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Sample records for silicone breast prosthesis

  1. Dosimetry of a silicone breast prosthesis

    SciTech Connect

    McGinley, P.H.; Powell, W.R.; Bostwick, J.

    1980-04-01

    Dose measurements were conducted in a phantom which simulates breast tissue and in another phantom which simulates a breast containing a silicone prosthesis. No detectable difference was found when the irradiations were carried out with tangential beams of /sup 60/Co radiation. The degree of backscatter and absorption of radiation by the prosthesis and phantom were also similar. A slight decrease in dose of approximately 8% was found at the interface between the prosthesis and muscle-equivalent material.

  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 Silicone...

  3. 21 CFR 878.3530 - Silicone inflatable breast prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 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 Silicone...

  4. 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...

  5. 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...

  6. 21 CFR 878.3530 - Silicone inflatable breast prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 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...

  7. 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 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 878.3540 - 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...

  10. 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 gel...

  11. 21 CFR 878.3540 - Silicone gel-filled breast prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 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 gel...

  12. Effect of silicone gel breast prosthesis on electron and photon dose distributions

    SciTech Connect

    Krishnan, L.; St. George, F.J.; Mansfield, C.M.; Krishnan, E.C.

    1983-01-01

    The effect of a silicone gel breast prosthesis on the absorbed dose distribution of 9--20 MeV electron beams and 1.25--15 MV photon beams was studied. Compared to water measurements, at depths smaller than the practical range of the electron beams, the central axis depth dose values below the prothesis were lower for all energies by as much as 3.5%. However, at depths near the practical range, the central axis depth dose values for the prosthesis were greater than that of water by as much as 33%. Since this occurs near the end of the electron range, the resultant difference may not be clinically significant. Results of the effect of breast prosthesis on photon depth dose distributions reveal that no clinically significant perturbation is produced by the breast prosthesis using Co-60, 6- and 15-MV radiations.

  13. Capsular synovial metaplasia mimicking silicone leak of a breast prosthesis: a case report

    PubMed Central

    Krishnanandan, Sarah; Abbassian, Ali; Sharma, Anup K; Cunnick, Giles

    2008-01-01

    Introduction Synovial metaplasia around a prosthesis and in particular around silicone breast implants has been noted by various investigators, but has unknown clinical significance. We report on a patient where a large amount of synovial fluid mimicked rupture of an implant. We believe this to be an unusual clinical presentation of this phenomenon. Review of the English language literature failed to identify a comparable case. Case presentation A 25-year-old woman had undergone bilateral breast augmentation for cosmetic reasons. One implant was subsequently subjected to two attempts at expansion to correct asymmetry. The patient was later found to have a large quantity of viscous fluid around the port of that same prosthesis. Histological assessment of the implant had consequently confirmed capsular synovial metaplasia. This had initially caused the suspicion of a silicone 'bleed' from the implant and had resulted in an unnecessary explantation. Conclusion Capsular synovial metaplasia should be ruled out before the removal of breast implants where a leak is suspected. Manipulation and expansion of an implant may be risk factors for the development of synovial metaplasia. PMID:18706084

  14. [TURNOVER CAPSULAR FLAPS FOR THE TREATMENT OF IMPENDING EXTRUSION OF SILICONE PROSTHESIS IN RECONSTRUCTED BREASTS].

    PubMed

    Eyal, Nir; Mattanes, Issa; Or, Nir Gal; BrizgaLin, Lionid; Amir, Aharon; Gil, Tamir; Bitterman, Arie; Hanna-Zaknun, Rene; Har-Shai, Yaron

    2015-09-01

    Pressure necrosis which might be followed by skin necrosis and implant extrusion is a dreaded complication of breast reconstructive surgery. Over the years, several techniques have been introduced to address this challenging problem. We offer a novel surgical technique to confront this perplexing complication. By using the capsule of the implant as a turnover flap, the soft tissue coverage is enhanced thereby decreasing the pressure between the breast prosthesis and the over-laying skin. The technique is simply reproduced, requires no new incisions, and avoids further morbidity to the involved breast reconstructed patient.

  15. 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.

  16. Breast Reconstruction and Prosthesis

    MedlinePlus

    ... For more information, visit komen.org or call Susan G. Komen’s breast care helpline at 1-877 ... buy bras and mastectomy bathing suits online. Resources Susan G. Komen ® 1-877 GO KOMEN (1-877- ...

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

    MedlinePlus

    ... Q: Do you have any tips for other women who might be trying to decide if a breast prosthesis is right for them? Andrea: You can always meet with ... out what kind of surgical options might be right for you. Q: Is there anything else you think women with breast cancer should know? Andrea: I think ...

  18. Computer-aided methods in bespoke breast prosthesis design and fabrication.

    PubMed

    Eggbeer, D; Evans, P

    2011-01-01

    This case study presents a method of utilizing computer-aided design technologies to provide bespoke, external breast prostheses. The technique is illustrated through a case study of a mastectomy patient. Photogrammetry methods were used to capture the breast form when supported by a brassiere and the unsupported breast and defect side. Computer-aided design techniques were used to generate a digital prosthesis based upon the supported breast shape and with a fitting surface that matched the defect side. Furthermore, a two-part mould was designed and fabricated using rapid prototyping methods. A colour-matched prosthesis was then fabricated in a gel-based, platinum-cured silicone.

  19. 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…

  20. 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…

  1. Use of Jonas Silicon-Silver prosthesis in erectile impotence.

    PubMed

    Rowe, P H; Royle, M G

    1983-12-01

    Eleven patients presenting over the last three years with erectile impotence who have been treated by the insertion of the Jonas Silicon-Silver penile prosthesis are reviewed. The insertion of this prosthesis is a minor procedure. It has a simple design, low cost, no permanent erection or mechanical problems and an excellent cosmetic and functional result.

  2. Rehabilitation of single finger amputation with customized silicone prosthesis

    PubMed Central

    Yadav, Niharika; Chand, Pooran; Jurel, Sunit Kumar

    2016-01-01

    Finger amputations are common in accidents at home, work, and play. Apart from trauma, congenital disease and deformity also leads to finger amputation. This results in loss of function, loss of sensation as well as loss of body image. Finger prosthesis offers psychological support and social acceptance in such cases. This clinical report describes a method to fabricate ring retained silicone finger prosthesis in a patient with partial finger loss. PMID:28163487

  3. Custom-made silicone hand prosthesis: A case study.

    PubMed

    Nayak, S; Lenka, P K; Equebal, A; Biswas, A

    2016-09-01

    Up to now, a cosmetic glove was the most common method for managing transmetacarpal (TMC) and carpometacarpal (CMC) amputations, but it is devoid of markings and body color. At this amputation level, it is very difficult to fit a functional prosthesis because of the short available length, unsightly shape, grafted skin, contracture and lack of functional prosthetic options. A 30-year-old male came to our clinic with amputation at the 1st to 4th carpometacarpal level and a 5th metacarpal that was projected laterally and fused with the carpal bone. The stump had grafted skin, redness, and an unhealed suture line. He complained of pain projected over the metacarpal and suture area. The clinical team members decided to fabricate a custom-made silicone hand prosthesis to accommodate the stump, protect the grafted skin, improve the hand's appearance and provide some passive function. The custom silicone hand prosthesis was fabricated with modified flexible wires to provide passive interphalangeal movement. Basic training, care and maintenance instructions for the prosthesis were given to the patient. The silicone hand prosthesis was able to restore the appearance of the lost digits and provide some passive function. His pain (VAS score) was reduced. Improvement in activities of daily living was found in the DASH questionnaire and Jebsen-Taylor Hand Function test. A silicone glove is a good option for more distal amputations, as it can accommodate any deformity, protect the skin, enhance the appearance and provide functional assistance. This case study provides a simple method to get passively movable fingers after proximal hand amputation. Copyright © 2016. Published by Elsevier Masson SAS.

  4. Osseointegrated silicone finger prosthesis using dental implants: a renovated technique.

    PubMed

    Vinnakota, Dileep Nag; Sankar, V Vijay; Chirumamilla, Naveen; Reddy, V Vamsikrishna

    2014-11-01

    In clinical practice, we come across patients with traumatically amputated or congenitally missing partial or complete fingers that can be restored using microsurgical replantation or transplantation procedures. However, in some cases this might not be possible due to systemic or local factors and the lost or missing part has to be replaced prosthetically to offer psychological and functional wellbeing. These prostheses can be constructed with various materials like acrylics or silicone retained with the help of auxiliary aids. However, these prostheses cause some hindrance in performing functions like writing, typing, etc. The aim of the present trial was to ameliorate the existing design of implant supported finger prosthesis. Distal phalange of middle finger replaced with implant supported silicone finger prosthesis is modified by utilizing a metal framework to support silicone material to improve rigidity while working. We could achieve a good function, esthetics and tactile sensibility with this modified design. Whenever, feasible this design can improve the performance and patients feel a deep sense of satisfaction and improved self-esteem with this modified prosthesis.

  5. Innovation of a new silicone prosthesis for inguinal hernioplasty: new method for silicone prosthesis production, a preliminary study.

    PubMed

    Vaghef Davari, Farzad; Khashayar, Patricia; Khorasani, Mohammadtaghi; Zafarghandi, Mohammadreza

    2015-01-01

    The main strategy in inguinal hernia repair is mesh hernioplasty (specially prolene mesh). Pain in anterior femoral, inguinal and scrotal areas, mainly due to sensory nerve injury in the very regions and vas deferen injury are the main complications reported following repairing inguinal hernia. In this study we decided to use semiliquid silicone in order to form it in an in-vivo prosthesis production method to perform hernioplasty. In this technique, silicone was produced through Room Temperature Vulcanization (RTV) technique, which is feasible in the room temperature. The produced semiliquid polymer was shaped in the inguinal canal in six cadavers. While the prostheses adequately covered all the anatomic area of the canal with an acceptable thickness in all of the cases, a satisfactory shape was developed in four cases. While 15 - 20 cc of silicone was needed to cover all anatomic areas properly, the hardness equal to 15 was achieved after curing process. New silicone prosthesis forms satisfyingly in the inguinal canal and can protect it by encapsulation mechanism. It is soft with no risk of damage to the nerves or vas. It is inert and has no toxicity to the adjacent tissue. This technique of silicone remodeling can also be used in other fields of surgery such as plastic or vascular surgery.

  6. Electron beam irradiation after reconstruction with silicone gel implant in breast cancer

    SciTech Connect

    Krishnan, L.; Krishnan, E.C.

    1986-06-01

    Irradiation for breast cancer in the presence of a silicone gel breast prosthesis is sometimes necessary. There is a concern among radiation and other oncologists as to whether the presence of the prosthetic implant would interfere with delivery of the needed irradiation doses. Electron beams, with their finite penetration and rapid fall-off, offer a mode of adequately treating the recurrence and minimizing the radiation to the underlying normal structures, such as the lung and the heart. The dose distribution using 9-20 MeV electrons in the presence of a breast prosthesis is compared to the dose distribution without the implant in a tissue equivalent water phantom. The results reveal no significant difference in the dose delivered due to the presence of the prosthesis. Clinical verification of the dosimetry in the presence of the prosthesis confirmed that the presence of the silicone gel implant does not compromise treatment by irradiation in the management of breast cancer.

  7. 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

    2014-12-09

    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.

  8. 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.

  9. Prosthetic management of mid-facial defect with magnet-retained silicone prosthesis.

    PubMed

    Buzayan, Muaiyed M

    2014-02-01

    Mid-facial defect is one of the most disfiguring and impairing defects. A design of prosthesis that is aesthetic and stable can be precious to a patient who has lost part of his face due to surgical excision. Prosthesis can restore the patients' self-esteem and confidence, which affects the patients and their life style. The aim of this case report is to describe a technique of mid-facial silicone prosthesis fabrication. To provide an aesthetic and stable facial prosthesis, the extra-oral prosthesis was fabricated using silicone material, while the intra-oral defect was restored with obturator prosthesis, and then both prostheses were connected and attached to each other using magnets. This clinical report describes the rehabilitation of a large mid-facial defect with a two-piece prosthesis. The silicone facial prosthesis was made hollow and lighter by using an acrylic framework. Two acrylic channels were included within the facial prosthesis to provide the patient with clean and patent airways. A sectional mid-facial prosthesis was made and retained in place by using magnets, which resulted in a significant improvement in the aesthetical and functional outcome without the need for plastic surgery. Silicone prostheses are reliable alternatives to surgery and should be considered in selected cases.

  10. The silicone breast implant controversy.

    PubMed

    Guerette, P H

    1995-02-01

    Feminists call it objectification. Consumer advocates call it victimization. Medical personnel call it augmentation. Women, implantation. Whatever the term, media hype and the increasing number of lawsuits against U.S. manufacturers of silicone breast implants has caused widespread concern among women and raised serious questions about the long term health risks and safety of breast implant devices.

  11. 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.

