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Sample records for silicone breast prosthesis

  1. 21 CFR 878.3540 - Silicone gel-filled breast prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Silicone gel-filled breast prosthesis. 878.3540...-filled breast prosthesis. (a) Identification—(1) Single-lumen silicone gel-filled breast prosthesis. A single-lumen silicone gel-filled breast prosthesis is a silicone rubber shell made of...

  2. 21 CFR 878.3530 - Silicone inflatable breast prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Silicone inflatable breast prosthesis. 878.3530 Section 878.3530 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3530...

  3. 21 CFR 878.3530 - Silicone inflatable breast prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Silicone inflatable breast prosthesis. 878.3530 Section 878.3530 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3530...

  4. 21 CFR 878.3530 - Silicone inflatable breast prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Silicone inflatable breast prosthesis. 878.3530 Section 878.3530 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3530...

  5. 21 CFR 878.3540 - Silicone gel-filled breast prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... application (PMA) is required. A PMA is required to be filed with the Food and Drug Administration on or... silicone gel-filled breast prosthesis shall have an approved PMA in effect before being placed...

  6. 21 CFR 878.3540 - Silicone gel-filled breast prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Silicone gel-filled breast prosthesis. 878.3540 Section 878.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3540 Silicone...

  7. 21 CFR 878.3540 - Silicone gel-filled breast prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Silicone gel-filled breast prosthesis. 878.3540 Section 878.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3540 Silicone...

  8. 21 CFR 878.3540 - Silicone gel-filled breast prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Silicone gel-filled breast prosthesis. 878.3540 Section 878.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3540 Silicone...

  9. 21 CFR 878.3530 - Silicone inflatable breast prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is... prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in...

  10. 21 CFR 878.3530 - Silicone inflatable breast prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is... prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in...

  11. [Silicone breast implants].

    PubMed

    Nielsen, M; Brandt, B; Breiting, V B; Christensen, L H; Thomsen, J L

    1989-12-18

    A brief review of the use of silicone breast implants, their structure, methods of implantation and complications is presented. Acute complications are rare, being mainly infection and hematoma. Long-term complications, on the contrary, are common, consisting mainly of capsular contracture around the prosthesis with subsequent pain and deformation of the breast. More rarely silicone granulomas form, and prosthesis rupture or herniation occurs. The importance of silicone leakage for these complications is discussed separately as well as the treatment of and prevention of capsular contracture and demonstration of silicone in tissue. A critical attitude towards the use of silicone breast implants, when these are used for purely cosmetic purposes, is recommended at present. New improved types of silicone breast implants are currently being tested clinically. PMID:2692262

  12. Magnetically retained silicone facial prosthesis.

    PubMed

    Venugopalan, S; Ariga, P; Aggarwal, P; Viswanath, A

    2014-01-01

    Patients with orocutaneous fistulas suffer from discomfort in terms of facial esthetics, food spill over and lack of psychological confidence to present them socially. Prosthetic camouflaging of facial defects and use of silicone maxillofacial material are the alternatives to the surgical retreatment. Silicone elastomers provide more options to clinician for customization of the facial prosthesis which is simple, esthetically good when coupled with bio magnets for retention. PMID:24553044

  13. Choosing a Breast Prosthesis: A Survivor's Perspective

    MedlinePlus

    ... shape, depending on a woman's preferences. Q: Why did you decide to wear a breast form/prosthesis ... could wear it with my prosthetic. Q: How did having a mastectomy and then wearing a prosthesis ...

  14. Breast Reconstruction and Prosthesis

    MedlinePlus

    ... feel of the breast after a mastectomy. A plastic surgeon can do it at the same time ... want breast reconstruction. • Have you talked with your plastic surgeon about your options? You may not be ...

  15. Pattern of External Breast Prosthesis Use by Post Mastectomy Breast Cancer Patients in India: Descriptive Study from Tertiary Care Centre.

    PubMed

    Ramu, D; Ramesh, Rakesh S; Manjunath, Suraj; Shivakumar; Goel, Vipin; Hemnath, G N; Alexander, Annie

    2015-12-01

    In India, Breast cancer is now the most common cancer in urban and 2nd most common in rural areas [1]. The incidence is rising, more younger women are getting affected and due to increase in survival rates there is an increase in the total number of women suffering from breast Cancer. So far there are no studies evaluating the pattern of breast prosthesis use in Indian scenario. The aim of this study is to address the patterns of external breast prosthesis used in India and view of Indian women on such prosthesis after mastectomy for breast cancer. This was a descriptive longitudinal study. In this study we interviewed (telephonic) 63 people, after three years of completing treatment under The Department of Surgical Oncology, St. Johns medical college, Bangalore. Among the study group, 27 members (40 %) were using various prosthesis, rest 36 women were not using any type of prosthesis. Among the users of prosthesis, silicon prosthesis was used by 6 women, padded cups by 8 women, cloth or cotton by 12 women and 1 woman used other type of prosthesis. Most women use simple items like cloth and cotton (44 %). Next most commonly used prosthesis are padded cups(). Only 22 % of women were found using silicon prosthesis in this study. Most of the well educated patients used external prosthesis either in the form of silicon prosthesis or padded cups. Most of women below age of 50 used external breast prosthesis. Use of prosthesis was more in urban compared to rural population (48 % vs 25 %). Prosthesis users worried more about the body image than women not using prosthesis. 25 % of women using prosthesis had body image issues where as only 5 % of non prosthesis users had such problems. Prosthesis users need improvement in terms of comfort, size, shape and affordability. Most common reasons for not using prosthesis are age, lack of motivation and awareness. Less than half of the women included in this study used external prosthesis after mastectomy for breast cancer

  16. Aesthetic finger prosthesis with silicone biomaterial

    PubMed Central

    Raghu, K M; Gururaju, C R; Sundaresh, K J; Mallikarjuna, Rachappa

    2013-01-01

    The fabrication of finger prosthesis is as much an art as it is science. The ideally constructed prosthesis must duplicate the missing structures so precisely that patients can appear in public without fear of attracting unwanted attraction. A 65-years-old patient reported with loss of his right index finger up to the second phalanx and wanted to get it replaced. An impression of the amputated finger and donor were made. A wax pattern of the prosthesis was fabricated using the donor impression; a trial was performed and flasked. Medical grade silicone was intrinsically stained to match the skin tone, following which it was packed, processed and finished. This clinical report describes a method of attaining retention by selective scoring of the master cast of partially amputated finger to enhance the vacuum effect at par with the proportional distribution of the positive forces on the tissues exerted by the prosthesis. PMID:23975917

  17. Women's Satisfaction with Their Breast Prosthesis: What Determines a Quality Prosthesis?

    ERIC Educational Resources Information Center

    Livingston, Patricia M.; White, Victoria M.; Roberts, Susan B.; Pritchard, Emma; Hayman, Jane; Gibbs, Anne; Hill, David J.

    2005-01-01

    The aim of this study is to determine what factors constitute a quality prosthesis and ascertain which factors affect prosthesis satisfaction. Sixty-four women who received full funding for their prosthesis and 38 women who received their hospital's usual funding were recruited. Women rated the information provided about breast prostheses very…

  18. Rehabilitation of amputed thumb with a silicone prosthesis

    PubMed Central

    Asnani, Pooja; Shivalingappa, Chandu Giriyapura; Mishra, Sunil Kumar; Somkuwar, Kirti; Khan, Faisal

    2015-01-01

    Creating prosthesis, having realistic skin surface and seamless visual integration with the surrounding tissues, requires both artistic and technical skill. Anatomical design, thin margins, lifelike fingernails and realistic color/contours are essential for patient satisfaction. Prosthesis is especially useful in case of lost body parts, as reconstructive surgery cannot fully restore aesthetics. This case report describes a simple technique for fabricating silicon finger prosthesis for a patient. PMID:25810684

  19. Silicone breast implant materials.

    PubMed

    Daniels, A U

    2012-01-01

    This opinion article has been written on request because of the recent public controversy over silicone breast implants produced by a now-defunct company, Poly Implant Prosthese (PIP) in France. More than 300,000 PIP devices have been implanted. The purposes of my article are to (1.) provide a general overview of silicone breast implant materials, (2.) to describe the general safety of these materials as reported to date, and (3.) to summarise current publicly available information about these aspects of the PIP prostheses. The materials covered are the silicone rubber from which the implant shells are made and the silicone gel used to fill the shell. The materials safety issues are biocompatibility (especially of the gel) and biodurability of the shell. The literature reviewed indicates that biocompatibility is not an issue with other current generation implants. However, biodurability is. A rough estimate of implant shell rupture rate is ~10+% at 10 years. Information is still emerging about the PIP implants. Initial regulatory disclosures suggest the PIP implants may have both biocompatibility and biodurability problems. They also suggest that PIP implants may have been produced using silicone materials not certified as medical grade. Governmental health and regulatory agencies are just now in the process of deciding what actions should be taken to protect patients. PMID:22826101

  20. Stretchable silicon nanoribbon electronics for skin prosthesis

    NASA Astrophysics Data System (ADS)

    Kim, Jaemin; Lee, Mincheol; Shim, Hyung Joon; Ghaffari, Roozbeh; Cho, Hye Rim; Son, Donghee; Jung, Yei Hwan; Soh, Min; Choi, Changsoon; Jung, Sungmook; Chu, Kon; Jeon, Daejong; Lee, Soon-Tae; Kim, Ji Hoon; Choi, Seung Hong; Hyeon, Taeghwan; Kim, Dae-Hyeong

    2014-12-01

    Sensory receptors in human skin transmit a wealth of tactile and thermal signals from external environments to the brain. Despite advances in our understanding of mechano- and thermosensation, replication of these unique sensory characteristics in artificial skin and prosthetics remains challenging. Recent efforts to develop smart prosthetics, which exploit rigid and/or semi-flexible pressure, strain and temperature sensors, provide promising routes for sensor-laden bionic systems, but with limited stretchability, detection range and spatio-temporal resolution. Here we demonstrate smart prosthetic skin instrumented with ultrathin, single crystalline silicon nanoribbon strain, pressure and temperature sensor arrays as well as associated humidity sensors, electroresistive heaters and stretchable multi-electrode arrays for nerve stimulation. This collection of stretchable sensors and actuators facilitate highly localized mechanical and thermal skin-like perception in response to external stimuli, thus providing unique opportunities for emerging classes of prostheses and peripheral nervous system interface technologies.

  1. Stretchable silicon nanoribbon electronics for skin prosthesis.

    PubMed

    Kim, Jaemin; Lee, Mincheol; Shim, Hyung Joon; Ghaffari, Roozbeh; Cho, Hye Rim; Son, Donghee; Jung, Yei Hwan; Soh, Min; Choi, Changsoon; Jung, Sungmook; Chu, Kon; Jeon, Daejong; Lee, Soon-Tae; Kim, Ji Hoon; Choi, Seung Hong; Hyeon, Taeghwan; Kim, Dae-Hyeong

    2014-01-01

    Sensory receptors in human skin transmit a wealth of tactile and thermal signals from external environments to the brain. Despite advances in our understanding of mechano- and thermosensation, replication of these unique sensory characteristics in artificial skin and prosthetics remains challenging. Recent efforts to develop smart prosthetics, which exploit rigid and/or semi-flexible pressure, strain and temperature sensors, provide promising routes for sensor-laden bionic systems, but with limited stretchability, detection range and spatio-temporal resolution. Here we demonstrate smart prosthetic skin instrumented with ultrathin, single crystalline silicon nanoribbon strain, pressure and temperature sensor arrays as well as associated humidity sensors, electroresistive heaters and stretchable multi-electrode arrays for nerve stimulation. This collection of stretchable sensors and actuators facilitate highly localized mechanical and thermal skin-like perception in response to external stimuli, thus providing unique opportunities for emerging classes of prostheses and peripheral nervous system interface technologies. PMID:25490072

  2. Prosthetic rehabilitation of large mid-facial defect with magnet-retained silicone prosthesis

    PubMed Central

    Shrivastava, Kirti Jajoo; Shrivastava, Saurabh; Agarwal, Surendra; Bhoyar, Anjali

    2015-01-01

    Rehabilitation of maxillofacial defect patients is a challenging task. The most common prosthetic treatment problem with such patients is, getting adequate retention, stability, and support. In cases of large maxillofacial defect, movement of the prosthesis is inevitable. The primary objectives in rehabilitating the maxillofacial defect patients are to restore the function of mastication, deglutition, speech, and to achieve normal orofacial appearance. This clinical report describes maxillofacial prosthetic rehabilitation of large midfacial defect including orbit along with its contents, zygoma and soft tissues including half of the nose, cheeks, upper lip of left side, accompanying postsurgical microstomia and orofacial communication, which resulted from severe fungal infection mucormycosis. The defect in this case was restored with magnet retained two piece maxillofacial prosthesis having hollow acrylic resin framework and an overlying silicone facial prosthesis. The retention of prosthesis was further enhanced with the use of spectacles. This type of combination prosthesis enhanced the cosmesis and functional acceptability of prosthesis. PMID:26929525

  3. Prosthetic rehabilitation of large mid-facial defect with magnet-retained silicone prosthesis.

    PubMed

    Shrivastava, Kirti Jajoo; Shrivastava, Saurabh; Agarwal, Surendra; Bhoyar, Anjali

    2015-01-01

    Rehabilitation of maxillofacial defect patients is a challenging task. The most common prosthetic treatment problem with such patients is, getting adequate retention, stability, and support. In cases of large maxillofacial defect, movement of the prosthesis is inevitable. The primary objectives in rehabilitating the maxillofacial defect patients are to restore the function of mastication, deglutition, speech, and to achieve normal orofacial appearance. This clinical report describes maxillofacial prosthetic rehabilitation of large midfacial defect including orbit along with its contents, zygoma and soft tissues including half of the nose, cheeks, upper lip of left side, accompanying postsurgical microstomia and orofacial communication, which resulted from severe fungal infection mucormycosis. The defect in this case was restored with magnet retained two piece maxillofacial prosthesis having hollow acrylic resin framework and an overlying silicone facial prosthesis. The retention of prosthesis was further enhanced with the use of spectacles. This type of combination prosthesis enhanced the cosmesis and functional acceptability of prosthesis. PMID:26929525

  4. Silicone breast implants and platinum.

    PubMed

    Wixtrom, Roger N

    2007-12-01

    Platinum, in a specific form, is used as a catalyst in the cross-linking reactions of the silicone gel and elastomer in breast implants. After manufacture, it remains in the devices at low-parts-per-million levels. Potential concerns have been raised as to whether this platinum might diffuse from silicone breast implants into the body and result in adverse health effects. The weight of evidence indicates that the platinum present is in its most biocompatible (zero valence) form, and the very minute levels (<0.1 percent) that might diffuse from the implants do not represent a significant health risk to patients. PMID:18090821

  5. Prosthesis

    MedlinePlus

    ... by prosthetic devices. False teeth are known as dental prostheses. An artificial replacement of the jaw bone is called a maxillofacial prosthesis. Penis implants are also known as penile prostheses.

  6. Silicone lymphadenopathy associated with failed prosthesis of the hallux: a case report and literature review.

    PubMed

    Sammarco, G J; Tabatowski, K

    1992-06-01

    Three years after replacement of a first metatarsophalangeal joint with a silicone prosthesis, a tennis player developed an enlarged ipsilateral femoral lymph node. The implant was also noted to have failed. Fine needle aspiration of the node revealed a foreign body giant cell reaction to particulates morphologically compatible with silicone elastomer. This finding suggests the potential utility of fine needle aspiration in the evaluation of patient response to foreign materials used in prosthetic devices. The lymphadenopathy also suggests that prosthetic metatarsophalangeal replacement in patients with high demand activities run the risk not only of failure of the prosthesis, but also of central migration of the particulate debris resulting from silicone elastomers. PMID:1624192

  7. Rehabilitation of Digital Defect with Silicone Finger Prosthesis: A Case Report

    PubMed Central

    Saxena, Deepesh; Jurel, Sunit; Gupta, Ajay; Tomar, Divya

    2014-01-01

    Patients with acquired defects often had severe trauma which leads to psychological instability, functional loss and poor aesthetics. Digital defects threaten the integrity of one’s self esteem and also leads to a reduced and compromised function. A well fitted and colour matched finger prosthesis can make a patient feel a capable person and not a handicap. This article describes a technique for fabrication of custom made finger prosthesis with a silicone elastomer. The customization of the prosthesis leads to a better fit and retention. An excellent shade matching is achieved by the use of intrinsic colours. The other advantages of using silicone as a material of choice for prosthesis fabrication are also discussed. PMID:25302277

  8. Fabrication of a new silicone auricular prosthesis without removing the existing metallic framework.

    PubMed

    Goveas, Reiyal; Shrestha, Binit; Srithavaj, M L Theerathavaj; Thaworanunta, Sita

    2014-12-01

    Silicone prostheses require constant repair and refabrication. Auricular prostheses retained with implants have better retention than adhesive-retained prostheses. However, refabrication is complicated if the patient is unwilling to surrender the metallic framework attached to the implants and revert to the use of adhesives. This article describes a technique by which the metal framework of the existing prosthesis need not be removed, thereby improving the patient's quality of life until the new prosthesis is delivered. PMID:24998323

  9. [Imaging in silicone breast implantation].

    PubMed

    Gielens, Maaike P M; Koolen, Pieter G L; Hermens, Roland A E C; Rutten, Matthieu J C M

    2013-01-01

    Recently, there have been concerns regarding the use of breast implants from Poly Implant Prothèse (PIP, Seyne sur Mer, France) for breast augmentation due to their tendency to rupture and the possibility of having toxic contents. MRI using a specific silicone-sensitive sequence has proven to be the most sensitive and specific technique in the detection of intra- and extracapsular implant rupture. However, given its high costs, it is important that this technique is used sparingly. In this clinical lesson, we compare the sensitivity and specificity of mammography, ultrasound, CT and MRI for the detection of breast implant rupture. Based on two cases, a diagnostic approach is given in order to reduce health care costs. PMID:24252405

  10. [Cytotoxicity of a new type silicone rubber for maxillofacial prosthesis: an in vitro evaluation].

    PubMed

    Tian, Ai; Chen, Yue; Liao, Jian; Sun, Xu; Teng, Minhua; Liang, Xing

    2014-10-01

    This study evaluated the cytotoxicity of a new type silicone rubber for maxillofacial prosthesis, which was developed by the present authors. According to the GB/T16886. 5- 2003, the samples were prepared and tested with cell counting kit-8 (CCK-8) assay, the relative growth rate (RGR) was calculated, and morphology of L929 cells were observed by scanning electron microscope and phase contrast microscope. The results showed that RGR of L929 cells were 91.65% (24 h), 87.03% (48 h), 87.30% (72 h), respectively, and the level of cytotoxicity was grade 1. The L929 cells showed typical fusiform shape and their morphology did not changed significantly after 24 h, 48 h and 72 h. These data indicated that the newly-developed silicone rubber material, as a maxillofacial prosthesis material, should be a safe biomaterial. PMID:25764719

  11. Silicon and silicone: theoretical and clinical implications of breast implants.

    PubMed

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

    1993-02-01

    In the past 10 years, there have been multiple published reports associating silicone breast implants with scleroderma, morphea, SLE, rheumatoid arthritis, CREST syndrome and "human adjuvant disease." The alleged offending material, silicone, is a synthetic polymer containing a silicon-oxygen backbone. Beginning with the heating of SiO2 in the presence of carbon, elemental silicon is produced. Methylchloride is added and the resulting product is hydrolyzed to form low molecular weight prepolymers which are linked to form linear silicone polymers and cross-linked to yield silicone rubbers or elastomers. The polymeric and hydrophobic characteristics of silicone and the presence of electrostatic charges and organic sidegroups make silicone a potentially ideal immunogen, leading to cross-reactivity with autoantigens. Silicon is an essential constituent of proteoglycans which theoretically could result in immunological cross-reactions between silicone and connective tissues. Although the literature contains numerous examples of silicone-associated autoimmune disease, there is no consistent pattern of immunological abnormalities observed. There are, however, some intriguing and interesting observations. Further large-scale studies are needed to determine if a link between silicone exposure and autoimmunity exists. Also, since the inducing events of autoimmune diseases are unknown, studies on silicone could provide a model for autoimmune diseases associated with toxicological factors. PMID:8441826

  12. Deterioration of the Provox silicone tracheoesophageal voice prosthesis: microbial aspects and structural changes.

    PubMed

    van Weissenbruch, R; Albers, F W; Bouckaert, S; Nelis, H J; Criel, G; Remon, J P; Sulter, A M

    1997-05-01

    Device life of tracheoesophageal voice prostheses is limited due to deterioration of the polymers. A group of 55 postlaryngectomy patients fitted with a Provox voice prosthesis have been studied prospectively during 6 months. Thirty-seven prostheses were replaced due to a dysfunctional valve mechanism. Although colonization with Candida species was highly associated with destruction of the silicone material, other upper respiratory tract commensals, e.g. Staphylococcus aureus, were also demonstrated. Electron microscopy of the contaminated devices showed colonization and disruption of the silicone material by penetrating yeast hyphae. During the study a remarkable increase of intratracheal phonatory pressures was assessed with progressive colonization of the prostheses. PMID:9199534

  13. Allergic reaction to platinum in silicone breast implants.

    PubMed

    Arepalli, Sambasiva R; Bezabeh, Shewit; Brown, S Lori

    2002-01-01

    Platinum is used as a catalyst in the manufacture of silicone breast implants. Because platinum is recognized as a potent sensitizer in certain circumstances, some have expressed concern that women with silicone breast implants are exposed to platinum, which is causing allergic reactions. We searched the literature for information on the level of platinum in breast implants and reports of sensitization that clearly related to platinum in women with breast implants. We found no published report with convincing evidence that platinum causes allergic reactions in women with breast implants or that women with breast implants are any more likely to have allergic reactions than women without breast implants. PMID:12627791

  14. Management of asymptomatic silicone-injected breast with reduction mammoplasty.

    PubMed

    Prasetyono, Theddeus Octavianus Hari; Sadikin, Patricia Marcellina

    2015-01-01

    Even though Silicone injection for breast augmentation has been related to disastrous long-term effects and complications, some patients do not develop significant symptoms at all (asymptomatic). Unfortunately, the management of asymptomatic Silicone-injected breast is still unclear and has never been reported exclusively. We present two cases of asymptomatic patients with a history of liquid Silicone injections who refused to have a mastectomy. They were concerned with the breast ptosis and chose to undergo reduction mammoplasty to improve the appearance of the breasts. Magnetic resonance imaging may be useful as an additional screening tool to confirm the diagnosis and exclude the presence of malignancy in breasts with injected Silicone. We believe that breast reduction may be the alternative option for women with a history of liquid Silicone injection who have no symptoms but desire to preserve their breasts and improve their aesthetics. PMID:26933290

  15. 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

  16. Breast prosthesis infection and pets: A case report and review of the literature

    PubMed Central

    Lenne, A.; Defourny, L.; Lafosse, A.; Martin, M.; Vandercam, B.; Berlière, M.; Lengelé, B.; Rodriguez-Villalobos, H.

