaded regions of all implants had very similar roughness parameters, independent of the geometry of the implant, which were also very similar to those of flat disks treated with the same process. In contrast, the flanks and valleys of the threads presented larger irregularities (Sa) with higher slopes (Sdq) and larger developed surface areas (Sdr) on all implants, particularly for implants with threads with smaller heights. The flanks and valleys displayed stronger textures (Str), particularly on the implants with threads with larger internal angles. Parameters associated with the height of the irregularities (Sa), the slope of the asperities (Sdq), the presence of a surface texture (Str), and the developed surface area of the irregularities (Sdr) were significantly affected by the macrogeometry of the implants. Flat disks subjected to the same surface treatment as dental implants reproduced only the surface topography of the flat regions of the implants.

Metallic orthopaedic implants and airport metal detectors.

PubMed

Kamineni, S; Legge, S; Ware, H

2002-01-01

Airport security can detect in vivo metallic implants. We hypothesized that a soft tissue shield and fast transit through archway detectors would decrease implant detectability, whereas greater implant mass would increase detectability. Twelve patients with 8 orthopaedic implants in vivo and 60 trauma and arthroplasty implants in vitro were subjected to standard airport security measures at Stanstead Airport (British Airports Authority), including arch and standard and nonstandard hand-held detectors. Archway detectors failed to detect some implants; hand-held detectors detected almost all implants except an ankle arthroplasty. Positive archway detection was related to implant transit speed through the detection field. The implant mass consistently affected detection in stainless steel and titanium implants, and a 1-inch wax shield had no effect. Patients with metallic implants should prepare routinely with documentation of their implant before traveling through security ports.

Conservative mastectomies and immediate reconstruction with the use of ADMs.

PubMed

Govshievich, Alexander; Somogyi, Ron B; Brown, Mitchell H

2015-12-01

In recent years, a novel approach to immediate breast reconstruction has been introduced with the advent of acellular dermal matrix (ADM). In the setting of conservative mastectomies where the native skin envelope is preserved, placement of ADM at the lower pole in continuity with the pectoralis major muscle (PMM) provides additional support, allowing direct-to-implant breast reconstruction. The following manuscript presents the senior author's experience with ADM-assisted reconstruction and provides a detailed description of surgical technique along with a comprehensive discussion of patient selection and potential complications. A retrospective chart review of patients undergoing direct-to-implant breast reconstruction following skin sparing or nipple sparing mastectomy with the use of ADM (AlloDerm; LifeCell Corp., Branchburg, USA) was conducted at Women's College Hospital in Toronto over a 5-year period [2008-2013]. Demographic data, previous radiation therapy and post-operative complications were recorded. A total of 72 patients representing 119 breasts were identified. Average follow-up was 16 months (range, 3-51 months). Twenty-seven complications were recorded for a complication rate of 22.7% (27/119). Complications included six cases of capsular contracture (Baker III/IV), five cases of red skin syndrome, four cases of rippling, three cases of dehiscence and two cases of seroma. Overall, direct-to-implant reconstruction was successfully completed in 97.5% of breasts (116/119). One case of infection was treated with explantation and conversion to autogenous reconstruction. Two breasts with tissue necrosis or dehiscence had the implants removed and replaced with tissue expanders. Overall reoperation rate was 9.7% (7/72 patients). ADM assisted direct-to-implant breast reconstruction has been shown to be a safe option for women who are candidates for skin sparing or nipple sparing mastectomies. Judicious patient selection, effective collaboration between the oncologic and reconstructive surgeon, careful evaluation of post-mastectomy skin flaps and precise surgical technique are paramount to the success of this technique.

Clinical and radiological investigations of mandibular overdentures supported by conventional or mini-dental implants: A 2-year prospective follow-up study.

PubMed

Temizel, Sonay; Heinemann, Friedhelm; Dirk, Cornelius; Bourauel, Christoph; Hasan, Istabrak

2017-02-01

Conventional dental implants are not applicable in the mandibular interforaminal region if bone volume is limited. Mini-dental implants offer an alternative means of supporting mandibular overdentures in a narrow residual ridge, without additional surgery. The purpose of this nonrandomized clinical trial was to compare the ability of mini-dental implants with that of conventional dental implants in supporting mandibular overdentures during a 2-year clinical follow-up. Bone quality, bone resorption, implant stability, and oral health were assessed radiographically. A total of 32 participants with edentulism were included. Twenty-two participants (99 implants) received 4 to 5 mini-dental implants (diameter: 1.8-2.4 mm; length: 13-15 mm, study group), and 10 participants (35 implants) received 2 to 4 conventional dental implants (diameter: 3.3-3.7 mm; length: 11-13 mm, control group). The selection of the participants in the study or control group was based on the available bone volume in the mandible. The selection was not randomized. The density of cortical bone thickness was measured in Hounsfield units (HU) from computed tomography data, and patients were followed for 2 years. The participants were examined 3, 6, 12, and 24 months after surgery. Primary stability immediately after the insertion of dental implants (Periotest), secondary stability 6 months after implantation, modified plaque, bleeding on probing indices, and probing depth were measured and analyzed statistically (α=.05). The mean HU value 6 months after implantation in the participants who received mini-dental implants was significantly (P=.035) higher (1250 HU) than that in the participants who received conventional dental implants (1100 HU). The probing depths around the conventional dental implants (1.6 and 1.8 mm, respectively) were significantly higher than those around the mini-dental implants (1.3 and 1.2 mm, respectively) 12 and 24 months after surgery, respectively (P<.001). The mean primary and secondary stability values for conventional dental implants were -4.0 and -4.9, respectively. The primary and secondary stability values for the mini-dental implants were -0.3 and -1.4, respectively. The Periotest values of the primary (measured immediately after implant insertion) and secondary implant stabilities (measured 6 months after implant insertion) were significantly higher for the conventional dental implants than for the mini-dental implants (P<.001). Based on this 2-year clinical trial, patients receiving mini-dental implants had clinical outcomes similar to those of patients receiving conventional dental implants to support overdenture prostheses. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Use of low-energy hydrogen ion implants in high-efficiency crystalline-silicon solar cells

NASA Technical Reports Server (NTRS)

Fonash, S. J.; Sigh, R.; Mu, H. C.

1986-01-01

The use of low-energy hydrogen implants in the fabrication of high-efficiency crystalline silicon solar cells was investigated. Low-energy hydrogen implants result in hydrogen-caused effects in all three regions of a solar cell: emitter, space charge region, and base. In web, Czochralski (Cz), and floating zone (Fz) material, low-energy hydrogen implants reduced surface recombination velocity. In all three, the implants passivated the space charge region recombination centers. It was established that hydrogen implants can alter the diffusion properties of ion-implanted boron in silicon, but not ion-implated arsenic.

Dental implants in patients with ectodermal dysplasia: A systematic review.

PubMed

Chrcanovic, Bruno Ramos

2018-05-21

This study sought to assess the clinical outcome and survival rate of oral implants placed in individuals with ectodermal dysplasia (ED), based on previously published studies. An electronic search without time restrictions was undertaken in 5 databases (PubMed/Medline, Web of Science, ScienceDirect, J-Stage, Lilacs). Descriptive statistics, Kaplan Meier estimator and implant failure probability were calculated. 90 publications were included, reporting 228 ED patients that received 1472 implants (1392 conventional, 47 zygomatic, 33 mini-implants). Mean age of the patients was 20.2 ± 6.8 years (2-56). Patients had a mean of 3.2 ± 2.5 maxillary and 2.1 ± 2.6 mandibular permanent teeth (min-max, 0-14). Patients received a mean of 8.2 ± 3.8 implants (1-20). Most implants were placed in the third decade of life, 24.6% of the implants were placed in children (0-17 years of age). 1391 implants had information on follow-up (72 failures, 5.2%). The 20-year CSR was 84.6%. The probability of failure was 4.5% (95%CI 3.5%-5.6%, p < 0.001). Additional treatments performed were Le Fort I (99 implants, 20 patients, 3.5% failed), grafting (497 implants, 77 patients, 5.2% failed), distraction osteogenesis (79 implants, 16 patients, 10.1% failed). Mean follow-up was 42.9 ± 41.9 months (min-max, 2-240). Dental implants placed in ED patients, either infants or adults, present a high survival rate (20-year CSR 84.6%). Copyright © 2018 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Displacement of dental implants in trabecular bone under a static lateral load in fresh bovine bone.

PubMed

Engelke, Wilfried; Müller, Alois; Decco, Oscar A; Rau, María J; Cura, Andrea C; Ruscio, Mara L; Knösel, Michael

2013-04-01

The study aims to provide objective data for the displacement of titanium screw implants in trabecular bone specimens. One hundred Semados implants (Bego, Bremen, Germany) were inserted in bovine type IV bone specimens. All implants had a diameter of 3.75 mm; 50 implants had a length of 8.5 mm and 50 implants had a length of 15 mm. Insertion torque was determined at intervals of 10, 20, and 30 Ncm. Implants were loaded horizontally with 10, 20, and 30 N for 2 seconds. An indicator strip was attached to the implant abutment to allow direct observation of implant movement relative to the bone surface. Horizontal displacement was assessed with an accuracy of measurement of 10 µm. Seven implants got lost by visible loosening. Degree of displacement was subject to evaluation with all others. Those implants showed a mean displacement of 59 µm for 10 N (n = 100), 173 µm for 20 N (n = 99), and 211 µm for 30 N (n = 93). The mean displacement of 15-mm implants (16, 37, 51 µm) was significantly lower compared with 8.5-mm implants (103, 311, 396 µm) corresponding to 10, 20, and 30 N as lateral loads. Displacement of screw implants in trabecular bone can be detected and visualized using commercially available endoscopes with a high magnification. A lateral load of 20 N indicates a mean displacement of over 100 µm and therefore results in a critical displacement. © 2011 Wiley Periodicals, Inc.

Drug delivery system and breast cancer cells

NASA Astrophysics Data System (ADS)

Colone, Marisa; Kaliappan, Subramanian; Calcabrini, Annarica; Tortora, Mariarosaria; Cavalieri, Francesca; Stringaro, Annarita

2016-06-01

Recently, nanomedicine has received increasing attention for its ability to improve the efficacy of cancer therapeutics. Nanosized polymer therapeutic agents offer the advantage of prolonged circulation in the blood stream, targeting to specific sites, improved efficacy and reduced side effects. In this way, local, controlled delivery of the drug will be achieved with the advantage of a high concentration of drug release at the target site while keeping the systemic concentration of the drug low, thus reducing side effects due to bioaccumulation. Various drug delivery systems such as nanoparticles, liposomes, microparticles and implants have been demonstrated to significantly enhance the preventive/therapeutic efficacy of many drugs by increasing their bioavailability and targetability. As these carriers significantly increase the therapeutic effect of drugs, their administration would become less cost effective in the near future. The purpose of our research work is to develop a delivery system for breast cancer cells using a microvector of drugs. These results highlight the potential uses of these responsive platforms suited for biomedical and pharmaceutical applications. At the request of all authors of the paper an updated version was published on 12 July 2016. The manuscript was prepared and submitted without Dr. Francesca Cavalieri's contribution and her name was added without her consent. Her name has been removed in the updated and re-published article.

The plastic surgery postcode lottery in England.

PubMed

Henderson, James

2009-12-01

The National Health Service (NHS) provides treatment free at the point of delivery to patients. Elective medical procedures in England are funded by 149 independent Primary Care Trusts (PCTs), which are each responsible for patients within a defined geographical area. There is wide variation of availability for many treatments, leading to a "postcode lottery" for healthcare provision in England. The aims were to review funding policies for cosmetic procedures, to evaluate the criteria used to decide eligibility against national guidelines, and to evaluate the extent of any postcode lottery for cosmetic surgery on the National Health Service. This study is the first comprehensive review of funding policies for cosmetic surgery in England. All PCTs in England were asked for their funding policies for cosmetic procedures including breast reduction & augmentation, removal of implants, mastopexy, abdominoplasty, facelift, blepharoplasty, rhinoplasty, pinnaplasty, body lifting, surgery for gynaecomastia and tattoo removal. Details of policies were received from 124/149 PCTs (83%). Guidelines varied widely; some refuse all procedures, whilst others allow a full range. Different and sometimes contradictory rules governing symptoms, body mass indices, breast sizes, weights, heights, and other criteria are used to assess patients for funding. Nationally produced guidelines were only followed by nine PCTs. A "postcode lottery" exists in the UK for plastic surgery procedures, despite national guidelines. Some of the more interesting findings are highlighted.

Osseointegration of titanium implants functionalised with phosphoserine-tethered poly(epsilon-lysine) dendrons: a comparative study with traditional surface treatments in sheep.

PubMed

Stübinger, Stefan; Nuss, Katja; Bürki, Alexander; Mosch, Isabel; le Sidler, Miché; Meikle, Steve T; von Rechenberg, Brigitte; Santin, Matteo

2015-02-01

The aim of this study was to analyse the osseointegrative potential of phosphoserine-tethered dendrons when applied as surface functionalisation molecules on titanium implants in a sheep model after 2 and 8 weeks of implantation. Uncoated and dendron-coated implants were implanted in six sheep. Sandblasted and etched (SE) or porous additive manufactured (AM) implants with and without additional dendron functionalisation (SE-PSD; AM-PSD) were placed in the pelvic bone. Three implants per group were examined histologically and six implants were tested biomechanically. After 2 and 8 weeks the bone-to-implant contact (BIC) total values of SE implants (43.7±12.2; 53.3±9.0%) and SE-PSD (46.7±4.5; 61.7±4.9%) as well as AM implants (20.49±5.1; 43.9±9.7%) and AM-PSD implants (19.7±3.5; 48.3±15.6%) showed no statistically significant differences. For SE-PSD and AM-PSD a separate analysis of only the cancellous BIC demonstrated a statistically significant difference after 2 and 8 weeks. Biomechanical findings proved the overall increased stability of the porous implants after 8 weeks. Overall, the great effect of implant macro design on osseointegration was further supported by additional phosphoserine-tethered dendrons for SE and AM implants.

A retrospective study of sintered porous-surfaced dental implants in restoring the edentulous posterior mandible: up to 9 years of functioning.

PubMed

Sohn, Dong-Seok; Kim, Woo-Sung; Lee, Won-Hyuk; Jung, Heui-Seung; Shin, Im-Hee

2010-10-01

The aim of this retrospective study was to evaluate the survival rate of sintered porous-surfaced implants placed in the edentulous posterior mandibles, in relation to implant length and diameter, crown-to-implant ratio, and types of prostheses, for a maximum of 9 years of functioning (mean: 55.8 months; range: 5-108 months). The study group consisted of 43 partially edentulous patients who visited Catholic University Hospital of Daegu and 1 private dental clinic. A total of 122 sintered porous-surfaced implants--Endopore (Innova Life Sciences, Toronto, Ontario, Canada)--were placed in the edentulous posterior mandibles. Two diameter sizes (4.1 and 5.0 mm) and 4 lengths (5.0, 7.0, 9.0, and 12.0 mm) were used. All implants were restored with fixed prostheses. One hundred three implants were splinted and 21 implants were nonsplinted. Panoramic views and periapical radiographs were taken at the time of the first, postoperative, crown placement, and following checkup visits. The survival rates of the implants in relation to length, diameter, crown-to-implant ratio, and types of prostheses were investigated. Statistical data were analyzed using SPSS Win.Ver 14.0 software with the χ² test. The survival rate of the 4.1-mm-diameter implants was 100% and 91.2% for the 5.0-mm-diameter implants. The survival rates of the implants of differing diameters were found to be statistically different (P = 0.005). The survival rates of both the 5.0-mm and 7.0-mm-length implants were 100%. The survival rate of the 9.0-mm-length implants was 97.9% and for the 12.0-mm-length implants was 95.1%. There was no statistical difference in survival rates for the differing lengths of implants. Of the 103 prostheses that were splinted, the survival rate was 98.0%. The survival rate of splinted prostheses was higher than that of the nonsplinted prostheses but was found to be not statistically different. There were no failed cases when the crown-to-implant ratio was <1.0. When the crown-to-implant ratio was between 1.0 and 1.4, the failure rate of the implants was 6.7%. No failure was recorded with the ratio range of 1.5 to 2.0. Relative to the crown-to-implant ratio of 1.0, the failure rates were statistically different (P = 0.048). The cumulative survival rate of the porous-surfaced implants placed in the edentulous posterior mandibles was 97.5%. Short porous-surfaced implants showed satisfactory results after a maximum of 9 years of functioning in the edentulous posterior mandibles.

Evaluation of 39 medical implants at 7.0 T

PubMed Central

Feng, David X; McCauley, Joseph P; Morgan–Curtis, Fea K; Salam, Redoan A; Pennell, David R; Loveless, Mary E

2015-01-01

Objective: With increased signal to noise ratios, 7.0-T MRI has the potential to contribute unique information regarding anatomy and pathophysiology of a disease. However, concerns for the safety of subjects with metallic medical implants have hindered advancement in this field. The purpose of the present research was to evaluate the MRI safety for 39 commonly used medical implants at 7.0 T. Methods: Selected metallic implants were tested for magnetic field interactions, radiofrequency-induced heating and artefacts using standardized testing techniques. Results: 5 of the 39 implants tested may be unsafe for subjects undergoing MRI at 7.0 T. Conclusion: Implants were deemed either “MR Conditional” or “MR Unsafe” for the 7.0-T MRI environment. Further research is needed to expand the existing database categorizing implants that are acceptable for patients referred for MRI examinations at 7.0 T. Advances in knowledge: Lack of MRI testing for common metallic medical implants limits the translational potential of 7.0-T MRI. For safety reasons, patients with metallic implants are not allowed to undergo a 7.0-T MRI scan, precluding part of the population that can benefit from the detailed resolution of ultra-high-field MRIs. This investigation provides necessary MRI testing of common medical implants at 7.0 T. PMID:26481696

KRAS, BRAF genotyping reveals genetic heterogeneity of ovarian borderline tumors and associated implants

PubMed Central

2013-01-01

Background Patients diagnosed for a serous ovarian borderline tumor (s-BOT) typically present with an excellent clinical outcome. However there have been controversies concerning the prognostic impact of so-called implants, an extra ovarian spread occurring alongside the s-BOT in certain cases. It remains obscure whether these implants actually resemble metastasis owning the same genetic pattern as the ovarian primary or whether they develop independently. Methods The current study, in the aim of further clarifying the genetic origin of implants, assessed BRAF/KRAS hot spot mutations and the p53/p16INK4a immunophenotype of s-BOTs and corresponding implants (n = 49) of 15 patients by pyro-sequencing and immunostaining, respectively. Results A significant proportion of both s-BOTs and implants showed KRAS or BRAF mutation and though p16INK4a was found to be abundantly expressed, p53 immunoreactivity was rather low. When genotypes of BRAF/KRAS mutated s-BOTs and corresponding implants were compared no patient presented with a fully matching mutation profile of s-BOTs and all corresponding implants. Conclusions The current study reveals genetic heterogeneity of s-BOTs and implants, as none of the markers examined showed constant reciprocity. Hence, our findings may assist to explain the different clinical presentation of s-BOTs and implants and might encourage to applying more individualized follow up protocols. PMID:24139521

Histologic analysis of resorbable blasting media surface implants retrieved from humans: a report of two cases

PubMed Central

2016-01-01

The purpose of this study is to evaluate the degree of osseointegration of resorbable blasting media (RBM) surface implants retrieved from humans. Three implants in the mandibular molar region that were surface-treated with RBM were retrieved from two patients. The implants were used to manufacture specimens in order to measure the bone-implant contact (BIC) ratio. The BIC ratios of the three implants were found to be an average of 69.0%±9.1%. In conclusion, that RBM surface implants are integrated into the host environment with histological significance and the BIC ratio of the RBM surface-treated implant was not significantly different from that of other surface-treated implants. PMID:26904493

SU-E-I-63: Quantitative Evaluation of the Effects of Orthopedic Metal Artifact Reduction (OMAR) Software On CT Images for Radiotherapy Simulation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jani, S

Purpose: CT simulation for patients with metal implants can often be challenging due to artifacts that obscure tumor/target delineation and normal organ definition. Our objective was to evaluate the effectiveness of Orthopedic Metal Artifact Reduction (OMAR), a commercially available software, in reducing metal-induced artifacts and its effect on computed dose during treatment planning. Methods: CT images of water surrounding metallic cylindrical rods made of aluminum, copper and iron were studied in terms of Hounsfield Units (HU) spread. Metal-induced artifacts were characterized in terms of HU/Volume Histogram (HVH) using the Pinnacle treatment planning system. Effects of OMAR on enhancing our abilitymore » to delineate organs on CT and subsequent dose computation were examined in nine (9) patients with hip implants and two (2) patients with breast tissue expanders. Results: Our study characterized water at 1000 HU with a standard deviation (SD) of about 20 HU. The HVHs allowed us to evaluate how the presence of metal changed the HU spread. For example, introducing a 2.54 cm diameter copper rod in water increased the SD in HU of the surrounding water from 20 to 209, representing an increase in artifacts. Subsequent use of OMAR brought the SD down to 78. Aluminum produced least artifacts whereas Iron showed largest amount of artifacts. In general, an increase in kVp and mA during CT scanning showed better effectiveness of OMAR in reducing artifacts. Our dose analysis showed that some isodose contours shifted by several mm with OMAR but infrequently and were nonsignificant in planning process. Computed volumes of various dose levels showed <2% change. Conclusions: In our experience, OMAR software greatly reduced the metal-induced CT artifacts for the majority of patients with implants, thereby improving our ability to delineate tumor and surrounding organs. OMAR had a clinically negligible effect on computed dose within tissues. Partially funded by unrestricted educational grant from Philips.« less

Bone morphology changes around two types of bone-level implants installed in fresh extraction sockets--a histomorphometric study in Beagle dogs.