  12. 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

  13. Role of toll-like receptor 4 in the inflammation reaction surrounding silicone prosthesis.

    PubMed

    Auquit-Auckbur, Isabelle; Caillot, Frédérique; Arnoult, Christophe; Menard, Jean-François; Drouot, Laurent; Courville, Philippe; Tron, François; Musette, Philippe

    2011-05-01

    The inflammation which occurs around the silicone prosthesis is a complex process that can provoke the failure of the device and compromise the health of the implanted patient. Toll-like receptors (TLRs), which are transmembrane proteins, are now known to act in the innate immune response and in endogenous inflammation. The aim of our study was to assess the role of TLR4 in the foreign body reaction to a silicone shell prosthesis. Disks of shell silicone prosthesis were implanted in the subcutaneous tissue of C57BL6-TLR4-/- and C57BL6-WT mice. At day 14, inflammatory cell infiltrate and vessel sections around the prosthesis were less numerous in TLR4-/- than in WT mice. A histomorphometric analysis showed that the capsule around the implant was 1.96-fold less thick in depleted TLR4 than in wild-type mice. In addition, vascular endothelial growth factor and transforming growth factor 1 were underexpressed in the surrounding tissue of the prosthesis in TLR4-/- mice. Our study suggests, from this foreign body response model against silicone in mice, that TLR4 plays a key role in the reaction process around silicone implants.

  14. 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.

  15. [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.

  16. Epidemiology of silicone-gel breast implants.

    PubMed

    Brown, S Lori

    2002-05-01

    Silicone breast implants have been marketed in the United States since 1963. Questions remain unanswered on the safety of these medical devices despite their popularity and availability. In 1992, the Food and Drug Administration restricted the availability of silicone-gel breast implants to women requiring them for reconstruction after breast cancer or for other medical indications. Inflatable saline breast implants have remained available for either reconstruction or for cosmetic augmentation while manufacturers completed studies addressing issues of safety and effectiveness. The Food and Drug Administration (FDA) has less concern today regarding a putative association between breast implants and autoimmune disease because of epidemiologic studies that have indicated that there is not a large increase in risk for connective tissue disease in women with breast implants. These studies have not ruled out a small increase in risk of connective tissue disease to these women nor have they addressed the issue of an atypical syndrome related to silicone. The FDA has continuing concerns over local complications that are related to breast implants. The current review provides a brief discussion of the regulatory history of silicone implants and of FDA concerns over breast implants, implant prevalence, studies of systemic and local complications related to breast implants, and a brief description of the FDA study of silicone-gel breast implant rupture.

  17. Shortened penis post penile prosthesis implantation treated with subcutaneous soft silicone penile implant: case report.

    PubMed

    Shirvanian, V; Lemperle, G; Araujo Pinto, C; Elist, J J

    2014-01-01

    Penile prosthesis surgery for erectile dysfunction has the highest satisfaction rates among all treatment options but is often associated with subjective and objective loss of penile length and girth following surgery. To present a novel technique using a subcutaneous soft silicone implant for reversal of penile shortening and narrowing after prosthesis surgery, with additional gains in overall penile length and girth. Nine patients were treated with the insertion of a subcutaneous soft silicone penile implant. All patients had previously reported a loss in penile length (0.5-2 cm), and seven of nine patients also reported a loss in penile girth (0.5-2.6 cm) after penile prosthesis surgery. During a follow-up period of 4-24 months, penile length and girth measurements showed a mean increase in length of 2.4 cm (±0.75 cm) and a mean increase in girth of 3.4 cm (±0.94 cm). The additional insertion of a subcutaneous soft silicone implant in patients with decreased penile length and girth after penile prosthesis surgery is an effective treatment option that provides reversal of lost penile length and girth.

  18. Severe ASIA syndrome associated with lymph node, thoracic, and pulmonary silicone infiltration following breast implant rupture: experience with four cases.

    PubMed

    Nesher, G; Soriano, A; Shlomai, G; Iadgarov, Y; Shulimzon, T R; Borella, E; Dicker, D; Shoenfeld, Y

    2015-04-01

    Silicone has been considered biologically inert; thus it has been employed in many medical devices and nowadays is commonly used in plastic surgery for mammary prosthesis. It is well tolerated in most cases. However, autoimmune disorders and siliconomas with granulomatous reactions after silicone implant rupture have been described. We report cases of four women who developed systemic disorders following rupture of silicone breast implants resulting in lymph node and thoracic silicone infiltration. The symptoms in these cases, including arthralgia, myalgia, generalized weakness, severe fatigue, sleeping disturbances, cognitive impairment, memory loss, irritable bowel syndrome, and weight loss, clearly match the criteria of the recently defined autoimmune/inflammatory syndrome induced by adjuvants (ASIA).

  19. Silicone Gel-Filled Breast Implants: Updated Safety Information

    MedlinePlus

    ... For Consumers Home For Consumers Consumer Updates Silicone Gel-Filled Breast Implants: Updated Safety Information Share Tweet ... When the Food and Drug Administration allowed silicone gel-filled breast implants back on the market in ...

  20. Fitting very short finger stumps with silicone prosthesis: a nonsurgical method.

    PubMed

    Leow, Michael E L; Chong, Alphonsus K S; Peng, Yeong-Pin; Pho, Robert W H

    2013-10-01

    The fitting of short finger stumps with silicone prosthesis is a challenge because of the suboptimal finger-prosthesis contact due to length and distal tapering of digital stumps. The purpose of this report was to describe and evaluate the Micropore(™)-polyvinyl chloride tube technique for fitting short finger stumps. For a total of 10 patients, short finger stumps were fitted using the technique. A short length of polyvinyl chloride tube, trimmed and contoured to fit, was secured on the distal stump tip with Micropore tape. The prosthesis was worn over the polyvinyl chloride tube extension. Three different fitting methods were evaluated: fitting with and without the Micropore-polyvinyl chloride tube technique, and with the use of skin adhesive on the stump. All patients achieved a very secure prosthetic fit with the Micropore-polyvinyl chloride tube technique. No incidences of prosthesis slippage were reported at the longest follow-up of 30 months. The Micropore-polyvinyl chloride tube technique is an effective method for fitting short finger stumps.

  1. Mechanical analysis and fabrication of a penetrating silicon microprobe as an artificial optic nerve visual prosthesis.

    PubMed

    Sui, Xiaohong; Han, Zhaolong; Zhou, Dai; Ren, Qiushi

    2012-01-01

    To investigate the mechanical response of a silicon microprobe while it penetrates the optic nerve. The finite element method was adopted to analyze models of the mechanical aspects of the silicon microprobe, including the effects of dimensions, the buckling load, lateral load, and the interaction between the microprobe and the tissue of the optic nerve. The silicon microprobe was fabricated based on silicon-on-insulator (SOI) wafer by micro-electro-mechanical system (MEMS) processing techniques. The designed microprobe shank was 750 µm long and 110 µm wide with thickness of 15 µm. Lateral barbs were included so as to decrease the stress at stimulating-site regions. The microprobe could withstand a 50 MPa vertical load on the shank tip before buckling, but was more likely to be damaged by a lateral load rather than a vertical one. The silicon microprobe was successfully fabricated by MEMS processing techniques based on a four-inch SOI wafer. Mechanical analysis of the interactions between shank and optic nerve tissue showed that the maximum stress changed during the process of the microprobe insertion. A silicon microprobe was designed as a potential visual prosthesis to be used for optic nerve stimulation. The mechanical issues were analyzed by means of the finite element method, and the implantable microprobe was fabricated based on a silicon-on-insulator wafer to maintain a uniform thickness.

  2. An Silicone Auricular Prosthesis Along with Retentive Aids-A Case Report

    PubMed Central

    Shubha, Joshi; P, Sowjanya; BN, Shalini; G, Jesudass

    2014-01-01

    Facial tissue loss presents with multiple functional and psychological problems. Its rehabilitation can improve the physical, mental and social well being of the patient. In conditions where surgical corrections are not favourable, the prosthetic approach to rehabilitate the missing structures can solve the problems, with added advantages of having complete control over colour and morphological outcome to match the surrounding skin and the counter lateral part. This case report describes the rehabilitation of a patient with the right auricular defect who was treated with a silicon auricular prosthesis and few ornaments were used as the retentive aids. PMID:25302274

  3. Collagen-conjugated tracheal prosthesis tested in dogs without omental wrapping and silicone stenting.

    PubMed

    Liu, Yu; Lu, Tao; Zhang, Yongxing; Qiao, Yulei; Xi, Junjie; Wang, Qun

    2016-11-01

    Artificial tracheas fabricated from collagen-conjugated mesh appear to overcome fatal postoperative complications, namely anastomotic dehiscence and prosthesis dislocation. Such prostheses are incorporated by host tissue, provided they are wrapped in omentum (necessitating an additional abdominal procedure) and a silicone tube is used as a stent (to be extracted several weeks postoperatively). To mitigate related host impact (i.e. injury, pain and distress), we investigated the feasibility of implanting this type of tracheal prosthesis (∼5 cm in length) alone, without omental wrapping and use of a silicone stent. Porous-type tracheal prostheses that were reinforced with a continuous polypropylene spiral and sealed by collagen sponge from porcine skin replaced segments of cervical trachea (∼5 cm long) in 10 dogs through the method of telescopic anastomosis. Omental wrapping and silicone stent placement were omitted. Postoperatively, bronchoscopic examination was performed periodically. When dogs died or were sacrificed, tracheal prostheses were harvested for haematoxylin and eosin staining and electron microscopic scanning of luminal surface conditions. With the exception of one death from an anaesthesia-related incident during fibre-optic bronchoscopy (postsurgical week 1), nine dogs survived uneventfully (until sacrifice), without prosthesis dislocation or anastomotic dehiscence. The longest observation period was 2 years and 8 months. Bronchoscopic examination revealed that no stenosis or local infection was evident in the prostheses of five dogs. Moderate (n = 2) and slight (n = 2) stenoses were observed in the other four animals. All four animals survived for a long time, without dyspnoea or stridor. Histological examination showed that partial inner surface of the artificial trachea was covered with the pseudostratified ciliated epithelium. Regeneration of ciliated epithelium was also confirmed by scanning electron microscopy. This pilot study revealed

  4. Silicone breast implants and immune disease.

    PubMed

    Shons, A R; Schubert, W

    1992-05-01

    Silicone was originally regarded as inert in the human body. Silicone medical devices have been associated with various complications that may involve an immune reaction to silicone or a silicone organic complex. There have been more than 80 cases reported in the medical literature of a varied systemic autoimmune illness in patients who have had various foreign materials placed in the breast. Controversy exists as to which complications have a cause and effect relationship, and which represent coincidental findings. It is difficult to distinguish between nonspecific local reactions and reactions that have an immunological basis. Approximately 1,000,000 to 2,000,000 women in the United States have had silicone breast implants inserted for reconstruction or augmentation mammaplasty; 28 of those patients have been reported to have developed a systemic autoimmune disease. Data on the 28 reported cases do not in any way prove a causal relationship between breast implants and immune disease. Given the natural incidence of autoimmune diseases, we would expect a coincidental occurrence in the United States of more than 1,000 cases of autoimmune disease in women who had undergone breast implant surgery. Additional information must be obtained to resolve the question. The true incidence of autoimmune disease in patients with implants needs to be determined. A prospective registry of implant patients should be established and comprehensive retrospective information obtained on the implant patient population. Further experimental work is necessary on the bioreactivity of silicone. Patients with implants and autoimmune disease, once identified, must be carefully evaluated by physicians who are experienced in the treatment of autoimmune disease.

  5. Breast Implants: Saline vs. Silicone

    MedlinePlus

    ... be inserted at the same time. If an MRI scan detects an implant rupture but you don't ... require additional, specialized views. You might need routine MRI scans. The Food and Drug Administration recommends monitoring silicone ...

  6. Impact of silicone prosthesis on hand function, grip power and grip-force tracking ability after finger amputation.

    PubMed

    Kuret, Zala; Burger, Helena; Vidmar, Gaj; Maver, Tomaz

    2016-12-01

    Literature mostly describes the cosmetic role of prostheses for finger amputation. The impact on hand function has not been systematically explored. Our aim was to describe the impact of silicone finger prostheses on hand function and gripping ability. Prospective descriptive cross-sectional study. We included 42 adult patients with partial or complete single- or multiple-digit amputation of one hand. We evaluated hand function of the injured hand without and with the prosthesis with the Southampton Hand Assessment Procedure, and grip power and tracking ability with a grip-force tracking system. Southampton Hand Assessment Procedure grip index scores were slightly higher when using the prosthesis as compared to not using it (though not reaching the minimum real difference reported in the literature), except for lateral grip. Grip power was not significantly affected by prosthesis use for power grip and lateral grip and slightly diminished for tip grip. Tracking errors only differed with respect to the signal type but not with respect to using the prosthesis. A minimum improvement of hand function can be expected at best with silicone prostheses for finger amputation, accompanied by a slight decrease in tip grip power. Based on our results, an evidence-based explanation can be given to patients after finger amputation regarding the functional benefits that can be expected from a silicone prosthesis. © The International Society for Prosthetics and Orthotics 2015.

  7. 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

  8. Breast reconstruction with submuscular prosthesis after modified radical or simple mastectomy. Surgical technique and early complications.