    2016-01-01

    Introduction Pets are not always the human’s best friends, particularly in the presence of comorbidities such as wounds. The following case report describes a Pasteurella multocida infection of a reconstructive breast implant due to a close contact between a cat and its owner. Presentation of case A 33-year-old woman developed a breast implant infection 13 days after an immediate breast reconstruction following a mastectomy for a multifocal ductal carcinoma. The wound was explored surgically and the implant removed. Culture extracted from fluid around the prosthesis evidenced the presence of P. multocida, a Gram-negative coccobacillus which is present in the oral commensal flora of cats and dogs. Conclusion In the case of breast infection, surgical revision – with or without removal of the implant – is required in order to carry out a meticulous intraoperative cleaning. Antibiotherapy is always necessary in such cases. Particularly when patients presenting comorbidities are concerned, the focus must be put on avoiding close contact of the wound with pets. PMID:27084983

  17. Chemoprophylaxis of fungal deterioration of the Provox silicone tracheoesophageal prosthesis in postlaryngectomy patients.

    PubMed

    van Weissenbruch, R; Bouckaert, S; Remon, J P; Nelis, H J; Aerts, R; Albers, F W

    1997-04-01

    A double-blind randomized trial was conducted among 36 laryngectomees to assess the influence of a buccal bioadhesive slow-release tablet containing miconazole nitrate on the lifetime of the Provox voice prosthesis. All patients colonized with Candida spp and treated with miconazole showed a significant decrease of colonization at the end of the study. Intratracheal phonatory pressures were remarkably higher after 2 months of follow-up in the placebo group. No local or systemic adverse reactions to miconazole were observed during this study. Patient compliance was acceptable according to regular miconazole determination in saliva samples. The device lifetime was significantly higher in patients treated with miconazole even after 1 year of follow-up. The use of a buccal bioadhesive slow-release tablet containing an antimycotic agent proves to be an adequate method of preventing fungal colonization and deterioration of silicone voice prostheses. PMID:9109726

  18. Management of Testicular Silicone Gel-Filled Prosthesis Rupture: Case Report of a Rare Event and a Review of the Literature

    PubMed Central

    Phan, Quang-Bao; Koutlidis, Nicolas; Duperron, Céline; Mourey, Eric; Michel, Frédéric; Cormier, Luc

    2016-01-01

    Introduction. We report a case of spontaneous rupture of a single testicular prosthesis in a patient who had undergone bilateral orchiectomy and silicone gel-filled prosthesis insertion. The consequences of this rare event are discussed. There is no management algorithm. Case Presentation. A 55-year-old man presented to our outpatient department with altered consistency in his right testicular prosthesis and a painful right hemiscrotum with no systemic symptoms thirty-three years after the implantation of the prosthesis. We removed this implant without replacement, in accordance with the patient's wishes. Conclusion. The long time between the implantation and the spontaneous rupture is remarkable and was never before described. The removal of the prosthesis was straightforward and it would have been possible to implant a new prosthesis after taking into account the condition of the skin. PMID:27123354

  19. Silicone breast implants: lessons from a saga.

    PubMed Central

    Bondurant, S.

    2001-01-01

    In the following eleven lessons learned from the silicone breast implant saga in the United States are listed. Some Lessons From The Saga Of Silicone Breast Implants In The U.S. 1. The intrinsic differences between science and the law mean that there will continue to be tension at the interface between the two. 2. Weak scientific evidence makes for weak scientific, clinical and legal judgments. 3. Health policy can influence the weighing of evidence as did the FDA ban on gel filled silicone breast implants in 1992. 4. As the probative value of scientific evidence decreases (that is, the quality and relevance of the evidence) the courts have increasing difficulty in evaluation. 5. Weak scientific evidence along with poor legal judgments can distort clinical understanding and result in harm to patients. 6. Widely publicized speculation and litigation can obscure less dramatic but frequent and serious complications. 7. Clinicans, toxicologists, industry and regulators should maintain surveillance of medical devices, in representative groups if not in all recipients of the devices. 8. The precise identity and composition of each medical device implanted into a person should be recorded both by the manufacturer and in the health care record. 9. The factual basis for informed consent should be vetted by a disinterested party. 10. Patients, clinicians and industry all have a strong interest in assuring the safety of medical devices through regulation. 11. The criteria and process for evaluating the admissibility of scientific evidence in legal proceedings have been improved but universal adoption of the improvements has not been accomplished and further changes may be necessary. PMID:11413774

  20. Capsular Contracture In Silicone Breast Implants: Insights From Rat Models.

    PubMed

    Vieira, Vilberto J; D'Acampora, Armando; Neves, Fernanda S; Mendes, Paulo R; Vasconcellos, Zulmar A DE; Neves, Rodrigo D'Eça; Figueiredo, Claudia P

    2016-09-01

    Breast augmentation with silicone implants is one of the most common procedures performed by plastic surgeons around the world. Capsular contracture is a frequent complication in breast augmentation and reconstructive surgery, that requires invasive intervention. The inflammatory response to implanted mammary prostheses appears to be directly associated to capsular contracture. This review discusses the evidences from rat models studies, on the role of inflammation and fibrosis in capsular contraction and its relation to silicone breast implants surface. PMID:27627068

  1. Rehabilitation of orbital defect with silicone orbital prosthesis retained by dental implants

    PubMed Central

    Guttal, Satyabodh Shesharaj; Desai, Jhanvi; Kudva, Adarsh; Patil, Basavaraj R

    2016-01-01

    Orbital defects can result from cancer, birth anomalies, or trauma leading to an onslaught of problems in the function and psyche of the patient. These defects are restored by surgical reconstruction and followed by placement of orbital prosthesis for cosmetic makeup. The use of dental implants in retaining orbital prosthesis improves patient acceptance of the prosthesis owing to better retention and stability than conventional adhesive retained prosthesis. This case report describes a custom-made magnetic retentive assembly anchored by a dental implant which offers the orbital prosthesis the simplicity of self-alignment and ease of use. PMID:26953033

  2. Microfabrication of an Implantable silicone Microelectrode array for an epiretinal prosthesis

    SciTech Connect

    Maghribi, M

    2003-06-10

    Millions of people suffering from diseases such as retinitis pigmentosa and macular degeneration are legally blind due to the loss of photoreceptor function. Fortunately a large percentage of the neural cells connected to the photoreceptors remain viable, and electrical stimulation of these cells has been shown to result in visual perception. These findings have generated worldwide efforts to develop a retinal prosthesis device, with the hope of restoring vision. Advances in microfabrication, integrated circuits, and wireless technologies provide the means to reach this challenging goal. This dissertation describes the development of innovative silicone-based microfabrication techniques for producing an implantable microelectrode array. The microelectrode array is a component of an epiretinal prosthesis being developed by a multi-laboratory consortium. This array will serve as the interface between an electronic imaging system and the human eye, directly stimulating retinal neurons via thin film conducting traces. Because the array is intended as a long-term implant, vital biological and physical design requirements must be met. A retinal implant poses difficult engineering challenges due to the size of the intraocular cavity and the delicate retina. Not only does it have to be biocompatible in terms of cytotoxicity and degradation, but it also has to be structurally biocompatible, with regard to smooth edges and high conformability; basically mimicking the biological tissue. This is vital to minimize stress and prevent physical damage to the retina. Also, the device must be robust to withstand the forces imposed on it during fabrication and implantation. In order to meet these biocompatibility needs, the use of non-conventional microfabrication materials such as silicone is required. This mandates the enhancement of currently available polymer-based fabrication techniques and the development of new microfabrication methods. Through an iterative process, devices

  3. [Computer-aided method and rapid prototyping for the personalized fabrication of a silicone bandage digital prosthesis].

    PubMed

    Ventura Ferreira, Nuno; Leal, Nuno; Correia Sá, Inês; Reis, Ana; Marques, Marisa

    2014-01-01

    The fabrication of digital prostheses has acquired growing importance not only for the possibility for the patient to overcome psychosocial trauma but also to promote grip functionality. An application method of three dimensional-computer-aided design technologies for the production of passive prostheses is presented by means of a fifth finger amputee clinical case following bilateral hand replantation.Three-dimensional-computerized tomography was used for the collection of anthropometric images of the hands. Computer-aided design techniques were used to develop the digital file-based prosthesis from the reconstruction images by inversion and superimposing the contra-lateral finger images. The rapid prototyping manufacturing method was used for the production of a silicone bandage prosthesis prototype. This approach replaces the traditional manual method by a virtual method that is basis for the optimization of a high speed, accurate and innovative process. PMID:25641294

  4. Silicone Breast Implants: A Rare Cause of Pleural Effusion

    PubMed Central

    Shaik, Imam H.; Gandrapu, Bindu; Flores, David; Matta, Jyoti; Syed, Amer K.

    2015-01-01

    Pleural effusions are one of the rarest complications reported in patients with silicone gel filled breast implants. The silicone implants have potential to provoke chronic inflammation of pleura and subsequent pulmonary complications such as pleural effusion. Herein, we report a 44-year-old female who presented with left sided pleural effusion, six weeks after a silicone breast implantation surgery. The most common infectious, inflammatory, and malignant causes of pleural effusion were excluded with pleural fluid cytology and cultures. With recurrent effusion in the setting of recent surgery, the chemical reaction to silicone breast implants was sought and exploration was performed which revealed foreign body reaction (FBR) to silicone material. The symptoms dramatically improved after the explantation. PMID:26693375

  5. A New Approach to Minimize Acellular Dermal Matrix Use in Prosthesis-based Breast Reconstruction

    PubMed Central

    Hadad, Ivan; Liu, Allen S.

    2015-01-01

    Background: Acellular dermal matrices (ADMs) are often used to improve lower-pole contour, as well as allow for single-stage reconstruction, but numerous studies have shown an increased complication rate using ADM. As such, our group has developed a minimal-ADM-use technique to lower complications while effectively recreating lower-pole contour. Methods: A total of 380 postmastectomy prosthesis-based breast reconstructions were performed in 265 patients by a single surgeon. One hundred eight reconstructions were performed using the traditional ADM technique, with a large piece of ADM along the entire inferior and lateral borders. Two hundred twenty-five reconstructions were performed with the minimal-use technique, patching only the lateral area of the reconstruction. Thirty-five reconstructions were performed without the use of any ADM for high-risk reconstructions, most often in morbidly obese patients. Results: Comparing the traditional technique with the minimal-use technique, the seroma rate dropped from 3% to 0%. The rate of infection and reconstruction loss fell from 9% to 1%. Upon greatly reducing or eliminating the use of ADM use in obese patients, the seroma rate decreased from 15.4% to 5.7%, and the reconstruction loss rate decreased from 38% to 9%. Conclusions: This article describes a new surgical approach to minimize the amount of ADM necessary to create an aesthetically pleasing breast reconstruction. We believe that this approach helps avoid the complications of seroma, infection, and loss of the reconstruction. In certain obese patients, total avoidance of ADM may be the better choice. PMID:26301161

  6. Polyarteritis Nodosa Presenting as Digital Gangrene and Breast Lesion following Exposure to Silicone Breast Implants

    PubMed Central

    Homsi, Yamen; Carlson, John Andrew; Homsi, Samer

    2015-01-01

    Polyarteritis nodosa (PAN) is a rare systemic necrotizing vasculitis of small and medium sized arteries. We report a case of a 49-year old woman who presented with PAN following exposure to silicone breast implants. Although the relationship between silicone implants and connective tissue diseases has been investigated in the literature, no prior reports were found documenting PAN after silicone mammoplasty. While the pathogenesis of idiopathic PAN is not known yet, responsiveness to immunosuppressive therapy may suggest an immunologic mechanism. More robust research is needed to understand the connection between silicone breast implants and autoimmunity. PMID:26844000

  7. [Socio-psychological aspects of prosthesis in women undergoing mastectomy for breast cancer].

    PubMed

    Gundareva, I D; Chulkova, V A

    1987-01-01

    A relationship between prosthetics, personality features and occupational rehabilitation of mastectomized women is discussed. Questionnaire-based data were obtained on patients' attitude towards prosthetics as well as on certain social and labor characteristics of 65 women under study. Prosthesis users approved of its cosmetic characteristics. Their satisfaction contributed to their adaptation to domestic and industrial environment. A tetrachoric coefficient correlation was established between "use of prosthesis" and "occupation". PMID:3590666

  8. Chemical fingerprinting of silicone-based breast implants.

    PubMed

    Keizers, Peter H J; Vredenbregt, Marjo J; Bakker, Frank; de Kaste, Dries; Venhuis, Bastiaan J

    2015-01-01

    With millions of women worldwide carrying them, silicone-based breast implants represent a large market. Even though silicone breast implants already have a history of use of more than 50 years, the discussion on their safety has not yet come to an end. To improve safety assessment, regulatory authorities should have the availability of a set of tests to be able to determine parameters of implant identity and quality. Therefore, the gels and envelopes of various brands and types of silicone-based breast implants have been subjected to infrared, Raman and NMR spectroscopy. We show that by using a combination of complementary spectroscopic techniques breast implants of various origins can be distinguished on typical chemical hallmarks. It was found that typical silicone-based implants display a surplus of vinyl signals in the gel, cyclosiloxane impurities are tolerable at low levels only and a barrier layer is present in the implant envelope. The techniques presented here and the results obtained offer a good starting point for market surveillance studies. PMID:25459933

  9. New biomaterial as a promising alternative to silicone breast implants.

    PubMed

    Teck Lim, Goy; Valente, Stephanie A; Hart-Spicer, Cherie R; Evancho-Chapman, Mary M; Puskas, Judit E; Horne, Walter I; Schmidt, Steven P

    2013-05-01

    One in eight American women develops breast cancer. Of the many patients requiring mastectomy yearly as a consequence, most elect some form of breast reconstruction. Since 2006, only silicone breast implants have been approved by the FDA for the public use. Unfortunately, over one-third of women with these implants experience complications as a result of tissue-material biocompatibility issues, which may include capsular contracture, calcification, hematoma, necrosis and implant rupture. Our group has been working on developing alternatives to silicone. Linear triblock poly(styrene-b-isobutylene-b-styrene) (SIBS) polymers are self-assembling nanostructured thermoplastic rubbers, already in clinical practice as drug eluting stent coatings. New generations with a branched (arborescent or dendritic) polyisobutylene core show promising potential as a biomaterial alternative to silicone rubber. The purpose of this pre-clinical research was to evaluate the material-tissue interactions of a new arborescent block copolymer (TPE1) in a rabbit implantation model compared to a linear SIBS (SIBSTAR 103T) and silicone rubber. This study is the first to compare the molecular weight and molecular weight distribution, tensile properties and histological evaluation of arborescent SIBS-type materials with silicone rubber before implantation and after explantation. PMID:23466517

  10. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Identification. A testicular prosthesis is an implanted device that consists of a solid or gel-filled silicone rubber prosthesis that is implanted surgically to resemble a testicle. (b) Classification. Class...

  11. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Identification. A testicular prosthesis is an implanted device that consists of a solid or gel-filled silicone rubber prosthesis that is implanted surgically to resemble a testicle. (b) Classification. Class...

  12. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Identification. A testicular prosthesis is an implanted device that consists of a solid or gel-filled silicone rubber prosthesis that is implanted surgically to resemble a testicle. (b) Classification. Class...

  13. 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. PMID:19055963

  14. Rapid fabrication of a digital prosthesis.

    PubMed

    Rokaya, Dinesh; Amornvit, Pokpong; Shrestha, Binit

    2015-12-01

    Finger prosthesis often needs refabrication due to its discoloration following use. This article presents a novel, economical, and cost-effective technique to duplicate the patient׳s existing prosthesis to obtain a new wax replica, which is then clinically tried and processed to obtain new silicone finger prosthesis. This technique requires comparatively less clinical and laboratory steps as to fabricate an entirely new prosthesis. The newly fabricated silicone finger prosthesis has the fit and marginal adaptation of the patient׳s existing prosthesis but the esthetics is improved. PMID:26684496

  15. Chemical and physicochemical properties of the high cohesive silicone gel from Poly Implant Prothèse (PIP) breast prostheses after explantation: a preliminary, comparative analytical investigation.

    PubMed

    Beretta, Giangiacomo; Malacco, Matteo

    2013-05-01

    Aim of this work was to gain a deeper insight into the analytical profile of the macromolecular and LMW fractions of polymeric silicones present in breast implants. The study was conducted on silicone gel samples from (i) breast prostheses (Poly Implant Prothèse, PIP) explanted from a patient that needed their therapeutical removal, (ii) from a virgin Mc Ghan 410 MX prosthesis and (iii) from a sample of technical-grade non-cohesive silicone. The gels were analysed using rheological techniques, attenuated total reflectance infrared spectroscopy (ATR-FT-IR), nuclear magnetic resonance ((1)H NMR), gas chromatography coupled to mass spectrometry (GC-MS) and flow injection electrospray mass spectrometry (FI-ESI-MS). Our results demonstrate that, compared to the virgin McGhan gel, the silicone present the PIP prostheses lacks a significant part of the cross-linking sites necessary for the high-cohesive properties of the gel, significant amounts of cholesterol have been absorbed from the breast tissue by the silicone material, demonstrating the lack of impermeability of its elastomer shell. The potential implications and consequences of these analytical results are discussed. PMID:23454600

  16. Human monocytes stimulation by particles of hydroxyapatite, silicon carbide and diamond: in vitro studies of new prosthesis coatings.

    PubMed

    Nordsletten, L; Høgåsen, A K; Konttinen, Y T; Santavirta, S; Aspenberg, P; Aasen, A O

    1996-08-01

    Aseptic loosening due to wear and debris formation constitutes the major problem in longevity of joint replacements. Diamond coated onto the prosthesis surface may reduce wear, owing to its excellent tribological properties. A thin diamond coating may be brittle, and we plan eventually to reinforce it with silicon carbide whiskers (SiC). In the present study we compared particles of diamond, SiC and hydroxyapatite (HA) in serum-free cultures of human monocytes. All particles were found to be phagocytozed, and monocyte morphology changed except after the ingestion of diamond. Interleukin-1 beta production was increased on average 30-fold and 38-fold in cultures exposed to HA and SiC, respectively, compared to control and diamond cultures (n = 6). Addition of the phagocytosis inhibitor cytochalasin B inhibited the morphological changes of the monocytes and reduced interleukin-1 beta production. In some experiments particles of polymethylmethacrylate were also included, and the interleukin-1 beta stimulation was in the same range as after HA and SiC stimulation. The results show that diamond particles in serum-free monocyte culture are inert, while SiC and HA have a stimulatory effect comparable to polymethylmethacrylate. With its excellent tribological and biocompatible properties, future studies with diamond coating are warranted. PMID:8853123

  17. 21 CFR 878.3590 - Ear prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ear prosthesis. 878.3590 Section 878.3590 Food and... GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3590 Ear prosthesis. (a) Identification. An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the...

  18. 21 CFR 878.3590 - Ear prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ear prosthesis. 878.3590 Section 878.3590 Food and... GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3590 Ear prosthesis. (a) Identification. An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the...

  19. 21 CFR 878.3590 - Ear prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ear prosthesis. 878.3590 Section 878.3590 Food and... GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3590 Ear prosthesis. (a) Identification. An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the...

  20. Investigations of silicone breast implants with the NMR-MOUSE.

    PubMed

    Krüger, Mirko; Schwarz, Annett; Blümich, Bernhard

    2007-02-01

    Silicone breast implants are used for breast augmentation and breast reconstruction. The issues of concern associated with such implants are: (a) the quality control of each implant before implantation, and (b) the detection of implant bleeding after implantation. We have studied the use of the Nuclear Magnetic Resonance-MObile Universal Surface Explorer (NMR-MOUSE) for the nondestructive testing of (a) the quality of implant shells, and (b) changes in implant gel due to leakage of body fluid into the implant. Depth profiles measured nondestructively through implant shells at different positions of each implant by the Profile NMR-MOUSE assured good reproducibility of the quality and thickness of different shell layers. The leakage of implants upon rupture was mimicked by observing changes in the transverse NMR relaxation time of the implant gel upon ingress of physiological saline solution and safflower oil through the rupture. Results demonstrate that nondestructive testing with unilateral NMR is a potential method for use in the quality control of implants and for the screening of implants for rupture after implantation. PMID:17275616

  1. Enhanced MRI and MRI-Guided Interventional Procedures in Women with Asymptomatic Silicone-Injected Breasts

    PubMed Central

    Cheung, Yun-Chung; Chen, Shin-Chih; Lo, Yung-Feng

    2012-01-01

    Asymptomatic women who have received silicone injection for breast augmentation have a risk of underestimating breast cancer by palpation, mammography, or breast sonography. Enhanced breast MRI is sensitive to display certain nonspecific enhanced lesions or suspicious lesions. Such nonspecific MRI-detected lesions could be managed by American College Radiology BI-RADS lexicon and selectively with MRI-guided techniques biopsy to prevent unnecessary surgery. PMID:22536144

  2. Silicone Breast Implant and Automatic Implantable Cardioverter Defibrillator: Can They Coexist? A Case Report

    PubMed Central

    Arik, Zaretski

    2016-01-01

    Summary: We present a case of a silicone breast implant rupture after insertion of an automatic implantable cardioverter defibrillator (AICD). A 51-year-old woman presented to our plastic surgery clinic to exchange her silicone breast implants. The patient underwent cosmetic mastopexy and breast augmentation in 2008. Because of recurrent myocardial infarctions and chronic heart failure, she underwent an insertion of an AICD in 2014 in which the left breast implant was hit. In this report, we discuss the first case of an AICD insertion, disrupting a breast implant. This case report illustrates the rare but real possibility of breast implant rupture after even minor surgical manipulation of the breast area. PMID:27622117

  3. A review of the use of silicone implants in breast surgery.

    PubMed

    Chao, Albert H; Garza, Ramon; Povoski, Stephen P

    2016-02-01

    Breast implant surgery is one of the most commonly performed procedures in the field of plastic surgery. While silicone implants are now routinely used in breast surgery, they have previously been the subject of controversy. This was particularly true in the U.S., where there was a moratorium on their use from 1992 to 2006. Following subsequent scientific validation of their safety, silicone implants have re-gained widespread acceptance for clinical use. Modern implant design has aimed to optimize aesthetic outcomes while minimizing implant-related complications, such as capsular contracture and device rupture. One of the most significant advances has been the use of highly cohesive silicone which, through extensive cross-linking, maintains its shape within the body in the presence of physiologic forces. Overall, silicone breast implants are associated with a high degree of patient satisfaction and low rates of complications. Further independent research is necessary to better establish long-term outcomes. PMID:26690709

  4. 21 CFR 888.3025 - Passive tendon prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Passive tendon prosthesis. 888.3025 Section 888...) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or...