PubMed

Alharbi, Hend M; Babay, Nadir; Alzoman, Hamad; Basudan, Sumaya; Anil, Sukumaran; Jansen, John A

2015-09-01

Minimizing crestal bone loss following immediate implant placement is considered the most challenging aspect in implant therapy. Implant surface topography and chemical modifications have been shown to influence the success of Osseointegration. The Straumann Bone Level implant, featuring SLActive surface, has been introduced with the aim of enhancing bone apposition. Similarly, the OsseoSpeed implants from Astra Tech claim to have an enhanced osseointegration. Because of the specific features in the implant design, both companies claim that crestal resorption is minimal with these implants. To evaluate the osseointegration and crestal bone level following immediate placement of Straumann Bone Level implant and OsseoSpeed implants in fresh extraction sockets in Beagle dogs. The distal roots of the second, third and fourth premolars were extracted in both sides of the mandible. The distal roots were removed using a dental elevator. A total of 60 fixtures were installed in 10 Beagle dogs. Two types of implants were used: Straumann Bone-Level implants, which were 8 × 3.3 mm in size, and Astra Tech OsseoSpeed 3.5 S MicroThread implants, which were 8 × 3.5 mm in size. The histomorphometrical evaluation was performed at the end of 4- and 12-week healing. The implant-bone contact and bone volume percentage were assessed. The bone-to-implant contact (BIC) and the bone volume did not show any significant changes for both types of implants. The OsseoSpeed™ implants showed 67.4% and 65.3% BIC, respectively, at 4 and 12 weeks compared with 71.7 and 73.1 for the Straumann Bone-Level implants. The bone volume around both types of implants did not differ significantly at both time periods. The crestal bone resorption was observed for both types of implants. The first BIC at buccal side and lingual side of the implants also did not differ significantly for both implant systems. This study showed that Straumann Bone Level and OsseoSpeed implants induced similar bone response after immediate implantation at 4 and 12 weeks. The immediate implant placement resulted in peri-implant crestal bone-level changes for both types of implants. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Effect of implant position, angulation, and attachment height on peri-implant bone stress associated with mandibular two-implant overdentures: a finite element analysis.

PubMed

Hong, Hae Ryong; Pae, Ahran; Kim, Yooseok; Paek, Janghyun; Kim, Hyeong-Seob; Kwon, Kung-Rock

2012-01-01

The aim of this study was to analyze and compare the level and distribution of peri-implant bone stresses associated with mandibular two-implant overdentures with different implant positions. Mathematical models of mandibles and overdentures were designed using finite element analysis software. Two intraosseous implants and ball attachment systems were placed in the interforaminal region. The overdenture, which was supported by the two implants, was designed to withstand bilateral and unilateral vertical masticatory loads (total 100 N). In all, eight types of models, which differed according to assigned implant positions, height of attachments, and angulation, were tested: MI (model with implants positioned in the lateral incisor sites), MC (implants in canine sites), MP (implants in premolar sites), MI-Hi (greater height of attachments), MC-M (canine implants placed with mesial inclination), MC-D (canine implants placed with distal inclination), MC-B (canine implants placed with buccal inclination), and MC-L (canine implants placed with lingual inclination). Peri-implant bone stress levels associated with overdentures retained by lateral incisor implants resulted in the lowest stress levels and the highest efficiency in distributing peri-implant stress. MI-Hi showed increased stress levels and decreased efficiency in stress distribution. As the implants were inclined, stress levels increased and the efficiency of stress distribution decreased. Among the inclined models, MC-B showed the lowest stress level and best efficiency in stress distribution. The lowest stress and the best stability of implants in mandibular two-implant overdentures were obtained when implants were inserted in lateral incisor areas with shorter attachments and were placed parallel to the long axes of the teeth.

Percutaneous Implants with Porous Titanium Dermal Barriers: An In Vivo Evaluation of Infection Risk

PubMed Central

Isackson, Dorthyann; McGill, Lawrence D.; Bachus, Kent N.

2010-01-01

Osseointegrated percutaneous implants are a promising prosthetic alternative for a subset of amputees. However, as with all percutaneous implants, they have an increased risk of infection since they breach the skin barrier. Theoretically, host tissues could attach to the metal implant creating a barrier to infection. When compared with smooth surfaces, it is hypothesized that porous surfaces improve the attachment of the host tissues to the implant, and decrease the infection risk. In this study, 4 titanium implants, manufactured with a percutaneous post and a subcutaneous disk, were placed subcutaneously on the dorsum of eight New Zealand White rabbits. Beginning at four weeks post-op, the implants were inoculated weekly with 108 CFU Staphylococcus aureus until signs of clinical infection presented. While we were unable to detect a difference in the incidence of infection of the porous metal implants, smooth surface (no porous coating) percutaneous and subcutaneous components had a 7-fold increased risk of infection compared to the implants with a porous coating on one or both components. The porous coated implants displayed excellent tissue ingrowth into the porous structures; whereas, the smooth implants were surrounded with a thick, organized fibrotic capsule that was separated from the implant surface. This study suggests that porous coated metal percutaneous implants are at a significantly lower risk of infection when compared to smooth metal implants. The smooth surface percutaneous implants were inadequate in allowing a long-term seal to develop with the soft tissue, thus increasing vulnerability to the migration of infecting microorganisms. PMID:21145778

Effect of implant macro-design on primary stability: A prospective clinical study.

PubMed

Lozano-Carrascal, Naroa; Salomó-Coll, Oscar; Gilabert-Cerdà, Marta; Farré-Pagés, Nuria; Gargallo-Albiol, Jordi; Hernández-Alfaro, Federico

2016-03-01

Implant restorations have become a high predictable treatment option. Several caracteristics such as surgical technique and implant design can influence the treatment outcomes. The aim of the present study was to evaluate the influence of implant macro-design on primary stability measured with resonance frequency analysis (RFA) and insertion torque (IT). Material and Mehods: A total of 47 implants divided in two groups: Test group (TI): 22 Tapered MIS® Seven implants; Control group (CI): 25 cylindrical Astra® Osseospeed implants. All implants were inserted following the manufacturers' standard protocols. Implant primary stability was measured at the moment of implant placement by registering insertion torque values (ITv) and ISQ values by means of Osstell™ Mentor (ISQv) (Integration Diagnostic Ltd., Goteborg, Sweden). In the mandible, mean ISQv for tapered implants (TI) was 71.67±5.16 and for cylindrical implants (CI) 57.15±4.83 (p=0.01). Mean insertion torque was 46.67±6.85 Ncm for TI and 35.77±6.72 Ncm for CI (p=0.01). In the maxilla, mean ISQ was 67.2±4.42 for tapered implants and 49.17±15.30 for cylindrical implants (p=0.01). Mean insertion torque for TI was 41.5±6.26 Ncm and for CI 39.17±6.34 Ncm (p>0.05). For tapered implants, no correlation could be found between implant diameter and primary stability. But for cylindrical implants there was a statistically significant correlation between implant diameter and primary stability: ITv (p=0.03); ISQv (p=0.04). Within the limits of the present study, tapered shaped implants achieve higher primary stability measured through ISQ and insertion torque values. Moreover, for cylindrical implants positive correlation has been established between implant diameter and primary stability.

Machined versus roughened immediately loaded and finally restored single implants inserted flapless: Preliminary 6-month data from a split- mouth randomised controlled trial.

PubMed

Cannizzaro, Gioacchino; Felice, Pietro; Loi, Ignazio; Viola, Paolo; Ferri, Vittorio; Leone, Michele; Lazzarini, Matteo; Trullenque-Eriksson, Anna; Esposito, Marco

To compare the outcome of immediately loaded single implants with a machined or a roughened surface. Fifty patients had two implant sites randomly allocated to receive flaplessplaced single Syra implants (Sweden & Martina), one with a machined and one with a roughened surface (sand-blasted with zirconia powder and acid etched), according to a split-mouth design. To be loaded immediately, implants had to be inserted with a torque superior to 50 Ncm. Implants were restored with definitive crowns in direct occlusal contact within 48 h. Patients were followed for 6 months after loading. Outcome measures were prosthetic and implant failures and complications. Two machined implants and four roughened implants were not loaded immediately. Six months after loading no dropout occurred. One implant loaded late, which had a rough implant surface, failed 20 days after loading (P (McNemar test) = 0.625; difference in proportions = -0.04; 95% CI: -0.15 to 0.07). Three crowns had to be remade on machined implants and four on roughened implants (P (McNemar test) = 1.000; difference in proportions = -0.02; 95% CI: -0.12 to 0.08). Three machined and five roughened implants experienced complications (P (McNemar test) = 0.625; difference in proportions = -0.04; 95% CI: -0.15 to 0.07). There were no statistically significant differences between groups for crown and implant losses as well as complications. Up to 6 months after loading both machined and roughened flapless-placed and immediately loaded single implants provided good and similar results, however, longer follow-ups are needed to evaluate the long-term prognosis of implants with different surfaces.

Effect of cyclic loading and retightening on reverse torque value in external and internal implants

PubMed Central

Cho, Woong-Rae; Huh, Yoon-Hyuk; Park, Chan-Jin

2015-01-01

PURPOSE The aim of this study was to evaluate the effect of cyclic loading and screw retightening on reverse torque value (RTV) in external and internal type implants. MATERIALS AND METHODS Cement-retained abutments were connected with 30 Ncm torque to external and internal type implants. Experimental groups were classified according to implant connection type and retightening/loading protocol. In groups with no retightening, RTV was evaluated after cyclic loading for 100,000 cycles. In groups with retightening, RTV was measured after 3, 10, 100 cycles as well as every 20,000 cycles until 100,000 cycles of loading. RESULTS Every group showed decreased RTV after cyclic loading. Before and after cyclic loading, external type implants had significantly higher RTVs than internal type implants. In external type implants, retightening did not affect the decrease in RTV. In contrast, retightening 5 times and retightening after 10 cycles of dynamic loading was effective for maintaining RTV in internal type implants. CONCLUSION Retightening of screws is more effective in internal type implants than external type implants. Retightening of screws is recommended in the early stage of functional loading. PMID:26330975

Scientific Fundamentals and Technological Development of Novel Biocompatible/Corrosion Resistant Ultrananocrystalline Diamond (UNCD) Coating Enabling Next Generation Superior Metal-Based Dental Implants

NASA Astrophysics Data System (ADS)

Kang, Karam

Current Ti-based dental implants exhibit failure (2-10%), due to various mechanisms, including chemical corrosion of the surface of the TiO2 naturally covered Ti-based implants. This thesis focused on developing a unique biocompatible/bio-inert/corrosion resistant/low cost Ultrananocrystalline Diamond (UNCD) coating (with 3-5 nm grain size) for encapsulation of Tibased micro-implants to potentially eliminate the corrosion/mechanical induced failure of current commercial Ti-based dental implants. Microwave Plasma Chemical Vapor Deposition (MPCVD) and Hot Filament Chemical Vapor Deposition (HFCVD) processes were used to grow UNCD coatings. The surface topography and chemistry of UNCD coatings were characterized using scanning electron microscopy (SEM), Raman, and X-ray photoelectron spectroscopies (XPS) respectively. In conclusion, this thesis contributed to establish the optimal conditions to grow UNCD coatings on the complex 3-D geometry of Ti-based micro-implants, with geometry similar to real implants, relevant to developing UNCD-coated Ti-based dental implants with superior mechanical/chemical performance than current Ti-based implants.

One-Piece Zirconia Ceramic versus Titanium Implants in the Jaw and Femur of a Sheep Model: A Pilot Study.

PubMed

Siddiqi, A; Duncan, W J; De Silva, R K; Zafar, S

2016-01-01

Reports have documented titanium (Ti) hypersensitivity after dental implant treatment. Alternative materials have been suggested including zirconia (Zr) ceramics, which have shown predictable osseointegration in animal studies and appear free of immune responses. The aim of the research was to investigate the bone-to-implant contact (BIC) of one-piece Zr, compared with one-piece Ti implants, placed in the jaws and femurs of domestic sheep. Ten New Zealand mixed breed sheep were used. A One-piece prototype Ti (control) and one Zr (test) implant were placed in the mandible, and one of each implant (Ti and Zr) was placed into the femoral epicondyle of each animal. The femur implants were submerged and unloaded; the mandibular implants were placed using a one-stage transgingival protocol and were nonsubmerged. After a healing period of 12 weeks, %BIC was measured. The overall survival rate for mandibular and femur implants combined was 87.5%. %BIC was higher for Zr implants versus Ti implants in the femur (85.5%, versus 78.9%) ( p = 0.002). Zirconia implants in the mandible showed comparable %BIC to titanium implants (72.2%, versus 60.3%) ( p = 0.087). High failure rate of both Zr and Ti one-piece implants in the jaw could be attributed to the one-piece design and surface characteristics of the implant that could have influenced osseointegration. Further clinical trials are recommended to evaluate the performance of zirconia implants under loading conditions.

Poly-ε-caprolactone Coated and Functionalized Porous Titanium and Magnesium Implants for Enhancing Angiogenesis in Critically Sized Bone Defects

PubMed Central

Roland, Laura; Grau, Michael; Matena, Julia; Teske, Michael; Gieseke, Matthias; Kampmann, Andreas; Beyerbach, Martin; Murua Escobar, Hugo; Haferkamp, Heinz; Gellrich, Nils-Claudius; Nolte, Ingo

2015-01-01

For healing of critically sized bone defects, biocompatible and angiogenesis supporting implants are favorable. Murine osteoblasts showed equal proliferation behavior on the polymers poly-ε-caprolactone (PCL) and poly-(3-hydroxybutyrate)/poly-(4-hydroxybutyrate) (P(3HB)/P(4HB)). As vitality was significantly better for PCL, it was chosen as a suitable coating material for further experiments. Titanium implants with 600 µm pore size were evaluated and found to be a good implant material for bone, as primary osteoblasts showed a vitality and proliferation onto the implants comparable to well bottom (WB). Pure porous titanium implants and PCL coated porous titanium implants were compared using Live Cell Imaging (LCI) with Green fluorescent protein (GFP)-osteoblasts. Cell count and cell covered area did not differ between the implants after seven days. To improve ingrowth of blood vessels into porous implants, proangiogenic factors like Vascular Endothelial Growth Factor (VEGF) and High Mobility Group Box 1 (HMGB1) were incorporated into PCL coated, porous titanium and magnesium implants. An angiogenesis assay was performed to establish an in vitro method for evaluating the impact of metallic implants on angiogenesis to reduce and refine animal experiments in future. Incorporated concentrations of proangiogenic factors were probably too low, as they did not lead to any effect. Magnesium implants did not yield evaluable results, as they led to pH increase and subsequent cell death. PMID:26703586

Early Loading of Fluoridated Implants Placed in Fresh Extraction Sockets and Healed Bone: A 3- to 5-Year Clinical and Radiographic Follow-Up Study of 39 Consecutive Patients.

PubMed

Oxby, Gert; Oxby, Fredrik; Oxby, Johan; Saltvik, Tomas; Nilsson, Peter

2015-10-01

Immediate placement of implants in extraction sockets for early loading is an attractive treatment modality due to reduced treatment time. However, the outcome of fluoridated implants in this situation with regard to bone levels and health of soft tissues is not well documented. To evaluate the outcome of early loading of OsseoSpeed(™) dental implants placed into fresh extraction sockets and healed bone in consecutive patients treated in a private clinic. A total of 182 OsseoSpeed(™) implants (Astra Tech Implant System, DENTSPLY Implants, Mölndal, Sweden), 72 in immediate extraction sockets and 110 in healed sites, were placed in 39 consecutive patients. The implants were loaded with permanent restorations within 60 days (average 31 days). Clinical and radiographic follow-up examinations were performed annually for at least 3 years (mean 55 months). An aesthetic index was used to evaluate the soft tissues adjacent to the prosthetic restorations. No implant was lost during the observation period, giving a survival rate of 100%. Bone level changes during the observation period were minimal, with a mean marginal bone loss of 0.3 ± 0.9 mm around the delayed implants and a mean marginal bone gain of 0.3 ± 1.4 mm around the immediate implants (p = .0036). The frequency distribution of bone level revealed that 85% of implants placed in fresh extraction sockets and 84% of implants in healed bone did not show any loss of bone level during follow-up (p = NS). Soft tissue complications were observed at two immediate implant sites in one patient. The remaining 180 implants received the highest aesthetic score. Moreover, no signs of peri-implant purulent infection or aggressive bone loss were found during the follow-up period. Early loading of fluoridated implants with permanent constructions appears to be a viable therapy for implants placed immediately in extraction sites and in healed bone. © 2014 Wiley Periodicals, Inc.

Effect of implant macro-design on primary stability: A prospective clinical study

PubMed Central

Lozano-Carrascal, Naroa; Salomó-Coll, Oscar; Gilabert-Cerdà, Marta; Farré-Pagés, Nuria; Hernández-Alfaro, Federico

2016-01-01

Background Implant restorations have become a high predictable treatment option. Several caracteristics such as surgical technique and implant design can influence the treatment outcomes. The aim of the present study was to evaluate the influence of implant macro-design on primary stability measured with resonance frequency analysis (RFA) and insertion torque (IT). Material and Methods A total of 47 implants divided in two groups: Test group (TI): 22 Tapered MIS® Seven implants; Control group (CI): 25 cylindrical Astra® Osseospeed implants. All implants were inserted following the manufacturers’ standard protocols. Implant primary stability was measured at the moment of implant placement by registering insertion torque values (ITv) and ISQ values by means of Osstell™ Mentor (ISQv) (Integration Diagnostic Ltd., Goteborg, Sweden). Results In the mandible, mean ISQv for tapered implants (TI) was 71.67±5.16 and for cylindrical implants (CI) 57.15±4.83 (p=0.01). Mean insertion torque was 46.67±6.85 Ncm for TI and 35.77±6.72 Ncm for CI (p=0.01). In the maxilla, mean ISQ was 67.2±4.42 for tapered implants and 49.17±15.30 for cylindrical implants (p=0.01). Mean insertion torque for TI was 41.5±6.26 Ncm and for CI 39.17±6.34 Ncm (p>0.05). For tapered implants, no correlation could be found between implant diameter and primary stability. But for cylindrical implants there was a statistically significant correlation between implant diameter and primary stability: ITv (p=0.03); ISQv (p=0.04). Conclusions Within the limits of the present study, tapered shaped implants achieve higher primary stability measured through ISQ and insertion torque values. Moreover, for cylindrical implants positive correlation has been established between implant diameter and primary stability. Key words:Primary stability, tapered, cylindrical, conical, implant macro-design. PMID:26827067

Analysis of the Factors Affecting Surgical Success of Implants Placed in Iranian Warfare Victims

PubMed Central

Jafarian, Mohammad; Bayat, Mohammad; Pakravan, Amir-Hossein; Emadi, Naghmeh

2016-01-01

Objective The aim was to evaluate the survival time and success rates of dental implants in warfare victims and factors that affect implant success. Subjects and Methods This retrospective study involved 250 Iranian warfare victims who received dental implants from 2003 to 2013. Patients' demographic characteristics, as well as the brand, diameter, length, location and failure rate of the implants were retrieved from patients' dental records and radiographs. The associations between these data and the survival rate were analyzed. Statistical analysis was carried out with χ2 and log-rank tests. Results Overall, out of the 1,533 dental implants, 61 (4s%) failed. The maxillary canine area had the highest failure rate [9 of 132 implants (6.8s%)], while the mandibular incisor region had the least number of failures [3 of 147 implants (2.0s%)] and the longest survival time (approximately 3,182 days). Maxillary canine areas had the shortest survival (about 2,996 days). The longest survival time was observed in implants with 11 mm length (3,179.72 ± 30.139 days) and 3.75-4 mm diameter (3,131.161 ± 35.96 days), and the shortest survival was found in implants with 11.5 mm length (2,317.79 ± 18.71 days) and 6.5 mm diameter (2,241.45 ± 182.21 days). Moreover, implants with 10 mm length (10.7s%) and 5.5-6 mm diameter (22.2s%) had the highest failure rate; however, the least failure rate occurred when the implants were 11.5 mm in length (1.9s%) and 3-3.5 mm in diameter (3.1s%). Conclusions The brand, length and diameter of implants affected the survival time, failure rate and time to failure. The location of the implant was not statistically significant regarding the mentioned factors, although it has clinical significance. PMID:27322534

A Retrospective Analysis of Dental Implants Replacing Failed Implants in Grafted Maxillary Sinus: A Case Series.

PubMed

Manor, Yifat; Chaushu, Gavriel; Lorean, Adi; Mijiritzky, Eithan

2015-01-01

To evaluate the survival rate of dental implants replacing failed implants in grafted maxillary sinuses using the lateral approach vs nongrafted posterior maxillae. A retrospective analysis was conducted to study the survival of secondary dental implants inserted in the posterior maxilla in previously failed implant sites between the years 2000 and 2010. The study group consisted of patients who had also undergone maxillary sinus augmentation, and the control group consisted of patients in whom implants in the posterior maxilla had failed. Clinical and demographic data were analyzed using a structured form. Seventy-five patients with a total of 75 replaced implants were included in the study. The study group comprised 40 patients and the control group, 35 patients. None of the replaced implants in the study group failed, resulting in an overall survival of 100%; three replaced implants in the control group failed (92% survival). The main reason for the primary implant removal was lack of osseointegration (35 [87.5%] of 40 study group implants and 23 [65.7%] of 35 control group implants [P = .027]). The difference between the groups with regard to the timing of primary implant failure was statistically significant. The study group had more early failures of the primary implant than did the control group (77% vs 62%; P = .038). Dental implants replaced in the posterior maxilla had a high survival rate. A higher rate of survival was found in augmented maxillary sinus sites. Within the limits of the present study, it can be concluded that previous implant failures in the grafted maxillary sinus should not discourage practitioners from a second attempt.

The immediate placement of dental implants into extraction sites with periapical lesions: a retrospective chart review.