    PubMed

    Asplund, O

    1983-01-01

    A series of 100 women who underwent breast reconstruction is reviewed. They had previously been treated for breast cancer with modified radical or simple mastectomy. The technique and early results of reconstruction are presented. The same surgeon performed all these operations and the technique was not varied. Emotional need for reconstruction was the main factor in patient selection. The interval between mastectomy and reconstruction was as a rule at least one year after removal of stage I cancer and 2-5 years in stage II cases. Scar correction was required significantly more often after oblique than after horizontal mastectomy incision. A submuscular pocket was created to accommodate the prosthesis and a muscle and fascia flap was used to add tissue and contour. No major early complications occurred. The submuscular implantation of prosthesis facilitated clinical follow-up. In a background population of breast cancer patients, the overall frequency of breast reconstruction was 4%. The figure for premenopausal patients with stage I breast cancer treated with modified radical mastectomy was 18%.

  9. Silicone breast implant rupture: a review

    PubMed Central

    Fowler, Jason D.; Barta, Ruth; Cunningham, Bruce

    2017-01-01

    Silicone breast implants have been in use for nearly 6 decades. In this time they have undergone significant changes in design and use. They have been subject to intense scrutiny with regard to safety and efficacy, including an almost 10 years moratorium on their use. The current generations of implants have been followed via the manufacturer’s Core studies in order to obtain long term data regarding safety and complications. The results of the more recent studies are compiled in this review. Rupture rates are initially very low and begin to increase after 6–8 years of implantation. Implant rupture may be detected by physical exam, ultrasound or magnetic resonance imaging (MRI). The majority of silicone implant ruptures are clinically undetectable. Symptomatic patients may present with capsular contracture, breast lumps or changes in breast shape. The most common cause of implant rupture is instrument damage during placement. Implant rupture may be confined to the peri-prosthetic capsule or may extravasate into the breast tissue. Patients with ruptured implants have been studied closely and the consensus of the literature states there are no health risks associated with implant rupture. Symptomatic patients with ruptured implants should be offered the choice of observation, or explantation and capsulectomy with or without replacement. PMID:28497020

  10. Breast milk metal ion levels in a young and active patient with a metal-on-metal hip prosthesis.

    PubMed

    Nelis, Raymond; de Waal Malefijt, Jan; Gosens, Taco

    2013-01-01

    Metal-on-metal resurfacing arthroplasty of the hip has been used increasingly over the last 10 years in younger active patients. The dissolution of the metal wear particles results in measurable increases in cobalt and chromium ions in the serum and urine of patients with a metal-on-metal bearing. We measured the cobalt, chromium, and molybdenum ion levels in urine; serum; and breast milk in a young and active patient with a metal-on-metal hip prosthesis after a pathologic fracture of the femoral neck. Metal-on-metal hip prosthesis leads to increasing levels of molybdenum in breast milk in the short-term follow-up. There are no increasing levels of chromium and cobalt ions in breast milk. Besides the already known elevated concentrations in serum of chromium and cobalt after implantation of a metal-on-metal hip prosthesis, we found no increasing levels of chromium and cobalt in urine.

  11. [Effects of cleaners on the color stability of prosthesis silicone rubbers].

    PubMed

    Xu, Zhe-wu; Jiang, Jie; Zhang, Xian-xian; Liang, Guo-bin; Li, Yan

    2011-05-01

    To evaluate the effect of different cleaners on the color stability of two silicone rubbers used for maxillofacial prosthesis, and to provide recommendations for clinical use. Thirty skin-color columniform specimens (12 mm diameter, 10 mm height) of two silicone rubber (A:A-2000; Z:ZY-1) were prepared, randomly divided into 6 groups according to the table of random number, and cleaned with the following solutions: isopropyl alcohol (I), three kinds of denture cleaners (P: Polident, S: Steradent, C: Cleansoft) and distilled water (D), simulating the total immersion time of 1 year (1, 15, 10, 3 and 10 min each time respectively). Control group was kept in dark place without treatment. The L(*), a(*), b(*) value were tested before and after immersion. Then color difference value was calculated. Color differences were different among groups. Color difference in group I (A: 2.15, Z: 2.00) were significantly greater than that in any other group. There were no significant differences between groups using denture cleaner P (A: 0.36, Z: 0.36), C (A: 0.42, Z: 0.37) and S (A: 0.33, Z: 0.38), and group D (A: 0.22, Z: 0.23). Isopropyl alcohol causes the most severe fading, and denture cleaners and distilled water cause obscure fading.

  12. Surface topography study of prepared 3D printed moulds via 3D printer for silicone elastomer based nasal prosthesis

    NASA Astrophysics Data System (ADS)

    Abdullah, Abdul Manaf; Din, Tengku Noor Daimah Tengku; Mohamad, Dasmawati; Rahim, Tuan Noraihan Azila Tuan; Akil, Hazizan Md; Rajion, Zainul Ahmad

    2016-12-01

    Conventional prosthesis fabrication is highly depends on the hand creativity of laboratory technologist. The development in 3D printing technology offers a great help in fabricating affordable and fast yet esthetically acceptable prostheses. This study was conducted to discover the potential of 3D printed moulds for indirect silicone elastomer based nasal prosthesis fabrication. Moulds were designed using computer aided design (CAD) software (Solidworks, USA) and converted into the standard tessellation language (STL) file. Three moulds with layer thickness of 0.1, 0.2 and 0.3mm were printed utilizing polymer filament based 3D printer (Makerbot Replicator 2X, Makerbot, USA). Another one mould was printed utilizing liquid resin based 3D printer (Objet 30 Scholar, Stratasys, USA) as control. The printed moulds were then used to fabricate maxillofacial silicone specimens (n=10)/mould. Surface profilometer (Surfcom Flex, Accretech, Japan), digital microscope (KH77000, Hirox, USA) and scanning electron microscope (Quanta FEG 450, Fei, USA) were used to measure the surface roughness as well as the topological properties of fabricated silicone. Statistical analysis of One-Way ANOVA was employed to compare the surface roughness of the fabricated silicone elastomer. Result obtained demonstrated significant differences in surface roughness of the fabricated silicone (p<0.01). Further post hoc analysis also revealed significant differences in silicone fabricated using different 3D printed moulds (p<0.01). A 3D printed mould was successfully prepared and characterized. With surface topography that could be enhanced, inexpensive and rapid mould fabrication techniques, polymer filament based 3D printer is potential for indirect silicone elastomer based nasal prosthesis fabrication.

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

    PubMed

    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.

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

    SciTech Connect

    Maghribi, Mariam Nader

    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

  15. 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

  16. Breast carcinoma originating from a silicone granuloma: a case report.

    PubMed

    Nakahori, Ryoichi; Takahashi, Ryuji; Akashi, Momoko; Tsutsui, Kana; Harada, Shino; Matsubayashi, Roka Namoto; Nakagawa, Shino; Momosaki, Seiya; Akagi, Yoshito

    2015-02-22

    Breast carcinoma rarely occurs in cases of foreign body granulomas following liquid silicone injection. Although the Food and Drug Administration (FDA) banned the use of all silicone injection products in 1992, liquid silicone injection for breast augmentation continues to be performed illegally. We herein report a case of breast carcinoma following liquid silicone injection in a 67-year-old female.A total of 45 years after liquid silicone injection, the patient had felt a breast mass in the right breast. Mammography showed a smooth mass that retracted the right nipple. Due to the presence of a marked acoustic shadow caused by the granulomas, evaluating the mass on ultrasonography was difficult. However, magnetic resonance imaging (MRI) showed a lobulated mass under the right nipple. The mass exhibited low signal intensity (SI) on T1-weighted images and intermingled high and low SI on T2-weighted images. Heterogeneous early enhancement with central low intensity was noted on dynamic contrast-enhanced MRI. Several oval-shaped low SI structures in the adipose tissue and disruption of the pectoralis major muscle were also observed. We diagnosed the patient with invasive ductal carcinoma based on a stereotactic-guided Mammotome® (a vacuum-assisted biopsy system manufactured by DEVICOR MEDICAL JAPAN, Tokyo, Japan) biopsy and subsequently performed mastectomy and axillary lymph node dissection (with a positive result for the sentinel node biopsy). Histologically, invasive ductal carcinoma was observed in the silicone granuloma.The development of foreign body granulomas following breast augmentation usually makes it difficult to detect breast cancer; thus, various devices are required to confirm the histological diagnosis of breast lesions. The stereotactic-guided Mammotome® biopsy system may be an effective device for diagnosing breast cancer developing in the augmented breast.

  17. [Breast repaired by silicone implant. Case report of necrobiosis lipoidica].

    PubMed

    Azoulay, B; Bosque, T; Burin des Roziers, B; Daoud, G; Cartier, S

    2012-02-01

    The authors report a very rare case of necrobiosis lipoidica, histopathologically confirmed, which happened in the breast a few months following the insertion of a silicone implant (post-mastectomy reconstruction). This case raises two problems: the physiopathology (role of the silicone implant) and the treatment of this accident, resistant to current therapy.

  18. [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.

  19. Digital Images of Breast Biopsies using a Silicon Strip Detector

    SciTech Connect

    Montano, Luis M.; Diaz, Claudia C.; Leyva, Antonio; Cabal, Fatima

    2006-09-08

    In our study we have used a silicon strip detector to obtain digital images of some breast tissues with micro calcifications. Some of those images will be shown and we will discuss the perspectives of using this technique as an improvement of breast cancer diagnostics.

  20. 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

  1. Novel technique for laparoscopic harvesting of latissimus dorsi flap with prosthesis implantation for breast reconstruction

    PubMed Central

    Xu, Shuman; Tang, Peng; Chen, Xianchun; Yang, Xi; Pan, Qinwen; Gui, Yu; Chen, Li

    2016-01-01

    Abstract Backgroud: An important drawback of the traditional technique for harvesting latissimus dorsi (LD) myocutaneous flap is a long, posterior donor-site incision. Current techniques involve endoscopic or robotic harvesting via a combined approach of open and closed surgery, which necessitates an open axillary incision and the use of special retractors. In this paper, we introduce a fully enclosed laparoscopic technique for harvesting LD flap (LDF) using only 3 small trocar ports. This technique eliminates the need for axillary and donor-site incisions and specialized retractors and considerably reduces the incision size. Methods: We performed laparoscopic harvesting of LDF with prosthesis implantation for immediate breast reconstruction (IBR) after nipple-sparing mastectomy in 2 patients with malignant breast neoplasm who wished to avoid a long scar on the back. Results: IBR using this technique was uneventful in both cases, without any donor-site complications or flap failure. Both patients were satisfied with the esthetic results of the procedure, especially the absence of a visible scar on the back. Conclusion: Enclosed laparoscopic harvesting of LDF is simpler and less invasive than the traditional methods. These preliminary results warrant further evaluation in a larger population to validate the benefits of this technique. PMID:27861385

  2. 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

  3. Unusual skin reaction to silicone content in breast implants.

    PubMed

    Marcusson, J A; Bjarnason, B

    1999-03-01

    We present a patient who had a long history of unsuccessful bilateral mammary operations with insertion and extraction of various implants, some of which were filled with silicone gel, others with saline. In addition to complications in the tissue surrounding the prosthesis, she had distant widespread skin lesions which, we believe, were due to leakage from the implant. A cutaneous test with material from various implants, such as the gel content and the shells, caused an unusually prolonged inflammatory response, which was difficult to classify as being either irritative or allergic. Macromorphologically and histologically, the provoked lesions resembled the previous cutaneous lesions. We believe that the patient's complications are due to an unusual host response to silicone.

  4. 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.

  5. 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.

  6. Modification of existed prosthesis into a flexible wall hollow bulb obturator by permanent silicone soft liner for a hemimaxillectomy patient with restricted mouth opening.

    PubMed

    Singh, Kunwarjeet; Kumar, Narendra; Gupta, Nidhi; Sikka, Rohan

    2015-07-01

    A patient of hemimaxillectomy with restricted mouth opening, wearing a hard acrylic bulb obturator encountered difficulty in insertion and removal of the prosthesis. The prosthesis was converted into a open hollow bulb obturator with flexible walls with permanent silicone soft liner for easy insertion and removal. Patients having acquired maxillary defects due to surgical resection of the maxilla often suffer with difficulty in mastication, swallowing, nasal regurgitation, speech disturbances and poor esthetics. Different types of obturator with various bulb designs most commonly fabricated from acrylic resins together with "acrylic resin plate and/or" metal framework are used to improve the quality of life of these patients by restoring the function. But restricted mouth opening in some of these patients makes it difficult to place and remove the prosthesis with hard acrylic bulb. Fabrication of flexible open hollow bulb and relining of remaining obturator with resilient permanent silicone soft liner makes easy insertion and removal of the prosthesis and also improve the retention by intimate contact of soft liner with the tissues. Permanent silicone soft liner open hollow bulb obturator is a novel way for the functional rehabilitation of a hemimaxillectomy patient suffering with restricted mouth opening. Copyright © 2015 Japan Prosthodontic Society. Published by Elsevier Ltd. All rights reserved.

  7. 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.