  5. Prosthesis coupling

    NASA Technical Reports Server (NTRS)

    Reswick, J. B.; Mooney, V.; Bright, C. W.; Owens, L. J. (Inventor)

    1979-01-01

    A coupling for use in an apparatus for connecting a prosthesis to the bone of a stump of an amputated limb is described which permits a bio-compatible carbon sleeve forming a part of the prosthesis connector to float so as to prevent disturbing the skin seal around the carbon sleeve. The coupling includes a flexible member interposed between a socket that is inserted within an intermedullary cavity of the bone and the sleeve. A lock pin is carried by the prosthesis and has a stem portion which is adapted to be coaxially disposed and slideably within the tubular female socket for securing the prosthesis to the stump. The skin around the percutaneous carbon sleeve is able to move as a result of the flexing coupling so as to reduce stresses caused by changes in the stump shape and/or movement between the bone and the flesh portion of the stump.

  6. The inner and outer of our thorax: silicone breast implants and pulmonary alveolar proteinosis.

    PubMed

    De Backer, H; Darquennes, K; Dooms, C; Yserbyt, J; Coolen, J; Verschakelen, J; Verbeken, E; Vrints, I; Wuyts, W

    2015-10-01

    Pulmonary alveolar (phospholipo)proteinosis (PAP) is a rare lung disease, predominantly autoimmune in nature. This case report describes a patient with insidious dyspnoea since 5 years and a milky appearance of her bronchoalveolar fluid, leading to the diagnosis of PAP. The onset of symptoms coincided with an exchange of her silicone breast implants. Giant cell reaction in axillary adenopathies pointed towards silicone leakage. Adjuvants, such as silicone, might boost pre-existing antigen reactions of the immune system, potentially leading to autoimmune phenomena. PMID:26083574

  7. Delayed Mammoplasty with Silicone Gel Implants following DIEP Flap Breast Reconstruction

    PubMed Central

    Walters, Jules A.; Sato, Erika A.; Martinez, Carlos A.; Hall, Jason J.

    2015-01-01

    Background: The deep inferior epigastric artery perforator (DIEP) flap is a state-of-the-art option for breast reconstruction. However, thin patients with medium- to large-size native breasts are not ideal candidates due to the limited amount of available tissue. We reviewed our experience utilizing the DIEP flap in combination with prosthetic implants. Methods: We conducted a retrospective chart review of 7 patients, totaling 11 implants, who underwent breast reconstruction with the DIEP flap and subsequent mammoplasty. All cases underwent previous mastectomies. No implant placement was offered at the time of their DIEP flap reconstruction. Immediate breast reconstruction with the DIEP flap was performed in 9 cases, whereas 2 required delayed reconstruction secondary to postmastectomy radiotherapy. No patients received postreconstruction radiotherapy. Breast asymmetry and inadequate volume were the primary indications for mammoplasty. For all cases, we used smooth, round silicone gel implants, which were placed in the subpectoral region. Results: Mean age was 43 years. One patient was actively smoking. Four patients underwent bilateral implant placement. The mean time of delay between breast reconstruction and mammoplasty was 61 weeks. Average volume of silicone implants was 229 mL. A medial pedicle vertical mastopexy was performed in 1 patient on a nonreconstructed breast to achieve symmetry. Five patients underwent nipple reconstruction. All patients underwent delayed mammoplasty without intraoperative complications and good aesthetic results. Conclusions: Delayed mammoplasty following DIEP flap breast reconstruction is a safe and feasible procedure for patients who seek an aesthetic and natural-looking breast but lack adequate abdominal tissue. PMID:26579346

  8. Preliminary Study on Biosynthesis of Bacterial Nanocellulose Tubes in a Novel Double-Silicone-Tube Bioreactor for Potential Vascular Prosthesis.

    PubMed

    Hong, Feng; Wei, Bin; Chen, Lin

    2015-01-01

    Bacterial nanocellulose (BNC) has demonstrated a tempting prospect for applications in substitute of small blood vessels. However, present technology is inefficient in production and BNC tubes have a layered structure that may bring danger after implanting. Double oxygen-permeable silicone tubes in different diameters were therefore used as a tube-shape mold and also as oxygenated supports to construct a novel bioreactor for production of the tubular BNC materials. Double cannula technology was used to produce tubular BNC via cultivations with Acetobacter xylinum, and Kombucha, a symbiosis of acetic acid bacteria and yeasts. The results indicated that Kombucha gave higher yield and productivity of BNC than A. xylinum. Bacterial nanocellulose was simultaneously synthesized both on the inner surface of the outer silicone tube and on the outer surface of the inner silicone tube. Finally, the nano BNC fibrils from two directions formed a BNC tube with good structural integrity. Scanning electron microscopy inspection showed that the tubular BNC had a multilayer structure in the beginning but finally it disappeared and an intact BNC tube formed. The mechanical properties of BNC tubes were comparable with the reported value in literatures, demonstrating a great potential in vascular implants or in functional substitutes in biomedicine. PMID:26090420

  9. Preliminary Study on Biosynthesis of Bacterial Nanocellulose Tubes in a Novel Double-Silicone-Tube Bioreactor for Potential Vascular Prosthesis

    PubMed Central

    Wei, Bin; Chen, Lin

    2015-01-01

    Bacterial nanocellulose (BNC) has demonstrated a tempting prospect for applications in substitute of small blood vessels. However, present technology is inefficient in production and BNC tubes have a layered structure that may bring danger after implanting. Double oxygen-permeable silicone tubes in different diameters were therefore used as a tube-shape mold and also as oxygenated supports to construct a novel bioreactor for production of the tubular BNC materials. Double cannula technology was used to produce tubular BNC via cultivations with Acetobacter xylinum, and Kombucha, a symbiosis of acetic acid bacteria and yeasts. The results indicated that Kombucha gave higher yield and productivity of BNC than A. xylinum. Bacterial nanocellulose was simultaneously synthesized both on the inner surface of the outer silicone tube and on the outer surface of the inner silicone tube. Finally, the nano BNC fibrils from two directions formed a BNC tube with good structural integrity. Scanning electron microscopy inspection showed that the tubular BNC had a multilayer structure in the beginning but finally it disappeared and an intact BNC tube formed. The mechanical properties of BNC tubes were comparable with the reported value in literatures, demonstrating a great potential in vascular implants or in functional substitutes in biomedicine. PMID:26090420

  10. Prosthesis Material

    NASA Technical Reports Server (NTRS)

    1995-01-01

    In this photograph, Sandra Rossi user her NASA-developed prosthesis for the first time. Derived from foam insulation technology used to protect the Space Shuttle External Tank from excessive heat, FAB/CAD, a subsidiary of the Harshberger Prosthetic and Orthotic Center, utilized the technology to replace the heavy, fragile plaster they used to produce master molds for prosthetics. The new material was lighter, cheaper and easier to manufacture than plaster, resulting in lower costs to the customer.

  11. Prosthesis Material

    NASA Technical Reports Server (NTRS)

    1995-01-01

    In this photograph, James Carden uses a NASA-developed prosthesis to moved planks around his home. Derived from foam insulation technology used to protect the Space Shuttle External Tank from excessive heat, FAB/CAD, a subsidiary of the Harshberger Prosthetic and Orthotic Center, utilized the technology to replace the heavy, fragile plaster they used to produce master molds for prosthetics. The new material was lighter, cheaper and easier to manufacture than plaster, resulting in lower costs to the customer.

  12. Prosthesis Material

    NASA Technical Reports Server (NTRS)

    2004-01-01

    In this photograph, Amputee Amie Bradly uses a NASA-developed prosthesis to paint her fingernails. Derived from foam insulation technology used to protect the Space Shuttle External Tank from excessive heat, FAB/CAD, a subsidiary of the Harshberger Prosthetic and Orthotic Center, utilized the technology to replace the heavy, fragile plaster they used to produce master molds for prosthetics. The new material was lighter, cheaper and easier to manufacture than plaster, resulting in lower costs to the customer.

  13. A fiber-reinforced composite prosthesis restoring a lateral midfacial defect: a clinical report.

    PubMed

    Kurunmäki, Hemmo; Kantola, Rosita; Hatamleh, Muhanad M; Watts, David C; Vallittu, Pekka K

    2008-11-01

    This clinical report describes the use of a glass fiber-reinforced composite (FRC) substructure to reinforce the silicone elastomer of a large facial prosthesis. The FRC substructure was shaped into a framework and embedded into the silicone elastomer to form a reinforced facial prosthesis. The prosthesis is designed to overcome the disadvantages associated with traditionally fabricated prostheses; namely, delamination of the silicone of the acrylic base, poor marginal adaptation over time, and poor simulation of facial expressions. PMID:18992568

  14. Prosthesis Material

    NASA Technical Reports Server (NTRS)

    1995-01-01

    FAB/CAM, a subsidiary of the Harshberger Prosthetic and Orthotic Center, Inc., approached Marshall for help in replacing the heavy, fragile plaster they used to produce master molds for prosthetics. Concurrently, Marshall and Martin Marietta were creating a commercial derivative of the foam insulation used to protect the Space Shuttle External Tank from excessive heat. FAB/CAM found the foam blanks to be lighter, cheaper and easier to manufacture than plaster, resulting in lower costs to the consumer. Martin Marietta markets the foam system, MARCORE, for the prosthesis market. The system also has commercial potential in high temperature insulation and structural applications.

  15. Retinal Prosthesis

    PubMed Central

    Weiland, James D.; Humayun, Mark S.

    2015-01-01

    Retinal prosthesis have been translated from the laboratory to the clinical over the past two decades. Currently, two devices have regulatory approval for the treatment of retinitis pigmentosa. These devices provide partial sight restoration and patients use this improved vision in their everyday lives. Improved mobility and object detection are some of the more notable findings from the clinical trials. However, significant vision restoration will require both better technology and improved understanding of the interaction between electrical stimulation and the retina. This paper reviews the recent clinical trials, highlights technology breakthroughs that will contribute to next generation of retinal prostheses. PMID:24710817

  16. Investigation of the silicone structure in breast implants using ¹H NMR.

    PubMed

    Formes, Andreas; Diehl, Bernd

    2014-05-01

    Against the background of the scandal about low-grade silicone breast implants of the French manufacturer Poly Implant Prothese (PIP), several types of implants were examined using (1)H NMR spectroscopy. The intention was to classify an implant according to its silicone structure. Therefore, the certificated raw material of the American silicone producer Nusil Technology was analyzed and used as a reference. The list of tested implants consists of implants by PFM medical, PIP, Silimed, Rofil, Eurosilicone, Mentor, Perouse Plastie, Polytech, Nagor, CUI, and McGhan. In the (1)H NMR spectrum the signal of the vinyl group, which is used to cross link silicone rubbers, is visible. It is possible to differentiate between silicones which have a vinyl terminated end group and silicones whose vinyl group is located within the chain of the polymer. The two different types of the vinyl group are one mean to classify the implants. Other categories besides the type of vinyl include the relative amount of the remaining vinyl in the implant and the chemical structure of the material used for the production of the envelope. With these characteristics the examined implants could be grouped into four types. PMID:24342752

  17. Capsular contracture by silicone breast implants: possible causes, biocompatibility, and prophylactic strategies.

    PubMed

    Steiert, Andreas E; Boyce, Maria; Sorg, Heiko

    2013-01-01

    The most common implanted material in the human body consists of silicone. Breast augmentation and breast reconstruction using silicone-based implants are procedures frequently performed by reconstructive and aesthetic surgeons. A main complication of this procedure continues to be the development of capsular contracture (CC), displaying the result of a fibrotic foreign body reaction after the implantation of silicone. For many years, experimental and clinical trials have attempted to analyze the problem of its etiology, treatment, and prophylaxis. Different theories of CC formation are known; however, the reason why different individuals develop CC in days or a month, or only after years, is unknown. Therefore, we hypothesize that CC formation, might primarily be induced by immunological mechanisms along with other reasons. This article attempts to review CC formation, with special attention paid to immunological and inflammatory reasons, as well as actual prophylactic strategies. In this context, the word "biocompatibility" has been frequently used to describe the overall biological innocuousness of silicone in the respective studies, although without clear-cut definitions of this important feature. We have therefore developed a new five-point scale with distinct key points of biocompatibility. Hence, this article might provide the basis for ongoing discussion in this field to reduce single-publication definitions as well as increase the understanding of biocompatibility. PMID:24324348

  18. 21 CFR 878.3750 - External prosthesis adhesive.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... adhesive. (a) Identification. An external prosthesis adhesive is a silicone-type adhesive intended to...

  19. 21 CFR 878.3750 - External prosthesis adhesive.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... adhesive. (a) Identification. An external prosthesis adhesive is a silicone-type adhesive intended to...

  20. Amine-modified hyaluronic acid-functionalized porous silicon nanoparticles for targeting breast cancer tumors

    NASA Astrophysics Data System (ADS)

    Almeida, Patrick V.; Shahbazi, Mohammad-Ali; Mäkilä, Ermei; Kaasalainen, Martti; Salonen, Jarno; Hirvonen, Jouni; Santos, Hélder A.

    2014-08-01

    Active targeting of nanoparticles to receptor-overexpressing cancer cells has great potential for enhancing the cellular uptake of nanoparticles and for reducing fast clearance of the nanoparticles from the body. Herein, we present a preparation method of a porous silicon (PSi)-based nanodelivery system for breast cancer targeting, by covalently conjugating a synthesized amide-modified hyaluronic acid (HA+) derived polymer on the surface of undecylenic acid-modified thermally hydrocarbonized PSi (UnTHCPSi) nanoparticles. The resulting UnTHCPSi-HA+ nanoparticles showed relatively small size, reduced polydispersibility, high biocompatibility, improved colloidal and human plasma stability, as well as enhanced cellular interactions and internalization. Moreover, we demonstrated that the enhanced cellular association of UnTHCPSi-HA+ relies on the capability of the conjugated HA+ to bind and consequently target CD44 receptors expressed on the surface of breast cancer cells, thus making the HA+-functionalized UnTHCPSi nanoparticles a suitable and promising nanoplatform for the targeting of CD44-overexpressing breast tumors and for drug delivery.Active targeting of nanoparticles to receptor-overexpressing cancer cells has great potential for enhancing the cellular uptake of nanoparticles and for reducing fast clearance of the nanoparticles from the body. Herein, we present a preparation method of a porous silicon (PSi)-based nanodelivery system for breast cancer targeting, by covalently conjugating a synthesized amide-modified hyaluronic acid (HA+) derived polymer on the surface of undecylenic acid-modified thermally hydrocarbonized PSi (UnTHCPSi) nanoparticles. The resulting UnTHCPSi-HA+ nanoparticles showed relatively small size, reduced polydispersibility, high biocompatibility, improved colloidal and human plasma stability, as well as enhanced cellular interactions and internalization. Moreover, we demonstrated that the enhanced cellular association of Un

  1. Natrelle 410 Extra-Full Projection Silicone Breast Implants: 2-Year Results from Two Prospective Studies

    PubMed Central

    McGuire, Patricia; Murphy, Diane K.

    2015-01-01

    Background: The safety and effectiveness of the Natrelle Style 410 highly cohesive silicone gel breast implant (Allergan, Inc., Irvine, Calif.) in full or moderate height and projection have been shown in a 10-year study. Extra-full projection implants may be an appropriate option for some women undergoing breast reconstruction. Methods: A total of 2795 women received at least one Natrelle 410 extra-full projection implant (X-style) for breast reconstruction in two similarly designed, prospective, multicenter studies. Data collected for 2 years after implantation in these studies were pooled to evaluate complication rates and subject and physician satisfaction. Results: Most subjects (76.0 percent) underwent bilateral reconstruction; a total of 4912 devices were implanted. Complication rates at 2 years were low. The most common complications were asymmetry (4.8 percent) and capsular contracture (3.3 percent). The cumulative risk of reoperation was 21.6 percent by subject and 16.6 percent by device; the most common reasons for reoperation were scarring (n = 97), asymmetry (n = 89), implant malposition (n = 78), and infection (n = 71). Subject and physician satisfaction rates exceeded 90 percent. At 2 years, 97 percent of physicians reported that the shape of the breast reflected the shape of the implant, and that the breast implant had maintained its original position. Conclusions: The safety profile of the Natrelle 410 extra-full projection implant mirrors that of its moderate projection and full projection counterparts. Both physicians and subjects were highly satisfied with the implants 2 years after surgery. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV. PMID:26090764

  2. 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

  3. Amine-modified hyaluronic acid-functionalized porous silicon nanoparticles for targeting breast cancer tumors

    PubMed Central

    Almeida, Patrick V.; Shahbazi, Mohammad-Ali; Mäkilä, Ermei; Kaasalainen, Martti; Salonen, Jarno; Hirvonen, Jouni; Santos, Hélder A.

    2014-01-01

    Active targeting of nanoparticles to receptor-overexpressing cancer cells has great potential for enhancing the cellular uptake of nanoparticles and for reducing fast clearance of the nanoparticles from the body. Herein, we present a preparation method of a porous silicon (PSi)-based nanodelivery system for breast cancer targeting, by covalently conjugating a synthesized amide-modified hyaluronic acid (HA+) derived polymer on the surface of undecylenic acid-modified thermally hydrocarbonized PSi (UnTHCPSi) nanoparticles. The resulting UnTHCPSi–HA+ nanoparticles showed relatively small size, reduced polydispersibility, high biocompatibility, improved colloidal and human plasma stability, as well as enhanced cellular interactions and internalization. Moreover, we demonstrated that the enhanced cellular association of UnTHCPSi–HA+ relies on the capability of the conjugated HA+ to bind and consequently target CD44 receptors expressed on the surface of breast cancer cells, thus making the HA+-functionalized UnTHCPSi nanoparticles a suitable and promising nanoplatform for the targeting of CD44-overexpressing breast tumors and for drug delivery. PMID:25074521

  4. Fabrication of a Custom Ocular Prosthesis

    PubMed Central

    Sethi, Tania; Kheur, Mohit; Haylock, Colin; Harianawala, Husain

    2014-01-01

    Defects of the eye may follow removal of a part of or the entire orbit. This results in the patient becoming visually, esthetically and psychologically handicapped. Restoring the defect with a silicone- or acrylic-based prosthesis not only restores esthetics but also gives back the lost confidence to the patient. This is a case report of a patient with a ‘pthisical eye’ and details the steps in fabrication of an ocular prosthesis. Particular attention has been given to the laboratory process in this technique to minimize the residual monomer content in the artificial eye. PMID:25100916

  5. Polycation-Functionalized Nanoporous Silicon Particles for Gene Silencing on Breast Cancer Cells

    PubMed Central

    Zhang, Mingzhen; Xu, Rong; Xia, Xiaojun; Yang, Yong; Gu, Jianhua; Qin, Guoting; Liu, Xuewu; Ferrari, Mauro; Shen, Haifa

    2013-01-01

    Nanoporous silicon particles (pSi), with a pore size in the range of 20~60 nm, were modified with polyethyleimine (PEI) to yield pSi-PEI particles, which were subsequently complexed with siRNA. Thus, pSi-PEI/siRNA particles were fabricated, with the PEI/siRNA nanocomplexes mainly anchored inside the nanopore of the pSi particles. These hybrid particles were used as carriers to deliver siRNA to human breast cancer cells. Due to the gradual degradation of the pSi matrix under physiological conditions, the PEI/siRNA nanocomplexes were released from the pore interior in a sustained manner. Physicochemical characterization revealed that the released PEI/siRNA nanocomplexes exhibited well-defined spherical shape and narrow particle size distribution between 15 and 30 nm. Gene knockdown against the ataxia telangiectasia mutated (ATM) cancer gene showed dramatic gene silencing efficacy. Moreover, comprehensive biocompatibility studies were performed for the pSi-PEI/siRNA particles both in vitro and in vivo and demonstrated that the pSi-PEI particles exhibited significantly enhanced biocompatibility. As a consequence, PEI-modified porous silicon particles may have substantial potential as safe and effective siRNA delivery systems. PMID:24103653

  6. Physico-chemical characteristics of coated silicone textured versus smooth breast implants differentially influence breast-derived fibroblast morphology and behaviour.

    PubMed

    Valencia-Lazcano, Anai A; Alonso-Rasgado, Teresa; Bayat, Ardeshir

    2014-12-01

    Capsule formation is an inevitable consequence of silicone breast implantation. Clinically challenging dense fibrocollagenous capsular contractures occur at different rates between smooth compared to textured surfaces. Host response is influenced by several factors including implant surface texture, chemistry and interactions between cells and the extracellular matrix (ECM). Specific coatings can modify the physico-chemical properties of implant surfaces eliciting specific cellular reactions. Therefore, we evaluated the physico-chemical characteristics of coated smooth versus textured silicone breast implants on breast-derived fibroblast morphology and behaviour using (a) confocal laser microscopy, (b) Raman spectroscopy and (c) the effect of four unique protein and glycosaminoglycan (GAG) coatings (aggrecan, collagen I, fibronectin and hyaluronic acid) on breast-derived fibroblast attachment, proliferation, morphology, spreading, cytotoxicity and gene expression. Collagen I, fibronectin and hyaluronic acid coatings exhibited satisfactory fibroblast adhesion (p<0.001) in comparison to uncoated surfaces. Cell adhesion was less on smooth surfaces compared to textured surfaces (p<0.001). Fibroblasts cultured on collagen I, fibronectin and hyaluronic acid coated implants demonstrated improved cell proliferation than uncoated surfaces (p<0.001). LDH assay showed that coating surfaces with collagen I, fibronectin and hyaluronic acid did not induce cytotoxicity. Alpha-actinin expression and fibroblast adhesion to the substrate were upregulated (p<0.001), in textured versus smooth surfaces. FAK, vinculin and paxillin expression were upregulated (p<0.001), in all surfaces coated with fibronectin and collagen I. In conclusion, we present original data for expression of adhesion-related genes, cell morphology and proliferation in breast fibroblasts following the application of specific coatings on breast implant surfaces. PMID:25238227

  7. 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. PMID:26968566

  8. Should silicone prostheses be considered for specimen banking? A pilot study into their use for human biomonitoring.

    PubMed

    Allan, Ian J; Bæk, Kine; Kringstad, Alfhild; Roald, Helge E; Thomas, Kevin V

    2013-09-01

    Persistent organic pollutant (POP) biomonitoring in humans is challenging and generally carried out using blood, breast milk or adipose tissue, with concentrations normalised to the lipid content of the sample matrix. The goal of this cross-sectional pilot study was to evaluate the validity and feasibility of explanted silicone prostheses as a matrix for persistent organic pollutant biomonitoring in humans. We postulate that pollutant concentrations in silicone prostheses inserted in the body will equilibrate with that in the body over time and provide a measure of the overall body burden. This study included silicone prostheses from 22 female patients of the Colosseum clinic (Oslo, Norway) collected between September 2010 and April 2012. Absorption of chlorinated and brominated POPs into silicone prostheses during implantation was observed. Relative levels of the different contaminants measured in prostheses were in agreement with those from serum and breast milk analyses from the general Norwegian population. The comparison of serum and breast milk-based literature data with prosthesis concentrations transposed into lipid-normalised concentrations supports the validity of the prosthesis measurements. The median of relative percent differences between measurements with replicate silicone prostheses from 11 patients was below 30%. Observed increases in prosthesis concentrations with patients' age were found to be very similar to literature data from studies of the Norwegian population. Silicone prostheses therefore represent a promising matrix for the biomonitoring of nonpolar and non-ionic pollutants in humans. Sample accessibility and body burden representativeness of the silicone prostheses suggest that specimen banking should be initiated. PMID:23955326

  9. Breast Implants

    MedlinePlus

    ... Updated Safety Information (Consumer Article) FDA Provides Updated Safety Data on Silicone Gel-Filled Breast Implants (Press Announcement) [ARCHIVED] Breast Implant Guidance for Industry (2006) Post Approval Studies Webpage Freedom of Information ...