PubMed

Bell, Christopher Lincoln; Diehl, David; Bell, Brian Michael; Bell, Robert E

2011-06-01

The purpose of this study was to evaluate the success of dental implants placed immediately into extraction sites in the presence of chronic periapical pathology. The charts of 655 patients who had implants immediately placed into fresh extraction sites were reviewed for the presence or absence of periapical radiolucencies. A total of 922 implants were included. Of the 922 implants, 285 were immediately placed into sockets that had chronic periapical infections. The remaining 637 implants, without signs of periapical pathology, were used as the control group. Success of the implants was defined as successful osseointegration, successful restoration, and absence of evidence of bone loss or peri-implantitis. Other variables such as age, gender, smoking, diabetes, bisphosphonate use, lucencies of adjacent teeth, and implant stability at the time of placement were also evaluated. Of the 922 implants, 285 were placed into sockets with periapical radiolucencies. The success rate of implants placed in the study group was 97.5%, whereas the success rate of the control group was 98.7%. The difference was not found to be statistically significant. The mean follow-up was 19.75 months, with a maximum of 93 months and a minimum of 3 months. A statistically higher failure rate was found for implants placed adjacent to retained teeth with periapical pathology. The placement of implants in sockets affected by chronic periapical pathology can be considered a safe and viable treatment option. There is a risk of implant failure when placing implants adjacent to teeth with periapical radiolucencies. Copyright © 2011 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

In vitro assessment of artifacts induced by titanium, titanium-zirconium and zirconium dioxide implants in cone-beam computed tomography.

PubMed

Sancho-Puchades, Manuel; Hämmerle, Christoph H F; Benic, Goran I

2015-10-01

The aim of this study was to test whether or not the intensity of artifacts around implants in cone-beam computed tomography (CBCT) differs between titanium, titanium-zirconium and zirconium dioxide implants. Twenty models of a human mandible, each containing one implant in the single-tooth gap position 45, were cast in dental stone. Five test models were produced for each of the following implant types: titanium 4.1 mm diameter (Ti4.1 ), titanium 3.3 mm diameter (Ti3.3 ), titanium-zirconium 3.3 mm diameter (TiZr3.3 ) and zirconium dioxide 3.5-4.5 mm diameter (ZrO3.5-4.5 ) implants. For control purposes, three models without implants were produced. Each model was scanned using a CBCT device. Gray values (GV) were recorded at eight circumferential positions around the implants at 0.5 mm, 1 mm and 2 mm from the implant surface (GVT est ). GV were assessed in the corresponding volumes of interest (VOI) in the control models without implants (GVC ontrol ). Differences of gray values (ΔGV) between GVT est and GVC ontrol were calculated as percentages. One-way ANOVA and post hoc tests were applied to detect differences between implant types. Mean ΔGV for ZrO3.5-4.5 presented the highest absolute values, generally followed by TiZr3.3 , Ti4.1 and Ti3.3 implants. The differences of ΔGV between ZrO3.5-4.5 and the remaining groups were statistically significant in the majority of the VOI (P ≤ 0.0167). ΔGV for TiZr3.3 , Ti4.1 and Ti3.3 implants did not differ significantly in the most VOI. For all implant types, ΔGV showed positive values buccally, mesio-buccally, lingually and disto-lingually, whereas negative values were detected mesially and distally. Zirconium dioxide implants generate significantly more artifacts as compared to titanium and titanium-zirconium implants. The intensity of artifacts around zirconium dioxide implants exhibited in average the threefold in comparison with titanium implants. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The appearance and effects of metallic implants in CT images.

PubMed

Kairn, T; Crowe, S B; Fogg, P; Trapp, J V

2013-06-01

The computed tomography (CT) imaging artefacts that metallic medical implants produce in surrounding tissues are usually contoured and over-ridden during radiotherapy treatment planning. In cases where radiotherapy treatment beams unavoidably pass though implants, it is especially important to understand the imaging artefacts that may occur within the implants themselves. This study examines CT images of a set of simple metallic objects, immersed in water, in order to evaluate reliability and variability of CT numbers (Hounsfield units, HUs) within medical implants. Model implants with a range of sizes (heights from 2.2 to 49.6 mm), electron densities (from 2.3 to 7.7 times the electron density of water) and effective atomic numbers (from 3.9 to 9.0 times the effective atomic number of water in a CT X-ray beam) were created by stacking metal coins from several currencies. These 'implants' were CT scanned within a large (31.0 cm across) and a small (12.8 cm across) water phantom. Resulting HU values are as much as 50 % lower than the result of extrapolating standard electron density calibration data (obtained for tissue and bone densities) up to the metal densities and there is a 6 % difference between the results obtained by scanning with 120 and 140 kVp tube potentials. Profiles through the implants show localised cupping artefacts, within the implants, as well as a gradual decline in HU outside the implants that can cause the implants' sizes to be over estimated by 1.3-9.0 mm. These effects are exacerbated when the implants are scanned in the small phantom or at the side of the large phantom, due to reduced pre-hardening of the X-ray beam in these configurations. These results demonstrate the necessity of over-riding the densities of metallic implants, as well as their artefacts in tissue, in order to obtain accurate radiotherapy dose calculations.

A prospective study of implants placed in augmented sinuses with minimal and moderate residual crestal bone: results after 1 to 5 years.

PubMed

Urban, Istvan A; Lozada, Jaime L

2010-01-01

The aims of this prospective study were to: (1) determine clinical and radiographic success and survival rates of implants placed in a staged procedure after sinus augmentation; and (2) compare the success and survival rate of implants in two patient groups with different ridge height prior to treatment (those with minimal residual crestal bone [⋜ 3.5 mm] below the sinus and those with moderate residual crestal bone [> 3.5 mm]). The study used anorganic bovine bone-derived mineral and autogenous bone for the sagittal sandwich bone augmentation technique, a collagen membrane to protect the sinus window, and a staged approach for implant placement; all implants featured an anodized surface. Two hundred forty-five implants were placed in 100 sinus sites (79 patients), and 244 have survived to date. The cumulative success and survival rates of all implants overall at 5 years were 96.5% (SE 2.0%) and 99.6% (SE 0.4%), respectively. The overall success and survival rates at 5 years for implants placed into minimal residual crestal bone were 94.1% (SE 3.4%) and 99.4% (SE 0.6%), respectively. For implants placed into moderate crestal bone, overall success and survival rates were both 100.0% (SE 0.0%). Success of implants placed after sinus augmentation appears similar to implants placed in native bone when a classical submerged implant healing time of 6 months is used. The success and survival rates and crestal bone remodeling of implants placed in minimal residual crestal bone were comparable to those of implants placed in moderate residual crestal bone.

Bacteriological evaluation for one-and two-piece implant design supporting mandibular overdenture

PubMed Central

Abdelwahed, Ahmed; Mahrous, Ahmed I.; Abadallah, Mohamed Farouk; Asfour, Hani; Aldawash, Hussien A.; Alagha, Ebaa I.

2015-01-01

Background: This study evaluated and compared the bacteriological effect of two-piece implants and one-piece implants in complete overdenture cases on supporting structures. Materials and Methods: Ten male completely edentulous patients were selected and randomly divided into two equal groups according to the implant design and surgical technique for this study; Group 1: Patients were rehabilitated with complete mandibular overdenture supported by two-piece implants one on each side of the lower arch following two-stage surgical technique and Group 2: Patients were rehabilitated with complete mandibular overdenture supported by one-piece implants one on each side. Evaluation was made at the time of insertion, 6, 12, and 18 months after overdenture insertion, by measuring bacteriological changes around implants abutments. Results: Complete overdenture supported by one-piece implants showed better effect on the bacteriological changes as compared to that supported by two-piece implants. Conclusion: Complete overdenture supported by one-piece implants one on each side of the lower arch showed better effect on the bacteriological changes than using the same prosthesis supported by two-piece implants. PMID:26903697

Retrospective analysis of survival rates and marginal bone loss on short implants in the mandible.

PubMed

Draenert, Florian G; Sagheb, Keyvan; Baumgardt, Katharina; Kämmerer, Peer W

2012-09-01

Short implants have become an interesting alternative to bone augmentation in dental implantology. Design of shorter implants and longer surveillance times are a current research issue. The goal of this study was to show the survival rates of short implants below 9 mm in the partly edentulous mandibular premolar and molar regions with fixed prosthetics. Marginal vertical and 2D bone loss was evaluated additionally. Different implant designs are orientationally evaluated. A total of 247 dental implants with fixed prosthetics (crowns and bridges) in the premolar and molar region of the mandible were evaluated; 47 implants were 9 mm or shorter. Patient data were evaluated to acquire implant survival rates, implant diameter, gender and age. Panoramic X-rays were analysed for marginal bone loss. Average surveillance time was 1327 days. Cumulative survival rate (CSR) of short implants was 98% (1 implants lost) compared to 94% in the longer implants group without significance. Thirty-five of the short implants were Astratech (0 losses) and 12 were Camlog Screw Line Promote Plus (1 loss). Early vertical and two-dimensional marginal bone loss was not significantly different in short and regular length implant group with an average of 0.6 mm and 0.7 mm(2) in short implants over the observation period. Within the limitations of this study, we conclude that short implants with a length of 9 mm or less have equal survival rates compared with longer implants over the observation period of 1-3 years. © 2011 John Wiley & Sons A/S.

Clinical Outcome of Hydroxyapatite Coated, Bioactive Glass Coated, and Machined Ti6Al4V Threaded Dental Implant in Human Jaws: A Short-Term Comparative Study.

PubMed

Mistry, Surajit; Roy, Rajiv; Kundu, Biswanath; Datta, Someswar; Kumar, Manoj; Chanda, Abhijit; Kundu, Debabrata

2016-04-01

Growing aspect of endosseous implant research is focused on surface modification of dental implants for the purpose of improving osseointegration. The aim of this study was to evaluate and compare the clinical outcome (ie, osseointegration) of hydroxyapatite coated, bioactive glass coated and machined titanium alloy threaded dental implants in human jaw bone after implantation. One hundred twenty-six implants (45 hydroxyapatite coated, 41 bioactive glass coated, and 40 machined titanium implants) have been placed in incisor areas of 62 adult patients. Outcome was assessed up to 12 months after prosthetic rehabilitation using different clinical and radiological parameters. Surface roughness of failed implants was analyzed by laser profilometer. Hydroxyapatite and bioactive glass coating materials were nontoxic and biocompatible. Least marginal bone loss in radiograph, significantly higher (P < 0.05) interface radiodensity, and less interfacial gaps were observed in computed tomography with bioactive glass coated implants at anterior maxilla compared to other 2 types. Bioactive glass coated implants are equally safe and effective as hydroxyapatite coated and machined titanium implants in achieving osseointegration; therefore, can be effectively used as an alternative coating material for dental implants.

Failure rates of mini-implants placed in the infrazygomatic region.

PubMed

Uribe, Flavio; Mehr, Rana; Mathur, Ajay; Janakiraman, Nandakumar; Allareddy, Veerasathpurush

2015-01-01

The purpose of this pilot study was to evaluate the failure rates of mini-implants placed in the infrazygomatic region and to evaluate factors that affect their stability. A retrospective cohort study of 30 consecutive patients (55 mini-implants) who had infrazygomatic mini-implants at a University Clinic were evaluated for failure rates. Patient, mini-implant, orthodontic, surgical, and mini-implant maintenance factors were evaluated by univariate logistic regression models for association to failure rates. A 21.8 % failure rate of mini-implants placed in the infazygomatic region was observed. None of the predictor variables were significantly associated with higher or lower odds for failed implants. Failure rates for infrazygomatic mini-implants were slightly higher than those reported in other maxilla-mandibular osseous locations. No predictor variables were found to be associated to the failure rates.

78 FR 17940 - Certain Computerized Orthopedic Surgical Devices, Software, Implants, and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-25

..., Software, Implants, and Components Thereof; Notice of Receipt of Complaint; Solicitation of Comments... Certain Computerized Orthopedic Surgical Devices, Software, Implants, and Components Thereof, DN 2945; the... importation of certain computerized orthopedic surgical devices, software, implants, and components thereof...

Implant breast reconstruction followed by radiotherapy: Can helical tomotherapy become a standard irradiation treatment?

DOE Office of Scientific and Technical Information (OSTI.GOV)

Massabeau, Carole, E-mail: cmassabeau@hotmail.com; Fournier-Bidoz, Nathalie; Wakil, Georges

2012-01-01

To evaluate the benefits and limitations of helical tomotherapy (HT) for loco-regional irradiation of patients after a mastectomy and immediate implant-based reconstruction. Ten breast cancer patients with retropectoral implants were randomly selected for this comparative study. Planning target volumes (PTVs) 1 (the volume between the skin and the implant, plus margin) and 2 (supraclavicular, infraclavicular, and internal mammary nodes, plus margin) were 50 Gy in 25 fractions using a standard technique and HT. The extracted dosimetric data were compared using a 2-tailed Wilcoxon matched-pair signed-rank test. Doses for PTV1 and PTV2 were significantly higher with HT (V95 of 98.91 andmore » 97.91%, respectively) compared with the standard technique (77.46 and 72.91%, respectively). Similarly, the indexes of homogeneity were significantly greater with HT (p = 0.002). HT reduced ipsilateral lung volume that received {>=}20 Gy (16.7 vs. 35%), and bilateral lungs (p = 0.01) and neighboring organs received doses that remained well below tolerance levels. The heart volume, which received 25 Gy, was negligible with both techniques. HT can achieve full target coverage while decreasing high doses to the heart and ipsilateral lung. However, the low doses to normal tissue volumes need to be reduced in future studies.« less

Malrotation of the McGhan Style 510 prosthesis.

PubMed

Schots, Jeroen M P; Fechner, Maarten R; Hoogbergen, Maarten M; van Tits, Herm W H J

2010-07-01

Anatomically shaped cohesive silicone breast implants are frequently used in aesthetic and reconstructive surgery. After successful results with the Style 410 prosthesis, McGhan (Natrelle, Allergan) introduced the Style 510 prosthesis. After using this novel prosthesis, the authors encountered a high number of prosthesis malrotations on self-reported follow-up. Therefore, a retrospective medical record review was performed to determine the prevalence of malrotation of the Style 510 prosthesis. From January of 2005 to December of 2006, 73 (146 prostheses) aesthetic augmentation mammaplasty procedures were performed using Style 510 prostheses. All prostheses were placed subglandularly through an inframammary incision. The postsurgical protocol for the first 3 weeks involved wearing a nonwired compression bra, abstinence from sports activities, and abstinence from heavy labor. Standard follow-up was at 1 week, 3 months, and if necessary. On self-reported follow-up, 8.2 percent of all prostheses were rotated. These rotations all occurred unilaterally after a mean period of 10 months (range, 3 to 19 months). No relation to an inciting incident or prosthesis volume could be found. The number of rotations of the Style 510 prosthesis seen after primary aesthetic breast augmentation is high. An obvious cause of this major problem has not been found. This led the authors to discontinue using the Style 510 prosthesis for primary aesthetic mammary augmentations in their practice.

Macro design morphology of endosseous dental implants.

PubMed

Sahiwal, Indira G; Woody, Ronald D; Benson, Byron W; Guillen, Guillermo E

2002-05-01

The identification of dental implant bodies in patients without available records is a considerable problem due to increased patient mobility and to the large number of implant systems with different designs. The purpose of this study was to document the designs of selected implants to help clinicians identify these implants from their radiographic images. More than 50 implant manufacturers were contacted and asked to provide implants with dimensions as close as possible to 3.75 mm (diameter) x 10 mm (length). Forty-four implants were donated, separated into threaded and non-threaded categories, and further sorted into tapered and non-tapered categories. The implants were examined visually, and features on the entire circumference and length of each implant were recorded and categorized as coronal, midbody, or apical. A series of tables describe the 44 implants according to coronal, midbody, and apical features. The results of this project offer dentists basic knowledge of the design of selected dental implants. Such knowledge can aid the radiographic identification of these implants.

In Vivo Response of Laser Processed Porous Titanium Implants for Load-Bearing Implants.

PubMed

Bandyopadhyay, Amit; Shivaram, Anish; Tarafder, Solaiman; Sahasrabudhe, Himanshu; Banerjee, Dishary; Bose, Susmita

2017-01-01

Applications of porous metallic implants to enhance osseointegration of load-bearing implants are increasing. In this work, porous titanium implants, with 25 vol.% porosity, were manufactured using Laser Engineered Net Shaping (LENS™) to measure the influence of porosity towards bone tissue integration in vivo. Surfaces of the LENS™ processed porous Ti implants were further modified with TiO 2 nanotubes to improve cytocompatibility of these implants. We hypothesized that interconnected porosity created via additive manufacturing will enhance bone tissue integration in vivo. To test our hypothesis, in vivo experiments using a distal femur model of male Sprague-Dawley rats were performed for a period of 4 and 10 weeks. In vivo samples were characterized via micro-computed tomography (CT), histological imaging, scanning electron microscopy, and mechanical push-out tests. Our results indicate that porosity played an important role to establish early stage osseointegration forming strong interfacial bonding between the porous implants and the surrounding tissue, with or without surface modification, compared to dense Ti implants used as a control.

KRAS, BRAF genotyping reveals genetic heterogeneity of ovarian borderline tumors and associated implants.

PubMed

Heublein, Sabine; Grasse, Katinka; Hessel, Harald; Burges, Alexander; Lenhard, Miriam; Engel, Jutta; Kirchner, Thomas; Jeschke, Udo; Mayr, Doris

2013-10-18

Patients diagnosed for a serous ovarian borderline tumor (s-BOT) typically present with an excellent clinical outcome. However there have been controversies concerning the prognostic impact of so-called implants, an extra ovarian spread occurring alongside the s-BOT in certain cases. It remains obscure whether these implants actually resemble metastasis owning the same genetic pattern as the ovarian primary or whether they develop independently. The current study, in the aim of further clarifying the genetic origin of implants, assessed BRAF/KRAS hot spot mutations and the p53/p16INK4a immunophenotype of s-BOTs and corresponding implants (n=49) of 15 patients by pyro-sequencing and immunostaining, respectively. A significant proportion of both s-BOTs and implants showed KRAS or BRAF mutation and though p16INK4a was found to be abundantly expressed, p53 immunoreactivity was rather low. When genotypes of BRAF/KRAS mutated s-BOTs and corresponding implants were compared no patient presented with a fully matching mutation profile of s-BOTs and all corresponding implants. The current study reveals genetic heterogeneity of s-BOTs and implants, as none of the markers examined showed constant reciprocity. Hence, our findings may assist to explain the different clinical presentation of s-BOTs and implants and might encourage to applying more individualized follow up protocols.

Systemic Assessment of Patients Undergoing Dental Implant Surgeries: A Trans- and Post-operative Analysis.

PubMed

Byakodi, Sanjay; Kumar, Sachin; Reddy, Rajesh Kumar; Kumar, Vipin; Sepolia, Shipra; Gupta, Shivangi; Singh, Harkanwal Preet

2017-01-01

Procedure-related and patient-related factors influence the prognosis of dental implants to a major extent. Hence, we aimed to evaluate and analyze various systemic factors in patients receiving dental implants. Fifty-one patients were included in the study, in which a total of 110 dental implants were placed. Complete examination of the subjects was done before and after placement of dental implants. Implant surgery was planned, and osseointegrated dental implants were placed in the subjects. Postoperative evaluation of the dental implant patients was done after 3 weeks. Anxiety levels were determined using State-Trait Anxiety Inventory (STAI) questionnaire on the surgery day and after 1 week of surgery. The participant describes how they feel at the moment by responding to twenty items as follows: (1) absolutely not, (2) slightly, (3) somewhat, or (4) very much. All the results were recorded and statistical analyzed by SPSS software. Out of 51, 29 patients were males while 22 were females, with ratio of 1.32:1. Female patients' mean age was 50.18 years while male patients' mean age was 52.71 years, with statistically nonsignificant difference between them. Functional rehabilitation was the main purpose of choosing dental implants in more than 90% of the subjects. Diameter of 3.75 mm was the shortest implants to be placed in the present study, whereas in terms of length, 8.5 mm was the shortest length of dental implant used in the present study. Tooth area in which maximum implants were placed in our study was 36 tooth region. Maximum implants were placed in Type II bone quality ( n = 38). Implants installed in the mandible were clamped more efficiently than implants placed in the maxilla ( P < 0.001). The difference of average STAI-State subscore before and after the surgery was statistically significant ( P < 0.05; significant). Mandibular dental implants show more clamping (torque) than maxillary dental implants.

Evaluation of marginal bone loss of dental implants with internal or external connections and its association with other variables: A systematic review.

PubMed

de Medeiros, Rodrigo Antonio; Pellizzer, Eduardo Piza; Vechiato Filho, Aljomar José; Dos Santos, Daniela Micheline; da Silva, Emily Vivianne Freitas; Goiato, Marcelo Coelho

2016-10-01

Different factors can influence marginal bone loss around dental implants, including the type of internal and external connection between the implant and the abutment. The evidence needed to evaluate these factors is unclear. The purpose of this systematic review was to evaluate marginal bone loss by radiographic analysis around dental implants with internal or external connections. A systematic review was conducted following the criteria defined by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Initially, a population, intervention, comparison, and outcome(s) (PICO) question was defined: does the connection type (internal or external) influence marginal bone loss in patients undergoing implantation? An electronic search of PubMed/MEDLINE and Scopus databases was performed for studies in English language published between January 2000 and December 2014 by 2 independent reviewers, who analyzed the marginal bone loss of dental implants with an internal and/or external connection. From an initial screening yield of 595 references and after considering inclusion and exclusion criteria, 17 articles were selected for this review. Among them, 10 studies compared groups of implants with internal and external connections; 1 study evaluated external connections; and 6 studies analyzed internal connections. A total of 2708 implants were placed in 864 patients. Regarding the connection type, 2347 implants had internal connections, and 361 implants had external connections. Most studies showed lower marginal bone loss values for internal connection implants than for external connection implants. Osseointegrated dental implants with internal connections exhibited lower marginal bone loss than implants with external connections. This finding is mainly the result of the platform switching concept, which is more frequently found in implants with internal connections. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

The Effect of Insertion Torque on the Clinical Outcome of Single Implants: A Randomized Clinical Trial.