  8. Type IV hypersensitivity to a textured silicone breast implant.

    PubMed

    Dargan, D; McGoldrick, C; Khan, K

    2012-07-01

    We present a case of hypersensitivity to a breast implant in a 57-year old female with breast cancer and hypersensitivity to adhesive dressings. A mastectomy, axillary node clearance, latissimus dorsi flap and silicone implant-based reconstruction were performed. The mammary wound dehisced within three weeks and the implant required removal. No pus was present, and cultures were negative. Three years later, a further silicone implant was inserted. Within three weeks from insertion, the patient required readmission with serous discharge from the wound, flu-like symptoms, low-grade pyrexia and painful swelling at the operative site. The implant was removed. Capsule biopsies demonstrated a large lymphoid cell reaction, in keeping with a delayed hypersensitivity reaction. Patch testing to samples of the implant was positive. Copyright © 2011 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

  9. Risk of infection is associated more with drain duration than daily drainage volume in prosthesis-based breast reconstruction

    PubMed Central

    Chen, Cheng-Feng; Lin, Shou-Fong; Hung, Chen-Fang; Chou, Pesus

    2016-01-01

    Abstract In prosthesis-based breast reconstruction, drains are used to prevent seroma formation and to reduce the risk of infection. However, prolonged drainage increases the risk of ascending infection. Although the volume often accepted for drain removal is ≤30 mL per day, the optimal timing to remove the drain for best clinical outcome remains controversial. We did a retrospective cohort study of 569 patients of prosthesis-based breast reconstruction with infection rate as the outcome variable; drain duration and last daily drainage volume as the main independent variables. Data on age, smoking history, diabetes mellitus history, body mass index, breast weight, tissue expander size, drain size, number of retrieved lymph nodes, tumor size, number of metastatic lymph nodes, tumor stage, mastectomy type, reconstruction type, submuscular implantation, skin defect, operative time, duration of antibiotics use, chemotherapy, and radiotherapy were collected as covariates. Multivariable logistic regression analysis was used to control for confounding. The total infection rate was 5.1% (29/569). The daily drainage volume ≥30 mL/d at the time of drain removal was not found associated with increased infection rate (P = 0.32). Of the various cutoff values of last daily drainage volume, none was found to be a determinant for drain removal where the risk of infection was concerned. By contrast, drain duration over 21 days significantly increased infection rate (P = 0.001). The multivariable logistic regression analysis showed an increase of 76.2% in the infection rate with each additional week of drain retention (P = 0.001). Breast weight also had a significant influence on risk of infection. Chemotherapy and drain size showed borderline effect on risk of infection whereas the last daily drainage volume was not associated with risk of infection In summary, our study revealed that drain duration, rather than the last daily drainage volume, significantly affects the

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

    PubMed

    Or, Friedman; Arik, Zaretski

    2016-08-01

    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.

  11. Experiences in the provision, fitting and supply of external breast prostheses: findings from a national survey.

    PubMed

    Gallagher, P; Buckmaster, A; O'Carroll, S; Kiernan, G; Geraghty, J

    2009-11-01

    A good-quality external breast prosthesis and prosthesis-fitting service is integral to recovery post-mastectomy. However, this area of care has minimal information or research available. The aim of this study was to investigate women's experience of the provision, fitting, supply and use of breast prostheses in Ireland. Three national surveys were undertaken with women (n = 527), breast care nurses (BCNs) (n = 32) and retail prosthesis fitters (n = 12). The findings identified the importance of the prosthesis for shape, appearance to self, appearance to others, sense of well-being, self-confidence and femininity. Dissatisfaction with weight, comfort and movement of the prosthesis was identified. Cost and travel distance were found to influence the replacement of the prosthesis. Dissatisfaction emerged with the display and choice of products, and brochure availability at the prosthesis fitting. Women preferred to be fitted for the first silicone prosthesis by a BCN in a hospital setting whereas for the replacement prosthesis they preferred a trained fitter at a specialized prosthesis supplier. BCNs and retail fitters identified the need for service guidelines and increased availability of professional development opportunities in prosthesis-fitting. These findings contributed to the development of standards of care for breast prosthesis-fitting services to benefit women and to provide guidelines for those providing the service.

  12. Whom should we SPY? A cost analysis of laser-assisted indocyanine green angiography in prevention of mastectomy skin flap necrosis during prosthesis-based breast reconstruction.

    PubMed

    Kanuri, Arjun; Liu, Allen S; Guo, Lifei

    2014-04-01

    Skin flap necrosis is the most common complication following prosthesis-based breast reconstruction. Many studies have reported on the efficacy of laser-assisted indocyanine green angiography (SPY Elite System) in detecting flap necrosis. A cost-effectiveness analysis of laser-assisted indocyanine green angiography is lacking. The authors performed a retrospective review of all consecutive immediate postmastectomy prosthesis-based reconstructions at the Brigham and Women's Hospital over a 7-year 10-month period. The rate of mastectomy skin flap necrosis and related implant loss was determined for the entire cohort and for the subgroups of patients at increased risk for developing this complication: smokers, obese patients, and patients with large breasts. Cost of treating implant loss and skin flap necrosis was calculated based on the average treatment courses and costs at the authors' institution. The cost of the SPY was obtained from LifeCell Corp. From January of 2004 through October of 2011, 79 of 710 prosthesis-based breast reconstructions (11.1 percent) developed mastectomy skin flap necrosis requiring excision and reclosure. Performing laser-assisted indocyanine green angiography on the entire cohort would result in an additional cost of $1537.30 per case of flap necrosis prevented. If laser-assisted indocyanine green angiography was performed on only these high-risk subgroups, the cost savings per case of flap necrosis prevented is $2098.80 for smokers, $5162.30 for patients with a body mass index greater than 30, and $1892.70 for patients with mastectomy weight greater than 800 g. Laser-assisted indocyanine green angiography is not cost-effective as a preventative measure for flap necrosis if used indiscriminately on all patients undergoing prosthesis-based breast reconstructions, but it is cost-effective for high-risk patients, such as smokers, obese patients, and patients with large breasts.

  13. Biocompatible heterogeneous porous gel matrix NeuroGel(TM) promotes regeneration of rat sciatic nerve within tubular silicone prosthesis (experimental study).

    PubMed

    Gatskiy, Alexander A; Tretyak, Ihor B; Tsymbaliuk, Vitaliy

    2014-08-01

    The purpose of this study was to investigate the ability of NeuroGel™ to promote and enhance the regeneration of rat sciatic nerve within a 10-mm gap using silicone tubular prosthesis, and to evaluate and compare the regeneration outcomes versus autologous grafting. The 10-mm gap of rat sciatic nerve was bridged through silicone tubular prosthesis filled with dehydrated NeuroGel™, and NeuroGel™ saturated with rat NGF-B (NG30-NGG60, NGgfB30-NGgfB60). To assess the regeneration of the peripheral nerve we utilized three general and most commonly applied methods: electrophysiologic, hystomorphometric, and functional methods. The average M-wave amplitude (AMW index), or the intermediary index of the number of regenerated axons, in animal groups NGG60 and NGgfB60 60 days post-op was: 2.44 ± 0.57 mV and 1.87 ± 0.48 mV. These indices were statistically lower compared to the indices obtained after autologous grafting. The average impulse conduction velocity along motor fibers (VMF index), or the intermediary index of myelination rate, was: 13.3 mm/ms and 13.3 mm/ms, respectively, statistically equal to indices obtained after autologous grafting. The average density (D) of regenerated fibers (direct numerical indicator in contrast to intermediary AMW index) in animal groups NGG60 and NGgfB60 was: 4,920 ± 178.88 and 5,340 ± 150.33 per mm(2), respectively. These indices were statistically higher versus indices obtained after autologous grafting. Myelination rates of regenerated fibers in animal groups NGG60 and NGgfB60 were 73 and 86 %, respectively. They were also statistically higher. The average sciatic functional index (SFI) in NGG60 and NGgfB60 was: -25.57 ± 3.05 and -24.124 ± 4.8, respectively, which is statistically equal to indices obtained after autologous grafting. Neurogel™ strongly promotes the regeneration of rat sciatic nerve within silicone tubular prosthesis. After bridging a 10-mm gap through silicone prosthesis with

  14. Osteomyelitis of sternum and rib after breast prosthesis implantation: A rare or underestimated infection?

    PubMed Central

    Seng, Piseth; Alliez, Antoine; Honnorat, Estelle; Menard, Amelie; Casanova, Dominique; Stein, Andreas

    2014-01-01

    Sternum and rib osteomyelitis complicated from breast implant infection is rare. We report a case of early sternum and rib osteomyelitis occurred during breast implant infection managed in an inter-regional referral center for bone/joint infections in the south of France. PMID:26793446

  15. 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

  16. Rupture of silicone-gel breast implants: causes, sequelae, and diagnosis.

    PubMed

    Brown, S L; Silverman, B G; Berg, W A

    1997-11-22

    Silicone-gel-filled breast implants have been widely used for breast augmentation and reconstruction after mastectomy. The rate of implant rupture and its sequelae are not known. We review the frequency, causes, sequelae, and detection of implant rupture. Materials testing of removed implants provides evidence that as implants age in vivo, they weaken and may rupture. Sequelae of rupture include migration of gel accompanied by inflammation and silicone granuloma formation. The role of free silicone gel in relation to idiopathic or atypical connective tissue disease is not clear. Magnetic resonance imaging is substantially more sensitive in the detection of rupture than is mammography or ultrasonography.

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

    PubMed

    Borghol, K; Gallagher, G; Skelly, B L

    2016-09-01

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

  18. Aesthetic breast augmentation: the double implant.

    PubMed

    Bosch, G; Jacobo, O

    2001-01-01

    The objectives of the augmentation prostheses are to increase the volume, enhance the shape, and improve the projection of the breast. Since 1962, plastic surgeons have used the silicone gel-filled breast implant created by Cronin and Gerow. The contents of the standard implant have been modified: silicone gel-filled, PVP, dextran, oil, saline hydrogel, etc. The shell of the prostheses had been made with a smooth surface, textured silicone, and polyurethane-covered silicone. The shape has been modified: In 1993, A. Miller patented the stacked breast implant used in breast reconstruction. This contribution tends to improve the projection of the breast. In 1994, the authors described a new surgical procedure for locating the standard implants named the double pocket technique. Simultaneously, the authors modified the shape of the prosthesis creating the double implant prostheses.

  19. Silicone implant and primary breast ALK1-negative anaplastic large cell lymphoma, fact or fiction?

    PubMed Central

    Li, Shiyong; Lee, Andrew K

    2010-01-01

    The safety of silicone-based implant for mammoplasty has been debated for decades. A series of anecdotal case reports and a recent epidemiological case-control study have suggested a possible association between silicone implant and the development of primary breast ALK1-negative anaplastic large cell lymphoma (ALCL), a rare type of peripheral T-cell lymphoma. In this report, we describe an additional case of primary breast ALK1-negative ALCL in the fibrous capsule and cystic fluid of silicone breast implant in a 58 year old woman who underwent breast reconstructive surgery after lumpectomy for her infiltrating breast adenocarcinoma. Morphologically and immunohistochemically, the lymphoma cells may be confused with recurrent infiltrating breast adenocarcinoma or other non-hematolymphoid malignancies. Molecular studies were needed to determine T-lineage differentiation of the malignant lymphoma cells. We will also review the case reports and case series published in the English literature and discuss our current understanding of silicone implant in primary breast ALK1-negative ALCL. PMID:19918336

  20. Novel modification of voice prosthesis.

    PubMed

    Al Kadah, Basel; Papaspyrou, George; Schneider, Mathias; Schick, Bernhard

    2016-03-01

    The undesired dilatation of the tracheooesophageal shunt after surgical implantation of voice prosthesis is a typical complication of this procedure. Temporary removal of the prosthesis and reinsertion after a short period of time is a first-line therapeutical option aiming shrinkage of the shunt. Failure of this measure generally is an indication of revision surgery. We present first experiences treating leakage problems with novel modified voice prosthesis without surgical intervention in specified cases. 11 patients (1 female, 10 male) aging between 51 and 71 years were presented with shunt leakage between 11/2008 and 11/2012 in the ENT-Department of the University Hospital of Homburg/Saar after a custom built voice prosthesis had been used initially successfully. A "Provox 2"(®) voice prosthesis was modified with two discs made of silicone each on the tracheal and oesophageal side and additionally reinforcing the diameter of the prosthesis by a silicone tube. The modified prosthesis was inserted in a retrograde way under general anesthesia, analogical to the approach used with the "Provox 1"(®)-prosthesis. The period of observation ranged between 12 and 48 months. As a measure of control swallowing of methylene blue was used. In all cases leakage suspended. Durability of the modified prosthesis ranged between 2 and 6 months. Neither the patients' complained about, nor did the physicians notice subjectively an impairment of the voice quality. Modifications of "Provox 2"(®)-prosthesis should be regarded in individual cases and constitute a reasonable alternative to revision surgery. A surgical approach is more intricate and costly, more taxing for the patient and susceptible to failure. We regard the necessity of general anesthesia for the insertion of the modified prosthesis as a disadvantage.

  1. Risk of infection is associated more with drain duration than daily drainage volume in prosthesis-based breast reconstruction: A cohort study.