  10. Silicon nanowire based biosensing platform for electrochemical sensing of Mebendazole drug activity on breast cancer cells.

    PubMed

    Shashaani, Hani; Faramarzpour, Mahsa; Hassanpour, Morteza; Namdar, Nasser; Alikhani, Alireza; Abdolahad, Mohammad

    2016-11-15

    Electrochemical approaches have played crucial roles in bio sensing because of their Potential in achieving sensitive, specific and low-cost detection of biomolecules and other bio evidences. Engineering the electrochemical sensing interface with nanomaterials tends to new generations of label-free biosensors with improved performances in terms of sensitive area and response signals. Here we applied Silicon Nanowire (SiNW) array electrodes (in an integrated architecture of working, counter and reference electrodes) grown by low pressure chemical vapor deposition (LPCVD) system with VLS procedure to electrochemically diagnose the presence of breast cancer cells as well as their response to anticancer drugs. Mebendazole (MBZ), has been used as antitubulin drug. It perturbs the anodic/cathodic response of the cell covered biosensor by releasing Cytochrome C in cytoplasm. Reduction of cytochrome C would change the ionic state of the cells monitored by SiNW biosensor. By applying well direct bioelectrical contacts with cancer cells, SiNWs can detect minor signal transduction and bio recognition events, resulting in precise biosensing. Our device detected the trace of MBZ drugs (with the concentration of 2nM) on electrochemical activity MCF-7 cells. Also, experimented biological analysis such as confocal and Flowcytometry assays confirmed the electrochemical results. PMID:27196254

  11. Natrelle Silicone Breast Implant Follow-up Study: Demographics, Lifestyle, and Surgical Characteristics of More Than 5000 Reconstruction Subjects

    PubMed Central

    Singh, Navin; Murphy, Diane K.

    2015-01-01

    Background: A large, multicenter, 10-year observational study is comparing the long-term safety and effectiveness of Natrelle silicone breast implants versus saline implants or national norms. Methods: Women who underwent primary augmentation, revision-augmentation, primary reconstruction, or revision-reconstruction were invited to participate. Enrolled subjects had completed surgery and received one implant or matching implants. Baseline demographics, health, lifestyle, and surgical characteristics are presented here for adult subjects who underwent primary reconstruction or revision-reconstruction. Results: Of 5637 subjects who underwent reconstruction surgery (86.7% primary reconstruction; 13.3% revision-reconstruction), 5407 received silicone implants and 230 received saline implants; 72.9% received bilateral implants. Silicone implants were used in 96.2% who underwent primary reconstruction and in 94.1% who underwent revision-reconstruction. Median age was about 3 years lower in those who underwent primary reconstruction versus revision-reconstruction. Most subjects were white nonsmokers and had attended college. Hispanic subjects were more likely to receive saline implants for primary reconstruction. Across groups, the most common characteristics by implant type or procedure included smooth-surface implants (90.8%), mastectomy scar site (69.7%), and partial (59.2%) or complete (33.9%) submuscular placement. Implant size was larger for revision-reconstruction versus primary reconstruction, and incision size was larger for silicone versus saline implants in subjects undergoing primary reconstruction. Conclusions: This study provides an unprecedented look at a large subject sample. The data offer surgeons an opportunity to make informed decisions regarding the most appropriate implant attributes and surgical approaches for women who desire breast implants for primary or revisionary breast reconstruction. PMID:26495202

  12. [Design and study of carbon fiber tracheal prosthesis].

    PubMed

    Qi, L; Liu, D; Han, Z; Wang, F

    1998-12-01

    32 healty adult dogs were selected for this experiment. 10 of them were subjected to the tracheal biomechanics test using indices including the relation between stretcher ratio (lambda) and stress (T), the squeeze stress (delta jy) of medical silk thread on trachea, the side stress (Ts) inducing the tracheal collapse, the functional maximum angle (psi max) of tracheal, and the sever area torsion angle (theta max) of tracheal functional maximum curved. According to the indices measured, two types of tracheal prosthesis were designed, and were made of carbon fiber and silicon. They were the straight tube type tracheal prosthesis and the bifurcate type tracheal prosthesis. The straight tube type tracheal prosthesis was studied with a design of two groups comprising a total of 11 dogs. In the experiment group (n = 6), the outer surface of the tube was not coated with silicon, the average survival period was 379.8 days. In the control group (n = 5), the outer surface of the tube was coated with silicon, the average survival period was 90.4 days. The bifurcate type tracheal prosthesis was studied in 11 dogs, the average survival period was 4.32 days. The main causes of death in the experiment were infection and anastomotic dehiscent. PMID:12552773

  13. 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

  14. Orbital prosthesis: a novel reconstructive approach.

    PubMed

    Soni, Bhavita Wadhwa; Soni, Nitin; Bansal, Mohit

    2014-09-01

    Rehabilitation of facial defects is a daunting task, requiring an individualized design of the technique for each patient. The disfigurement associated with the loss of an eye may result in significant physical and emotional problems. Various treatment modalities are available, one of which is the use of implants. Although implant-supported orbital prosthesis has a superior outcome, it may not be advisable in all the patients due to economic factors. The present article describes a reconstructive approach for a patient with exenterated right eye using silicone orbital prosthesis which improved his psychological, physical, social, functional, emotional and spiritual needs. Multidisciplinary management and team approach are essential in providing accurate and effective rehabilitation. PMID:25284538

  15. 21 CFR 888.3025 - Passive tendon prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a... flexor tendon of the hand. The device is implanted for a period of 2 to 6 months to aid growth of a new tendon sheath. The device is not intended as a permanent implant nor to function as a replacement for...

  16. 21 CFR 888.3025 - Passive tendon prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a... flexor tendon of the hand. The device is implanted for a period of 2 to 6 months to aid growth of a new tendon sheath. The device is not intended as a permanent implant nor to function as a replacement for...

  17. 21 CFR 888.3025 - Passive tendon prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a... flexor tendon of the hand. The device is implanted for a period of 2 to 6 months to aid growth of a new tendon sheath. The device is not intended as a permanent implant nor to function as a replacement for...

  18. 21 CFR 888.3025 - Passive tendon prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a... flexor tendon of the hand. The device is implanted for a period of 2 to 6 months to aid growth of a new tendon sheath. The device is not intended as a permanent implant nor to function as a replacement for...

  19. Risks of Breast Implants

    MedlinePlus

    ... larger and longer than these conducted so far. Breastfeeding Some women who undergo breast augmentation can successfully ... breast implant silicone shell into breast milk during breastfeeding. Although there are currently no established methods for ...

  20. A new tracheal prosthesis made from collagen grafted mesh.

    PubMed

    Okumura, N; Nakamura, T; Takimoto, Y; Natsume, T; Teramachi, M; Tomihata, K; Ikada, Y; Shimizu, Y

    1993-01-01

    The authors studied the efficacy of a new tracheal prosthesis made from mesh. The prosthesis, 50 mm long and 18-22 mm in diameter, is made from a Marlex mesh cylinder reinforced with a continuous polypropylene spiral that is grafted and coated with porcine collagen to increase its biocompatibility and provide an airtight seal during the initial implantation stage. Circumferential surgical resection and replacement of a seven to nine ring segment of the cervical trachea was performed in 20 adult mongrel dogs. At the time of surgery, a silicone tube was inserted into the tracheal prosthetic lumen to promote secretory transportation until the prosthesis was covered with host tissue. The silicone tube was removed during fiber bronchoscopy 1 month after surgery. With the exception of the prostheses in 3 dogs that died of unrelated causes, all were infiltrated by connective tissue and incorporated completely by the host. One of these 17 dogs died of suffocation caused by luminal stenosis 2.5 months after surgery, but the others survived until they were killed at more than 6 months. The luminal surfaces of the reconstructed tracheae were covered with respiratory epithelium to varying degrees, and in one dog killed at 22 months after surgery, confluent epithelization throughout the length of the prosthesis was confirmed histologically. In eight dogs, prosthetic luminal stenosis occurred because of overgrowth of granulation tissue, which generally was mild in all but three dogs. The authors conclude that this tracheal prosthesis is highly biocompatible and shows promise for clinical application. PMID:8268582

  1. Silicone migration to the contralateral axillary lymph nodes and breast after highly cohesive silicone gel implant failure: a case report

    PubMed Central

    2009-01-01

    Highly cohesive silicone gel implants are advertised for aesthetic and safety advantages. Our case is the fourth report describing early implant rupture and contralateral migration of siliconoma. Despite the greater degree of gel cohesiveness, a continued vigilance for signs and symptoms of migration is highly recommended. PMID:20101283

  2. 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

  3. Cyclodextrin-Modified Porous Silicon Nanoparticles for Efficient Sustained Drug Delivery and Proliferation Inhibition of Breast Cancer Cells.

    PubMed

    Correia, Alexandra; Shahbazi, Mohammad-Ali; Mäkilä, Ermei; Almeida, Sérgio; Salonen, Jarno; Hirvonen, Jouni; Santos, Hélder A

    2015-10-21

    Over the past decade, the potential of polymeric structures has been investigated to overcome many limitations related to nanosized drug carriers by modulating their toxicity, cellular interactions, stability, and drug-release kinetics. In this study, we have developed a successful nanocomposite consisting of undecylenic acid modified thermally hydrocarbonized porous silicon nanoparticles (UnTHCPSi NPs) loaded with an anticancer drug, sorafenib, and surface-conjugated with heptakis(6-amino-6-deoxy)-β-cyclodextrin (HABCD) to show the impact of the surface polymeric functionalization on the physical and biological properties of the drug-loaded nanoparticles. Cytocompatibility studies showed that the UnTHCPSi-HABCD NPs were not toxic to breast cancer cells. HABCD also enhanced the suspensibility and both the colloidal and plasma stabilities of the UnTHCPSi NPs. UnTHCPSi-HABCD NPs showed a significantly increased interaction with breast cancer cells compared to bare NPs and also sustained the drug release. Furthermore, the sorafenib-loaded UnTHCPSi-HABCD NPs efficiently inhibited cell proliferation of the breast cancer cells. PMID:26440739

  4. A Simplified Technique for Fabrication of Orbital Prosthesis

    PubMed Central

    Thakral, G.K.; Mohapatra, Abhilash; Seth, Jyotsna; Vashisht, Pallavi

    2014-01-01

    Eye is a vital organ not only for vision, but also an important component of facial expression, and over-all personality of a person. Loss of eye, apart from leading to impaired vision has a crippling effect on the psychology of the patient. Prosthodontic rehabilitation of such cases includes fabrication of prosthesis by acrylic resin, silicone and implants. However, not all patients are willing to use implants for maxillofacial rehabilitation. Therefore, a custom made orbital prosthesis serves as an affordable and satisfactory alternative. PMID:25121068

  5. Transaxillary dual-plane augmentation mammaplasty: experience with 98 breasts.

    PubMed

    Luan, Jie; Mu, Dali; Mu, Lanhua

    2009-11-01

    The dual plane technique is a popular procedure for breast augmentation. However, traditional dual-plane augmentation mammaplasty usually requires incisions through the areola or inframammary crease, which produces a scar on the breast. Therefore, women may not favour this technique, especially Chinese women who are genetically susceptible to hyperplastic scars. In our institution, endoscopic transaxillary dual-plane augmentation mammaplasty was performed in patients under general anaesthesia. Incisions (4 cm long) were designed to overlap the natural creases of the skin bilaterally behind the mid-transaxillary frontline. The space behind the pectoralis major muscle was separated conventionally. Assisted by a 10mm/30 degrees endoscope, part of the ectopectoralis was excised. Through the transaxillary incision, the rough-surfaced silicone gel breast prosthesis was implanted. The volume varied from 185 to 315 g, and a routine indwelling drainage tube was inserted. From March 2006 to May 2007, we performed 49 cases of augmentation mammaplasty applying endoscopic-assisted dual-plane technique. At 6- to 12-month follow up, the surgical outcomes were satisfactory. There were no complications, such as capsular contracture, bleeding, scar hyperplasia, or infection. We believe that the dual-plane augmentation mammaplasty can be performed via transaxillary incision using an endoscope. Since the surgical incision is far from the front of the breast with this method, no scarring of the breast develops. Furthermore, the adoption of the dual-plane technique provides superior form to the anatomical prosthesis in the breast, alleviates postoperative pain, and improves suppleness of the postoperative breast. PMID:18838324

  6. Electrochemical approach for monitoring the effect of anti tubulin drugs on breast cancer cells based on silicon nanograss electrodes.

    PubMed

    Zanganeh, Somayeh; Khosravi, Safoora; Namdar, Naser; Amiri, Morteza Hassanpour; Gharooni, Milad; Abdolahad, Mohammad

    2016-09-28

    One of the most interested molecular research in the field of cancer detection is the mechanism of drug effect on cancer cells. Translating molecular evidence into electrochemical profiles would open new opportunities in cancer research. In this manner, applying nanostructures with anomalous physical and chemical properties as well as biocompatibility would be a suitable choice for the cell based electrochemical sensing. Silicon based nanostructure are the most interested nanomaterials used in electrochemical biosensors because of their compatibility with electronic fabrication process and well engineering in size and electrical properties. Here we apply silicon nanograss (SiNG) probing electrodes produced by reactive ion etching (RIE) on silicon wafer to electrochemically diagnose the effect of anticancer drugs on breast tumor cells. Paclitaxel (PTX) and mebendazole (MBZ) drugs have been used as polymerizing and depolymerizing agents of microtubules. PTX would perturb the anodic/cathodic responses of the cell-covered biosensor by binding phosphate groups to deformed proteins due to extracellular signal-regulated kinase (ERK(1/2)) pathway. MBZ induces accumulation of Cytochrome C in cytoplasm. Reduction of the mentioned agents in cytosol would change the ionic state of the cells monitored by silicon nanograss working electrodes (SiNGWEs). By extending the contacts with cancer cells, SiNGWEs can detect minor signal transduction and bio recognition events, resulting in precise biosensing. Effects of MBZ and PTX drugs, (with the concentrations of 2 nM and 0.1 nM, respectively) on electrochemical activity of MCF-7 cells are successfully recorded which are corroborated by confocal and flow cytometry assays. PMID:27619088

  7. Thalamic Visual Prosthesis.

    PubMed

    Nguyen, Hieu T; Tangutooru, Siva M; Rountree, Corey M; Kantzos, Andrew J Kantzos; Tarlochan, Faris; Yoon, W Jong; Troy, John B

    2016-08-01

    Glaucoma is a neurological disorder leading to blindness initially through the loss of retinal ganglion cells, followed by loss of neurons higher in the visual system. Some work has been undertaken to develop prostheses for glaucoma patients targeting tissues along the visual pathway, including the lateral geniculate nucleus (LGN) of the thalamus, but especially the visual cortex. This review makes the case for a visual prosthesis that targets the LGN. The compact nature and orderly structure of this nucleus make it a potentially better target to restore vision than the visual cortex. Existing research for the development of a thalamic visual prosthesis will be discussed along with the gaps that need to be addressed before such a technology could be applied clinically, as well as the challenge posed by the loss of LGN neurons as glaucoma progresses. PMID:27214884

  8. Chemical modification of silicon nitride microsieves for capture of MCF-7 circulating tumor cells of breast cancer

    NASA Astrophysics Data System (ADS)

    Dien To, Thien; Thoai Le, Huyen; Thi Dinh, Mai Ngoc; Nguyen, Anh Tuan; Doan, Tin Chanh Duc; Mau Dang, Chien

    2015-01-01

    Chemical modification of silicon nitride (SiN) microsieves with glutaraldehyde and 3-glycidoxypropyldimethylethoxysilane (GOPS) for bio-coupling with an antibody to capture MCF-7 circulating tumor cells of breast cancer is reported. In this research, the antibody monoclonal anti-cytokerantin-FITC with fluorescein isothiocyanate label was used due to its good selectivity to MCF-7 circulating tumor cells of breast cancer. Modification efficiency was determined by the variation of contact angle. The increase in contact angle of the microsieves treated with glutaraldehyde and GOPS indicated that the microsieve surface changed from hydrophilic to hydrophobic. These results confirmed the successful immobilization of glutaraldehyde and GOPS onto SiN microsieves. Antibody binding effect was evaluated by fluorescence microscopy. Fluorescent images exhibited that GOPS was more effective than the glutaraldehyde treatment. The GOPS-treated microsieves were then used for capture of MCF-7 cells in phosphate buffered saline (PBS). The fluorescent images proved that the surface modification of SiN microsieves with GOPS helped to increase the efficiency of MCF-7 capture.

  9. Influence of curing agent on fibrosis around silicone implants.

    PubMed

    Joseph, Josna; Mohanty, Mira

    2013-01-01

    Severe capsular contracture around silicone expander breast implants leading to pain and failure is a major clinical problem. Even though earlier studies have implicated the immunogenicity of silicone, the role of physical and chemical properties of the silicone material in excessive collagen deposition and fibrosis has been less addressed. The present study investigates whether there is any correlation between the type of curing systems i.e. addition and free radical curing and the fibrosis around silicone elastomer. The experiment carried out uses commercially available silicone ventriculo-peritoneal shunt material elastomer cured by platinum and the results are compared with results obtained in a similar study carried out by the authors using commercially available silicone tissue expander material cured by peroxide. Ultra-high molecular weight poly-ethylene (UHMWPE), the standard reference for biocompatibility evaluation, was used as the control material. The materials were implanted in rat skeletal muscle for 30 and 90 days. Inflammatory cells, myofibroblasts, cytokines, and collagen deposition at the material-tissue interface were identified by haematoxylin-eosin and Masson's Trichrome stains and semi-quantitated based on immunohistochemical studies. Results indicate that even though the cellular response in the initial phase of wound healing was similar in both platinum and peroxide-cured materials, the collagen deposition in the proliferative phase was more around peroxide-cured material in comparison to the platinum-cured silicone elastomer. There is a need to look into the molecular mechanisms of this interaction and the possibility of using curing systems other than free radical peroxide in the manufacture of silicone elastomer expanders for breast prosthesis. PMID:23683043

  10. Enhancement of Capture Sensitivity for Circulating Tumor Cells in a Breast Cancer Patient's Blood by Silicon Nanowire Platform.