PubMed

Barone, Antonio; Alfonsi, Fortunato; Derchi, Giacomo; Tonelli, Paolo; Toti, Paolo; Marchionni, Saverio; Covani, Ugo

2016-06-01

The insertion torque value has been extensively used as an indicator for implant primary stability, which is considered a determining parameter for the implants success. The primary goal of the present randomized clinical trial was to evaluate and compare the clinical outcome for implants placed with high insertion torque (between 50 Ncm and 100 Ncm) and regular insertion torque (within 50 Ncm) in healed ridges. Partially edentulous patients, missing one or more mandibular or maxillary teeth, having an adequate amount of bone, requiring implant placement, were randomized to receive Blossom CT implants with regular insertion torque (<50 Ncm) or CT implants with high insertion torque (≥50 Ncm). Implants were left to heal submerged for 3 months. Implants were restored with individualized abutments and cemented metal-ceramic crowns. Acquired measurements were: insertion torque values (IT), thickness of buccal bone plate after implant osteotomy preparation (BBT), marginal bone level (MBL), and facial soft tissue level (FST). All patients were followed 12 months after implant placement. One hundred sixteen implants were placed in one hundred sixteen patients and enrolled for the study. Fifty-eight implants were randomly allocated in regular-IT and high-IT groups with a mean insertion torque ranging from 20 Ncm to 50 Ncm and from 50 Ncm to 100 Ncm, respectively. Three implants failed, and another five implants showed at the 12-month evaluation a marginal bone loss (ΔMBL) greater than 1.5 mm, being considered unsuccessful. The findings suggested that implants inserted with high-IT (≥50 Ncm) in healed bone ridges showed more peri-implant bone remodeling and buccal soft tissue recession than implants inserted with a regular-IT (<50 Ncm). Moreover, sites with a thick buccal bone wall (≥1 mm) - after implant osteotomy site preparation - seemed to be less prone to buccal soft tissue recession after 12 months than sites with a thin buccal bone wall (<1 mm). © 2015 Wiley Periodicals, Inc.

Histological, mechanical, and radiological study of osteoformation in titanium foam implants.

PubMed

Ito, Kiyoshi; Horiuchi, Tetsuyoshi; Arai, Yoshinori; Kawahara, Ichiro; Hongo, Kazuhiro

2014-11-01

Titanium (Ti) is widely used for implants because of its high mechanical reliability and because it aids osteoformation. However, it also produces artifacts during radiological imaging. Further, Ti implants can sometimes cause the surrounding bone to break. Owing to recent advances, Ti can be transformed into sponge-like, porous materials having a three-dimensional network of pores; such materials are called Ti foams. These foams exhibit distinct characteristics that make them more suitable than nonporous Ti. The objective of this study was to evaluate Ti foams as implant materials. Implants based on Ti foams having porosities of 80% and 90% were embedded in the femurs of 11 rabbits. Implants based on 0% porosity Ti were used as controls. Five rabbits were sacrificed 4 weeks after implantation, while the remaining were sacrificed after 12 weeks. The femurs containing the Ti implants were harvested and analyzed. Biomechanical analyses showed that the 80% porosity implants induced greater osteoformation. There were significant differences in the average pushout strengths of the control and 80% porosity implants after 4 weeks (p = 0.048) and 12 weeks (p = 0.001). Histopathological analyses confirmed osteoformation in the case of the 80% porosity implants. Analyses of the micro-computed tomography images of the Ti foam-based implants did not suggest the presence of artifacts. The 80% porosity Ti implants did not exhibit the shortcomings associated with conventional Ti implants. In addition, they induced greater osteoformation. Finally, the Ti foams did not produce radiological artifacts.

MRI information for commonly used otologic implants: review and update.

PubMed

Azadarmaki, Roya; Tubbs, Rhonda; Chen, Douglas A; Shellock, Frank G

2014-04-01

To review information on magnetic resonance imaging (MRI) issues for commonly used otologic implants. Manufacturing companies, National Library of Medicine's online database, and an additional online database (www.MRIsafety.com). A literature review of the National Library of Medicine's online database with focus on MRI issues for otologic implants was performed. The MRI information on implants provided by manufacturers was reviewed. Baha and Ponto Pro osseointegrated implants' abutment and fixture and the implanted magnet of the Sophono Alpha 1 and 2 abutment-free systems are approved for 3-Tesla magnetic resonance (MR) systems. The external processors of these devices are MR Unsafe. Of the implants tested, middle ear ossicular prostheses, including stapes prostheses, except for the 1987 McGee prosthesis, are MR Conditional for 1.5-Tesla (and many are approved for 3-Tesla) MR systems. Cochlear implants with removable magnets are approved for patients undergoing MRI at 1.5 Tesla after magnet removal. The MED-EL PULSAR, SONATA, CONCERT, and CONCERT PIN cochlear implants can be used in patients undergoing MRI at 1.5 Tesla with application of a protective bandage. The MED-EL COMBI 40+ can be used in 0.2-Tesla MR systems. Implants made from nonmagnetic and nonconducting materials are MR Safe. Knowledge of MRI guidelines for commonly used otologic implants is important. Guidelines on MRI issues approved by the US Food and Drug Administration are not always the same compared with other parts of the world. This monograph provides a current reference for physicians on MRI issues for commonly used otologic implants.

A Three-Dimensional Finite Element Analysis of the Stress Distribution Generated by Splinted and Nonsplinted Prostheses in the Rehabilitation of Various Bony Ridges with Regular or Short Morse Taper Implants.

PubMed

Toniollo, Marcelo Bighetti; Macedo, Ana Paula; Rodrigues, Renata Cristina; Ribeiro, Ricardo Faria; de Mattos, Maria G

The aim of this study was to compare the biomechanical performance of splinted or nonsplinted prostheses over short- or regular-length Morse taper implants (5 mm and 11 mm, respectively) in the posterior area of the mandible using finite element analysis. Three-dimensional geometric models of regular implants (Ø 4 × 11 mm) and short implants (Ø 4 × 5 mm) were placed into a simulated model of the left posterior mandible that included the first premolar tooth; all teeth posterior to this tooth had been removed. The four experimental groups were as follows: regular group SP (three regular implants were rehabilitated with splinted prostheses), regular group NSP (three regular implants were rehabilitated with nonsplinted prostheses), short group SP (three short implants were rehabilitated with splinted prostheses), and short group NSP (three short implants were rehabilitated with nonsplinted prostheses). Oblique forces were simulated in molars (365 N) and premolars (200 N). Qualitative and quantitative analyses of the minimum principal stress in bone were performed using ANSYS Workbench software, version 10.0. The use of splinting in the short group reduced the stress to the bone surrounding the implants and tooth. The use of NSP or SP in the regular group resulted in similar stresses. The best indication when there are short implants is to use SP. Use of NSP is feasible only when regular implants are present.

Immediate loading of titanium hexed screw-type implants in the edentulous patient: case report.

PubMed

Calvo, M P; Muller, E; Garg, A K

2000-01-01

Histologic and histomorphometric studies in both animals and humans have shown that more rapid and greater bone-to-implant contact can be achieved with implants that incorporate certain surface characteristics compared with the original machined-surface implants. Such findings are significant because various implant designs may allow the fixtures to sufficiently resist functional loading sooner than originally thought. The case report presented here indicates that immediate loading of hexed titanium screw-type implants in the anterior mandible can lead to successful osseointegration and clinical outcome. The number of implants placed, their distribution, and the type of rigid connection are critical considerations for immediate loading. A bone height that can accommodate dental implants > or = 10 mm long is recommended. Biomechanically, the implants to be immediately loaded must be stable and resistant to macromovement to ensure good osseointegration.

Metal ion levels in patients with stainless steel spinal instrumentation.

PubMed

McPhee, I Bruce; Swanson, Cheryl E

2007-08-15

Case-control study. To determine whether metal ion concentrations are elevated in patients with spinal instrumentation. Studies have shown that serum and urinary levels of component metal ions are abnormally elevated in patients with total joint arthroplasties. Little is known of metal ion release and concentrations in patients with spinal instrumentation. The study group consisted of patients who had undergone spinal instrumentation for various spinal disorders with a variety of stainless steel implants, 5 to 25 years previously. A group of volunteers without metal implants were controls. All subjects were tested for serum nickel, blood chromium, and random urine chromium/creatinine ratio estimation. The study group consisted of 32 patients with retained implants and 12 patients whose implants had been removed. There were 26 unmatched controls. There was no difference in serum nickel and blood chromium levels between all 3 groups. The mean urinary chromium/creatinine ratio for patients with implants and those with implants removed was significantly greater than controls (P < 0.001). The difference between study subgroups was not significant (P = 0.16). Of several patient and instrumentation variables, only the number of couplings approached significance for correlation with the urine chromium excretion (P = 0.07). Spinal implants do not raise the levels of serum nickel and blood chromium. There is evidence that metal ions are released from spinal implants and excreted in urine. The excretion of chromium in patients with spinal implants was significantly greater than normal controls although lower where the implants have been removed. The findings are consistent with low-grade release of ions from implants with rapid clearance, thus maintaining normal serum levels. Levels of metal ions in the body fluids probably do not reach a level that causes late side-effect; hence, routine removal of the implants cannot be recommended.

Comparison of marginal bone loss between internal- and external-connection dental implants in posterior areas without periodontal or peri-implant disease.

PubMed

Kim, Dae-Hyun; Kim, Hyun Ju; Kim, Sungtae; Koo, Ki-Tae; Kim, Tae-Il; Seol, Yang-Jo; Lee, Yong-Moo; Ku, Young; Rhyu, In-Chul

2018-04-01

The purpose of this retrospective study with 4-12 years of follow-up was to compare the marginal bone loss (MBL) between external-connection (EC) and internal-connection (IC) dental implants in posterior areas without periodontal or peri-implant disease on the adjacent teeth or implants. Additional factors influencing MBL were also evaluated. This retrospective study was performed using dental records and radiographic data obtained from patients who had undergone dental implant treatment in the posterior area from March 2006 to March 2007. All the implants that were included had follow-up periods of more than 4 years after loading and satisfied the implant success criteria, without any peri-implant or periodontal disease on the adjacent implants or teeth. They were divided into 2 groups: EC and IC. Subgroup comparisons were conducted according to splinting and the use of cement in the restorations. A statistical analysis was performed using the Mann-Whitney U test for comparisons between 2 groups and the Kruskal-Wallis test for comparisons among more than 2 groups. A total of 355 implants in 170 patients (206 EC and 149 IC) fulfilled the inclusion criteria and were analyzed in this study. The mean MBL was 0.47 mm and 0.15 mm in the EC and IC implants, respectively, which was a statistically significant difference ( P <0.001). Comparisons according to splinting (MBL of single implants: 0.34 mm, MBL of splinted implants: 0.31 mm, P =0.676) and cement use (MBL of cemented implants: 0.27 mm, MBL of non-cemented implants: 0.35 mm, P =0.178) showed no statistically significant differences in MBL, regardless of the implant connection type. IC implants showed a more favorable bone response regarding MBL in posterior areas without peri-implantitis or periodontal disease.

[Bilateral cochlear implants in children: acquisition of binaural hearing].

PubMed

Ramos-Macías, Angel; Deive-Maggiolo, Leopoldo; Artiles-Cabrera, Ovidio; González-Aguado, Rocío; Borkoski-Barreiro, Silvia A; Masgoret-Palau, Elizabeth; Falcón-González, Juan C; Bueno-Yanes, Jorge

2013-01-01

Several studies have indicated the benefit of bilateral cochlear implants in the acquisition of binaural hearing and bilateralism. In children with cochlear implants, is it possible to achieve binaurality after a second implant? When is the ideal time to implant them? The objective of this study was to analyse the binaural effect in children with bilateral implants and the differences between subjects with simultaneous and sequential implants with both short and long intervals. There were 90 patients between 1 and 2 years of age (the first surgery), implanted between 2000 and 2008. Of these, 25 were unilateral users and 65 bilateral; 17 patients had received simultaneous implants, 29 had sequential implants before 12 months after the first one (short interimplant period) and 19 after 12 months (long period). All of them were tested for silent and noisy verbal perception and a tonal threshold audiometry was performed. The silent perception test showed that the simultaneous and short period sequential implant patients (mean: 84.67%) versus unilateral and long period sequential implants (mean: 79.66%), had a statistically-significant difference (P=0,23). Likewise, the noisy perception test showed a difference with statistical significance (P=0,22) comparing the simultaneous implanted and short period sequential implants (mean, 77.17%) versus unilateral implanted and long period sequential ones (mean: 69.32%). The simultaneous and sequential short period implants acquired the advantages of binaural hearing. Copyright © 2012 Elsevier España, S.L. All rights reserved.

Short dental implants: an emerging concept in implant treatment.

PubMed

Al-Hashedi, Ashwaq Ali; Taiyeb Ali, Tara Bai; Yunus, Norsiah

2014-06-01

Short implants have been advocated as a treatment option in many clinical situations where the use of conventional implants is limited. This review outlines the effectiveness and clinical outcomes of using short implants as a valid treatment option in the rehabilitation of edentulous atrophic alveolar ridges. Initially, an electronic search was performed on the following databases: Medline, PubMed, Embase, Cochrane Database of Systematic Reviews, and DARE using key words from January 1990 until May 2012. An additional hand search was included for the relevant articles in the following journals: International Journal of Oral and Maxillofacial Implants, Clinical Oral Implants Research, Journal of Clinical Periodontology, International Journal of Periodontics, Journal of Periodontology, and Clinical Implant Dentistry and Related Research. Any relevant papers from the journals' references were hand searched. Articles were included if they provided detailed data on implant length, reported survival rates, mentioned measures for implant failure, were in the English language, involved human subjects, and researched implants inserted in healed atrophic ridges with a follow-up period of at least 1 year after implant-prosthesis loading. Short implants demonstrated a high rate of success in the replacement of missing teeth in especially atrophic alveolar ridges. The advanced technology and improvement of the implant surfaces have encouraged the success of short implants to a comparable level to that of standard implants. However, further randomized controlled clinical trials and prospective studies with longer follow-up periods are needed.

Incidence of Peri-implant Diseases on Implants With and Without Laser-Microgrooved Collar: A 5-Year Retrospective Study Carried Out in Private Practice Patients.

PubMed

Guarnieri, Renzo; Grande, Maurizio; Zuffetti, Francesco; Testori, Tiziano

To retrospectively evaluate the incidence of peri-implant mucositis and peri-implantitis around dental implants with the same body design and surface but different collar surface (laser-microgrooved vs not laser-microgrooved) after 5 years of loading in private practice patients. The study was carried out on patients at a private dental clinic enrolled in a periodontal maintenance program, who received at least one implant with a laser-microgrooved collar surface and one implant without a laser-microgrooved collar surface. Clinical variables such as plaque, pocket depth, bleeding on probing, suppuration, and radiographic marginal bone loss at > 5 years around implants were investigated. The correlation between the prevalence of peri-implant mucositis/peri-implantitis and biotype, keratinized tissue width, prosthetic connection type, and prosthetic design type was also analyzed. A total of 166 implants in 74 patients were investigated. At the end of the 5-year follow-up period, 38 implants presented peri-implant mucositis, accounting for 22.8% of the total, affecting a total of 24 patients (32.4%), while 13 implants (7.8%) in 10 patients (13.5%) were diagnosed with peri-implantitis. Sixteen of 82 laser-microgrooved implants (19.5%) and 24 of 84 implants (28.5%) without a laser-microgrooved collar presented peri-implant mucositis, while 3 of 82 (3.6%) of laser-microgrooved implants and 10 of 84 (11.9%) implants without a laser-microgrooved collar demonstrated peri-implantitis. Differences in implant-based incidence of peri-implant diseases between implants with and without a laser-microgrooved collar were statistically significant (P < .05). In private practice patients enrolled in a professional, controlled oral hygiene regimen, implants with a laser-microgrooved collar, compared with implants without a laser-microgrooved collar, presented a statistically significantly lower incidence of peri-implant diseases.

Failure analysis of fractured dental zirconia implants.

PubMed

Gahlert, M; Burtscher, D; Grunert, I; Kniha, H; Steinhauser, E

2012-03-01

The purpose of the present study was the macroscopic and microscopic failure analysis of fractured zirconia dental implants. Thirteen fractured one-piece zirconia implants (Z-Look3) out of 170 inserted implants with an average in situ period of 36.75±5.34 months (range from 20 to 56 months, median 38 months) were prepared for macroscopic and microscopic (scanning electron microscopy [SEM]) failure analysis. These 170 implants were inserted in 79 patients. The patient histories were compared with fracture incidences to identify the reasons for the failure of the implants. Twelve of these fractured implants had a diameter of 3.25 mm and one implant had a diameter of 4 mm. All fractured implants were located in the anterior side of the maxilla and mandibula. The patient with the fracture of the 4 mm diameter implant was adversely affected by strong bruxism. By failure analysis (SEM), it could be demonstrated that in all cases, mechanical overloading caused the fracture of the implants. Inhomogeneities and internal defects of the ceramic material could be excluded, but notches and scratches due to sandblasting of the surface led to local stress concentrations that led to the mentioned mechanical overloading by bending loads. The present study identified a fracture rate of nearly 10% within a follow-up period of 36.75 months after prosthetic loading. Ninety-two per cent of the fractured implants were so-called diameter reduced implants (diameter 3.25 mm). These diameter reduced implants cannot be recommended for further clinical use. Improvement of the ceramic material and modification of the implant geometry has to be carried out to reduce the failure rate of small-sized ceramic implants. Nevertheless, due to the lack of appropriate laboratory testing, only clinical studies will demonstrate clearly whether and how far the failure rate can be reduced. © 2011 John Wiley & Sons A/S.

Evaluation of fracture torque resistance of orthodontic mini-implants.

PubMed

Dalla Rosa, Fernando; Burmann, Paola Fp; Ruschel, Henrique C; Vargas, Ivana A; Kramer, Paulo F

2016-12-01

This study sought to assess the fracture torque resistance of mini-implants used for orthodontic anchorage. Five commercially available brands of mini-implants were used (SIN®, CONEXÃO®, NEODENT®, MORELLI®, andFORESTADENT®). Ten mini-implants of each diameter of each brand were tested, for a total 100 specimens. The mini-implants were subject to a static torsion test as described in ASTMstandard F543. Analysis of variance (ANOVA) with the Tukey multiple comparisons procedure was used to assess results. Overall, mean fracture strength ranged from 15.7 to 70.4 N·cm. Mini-implants with larger diameter exhibited higher peak torque values at fracture and higher yield strength, regardless of brand. In addition, significant differences across brands were observed when implants were stratified by diameter. In conclusion, larger mini-implant diameter is associated with increased fracture torque resistance. Additional information on peak torque values at fracture of different commercial brands of mini-implants may increase the success rate of this orthodontic anchorage modality. Sociedad Argentina de Investigación Odontológica.

[RESEARCH PROGRESS OF THREE-DIMENSIONAL PRINTING TECHNIQUE FOR SPINAL IMPLANTS].

PubMed

Lu, Qi; Yu, Binsheng

2016-09-08

To summarize the current research progress of three-dimensional (3D) printing technique for spinal implants manufacture. The recent original literature concerning technology, materials, process, clinical applications, and development direction of 3D printing technique in spinal implants was reviewed and analyzed. At present, 3D printing technologies used to manufacture spinal implants include selective laser sintering, selective laser melting, and electron beam melting. Titanium and its alloys are mainly used. 3D printing spinal implants manufactured by the above materials and technology have been successfully used in clinical. But the problems regarding safety, related complications, cost-benefit analysis, efficacy compared with traditional spinal implants, and the lack of relevant policies and regulations remain to be solved. 3D printing technique is able to provide individual and customized spinal implants for patients, which is helpful for the clinicians to perform operations much more accurately and safely. With the rapid development of 3D printing technology and new materials, more and more 3D printing spinal implants will be developed and used clinically.

A resonance frequency analysis of sandblasted and acid-etched implants with different diameters: a prospective clinical study during the initial healing period

PubMed Central

2017-01-01

Purpose The possibility of immediate or early loading has become popular in implant dentistry. A prerequisite for the immediate or early loading of an implant prosthesis is the achievement of initial stability in the implant. Moreover, in response to clinicians' interest in verifying clinical stability to determine the optimal time point for functional loading, a non-invasive method to assess implant stability has been developed on the basis of resonance frequency analysis (RFA). The primary objective of this study was to monitor the stability of sandblasted, large-grit, and acid-etched (SLA) implants with different diameters during the early phases of healing by RFA. The secondary objective was to evaluate how the initial stability of implants varied depending on different surface modifications and other contributing factors. Methods Thirty-five implants (25 SLA implants and 10 resorbable blasting media [RBM] implants) placed in 20 subjects were included. To measure implant stability, RFA was performed at baseline and at 1, 2, 3, 4, 6, and 10 weeks after surgery. Results The longitudinal changes in the implant stability quotient (ISQ) values were similar for the SLA implants with different diameters and for the RBM implants. During the initial healing period, the ISQ decreased after installation and reached its lowest values at 1 week and 2 weeks, respectively. The mean ISQ values in the SLA implants were significantly higher in Ø 5.0 mm implants than in Ø 4.0 mm implants. Men showed a higher ISQ than women. Mandibular sites showed a higher ISQ than maxillary sites. Conclusions All implants used in this study are suitable for immediate or early loading under appropriate indications. A wider diameter and SLA surface treatment of implants could improve the stability, if the implant is fixed with at least 30 Ncm of insertion torque. PMID:28462009

Selective laser melting porous metallic implants with immobilized silver nanoparticles kill and prevent biofilm formation by methicillin-resistant Staphylococcus aureus.

PubMed

van Hengel, Ingmar A J; Riool, Martijn; Fratila-Apachitei, Lidy E; Witte-Bouma, Janneke; Farrell, Eric; Zadpoor, Amir A; Zaat, Sebastian A J; Apachitei, Iulian

2017-09-01

Implant-associated infection and limited longevity are two major challenges that orthopedic devices need to simultaneously address. Additively manufactured porous implants have recently shown tremendous promise in improving bone regeneration and osseointegration, but, as any conventional implant, are threatened by infection. In this study, we therefore used rational design and additive manufacturing in the form of selective laser melting (SLM) to fabricate porous titanium implants with interconnected pores, resulting in a 3.75 times larger surface area than corresponding solid implants. The SLM implants were biofunctionalized by embedding silver nanoparticles in an oxide surface layer grown using plasma electrolytic oxidation (PEO) in Ca/P-based electrolytes. The PEO layer of the SLM implants released silver ions for at least 28 days. X-ray diffraction analysis detected hydroxyapatite on the SLM PEO implants but not on the corresponding solid implants. In vitro and ex vivo assays showed strong antimicrobial activity of these novel SLM PEO silver-releasing implants, without any signs of cytotoxicity. The rationally designed SLM porous implants outperformed solid implants with similar dimensions undergoing the same biofunctionalization treatment. This included four times larger amount of released silver ions, two times larger zone of inhibition, and one additional order of magnitude of reduction in numbers of CFU in an ex vivo mouse infection model. Copyright © 2017 Elsevier Ltd. All rights reserved.