    PubMed

    Chen, Cheng-Feng; Lin, Shou-Fong; Hung, Chen-Fang; Chou, Pesus

    2016-12-01

    In prosthesis-based breast reconstruction, drains are used to prevent seroma formation and to reduce the risk of infection. However, prolonged drainage increases the risk of ascending infection. Although the volume often accepted for drain removal is ≤30 mL per day, the optimal timing to remove the drain for best clinical outcome remains controversial.We did a retrospective cohort study of 569 patients of prosthesis-based breast reconstruction with infection rate as the outcome variable; drain duration and last daily drainage volume as the main independent variables. Data on age, smoking history, diabetes mellitus history, body mass index, breast weight, tissue expander size, drain size, number of retrieved lymph nodes, tumor size, number of metastatic lymph nodes, tumor stage, mastectomy type, reconstruction type, submuscular implantation, skin defect, operative time, duration of antibiotics use, chemotherapy, and radiotherapy were collected as covariates. Multivariable logistic regression analysis was used to control for confounding.The total infection rate was 5.1% (29/569). The daily drainage volume ≥30 mL/d at the time of drain removal was not found associated with increased infection rate (P = 0.32). Of the various cutoff values of last daily drainage volume, none was found to be a determinant for drain removal where the risk of infection was concerned. By contrast, drain duration over 21 days significantly increased infection rate (P = 0.001). The multivariable logistic regression analysis showed an increase of 76.2% in the infection rate with each additional week of drain retention (P = 0.001). Breast weight also had a significant influence on risk of infection. Chemotherapy and drain size showed borderline effect on risk of infection whereas the last daily drainage volume was not associated with risk of infectionIn summary, our study revealed that drain duration, rather than the last daily drainage volume, significantly affects the infection rate in

  2. Immediate breast reconstruction with subpectoral implantation after transaxillary subcutaneous mastectomy for siliconoma.

    PubMed

    Megumi, Y

    1989-01-01

    Immediate breast reconstruction on 14 patients suffering from breast hardening after augmentation mammaplasty by injection of silicone gel was performed. Transaxillary subcutaneous mastectomy was done followed by insertion of a double-lumen prosthesis into the subpectoralis plane. The result was greatly influenced by the amount of injected silicone gel. The patient was carefully observed after surgery, and the prosthesis was immediately removed when abnormal skin changes became apparent. Seven cases had no hardening on either side and 1 case had hardening on one side, 3 cases had hardening on both sides and 1 case on one side, 2 cases had the prosthesis removed from both sides and 2 cases from one side. All other cases with hardening or prosthesis removal, except one with removal from both sides, were subsequently reconstructed after more than three months.

  3. Contralateral intramammary silicone lymphadenitis in a patient with an intact standard dual-lumen breast implant in the opposite reconstructed breast.

    PubMed

    Collado-Mesa, Fernando; Yepes, Monica; Doshi, Purvi; Umar, Saleem A; Net, Jose

    2013-11-01

    Silicone lymphadenopathy is a recognized complication of silicone gel implant rupture; the ipsilateral axillary lymph nodes are most commonly involved. We report imaging findings on a range of different imaging modalities and biopsy results in a case of biopsy-proven silicone lymphadenitis involving contralateral intramammary and axillary lymph nodes in a patient with an intact standard dual-lumen breast implant in the opposite reconstructed breast. This case demonstrates that in a patient with disrupted lymph drainage due to prior mastectomy and axillary node dissection for breast cancer treatment, silicone particles can migrate in a retrograde fashion via the ipsilateral internal mammary lymph nodes and reach not only the contralateral axilla but also the outer quadrants of the contralateral breast, even in the presence of an intact breast implant.

  4. [Shift the skin paddle in an additional incision improves the result: Study of a series of 82 breast reconstructions by latissimus dorsi flap and prosthesis implantation at 10 years].

    PubMed

    Chiriac, S; Dissaux, C; Bruant-Rodier, C; Djerada, Z; Bodin, F; François, C

    2016-11-17

    The position of the skin paddle on the breast area is a fundamental element for the breast reconstructions by latissimus dorsi flap and prosthesis implantation. Should, as Millard advocated, to recreate the initial defect and include it in the mastectomy scar or is it better in an additional incision as have others authors. This study compares the long-term morphological results of these two attitudes, with or without additional incision.

  5. A Simple and Practical Method for Setting Up a Criterion of Projection of Silicone Breast Implant After Simple Mastectomy

    PubMed Central

    Ando, Jiro; Harao, Michiko; Takemae, Masaru; Kishi, Kazuo

    2017-01-01

    Objective: In breast reconstruction, decision of projection of silicone breast implant in tissue expander replacement is difficult because of the need to consider several parameters that cannot be expressed in accurate numerical form. The present study aimed at a quantitative analysis based on decreased projection of the reconstructed side compared with silicone breast implant projection and to develop a new method for simple and practical decision of silicone breast implant projection. Methods: Thirty-five patients who had mammary carcinoma and were treated with simple mastectomy, tissue expander insertion, and replacement with anatomical silicone breast implant from April 2013 to March 2016 were retrospectively identified. We recorded the projection of used silicone breast implant (Pi). The projections of reconstructed breast 6 months after silicone breast implant insertion (Pr) and that of the unaffected breast during silicone breast implant selection (Pu) were measured. The difference between Pi and Pr was defined as the revised numerical value (Rev). We investigated whether Rev significantly differed according to age, body mass index, or Pu and analyzed correlations between Rev and age, Pu, and body mass index. Results: Mean Rev in all patients was 1.2 ± 0.3 cm. Rev was significantly higher in patients with higher body mass index than in those with lower body mass index (P < .01) and in patients with higher Pu than in those with lower Pu (P < .01). Significant positive correlations of Rev with body mass index and Pu were found (β = .63, P < .01 and β = .67, P < .01, respectively). Conclusions: Rev was a simple, practical, and cost-effective concept. We believe that it is a useful indicator for deciding silicone breast implant projection. PMID:28890745

  6. A Simple and Practical Method for Setting Up a Criterion of Projection of Silicone Breast Implant After Simple Mastectomy.

    PubMed

    Ishii, Naohiro; Ando, Jiro; Harao, Michiko; Takemae, Masaru; Kishi, Kazuo

    2017-01-01

    Objective: In breast reconstruction, decision of projection of silicone breast implant in tissue expander replacement is difficult because of the need to consider several parameters that cannot be expressed in accurate numerical form. The present study aimed at a quantitative analysis based on decreased projection of the reconstructed side compared with silicone breast implant projection and to develop a new method for simple and practical decision of silicone breast implant projection. Methods: Thirty-five patients who had mammary carcinoma and were treated with simple mastectomy, tissue expander insertion, and replacement with anatomical silicone breast implant from April 2013 to March 2016 were retrospectively identified. We recorded the projection of used silicone breast implant (Pi). The projections of reconstructed breast 6 months after silicone breast implant insertion (Pr) and that of the unaffected breast during silicone breast implant selection (Pu) were measured. The difference between Pi and Pr was defined as the revised numerical value (Rev). We investigated whether Rev significantly differed according to age, body mass index, or Pu and analyzed correlations between Rev and age, Pu, and body mass index. Results: Mean Rev in all patients was 1.2 ± 0.3 cm. Rev was significantly higher in patients with higher body mass index than in those with lower body mass index (P < .01) and in patients with higher Pu than in those with lower Pu (P < .01). Significant positive correlations of Rev with body mass index and Pu were found (β = .63, P < .01 and β = .67, P < .01, respectively). Conclusions: Rev was a simple, practical, and cost-effective concept. We believe that it is a useful indicator for deciding silicone breast implant projection.

  7. The effect of immediate breast reconstruction with Becker-25 prosthesis on the preservation of proper body posture in patients after mastectomy.

    PubMed

    Ciesla, S; Polom, K

    2010-07-01

    This was a prospective study comparing coronal, sagittal and transverse plane body posture parameters in women after radical mastectomy and women after radical mastectomy with immediate breast reconstruction (IBR) for stage I and II breast cancer. The three studied groups were one that underwent Madden's radical mastectomy (n = 38), a second with skin sparing mastectomy with IBR with expander-prosthesis Becker-25 (n = 38), and the control (n = 38). All the women were examined to determine their body posture in the coronal, sagittal and transverse planes using three-dimensional (3D) body surface analysis before and 6, 12, 18 and 24 months after surgery. There is a significant difference body posture in the coronal, sagittal and transverse planes between groups of patients after mastectomy with IBR comparing with patients after mastectomy alone. The women after radical mastectomy demonstrated the greatest postural changes in particular parameters of body posture in postsurgical months 18 and 24. The IBR group only demonstrated significant postural changes in one parameter, though as time after surgery increased, these changes decreased. IBR after mastectomy has an impact on proper body posture. Photogrammetric examination revealed important body posture disturbances only in the radical mastectomy group. It gives useful information on body posture parameters in the evaluation of quality of life in breast cancer survivors. It appears that immediate breast reconstruction helps to preserve proper body posture after mastectomy.

  8. Breast Reconstruction with Implants

    MedlinePlus

    ... removes your breast to treat or prevent breast cancer. One type of breast reconstruction uses breast implants — silicone devices filled with silicone gel or salt water (saline) — to reshape your breasts. Breast reconstruction ...

  9. 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 a...

  10. 21 CFR 888.3025 - Passive tendon prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 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 a...

  11. 21 CFR 888.3025 - Passive tendon prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 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 a...

  12. 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 silicone...

  13. 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 silicone...

  14. 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 silicone...

  15. Association between Enlarged Axillary Lymph Nodes and Silicone Breast Implant Ruptures seen on Magnetic Resonance Imaging.

    PubMed

    Klang, Eyal; Amitai, Michal M; Raskin, Stephen; Rozendorn, Noa; Keddel, Nicholas; Pickovsky, Jana; Sklair-Levy, Miri

    2016-12-01

    Silicone breast augmentation is a common cosmetic surgery. Previous case reports demonstrated lymphadenopathy in the presence of implant ruptures. To investigate the association between enlarged axillary lymph nodes and silicone implant ruptures as seen on breast magnetic resonance imaging (MRI). Two groups were derived retrospectively from breast MRI reports in our institution for the period December 2011-May 2014. A search of our hospital records for "silicone" and "lymph node" was performed (group A), and the relationship between the presence of enlarged nodes and ruptures was evaluated. The prevalence of ruptures in the presence of nodes was calculated and the association between MRI imaging features and ruptures evaluated. A search for "silicone" and "implant rupture" was performed (group B) and, as for group A, the relationship between the presence of ruptures and nodes was evaluated and the prevalence of enlarged nodes in the presence of ruptures calculated. Group A comprised 45 women with enlarged nodes. Intracapsular ruptures were associated with nodes (P = 0.005), while extracapsular ruptures showed a trend of association with nodes (P = 0.08). The prevalence of ruptures in the presence of nodes was 31.4%. Nodes associated with ruptures showed a strong silicone signal (P = 0.008) and absent enhancement (P = 0.005). Group B comprised 73 women with ruptures. Enlarged nodes were associated with both intra- and extracapsular ruptures (P < 0.001 and P = 0.002 respectively). The prevalence of nodes in the presence of ruptures was 22.2%. Enlarged axillary nodes were associated with ruptures in two groups of patients. This finding can guide clinical decisions when either enlarged nodes or ruptures are encountered in patients with silicone implants. The association between silicone lymphadenopathy and implant rupture raises concerns regarding the role of rupture in silicone-induced systemic disease.

  16. Regulatory science of new technology: tendency of medical professionals' interests on silicone breast implants.

    PubMed

    Nakazaki, Tomomichi; Ikeda, Koji; Iwasaki, Kiyotaka; Umezu, Mitsuo

    2016-09-01

    New technology related to artificial organs is most attractive for worldwide researchers. We believe they must contribute for the future patients against untreatable diseases. Regulatory science is a new science to establish 'social acceptance' of new technology into the clinical market as soon as possible. In the history of silicone breast implants, we could recognize risks many times; however, we missed such chances to prevent a subsequent crisis. We analyzed the trend of published literature related to silicone breast implants to review the medical professionals' interests on such risks. This trend showed, despite issues of a social acceptance of silicone breast implants in a few countries, other countries' medical professionals had no interest. Our hypothesis is 'medical professionals face the government and do not have contributed to re-establish the social acceptance of new technologies for patients'. Any technology does not have the complete evidence of safety, efficacy and quality, despite regulatory authorities' review and approval with clinical evidences. medical professionals need to conduct subsequently the epidemiological study, to take a meta-analysis periodically and to create/update the guidance for their patients under their professional ethics after the marketing of new technologies. We need to take seriously the 'lesson learned' from the history of silicone breast implants for all kind of new technologies existed in the present.

  17. A profile of symptomatic patients with silicone breast implants: a Sjögrens-like syndrome.

    PubMed

    Freundlich, B; Altman, C; Snadorfi, N; Greenberg, M; Tomaszewski, J

    1994-08-01

    Exposure of breast tissue to silicone has been associated with autoimmune diseases in the medical literature since the 1960's. Japanese women injected with raw silicone had features of a collagen vascular disease but did not meet criteria for a specific diagnosis. Subsequently, we have seen women with silicone breast implants that have similar problems. We performed a prospective noncontrolled study on women with silicone breast implants. Results from the first 50 consecutive women revealed the most prominent complaints in this group were fatigue (89%), generalized stiffness (75%), poor sleep (71%), and arthralgias (78%). Other problems included Raynaud's phenomenon, alopecia, adenopathy, night sweats, and frequent sore throats. Unexpectedly, half of these women complained of dry eyes and dry mouths. Positive antinuclear antibodies and or rheumatoid factors were discovered in 38% of patients although the anti-SSA antibody was found in only one patient and anti-SSB in none. Labial salivary gland biopsies in 5 cases showed mononuclear cell infiltrates compatible with Sjögren's syndrome in 4. The infiltrating cells were predominantly CD68 positive monocyte/macrophages, which is different from what is found in Sjögren's syndrome. These findings may indicate the presence of a unique syndrome associated with silicone implants that is characterized by musculoskeletal pain and autoimmune features.