    PubMed

    Kim, Dong-Joo; Choi, Mun-Ki; Jeong, Jin-Tak; Lim, Jung-Taek; Lee, Han-Byoel; Han, Wonshik; Lee, Sang-Kwon

    2016-04-01

    The separation of circulating tumor cells (CTCs) from the blood of cancer patients with high sensitivity is an essential technique for selecting chemotherapeutic agents at a patient-by-patient level. Recently, various research groups have reported a nanostructure-based platform for rare cell capture due to its high surface area and 3D nanotopographic features. However, evaluation of capture sensitivity based on chemical modification of the nanostructure surface has not yet been performed. Here, we evaluated the capture sensitivity for CTCs from the blood of three patients diagnosed with stage IV metastatic breast cancer by using the following three platforms: streptavidin-conjugated silicon nanowire (STR-SiNW), poly-l-lysine-coated silicon nanowire (PLL-SiNW), and poly-l-lysine-coated glass (PLL-glass). The number of evaluated CTCs on STR-SiNW, PLL-SiNW, and PLL-glass were 16.2 ± 5.5 cells, 7.3 ± 2.9 cells, and 4.7 ± 1.5 cells, respectively, per 0.5 ml. Therefore, we suggest that the STR-SiNW platform is highly adaptable for the quantitative evaluation of CTCs from the blood of cancer patients in the clinical setting. PMID:27301191

  11. A study of the aging of silicone breast implants using 29Si, 1H relaxation and DSC measurements.

    PubMed

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

    2004-08-01

    In this study 26 previously implanted silicone breast implants from the same manufacturer (Dow Corning) were investigated with two different analytical methods to characterize potential aging processes such as migration of monomer material from the gel and shell to local and distant sites, chemical alterations of the polymer, and infiltration of body compounds such as lipids. (1)H and (29)Si NMR relaxation measurements (spin-lattice, T1, and spin-spin, T2, relaxation times) were used to study the molecular dynamics of polysiloxane chains, both in gels and in shells. In addition, changes in physical properties were monitored by differential scanning calorimetry (DSC). The results of these measurements indicate that NMR relaxation times are influenced by implant generation, implantation time, shell texture and implant status. (1)H T2 values of shells and gels show a tendency to increase with increasing implantation time, indicating higher mobility and possible disintegration of the polymer network of older implants. Furthermore, the data suggest that aging also involves the migration of low cyclic molecular weight (LMW) silicone and linear chain polymer material from the gels into the shells. The high "bleeding" rate of second-generation (G2) implants (implantation period around 1973-1985), exhibiting thin shells is reflected in reduced relaxation times of these devices, most likely due to a loss of low molecular weight fractions from the gels. Moreover, "gel bleeding" also influences the melting behavior observed in DSC studies. Increased shell rigidity (high Tm and Tg) tends to be correlated with longer (29)Si relaxation times of the corresponding gels, suggesting a reduced transfer of LMW silicones and linear chain polymer from the gel to the shell and to the outside. Remarkably, textured implants seem to be less susceptible to degradation processes than implants with thin shells. PMID:15046931

  12. Desmoid tumor occurring after reconstruction mammaplasty for breast carcinoma.

    PubMed

    Dale, P S; Wardlaw, J C; Wootton, D G; Resnick, J I; Giuliano, A E

    1995-11-01

    We present a case of desmoid tumor associated with prior alloplastic breast reconstruction. Wide local excision that includes chest wall resection, if necessary, is the primary treatment of choice. Patients with extensive nonresectable or recurrent disease may benefit from radiation therapy. Systemic therapy is a possibility in certain cases, but its toxicity generally precludes its use with this nonmetastatic tumor. Although this is the fourth reported case of desmoid tumor arising after implantation of a silicone prosthesis, we cannot claim a causal relationship. Careful follow-up consisting of yearly physical and mammagraphic examinations may facilitate early diagnosis and treatment of locally aggressive desmoid tumors but is not warranted, except in the context of routine screening for breast carcinoma. PMID:8579271

  13. Balloon-dilatable arterial banding prosthesis: experimental study.

    PubMed

    Vince, D J; Culham, J A; Taylor, G P

    1987-07-01

    Two arterial banding prostheses were developed that could be dilated by an intraluminal balloon dilator. One prosthesis consisted of radiopaque umbilical tape with a pleat secured by four 8-0 silk sutures thinly coated with silicone type A medical adhesive. This design was used to band the main pulmonary artery in five dogs, the subclavian artery in five, and the aorta in one. The second prosthesis, a stainless steel fatigued helix encased in a siliconized shield, was used to band the main pulmonary artery in two dogs and the descending aorta in two. After a mean duration of 89 days the bands were dilated with an intraluminal balloon dilator at 6 atm (608 kPa) of pressure for 30 seconds. In all 15 experiments the bands dilated and the gradient at the band was reduced. The stainless steel helix was more successful and has technical advantages for clinical application. PMID:2954182

  14. Human adjuvant disease: remission of silicone induced autoimmune disease after explanation of breast augmentation.

    PubMed Central

    kaiser, W; Biesenbach, G; Stuby, U; Grafinger, P; Zazgornik, J

    1990-01-01

    Autoimmune diseases following silicone or paraffin implantation are rarely encountered complications of plastic surgery. A 42 year old woman is presented who developed clinical and immunological features of systemic lupus erythematosus 11 years after silicone augmentation. After explanation antinuclear antibody titres decreased from 1/1280 to 1/160, C4 complement fraction and the previously raised angiotensin converting enzyme normalised in step with clinical improvement. It is important that plastic surgeons and rheumatologists should be aware of this possible association. PMID:2256743

  15. Characterization of a light switchable microelectrode array for retinal prosthesis

    NASA Astrophysics Data System (ADS)

    Zhang, Xinyi; Xiong, Tao; Chiou, Pei-Yu; Li, Zhihong

    2011-12-01

    A light switchable microelectrode array for retinal prosthesis, which is performed with the photosensitive conductivity of hydrogenated amorphous silicon (a-Si:H) and of more advantages over the two major current retinal prosthetic categories, is characterized. Sensitivity to different visible wavelengths and light intensities are verified as well. Preliminary impedance test invitro shows appropriate impedance for neuron stimulation applications. It is indicated that such device provides a promising potential to restore a certain degree of visual function.

  16. 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

  17. A randomized, double-blind, crossover trial comparing a silicone- versus water-based lubricant for sexual discomfort after breast cancer.

    PubMed

    Hickey, Martha; Marino, Jennifer L; Braat, Sabine; Wong, Swee

    2016-07-01

    Discomfort during sexual activity is common after breast cancer. Vaginal estrogens are effective but commonly avoided due to systemic absorption. Despite the large commercial market for vaginal lubricants, no randomized studies have compared products. We aimed to compare efficacy and acceptability of two major types of lubricant for discomfort during sexual activity in postmenopausal breast cancer patients. In a single-center, randomized, double-blind, AB/BA crossover design, sexually active postmenopausal breast cancer patients used each lubricant for 4 weeks. The primary patient-reported efficacy outcome was total discomfort related to sexual activity (Fallowfield Sexual Activity Questionnaire Discomfort subscale SAQ-D). Acceptability was measured by patient preference and reported intention to continue using the products. Of 38 women analyzed, over 90 % experienced clinically significant sexually related distress at baseline. Water- and silicone-based lubricants did not differ statistically in efficacy based on total sexual discomfort (difference 0.7, 95 % confidence interval (CI) 0-1.4, p = 0.06). In a post hoc analysis, pain/discomfort during penetration improved more during silicone-based lubricant use than during water-based lubricant use (odds ratio 5.4, 95 % CI 1.3-22.1, p = 0.02). All aspects of sexual discomfort measured with diaries were reported more commonly with water- than silicone-based lubricant. Almost twice as many women preferred silicone-based to water-based lubricant than the converse (n = 20, 65 %, vs. n = 11, 35 %). 88 % continued to experience clinically significant sexually related distress despite use of either lubricant. Total sexual discomfort was lower after use of silicone-based lubricant than water-based, but many women continue to experience sexually related distress. PMID:27306420

  18. Breast imaging using an amorphous silicon-based full-field digital mammographic system: stability of a clinical prototype.

    PubMed

    Vedantham, S; Karellas, A; Suryanarayanan, S; D'Orsi, C J; Hendrick, R E

    2000-11-01

    An amorphous silicon-based full-breast imager for digital mammography was evaluated for detector stability over a period of 1 year. This imager uses a structured CsI:TI scintillator coupled to an amorphous silicon layer with a 100-micron pixel pitch and read out by special purpose electronics. The stability of the system was characterized using the following quantifiable metrics: conversion factor (mean number of electrons generated per incident x-ray), presampling modulation transfer function (MTF), detector linearity and sensitivity, detector signal-to-noise ratio (SNR), and American College of Radiology (ACR) accreditation phantom scores. Qualitative metrics such as flat field uniformity, geometric distortion, and Society of Motion Picture and Television Engineers (SMPTE) test pattern image quality were also used to study the stability of the system. Observations made over this 1-year period indicated that the maximum variation from the average of the measurements were less than 0.5% for conversion factor, 3% for presampling MTF over all spatial frequencies, 5% for signal response, linearity and sensitivity, 12% for SNR over seven locations for all 3 target-filter combinations, and 0% for ACR accreditation phantom scores. ACR mammographic accreditation phantom images indicated the ability to resolve 5 fibers, 4 speck groups, and 5 masses at a mean glandular dose of 1.23 mGy. The SMPTE pattern image quality test for the display monitors used for image viewing indicated ability to discern all contrast steps and ability to distinguish line-pair images at the center and corners of the image. No bleeding effects were observed in the image. Flat field uniformity for all 3 target-filter combinations displayed no artifacts such as gridlines, bad detector rows or columns, horizontal or vertical streaks, or bad pixels. Wire mesh screen images indicated uniform resolution and no geometric distortion. PMID:11110258

  19. Synthesis of D-mannose capped silicon nanoparticles and their interactions with MCF-7 human breast cancerous cells.

    PubMed

    Ahire, Jayshree H; Chambrier, Isabelle; Mueller, Anja; Bao, Yongping; Chao, Yimin

    2013-08-14

    Silicon nanoparticles (SiNPs) hold prominent interest in various aspects of biomedical applications. For this purpose, surface functionalization of the NPs is essential to stabilize them, target them to specific disease area, and allow them to selectively bind to the cells or the bio-molecules present on the surface of the cells. However, no such functionalization has been explored with Si nanoparticles. Carbohydrates play a critical role in cell recognition. Here, we report the first synthesis of silicon nanoparticles functionalized with carbohydrates. In this study, stable and brightly luminescent d-Mannose (Man) capped SiNPs have been synthesized from amine terminated SiNPs and d-mannopyranoside acid. The surface functionalization is confirmed by Fourier transform infrared spectroscopy (FTIR), nuclear magnetic resonance spectroscopy (NMR), and energy dispersive X-ray spectroscopy (EDX) studies. The mean diameter of the crystal core is 5.5 nm, as measured by transmission electron microscopy (TEM), while the hydrodynamic diameter obtained by dynamic light scattering (DLS) is 16 nm. The quantum yield (QY) of photoluminescence emission is found to be 11.5%, and the nanoparticles exhibit an exceptional stability over two weeks. The Man-capped SiNPs may prove to be valuable tools for further investigating glycobiological, biomedical, and material science fields. Experiments are carried out using Concanavalin A (ConA) as a target protein in order to prove the hypothesis. When Man functionalized SiNPs are treated with ConA, cross-linked aggregates are formed, as shown in TEM images as well as monitored by photoluminescence spectroscopy (PL). Man functionalized SiNPs can target cancerous cells. Visualization imaging of SiNPs in MCF-7 human breast cancer cells shows the fluorescence is distributed throughout the cytoplasm of these cells. PMID:23815685

  20. Rehabilitation of a missing ear with an implant retained auricular prosthesis.

    PubMed

    Guttal, Satyabodh Sheshraj; Shanbhag, Shruti; Kulkarni, Sudhindra S; Thakur, Srinath L

    2015-01-01

    Burns can leave a patient with a severely debilitating disability even after treatment. The objectives of burn rehabilitation are to minimize the adverse effects caused by the injury while rehabilitating the patient's physical and psychological well-being, maximizing social integration. Long-term success of maxillofacial prostheses mainly depends on the retention. Extra oral implant retained prostheses have proved to be a predictable treatment option for maxillofacial rehabilitation. Replacement of a severely deformed external ear with burned tissues may be satisfactorily accomplished by a cosmetic prosthesis anchored by implants integrated in the skull. The use of such implants is now a well-recognized method for creating a stable result in maxillofacial rehabilitation. This case report describes a safe, simple and economical method for the rehabilitation of a patient with missing right auricle using an implant supported silicone prosthesis. The implant was placed in the mastoid region of the temporal bone. Reconstruction of the ear was done with auricular silicone prosthesis, retained using magnets incorporated in an autopolymerizing resin shim to decrease the weight of the prosthesis on a single implant. This method eliminates the need of tedious laboratory procedures and exact casting and fitting requirements of a metal substructure while minimizing the overall weight and cost of the prosthesis while maintaining adequate support, esthetics and retention of the prosthesis. PMID:26929490

  1. Vocal rehabilitation after total laryngectomy using the Provox voice prosthesis.

    PubMed

    Van Weissenbruch, R; Albers, F W

    1993-10-01

    Vocal rehabilitation in laryngectomized patients can be attained by surgical (tracheoesophageal speech) or conservative methods (oesophageal speech or artificial larynx). We prospectively studied voice restoration in 37 patients who underwent total laryngectomy in the period from February 1991 to February 1993. The patients were given the opportunity to assess both non-shunt oesophageal speech and shunt oesophageal speech using the Provox voice prosthesis. The Provox low resistance, self-retaining voice prosthesis is a biflanged device made of silicon rubber. A primary tracheoesophageal puncture was made in 28 patients, while a secondary puncture was performed in another nine patients. The results were assessed according to criteria established at the 'Third International Congress on Voice Prosthesis' in Groningen (1988). Functional tracheoesophageal speech after primary puncture was achieved in 95% of patients 12 months after puncture, while oesophageal voice was acquired by 55%. Only minor surgical and prosthesis-related complications were encountered during this follow-up period in 29% of the patients. The device lifetime varied from 3 months to at least 2 years (mean 5.4 months). PMID:8877200

  2. Rehabilitation of a Partial Nasal Defect with Facial Prosthesis: A Case Report

    PubMed Central

    Negahdari, Ramin; Pournasrollah, Alireza; Bohlouli, Sepideh; Sighari Deljavan, Alireza

    2014-01-01

    >Malignancies of the midface result in cosmetic deformities that make maxillofacial prosthesis as an integral part of the treatment plan. Facial defects can be devastating in their impact on physical structure and function of the affected individual, leading to potentional compromises in quality of life. Reconstruction of nasal defects is a challenge for the prosthodontist because of esthetic and retention problems associated with the facial prosthesis. This paper reports the rehabilitation of a partial nasal defect caused by basal cell carcinoma treatment using a nasal prosthesis made with silicone elastomers and mechanical and anatomical retentive aids. The patient had no problem with the prosthesis, except for a partial loss of extrinsic coloration in the two-year follow-up. PMID:25587390

  3. Photovoltaic retinal prosthesis

    NASA Astrophysics Data System (ADS)

    Loudin, James; Mathieson, Keith; Kamins, Ted; Wang, Lele; Galambos, Ludwig; Huie, Philip; Sher, Alexander; Harris, James; Palanker, Daniel

    2011-03-01

    Electronic retinal prostheses seek to restore sight to patients suffering from retinal degenerative disorders. Implanted electrode arrays apply patterned electrical stimulation to surviving retinal neurons, producing visual sensations. All current designs employ inductively coupled coils to transmit power and/or data to the implant. We present here the design and initial testing of a photovoltaic retinal prosthesis fabricated with a pixel density of up to 177 pixels/mm2. Photodiodes within each pixel of the subretinal array directly convert light to stimulation current, avoiding the use of bulky coil implants, decoding electronics, and wiring, and thereby reducing surgical complexity. A goggles-mounted camera captures the visual scene and transmits the data stream to a pocket processor. The resulting images are projected into the eyes by video goggles using pulsed, near infrared (~900 nm) light. Prostheses with three pixel densities (15, 55, and 177 pix/mm2) are being fabricated, and tests indicate a charge injection limit of 1.62 mC/cm2 at 25Hz. In vitro tests of the photovoltaic retinal stimulation using a 512-element microelectrode array have recorded stimulated spikes from the ganglion cells, with latencies in the 1-100ms range, and with peak irradiance stimulation thresholds varying from 0.1 to 1 mW/mm2. With 1ms pulses at 25Hz the average irradiance is more than 100 times below the IR retinal safety limit. Elicited retinal response disappeared upon the addition of synaptic blockers, indicating that the inner retina is stimulated rather than the ganglion cells directly, and raising hopes that the prosthesis will preserve some of the retina's natural signal processing.

  4. Prosthesis for Open Pleurostomy (POP): Management for Chronic Empyemas

    PubMed Central

    Filomeno, Luiz Tarcísio Brito; de Campos, José Ribas Milanez; Machuca, Tiago Noguchi; Neves-Pereira, João Carlos das; Terra, Ricardo Mingarini

    2009-01-01

    OBJECTIVES We developed a prosthesis for open pleurostomy cases where pulmonary decortication is not indicated, or where post-pneumonectomy space infection occurs. The open pleural window procedure not only creates a large hole in the chest wall that is shocking to patients, also results in a permanent deformation of the thorax. prosthesis for open pleurostomy is a self-retained silicone tube that requires the removal of 3 cm of one rib for insertion, and acts as a mature conventional open pleural window. Herein, we report our 13–year experience with this device in the management of different kinds of pleural empyema. METHODS Forty-four consecutive patients with chronic empyema were treated. The etiology of empyema was diverse: pneumonia, 20; lung resections, 12 (pneumonectomies, 7; lobectomies, 4; non-anatomical, 1); mixed-tuberculous, 6; and mixed-malignant pleural effusion, 6. After debridment of both pleural surfaces, the prosthesis for open pleurostomy was inserted and attached to a small recipient plastic bag. RESULTS Infection control was achieved in 20/20 (100%) of the parapneumonic empyemas, in 3/4 (75%) of post-lobectomies, in 6/7 (85%) of post-pneumectomies, in 6/6 (100%) of mixed-tuberculous cases, and in 4/6 (83%) of mixed-malignant cases. Lung re-expansion was also successful in 93%, 75%, 33%, and 40% of the groups, respectively. CONCLUSIONS Prosthesis for open pleurostomy insertion is a minimally invasive procedure that can be as effective as conventional open pleural window for management of chronic empyemas. Thus, we propose that the use of prosthesis for open pleurostomy should replace the conventional method. PMID:19330246

  5. [Central auditory prosthesis].

    PubMed

    Lenarz, T; Lim, H; Joseph, G; Reuter, G; Lenarz, M

    2009-06-01

    Deaf patients with severe sensory hearing loss can benefit from a cochlear implant (CI), which stimulates the auditory nerve fibers. However, patients who do not have an intact auditory nerve cannot benefit from a CI. The majority of these patients are neurofibromatosis type 2 (NF2) patients who developed neural deafness due to growth or surgical removal of a bilateral acoustic neuroma. The only current solution is the auditory brainstem implant (ABI), which stimulates the surface of the cochlear nucleus in the brainstem. Although the ABI provides improvement in environmental awareness and lip-reading capabilities, only a few NF2 patients have achieved some limited open set speech perception. In the search for alternative procedures our research group in collaboration with Cochlear Ltd. (Australia) developed a human prototype auditory midbrain implant (AMI), which is designed to electrically stimulate the inferior colliculus (IC). The IC has the potential as a new target for an auditory prosthesis as it provides access to neural projections necessary for speech perception as well as a systematic map of spectral information. In this paper the present status of research and development in the field of central auditory prostheses is presented with respect to technology, surgical technique and hearing results as well as the background concepts of ABI and AMI. PMID:19517084

  6. Multispectral breast imaging using a ten-wavelength, 64x64 source/detector channels silicon photodiode-based diffuse optical tomography system

    SciTech Connect

    Li Changqing; Zhao Hongzhi; Anderson, Bonnie; Jiang Huabei

    2006-03-15

    We describe a compact diffuse optical tomography system specifically designed for breast imaging. The system consists of 64 silicon photodiode detectors, 64 excitation points, and 10 diode lasers in the near-infrared region, allowing multispectral, three-dimensional optical imaging of breast tissue. We also detail the system performance and optimization through a calibration procedure. The system is evaluated using tissue-like phantom experiments and an in vivo clinic experiment. Quantitative two-dimensional (2D) and three-dimensional (3D) images of absorption and reduced scattering coefficients are obtained from these experiments. The ten-wavelength spectra of the extracted reduced scattering coefficient enable quantitative morphological images to be reconstructed with this system. From the in vivo clinic experiment, functional images including deoxyhemoglobin, oxyhemoglobin, and water concentration are recovered and tumors are detected with correct size and position compared with the mammography.

  7. A case history on an innovative solution for VOC and air toxics control designed for a medical prosthetic manufacturer of silicon breast implants

    SciTech Connect

    Quan-Handley, P.

    1997-12-31

    The case history presented here is based on the selection, design, installation, testing in, and continuous operation of a recuperative type thermal oxidation system with a built on heat exchanger unit (with a thermal efficiency of 85%) and ancillary ventilation/exhaust collection system designed for McGhan Medical Corporation (McGhan), a medical prosthetic manufacturer of silicon breast implants, located in Santa Barbara, California. There is now available three (3) consecutive years of emissions source test data which verify the achievement of the overall equipment VOC destruction removal efficiency (DRE) initially projected at 98.5% or 10 ppmv.

  8. Advanced engineering tools for design and fabrication of a custom nasal prosthesis

    NASA Astrophysics Data System (ADS)

    Oliveira, Inês; Leal, Nuno; Silva, Pedro; da Costa Ferreira, A.; Neto, Rui J.; Lino, F. Jorge; Reis, Ana

    2012-09-01

    Unexpected external defects resulting from neoplasms, burns, congenital malformations, trauma or other diseases, particularly when involving partial or total loss of an external organ, can be emotionally devastating. These defects can be restored with prosthesis, obtained by different techniques, materials and methods. The increase of patient numbers and cost constraints lead to the need of exploring new techniques that can increase efficiency. The main goal of this project was to develop a full engineering-based manufacturing process to obtain soft-tissue prosthesis that could provide faster and less expensive options in the manufacturing of customized prosthesis, and at the same time being able to reproduce the highest degree of details, with the maximum comfort for the patient. Design/methodology/approach - This case report describes treatment using silicone prosthesis with an anatomic retention for an 80-years-old woman with a rhinectomy. The proposed methodology integrates non-contact structured light scanning, CT and reverse engineering with CAD/CAM and additive manufacturing technology. Findings - The proposed protocol showed encouraging results since reveals being a better solution for fabricating custom-made facial prostheses for asymmetrical organs than conventional approaches. The process allows the attainment of prosthesis with the minimum contact and discomfort for the patient, disclosing excellent results in terms of aesthetic, prosthesis retention and in terms of time and resources consumed.

  9. Complications of Poly Implant Prothèse breast implants: the current discussion.

    PubMed

    Kolios, Leila; Hirche, Christoph; Spiethoff, Alexander; Daigeler, Adrien; Lehnhardt, Marcus

    2013-03-01

    Against the background of the current discussion about Poly Implant Prothèse (PIP, Seyne-sur-mer, France) breast implants, we want to present a case demonstrating the complications such as implant rupture, silicone dissemination and level III silicone lymphadenopathy. A 29-year-old woman with cosmetic breast augmentation with PIP implants 5 years previously showed a sensitive swelling in her right axilla and neck region. All tests to detect an infectious or lymphomatous lymphadenopathy were negative. After ultrasound and MRI, rupture of the right implant was assumed and multiple pathologically enlarged lymph nodes up to supraclavicular region were shown. An excision biopsy of one axillary lymph node was performed; the histological examination detected a strong silicone lymphadenopathy. Surgical removal of both implants as well as capsulectomy was performed and 14 axillary lymph nodes up to level II were resected. Histologic evaluation confirmed the previous results. Our case underlines the actual discussion concerning increased rupture rate and massive silicone lymphadenopathy by PIP implants. The Agence Francaise de Sécurité Sanitaire des Produits de Santé (AFSSAPS) recommends clinical and ultrasound examination every 6 months for women with PIP implants. Any rupture, suspected rupture or leakage of prosthesis should lead to its explantation as well as that of the contralateral implant. In cases of unusual signs of inflammation, histological and immunohistochemical samples are to be taken. PMID:23480085

  10. Photovoltaic retinal prosthesis: implant fabrication and performance

    NASA Astrophysics Data System (ADS)

    Wang, Lele; Mathieson, K.; Kamins, T. I.; Loudin, J. D.; Galambos, L.; Goetz, G.; Sher, A.; Mandel, Y.; Huie, P.; Lavinsky, D.; Harris, J. S.; Palanker, D. V.