Osseointegration of three-dimensional designed titanium implants manufactured by selective laser melting.

PubMed

Shaoki, Algabri; Xu, Jia-Yun; Sun, Haipeng; Chen, Xian-Shuai; Ouyang, Jianglin; Zhuang, Xiu-Mei; Deng, Fei-Long

2016-10-27

The selective laser melting (SLM) technique is a recent additive manufacturing (AM) technique. Several studies have reported success in the SLM-based production of biocompatible orthopaedic implants and three-dimensional bone defect constructs. In this study, we evaluated the surface properties and biocompatibility of an SLM titanium implant in vitro and compared them with those of a machined (MA) titanium control surface. In addition, we evaluated the osseointegration capability of the SLM implants in vivo and compared it with those of MA and Nobel-speedy (Nobel-S) implants. SLM microtopographical surface analysis revealed porous and high roughness with varied geometry compared with a smooth surface in MA Ti samples but with similar favourable wettability. Osteoblast proliferation and alkaline phosphatase activity were significantly enhanced on the SLM surface. Histological analysis of the bone-implant contact ratio revealed no significant difference among SLM, MA, and Nobel-S implants. Micro-CT assessment indicated that there was no significant difference in bone volume fraction around the implant among SLM implants and other types of surface modification implants. The removal torque value measurement of SLM implants was significantly lower that of than Nobel-S implants P < 0.001 and higher than that of MA implants. The study demonstrates the capability of SLM implants to integrate with living bone. The SLM technique holds promise as a new dental implant manufacturing technique.

Bone attachment to glass-fibre-reinforced composite implant with porous surface.

PubMed

Mattila, R H; Laurila, P; Rekola, J; Gunn, J; Lassila, L V J; Mäntylä, T; Aho, A J; Vallittu, P K

2009-06-01

A method has recently been developed for producing fibre-reinforced composites (FRC) with porous surfaces, intended for use as load-bearing orthopaedic implants. This study focuses on evaluation of the bone-bonding behaviour of FRC implants. Three types of cylindrical implants, i.e. FRC implants with a porous surface, solid polymethyl methacrylate (PMMA) implants and titanium (Ti) implants, were inserted in a transverse direction into the intercondular trabeculous bone area of distal femurs and proximal tibias of New Zealand White rabbits. Animals were sacrificed at 3, 6 and 12 weeks post operation, and push-out tests (n=5-6 per implant type per time point) were then carried out. At 12 weeks the shear force at the porous FRC-bone interface was significantly higher (283.3+/-55.3N) than the shear force at interfaces of solid PMMA/bone (14.4+/-11.0 N; p<0.001) and Ti/bone (130.6+/-22.2N; p=0.001). Histological observation revealed new bone growth into the porous surface structure of FRC implants. Solid PMMA and Ti implants were encapsulated mostly with fibrous connective tissue. Finite element analysis (FEA) revealed that porous FRC implants had mechanical properties which could be tailored to smooth the shear stress distribution at the bone-implant interface and reduce the stress-shielding effect.

Role of clinician's experience and implant design on implant stability. An ex vivo study in artificial soft bones.

PubMed

Romanos, Georgios E; Basha-Hijazi, Abdulaziz; Gupta, Bhumija; Ren, Yan-Fang; Malmstrom, Hans

2014-04-01

Clinical experience in implant placement is important in order to prevent implant failures. However, the implant design affects the primary implant stability (PS) especially in poor quality bones. Therefore, the aim of this study was to compare the effect of clinician surgical experience on PS, when placing different type of implant designs. A total of 180 implants (90 parallel walled-P and 90 tapered-T) were placed in freshly slaughtered cow ribs. Bone quality was evaluated by two examiners during surgery and considered as 'type IV' bone. Implants (ø 5 mm, length: 15 mm, Osseotite, BIOMET 3i, Palm Beach Gardens, FL, USA) were placed by three different clinicians (master/I, good/II, non-experienced/III, under direct supervision of a manufacturer representative; 30 implants/group). An independent observer assessed the accuracy of placement by resonance frequency analysis (RFA) with implant stability quotient (ISQ) values. Two-way analysis of variance (ANOVA) and Tukey's post hoc test were used to detect the surgical experience of the clinicians and their interaction and effects of implant design on the PS. All implants were mechanically stable. The mean ISQ values were: 49.57(± 18.49) for the P-implants and 67.07(± 8.79) for the T-implants. The two-way ANOVA showed significant effects of implant design (p < .0001), clinician (p < .0001), and their interaction (p < .0001). The Tukey's multiple comparison test showed significant differences in RFA for the clinician group I/II (p = .015) and highly significant (p < .0001) between I/III and II/III. The P-implants presented (for I, II, and III) mean ISQ values 31.25/49.18/68.17 and the T-implants showed higher ISQ values, 70.15/62.08/68.98, respectively. Clinicians I and II did not show extreme differences for T-implants (p = .016). In contrast, clinician III achieved high ISQ values using P- and T-implants following the exact surgical protocol based on the manufacturer guidelines. T-implants provided high stability for experienced clinicians compared with P-implants. T-implants achieved greater PS than the P-implants. All clinicians consistently achieved PS; however, experienced clinicians achieved higher ISQ values with T-implants in poor quality bone. © 2012 Wiley Periodicals, Inc.

Customizable cap implants for neurophysiological experimentation.

PubMed

Blonde, Jackson D; Roussy, Megan; Luna, Rogelio; Mahmoudian, Borna; Gulli, Roberto A; Barker, Kevin C; Lau, Jonathan C; Martinez-Trujillo, Julio C

2018-04-22

Several primate neurophysiology laboratories have adopted acrylic-free, custom-fit cranial implants. These implants are often comprised of titanium or plastic polymers, such as polyether ether ketone (PEEK). Titanium is favored for its mechanical strength and osseointegrative properties whereas PEEK is notable for its lightweight, machinability, and MRI compatibility. Recent titanium/PEEK implants have proven to be effective in minimizing infection and implant failure, thereby prolonging experiments and optimizing the scientific contribution of a single primate. We created novel, customizable PEEK 'cap' implants that contour to the primate's skull. The implants were created using MRI and/or CT data, SolidWorks software and CNC-machining. Three rhesus macaques were implanted with a PEEK cap implant. Head fixation and chronic recordings were successfully performed. Improvements in design and surgical technique solved issues of granulation tissue formation and headpost screw breakage. Primate cranial implants have traditionally been fastened to the skull using acrylic and anchor screws. This technique is prone to skin recession, infection, and implant failure. More recent methods have used imaging data to create custom-fit titanium/PEEK implants with radially extending feet or vertical columns. Compared to our design, these implants are more surgically invasive over time, have less force distribution, and/or do not optimize the utilizable surface area of the skull. Our PEEK cap implants served as an effective and affordable means to perform electrophysiological experimentation while reducing surgical invasiveness, providing increased strength, and optimizing useful surface area. Crown Copyright © 2018. Published by Elsevier B.V. All rights reserved.

Short Implants: New Horizon in Implant Dentistry

PubMed Central

Gulati, Manisha; Garg, Meenu; Pathak, Chetan

2016-01-01

The choice of implant length is an essential factor in deciding the survival rates of these implants and the overall success of the prosthesis. Placing an implant in the posterior part of the maxilla and mandible has always been very critical due to poor bone quality and quantity. Long implants can be placed in association with complex surgical procedures such as sinus lift and bone augmentation. These techniques are associated with higher cost, increased treatment time and greater morbidity. Hence, there is need for a less invasive treatment option in areas of poor bone quantity and quality. Data related to survival rates of short implants, their design and prosthetic considerations has been compiled and structured in this manuscript with emphasis on the indications, advantages of short implants and critical biomechanical factors to be taken into consideration when choosing to place them. Studies have shown that comparable success rates can be achieved with short implants as those with long implants by decreasing the lateral forces to the prosthesis, eliminating cantilevers, increasing implant surface area and improving implant to abutment connection. Short implants can be considered as an effective treatment alternative in resorbed ridges. Short implants can be considered as a viable treatment option in atrophic ridge cases in order to avoid complex surgical procedures required to place long implants. With improvement in the implant surface geometry and surface texture, there is an increase in the bone implant contact area which provides a good primary stability during osseo-integration. PMID:27790598

Influence of the overall stiffness of a load-bearing porous titanium implant on bone ingrowth in critical-size mandibular bone defects in sheep.

PubMed

Schouman, T; Schmitt, M; Adam, C; Dubois, G; Rouch, P

2016-06-01

The aim of this work was to assess the influence of reduction of the apparent mechanical properties of fully load-bearing porous titanium implants used in mandibular bone defects. Segmental 18mm long bone defects were created bilaterally in the lower jaws of adult ewes. One group of 6 ewes (group A) was treated with load-bearing 'rigid' (high stiffness) porous implants on the right side, and with control on the left side. A second group of 6 ewes (group B) was treated with 'flexible' porous and control implants exhibiting apparent mechanical properties ten times lower than the rigid implants. The mechanical behavior of the reconstructed hemi-mandibles was assessed by cantilever testing and bone ingrowth into the segmental defects was assessed by BV/TV measurement within the implant using micro-CT 12 weeks after implantation. A significantly higher rigidity was identified for porous implants compared with control implants at the anterior interface in group B. BV/TV of porous implants was significantly higher than that of control implants in group A. BV/TV differences were significant between porous and control implants in group B and were homogeneous along the main axis. Significantly higher BV/TV was identified in most sub-volumes of group B porous implants compared with group A. This work highlights the critical importance of the tuning of scaffolds to promote bone ingrowth with reference to the local strains occurring within the porous scaffold, which in this application was achieved using fully load-bearing low-stiffness porous titanium implants. Copyright © 2016 Elsevier Ltd. All rights reserved.

Evaluation of bone response to titanium-coated polymethyl methacrylate resin (PMMA) implants by X-ray tomography.

PubMed

Shalabi, Manal M; Wolke, Johannes G C; Cuijpers, Vincent M J I; Jansen, John A

2007-10-01

High-resolution three-dimensional data about the bone response to oral implants can be obtained by using microfocus computer tomography. However, a disadvantage is that metallic implants cause streaking artifacts due to scattering of X-rays, which prevents an accurate evaluation of the interfacial bone-to-implant contact. It has been suggested that the use of thin titanium coatings deposited on polymeric implants can offer an alternative option for analyzing bone contact using micro-CT imaging. Consequently, the aim of the current study was to investigate bone behavior to titanium-coated polymethylmethacrylate (PMMA) implants by micro-CT and histological evaluation. For the experiment titanium-coated PMMA implants were used. The implants had a machined threaded appearance and were provided with a 400-500 nm thick titanium coating. The implants were inserted in the right or left tibia of 10 goats. After an implantation period of 12 weeks the implants were retrieved and prepared for micro-computer tomography (microCT), light microscopy, and X-ray microanalysis. The micro-CT showed that the screw-threads and typical implant configuration were well maintained through the installation procedure. Overall, histological responses showed that the titanium-coated implants were well tolerated and caused no atypical tissue response. In addition, the bone was seen in direct contact with the titanium-coated layer. The X-ray microanalysis results confirmed the light microscopical data. In conclusion, the obtained results proof the final use of titanium-coated PMMA implants for evaluation of the bone-implant response using microCT. However, this study also confirms that for a proper analysis of the bone-implant interface the additional use of microscopical techniques is still required.

Evaluation of Stress Distribution of Mini Dental Implant-Supported Overdentures in Complete Cleft Palate Models: A Three-Dimensional Finite Element Analysis Study.

PubMed

Soğancı, Gökçe; Yazıcıoğlu, Hüseyin

2016-01-01

Mini dental implants could be an alternative treatment method for prosthetic treatment of edentulous cleft palate. The aim of this study was to analyze stress distribution around the cortical bone and different plans using a varied number of mini dental implants in edentulous unilateral complete cleft palates. Three edentulous maxillary models were modified to create unilateral complete cleft palates. Mini dental implants (2.4 × 15 mm) were located as two mini implants at the premolar region, four mini implants at the premolar and molar region, and six mini implants at the first premolar, second premolar, and first molar regions in the models, respectively. Mucosa, o-ring/ball attachments, and overdentures were simulated. Vertical and horizontal loads of 100 N were applied on both the right and left molar teeth of the overdenture for each model. Maximum and minimum principal stress values and the distribution at cortical bone around the implants and cleft palates were evaluated by finite element analysis. Stress values under vertical loads were lower than values under horizontal loadings for all models. Stress values were found to be lower in the first model than in the second and third models. The highest stress values were found around implants in the second model. The unilateral feature of a complete cleft pattern affected the stress distribution. Stresses occured mostly around implants when the overdenture was supported by six implants; however, the stress distribution around implants was low with two implants because of tissue support.

Survival of Implants in Immediate Extraction Sockets of Anterior Teeth: Early Clinical Results

PubMed Central

Sabir, Mohammad

2015-01-01

Background The aims and objectives of this study were placement of implants in freshly extracted sockets of anterior teeth and to evaluate the implant stability, peri-implant radiolucency and gingival inflammation around implant over a short period of 30 months. Materials and Methods A total of 12 patients (8 male and 4 female), ranging in the age from 20 to 50 years, from March 2007 to June 2007, were evaluated for immediate implant placement into 22 fresh extraction sockets. Only maxillary and mandibular anterior teeth/roots (central incisors, lateral incisors and canines) were considered for replacement with implants. One piece implant with integrated abutment and integrated surface, non-submerged, threaded and tapered at apical 5 mm, sand-blasted and acid etched surfaced implants (HI-TEC TRX-OP Implants of Life Care Company) were used. Results The mobility was not present in any of the implants at all the follow up visits. There were 2 implants at 6 month, 1 implant at 12 month, 1 implant at 18 month visits, showing peri-implant radiolucency at some sites at bone to implant contact site. Severe gingival inflammation was not observed in any of the implant site. At every follow-up visit, every implant met the criteria of success and none was found to be failed over a 30 months duration i.e. 100% success rate was achieved by implants in immediate extraction socket. Conclusion The success rate of implant survival in this study was found 100%. These implants have fulfilled all the criteria of implant success and based on the defined criteria, the success rate of implants placed in immediate extraction sockets of anterior teeth compared favorably with the conventional implants. The early results of the present study showed that high survival rates with the implants in immediate extraction sockets can be achieved. PMID:26266220

Evaluation of mandibular posterior single implants with two different surfaces: a 5-year comparative study.

PubMed

Jung, Ui-Won; Choi, Jung-Yoo; Kim, Chang-Sung; Cho, Kyoo-Sung; Chai, Jung-Kiu; Kim, Chong-Kwan; Choi, Seong-Ho

2008-10-01

Anatomic and biomechanical limitations can jeopardize successful single implantation in the mandibular posterior area. To overcome the limitations, the design and the surface of the fixtures were modified. This study evaluated the cumulative survival rate (CSR) of mandibular molars replaced with a sand-blasted, large-grit, acid-etched (SLA) single implant or an anodized (ANO) single implant and examined associated factors, such as the surface treatment, position, and length and diameter of the implants. One hundred ninety-three single implants restored with an SLA implant and 112 single implants restored with an ANO implant in the mandibular molar area were selected from subjects who had visited the Department of Periodontology, Dental Hospital of Yonsei University, from March 2001 through June 2006. In the SLA group, 123 and 70 implants were placed in the first and second molar area, respectively. In the ANO group, 55 and 57 implants were placed in the first and second molar area, respectively. The 1- to 6-year CSR of the SLA and ANO groups was calculated using the life-table analysis. In addition, associated factors, such as the surface treatment, position, and length and diameter of the implants, were compared and analyzed using the chi(2) test (P <0.05). Two of 193 implants in the SLA group failed, giving a CSR of 98.96%; four of 112 ANO implants failed, giving a CSR of 96.43%. There were no significant differences with regard to the surface treatment, position, and length and diameter of the implants. Despite the anatomic and biomechanical limitation in the mandibular posterior area, mandibular posterior single implants showed a high CSR during the observation period. Mandibular posterior single implants can be an effective and reliable treatment modality that is not affected by the surface treatment, position, or length and diameter of the implant.

Effect of cyclic loading and retightening on reverse torque value in external and internal implants.

PubMed

Cho, Woong-Rae; Huh, Yoon-Hyuk; Park, Chan-Jin; Cho, Lee-Ra

2015-08-01

The aim of this study was to evaluate the effect of cyclic loading and screw retightening on reverse torque value (RTV) in external and internal type implants. Cement-retained abutments were connected with 30 Ncm torque to external and internal type implants. Experimental groups were classified according to implant connection type and retightening/loading protocol. In groups with no retightening, RTV was evaluated after cyclic loading for 100,000 cycles. In groups with retightening, RTV was measured after 3, 10, 100 cycles as well as every 20,000 cycles until 100,000 cycles of loading. Every group showed decreased RTV after cyclic loading. Before and after cyclic loading, external type implants had significantly higher RTVs than internal type implants. In external type implants, retightening did not affect the decrease in RTV. In contrast, retightening 5 times and retightening after 10 cycles of dynamic loading was effective for maintaining RTV in internal type implants. Retightening of screws is more effective in internal type implants than external type implants. Retightening of screws is recommended in the early stage of functional loading.

Implant treatment in atrophic posterior mandibles: vertical regeneration with block bone grafts versus implants with 5.5-mm intrabony length.

PubMed

Peñarrocha-Oltra, David; Aloy-Prósper, Amparo; Cervera-Ballester, Juan; Peñarrocha-Diago, Maria; Canullo, Luigi; Peñarrocha-Diago, Miguel

2014-01-01

To retrospectively compare the outcomes of implants placed in posterior mandibles vertically regenerated with onlay autogenous block bone grafts and short dental implants. Consecutive patients with vertical bone atrophy in edentulous mandibular posterior regions (7 to 8 mm of bone above the inferior alveolar nerve) were treated with either implants placed in regenerated bone using autologous block bone grafts (group 1) or short implants (with 5.5-mm intrabony length) in native bone (group 2) between 2005 and 2010 and followed for 12 months after loading. The procedure used was the established treatment protocol for this type of patient at the Oral Surgery Unit (University of Valencia, Spain) at the time of surgery. All grafts were obtained using piezosurgery. The outcomes assessed were: complications related to the procedure, implant survival, implant success, and peri-implant marginal bone loss. Statistical analysis was done using the Fisher exact test and the Mann-Whitney test. Thirty-seven patients were included, 20 (45 implants) in group 1 and 17 (35 implants) in group 2. In group 1, 13 implants were less than 10 mm long (2 were 7 mm and 11 were 8.5 mm), and 32 were 10 mm or longer; the diameter was 3.6 mm in 6 implants, 4.2 mm in 31, and 5.5 mm in 8. In group 2 all implants were 7 mm long; the diameter measured 4.2 mm in 14 implants and 5.5 mm in 21 implants. Complications related to the block bone grafting procedure were temporary hypoesthesia in one patient, wound dehiscence with graft exposure in three patients, and exposure of the osteosynthesis screw without bone graft exposure in one patient. After 12 months, implant survival rates were 95.6% in group 1 and 97.1 % in group 2; success rates were 91.1% and 97.1%, respectively. The average marginal bone loss was 0.7 ± 1.1 mm in group 1 and 0.6 ± 0.3 mm in group 2. When residual bone height over the mandibular canal is between 7 and 8 mm, short implants (with 5.5-mm intrabony length) might be a preferable treatment option over vertical augmentation, reducing chair time, expense, and morbidity.

In vivo osseointegration of dental implants with an antimicrobial peptide coating.

PubMed

Chen, X; Zhou, X C; Liu, S; Wu, R F; Aparicio, C; Wu, J Y

2017-05-01

This study aimed to evaluate the in vivo osseointegration of implants with hydrophobic antimicrobial GL13K-peptide coating in rabbit femoral condyles by micro-CT and histological analysis. Six male Japanese Rabbits (4 months old and weighing 2.5 kg each) were included in this study. Twelve implants (3.75 mm wide, 7 mm long) were randomly distributed in two groups, with six implants in the experimental group coated with GL13K peptide and six implants in the control group without surface coating. Each implant in the test and the control group was randomly implanted in the left or right side of femoral condyles. On one side randomly-selected of the femur, each rabbit received a drill that was left without implant as control for the natural healing of bone. After 3 weeks of healing radiographic evaluation of the implant sites was taken. After 6 weeks of healing, rabbits were sacrificed for evaluation of the short-term osseointegration of the dental implants using digital radiography, micro-CT and histology analysis. To perform evaluation of osseointegration, implant location and group was double blinded for surgeon and histology/radiology researcher. Two rabbits died of wound infection in sites with non-coated implants 2 weeks after surgery. Thus, at least four rabbits per group survived after 6 weeks of healing. The wounds healed without suppuration and inflammation. No implant was loose after 6 weeks of healing. Radiography observations showed good osseointegration after 3 and 6 weeks postoperatively, which proved that the tissues followed a natural healing process. Micro-CT reconstruction and analysis showed that there was no statistically significant difference (P > 0.05) in volume of bone around the implant between implants coated with GL13K peptide and implants without coating. Histomorphometric analysis also showed that the mineralized bone area was no statistically different (P > 0.05) between implants coated with GL13K peptide and implants without coating. This study demonstrates that titanium dental implants with an antimicrobial GL13K coating enables in vivo implant osseointegration at similar bone growth rates than gold-standard non-coated dental implants up to 6 weeks of implantation in rabbit femurs.