  18. 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 polyester reinforced medical grade silicone elastomer intended for use in the surgical reconstruction of...

  19. 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 polyester reinforced medical grade silicone elastomer intended for use in the surgical reconstruction of...

  20. 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.

  1. Immune functional impairment in patients with clinical abnormalities and silicone breast implants.

    PubMed

    Vojdani, A; Campbell, A; Brautbar, N

    1992-01-01

    Silicone, previously thought to be a biologically inert and harmless material, has now been reported to elicit antibody response and to be responsible for adjuvant disease in humans. The present study was designed to evaluate the immune function of forty individuals who had undergone silicone breast augmentation for a period of longer than ten years and who were compared with 40 sex and age-matched controls. The following immunological functions were studied: lymphocyte subset analysis, lymphocyte mitogenic response, NK cytotoxic activity and markers for autoimmunity such as ANA, rheumatoid factor immune complexes such as smooth muscle, myelin, and thyroid, and tissue antibodies. Results of lymphocyte subpopulation analysis showed significantly elevated T helper/suppressor ratio in 60% and significantly decreased T helper/suppressor ratio in 7.5% of the silicone implant group, while the control group showed increased helper/suppressor ratio only in 10% of tested individuals and no significant decrease in the T helper/suppressor ratio. There was 20% inhibition in T cell mitogenic responses in the silicone implant group, which is significant when compared to the controls. When NK cytotoxic activity was compared between the two groups, significant inhibition in the ability of lymphocytes to kill tumor target cells was observed in the silicone implant group. This inability of target cell lysis was attributed to the demonstrated lack of granularity of NK cells from the silicone implant group. There was significant increase in: immune complexes, anti-nuclear antibodies, anti-thyroid antibodies, anti-striated muscle cell antibody, and anti-myelin basic protein antibodies. These immunological abnormalities in individuals who underwent silicone breast augmentation indicate a mechanism of tissue injury to these patients, causing autoimmune diseases or syndromes. Since autoimmunity in some other conditions is associated with abnormalities in the HLA serotyping system, and

  2. 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.

  3. 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

  4. Shur-clens: an agent to remove silicone gel after breast implant rupture.

    PubMed

    Bitar, George J; Nguyen, Diem B; Knox, Laura K; Dahman, Mohammed I; Morgan, Raymond F; Rodeheaver, George T

    2002-02-01

    Removal of silicone gel from surrounding tissues after implant rupture is difficult. Local inflammation, infection, and silicone granulomas warrant thorough removal of the silicone gel. Shur-Clens (20% solution of the surfactant poloxamer 188), povidone-iodine, and saline are agents that are used to aid in the removal of silicone gel from tissue. The purpose of this study was to compare the efficacy of silicone gel removal by these three agents in vitro. Shur-Clens, povidone-iodine, and saline were compared as solvents for silicone gel. Four weight increments of silicone gel (0.02 g, 0.04 g, 0.06 g, and 0.08 g) were placed on glass slides. These slides were placed in separate beakers containing 40 ml test solution. The slides were soaked for 1 minute with gentle agitation. The slides were removed, rinsed gently with de-ionized water, and placed in a vacuum desiccator to dry. The slides were weighed to determine the amount of silicone removed after soaking in the solution. Analysis of variance was used to determine the significance between the three solvents. The percentages of silicone gel removed for the four weight increments (0.02 g, 0.04 g, 0.06 g, and 0.08 g) in saline were 5.6%, 2.9%, 2.1%, and 5.8%, respectively. In povidone-iodine solution, the percentages were 18.9%, 25.4%, 28.8%, and 51.9%. In Shur-Clens, the percentages were 31.3%, 43.0%, 63.5%, and 79.9%. The greater percentage of silicone gel removed by Shur-Clens was significant compared with the other solutions (p < or = 0.05). Shur-Clens was shown to be a more effective solvent for removal of silicone gel in vitro. This enhanced efficacy is a result of the fact that Shur-Clens contains 20% of the surfactant poloxamer 188. The authors' clinical experience with 7 patients who underwent ruptured silicone breast implant removal demonstrated the superiority of Shur-Clens. Shur-Clens is a surfactant cleanser that is widely available, is inexpensive, and has a good safety profile. They propose the use of

  5. 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.

  6. Novel technique for laparoscopic harvesting of latissimus dorsi flap with prosthesis implantation for breast reconstruction: A preliminary study with 2 case reports.

    PubMed

    Xu, Shuman; Tang, Peng; Chen, Xianchun; Yang, Xi; Pan, Qinwen; Gui, Yu; Chen, Li

    2016-11-01

    An important drawback of the traditional technique for harvesting latissimus dorsi (LD) myocutaneous flap is a long, posterior donor-site incision. Current techniques involve endoscopic or robotic harvesting via a combined approach of open and closed surgery, which necessitates an open axillary incision and the use of special retractors. In this paper, we introduce a fully enclosed laparoscopic technique for harvesting LD flap (LDF) using only 3 small trocar ports. This technique eliminates the need for axillary and donor-site incisions and specialized retractors and considerably reduces the incision size. We performed laparoscopic harvesting of LDF with prosthesis implantation for immediate breast reconstruction (IBR) after nipple-sparing mastectomy in 2 patients with malignant breast neoplasm who wished to avoid a long scar on the back. IBR using this technique was uneventful in both cases, without any donor-site complications or flap failure. Both patients were satisfied with the esthetic results of the procedure, especially the absence of a visible scar on the back. Enclosed laparoscopic harvesting of LDF is simpler and less invasive than the traditional methods. These preliminary results warrant further evaluation in a larger population to validate the benefits of this technique.

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

    PubMed Central

    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

  8. The association of matrix Gla protein isomers with calcification in capsules surrounding silicone breast implants.

    PubMed

    Hunter, Larry W; Lieske, John C; Tran, Nho V; Miller, Virginia M

    2011-11-01

    Implanted silicone medical prostheses induce a dynamic sequence of histologic events in adjacent tissue resulting in the formation of a fibrotic peri-prosthetic capsule. In some cases, capsular calcification occurs, requiring surgical intervention. In this study we investigated capsules from silicone gel-filled breast prostheses to test the hypothesis that this calcification might be regulated by the small vitamin K-dependent protein, matrix Gla protein (MGP), a potent inhibitor of arterial calcification, or by Fetuin-A, a hepatocyte-derived glycoprotein also implicated as a regulator of pathologic calcification. Immunolocalization studies of explanted capsular tissue, using conformation-specific antibodies, identified the mineralization-protective γ-carboxylated MGP isomer (cMGP) within cells of uncalcified capsules, whereas the non-functional undercarboxylated isomer (uMGP) was typically absent. Both were upregulated in calcific capsules and co-localized with mineral plaque and adjacent fibers. Synovial-like metaplasia was present in one uncalcified capsule in which MGP species were differentially localized within the pseudosynovium. Fetuin-A was localized to cells within uncalcified capsules and to mineral deposits within calcific capsules. The osteoinductive cytokine bone morphogenic protein-2 localized to collagen fibers in uncalcified capsules. These findings demonstrate that MGP, in its vitamin K-activated conformer, may represent a pharmacological target to sustain the health of the peri-prosthetic tissue which encapsulates silicone breast implants as well as other implanted silicone medical devices.

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

    PubMed

    Cordeiro, Peter G; McGuire, Patricia; Murphy, Diane K

    2015-10-01

    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. 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. 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. 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. Therapeutic, IV.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

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

    PubMed

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

    2013-04-01

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

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

    PubMed Central

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

    2014-01-01

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

  18. Silicone gel breast implant adverse event reports to the Food and Drug Administration, 1984-1995.

    PubMed Central

    Brown, S L; Parmentier, C M; Woo, E K; Vishnuvajjala, R L; Headrick, M L

    1998-01-01

    OBJECTIVES: To characterize the adverse event reports on silicone gel breast implants (SGBIs), including death reports, submitted to the Food and Drug Administration (FDA) from 1984 through 1995 and to analyze changes in the type and complexity of reports following extensive media coverage of breast implants. METHODS: The authors analyzed mandatory and voluntary reports from the adverse events reporting system for medical devices at the FDA. RESULTS: In 1988, adverse event reports related to SGBIs accounted for 2.4% of the 14,473 mandatory reports entered into the FDA database on medical devices. In 1992, SGBI-related reports accounted for 30.3% of the total 66,476 mandatory reports of adverse events. The most frequently reported adverse event in 1988, before the widespread publicity on breast implants, was implant burst or rupture. In contrast, in 1992 the most frequently reported event was reaction, a term used to describe a range of adverse effects. CONCLUSIONS: The numbers of mandatory and voluntary reports of SGBI-related adverse events increased exponentially, as did the complexity of the reports, following publicity over the lack of safety data on breast implants and a short voluntary moratorium on their sale. A significant proportion of reports lacked information on specific medical symptoms or diagnoses. PMID:9847926

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

    PubMed

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

    2013-07-01

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

  20. Galactorrhea after aesthetic breast augmentation with silicone implants: report of two cases and management of postoperative galactorrhea.

    PubMed

    Ayestaray, Benoit; Dudrap, Emmanuel; Chaibi, Amir

    2011-06-01

    Galactorrhea is a rare event after breast augmentation. The physiopathologic bases of galactorrhea depend on the central secretion of prolactin. These physiopathologic bases must be clearly understood for the prevention and treatment of postoperative galactorrhea. This report describes two cases of a postoperative galactorrhea after aesthetic breast augmentation with silicone implants. The clinical appearance closely resembles a postoperative sepsis without hyperthermia. Bacteriologic samples are negative. Endocrinologic examination finds a characteristic hyperprolactinemia. The evolution is favorable under dopaminergic agonists.

  1. 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

  2. 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.

  3. Groningen prosthesis for voice rehabilitation after laryngectomy.

    PubMed

    Annyas, A A; Nijdam, H F; Escajadillo, J R; Mahieu, H F; Leever, H

    1984-02-01

    Singer and Blom's endoscopic technique, using a single valved silicone prosthesis, constituted a dramatic advance in speech rehabilitation following total laryngectomy. Since 1980, we have developed a silicone biflanged prosthesis that overcomes some of the inconveniences of previous prostheses. Insertion via the mouth and the oesophagus, or as a primary procedure during total laryngectomy is easily done with the use of specially developed instruments. The success rate in 36 patients in which the voice button was inserted at the time of total laryngectomy was 86.2%.

  4. Radiation therapy after breast augmentation or reconstruction in early or recurrent breast cancer.

    PubMed

    Ryu, J; Yahalom, J; Shank, B; Chaglassian, T A; McCormick, B

    1990-09-01

    Fourteen patients whose augmented or reconstructed breasts were treated with radiation therapy were analyzed. Silicone gel implants were used in 13 patients and free-injected silicone in one patient. The total radiation dose ranged from 4400 to 6200 cGy using tangential photon fields or an en face electron field by megavoltage equipment. In several cases, electron boost radiation was added to the tumor bed. The majority of the patients tolerated therapy well with minimal transient skin reactions; only three patients required a treatment break secondary to moist desquamation. Three patients developed documented implant encapsulation, although the majority retained good to excellent cosmesis. In summary, when breast carcinoma arises in the augmented or reconstructed breast, conservative management (i.e., limited surgery and definitive irradiation) is feasible without compromising the therapy or the cosmetic result. Thus, conservative management should be offered as an option to patients who are interested in breast prosthesis conservation.

  5. Radiation therapy after breast augmentation or reconstruction in early or recurrent breast cancer

    SciTech Connect

    Ryu, J.; Yahalom, J.; Shank, B.; Chaglassian, T.A.; McCormick, B. )

    1990-09-01

    Fourteen patients whose augmented or reconstructed breasts were treated with radiation therapy were analyzed. Silicone gel implants were used in 13 patients and free-injected silicone in one patient. The total radiation dose ranged from 4400 to 6200 cGy using tangential photon fields or an en face electron field by megavoltage equipment. In several cases, electron boost radiation was added to the tumor bed. The majority of the patients tolerated therapy well with minimal transient skin reactions; only three patients required a treatment break secondary to moist desquamation. Three patients developed documented implant encapsulation, although the majority retained good to excellent cosmesis. In summary, when breast carcinoma arises in the augmented or reconstructed breast, conservative management (i.e., limited surgery and definitive irradiation) is feasible without compromising the therapy or the cosmetic result. Thus, conservative management should be offered as an option to patients who are interested in breast prosthesis conservation.

  6. 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

  7. Comprehensive Rehabilitation of Partially Amputated Index Finger with Silicone Prosthesis: A Case Report with 3 years of Follow Up.

    PubMed

    Ahmad, Manawar; Balakrishnan, Dhanasekar; Narayan, Aparna; Naim, Hina

    2014-12-01

    The loss of all or part of a finger following traumatic amputation may have a negative impact on physical and psychological well-being. An esthetic prosthesis can offer psychological, functional, and rehabilitative advantages. One of the major problems associated with somato-prosthetic replacement of partially amputated finger is inadequate retention of the prosthesis. This may stem from the weight of the prosthesis, inadequate tissue support, and/or the particular area of the finger to be replaced. A number of means have been employed to enhance retention. Among the more common are adhesives, adhesive tape, magnets and implants. The purpose of this article is to describe a technique which eliminates the need for adhesive materials and utilizes copper wire to fabricate a finger ring as a primary means of retention. This technique can be utilized whenever the prosthesis encompasses more than 180° of the affected area. This clinical report presents a case of rehabilitation of a partially amputated index finger defect and describes a method of retention for the same with a copper ring.