    2012-08-01

    The objective of this work is to develop and test a photovoltaic retinal prosthesis for restoring sight to patients blinded by degenerative retinal diseases. A silicon photodiode array for subretinal stimulation has been fabricated by a silicon-integrated-circuit/MEMS process. Each pixel in the two-dimensional array contains three series-connected photodiodes, which photovoltaically convert pulsed near-infrared light into bi-phasic current to stimulate nearby retinal neurons without wired power connections. The device thickness is chosen to be 30 µm to absorb a significant portion of light while still being thin enough for subretinal implantation. Active and return electrodes confine current near each pixel and are sputter coated with iridium oxide to enhance charge injection levels and provide a stable neural interface. Pixels are separated by 5 µm wide trenches to electrically isolate them and to allow nutrient diffusion through the device. Three sizes of pixels (280, 140 and 70 µm) with active electrodes of 80, 40 and 20 µm diameter were fabricated. The turn-on voltages of the one-diode, two-series-connected diode and three-series-connected diode structures are approximately 0.6, 1.2 and 1.8 V, respectively. The measured photo-responsivity per diode at 880 nm wavelength is ˜0.36 A W-1, at zero voltage bias and scales with the exposed silicon area. For all three pixel sizes, the reverse-bias dark current is sufficiently low (<100 pA) for our application. Pixels of all three sizes reliably elicit retinal responses at safe near-infrared light irradiances, with good acceptance of the photodiode array in the subretinal space. The fabricated device delivers efficient retinal stimulation at safe near-infrared light irradiances without any wired power connections, which greatly simplifies the implantation procedure. Presence of the return electrodes in each pixel helps to localize the current, and thereby improves resolution.

  11. Knee joint replacement prosthesis (image)

    MedlinePlus

    A prosthesis is a device designed to replace a missing part of the body, or to make a part of the body work better. The metal prosthetic device in knee joint replacement surgery replaces cartilage and bone which is damaged from disease or aging.

  12. Obturator prosthesis for hemimaxillectomy patients

    PubMed Central

    Singh, Mayank; Bhushan, Akshay; Kumar, Narendra; Chand, Sharad

    2013-01-01

    Rehabilitation of hemimaxillectomy patients can be challenging. The most common problem with prosthetic treatment in such patients is in getting adequate retention, stability, and support. The size and location of the defect usually influences the amount of impairment and difficulty in prosthetic rehabilitation. The obturator prosthesis is commonly used as an effective means for rehabilitating hemimaxillectomy cases. In cases of large maxillary defects, movement of the obturator prosthesis is inevitable and requires a form of indirect retention to limit the rotation of the prosthesis. The goal of prosthodontics is rehabilitation of missing oral and extraoral structures along with restoration of the normal functions of mastication, speech, swallowing, appearance, and so on. Malignancies are common in the oral region, which are treated through surgical intervention. Surgical intervention creates communication between the oral cavity, nasal cavity, and maxillary sinus. In such cases, it is very difficult for the patient to perform various normal functions like mastication, swallowing, speaking, and so on. Prosthodontic rehabilitation with obturator prosthesis restores the missing structures and acts as a barrier between the communication among the various cavities. PMID:24163568

  13. Eye muscle prosthesis.

    PubMed

    Scott, A B; Miller, J M; Collins, C C

    1992-01-01

    We inserted a silicone rubber elastic band along the course of a paralyzed lateral rectus and of a paralyzed superior oblique to restore alignment and to provide a spring against which the antagonist could pull. The lateral rectus band has been in place for 7 years. It provides alignment and a field of single binocular vision of 20 degrees. The superior oblique band has been in place for 17 months. It provides alignment and single vision over 30 degrees from the primary position except for a restriction in upgaze-adduction to 25 degrees (Brown syndrome) and in downgaze-adduction to 20 degrees. Such engineered elastic bands are a useful addition to current surgical techniques for management of cases of paralysis and restriction. PMID:1512661

  14. [Silicone in autoimmune diseases and cancer].

    PubMed

    Elejabeitia, J

    1999-01-01

    In 1992 the Food and Drug Administration (FDA) announced the restriction of silicone gel-filled breast implants until research protocol studies evaluate the relationship of silicone to connective tissue diseases, and the association of the silicone implants with breast carcinoma. Since them comprehensive epidemiologic studies have concluded that there is no connection between breast implants and the known connective tissue diseases or between the implants and breast carcinoma. During the same year, The American College of Rheumatology said that it have not been demonstrated the relationship between silicone gel breast implants and any systemic disease. Although this, the FDA restriction continues. PMID:11256005

  15. Tracheostomy cannulas and voice prosthesis

    PubMed Central

    Kramp, Burkhard; Dommerich, Steffen

    2011-01-01

    Cannulas and voice prostheses are mechanical aids for patients who had to undergo tracheotomy or laryngectomy for different reasons. For better understanding of the function of those artificial devices, first the indications and particularities of the previous surgical intervention are described in the context of this review. Despite the established procedure of percutaneous dilatation tracheotomy e.g. in intensive care units, the application of epithelised tracheostomas has its own position, especially when airway obstruction is persistent (e.g. caused by traumata, inflammations, or tumors) and a longer artificial ventilation or special care of the patient are required. In order to keep the airways open after tracheotomy, tracheostomy cannulas of different materials with different functions are available. For each patient the most appropriate type of cannula must be found. Voice prostheses are meanwhile the device of choice for rapid and efficient voice rehabilitation after laryngectomy. Individual sizes and materials allow adaptation of the voice prostheses to the individual anatomical situation of the patients. The combined application of voice prostheses with HME (Head and Moisture Exchanger) allows a good vocal as well as pulmonary rehabilitation. Precondition for efficient voice prosthesis is the observation of certain surgical principles during laryngectomy. The duration of the prosthesis mainly depends on material properties and biofilms, mostly consisting of funguses and bacteries. The quality of voice with valve prosthesis is clearly superior to esophagus prosthesis or electro-laryngeal voice. Whenever possible, tracheostoma valves for free-hand speech should be applied. Physicians taking care of patients with speech prostheses after laryngectomy should know exactly what to do in case the device fails or gets lost. PMID:22073098

  16. High resolution optoelectronic retinal prosthesis

    NASA Astrophysics Data System (ADS)

    Loudin, Jim; Dinyari, Rostam; Huie, Phil; Butterwick, Alex; Peumans, Peter; Palanker, Daniel

    2009-02-01

    Electronic retinal prostheses seek to restore sight in patients with retinal degeneration by delivering pulsed electric currents to retinal neurons via an array of microelectrodes. Most implants use inductive or optical transmission of information and power to an intraocular receiver, with decoded signals subsequently distributed to retinal electrodes through an intraocular cable. Surgical complexity could be minimized by an "integrated" prosthesis, in which both power and data are delivered directly to the stimulating array without any discrete components or cables. We present here an integrated retinal prosthesis system based on a photodiode array implant. Video frames are processed and imaged onto the retinal implant by a video goggle projection system operating at near-infrared wavelengths (~ 900 nm). Photodiodes convert light into pulsed electric current, with charge injection maximized by specially optimized series photodiode circuits. Prostheses of three different pixel densities (16 pix/mm2, 64 pix/mm2, and 256 pix/mm2) have been designed, simulated, and prototyped. Retinal tissue response to subretinal implants made of various materials has been investigated in RCS rats. The resulting prosthesis can provide sufficient charge injection for high resolution retinal stimulation without the need for implantation of any bulky discrete elements such as coils or tethers. In addition, since every pixel functions independently, pixel arrays may be placed separately in the subretinal space, providing visual stimulation to a larger field of view.

  17. Contact dermatitis from a prosthesis.

    PubMed

    Munoz, Carla A; Gaspari, Anthony; Goldner, Ronald

    2008-01-01

    Patients wearing a prosthesis face a wide variety of medical problems. Skin complications have long been recognized, but their prevalence is still unknown. The most frequently reported disorders are allergic contact dermatitis (ACD), acroangiodermatitis, epidermoid cysts, epidermal hyperplasia, follicular hyperkeratosis, verrucous hyperplasia, bullous diseases, hyperhidrosis, infections, malignancies, and ulcerations. Contact dermatitis represents one-third of the dermatoses in amputees wearing prostheses. All patients who are suspected of having ACD should be patch tested with standard allergen series as well as materials from the patient's own prosthesis, topical medicaments, moisturizers, and cosmetics. We report a patient with an ACD to mixed dialkyl thiourea present in the rubber parts of his below-the-knee prosthesis. Thiourea derivates are used as accelerators in the manufacture of chloroprene rubber and as fixatives in photography and photocopy paper. Allergy to thiourea is relatively uncommon; different studies have shown a prevalence of 0.7% up to 2.4% in patch-tested patients. Thiourea derivates are often the allergic sources in ACD involving high-grade rubber products made of neoprene such as diving suits, protective goggles, knee braces, and continuous positive airway pressure masks. They are also present in the rubber material of prostheses, as in the case of our patient. PMID:18413115

  18. Candida albicans binds to saliva proteins selectively adsorbed to silicone.

    PubMed

    Holmes, Ann R; van der Wielen, Pauline; Cannon, Richard D; Ruske, Dean; Dawes, Patrick

    2006-10-01

    Explanted voice prostheses obtained from 5 patients at the time of prosthesis replacement were consistently colonized by yeast, in particular Candida albicans. A simple, reproducible, in vitro model of C. albicans adherence to saliva-coated voice prosthesis silicone was developed. Whole saliva promoted adherence of C. albicans to silicone in a dose-dependent manner. Saliva rinses from voice prosthesis patients also promoted binding of C. albicans to silicone in vitro (mean adherence 14.9% +/- 2.8% of input C. albicans cells). This was significantly higher than C. albicans adherence to silicone in the absence of saliva (P < .001) or adherence promoted by saliva rinses from healthy volunteers (P < .005). Polyacrylamide gel electrophoresis analysis and a blot overlay adherence assay revealed that certain salivary proteins were selectively adsorbed to silicone and that C. albicans yeast cells adhered specifically to the adsorbed salivary proteins. PMID:16997116

  19. Rapid development of auricular prosthesis using CAD and rapid prototyping technologies.

    PubMed

    Subburaj, K; Nair, C; Rajesh, S; Meshram, S M; Ravi, B

    2007-10-01

    External ear defects can be corrected by surgery, but this may not be feasible for personal or medical reasons. Reconstructive solutions are a good alternative, but rely on the artistry and availability of the anaplastologist. A semi-automated methodology using computer-aided design (CAD) and rapid prototyping (RP) technologies was developed for auricular prosthesis development, and demonstrated in a real-life case. The correct geometry and position of the prosthesis were ensured by stacking the computed tomography scan images of the contralateral normal ear in reverse order, and joining them using a medical modelling software program. The CAD model of the remnant portion of the defective ear was subtracted from the model of the mirrored contralateral ear, using a haptic CAD system, to obtain the final geometry of the prosthesis. Polymer models were fabricated in RP systems, and used for making a corresponding mould. Medical grade silicone rubber of the appropriate colour was packed into the mould to fabricate the final ear prosthesis and fitted to the deficient side of the patient using medical grade adhesive. The computer-aided methodology gave a high level of accuracy in terms of shape, size and position of the prosthesis, and a significantly shorter lead time compared to the conventional (manual) technique. PMID:17822875

  20. Breast implant-associated ALK-negative anaplastic large cell lymphoma: a case report and discussion of possible pathogenesis

    PubMed Central

    George, Eva V; Pharm, John; Houston, Courtney; Al-Quran, Semar; Brian, Grey; Dong, Huijia; Hai, Wang; Reeves, Westley; Yang, Li-Jun

    2013-01-01

    Breast implant associated anaplastic large cell lymphoma (BIA-ALCL) is a recently recognized clinical entity, with only 39 well-documented cases reported worldwide, including 3 fatalities. Because of its rarity, the clinical and pathologic features of this malignancy have yet to be fully defined. Moreover, the pathogenesis of ALCL in association with textured silicone gel breast implants is poorly understood. Here we report a case of BIA-ALCL arising in a 67-year-old woman with a mastectomy due to breast cancer followed by implantation of textured silicone gel breast prosthesis. The patient presented with breast enlargement and tenderness 8 years following reconstructive surgery. MRI revealed a fluid collection surrounding the affected breast implant. Pathologic examination confirmed the presence of malignant ALCL T cells that were CD30+, CD8+, CD15+, HLA-DR+, CD25+ ALK- and p53. A diagnosis of indolent BIA-ALCL was made since tumor cells were not found outside of the capsule. Interestingly, an extensive mixed lymphocytic infiltrate and ectopic lymphoid tissue (lymphoid neogenesis) adjacent to the fibrous implant capsule were present. The patient was treated with capsulectomy and implantation of new breast prostheses. Six months later, the patient was found to have BIA-ALCL involvement of an axillary lymph node with cytogenetic evolutionof the tumor. To our knowledge, this is the sixth reported case of aggressive BIA-ALCL. Unique features of this case include the association with lymphoid neogenesis and the in vivo cytogenetic progression of the tumor. This case provides insight into the potential role of chronic inflammation and genetic instability in the pathogenesis of BIA-ALCL. PMID:23923082

  1. Breast implant-associated ALK-negative anaplastic large cell lymphoma: a case report and discussion of possible pathogenesis.

    PubMed

    George, Eva V; Pharm, John; Houston, Courtney; Al-Quran, Semar; Brian, Grey; Dong, Huijia; Hai, Wang; Reeves, Westley; Yang, Li-Jun

    2013-01-01

    Breast implant associated anaplastic large cell lymphoma (BIA-ALCL) is a recently recognized clinical entity, with only 39 well-documented cases reported worldwide, including 3 fatalities. Because of its rarity, the clinical and pathologic features of this malignancy have yet to be fully defined. Moreover, the pathogenesis of ALCL in association with textured silicone gel breast implants is poorly understood. Here we report a case of BIA-ALCL arising in a 67-year-old woman with a mastectomy due to breast cancer followed by implantation of textured silicone gel breast prosthesis. The patient presented with breast enlargement and tenderness 8 years following reconstructive surgery. MRI revealed a fluid collection surrounding the affected breast implant. Pathologic examination confirmed the presence of malignant ALCL T cells that were CD30+, CD8+, CD15+, HLA-DR+, CD25+ ALK- and p53. A diagnosis of indolent BIA-ALCL was made since tumor cells were not found outside of the capsule. Interestingly, an extensive mixed lymphocytic infiltrate and ectopic lymphoid tissue (lymphoid neogenesis) adjacent to the fibrous implant capsule were present. The patient was treated with capsulectomy and implantation of new breast prostheses. Six months later, the patient was found to have BIA-ALCL involvement of an axillary lymph node with cytogenetic evolution of the tumor. To our knowledge, this is the sixth reported case of aggressive BIA-ALCL. Unique features of this case include the association with lymphoid neogenesis and the in vivo cytogenetic progression of the tumor. This case provides insight into the potential role of chronic inflammation and genetic instability in the pathogenesis of BIA-ALCL. PMID:23923082

  2. [Complications of breast augmentation - a case report].

    PubMed

    Zedníková, I; Třešková, I; Schmiedhuber, P; Hes, O

    2012-08-01

    As with any surgery, breast augmentation does have certain risks and complications. The aim of this article is to point out a rare complication of breast augmentation - axillary silicone lymphadenopathy (defined as the presence of silicone in the lymph nodes). The authors present a case report of silicone lymphadenopathy in a young woman after the rupture of a silicone breast implant. As the number of women with breast implants is increasing, it is necessary to bear this rare complication of breast augmentation in mind in differential diagnosis of axillary lymphadenopathy. PMID:23153428

  3. BIORESORBABLE POLYMERIC MENISCAL PROSTHESIS: STUDY IN RABBITS

    PubMed Central

    Cardoso, Tulio Pereira; de Rezende Duek, Eliana Aparecida; Amatuzzi, Marco Martins; Caetano, Edie Benedito

    2015-01-01

    Objective: To induce growth of a neomeniscus into the pores of a prosthesis in order to protect the knee joint cartilage. Methods: 70 knees of 35 New Zealand rabbits were operated. The rabbits were five to seven months old, weighed 2 to 3.8 kilograms, and 22 were male and 13 were female. Each animal underwent medial meniscectomy in both knees during a single operation. A bioabsorbable polymeric meniscal prosthesis composed of 70% polydioxanone and 30% L-lactic acid polymer was implanted in one side. The animals were sacrificed after different postoperative time intervals. The femoral condyles and neomeniscus were subjected to histological analysis. Histograms were used to measure the degradation and absorption of the prosthesis, the growth of meniscal tissue in the prosthesis and the degree of degradation of the femoral condyle joint cartilage. Results: The data obtained showed that tissue growth histologically resembling a normal meniscus occurred, with gradual absorption of the prosthesis, and the percentages of chondrocytes on the control side and prosthesis side. Conclusion: Tissue growth into the prosthesis pores that histologically resembled the normal rabbit meniscus was observed. The joint cartilage of the femoral condyles on the prosthesis side presented greater numbers of chondrocytes in all its layers. PMID:27022549

  4. 21 CFR 878.3590 - Ear prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ear prosthesis. 878.3590 Section 878.3590 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3590 Ear prosthesis. (a) Identification....

  5. 21 CFR 878.3680 - Nose prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis....

  6. 21 CFR 878.3550 - Chin prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis....

  7. 21 CFR 878.3590 - Ear prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ear prosthesis. 878.3590 Section 878.3590 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3590 Ear prosthesis. (a) Identification....

  8. 21 CFR 878.3550 - Chin prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis....

  9. 21 CFR 878.3720 - Tracheal prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Tracheal prosthesis. 878.3720 Section 878.3720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3720 Tracheal prosthesis....

  10. 21 CFR 878.3720 - Tracheal prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Tracheal prosthesis. 878.3720 Section 878.3720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3720 Tracheal prosthesis....

  11. 21 CFR 878.3720 - Tracheal prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Tracheal prosthesis. 878.3720 Section 878.3720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3720 Tracheal prosthesis....

  12. 21 CFR 878.3550 - Chin prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis....

  13. 21 CFR 878.3550 - Chin prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis....

  14. 21 CFR 878.3680 - Nose prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis....

  15. 21 CFR 878.3680 - Nose prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis....

  16. 21 CFR 878.3680 - Nose prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis....

  17. 21 CFR 878.3680 - Nose prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis....

  18. 21 CFR 878.3550 - Chin prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis....

  19. 21 CFR 878.3720 - Tracheal prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Tracheal prosthesis. 878.3720 Section 878.3720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3720 Tracheal prosthesis....

  20. 21 CFR 878.3720 - Tracheal prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Tracheal prosthesis. 878.3720 Section 878.3720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3720 Tracheal prosthesis....

  1. Cervical silicone lymphadenopathy.

    PubMed

    Gilbert, Latoni Kaysha; Thiruchelvam, Janavikulam

    2016-07-01

    A patient presented to the department of oral and maxillofacial surgery with a rare case of cervical silicone lymphadenopathy. She had a painless ovoid mass in the left side of her neck and had had cosmetic breast augmentation 10 years before. Radiological imaging and core biopsy examination were consistent with silicone lymphadenopathy. PMID:26830068

  2. Semiconstrained distal radioulnar joint prosthesis.

    PubMed

    Savvidou, Christiana; Murphy, Erin; Mailhot, Emilie; Jacob, Shushan; Scheker, Luis R

    2013-02-01

    Distal radioulnar joint (DRUJ) problems can occur as a result of joint instability, abutment, or incongruity. The DRUJ is a weight-bearing joint; the ulnar head is frequently excised either totally or partially, and in some cases it is fused, because of degenerative, rheumatoid, or posttraumatic arthritis. Articles about these procedures report the ability to pronate and supinate, but they rarely discuss grip strength, and even less do they address lifting capacity. We report the long term results of the first 35 patients who underwent total DRUJ arthroplasty with the Aptis DRUJ prosthesis after 5 years follow-up. Surgical indications were all causes of dysfunctional DRUJ (degenerative, posttraumatic, autoimmune, congenital). We recorded data for patient demographics, range of motion (ROM), strength, and lifting capacity of the operated and of the nonoperated extremity. Pain and functional assessments were also recorded. The Aptis DRUJ prosthesis, a bipolar self-stabilizing DRUJ endoprosthesis that restores forearm function, consists of a semiconstained and modular implant designed to replace the function of the ulnar head, the sigmoid notch of the radius, and the triangular fibrocartilage ligaments. The surgical technique is presented in detail. The majority of the patients regained adequate ROM and improved their strength and lifting capacity to the operated side. Pain and activities of daily living were improved. Twelve patients experienced complications, most commonly being extensor carpi ulnaris (ECU) tendinitis, ectopic bone formation, bone resorption with stem loosening, low-grade infection, and need for ball replacement. The Aptis total DRUJ replacement prosthesis is an alternative to salvage procedures that enables a full range of motion as well as the ability to grip and lift weights encountered in daily living activities. PMID:24436788

  3. Indirect method of base adaptation against supporting element of tooth root for a partial overdenture prosthesis.

    PubMed

    Oh, Won-suk; Park, Ju-mi

    2014-08-01

    The base of a partial overdenture prosthesis should be fitted intraorally against the supporting element of a tooth root. Chairside relining is a common method; however, an autopolymerizing acrylic resin presents high porosity when polymerized intraorally. This article describes an indirect method where an impression is made with a silicone occlusion registration material to create a replica of the supporting elements of the residual ridge and the tooth root in a high-viscosity polyvinyl siloxane impression material. PMID:24412183

  4. [Dental feats 1. An implant-supported orbital prosthesis after ablative tumor surgery].

    PubMed

    Cune, M S; Bogie, L B; van Es, R J; Verhoeven, J W; Steijvers, M P; Rutges, P J

    2003-07-01

    Extraoral implants are used with increasing frequency, in order to provide retention for facial prostheses. Facial prostheses can replace lost extraoral hard and soft tissues using acrylic or silicone materials. The surgeon, maxillofacial prosthodontist and dental technician are facing particular treatment considerations and practical problems. Some of these are demonstrated and discussed in this article by means of a case-report. A patient received an orbital prosthesis which obtains its retention from implants, placed in the lateral orbital rim. PMID:12891887

  5. [Actuality with the breast implants].

    PubMed

    Duchateau, J

    2013-09-01

    The author presents the history of breast implants, and the modern evolution where breast implants are largely used in both cosmetic and reconstructive surgery. Breast augmentation is one of the most performed cosmetic procedures, with a high satisfaction rate. However, one needs to remind that breast implants have a limited duration of life. The estimated rate of breast implant rupture after 10 years is of 10% in the current literature, This rate will probably become lower with the new more cohesive implants recently available on the market. It is therefore essential to propose a regular follow-up to all patients having breast implants. This follow-up is performed using a combination of physical examination, mammograms, ultrasound and MRI. The more specific therapeutic approach for patients having a PIP prosthesis will also be discussed. PMID:24195240

  6. Prosthesis infection: prevention and treatment.

    PubMed

    de Donato, G; Setacci, F; Galzerano, G; Ruzzi, U; Borrelli, M P; Mazzitelli, G; Setacci, C

    2014-12-01

    Implantation of a vascular prosthesis increases surgical site infection risk by producing a microenvironment conducive to bacterial attachment and biofilm formation, which sustains bacterial colonization and protects encased organisms from host defenses and antimicrobial therapy. Many maneuvers are used in an attempt to reduce infection in arterial reconstructions, but there are no clear guidelines on the most appropriate or effective. As well, there is no good evidence to guide management. A general principle is that indication for removal of the entire infected graft is mandatory when a suture line is involved in the infectious process, an infected anastomotic aneurism and a suture-line hemorrhage is evident, or when a graft-enteric fistula is diagnosed. Conservative, non-resectional management of graft infection is still a respectable solution for selected patients, as those with significant comorbidities, or those where the implanted aortic graft is in a location that precludes excision without causing a high likelihood of morbidity and/or mortality. Anyway, definitive management depends on the patient's condition and a tailored approach should be always offered. Surgical techniques favor in terms of mortality, patency and reinfection rate the in situ reconstruction. Currently, the choice of the technique used relies on center and operator's experience. This article summarizes the incidence of graft infection, analyze the predisponding factors to graft infection, and review current strategies for prevention and treatment of prosthesis and endograft infection. PMID:25017788

  7. Stretch due to Penile Prosthesis Reservoir Migration

    PubMed Central

    Baten, E.; Vandewalle, T.; van Renterghem, K.