Paired evaluation of calvarial reconstruction with prototyped titanium implants with and without ceramic coating.

PubMed

Calderoni, Davi Reis; Gilioli, Rovilson; Munhoz, André Luiz Jardini; Maciel Filho, Rubens; Zavaglia, Cecília Amélia de Carvalho; Lambert, Carlos Salles; Lopes, Eder Socrates Najar; Toro, Ivan Felizardo Contrera; Kharmandayan, Paulo

2014-09-01

To investigate the osseointegration properties of prototyped implants with tridimensionally interconnected pores made of the Ti6Al4V alloy and the influence of a thin calcium phosphate coating. Bilateral critical size calvarial defects were created in thirty Wistar rats and filled with coated and uncoated implants in a randomized fashion. The animals were kept for 15, 45 and 90 days. Implant mechanical integration was evaluated with a push-out test. Bone-implant interface was analyzed using scanning electron microscopy. The maximum force to produce initial displacement of the implants increased during the study period, reaching values around 100N for both types of implants. Intimate contact between bone and implant was present, with progressive bone growth into the pores. No significant differences were seen between coated and uncoated implants. Adequate osseointegration can be achieved in calvarial reconstructions using prototyped Ti6Al4V Implants with the described characteristics of surface and porosity.

Using Aerospace Technology To Design Orthopedic Implants

NASA Technical Reports Server (NTRS)

Saravanos, D. A.; Mraz, P. J.; Davy, D. T.

1996-01-01

Technology originally developed to optimize designs of composite-material aerospace structural components used to develop method for optimizing designs of orthopedic implants. Development effort focused on designing knee implants, long-term goal to develop method for optimizing designs of orthopedic implants in general.

The effect of authentic metallic implants on the SAR distribution of the head exposed to 900, 1800 and 2450 MHz dipole near field

NASA Astrophysics Data System (ADS)

Virtanen, H.; Keshvari, J.; Lappalainen, R.

2007-03-01

As the use of radiofrequency (RF) electromagnetic (EM) fields has increased along with increased use of wireless communication, the possible related health risks have also been widely discussed. One safety aspect is the interaction of medical implants and RF devices like mobile phones. In the literature, effects on active implants like pacemakers have been discussed but the studies of passive metallic (i.e. conductive) implants are rare. However, some studies have shown that the EM power absorption in tissues may be enhanced due to metallic implants. In this study, the effect of authentic passive metallic implants in the head region was examined. A half-wave dipole antenna was used as an exposure source and the specific absorption rate (SAR, W kg-1) in the near field was studied numerically. The idea was to model the presumably worst cases of most common implants in an accurate MRI-based phantom. As exposure frequencies GSM (900 and 1800 MHz) and UMTS (2450 MHz) regions were considered. The implants studied were skull plates, fixtures, bone plates and ear rings. The results indicate that some of the implants, under very rare exposure conditions, may cause a notable enhancement in peak mass averaged SAR.

Histological Evidence of the Osseointegration of Fractured Direct Metal Laser Sintering Implants Retrieved after 5 Years of Function.

PubMed

Mangano, Francesco; Mangano, Carlo; Piattelli, Adriano; Iezzi, Giovanna

2017-01-01

Direct metal laser sintering (DMLS) is an additive manufacturing technique that allows the fabrication of dental implants layer by layer through the laser fusion of titanium microparticles. The surface of DMLS implants is characterized by a high open porosity with interconnected pores of different sizes; therefore, it has the potential to enhance and accelerate bone healing. To date, however, there are no histologic/histomorphometric studies in the literature evaluating the interface between bone and DMLS implants in the long-term. To evaluate the interface between bone and DMLS implants retrieved after 5 years of functional loading. Two fractured DMLS implants were retrieved from the human jaws, using a 5 mm trephine bur. Both the implants were clinically stable and functioned regularly before fracture. The specimens were processed for histologic/histomorphometric evaluation; the bone-to-implant contact (BIC%) was calculated. Compact, mature lamellar bone was found over most of the DMLS implants in close contact with the implant surface; the histomorphometric evaluation showed a mean BIC% of 66.1% (±4.5%). The present histologic/histomorphometric study showed that DMLS implants were well integrated in bone, after 5 years of loading, with the peri-implant bone undergoing continuous remodeling at the interface.

The effect of authentic metallic implants on the SAR distribution of the head exposed to 900, 1800 and 2450 MHz dipole near field.

PubMed

Virtanen, H; Keshvari, J; Lappalainen, R

2007-03-07

As the use of radiofrequency (RF) electromagnetic (EM) fields has increased along with increased use of wireless communication, the possible related health risks have also been widely discussed. One safety aspect is the interaction of medical implants and RF devices like mobile phones. In the literature, effects on active implants like pacemakers have been discussed but the studies of passive metallic (i.e. conductive) implants are rare. However, some studies have shown that the EM power absorption in tissues may be enhanced due to metallic implants. In this study, the effect of authentic passive metallic implants in the head region was examined. A half-wave dipole antenna was used as an exposure source and the specific absorption rate (SAR, W kg(-1)) in the near field was studied numerically. The idea was to model the presumably worst cases of most common implants in an accurate MRI-based phantom. As exposure frequencies GSM (900 and 1800 MHz) and UMTS (2450 MHz) regions were considered. The implants studied were skull plates, fixtures, bone plates and ear rings. The results indicate that some of the implants, under very rare exposure conditions, may cause a notable enhancement in peak mass averaged SAR.

Stress on external hexagon and Morse taper implants submitted to immediate loading

PubMed Central

Odo, Caroline H.; Pimentel, Marcele J.; Consani, Rafael L.X.; Mesquita, Marcelo F.; Nóbilo, Mauro A.A.

2015-01-01

Background/Aims This study aimed to evaluate the stress distribution around external hexagon (EH) and Morse taper (MT) implants with different prosthetic systems of immediate loading (distal bar (DB), casting technique (CT), and laser welding (LW)) by using photoelastic method. Methods Three infrastructures were manufactured on a model simulating an edentulous lower jaw. All models were composed by five implants (4.1 mm × 13.0 mm) simulating a conventional lower protocol. The samples were divided into six groups. G1: EH implants with DB and acrylic resin; G2: EH implants with titanium infrastructure CT; G3: EH implants with titanium infrastructure attached using LW; G4: MT implants with DB and acrylic resin; G5: MT implants with titanium infrastructure CT; G6: MT implants with titanium infrastructure attached using LW. After the infrastructures construction, the photoelastic models were manufactured and a loading of 4.9 N was applied in the cantilever. Five pre-determined points were analyzed by Fringes software. Results Data showed significant differences between the connection types (p < 0.0001), and there was no significant difference among the techniques used for infrastructure. Conclusion The reduction of the stress levels was more influenced by MT connection (except for CT). Different bar types submitted to immediate loading not influenced stress concentration. PMID:26605142

A retrospective study on clinical and radiological outcomes of oral implants in patients followed up for a minimum of 20 years.

PubMed

Chrcanovic, Bruno Ramos; Kisch, Jenö; Albrektsson, Tomas; Wennerberg, Ann

2018-04-01

Very long-term follow-up of oral implants is seldom reported in the literature. To assess oral implant failure rates and marginal bone loss (MBL) of patients followed up for a minimum of 20 years. Implants placed in patients followed up for 20+ years were included. Descriptive statistics, survival analyses, generalized estimating equations were performed. Three-hundred implants were randomly selected for MBL. 1,045 implants (227 patients) were included. Implant location, irradiation, and bruxism affected the implant survival rate. Thirty-five percent of the failures occurred within the first year after implantation, and another 26.8% in the second/third year. There was a cumulative survival rate of 87.8% after 36 years of follow-up. In the last radiological follow up, 35 implants (11.7%) had bone gain, and 35 implants (11.7%) presented at least 3 mm of MBL. Twenty-six out of 86 failed implants with available radiograms presented severe MBL in the last radiological register before implant failure. Most of the implant failures occurred at the first few years after implantation, regardless of a very long follow up. MBL can be insignificant in long-term observations, but it may, nevertheless, be the cause of secondary failure of oral implants in some cases. © 2017 Wiley Periodicals, Inc.

Improved osseointegration properties of hierarchical microtopographic/nanotopographic coatings fabricated on titanium implants.

PubMed

Zemtsova, Elena G; Yudintceva, Natalia M; Morozov, Pavel E; Valiev, Ruslan Z; Smirnov, Vladimir M; Shevtsov, Maxim A

2018-01-01

Titanium (Ti) implants are extensively used in reconstructive surgery and orthopedics. However, the intrinsic inertness of untreated Ti implants usually results in insufficient osseointegration. In order to improve the osteoconductivity properties of the implants, they are coated with hierarchical microtopographic/nanotopographic coatings employing the method of molecular layering of atomic layer deposition (ML-ALD). The analysis of the fabricated nanostructured relief employing scanning electron microscopy, atomic force microscopy, and electron spectroscopy for chemical analysis clearly demonstrated the formation of the nanotopographic (<100 nm) and microtopographic (0.1-0.5 μm) titano-organic structures on the surface of the nanograined Ti implants. Subsequent coincubation of the MC3T3-E1 mouse osteoblasts on the microtopographic/nanotopographic surface of the implants resulted in enhanced osteogenic cell differentiation (the production of alkaline phosphatase, osteopontin, and osteocalcin). In vivo assessment of the osseointegrative properties of the microtopographically/nanotopographically coated implants in a model of below-knee amputation in New Zealand rabbits demonstrated enhanced new bone formation in the zone of the bone-implant contact (as measured by X-ray study) and increased osseointegration strength (removal torque measurements). The fabrication of the hierarchical microtopographic/nanotopographic coatings on the nanograined Ti implants significantly improves the osseointegrative properties of the intraosseous Ti implants. This effect could be employed in both translational and clinical studies in orthopedic and reconstructive surgery.

Numerical assessment of bone remodeling around conventionally and early loaded titanium and titanium-zirconium alloy dental implants.

PubMed

Akça, Kıvanç; Eser, Atılım; Çavuşoğlu, Yeliz; Sağırkaya, Elçin; Çehreli, Murat Cavit

2015-05-01

The aim of this study was to investigate conventionally and early loaded titanium and titanium-zirconium alloy implants by three-dimensional finite element stress analysis. Three-dimensional model of a dental implant was created and a thread area was established as a region of interest in trabecular bone to study a localized part of the global model with a refined mesh. The peri-implant tissues around conventionally loaded (model 1) and early loaded (model 2) implants were implemented and were used to explore principal stresses, displacement values, and equivalent strains in the peri-implant region of titanium and titanium-zirconium implants under static load of 300 N with or without 30° inclination applied on top of the abutment surface. Under axial loading, principal stresses in both models were comparable for both implants and models. Under oblique loading, principal stresses around titanium-zirconium implants were slightly higher in both models. Comparable stress magnitudes were observed in both models. The displacement values and equivalent strain amplitudes around both implants and models were similar. Peri-implant bone around titanium and titanium-zirconium implants experiences similar stress magnitudes coupled with intraosseous implant displacement values under conventional loading and early loading simulations. Titanium-zirconium implants have biomechanical outcome comparable to conventional titanium implants under conventional loading and early loading.

Knowledge and attitude of elderly persons towards dental implants.

PubMed

Müller, Frauke; Salem, Kamel; Barbezat, Cindy; Herrmann, François R; Schimmel, Martin

2012-06-01

Despite their unrivalled place in restorative treatment, dental implants are still scarcely used in elderly patients. The aim of this survey was therefore to identify potential barriers for accepting an implant treatment. Participants were recruited from a geriatric hospital, two long-term-care facilities and a private clinic. The final study sample comprised 92 persons, 61 women and 31 men with an average age of 81.2 ± 8.0 years. In a semi-structured interview, the participants' knowledge of implants and attitude towards a hypothetical treatment with dental implants were evaluated. Twenty-seven participants had never heard of dental implants, and another 13 participants could not describe them. The strongest apprehensions against implants were cost, lack of perceived necessity and old age. Univariate and multiple linear regression analysis identified being women, type and quality of denture, having little knowledge on implants and being hospitalised as the risk factors for refusing implants. However, old age as such was not associated with a negative attitude. The acceptance of dental implants in the elderly population might be increased by providing further information and promoting oral health in general. Regardless of the age, dental implants should be placed when patients are still in good health and live independently. © 2011 The Gerodontology Society and John Wiley & Sons A/S.

Use of a single implant of elcometrine (ST-1435), a nonorally active progestin, as a long acting contraceptive for postpartum nursing women.

PubMed

Coutinho, E M; Athayde, C; Dantas, C; Hirsch, C; Barbosa, I

1999-02-01

Because of its unique features, the contraceptive effectiveness and tolerance during breast-feeding of 16-methylene-17 alpha-acetoxy-19-nor-4-pregnene-3,20-dione (elcometrine), delivered within a single subdermal capsule of medical grade polydimethylsiloxane, was investigated. Unlike other progestational steroids, elcometrine has no affinity for androgen and estrogen receptors and is inactive by the oral route. A total of 66 breast-feeding women receiving elcometrine by the subdermal route were enrolled in the study, and 69 women who elected to use Copper-T380 intrauterine devices (IUD) served as control subjects. The women and their infants were observed until the end of the first postpartum year. There were no significant differences in growth and development measurements among the infants in the elcometrine and control groups. The percentage of infants continuing to breast-feed at 3 and 6 months was significantly higher in the elcometrine group. There were no significant differences between the concentration of elcometrine in the mother's blood and milk. At 75 days, blood levels of elcometrine in the infants were near the undetectable and were significantly lower than the levels in maternal blood or milk (p < 0.01). In 15 of 25 infants, blood levels of elcometrine were at the limit of assay sensitivity or undetectable. Two pregnancies occurred in women using IUD, whereas none occurred in those using implants. There were menstrual bleeding irregularities in both groups. A single elcometrine capsule placed subcutaneously at 6-monthly intervals appears to be an effective method of contraception for lactating women and results in blood concentrations of nursing infants at or near undetectable levels.

Sustained delivery and efficacy of polymeric nanoparticles containing osteopontin and bone sialoprotein antisenses in rats with breast cancer bone metastasis.

PubMed

Elazar, Victoria; Adwan, Hassan; Bäuerle, Tobias; Rohekar, Keren; Golomb, Gershon; Berger, Martin R

2010-04-01

Poor prognosis in mammary carcinoma is associated with a certain expression profile of a defined set of genes including osteopontin and bone sialoprotein. Efficient and specific delivery of antisenses (AS) and a protection of the sequences from degradation are the crucial conditions for AS therapeutic efficiency. We hypothesized that effective and safe AS delivery direceted against these genes could be achieved by polymeric nanoparticles (NP) fabricated from a biocompatible polymer. Due to their nano-size range and small negative charge, AS-NP can overcome the absorption barrier offering increased resistance to nuclease degradation, sustained duration of AS administration, and consequently, prolonged antisense action. The ASs designed against OPN and BSP-II were successfully encapsulated in NP composed of the biodegradable and biocompatible polylactide-co-glycolide polymer (PLGA), exhibiting sustained release and stability of the ASs. The therapeutic efficacy of the AS-NP delivery system was examined in vitro, and in a breast cancer bone metastasis animal model of MDA-MB-231 human breast cancer cells in nude rats. Treatment with OPN-AS or BSP-AS loaded NP in comparison with osmotic mini-pumps (locoregional injection and SC implants, respectively) resulted in a significant decrease in both, tumor bone metastasis incidence and in the size of the lesions in rats with metastases. Despite its smaller dose, AS-NP exhibited a better therapeutic efficacy than osmotic mini-pumps in terms of lesion ratio at later time periods (8-12 weeks). It may be concluded that AS delivery by NP is a promising therapeutic modality providing stability of the encapsulated AS and a sustained release.

Irradiated patients and survival rate of dental implants: A systematic review and meta-analysis.

PubMed

Smith Nobrega, Adhara; Santiago, Joel Ferreira; de Faria Almeida, Daniel Augusto; Dos Santos, Daniela Micheline; Pellizzer, Eduardo Piza; Goiato, Marcelo Coelho

2016-12-01

Radiotherapy has been considered a contraindication for rehabilitation with dental implants because it can change the survival rate of implants. Nevertheless, the installation of implants in irradiated patients has been used with varying success. The purpose of this systematic review was to compare the success rate of implants placed in irradiated human bone tissue with that of implants placed in nonirradiated areas. Searches were performed in the EMBASE, Cochrane, and PubMed/Medline databases up to December 2013 to identify clinical trials addressing the subject. This systematic review was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The relative risks of implant failure and survival curves were calculated considering a confidence interval of 95%. Heterogeneity was analyzed by using a funnel chart. A total of 40 studies involving 2220 participants and 9231 dental implants were selected. The survival curve of the studies indicated a survival rate of 84.3% for implants installed in irradiated bone tissue. The meta-analysis indicated statistically significant differences (P<.001) between item success rates of implants placed in irradiated areas and those of implants placed in nonirradiated areas. Dental implants installed in the irradiated area of an oral cavity have a high survival rate, but strict monitoring is needed to prevent complications, thereby reducing possible failures. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Short Implants: New Horizon in Implant Dentistry.

PubMed

Jain, Neha; Gulati, Manisha; Garg, Meenu; Pathak, Chetan

2016-09-01

The choice of implant length is an essential factor in deciding the survival rates of these implants and the overall success of the prosthesis. Placing an implant in the posterior part of the maxilla and mandible has always been very critical due to poor bone quality and quantity. Long implants can be placed in association with complex surgical procedures such as sinus lift and bone augmentation. These techniques are associated with higher cost, increased treatment time and greater morbidity. Hence, there is need for a less invasive treatment option in areas of poor bone quantity and quality. Data related to survival rates of short implants, their design and prosthetic considerations has been compiled and structured in this manuscript with emphasis on the indications, advantages of short implants and critical biomechanical factors to be taken into consideration when choosing to place them. Studies have shown that comparable success rates can be achieved with short implants as those with long implants by decreasing the lateral forces to the prosthesis, eliminating cantilevers, increasing implant surface area and improving implant to abutment connection. Short implants can be considered as an effective treatment alternative in resorbed ridges. Short implants can be considered as a viable treatment option in atrophic ridge cases in order to avoid complex surgical procedures required to place long implants. With improvement in the implant surface geometry and surface texture, there is an increase in the bone implant contact area which provides a good primary stability during osseo-integration.

Biomechanical 3-Dimensional Finite Element Analysis of Obturator Protheses Retained with Zygomatic and Dental Implants in Maxillary Defects

PubMed Central

Akay, Canan; Yaluğ, Suat

2015-01-01

Background The objective of this study was to investigate the stress distribution in the bone around zygomatic and dental implants for 3 different implant-retained obturator prostheses designs in a Aramany class IV maxillary defect using 3-dimensional finite element analysis (FEA). Material\\Methods A 3-dimensional finite element model of an Aramany class IV defect was created. Three different implant-retained obturator prostheses were modeled: model 1 with 1 zygomatic implant and 1 dental implant, model 2 with 1 zygomatic implant and 2 dental implants, and model 3 with 2 zygomatic implants. Locator attachments were used as a superstructure. A 150-N load was applied 3 different ways. Qualitative analysis was based on the scale of maximum principal stress; values obtained through quantitative analysis are expressed in MPa. Results In all loading conditions, model 3 (when compared models 1 and 2) showed the lowest maximum principal stress value. Model 3 is the most appropirate reconstruction in Aramany class IV maxillary defects. Two zygomatic implants can reduce the stresses in model 3. The distribution of stresses on prostheses were more rational with the help of zygoma implants, which can distribute the stresses on each part of the maxilla. Conclusions Aramany class IV obturator prosthesis placement of 2 zygomatic implants in each side of the maxilla is more advantageous than placement of dental implants. In the non-defective side, increasing the number of dental implants is not as suitable as zygomatic implants. PMID:25714086

Complete overdentures retained by mini implants: A systematic review.

PubMed

Lemos, Cleidiel Aparecido Araujo; Verri, Fellippo Ramos; Batista, Victor Eduardo de Souza; Júnior, Joel Ferreira Santiago; Mello, Caroline Cantieri; Pellizzer, Eduardo Piza

2017-02-01

The purpose of this systematic review was to evaluate the use of mini implants to retain complete overdentures in terms of survival rates of mini implants, marginal bone loss, satisfaction, and quality of life. This report followed the PRISMA Statement and PICO question. This review has been registered at PROSPERO under the number CRD42016036141. Two independent reviewers performed a comprehensive search of studies published until September 2016 and listed in the PubMed/MEDLINE, Embase, and The Cochrane Library databases. The focused question was: is the use of mini implants feasible for prosthodontic rehabilitation with complete overdentures? The 24 studies selected for review evaluated 1273 patients whose mean age was 65.93 years; these patients had received 2494 mini implants and 386 standard implants for retaining overdenture prosthesis. The mean follow-up time was 2.48 years (range: 1-7 years). There was a higher survival rate of mini implants (92.32%). More frequent failures for maxillary (31.71%) compared with mandibular arches (4.89%). The majority of studies revealed marginal bone loss values similar to those of standard implants (<1.5mm). All studies verified an increase in satisfaction and quality of life after rehabilitation treatment with mini dental implants. The present systematic review indicates that the use of mini implants for retaining overdenture prosthesis is considered an alternative treatment when standard treatment is not possible, since it presents high survival rates, acceptable marginal bone loss, and improvements in variables related to satisfaction and quality of life. Based on the results of this study, the use of a minimum 4 and 6 mini implants can be considered a satisfactory treatment option for rehabilitation of the mandibular and maxillary arches respectively with a complete overdenture. Copyright © 2016. Published by Elsevier Ltd.

Success of dental implants in vascularised fibular osteoseptocutaneous flaps used as onlay grafts after marginal mandibulectomy.