  8. 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

  9. 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

  10. Finger prosthesis: a boon to handicapped

    PubMed Central

    Gupta, Ridhima; Kumar, Lakshya; Rao, Jitendra; Singh, Kamleshwar

    2013-01-01

    This is a clinical case report of a 52-year-old male patient with four partially missing fingers of the left hand. The article describes the clinical and laboratory procedure of making prosthesis with modern silicone material. A wax pattern was fabricated using the right hand of the patient. A special type of wax was formulated to make the pattern so that it can be easily moulded and carved. Intrinsic and extrinsic staining was also performed to match the adjacent skin colour. The patient was given the finger prosthesis and was asked to use a half glove (sports) to mask the junction between the prosthesis and the normal tissue. It also provides additional retention to the artificial fingers. The patient felt his social acceptance improved after wearing the finger prosthesis. PMID:23988821

  11. Different techniques in fabrication of ocular prosthesis.

    PubMed

    Cevik, Pinar; Dilber, Erhan; Eraslan, Oguz

    2012-11-01

    Loss of an eye caused by cancer, trauma, or congenital defect creates a deep psychological impact on an individual's life especially social and professional life. Custom-made prosthesis, compared to stock prosthesis, provides a better fit to the eye socket, better cosmetic results, and less discomfort to the patient in the long term. The main objective of this article was to describe 3 different alternative and practical techniques of fabricating custom-made ocular prosthesis. An impression of anophthalmic socket was made with the addition of cured silicone-based precision impression material in all techniques. A master cast was prepared and duplicated with condensation silicone. A self-cure acrylic resin was polymerized in the silicone model and was fitted into the patient's eye socket. A digital photograph of the patient's iris was made using a digital camera and printed on good-quality photo paper in various shades and sizes in the first and the second techniques. Then the photo paper was coated with PVC so as not to allow any color flowing. The proper iris was then inserted to the acrylic base. The prosthesis was final processed using orthodontic heat polymerizing clear acrylic resin.In the other technique, after the trying-in process with wax pattern, an acrylic base was fabricated using heat polymerizing scleral acrylic resin. The prosthetic iris was fabricated from a transparent contact lens by painting the lens with watercolor paints and attaching it to an acrylic resin with tissue conditioner. The final process was made with heat polymerizing transparent acrylic resin. Custom-made prosthesis allows better esthetic and functional results to the patient in comparison to stock prosthesis. Further follow-up is necessary to check the condition and fit of the ocular prosthesis in such patients.

  12. Breast Implants

    MedlinePlus

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

  13. Counterfactual thinking and quality of life among women with silicone breast implants.

    PubMed

    Parker, Patricia A; Middleton, Michael S; Kulik, James A

    2002-08-01

    This study examined the relationship of counterfactual thinking (thoughts about how one's current situation might have turned out differently) with psychosocial adjustment and quality of life in a sample of women with silicone breast implants. Seventy-four women who were concerned about or who were experiencing problems with their implants were recruited following magnetic resonance imaging (MRI) evaluation. Participants completed measures of counterfactual thinking, psychosocial adjustment, and quality of life (QOL). Results indicated that counterfactual thinking was significantly associated with more psychosocial adjustment difficulties, more perceived implant-related health problems, and poorer QOL in the physical health domain. These findings provide additional insight into the factors that may influence adjustment in a complex and poorly understood population and also have implications for understanding the adjustment process to other types of illnesses.

  14. Silicone-induced granuloma of breast implant capsule (SIGBIC): similarities and differences with anaplastic large cell lymphoma (ALCL) and their differential diagnosis

    PubMed Central

    Fleury, Eduardo de Faria Castro; Rêgo, Milena Morais; Ramalho, Luciana Costa; Ayres, Veronica Jorge; Seleti, Rodrigo Oliveira; Ferreira, Carlos Alberto Pecci; Roveda, Decio

    2017-01-01

    Primary breast lymphoma is a rare disease and accounts for 0.5% of cases of breast cancer. Most primary breast lymphomas develop from B cells, and the involvement of T cells is rare. Anaplastic large cell lymphoma (ALCL) is a recently discovered T-cell lymphoma associated with breast implants. Only a few cases have been reported to date. It is believed that the incidence of ALCL is increasing because of the increasing number of breast implants. The clinical presentation is variable and can manifest as a palpable mass in the breast or armpit, breast pain, or capsular contracture. Because of the rarity of the disease and the lack of knowledge to date, clinical diagnosis is often delayed, with consequent delays in treatment. The cause and pathogenesis have not been fully elucidated, and there are no evidence-based guidelines for diagnosis, treatment, or follow-up of this disease. We present a review of cases of patients with silicone breast implants, including ALCL, a rare type of breast cancer that is still under study, and silicone-induced granuloma of breast implant capsule and its differential diagnosis, and discuss if a silicone-induced granuloma of breast implant capsule could be the precursor of the disease. PMID:28331364

  15. Silicone-induced granuloma of breast implant capsule (SIGBIC): similarities and differences with anaplastic large cell lymphoma (ALCL) and their differential diagnosis.

    PubMed

    Fleury, Eduardo de Faria Castro; Rêgo, Milena Morais; Ramalho, Luciana Costa; Ayres, Veronica Jorge; Seleti, Rodrigo Oliveira; Ferreira, Carlos Alberto Pecci; Roveda, Decio

    2017-01-01

    Primary breast lymphoma is a rare disease and accounts for 0.5% of cases of breast cancer. Most primary breast lymphomas develop from B cells, and the involvement of T cells is rare. Anaplastic large cell lymphoma (ALCL) is a recently discovered T-cell lymphoma associated with breast implants. Only a few cases have been reported to date. It is believed that the incidence of ALCL is increasing because of the increasing number of breast implants. The clinical presentation is variable and can manifest as a palpable mass in the breast or armpit, breast pain, or capsular contracture. Because of the rarity of the disease and the lack of knowledge to date, clinical diagnosis is often delayed, with consequent delays in treatment. The cause and pathogenesis have not been fully elucidated, and there are no evidence-based guidelines for diagnosis, treatment, or follow-up of this disease. We present a review of cases of patients with silicone breast implants, including ALCL, a rare type of breast cancer that is still under study, and silicone-induced granuloma of breast implant capsule and its differential diagnosis, and discuss if a silicone-induced granuloma of breast implant capsule could be the precursor of the disease.

  16. Challenges in prosthesis classification.

    PubMed

    Robertsson, Otto; Mendenhall, Stan; Paxton, Elizabeth W; Inacio, Maria C S; Graves, Stephen

    2011-12-21

    Accurate prosthesis classification is critical for total joint arthroplasty surveillance and assessment of comparative effectiveness. Historically, prosthesis classification was based solely on the names of the prosthesis manufacturers. As a result, prosthesis designs changed without corresponding name changes, and other prostheses' names changed over time without substantial design modifications. As the number of prostheses used in total joint arthroplasty on the market increased, catalog and lot numbers associated with prosthesis descriptions were introduced by manufacturers. Currently, these catalog and lot numbers are not standardized, and there is no consensus on categorization of these numbers into brands or subbrands. Classification of the attributes of a prosthesis also varies, limiting comparisons of prostheses across studies and reports. The development of a universal prosthesis classification system would standardize prosthesis classification and enhance total joint arthroplasty research collaboration worldwide. This is a current area of focus for the International Consortium of Orthopaedic Registries (ICOR).

  17. 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.

  18. 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

  19. Allergic contact dermatitis to synthetic rubber following breast augmentation.

    PubMed

    Cantisani, C; Cigna, E; Grieco, T; Miller, D M; De Gado, F; Calvieri, S; Scuderi, N

    2007-06-01

    Allergic reactions associated with silicone injection and implant were examined in a 50-year-old woman with a granulomatous reaction following breast silicone-gel prosthesis rupture who developed a delayed hypersensitivity to rubber compounds. Patch tests with SIDAPA, dental, and rubber series as well as open tests with latex, silicone and non silicone tubes, open application test with silicone gel, and skin prick test for aero and food-allergens were performed. Total and specific serum IgE measured by CAP-FEIA. Skin tests revealed a delayed-type hypersensitivity to thioureas, thiuram mixture and platinum. Specific IgE to natural rubber latex were found. Allergic contact dermatitis from thioureas, thiurams and platinum might be under-diagnosed, as they are not tested as part of the standard patch test series. Clinicians should consider this diagnosis in patients submitted to several cosmetic treatments.

  20. Silicate antibodies in women with silicone breast implants: development of an assay for detection of humoral immunity.

    PubMed Central

    Shen, G Q; Ojo-Amaize, E A; Agopian, M S; Peter, J B

    1996-01-01

    Silicon, in the form of sodium silicate (Na2SiO3), adsorbed onto bovine serum albumin (BSA)-precoated plates served as the solid-phase antigen in an enzyme immunoassay to detect silicate-reactive antibodies in the plasma of 40 symptomatic women with silicone breast implants, 91 asymptomatic women with silicone breast implants, 50 healthy control women, and 52 women with rheumatic diseases and without silicone breast implants, Silicate-reactive antibodies of immunoglobulin G (IgG) or IgM isotypes were detected in the plasma of 30% (12 of 40) of the symptomatic women with silicone breast implants; 9% (8 of 91) of the asymptomatic women with silicone breast implants; 5% (1 of 20) of the women without implants who had systemic lupus erythematosus; and 0% (0 of 32) of the women without implants who had either Sjögren syndrome, scleroderma, or rheumatoid arthritis. Only 2% (1 of 50) of the sera from the healthy control women contained silicate-reactive antibodies. Preincubation of sera with silicate and eight other metal compounds (including SiO2) demonstrated that the IgG and IgM antibodies bound specifically to silicate, because preincubation with Na2SiO3 inhibited more than 90% of the activity, whereas CrO3, Li2SO4, MgSO4, NiSO4, HgCl2, ZrOCl2, BeSO4, and SiO2 failed to inhibit the IgG or IgM antibody binding to the silicate-BSA plates. Furthermore, the F(ab')2 portion and not the Fc portion of the silicate-reactive IgG was reactive with BSA-bound silicate in the enzyme immunoassay. The assay for silicate-reactive antibodies was quantified by assigning arbitrary units to a standard curve composed of serial twofold dilutions of high-positive (ten times higher than the cutoff) silicate antibody sera. This novel assay is a useful method for detecting and quantifying humoral immune response to silicate. PMID:8991630

  1. 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.

  2. Massive inflammatory reaction following the removal of a ruptured silicone implant masking the invasive breast cancer - case report and literature review.

    PubMed

    Nowaczyk, Piotr; Budnicka, Aleksandra; Wichtowski, Mateusz; Kurzawa, Paweł; Murawa, Dawid

    2016-01-01

    This paper presents a case of a patient with invasive ductal breast cancer following breast augmentation. Following breast implants rupture in March 2013 the breast implants have been removed - histopathological examination revealed leaked silicone with inflammatory infiltration, without evidence of cancerous lesions. Diagnostic imaging revealed multiple encapsulated silicone particles and clusters of post-inflammatory macrocalcifications in both breasts. In January 2014 the patient presented with symptoms of massive inflammation of the left breast. Following surgical consultation the patient had undergone radical left-sided mastectomy with lymphadenectomy. Postoperative histopathological examination revealed a multifocal advanced invasive ductal cancer G3 pT3pN3a (vascular invasion, metastases in 11 of 12 examined axillary lymph nodes). Following surgery the patient was qualified for further treatment - chemotherapy, radiotherapy, hormone therapy. The discussion includes a review of literature on the risk evaluation of co-occurrence of breast cancers in women with silicone breast implants and presents diagnostic challenges of breast cancer in this patient group.

  3. Evaluation of the Shore A hardness of silicone for facial prosthesis as to the effect of storage period and chemical disinfection.

    PubMed

    Guiotti, Aimée Maria; Goiato, Marcelo Coelho; dos Santos, Daniela Micheline

    2010-03-01

    The failure of facial prostheses is caused by limitations in the properties of existing materials, especially flexibility and durability. Therefore, this study evaluated the Shore A hardness of silicone used for fabrication of facial prostheses, Silastic MDX4-4210, according to the influence of storage period, daily disinfection, and 2 types of pigmentation. Thirty specimens were fabricated and divided in 3 groups: colorless, pigmented with makeup, and pigmented with iron oxide. Analysis of results was assessed on a Shore A hardness meter immediately, 6 months, and 1 year after fabrication of specimens, following the guidelines of the American Society for Testing and Materials. The hardness values were statistically analyzed by the Tukey test. The silicone exhibited an increase in hardness with time. However, the hardness was stable from 6 months to 1 year. It was concluded that the silicone is within the values of Shore A hardness reported in the literature, regardless of the storage period, pigmentation, and chemical disinfection.

  4. 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

  5. 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.

  6. A comparison of long-term cost and clinical outcomes between the two-stage sequence expander/prosthesis and autologous deep inferior epigastric flap methods for breast reconstruction in a public hospital.