    2016-01-01

    A 43-year old patient presented to the emergency department with stretch, due to impossible deflation of the penile prosthesis, 4 years after successful implant. A CT-scan showed migration of the reservoir to the left rectus abdominis muscle. Refilling of the reservoir was inhibited by muscular compression, causing stretch. Removal and replacement of the reservoir was performed, after which the prosthesis was well-functioning again. Migration of the penile prosthesis reservoir is extremely rare but can cause several complications, such as stretch. PMID:26793592

  8. Chest wall reconstruction with methacrylate prosthesis in Poland syndrome.

    PubMed

    Arango Tomás, Elisabet; Baamonde Laborda, Carlos; Algar Algar, Javier; Salvatierra Velázquez, Angel

    2013-10-01

    Poland syndrome is a rare congenital malformation. This syndrome was described in 1841 by Alfred Poland at Guy's Hospital in London. It is characterized by hypoplasia of the breast and nipple, subcutaneous tissue shortages, lack of the costosternal portion of the pectoralis major muscle and associated alterations of the fingers on the same side. Corrective treatment of the chest and soft tissue abnormalities in Poland syndrome varies according to different authors. We report the case of a 17-year-old adolescent who underwent chest wall reconstruction with a methyl methacrylate prosthesis. This surgical procedure is recommended for large anterior chest wall defects, and it prevents paradoxical movement. Moreover it provides for individual remodeling of the defect depending on the shape of the patient's chest. PMID:23453291

  9. 21 CFR 878.3610 - Esophageal prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal prosthesis... of a plastic, metal, or polymeric material that is intended to be implanted to restore the...

  10. Custom Ocular Prosthesis: A Palliative Approach

    PubMed Central

    Thakkar, Prachi; Patel, JR; Sethuraman, Rajesh; Nirmal, Narendra

    2012-01-01

    The goal of palliative care is the achievement of the best quality of life for patients and their families. Eyes are generally the first features of the face to be noticed. Loss of an eye is a traumatic event which has a crippling effect on the psychology of the patient. Several ocular and orbital disorders require surgical intervention that may result in ocular defects. An ocular prosthesis is fabricated to restore the structure, function, and cosmetics of the defects created by such conditions. Although an implant eye prosthesis has a superior outcome, due to economic factors it may not be a feasible option for all patients. Therefore, a custom-made ocular prosthesis is a good alternative. This case report presents a palliative treatment for a patient with an enucleated eye by fabricating a custom ocular prosthesis which improved his psychological, physical, social, functional, emotional and spiritual needs. PMID:22837616

  11. Updates on the Construction of an Eyeglass-Supported Nasal Prosthesis Using Computer-Aided Design and Rapid Prototyping Technology.

    PubMed

    Ciocca, Leonardo; Tarsitano, Achille; Marchetti, Claudio; Scotti, Roberto

    2016-01-01

    This study was undertaken to design an updated connection system for an eyeglass-supported nasal prosthesis using rapid prototyping techniques. The substructure was developed with two main endpoints in mind: the connection to the silicone and the connection to the eyeglasses. The mold design was also updated; the mold was composed of various parts, each carefully designed to allow for easy release after silicone processing and to facilitate extraction of the prosthesis without any strain. The approach used in this study enabled perfect transfer of the reciprocal position of the prosthesis with respect to the eyeglasses, from the virtual to the clinical environment. Moreover, the reduction in thickness improved the flexibility of the prosthesis and promoted adaptation to the contours of the skin, even during functional movements. The method described here is a simplified and viable alternative to standard construction techniques for nasal prostheses and offers improved esthetic and functional results when no bone is available for implant-supported prostheses. PMID:26288248

  12. 21 CFR 878.3800 - External aesthetic restoration prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... external prosthesis adhesive. The device is not intended to be implanted. (b) Classification. Class I... an external prosthesis adhesive to fasten it to the body, the device is exempt from the current...

  13. 21 CFR 872.3960 - Mandibular condyle prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Identification. A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw to... requirement for premarket approval for any mandibular condyle prosthesis intended to be implanted in the...

  14. 21 CFR 872.3960 - Mandibular condyle prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Identification. A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw to... requirement for premarket approval for any mandibular condyle prosthesis intended to be implanted in the...

  15. Combined transscleral fixation of an artificial iris prosthesis with an intraocular lens.

    PubMed

    Gunenc, Uzeyır; Ozturk, Taylan; Arikan, Gul; Kaya, Mahmut

    2016-02-01

    Post-traumatic aniridia combined with aphakia may be seen after globe injury. Aside from esthetic aspects, partial or total loss of the iris tissue may also be related to various degrees of glare and photophobia. Such patients suffer from severe visual impairment secondary to aphakia. Herein we describe a novel surgical technique for the management of an aphakic eye with traumatic aniridia for a patient who underwent transscleral fixation of a custom-tailored artificial iris prosthesis combined with a rigid intraocular lens (IOL). Tight suturing of the IOL haptic eyelets on the silicone iris prosthesis and fixation of such a complex to the scleral wall may provide excellent cosmetic and functional outcomes in aphakic eyes with aniridia. PMID:26840171

  16. Life Estimation of Hip Joint Prosthesis

    NASA Astrophysics Data System (ADS)

    Desai, C.; Hirani, H.; Chawla, A.

    2014-11-01

    Hip joint is one of the largest weight-bearing structures in the human body. In the event of a failure of the natural hip joint, it is replaced with an artificial hip joint, known as hip joint prosthesis. The design of hip joint prosthesis must be such so as to resist fatigue failure of hip joint stem as well as bone cement, and minimize wear caused by sliding present between its head and socket. In the present paper an attempt is made to consider both fatigue and wear effects simultaneously in estimating functional-life of the hip joint prosthesis. The finite element modeling of hip joint prosthesis using HyperMesh™ (version 9) has been reported. The static analysis (load due to the dead weight of the body) and dynamic analysis (load due to walking cycle) have been described. Fatigue life is estimated by using the S-N curve of individual materials. To account for progressive wear of hip joint prosthesis, Archard's wear law, modifications in socket geometry and dynamic analysis have been used in a sequential manner. Using such sequential programming reduction in peak stress has been observed with increase in wear. Finally life is estimated on the basis of socket wear.

  17. Robotic lower limb prosthesis design through simultaneous computer optimizations of human and prosthesis costs

    PubMed Central

    Handford, Matthew L.; Srinivasan, Manoj

    2016-01-01

    Robotic lower limb prostheses can improve the quality of life for amputees. Development of such devices, currently dominated by long prototyping periods, could be sped up by predictive simulations. In contrast to some amputee simulations which track experimentally determined non-amputee walking kinematics, here, we explicitly model the human-prosthesis interaction to produce a prediction of the user’s walking kinematics. We obtain simulations of an amputee using an ankle-foot prosthesis by simultaneously optimizing human movements and prosthesis actuation, minimizing a weighted sum of human metabolic and prosthesis costs. The resulting Pareto optimal solutions predict that increasing prosthesis energy cost, decreasing prosthesis mass, and allowing asymmetric gaits all decrease human metabolic rate for a given speed and alter human kinematics. The metabolic rates increase monotonically with speed. Remarkably, by performing an analogous optimization for a non-amputee human, we predict that an amputee walking with an appropriately optimized robotic prosthesis can have a lower metabolic cost – even lower than assuming that the non-amputee’s ankle torques are cost-free. PMID:26857747

  18. 21 CFR 872.3940 - Total temporomandibular joint prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Total temporomandibular joint prosthesis. 872.3940... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3940 Total temporomandibular joint prosthesis. (a) Identification. A total temporomandibular joint prosthesis is a device that is intended to...

  19. 21 CFR 884.3650 - Fallopian tube prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Fallopian tube prosthesis. 884.3650 Section 884.3650 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... § 884.3650 Fallopian tube prosthesis. (a) Identification. A fallopian tube prosthesis is a...

  20. 21 CFR 870.3450 - Vascular graft prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Vascular graft prosthesis. 870.3450 Section 870... prosthesis. (a) Identification. A vascular graft prosthesis is an implanted device intended to repair... Prostheses 510(k) Submissions.”...

  1. 21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device...

  2. 21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device...

  3. 21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device...

  4. 21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made...

  5. 21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of...

  6. 21 CFR 872.3940 - Total temporomandibular joint prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Total temporomandibular joint prosthesis. 872.3940... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3940 Total temporomandibular joint prosthesis. (a) Identification. A total temporomandibular joint prosthesis is a device that is intended to...

  7. 21 CFR 872.3940 - Total temporomandibular joint prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Total temporomandibular joint prosthesis. 872.3940... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3940 Total temporomandibular joint prosthesis. (a) Identification. A total temporomandibular joint prosthesis is a device that is intended to...

  8. 21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made...

  9. 21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made...

  10. 21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of...

  11. 21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of...

  12. 21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of...

  13. 21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made...

  14. 21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made...

  15. 21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device...

  16. 21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of...

  17. [Infections of penile prosthesis: treatment and prevention].

    PubMed

    Olivo, V; Ramírez-Ronda, C H

    1994-01-01

    To date, there are 10,000,000 men with impotence in the United States and it is estimated that at least 17,000 penile prosthesis are implanted annually. The most fearsome complication is the infection of the prosthesis which is usually caused by Staphylococcus epidermidis (in 40-80% of the cases). In general, the incidence of infection is actually 0.8-8.3%, but it can increase to 37% in patients with tertiary implants. The initial empiric treatment is usually with vancomycin and aminoglycosides and prophylaxis is recommended with a penicillinase-resistant synthetic penicillins, first generation cephalosporins, or vancomycin in case of penicillin allergy. PMID:7857483

  18. Production of porous coating on a prosthesis

    DOEpatents

    Sump, Kenneth R.

    1987-01-01

    Preselected surface areas of a prosthesis are covered by a blend of matching primary metallic particles and expendable particles. The particles are compressed and heated to assure that deformation and metallurgical bonding occurs between them and between the primary particles and the surface boundaries of the prosthesis. Porosity is achieved by removal of the expendable material. The result is a coating including discrete bonded particles separated by a network of interconnected voids presenting a homogeneous porous coating about the substrate. It has strength suitable for bone implant usage without intermediate adhesives, and adequate porosity to promote subsequent bone ingrowth.

  19. Rehabilitation of Glossectomy Cases with Tongue Prosthesis: A Literature Review

    PubMed Central

    Balasubramaniam, Muthu Kumar; Shanmugam, Gokul; Tah, Rajdeep

    2016-01-01

    Tongue is the only movable muscular organ without any bone in the human body. It has very important role in perception of taste and sensations like touch, pressure, heat and cold. The purpose of the article is to review various types of tongue prosthesis and their clinical applications. This review helps the clinician to choose the appropriate type of tongue prosthesis for different clinical situations, retention of tongue prosthesis and material selection for each type of prosthesis. A broad search of published literature was performed using the keyword glossectomy, glossal prosthesis and tongue prosthesis from 1980 to 2014 in Medline, Google scholar, internet and text book. This review gives basic knowledge of glossal prosthesis and selection of the same for various clinical conditions. PMID:27042596

  20. Rehabilitation of Glossectomy Cases with Tongue Prosthesis: A Literature Review.

    PubMed

    Balasubramaniam, Muthu Kumar; Chidambaranathan, Ahila Singaravel; Shanmugam, Gokul; Tah, Rajdeep

    2016-02-01

    Tongue is the only movable muscular organ without any bone in the human body. It has very important role in perception of taste and sensations like touch, pressure, heat and cold. The purpose of the article is to review various types of tongue prosthesis and their clinical applications. This review helps the clinician to choose the appropriate type of tongue prosthesis for different clinical situations, retention of tongue prosthesis and material selection for each type of prosthesis. A broad search of published literature was performed using the keyword glossectomy, glossal prosthesis and tongue prosthesis from 1980 to 2014 in Medline, Google scholar, internet and text book. This review gives basic knowledge of glossal prosthesis and selection of the same for various clinical conditions. PMID:27042596

  1. Portable and accurate 3D scanner for breast implant design and reconstructive plastic surgery

    NASA Astrophysics Data System (ADS)

    Rigotti, Camilla; Borghese, Nunzio A.; Ferrari, Stefano; Baroni, Guido; Ferrigno, Giancarlo

    1998-06-01

    In order to evaluate the proper breast implant, the surgeon relies on a standard set of measurements manually taken on the subject. This approach does not allow to obtain an accurate reconstruction of the breast shape and asymmetries can easily arise after surgery. The purpose of this work is to present a method which can help the surgeon in the choice of the shape and dimensions of a prosthesis allowing for a perfect symmetry between the prosthesis and the controlateral breast and can be used as a 3D visual feedback in plastic surgery.

  2. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (premarket approval). (c) Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and... testicular prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed...

  3. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (premarket approval). (c) Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and... testicular prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed...

  4. Argus II retinal prosthesis system: An update.

    PubMed

    Rachitskaya, Aleksandra V; Yuan, Alex

    2016-09-01

    This review focuses on a description of the Argus II retinal prosthesis system (Argus II; Second Sight Medical Products, Sylmar, CA) that was approved for humanitarian use by the FDA in 2013 in patients with retinitis pigmentosa with bare or no light perception vision. The article describes the components of Argus II, the studies on the implant, and future directions. PMID:26855177

  5. 21 CFR 878.3610 - Esophageal prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal...

  6. 21 CFR 878.3610 - Esophageal prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal...

  7. 21 CFR 878.3610 - Esophageal prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal...

  8. 21 CFR 878.3610 - Esophageal prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal...

  9. Reading Visual Braille with a Retinal Prosthesis

    PubMed Central

    Lauritzen, Thomas Z.; Harris, Jordan; Mohand-Said, Saddek; Sahel, Jose A.; Dorn, Jessy D.; McClure, Kelly; Greenberg, Robert J.

    2012-01-01

    Retinal prostheses, which restore partial vision to patients blinded by outer retinal degeneration, are currently in clinical trial. The Argus II retinal prosthesis system was recently awarded CE approval for commercial use in Europe. While retinal prosthesis users have achieved remarkable visual improvement to the point of reading letters and short sentences, the reading process is still fairly cumbersome. This study investigates the possibility of using an epiretinal prosthesis to stimulate visual braille as a sensory substitution for reading written letters and words. The Argus II retinal prosthesis system, used in this study, includes a 10 × 6 electrode array implanted epiretinally, a tiny video camera mounted on a pair of glasses, and a wearable computer that processes the video and determines the stimulation current of each electrode in real time. In the braille reading system, individual letters are created by a subset of dots from a 3 by 2 array of six dots. For the visual braille experiment, a grid of six electrodes was chosen out of the 10 × 6 Argus II array. Groups of these electrodes were then directly stimulated (bypassing the camera) to create visual percepts of individual braille letters. Experiments were performed in a single subject. Single letters were stimulated in an alternative forced choice (AFC) paradigm, and short 2–4-letter words were stimulated (one letter at a time) in an open-choice reading paradigm. The subject correctly identified 89% of single letters, 80% of 2-letter, 60% of 3-letter, and 70% of 4-letter words. This work suggests that text can successfully be stimulated and read as visual braille in retinal prosthesis patients. PMID:23189036

  10. [Preliminary results in the use of polydimethylsiloxane textured elastomers (Bioplastique) in the treatment of leakage around tracheoesophageal voice prosthesis].

    PubMed

    Bertino, G; Benazzo, M; Occhini, A; Aresi, G; Mira, E

    2002-10-01

    Leakage around the prosthesis is one of the worst problems afflicting patients fitted with tracheoesophageal (TE) voice prosthesis. Removing the prosthesis for a few days can reduce the size of the fistula, or the leakage may be eliminated simply by replacing the prosthesis. In cases that are refractory to such treatment, the perifistular injection of different types of autologous, heterologous or alloplastic substances has been proposed. A new kind of silicone, previously available abroad, has recently appeared on the Italian market as well; constituted by polydimethylsiloxane textured elastomers (Bioplastique) for soft tissue implants, it appears to guarantee excellent standards of long-term safety and stability. Three patients fitted with Provox2 tracheoesophageal voice protheses who had been experiencing leakage for about 4 months underwent Bioplastique implant procedures. The correction of the fistula size was easy to accomplish and well tolerated by the patients. There was no sign of inflammation, formation of granulomas or other pathological modifications, and the size of the fistula, together with its fluid-tightness, remained stable in time. From our point of view, the Bioplastique implant appears to provide valid and effective treatment of gaping TE fistulas. PMID:12510340

  11. Breast Cancer

    MedlinePlus

    ... version of this page please turn Javascript on. Breast Cancer What is Breast Cancer? How Tumors Form The body is made up ... tumors form in the breast tissue. Who Gets Breast Cancer? Breast cancer is one of the most common ...

  12. Design and Control of a Powered Transfemoral Prosthesis

    PubMed Central

    Sup, Frank; Bohara, Amit; Goldfarb, Michael

    2009-01-01

    The paper describes the design and control of a transfemoral prosthesis with powered knee and ankle joints. The initial prototype is a pneumatically actuated powered-tethered device, which is intended to serve as a laboratory test bed for a subsequent self-powered version. The prosthesis design is described, including its kinematic optimization and the design of a three-axis socket load cell that measures the forces and moments of interaction between the socket and prosthesis. A gait controller is proposed based on the use of passive impedance functions that coordinates the motion of the prosthesis with the user during level walking. The control approach is implemented on the prosthesis prototype and experimental results are shown that demonstrate the promise of the active prosthesis and control approach in restoring fully powered level walking to the user. PMID:19898683

  13. Monomelic hypertrophic osteoarthropathy secondary to aortic prosthesis infection.

    PubMed

    Hernández, M V; Antonio del Olmo, J; Orellana, C; Mestres, C A; Mũnoz-Gómez, J

    1995-01-01

    We describe a case of hypertrophic osteoarthropathy (HOA), exclusively located in the left lower leg and secondary to vascular prosthesis infection. Four years before, the patient underwent aortofemoral bifurcation grafting because of a ruptured aortic aneurysm. The investigations revealed prosthesis infection by Pseudomona aeruginosa and Bacteroides thetaiotamicron. The onset of HOA in a patient with a vascular prosthesis can help to achieve an early diagnosis of graft infection. The literature on this uncommon association is reviewed. PMID:7699670

  14. Patient satisfaction with Mentor inflatable penile prosthesis.

    PubMed

    Whalen, R K; Merrill, D C

    1991-06-01

    Patient satisfaction with the Mentor inflatable penile prosthesis was assessed by sending a thirty-six-item questionnaire to 251 patients who had undergone implantation of the device by the senior author (D.C.M.). A total of 152 (61%) of the patients responded. Recovery time, satisfaction, reasons for dissatisfaction, perceptions of erection quality, and psychosexual parameters were evaluated. Eight-eight percent of the patients were engaging in regular sexual activity. Depending on the definition of satisfaction, 81-89 percent of the respondents reported that they were satisfied with the prosthesis. Sixty-eight percent of the survey group were satisfied with the length, width, and firmness of their prosthetic-induced erection. The majority of patients reported improvement in psychosexual functioning after implantation. Reasons for dissatisfaction included inadequate penile length, insufficient firmness, and difficulty with inflation and deflation of the penile cylinders. PMID:2038786

  15. Inflatable penile prosthesis (IPP): diagnosis of complications.

    PubMed

    Hartman, Robert P; Kawashima, Akira; Takahashi, Naoki; LeRoy, Andrew J; King, Bernard F

    2016-06-01

    Inflatable penile prostheses are a common treatment for erectile dysfunction that is unresponsive to less-invasive measures. Complications can arise at the time of the placement of the prosthesis or at a later date. Complications may be related to infection and/or mechanical failure of one or more of the prosthesis components including cylinder, reservoir, pump, and tubing. Mechanical failure includes kinking, migration, and aneurysmal dilation of the cylinder, erosion of the tunica albuginea of the corpora cavernosum by the cylinder, disconnection of the tubing, and migration of the reservoir. MRI of the entire components with the cylinders in both flaccid and inflated states is the best imaging modality available to image patients with suspected implant complications. PMID:26907716

  16. Innovative Approach for Interim Facial Prosthesis Using Digital Technology.

    PubMed

    Yoshioka, Fumi; Ozawa, Shogo; Hyodo, Ikuo; Tanaka, Yoshinobu

    2016-08-01

    Despite the important role of facial prosthetic treatment in the rehabilitation of head and neck cancer patients, delay in its implementation can be unavoidable, preventing patients from receiving a prompt facial prosthesis and resuming a normal social life. Here, we introduce an innovative method for the fabrication of an interim facial prosthesis. Using a 3D modeling system, we simplified the fabrication method and used a titanium reconstruction plate for facial prosthesis retention. The patient received the facial prosthesis immediately after surgery and resumed a normal social life earlier than is typically observed with conventional facial prosthetic treatment. PMID:26295755

  17. 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. PMID:26584233

  18. Fabrication of a Cranial Prosthesis Combined with an Ocular Prosthesis Using Rapid Prototyping: A Case Report

    PubMed Central

    Shankaran, Gayatri; Dhirawani, Rajesh

    2016-01-01

    Rapid prototyping (RP) is a technique of manufacturing parts by the additive layer manufacturing technology; where, a three-dimensional (3D) model created in a computer aided design (CAD) system is sectioned into 2D profiles, which are further constructed by RP layer by layer. Its use is not limited to industrial or engineering fields and has extended to the medical field for the manufacturing of custom implants and prostheses, the study of anatomy and surgical planning. Nowadays, dentists are more frequently encountered with the individuals affected with craniofacial defects due to trauma. In such cases, the craniomaxillofacial rehabilitation is a real challenge to bring the patients back to society and promote their well-being. The conventional impression technique for facial prosthesis fabrication has the disadvantage of deforming the soft tissue and causing discomfort for the patient. Herein, we describe the fabrication of a cranial prosthesis combined with an ocular prosthesis with RP and stereolithography. PMID:27536331

  19. Fabrication of a Cranial Prosthesis Combined with an Ocular Prosthesis Using Rapid Prototyping: A Case Report.

    PubMed

    Shankaran, Gayatri; Deogade, Suryakant Chhagan; Dhirawani, Rajesh

    2016-01-01

    Rapid prototyping (RP) is a technique of manufacturing parts by the additive layer manufacturing technology; where, a three-dimensional (3D) model created in a computer aided design (CAD) system is sectioned into 2D profiles, which are further constructed by RP layer by layer. Its use is not limited to industrial or engineering fields and has extended to the medical field for the manufacturing of custom implants and prostheses, the study of anatomy and surgical planning. Nowadays, dentists are more frequently encountered with the individuals affected with craniofacial defects due to trauma. In such cases, the craniomaxillofacial rehabilitation is a real challenge to bring the patients back to society and promote their well-being. The conventional impression technique for facial prosthesis fabrication has the disadvantage of deforming the soft tissue and causing discomfort for the patient. Herein, we describe the fabrication of a cranial prosthesis combined with an ocular prosthesis with RP and stereolithography. PMID:27536331

  20. Longitudinal performance of an implantable vestibular prosthesis

    PubMed Central

    Phillips, Christopher; Ling, Leo; Oxford, Trey; Nowack, Amy; Nie, Kaibao; Rubinstein, Jay T.; Phillips, James O.