PubMed

Chang, Y-M; Pan, Y-H; Shen, Y-F; Chen, J-K; ALDeek, N F; Wei, F-C

2016-12-01

We have evaluated the survival of dental implants placed in vascularised fibular flap onlay grafts placed over marginal mandibulectomies and the effects on marginal bone loss of different types of soft tissue around implants under functional loading. From 2001-2009 we studied a total of 11 patients (1 woman and10 men), three of whom had had ameloblastoma and eight who had had squamous cell carcinomas resected. A total of 38 dental implants were placed either at the time of transfer of the vascularised fibular ostoseptocutaneous flaps (nine patients with 30 implants) or secondarily (two patients with eight implants). Four patients were given palatal mucosal grafts to replace intraoral skin flaps around the dental implants (n=13), and the other seven had the skin flaps around the dental implants thinned (n=25) at the second stage of implantation of the osteointegrated teeth. All vascularised fibular osteoseptocutaneous flaps were successfully transferred, and all implants survived a mean (range) of 73 (33-113) months after occlusal functional loading. The mean (SD) marginal bone loss was 0.5 (0.3) mm on both mesial and distal sides in patients who had palatal mucosal grafts, but 1.8 (1.6) mm, and 1.7 (1.5) mm, respectively, on the mesial and distal sides in the patients who had had thinning of their skin flaps. This difference is significant (p=0.008) with less resorption of bone in the group who had palatal mucosal grafts. Palatal mucosa around the implants helps to reduce resorption of bone after functional loading of implants. Copyright © 2016 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Facilitators and barriers influencing the readiness to receive dental implants in a geriatric institutionalised population-A randomized non-invasive interventional study.

PubMed

Merz, Miriam A; Terheyden, Hendrik; Huber, Christian G; Seixas, Azizi A; Schoetzau, Andreas; Schneeberger, Andres R

2017-09-01

Although elderly people have many serious dental issues and are in need of prosthesis, few opt for dental implants. The aim of this study was to investigate barriers that prevent elderly people from receiving dental implants. Specifically, we examined (i) whether the message was delivered before or after the interview had an impact, and (ii) whether it did matter who delivered the message. Sixty-six residents from seven residential homes in the Canton of Grisons, Switzerland were included. The sample was randomized to a treatment group that received comprehensive education about dental implants before the interview and a control group that received education after completing the questionnaire. The sample consisted of 54 women (81.8%) and 12 males (18.2%) with an average age of 86.2 years. Education before the interview did not show any impact on the attitude towards dental implants. Main reasons for a negative attitude towards implants were old age and high costs. Participants who received information about implants from their relatives and their own dentist and not from the study dentist were significantly more willing to receive implants. Providing an adequate education about benefits and risks of receiving dental implants does not change the attitude towards dental implants. The source of information/messenger does influence attitudes towards implants. If the person delivering the education and information is a relative or a known medical person, the person's attitude is more likely to change as compared to people receiving the information from an unrelated person. © 2017 John Wiley & Sons A/S and The Gerodontology Association. Published by John Wiley & Sons Ltd.

Educational Interpreters: Meeting the Communication Needs of Children with Cochlear Implants

ERIC Educational Resources Information Center

Melton, Julie; Higbee, Renee

2013-01-01

Since the early 1990s, when the U.S. Food and Drug Administration approved cochlear implants for deaf and hard of hearing children, the number of children who have cochlear implants has increased in mainstream settings. Recent research suggests that these students, like their deaf and hard of hearing peers without implants who use sign language,…

ALGEBRA: ALgorithm for the heterogeneous dosimetry based on GEANT4 for BRAchytherapy.

PubMed

Afsharpour, H; Landry, G; D'Amours, M; Enger, S; Reniers, B; Poon, E; Carrier, J-F; Verhaegen, F; Beaulieu, L

2012-06-07

Task group 43 (TG43)-based dosimetry algorithms are efficient for brachytherapy dose calculation in water. However, human tissues have chemical compositions and densities different than water. Moreover, the mutual shielding effect of seeds on each other (interseed attenuation) is neglected in the TG43-based dosimetry platforms. The scientific community has expressed the need for an accurate dosimetry platform in brachytherapy. The purpose of this paper is to present ALGEBRA, a Monte Carlo platform for dosimetry in brachytherapy which is sufficiently fast and accurate for clinical and research purposes. ALGEBRA is based on the GEANT4 Monte Carlo code and is capable of handling the DICOM RT standard to recreate a virtual model of the treated site. Here, the performance of ALGEBRA is presented for the special case of LDR brachytherapy in permanent prostate and breast seed implants. However, the algorithm is also capable of handling other treatments such as HDR brachytherapy.

Nódulos subcutáneos faciales de 3 meses de evolución.

PubMed

Martinez-Lopez, Antonio; Pérez-Lopez, Israel; Sánchez-Cano, Daniel; Ruiz-Villaverde, Ricardo

2017-02-15

Siliconomas are subcutaneous nodules that usuallyappear as a consequence of the migration of freesilicon implanted in other locations. They are morefrequent in women with abnormal breast implants,such as poly implant prostheses (PIP), but they may alsoappear after illegal injection of free silicone. We reporta 57-year-old woman who attended our Dermatologyclinic complaining of relapsing facial panniculitis ofunknown origin. After a thorough work-up, thesenodules were determined to be the consequence ofdermal filler made with fluid silicone, which had beeninjected 20 years prior. High frequency skin ultrasoundof one of the nodules showed a hyperechoic image,also known as "snowstorm," which was located in thesubcutaneous tissue. The disposition of silicone in thisplane obscures the view of any sonographic structurein the underlying plane. Cutaneous sonographyhas become one of the most useful non-invasivetechniques in diagnosis of filler complications andother inflammatory diseases. Combined treatmentwith prednisone and allopurinol was successful, withno recurrence after 1 year of follow-up.

Corrosion and fatigue of surgical implants

NASA Technical Reports Server (NTRS)

Lisagor, W. B.

1975-01-01

Implants for the treatment of femoral fractures, mechanisms leading to the failure or degradation of such structures, and current perspectives on surgical implants are discussed. Under the first heading, general usage, materials and procedures, environmental conditions, and laboratory analyses of implants after service are considered. Corrosion, crevice corrosion, stress corrosion cracking, intergranular corrosion, pitting corrosion, fatigue, and corrosion fatigue are the principal degradation mechanisms described. The need for improvement in the reliability of implants is emphasized.

Implant-bone interface stress distribution in immediately loaded implants of different diameters: a three-dimensional finite element analysis.

PubMed

Ding, Xi; Zhu, Xing-Hao; Liao, Sheng-Hui; Zhang, Xiu-Hua; Chen, Hong

2009-07-01

To establish a 3D finite element model of a mandible with dental implants for immediate loading and to analyze stress distribution in bone around implants of different diameters. Three mandible models, embedded with thread implants (ITI, Straumann, Switzerland) with diameters of 3.3, 4.1, and 4.8 mm, respectively, were developed using CT scanning and self-developed Universal Surgical Integration System software. The von Mises stress and strain of the implant-bone interface were calculated with the ANSYS software when implants were loaded with 150 N vertical or buccolingual forces. When the implants were loaded with vertical force, the von Mises stress concentrated on the mesial and distal surfaces of cortical bone around the neck of implants, with peak values of 25.0, 17.6 and 11.6 MPa for 3.3, 4.1, and 4.8 mm diameters, respectively, while the maximum strains (5854, 4903, 4344 muepsilon) were located on the buccal cancellous bone around the implant bottom and threads of implants. The stress and strain were significantly lower (p < 0.05) with the increased diameter of implant. When the implants were loaded with buccolingual force, the peak von Mises stress values occurred on the buccal surface of cortical bone around the implant neck, with values of 131.1, 78.7, and 68.1 MPa for 3.3, 4.1, and 4.8 mm diameters, respectively, while the maximum strains occurred on the buccal surface of cancellous bone adjacent to the implant neck, with peak values of 14,218, 12,706, and 11,504 microm, respectively. The stress of the 4.1-mm diameter implants was significantly lower (p < 0.05) than those of 3.3-mm diameter implants, but not statistically different from that of the 4.8 mm implant. With an increase of implant diameter, stress and strain on the implant-bone interfaces significantly decreased, especially when the diameter increased from 3.3 to 4.1 mm. It appears that dental implants of 10 mm in length for immediate loading should be at least 4.1 mm in diameter, and uniaxial loading to dental implants should be avoided or minimized.

Collagen implants equipped with 'fish scale'-like nanoreservoirs of growth factors for bone regeneration.

PubMed

Eap, Sandy; Ferrand, Alice; Schiavi, Jessica; Keller, Laetitia; Kokten, Tunay; Fioretti, Florence; Mainard, Didier; Ladam, Guy; Benkirane-Jessel, Nadia

2014-01-01

Implants triggering rapid, robust and durable tissue regeneration are needed to shorten recovery times and decrease risks of postoperative complications for patients. Here, we describe active living collagen implants with highly promising bone regenerative properties. Bioactivity of the implants is obtained through the protective and stabilizing layer-by-layer immobilization of a protein growth factor in association with a polysaccharide (chitosan), within the form of nanocontainers decorating the collagen nanofibers. All components of the implants are US FDA approved. From both in vitro and in vivo evaluations, the sophisticated strategy described here should enhance, at a reduced cost, the safety and efficacy of the therapeutic implants in terms of large bone defects repair compared with current simplistic approaches based on the soaking of the implants with protein growth factor.

Oral Health-Related Quality of Life in Edentulous Patients with Two- vs Four-Locator-Retained Mandibular Overdentures: A Prospective, Randomized, Crossover Study.

PubMed

Karbach, Julia; Hartmann, Sinsa; Jahn-Eimermacher, Antje; Wagner, Wilfried

2015-01-01

To compare the oral health-related quality of life (OHRQoL) in a prospective, randomized crossover trial in patients with mandibular overdentures retained with two or four locators. In 30 patients with edentulous mandibles, four implants (ICX-plus implants [Medentis Medical]) were placed in the intraforaminal area. Eight weeks after transgingival healing, patients were randomly assigned to have two or four implants incorporated in the prosthesis. After 3 months, the retention concepts were switched. The patients with a two-implant-supported overdenture had four implants incorporated, whereas patients with a four-implant-supported overdenture had two retention locators taken out. After 3 more months, all four implants were retained in the implant-supported overdenture in every patient. To measure OHRQoL of the patients, the Oral Health Impact Profile 14, German version (OHIP-14 G), was used. A considerable increase in OHRQoL could be seen in all patients after the prosthesis was placed on the implants. Also, a statistically significant difference of OHRQoL could be seen in the OHIP-14 G scores between two-implant and four-implant overdentures. Patients had a higher OHRQoL after incorporation of four implants in the overdenture compared with only two implants. Patients with implant-retained overdentures had better OHRQoL compared with those with conventional dentures. The number of incorporated implants in the locator-retained overdenture also influenced the increase in OHRQoL, with four implants having a statistically significant advantage over two implants.

One-Piece Zirconia Ceramic versus Titanium Implants in the Jaw and Femur of a Sheep Model: A Pilot Study

PubMed Central

De Silva, R. K.; Zafar, S.

2016-01-01

Reports have documented titanium (Ti) hypersensitivity after dental implant treatment. Alternative materials have been suggested including zirconia (Zr) ceramics, which have shown predictable osseointegration in animal studies and appear free of immune responses. The aim of the research was to investigate the bone-to-implant contact (BIC) of one-piece Zr, compared with one-piece Ti implants, placed in the jaws and femurs of domestic sheep. Ten New Zealand mixed breed sheep were used. A One-piece prototype Ti (control) and one Zr (test) implant were placed in the mandible, and one of each implant (Ti and Zr) was placed into the femoral epicondyle of each animal. The femur implants were submerged and unloaded; the mandibular implants were placed using a one-stage transgingival protocol and were nonsubmerged. After a healing period of 12 weeks, %BIC was measured. The overall survival rate for mandibular and femur implants combined was 87.5%. %BIC was higher for Zr implants versus Ti implants in the femur (85.5%, versus 78.9%) (p = 0.002). Zirconia implants in the mandible showed comparable %BIC to titanium implants (72.2%, versus 60.3%) (p = 0.087). High failure rate of both Zr and Ti one-piece implants in the jaw could be attributed to the one-piece design and surface characteristics of the implant that could have influenced osseointegration. Further clinical trials are recommended to evaluate the performance of zirconia implants under loading conditions. PMID:28058261

Analysis of the influence of the macro- and microstructure of dental zirconium implants on osseointegration: a minipig study.

PubMed

Mueller, Cornelia Katharina; Solcher, Philipp; Peisker, Andrè; Mtsariashvilli, Maia; Schlegel, Karl Andreas; Hildebrand, Gerhard; Rost, Juergen; Liefeith, Klaus; Chen, Jiang; Schultze-Mosgau, Stefan

2013-07-01

It was the aim of this study to analyze the influence of implant design and surface topography on the osseointegration of dental zirconium implants. Six different implant designs were tested in the study. Nine or 10 test implants were inserted in the frontal skull in each of 10 miniature pigs. Biopsies were harvested after 2 and 4 months and subjected to microradiography. No significant differences between titanium and zirconium were found regarding the microradiographically detected bone-implant contact (BIC). Cylindric zirconium implants showed a higher BIC at the 2-month follow-up than conic zirconium implants. Among zirconium implants, those with an intermediate Ra value showed a significantly higher BIC compared with low and high Ra implants 4 months after surgery. Regarding osseointegration, titanium and zirconium showed equal properties. Cylindric implant design and intermediate surface roughness seemed to enhance osseointegration. Copyright © 2013 Elsevier Inc. All rights reserved.

Evaluation of the Etiologies of Implant Fracture in Patients With Fractures of the Implants of Lower Limbs’ Long Bones

PubMed Central

Yeganeh, Ali; Otoukesh, Babak; Kaghazian, Peyman; Yeganeh, Nima; Boddohi, Bahram; Moghtadaei, Mehdi

2015-01-01

Background: Orthopedics implants are important tools for treatment of bone fractures. Despite available recommendations for designing and making the implants, there are multiple cases of fracture of these implants in the body. Hence, in this study the frequency of failure of implants in long bones of lower extremities was evaluated. Methods and Materials: In this cross-sectional study, two types of fractured implants in the body were analyzed and underwent metalogical, mechanical, and modeling and stress-bending analysis. Results: The results revealed that the main cause of fractures was decreased mechanical resistance due to inappropriate chemical composition (especially decreased percentages of Nickel and Molybdenum). Conclusions: It may be concluded that following the standard chemical composition and use of optimal making method are the most important works for prevention of failure of implants. PMID:26843735

Maxillary implant-retained partial overdenture with Dolder bar attachment: a clinical report.

PubMed

Kim, Hyeongil; Buhite, Robert J; Monaco, Edward A

2015-03-01

This article describes a technique for maintaining a maxillary Kennedy III partial removable dental prosthesis design in a patient who had non-restorable failing abutments by replacing the abutments with dental implants. Two implants were placed immediately after extraction of the abutment teeth in the anterior maxilla. After the implants were fully integrated, a Dolder bar attachment was fitted onto the implants. A new maxillary partial removable dental prosthesis was fabricated using the implants and the remaining natural teeth as abutments to restore function and esthetics. With the aid of dental implants, this Kennedy III maxillary removable dental prosthesis design could provide additional retention and support by promoting cross-arch stability and tissue, implant and tooth support. The patient's satisfaction was significantly increased.

In vitro biological outcome of laser application for modification or processing of titanium dental implants.

PubMed

Hindy, Ahmed; Farahmand, Farzam; Tabatabaei, Fahimeh Sadat

2017-07-01

There are numerous functions for laser in modern implant dentistry including surface treatment, surface coating, and implant manufacturing. As laser application may potentially improve osseointegration of dental implants, we systematically reviewed the literature for in vitro biological responses to laser-modified or processed titanium dental implants. The literature was searched in PubMed, ISI Web, and Scopus, using keywords "titanium dental implants," "laser," "biocompatibility," and their synonyms. After screening the 136 references obtained, 28 articles met the inclusion criteria. We found that Nd:YAG laser was the most commonly used lasers in the treatment or processing of titanium dental implants. Most of the experiments used cell attachment and cell proliferation to investigate bioresponses of the implants. The most commonly used cells in these assays were osteoblast-like cells. Only one study was conducted in stem cells. These in vitro studies reported higher biocompatibility in laser-modified titanium implants. It seems that laser radiation plays a vital role in cell response to dental implants; however, it is necessary to accomplish more studies using different laser types and parameters on various cells to offer a more conclusive result.

Prefabricated fibula free flap with dental implants for mandibular reconstruction.

PubMed

Pauchet, D; Pigot, J-L; Chabolle, F; Bach, C-A

2018-03-02

Free fibula transplant is routinely used for mandibular reconstruction in head and neck cancer. Dental rehabilitation, the objective of mandibular reconstruction, requires the use of dental implants as supports for fixed or removable dentures. Positioning of fibular bone grafts and implants determines implant osseointegration and the possibilities of dental rehabilitation. Prefabrication of a fibula free flap with dental implants prior to harvesting as a free flap can promote implant osseointegration. The position of the implants must then be precisely planned. Virtual surgery and computer-assisted design and prefabrication techniques are used to plan the reconstruction and then reproduce this planning by means of tailored fibula and mandible cutting guides, thereby ensuring correct positioning of fibular bone fragments and implants. The prefabricated fibula free flap technique requires two surgical procedures (prefabrication and flap transfer) and precise preoperative planning. Prefabricated fibula free flap with dental implants, by improving the quality of osseointegration of the implants before flap transfer, extends the possibilities of prosthetic rehabilitation in complex secondary mandibular reconstructions. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Performance of laser sintered Ti-6Al-4V implants with bone-inspired porosity and micro/nanoscale surface roughness in the rabbit femur.

PubMed

Cohen, David J; Cheng, Alice; Sahingur, Kaan; Clohessy, Ryan M; Hopkins, Louis B; Boyan, Barbara D; Schwartz, Zvi

2017-04-28

Long term success of bone-interfacing implants remains a challenge in compromised patients and in areas of low bone quality. While surface roughness at the micro/nanoscale can promote osteogenesis, macro-scale porosity is important for promoting mechanical stability of the implant over time. Currently, machining techniques permit pores to be placed throughout the implant, but the pores are generally uniform in dimension. The advent of laser sintering provides a way to design and manufacture implants with specific porosity and variable dimensions at high resolution. This approach enables production of metal implants that mimic complex geometries found in biology. In this study, we used a rabbit femur model to compare osseointegration of laser sintered solid and porous implants. Ti-6Al-4V implants were laser sintered in a clinically relevant size and shape. One set of implants had a novel porosity based on human trabecular bone; both sets had grit-blasted/acid-etched surfaces. After characterization, implants were inserted transaxially into rabbit femora; mechanical testing, micro-computed tomography (microCT) and histomorphometry were conducted 10 weeks post-operatively. There were no differences in pull-out strength or bone-to-implant contact. However, both microCT and histomorphometry showed significantly higher new bone volume for porous compared to solid implants. Bone growth was observed into porous implant pores, especially near apical portions of the implant interfacing with cortical bone. These results show that laser sintered Ti-6Al-4V implants with micro/nanoscale surface roughness and trabecular bone-inspired porosity promote bone growth and may be used as a superior alternative to solid implants for bone-interfacing implants.

Performance of laser sintered Ti-6Al-4V implants with bone-inspired porosity and micro/nanoscale surface roughness in the rabbit femur

PubMed Central

Cohen, David J.; Cheng, Alice; Sahingur, Kaan; Clohessy, Ryan M.; Hopkins, Louis B.; Boyan, Barbara D.; Schwartz, Zvi

2018-01-01

Long term success of bone-interfacing implants remains a challenge in compromised patients and in areas of low bone quality. While surface roughness at the micro/nanoscale can promote osteogenesis, macro-scale porosity is important for promoting mechanical stability of the implant over time. Currently, machining techniques permit pores to be placed throughout the implant, but the pores are generally uniform in dimension. The advent of laser sintering provides a way to design and manufacture implants with specific porosity and variable dimensions at high resolution. This approach enables production of metal implants that mimic complex geometries found in biology. In this study, we used a rabbit femur model to compare osseointegration of laser sintered solid and porous implants. Ti-6Al-4V implants were laser sintered in a clinically relevant size and shape. One set of implants had a novel porosity based on human trabecular bone; both sets had grit-blasted/acid-etched surfaces. After characterization, implants were inserted transaxially into rabbit femora; mechanical testing, microCT and histomorphometry were conducted 10 weeks postoperatively. There were no differences in pull-out strength or bone-to-implant contact. However, both microCT and histomorphometry showed significantly higher new bone volume for porous compared to solid implants. Bone growth was observed into porous implant pores, especially near apical portions of the implant interfacing with cortical bone. These results show that laser sintered Ti-6Al-4V implants with micro/nanoscale surface roughness and trabecular bone-inspired porosity promote bone growth and may be used as a superior alternative to solid implants for bone-interfacing implants. PMID:28452335

Lateral forces exerted through ball or bar attachments in relation to the inclination of mini-implant underneath overdentures: in vitro study.

PubMed

Takagaki, Kyozo; Gonda, Tomoya; Maeda, Yoshinobu

2015-09-01

Lateral force to mini-implants should be avoided because mini-implants are weak mechanically because of its small diameter. Overdentures retained by mini-implants are usually formed using ball attachments. However, bar attachments can offer the advantage of splinting the mini-implants. This study examined the effect of attachments in withstanding these lateral forces in tilted mini-implants of overdentures. Strain gauges were attached to the mini-implants (2.5 × 18 mm) embedded in an acrylic resin block. Two mini-implants were inserted vertically (Control) or with one mini-implant inclined at 10° or 20° (10-inclined and 20-inclined, respectively). The female portions of the attachments were secured to the denture base. A prefabricated ball attachment and CAD/CAM-fabricated bar attachment were compared. A vertical load of 49 N was applied to the occlusal surface at a distance 10 mm away from the center of two mini-implants. The lateral force borne by the mini-implants was measured via the attached strain gauge. Mann-Whitney U-test and an analysis of Bonferroni correction were used to compare differences between the two attachments and among the three models (P < 0.05). The lateral force exerted to the inclined mini-implant was significantly greater than that borne by a vertical mini-implant for both attachment types. The lateral force on the 20° inclined mini-implants with bar attachments was smaller than that on mini-implants with ball attachments. Inclined mini-implants are subjected to greater stresses than vertical ones, and a bar attachment can reduce the lateral forces borne by the mini-implant when one mini-implant inclined at 20°. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Survival of Implants in Immediate Extraction Sockets of Anterior Teeth: Early Clinical Results.