    2014-01-01

    Loss of vestibular function may be treatable with an implantable vestibular prosthesis that stimulates semicircular canal afferents with biphasic pulse trains. Several studies have demonstrated short-term activation of the vestibulo-ocular reflex (VOR) with electrical stimulation. Fewer long-term studies have been restricted to small numbers of animals and stimulation designed to produce adaptive changes in the electrically elicited response. This study is the first large consecutive series of implanted rhesus macaque to be studied longitudinally using brief stimuli designed to limit adaptive changes in response, so that the efficacy of electrical activation can be studied over time, across surgeries, canals and animals. The implantation of a vestibular prosthesis in animals with intact vestibular end organs produces variable responses to electrical stimulation across canals and animals, which change in threshold for electrical activation of eye movements and in elicited slow phase velocities over time. These thresholds are consistently lower, and the slow phase velocities higher, than those obtained in human subjects. The changes do not appear to be correlated with changes in electrode impedance. The variability in response suggests that empirically derived transfer functions may be required to optimize the response of individual canals to a vestibular prosthesis, and that this function may need to be remapped over time. PMID:25245586

  1. Access to Breast Prostheses via a Government-Funded Service in Victoria, Australia: Experience of Women and Service Providers

    ERIC Educational Resources Information Center

    Livingston, Patricia M.; White, Victoria; Roberts, Susan; Pritchard, Emma; Gibbs, Anne; Hill, David J.

    2003-01-01

    For many women, the only alternative to breast reconstruction following a mastectomy is to use external prostheses, which need replacing regularly at a cost of up to $395 per prosthesis. Commonwealth and state governments across Australia have responded to this need by providing subsidies to assist in the purchase of breast prostheses. However,…

  2. Conversion prosthesis: a transitional fixed implant-supported prosthesis for an edentulous arch--a technical note.

    PubMed

    Balshi, T J; Wolfinger, G J

    1996-01-01

    A technique for fabricating a provisional fixed prosthesis for an edentulous arch immediately following abutment connection, termed conversion prosthesis, is described in detail. Advantages of the restoration include the following: it provides a fixed prosthesis immediately following stage 2 surgery with improved function, stability, and distribution of load; it protects the sutured mucosa; it serves as a prototype for the final prosthesis; it can be used as a verification jig; it preserves the original vertical dimension of occlusion; it aids in obtaining and transferring the interocclusal record; it assists long-term patient maintenance; and it reduces treatment visits. The advantages of its use clearly outweigh the disadvantages. PMID:8820130

  3. Polyacrylamide gel breast augmentation: report of two cases and review of the literature.

    PubMed

    Margolis, Nathaniel E; Bassiri-Tehrani, Brian; Chhor, Chloe; Singer, Cory; Hernandez, Osvaldo; Moy, Linda

    2015-01-01

    Polyacrylamide gel (PAAG) injection remains an uncommon method of breast augmentation. Providers must recognize the clinical and radiological manifestations to optimize management. The clinical and radiological findings of PAAG injection may mimic malignancy and silicone breast augmentation. We described two patients with prior PAAG breast augmentation with physical exam and imaging findings concerning for malignancy. We reviewed the literature on PAAG breast augmentation and compare PAAG to silicone breast augmentation. The management of such patients is discussed. PMID:25670236

  4. Engagement in activities revealing the body and psychosocial adjustment in adults with a trans-tibial prosthesis.

    PubMed

    Donovan-Hall, M K; Yardley, L; Watts, R J

    2002-04-01

    The purpose of this study was to examine the effects of the appearance of a prosthesis on social behaviour, social discomfort and psychological well-being in eleven amputees taking delivery of a prosthesis with a silicone cover. Two new scales were developed: the 'Engagement in everyday activities involving revealing the body' (EEARB); and the 'Discomfort-Engagement in everyday activities involving revealing the body' (Discomfort-EEARB) scales. The psychometric properties of these scales were determined using a sample of 101 able-bodied adults. The Hospital Anxiety and Depression Scale and the Rosenberg Self-Esteem Scale were also used to measure psychological well-being in the amputee sample. The EEARB and Discomfort-EEARB proved to have good reliability and validity. Comparison of amputees' scores prior to receiving the silicone cosmesis with those of the able-bodied adults revealed significant behavioural limitations and social discomfort, associated with low self-esteem, anxiety and depression. There was a significant increase in amputees' scores three months afier taking delivery of their prosthesis, indicating that amputees reported engaging in more activities which involved revealing their body, and that they would feel more comfortable in situations which involved revealing the body. As the amputee sample available was small and self-selected, it is not possible to generalise these findings to the amputee population as a whole. However, since there is little previous research investigating the effects of the appearance of the prosthesis, these findings demonstrate the need for further research in this area. PMID:12043922

  5. Prosthesis Socket Pressure Tools v. 1.0

    Energy Science and Technology Software Center (ESTSC)

    2010-04-28

    Renders, saves, and analyzes pressure from several sensors in a prosthesis™ socket. The program receives pressure data from 64 manometers and parses the pressure for each individual sensor. The program can then display those pressures as number in a table. The program also interpolates pressures between manometers to create a larger set of data. This larger set of data is displayed as a simple contour plot. That same contour plot can also be placed onmore » a three-dimensional surface in the shape of a prosthesis.This program allows for easy identification of high pressure areas in a prosthesis to reduce the user™s discomfort. The program parses the sensor pressures into a human-readable numeric format. The data may also be used to actively adjust bladders within the prosthesis to spread out pressure in real time, according to changing demands placed on the prosthesis. Interpolation of the pressures to create a larger data set makes it even easier for a human to identify particular areas of the prosthesis that are under high pressure. After identifying pressure points, a prosthetician can then redesign the prosthesis and/or command the bladders in the prosthesis to attempt to maintain constant pressures.« less

  6. 21 CFR 878.3800 - External aesthetic restoration prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false External aesthetic restoration prosthesis. 878.3800 Section 878.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... External aesthetic restoration prosthesis. (a) Identification. An external aesthetic restoration...

  7. 21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Finger joint polymer constrained prosthesis. 888.3230 Section 888.3230 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification....

  8. A direct bonded fixed partial dental prosthesis: a clinical report.

    PubMed

    Tanoue, Naomi; Tanaka, Takuo

    2015-01-01

    A direct bonded fixed partial dental prosthesis, with a composite resin denture tooth as a pontic, a tri-n-butylborane initiated adhesive resin, and screw posts for reinforcement, was still functioning after an observation period of 20 years. The prosthesis was found to be reliable for long-term clinical use when chemically and mechanically reinforced. PMID:25277033

  9. 21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... implant). 872.3970 Section 872.3970 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... disc prosthesis (interpositional implant). (a) Identification. An interarticular disc prosthesis (interpositional implant) is a device that is intended to be an interface between the natural articulating...

  10. 21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... implant). 872.3970 Section 872.3970 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... disc prosthesis (interpositional implant). (a) Identification. An interarticular disc prosthesis (interpositional implant) is a device that is intended to be an interface between the natural articulating...

  11. 21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... implant). 872.3970 Section 872.3970 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... disc prosthesis (interpositional implant). (a) Identification. An interarticular disc prosthesis (interpositional implant) is a device that is intended to be an interface between the natural articulating...

  12. Magnet-Retained Facial Prosthesis Combined with Maxillary Obturator

    PubMed Central

    Hatami, Mahnaz; Badrian, Hamid; Samanipoor, Siamak; Goiato, Marcelo Coelho

    2013-01-01

    Prosthetic rehabilitation of the midfacial defects has always perplexed prosthodontists. These defects lead to functional and esthetic deficiencies. The purpose of this clinical case report was the presentation of the prosthetic rehabilitation of an extraoral-intraoral defect using two-piece prosthesis magnetically connected. This prosthesis has dramatically improved the patient's speech, mastication, swallowing, and esthetic. PMID:23738151

  13. Three-piece Inflatable Penile Prosthesis: Surgical Techniques and Pitfalls

    PubMed Central

    Al-Enezi, Ahmad; Al-Khadhari, Sulaiman; Al-Shaiji, Tariq F.

    2011-01-01

    Penile prosthesis surgery plays a vital role in the treatment of erectile dysfunction (ED). As far as outcome is concerned, it is one of the most rewarding procedures for both patients and surgeons. We describe our surgical technique for implantation of the three-piece inflatable penile prosthesis and point out the major surgical pitfalls accompanying this procedure and their specific management. The psychological outcome of penile prosthesis surgery is also discussed. Different surgical approaches are available when performing the procedure. A number of procedure-related problems can be encountered and a thorough knowledge of these is of paramount importance. Penile prosthesis surgery has a favorable psychological outcome. Surgery for implantation of an inflatable penile prosthesis is a rewarding procedure, with a high yield of patient satisfaction. Urologists should have thorough understanding of the surgical pitfalls peculiar to this procedure and their management. PMID:22413049

  14. Amputation and prosthesis implantation shape body and peripersonal space representations.

    PubMed

    Canzoneri, Elisa; Marzolla, Marilena; Amoresano, Amedeo; Verni, Gennaro; Serino, Andrea

    2013-01-01

    Little is known about whether and how multimodal representations of the body (BRs) and of the space around the body (Peripersonal Space, PPS) adapt to amputation and prosthesis implantation. In order to investigate this issue, we tested BR in a group of upper limb amputees by means of a tactile distance perception task and PPS by means of an audio-tactile interaction task. Subjects performed the tasks with stimulation either on the healthy limb or the stump of the amputated limb, while wearing or not wearing their prosthesis. When patients performed the tasks on the amputated limb, without the prosthesis, the perception of arm length shrank, with a concurrent shift of PPS boundaries towards the stump. Conversely, wearing the prosthesis increased the perceived length of the stump and extended the PPS boundaries so as to include the prosthetic hand, such that the prosthesis partially replaced the missing limb. PMID:24088746

  15. Biodegradation and biocompatibility of a degradable chitosan vascular prosthesis

    PubMed Central

    Kong, Xiaoying; Xu, Wenhua

    2015-01-01

    An instrument made by ourselves was used to fabricate biodegradable chitosan-heparin artificial vascular prosthesis with small internal diameter (2 mm) and different crosslinking degree from biodegradable chitosan, chitosan derivates and heparin. In vivo and in vitro degradation studies, inflammatory analysis and electron microscope scanning of this artificial vascular prosthesis were performed. It was observed that 50% of the prosthesis decomposed in vivo and was replaced by natural tissues. The degradation process of the chitosan-heparin artificial vascular prosthesis of small diameter could be controlled by changing the crosslinking degree. This kind of artificial vascular prosthesis shows good biocompatibility that can be controllability designed to achieve desirable in vascular replacement application. PMID:26064241

  16. Development and functional evaluation of biomimetic silicone surfaces with hierarchical micro/nano-topographical features demonstrates favourable in vitro foreign body response of breast-derived fibroblasts.

    PubMed

    Kyle, Daniel J T; Oikonomou, Antonios; Hill, Ernie; Bayat, Ardeshir

    2015-06-01

    Reproducing extracellular matrix topographical cues, such as those present within acellular dermal matrix (ADM), in synthetic implant surfaces, may augment cellular responses, independent of surface chemistry. This could lead to enhanced implant integration and performance while reducing complications. In this work, the hierarchical micro and nanoscale features of ADM were accurately and reproducibly replicated in polydimethylsiloxane (PDMS), using an innovative maskless 3D grayscale fabrication process not previously reported. Human breast derived fibroblasts (n=5) were cultured on PDMS surfaces and compared to commercially available smooth and textured silicone implant surfaces, for up to one week. Cell attachment, proliferation and cytotoxicity, in addition to immunofluorescence staining, SEM imaging, qRT-PCR and cytokine array were performed. ADM PDMS surfaces promoted cell adhesion, proliferation and survival (p=<0.05), in addition to increased focal contact formation and spread fibroblast morphology when compared to commercially available implant surfaces. PCNA, vinculin and collagen 1 were up-regulated in fibroblasts on biomimetic surfaces while IL8, TNFα, TGFβ1 and HSP60 were down-regulated (p=<0.05). A reduced inflammatory cytokine response was also observed (p=<0.05). This study represents a novel approach to the development of functionalised biomimetic prosthetic implant surfaces which were demonstrated to significantly attenuate the acute in vitro foreign body reaction to silicone. PMID:25818416

  17. Breast pain

    MedlinePlus

    Pain - breast; Mastalgia; Mastodynia; Breast tenderness ... There are many possible causes for breast pain. For example, hormone level changes from menstruation or pregnancy often cause breast tenderness. Some swelling and tenderness just before your period ...

  18. Ultrasound - Breast

    MedlinePlus

    ... discharge) and to characterize potential abnormalities seen on mammography or breast magnetic resonance imaging (MRI). Ultrasound imaging ... supply in breast lesions . Supplemental Breast Cancer Screening Mammography is the only screening tool for breast cancer ...

  19. Breast lift

    MedlinePlus

    ... enable JavaScript. A breast lift, or mastopexy, is cosmetic breast surgery to lift the breasts. The surgery ... the position of the areola and nipple. Description Cosmetic breast surgery can be done at an outpatient ...

  20. Site development interim removable dental prosthesis.

    PubMed

    Pasquinelli, Kirk L; Sze, Alexander J; Matosian, Alex J

    2016-07-01

    Transitioning a patient with partial edentulism through hard and soft tissue grafting to an implant restoration with an interim removable dental prosthesis (IRDP) presents a challenge to the restorative dentist. The management of grafted sites requires care, and without the appropriate design, an IRDP may impede surgical outcomes and place the graft at risk for displacement or necrosis. A site development IRDP (SDIRDP) for a grafted site must fulfill restorative goals and promote the surgical objectives for site development. A technique is described for fabricating an SDIRDP that facilitates surgical procedures and maintains prosthetic goals. PMID:26831920

  1. [Radio-carpal amputation and prosthesis].

    PubMed

    Cauquil, C; Thaury, M N; de Godebout, J; Ster, J; Ster, F; Bouzigues, B; Ducros, P

    1992-01-01

    Radio-carpal amputation was rejected for a long time because of the difficulties of fitting both myoelectrical and mechanical prostheses, only allowing a purely aesthetic prosthesis. As a result of miniaturization of control systems and the progress in computers, we believe that this now constitutes the best site for amputation whenever it is possible. Preservation of the antero-posterior bony contours of the radius allows the use of short sockets attached by a system of clips. In this way, flexion-extension of the elbow is left free and the movements of pronation and supination can be used. Liberation of the proximal joints facilitates integration of the prosthetic hand. PMID:1375500

  2. Silicone metalization

    DOEpatents

    Maghribi, Mariam N.; Krulevitch, Peter; Hamilton, Julie

    2006-12-05

    A system for providing metal features on silicone comprising providing a silicone layer on a matrix and providing a metal layer on the silicone layer. An electronic apparatus can be produced by the system. The electronic apparatus comprises a silicone body and metal features on the silicone body that provide an electronic device.

  3. Silicone metalization

    DOEpatents

    Maghribi, Mariam N.; Krulevitch, Peter; Hamilton, Julie

    2008-12-09

    A system for providing metal features on silicone comprising providing a silicone layer on a matrix and providing a metal layer on the silicone layer. An electronic apparatus can be produced by the system. The electronic apparatus comprises a silicone body and metal features on the silicone body that provide an electronic device.

  4. A model for intracortical visual prosthesis research.

    PubMed

    Troyk, Philip; Bak, Martin; Berg, Joshua; Bradley, David; Cogan, Stuart; Erickson, Robert; Kufta, Conrad; McCreery, Douglas; Schmidt, Edward; Towle, Vernon

    2003-11-01

    In the field of visual prosthesis research, it has generally been held that animal models are limited to testing the safety of implantable hardware due to the inability of the animal to provide a linguistic report of perceptions. In contrast, vision scientists make extensive use of trained animal models to investigate the links between visual stimuli, neural activities, and perception. We describe an animal model for cortical visual prosthesis research in which novel animal psychophysical testing has been employed to compensate for the lack of a linguistic report. One hundred and fifty-two intracortical microelectrodes were chronically implanted in area V1 of a male macaque. Receptive field mapping was combined with eye-tracking to develop a reward-based training procedure. The animal was trained to use electrically induced point-flash percepts, called phosphenes, in performing a memory saccade task. It is our long-term goal to use this animal model to investigate stimulation strategies in developing a multichannel sensory cortical interface. PMID:14616519

  5. A Walking Controller for a Powered Ankle Prosthesis

    PubMed Central

    Shultz, Amanda H.; Mitchell, Jason E.; Truex, Don; Lawson, Brian E.; Ledoux, Elissa; Goldfarb, Michael

    2015-01-01

    This paper describes a walking controller implemented on a powered ankle prosthesis prototype and assessed by a below-knee amputee subject on a treadmill at three speeds. The walking controller is a finite state machine which emulates a series of passive impedance functions at the joint in order to reproduce the behavior of a healthy joint. The assessments performed demonstrate the ability of the powered prosthesis prototype and walking controller to reproduce essential biomechanical aspects (i.e. joint angle, torque, and power profiles) of the healthy joint, especially relative to a passive prosthesis. PMID:25571414

  6. Implantable multilayer microstrip antenna for retinal prosthesis: antenna testing.

    PubMed

    Permana, Hans; Fang, Qiang; Rowe, Wayne S T

    2012-01-01

    Retinal prosthesis has come to a more mature stage and become a very strategic answer to Retinitis Pigmentosa (RP) and Age-related Macular Degeneration (AMD) diseases. In a retinal prosthesis system, wireless link holds a great importance for the continuity of the system. In this paper, an implantable multilayer microstrip antenna was proposed for the retinal prosthesis system. Simulations were performed in High Frequency Structure Simulator (HFSS) with the surrounding material of air and Vitreous Humor fluid. The fabricated antenna was measured for characteristic validation in free space. The results showed that the real antenna possessed similar return loss and radiation pattern, while there was discrepancy with the gain values. PMID:23366231

  7. What Is Breast Cancer?

    MedlinePlus

    ... Next Topic Types of breast cancers What is breast cancer? Breast cancer starts when cells in the breast ... breast cancer? ” and Non-cancerous Breast Conditions . How Breast Cancer Spreads Breast cancer can spread through the lymph ...

  8. The ruptured PIP breast implant.

    PubMed

    Helyar, V; Burke, C; McWilliams, S

    2013-08-01

    Public concern erupted about the safety of Poly Implant Prothèse (PIP) breast implants when it was revealed in 2011 that they contained an inferior, unlicensed industrial-grade silicone associated with a high rate of rupture. There followed national guidance for UK clinicians, which led to a considerable increase in referrals of asymptomatic women for breast implant assessment. In this review we discuss possible approaches to screening the PIP cohort and the salient characteristics of a ruptured implant. PMID:23622796

  9. Current status of breast reconstruction in China: an experience of 951 breast reconstructions from a single institute

    PubMed Central

    Huang, Nai-Si; Quan, Chen-Lian; Ma, Lin-Xiao-Xi; Si, Jing; Chen, Jia-Jian; Yang, Ben-Long; Huang, Xiao-Yan; Liu, Guang-Yu; Shen, Zhen-Zhou; Shao, Zhi-Min

    2016-01-01

    Background Since mastectomy remained the primary strategy for treating breast cancer in China, post-mastectomy reconstruction is of great importance in the Chinese population. The current study aimed to assess the current status of breast reconstruction in China. Methods We reviewed all patients who received breast reconstruction from August 2000 to July 2015 in the Department of Breast Surgery in our institute. Patients’ baseline characteristics, reconstruction strategy, final pathology and loco-regional recurrence (LRR) information were collected. Results A total of 951 breast reconstructions were conducted during the past 15 years, among which 247 (27.0%) were abdominal flap reconstruction; 471 (51.5%) were latissimus dorsi myocutaneous ± implant; and 233 (25.5%) were prosthesis-based reconstruction. The majority of cases (78.1%) were invasive breast cancer and up to 894 cases (94.0%) were immediate reconstruction. Prosthesis-based reconstruction rapidly increased in recent years, and was associated with bilateral reconstruction, contralateral augmentation and higher complications. 18 patients (2.0%) developed local-regional recurrence at the median follow-up time of 26.6 months (range, 3.7–62.0 months). A total of 66 nipple-areolar complex-sparing mastectomies (NSMs) (6.9%) were performed, none of which developed recurrence. Conclusions Breast reconstruction cases increased over the 15 years with the change of paradigm. Most strikingly, prosthesis-based reconstruction rapidly gained its prevalence and became the most common strategy. NSM was only performed for highly selected patients. Patients with breast reconstruction were able to achieve satisfactory loco-regional control in our cohort. PMID:27294034

  10. Breast augmentation with an unknown substance

    PubMed Central

    Ebrahim, Lamya; Morrison, David; Kop, Alan; Taylor, Donna

    2014-01-01

    Before the widespread use of silicone implants various foreign substances were injected directly into the breasts. The nature of these materials sometimes remains unknown and can cause various complications requiring surgical intervention. Preoperative diagnostic imaging can help characterise the type and distribution of the injected material, thereby assisting in making decisions regarding treatment. We report a case of breast augmentation with an unknown substance, aiming to highlight some imaging characteristics of different breast augmentation substances. PMID:24957586