PubMed

Sabir, Mohammad; Alam, Mohammad Nazish

2015-06-01

The aims and objectives of this study were placement of implants in freshly extracted sockets of anterior teeth and to evaluate the implant stability, peri-implant radiolucency and gingival inflammation around implant over a short period of 30 months. A total of 12 patients (8 male and 4 female), ranging in the age from 20 to 50 years, from March 2007 to June 2007, were evaluated for immediate implant placement into 22 fresh extraction sockets. Only maxillary and mandibular anterior teeth/roots (central incisors, lateral incisors and canines) were considered for replacement with implants. One piece implant with integrated abutment and integrated surface, non-submerged, threaded and tapered at apical 5 mm, sand-blasted and acid etched surfaced implants (HI-TEC TRX-OP Implants of Life Care Company) were used. The mobility was not present in any of the implants at all the follow up visits. There were 2 implants at 6 month, 1 implant at 12 month, 1 implant at 18 month visits, showing peri-implant radiolucency at some sites at bone to implant contact site. Severe gingival inflammation was not observed in any of the implant site. At every follow-up visit, every implant met the criteria of success and none was found to be failed over a 30 months duration i.e. 100% success rate was achieved by implants in immediate extraction socket. The success rate of implant survival in this study was found 100%. These implants have fulfilled all the criteria of implant success and based on the defined criteria, the success rate of implants placed in immediate extraction sockets of anterior teeth compared favorably with the conventional implants. The early results of the present study showed that high survival rates with the implants in immediate extraction sockets can be achieved.

Qualitative and quantitative observations of bone tissue reactions to anodised implants.

PubMed

Sul, Young-Taeg; Johansson, Carina B; Röser, Kerstin; Albrektsson, Tomas

2002-04-01

Research projects focusing on biomaterials related factors; the bulk implant material, the macro-design of the implant and the microsurface roughness are routinely being conducted at our laboratories. In this study, we have investigated the bone tissue reactions to turned commercially pure (c.p.) titanium implants with various thicknesses of the oxide films after 6 weeks of insertion in rabbit bone. The control c.p. titanium implants had an oxide thickness of 17-200 nm while the test implants revealed an oxide thickness between 600 and 1000 nm. Routine histological investigations of the tissue reactions around the implants and enzyme histochemical detections of alkaline and acid phosphatase activities demonstrated similar findings around both the control and test implants. In general, the histomorphometrical parameters (bone to implant contact and newly formed bone) revealed significant quantitative differences between the control and test implants. The test implants demonstrated a greater bone response histomorphometrically than control implants and the osteoconductivity was more pronounced around the test implant surfaces. The parameters that differed between the implant surfaces, i.e. the oxide thickness, the pore size distribution, the porosity and the crystallinity of the surface oxides may represent factors that have an influence on the histomorphometrical results indicated by a stronger bone tissue response to the test implant surfaces, with an oxide thickness of more than 600 nm.

Influence of Palatal Coverage and Implant Distribution on Implant Strain in Maxillary Implant Overdentures.

PubMed

Takahashi, Toshihito; Gonda, Tomoya; Mizuno, Yoko; Fujinami, Yozo; Maeda, Yoshinobu

2016-01-01

Maxillary implant overdentures are often used in clinical practice. However, there is no agreement or established guidelines regarding prosthetic design or optimal implant placement configuration. The purpose of this study was to examine the influence of palatal coverage and implant number and distribution in relation to impact strain under maxillary implant overdentures. A maxillary edentulous model with implants and experimental overdentures with and without palatal coverage was fabricated. Four strain gauges were attached to each implant, and they were positioned in the anterior, premolar, and molar areas. A vertical occlusal load of 98 N was applied through a mandibular complete denture, and the implant strains were compared using one-way analysis of variance (P = .05). The palatolabial strain was much higher on anterior implants than on other implants in both denture types. Although there was no significant difference between the strain under dentures with and without palatal coverage, palateless dentures tended to result in higher implant strain than dentures with palatal coverage. Dentures supported by only two implants registered higher strain than those supported by four or six implants. Implants under palateless dentures registered higher strain than those under dentures with palatal coverage. Anterior implants exhibited higher palatolabial strain than other implants regardless of palatal coverage and implant configuration; it is therefore recommended that maxillary implant overdentures should be supported by six implants with support extending to the distal end of the arch.

Marginal Bone Loss Around Early-Loaded SLA and SLActive Implants: Radiological Follow-Up Evaluation Up to 6.5 Years.

PubMed

Şener-Yamaner, Işil Damla; Yamaner, Gökhan; Sertgöz, Atilla; Çanakçi, Cenk Fatih; Özcan, Mutlu

2017-08-01

The aim of this study was to compare marginal bone loss around early-loaded SLA and SLActive tissue-level implants (Straumann Dental Implants; Institut Straumann AG, Basel, Switzerland) after a mean of 81-month follow-up period. One hundred seven SLA and 68 SLActive implants were placed in 55 patients and loaded with final restoration after 8 and 3 weeks of healing time, respectively. Marginal bone loss around implants was determined radiographically at initial and after a mean observation time ranging between 20 and 81 months. The effect of location (mandible vs maxilla), smoking habit, sex, implant length and diameter, and the type of prosthesis on the marginal bone loss was evaluated. The overall cumulative survival rate was 98.2% being 99% for SLA implants and 97% for SLActive implants. After 20-month follow-up period, mean marginal bone loss values for the SLA and SLActive implants were 0.24 and 0.17 mm, respectively. After 81 months, mean marginal bone loss for the SLA and SLActive implants reached 0.71 and 0.53 mm, respectively. Marginal bone loss was affected by the length and type of implant and patients' smoking habit after a mean observation time of 20 months. However, none of the parameters had any significant effect on the marginal bone loss after a follow-up period of 81 months. With both SLA and SLActive implants, successful clinical results could be achieved up to 6.5 years of follow-up period.

Bone bonding strength of diamond-structured porous titanium-alloy implants manufactured using the electron beam-melting technique.

PubMed

Hara, Daisuke; Nakashima, Yasuharu; Sato, Taishi; Hirata, Masanobu; Kanazawa, Masayuki; Kohno, Yusuke; Yoshimoto, Kensei; Yoshihara, Yusuke; Nakamura, Akihiro; Nakao, Yumiko; Iwamoto, Yukihide

2016-02-01

The present study examined the bone bonding strength of diamond-structured porous titanium-alloy (Porous-Ti-alloy) manufactured using the electron beam-melting technique in comparison with fiber mesh-coated or rough-surfaced implants. Cylindrical implants with four different pore sizes (500, 640, 800, and 1000μm) of Porous-Ti-alloy, titanium fiber mesh (FM), and surfaces roughened by titanium arc spray (Ti-spray) were implanted into the distal femur of rabbits. Bone bonding strength and histological bone ingrowth were evaluated at 4 and 12weeks after implantation. The bone bonding strength of Porous-Ti-alloy implants (640μm pore size) increased over time from 541.4N at 4weeks to 704.6N at 12weeks and was comparable to that of FM and Ti-spray implants at both weeks. No breakage of the porous structure after mechanical testing was found with Porous-Ti-alloy implants. Histological bone ingrowth that increased with implantation time occurred along the inner structure of Porous-Ti-alloy implants. There was no difference in bone ingrowth in Porous-Ti-alloy implants with pore sizes among 500, 640, and 800μm; however, less bone ingrowth was observed with the 1000μm pore size. These results indicated Porous-Ti-alloy implants with pore size under 800μm provided biologically active and mechanically stable surface for implant fixation to bone, and had potential advantages for weight bearing orthopedic implants such as acetabular cups. Copyright © 2015 Elsevier B.V. All rights reserved.

A prospective, split-mouth study comparing tilted implants with angulated connection versus conventional implants with angulated abutment.

PubMed

Van Weehaeghe, Manú; De Bruyn, Hugo; Vandeweghe, Stefan

2017-12-01

An angulation of the implant connection could overcome the problems related to angulated abutments. This study compares conventional implants with angulated abutment to tilted implants with an angulated connection. Twenty patients were treated in the edentulous mandible. In the posterior jaw locations, one conventional tilted implant with angulated abutment and one angulated implant without abutment were placed. In the anterior jaw, two conventional implants were placed, one with and one without abutment. Implants were immediately loaded and 3 months later, the final bridge (PFM or monolithic zirconia) was placed. After a follow-up of 48 months, 17 patients were available for clinical examination. The mean overall marginal bone loss (MBL) was 1.26 mm. No significant differences in implant survival, MBL, periodontal indices, patients' satisfaction, or complications was found between implants restored on abutment or implant level, between the posteriorly located angulated implant nor angulated abutment, and between both anterior implants with or without abutment. The posterior implants demonstrated less MBL compared to the anterior implants (P < .001). There was no significant difference in MBL between the implants restored with zirconia or PFM bridges (P = .294). Overall mean pocket depth was 2.83 mm. More plaque was found in the PFM group compared to the full-zirconia group, at the bridge (P = .042) and the implants (P = .029). There was no difference between both materials in pocket depth (P = .635) or bleeding (P = .821). One zirconia bridge fractured, two angulated abutment were replaced and four loose bridge screws connected to the angulated abutments had to be tightened. Patients were overall satisfied (4.74/5). An implant with angulated connection may results in a stronger connection but does not affect the marginal bone loss. No difference in MBL was seen between implants restored on abutment or implant level. Zirconia seems to reduce the amount of plaque. © 2017 Wiley Periodicals, Inc.

Biomechanical validation of finite element models for two silicone metacarpophalangeal joint implants.

PubMed

Hussein, A I; Stranart, J C; Meguid, S A; Bogoch, E R

2011-02-01

Silicone implants are used for prosthetic arthroplasty of metacarpophalangeal (MCP) joints severely damaged by rheumatoid arthritis. Different silicone elastomer MCP implant designs have been developed, including the Swanson and the NeuFlex implants. The goal of this study was to compare the in vitro mechanical behavior of Swanson and NeuFlex MCP joint implants. Three-dimensional (3D) finite element (FE) models of the silicone implants were modeled using the commercial software ANSYS and subjected to angular displacement from 0 deg to 90 deg. FE models were validated using mechanical tests of implants incrementally bent from 0 deg to 90 deg in a joint simulator. Swanson size 2 and 4 implants were compared with NeuFlex size 10 and 30 implants, respectively. Good agreement was observed throughout the range of motion for the flexion bending moment derived from 3D FE models and mechanical tests. From 30 deg to 90 deg, the Swanson 2 demonstrated a greater resistance to deformation than the NeuFlex 10 and required a greater bending moment for joint flexion. For larger implant sizes, the NeuFlex 30 had a steeper moment-displacement curve, but required a lower moment than the Swanson 4, due to implant preflexion. On average, the stress generated at the implant hinge from 30 deg to 90 deg was lower in the NeuFlex than in the Swanson. On average, starting from the neutral position of 30 deg for the preflexed NeuFlex implant, higher moments were required to extend the NeuFlex implants to 0 deg compared with the Swanson implants, which returned spontaneously to resting position. Implant toggling within the medullary canals was less in the NeuFlex than in the Swanson. The differential performance of these implants may be useful in implant selection based on the preoperative condition(s) of the joint and specific patient functional needs.

Success and High Predictability of Intraorally Welded Titanium Bar in the Immediate Loading Implants

PubMed Central

Fogli, Vaniel; Camerini, Michele; Carinci, Francesco

2014-01-01

The implants failure may be caused by micromotion and stress exerted on implants during the phase of bone healing. This concept is especially true in case of implants placed in atrophic ridges. So the primary stabilization and fixation of implants are an important goal that can also allow immediate loading and oral rehabilitation on the same day of surgery. This goal may be achieved thanks to the technique of welding titanium bars on implant abutments. In fact, the procedure can be performed directly in the mouth eliminating possibility of errors or distortions due to impression. This paper describes a case report and the most recent data about long-term success and high predictability of intraorally welded titanium bar in immediate loading implants. PMID:24963419

Influence of the height of the external hexagon and surface treatment on fatigue life of commercially pure titanium dental implants.

PubMed

Gil, Francisco Javier; Aparicio, Conrado; Manero, Jose M; Padros, Alejandro

2009-01-01

This study evaluated the effect of external hexagon height and commonly applied surface treatments on the fatigue life of titanium dental implants. Electropolished commercially pure titanium dental implants (seven implants per group) with three different external hexagon heights (0.6, 1.2, and 1.8 mm) and implants with the highest external hexagon height (1.8 mm) and different surface treatments (electropolishing, grit blasting with aluminium oxide, and acid etching with sulfuric acid) were tested to evaluate their mechanical fatigue life. To do so, 10-Hz triangular flexural load cycles were applied at 37 degrees C in artificial saliva, and the number of load cycles until implant fracture was determined. Tolerances of the hexagon/abutment fit and implant surface roughness were analyzed by scanning electron microscopy and light interferometry. Transmission electron microscopy and electron diffraction analyses of titanium hydrides were performed. First, the fatigue life of implants with the highest hexagon (8,683 +/- 978 load cycles) was more than double that of the implants with the shortest hexagons (3,654 +/- 789 load cycles) (P < .02). Second, the grit-blasted implants had the longest fatigue life of the tested materials (21,393 +/- 2,356 load cycles), which was significantly greater than that of the other surfaces (P < .001). The compressive surface residual stresses induced when blasting titanium are responsible for this superior mechanical response. Third, precipitation of titanium hydrides in grain boundaries of titanium caused by hydrogen adsorption from the acid solution deteriorates the fatigue life of acid-etched titanium dental implants. These implants had the shortest fatigue life (P < .05). The fatigue life of threaded root-form dental implants varies with the height of the external hexagon and/or the surface treatment of the implant. An external hexagon height of 1.8 mm and/or a blasting treatment appear to significantly increase fatigue life of dental implants.

Sliding mechanics with microscrew implant anchorage.

PubMed

Park, Hyo-Sang; Kwon, Tae-Geon

2004-10-01

Three cases are illustrated. One was treated with maxillary microscrew implants, another with mandibular microscrew implants, and the third with both maxillary and mandibular microscrew implants. With the maxillary microscrew implants, the maxillary anterior teeth were retracted bodily with a slight intrusion and all the premolar extraction space was closed without loss of anchorage. Furthermore, the maxillary posterior teeth showed distal movement. The mandibular microscrew implants controlled the vertical position of the mandibular posterior teeth and played an important role in improving the facial profile. The efficacy of sliding mechanics with microscrew implant anchorage on the treatment of skeletal Class II malocclusion is also discussed.

Update on the epidemiology of the rheumatic diseases.

PubMed

Gabriel, S E

1996-03-01

Epidemiologic studies continue to enhance our understanding of the rheumatic diseases. Such studies now indicate that 26 million American women are at risk for osteoporotic fractures. Contrary to previous recommendations, the identification and treatment of patients at risk for osteoporosis may be valuable even among very elderly people. Other epidemiologic studies suggest that the incidence of rheumatoid arthritis is decreasing and that it is a more benign disease than previously recognized. Osteoarthritis remains a leading cause of physical and work disability in North America. The roles of occupational physical activity, obesity, and highly competitive (though not low-impact) exercise as risk factors for osteoarthritis continue to be explored. Pharmacoepidemiologic research has recently demonstrated that a policy of prior authorization for prescription of nonsteroidal anti-inflammatory drugs may be highly cost effective. Finally, controlled epidemiologic studies have not confirmed an association between silicone breast implants and connective tissue diseases, a conclusion recently endorsed by the American College of Rheumatology.

Impact of crestal and subcrestal implant placement in peri-implant bone: A prospective comparative study

PubMed Central

Pellicer-Chover, Hilario; Peñarrocha-Diago, María; Peñarrocha-Oltra, David; Gomar-Vercher, Sonia; Agustín-Panadero, Rubén

2016-01-01

Background To assess the influence of the crestal or subcrestal placement of implants upon peri-implant bone loss over 12 months of follow-up. Material and Methods Twenty-six patients with a single hopeless tooth were recruited in the Oral Surgery Unit (Valencia University, Valencia, Spain). The patients were randomized into two treatment groups: group A (implants placed at crestal level) or group B (implants placed at subcrestal level). Control visits were conducted by a trained clinician at the time of implant placement and 12 months after loading. A previously established standard protocol was used to compile general data on all patients (sex and age, implant length and diameter, and brushing frequency). Implant success rate, peri-implant bone loss and the treatment of the exposed implant surface were studied. The level of statistical significance was defined as 5% (α=0.05). Results Twenty-three patients (8 males and 15 females, mean age 49.8±11.6 years, range 28-75 years) were included in the final data analyses, while three were excluded. All the included subjects were nonsmokers with a brushing frequency of up to twice a day in 85.7% of the cases. The 23 implants comprised 10 crestal implants and 13 subcrestal implants. After implant placement, the mean bone position with respect to the implant platform in group A was 0.0 mm versus 2.16±0.88 mm in group B. After 12 months of follow-up, the mean bone positions were -0.06±1.11 mm and 0.95±1.50 mm, respectively - this representing a bone loss of 0.06±1.11 mm in the case of the crestal implants and of 1.22±1.06 mm in the case of the subcrestal implants (p=0.014). Four crestal implants and 5 subcrestal implants presented peri-implant bone levels below the platform, leaving a mean exposed treated surface of 1.13 mm and 0.57 mm, respectively. The implant osseointegration success rate at 12 months was 100% in both groups. Conclusions Within the limitations of this study, bone loss was found to be greater in the case of the subcrestal implants, though from the clinical perspective these implants presented bone levels above the implant platform after 12 months of follow-up. Key words:Immediate implants, tooth extraction, dental implants, single-tooth, crestal bone, placement level. PMID:26615504

Access to breast reconstruction after mastectomy and patient perspectives on reconstruction decision making.

PubMed

Morrow, Monica; Li, Yun; Alderman, Amy K; Jagsi, Reshma; Hamilton, Ann S; Graff, John J; Hawley, Sarah T; Katz, Steven J

2014-10-01

Most women undergoing mastectomy for breast cancer do not undergo breast reconstruction. To examine correlates of breast reconstruction after mastectomy and to determine if a significant unmet need for reconstruction exists. We used Surveillance, Epidemiology, and End Results registries from Los Angeles, California, and Detroit, Michigan, for rapid case ascertainment to identify a sample of women aged 20 to 79 years diagnosed as having ductal carcinoma in situ or stages I to III invasive breast cancer. Black and Latina women were oversampled to ensure adequate representation of racial/ethnic minorities. Eligible participants were able to complete a survey in English or Spanish. Of 3252 women sent the initial survey a median of 9 months after diagnosis, 2290 completed it. Those who remained disease free were surveyed 4 years later to determine the frequency of immediate and delayed reconstruction and patient attitudes toward the procedure; 1536 completed the follow-up survey. The 485 who remained disease free at follow-up underwent analysis. Disease-free survival of breast cancer. Breast reconstruction at any time after mastectomy and patient satisfaction with different aspects of the reconstruction decision-making process. Response rates in the initial and follow-up surveys were 73.1% and 67.7%, respectively (overall, 49.4%). Of 485 patients reporting mastectomy at the initial survey and remaining disease free, 24.8% underwent immediate and 16.8% underwent delayed reconstruction (total, 41.6%). Factors significantly associated with not undergoing reconstruction were black race (adjusted odds ratio [AOR], 2.16 [95% CI, 1.11-4.20]; P = .004), lower educational level (AOR, 4.49 [95% CI, 2.31-8.72]; P < .001), increased age (AOR in 10-year increments, 2.53 [95% CI, 1.77-3.61]; P < .001), major comorbidity (AOR, 2.27 [95% CI, 1.01-5.11]; P = .048), and chemotherapy (AOR, 1.82 [95% CI, 0.99-3.31]; P = .05). Only 13.3% of women were dissatisfied with the reconstruction decision-making process, but dissatisfaction was higher among nonwhite patients in the sample (AOR, 2.87 [95% CI, 1.27-6.51]; P = .03). The most common patient-reported reasons for not having reconstruction were the desire to avoid additional surgery (48.5%) and the belief that it was not important (33.8%), but 36.3% expressed fear of implants. Reasons for avoiding reconstruction and systems barriers to care varied by race; barriers were more common among nonwhite participants. Residual demand for reconstruction at 4 years was low, with only 30 of 263 who did not undergo reconstruction still considering the procedure. Reconstruction rates largely reflect patient demand; most patients are satisfied with the decision-making process about reconstruction. Specific approaches are needed to address lingering patient-level and system factors with a negative effect on reconstruction among minority women.

Effect of different sterilization modes on the surface morphology, ion release, and bone reaction of retrieved micro-implants.

PubMed

El-Wassefy, Noha; El-Fallal, Abeer; Taha, Mahasen

2015-01-01

To compare as-received and sterilized micro-implants in order to assess the prospects of reusing them. Forty micro-implants from a single manufacturing lot were used in the study. Thirty were retrieved from patients after successful service in their mouth and with no signs of failure. The retrieved micro-implants were divided into three groups, according to method of sterilization: autoclave, gamma radiation, or ultraviolet radiation. All groups were subjected to scanning electron microscope analysis for surface morphology assessment. The specimens were immersed in a standard simulated body-fluid solution kept at 37°C in an incubator; the solution was then withdrawn at 24 hours and 30 days to evaluate aluminum and vanadium ion release by atomic absorption spectrophotometer in parts per billion. The micro-implants were then surgically implanted into the tibia of rabbits for a 1-month healing period, and the bone-implant blocks were processed for routine histologic examination. This study revealed that sterilized micro-implants had altered surface topography, different ion release values, and different histologic cell reactions than the as-received micro-implants. Within the limitations of this study, it can be concluded that retrieved self-drilling micro-implants have tip sharpness variations that require correction before insertion by bone drilling. The autoclave-sterilized micro-implants showed better histologic results than micro-implants sterilized by gamma or ultraviolet rays.