    PubMed

    Lagares-Borrego, A; Gacto-Sanchez, P; Infante-Cossio, P; Barrera-Pulido, F; Sicilia-Castro, D; Gomez-Cia, T

    2016-02-01

    Postmastectomy breast reconstruction involves the use of large amounts of hospital resources. This study provides comparative data on the clinical results and long-term economic costs of two methods of breast reconstruction in a public hospital. A prospective cohort study was performed to evaluate the costs incurred by delayed unilateral breast reconstruction performed using either the two-stage sequence expander/prosthesis (E-P) or autologous deep inferior epigastric flap (DIEP) method during 2005-2013 in 134 patients. The major evaluated variables included previous clinical records, history of radiotherapy, and number of surgical procedures. Total costs accounted for both direct intra- and extra-hospital costs derived from the initial reconstruction and those resulting from associated reoperations due to aesthetic retouches and/or complications. Patients undergoing E-P reconstruction required a higher number of surgery sessions to complete the reconstruction (3.07 vs. 2.32, p < 0.001) and showed higher rates of surgery-related complications (40.29% vs. 32.82%). No statistically significant differences were found between the two surgical methods in terms of total costs (€18857.77 DIEP vs. €20502.08 E-P; p = 0.89). In the E-P cohort, active smoking and history of radiotherapy were statistically significant risk factors of complications. In the DIEP group, only active smoking was significantly associated with complications. Compared to the E-P method, breast reconstruction using the DIEP method is more cost-effective and involves fewer serious complications that result in reconstruction failure or undesirable aesthetic results. E-P reconstruction presents a higher number of complications that may cause surgical failure or poor outcomes. Copyright © 2015 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

  7. Textured and smooth breast implants: is there a difference in the chemical structure of silicone?: an analysis with fourier transformation infrared and attenuated total reflectance spectroscopy.

    PubMed

    Persichetti, Paolo; Tenna, Stefania; Delfino, Sergio; Abbruzzese, Franca; Trombetta, Marcella; Scuderi, Nicolò

    2009-10-01

    Scientific controversy concerning silicone and its biocompatibility has been ongoing for the last 10 years. This study on textured and smooth silicone breast implant shells using fourier transformation infrared spectroscopy associated with attenuated total reflectance cells aimed to identify eventual chemical modifications of silicone induced by texturization. The surfaces of 8 new implants produced by 2 well-known manufactures have been taken into consideration. A sample 1 cm2 has been harvested from the anterior and posterior sides of textured and smooth shells. Infrared spectra were then recorded, evaluated, and compared with the reference spectrum of pure silicone. Potentially reactive groups, known as silanols, were identified, in all shells, intensity increasing in textured implants (P < 0.05), whereas no silanols were detected in the spectrum of pure silicone. These results suggest that polar groups, present in manipulated silicone might influence capsula formation.

  8. Changes in photon dose distributions due to breast prostheses

    SciTech Connect

    Klein, E.E. ); Kuske, R.R. )

    1993-02-15

    Subcutaneous prosthetic implants have been routinely used for cosmetic augmentation and for tissue replacement following mastectomy over the last 15 years. The implants come in many forms as the gel filler material and surrounding shell material(s) vary significantly. This study uses a thin window parallel-plate chamber and thermoluminescent dosimeters to quantify any dosimetric changes to surrounding breast tissue due to the presence of the prosthesis. A mammographic phantom was compared to four commercial prostheses, namely two silicon gel fillers within two different shells (silicon or silicon/polyurethane), a tri-glyceride within silicon and a bio-oncotic gel within silicon and a bio-oncotic gel within silicon/polyurethane. The latter two implants were designed with a low-Z fill for diagnostic imaging benefits. Ion chamber results indicate no significant alteration of depth doses away from the implant with only minor canceling (parallel opposed) interface perturbations for all implants. In addition the physical changes to the irradiated prostheses were quantified by tonometry testing and qualified by color change. Each implant exhibited color change following 50 Gy, and the bio-oncotic gel became significantly less formable following irradiation, and even less formable 6 weeks postirradiation. The data indicates that prostheses do not affect the photon beam distribution, but radiation does affect the prosthesis. 9 refs., 10 figs., 5 tabs.

  9. Prophylactic Leukotriene Inhibitor Therapy for the Reduction of Capsular Contracture in Primary Silicone Breast Augmentation: Experience with over 1100 Cases

    PubMed Central

    2017-01-01

    Background: The role of leukotriene inhibitors used immediately postoperatively to potentially influence the development of capsular contracture is unknown. The purpose of this study was to evaluate the incidence of capsular contracture among women undergoing primary smooth silicone gel breast augmentation, with or without postoperative leukotriene inhibitor therapy. Methods: Between 2007 and 2013, 1122 consecutive women undergoing primary silicone gel breast augmentation were evaluated retrospectively. All underwent augmentation with smooth, Mentor Memory Gel implants, using a dual-plane technique, with periareolar or inframammary approaches. Patients were treated voluntarily with either no leukotriene inhibitor, montelukast (Singulair), or zafirlukast (Accolate) for 3 months. All patients received informed consent for the off-label use of leukotriene inhibitors. Liver function studies were obtained for all patients undergoing Accolate therapy after 1 month of therapy. The presence of capsular contracture was measured by the Baker scale at 1 year postoperatively. Results: Patients receiving Accolate therapy (n = 520) demonstrated an encapsulation rate of 2.19 percent. Women receiving Singulair therapy (n = 247) had an encapsulation rate of 3.27 percent. Patients not receiving leukotriene inhibitor therapy had an encapsulation rate of 5.02 percent. There were no long-term complications among patients evaluated. Conclusions: Accolate therapy used for 3 months postoperatively was associated with significantly lower capsular contracture rates compared with untreated patients at 1-year follow-up (p < 0.05). Patients treated with Singulair demonstrated lower contracture rates compared with controls, but the differences were not statistically significant. The findings suggest that Accolate therapy, with monitoring and consent, reduces the incidence of capsular contracture following primary smooth silicone gel breast augmentation. CLINICAL QUESTION/LEVEL OF EVIDENCE

  10. Modified technique to fabricate a hollow light-weight facial prosthesis for lateral midfacial defect: a clinical report

    PubMed Central

    2010-01-01

    Large oro-facial defects result from cancer treatment consequences in serious functional as well as cosmetic deformities. Acceptable cosmetic results usually can be obtained with a facial prosthesis. However, retention of a large facial prosthesis can be challenging because of its size and weight. This article describes prosthetic rehabilitation of a 57-year-old man having a right lateral mid-facial defect with intraoral-extraoral combination prosthesis. A modified technique to fabricate a hollow substructure in heat-polymerizing polymethyl-methacrylate to support silicone facial prosthesis was illustrated. The resultant facial prosthesis was structurally durable and light in weight facilitating the retention with magnets satisfactorily. This technique is advantageous as there is no need to fabricate the whole prosthesis again in case of damage of the silicone layer because the outer silicone layer can be removed and re-packed on the substructure if the gypsum-mold is preserved. PMID:21165271

  11. Fibromatosis associated with silicone breast implant: ultrasonography and MR imaging findings.

    PubMed

    Shim, Hyun Seok; Kim, Seon-Jeong; Kim, Ok Hwa; Jung, Hyun Kyung; Kim, Suk Jung; Kim, Woogyeong; Kim, Woon Won

    2014-01-01

    Desmoid type fibromatosis is an uncommon benign disease entity of which its etiology is currently unknown. It constitutes 0.3% of all solid neoplasms, but it is rarely seen in the breast and even more scarcely reported to develop in association with breast implant. We present ultrasonography and magnetic resonance imaging findings of a 29-year-old female patient with fibromatosis after breast implant surgery. Knowledge of imaging findings of breast fibromatosis associated with implant will be helpful for accurate diagnosis and appropriate management.

  12. 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.

  13. Is the shear wave sonographic elastography correlated with pain after breast augmentation with silicone implants an indication of inflammatory activity? A preliminary report

    PubMed Central

    Kubasik, Mikołaj; Gaca, Michał; Opala, Tomasz

    2011-01-01

    Introduction Formation of a capsule is a natural inflammatory response to a foreign body such as a breast implant. Breast capsular contracture is the most severe complication of implant surgery. Aim To evaluate breast tissues and the periprosthetic reaction with sonoelastography. Material and methods Nineteen patients aged 20-41 underwent breast augmentation with silicone-filled implants. Their 38 breasts were evaluated before surgery, and 7 and 14 days after surgery. Whole breast stiffness was measured by applanation tonometry. Patients underwent shear wave elastography and Young's moduli of breast tissues and the periprosthetic capsule were estimated. During surgery patients underwent standard anaesthesia and were released home 2 days later after removal of drainage. Each day, patients completed the pain visual analogue scale questionnaire separately for left and right breasts. Results Applanation tonometry did not correlate with any parameter. In shear wave elastography we observed statistically significant changes in elasticity of all breast tissues with the highest values on day 7 after surgery and decreasing on day 14. The correlations between pain and capsule elasticity in lower quadrants measured were significant between days 4 and 10, whereas correlations of pain with applanation tonometry were insignificant. Glandular tissue elasticity in lower quadrants did not correlate with pain, whereas in upper quadrants there was a significant correlation on days 6-10. Fatty tissue, muscle and thoracic fascia elasticity did not correlate with breast pain. Breast implant volume correlated with pain only shortly after surgery, but did not correlate with any sonoelastographic parameters. Conclusions Breast pain correlates strongly with periprosthetic stiffness in elastography 4 to 10 days after breast augmentation, suggesting the possible role of an inflammatory reaction. PMID:23255983

  14. 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.

  15. Biodynamic total hip prosthesis.

    PubMed

    Pipino, F; Calderale, P M

    1987-09-01

    The biodynamic total hip prosthesis which was devised in 1977-78 and implanted in 1979 was derived from a series of experimental studies and a lengthy clinical experience, both dating back to 1968. This prosthesis introduced two new and original concepts into the field of prosthetic hip surgery: 1) the biequatorial design of the cup; 2) the preservation of the femoral neck. This prosthetic system is based on maximum preservation of the bone stock as well as hip function. The biequatorial cup allows for positioning corresponding to that of the normal acetabulum. The femoral component incorporates features (collar, sagittal and frontal angulation, external surface, etc.) which facilitate proximal cortical fixation and cancellous metaphyseal biological anchoring, thus ensuring total adhesion. The average 3.5 years follow-up (maximum 7 years, minimum one year) in 280 cases confirms the effectiveness of this prosthesis and the validity of the basic principles on which it is founded.

  16. Full breast digital mammography with an amorphous silicon-based flat panel detector: physical characteristics of a clinical prototype.

    PubMed

    Vedantham, S; Karellas, A; Suryanarayanan, S; Albagli, D; Han, S; Tkaczyk, E J; Landberg, C E; Opsahl-Ong, B; Granfors, P R; Levis, I; D'Orsi, C J; Hendrick, R E

    2000-03-01

    The physical characteristics of a clinical prototype amorphous silicon-based flat panel imager for full-breast digital mammography have been investigated. The imager employs a thin thallium doped CsI scintillator on an amorphous silicon matrix of detector elements with a pixel pitch of 100 microm. Objective criteria such as modulation transfer function (MTF), noise power spectrum, detective quantum efficiency (DQE), and noise equivalent quanta were employed for this evaluation. The presampling MTF was found to be 0.73, 0.42, and 0.28 at 2, 4, and 5 cycles/mm, respectively. The measured DQE of the current prototype utilizing a 28 kVp, Mo-Mo spectrum beam hardened with 4.5 cm Lucite is approximately 55% at close to zero spatial frequency at an exposure of 32.8 mR, and decreases to approximately 40% at a low exposure of 1.3 mR. Detector element nonuniformity and electronic gain variations were not significant after appropriate calibration and software corrections. The response of the imager was linear and did not exhibit signal saturation under tested exposure conditions.

  17. 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.

  18. Appropriate use of magnetic resonance imaging and ultrasound to detect early silicone gel breast implant rupture in postmastectomy reconstruction.

    PubMed

    Rietjens, Mario; Villa, Gaetano; Toesca, Antonio; Rizzo, Stefania; Raimondi, Sara; Rossetto, Fabio; Sangalli, Claudia; De Lorenzi, Francesca; Manconi, Andrea; Gustavo, Angelo; Matthes, Zucca; Chahuan, Badir; Brenelli, Fabricio; Bellomi, Massimo; Petit, Jean Yves

    2014-07-01

    Implant rupture is one of the most important sequelae of breast reconstruction after mastectomy. The primary aim of this study was to compare magnetic resonance imaging and ultrasound evaluation with intraoperative findings and provide a reliable description of the occurrence of each radiological sign. The authors prospectively recruited a consecutive series of 102 postmastectomy patients requiring implant change for aesthetic purposes. Magnetic resonance imaging and ultrasound evaluation results were compared with intraoperative findings. Sensitivity, specificity, positive predictive value, negative predictive value, and the overall accuracy of magnetic resonance imaging and ultrasound in detecting ruptured implants were calculated, along with their corresponding 95 percent confidence intervals. Magnetic resonance imaging performs better than ultrasound for diagnosis of breast implant rupture, with overall accuracies of 94 and 72 percent, respectively. The negative predictive value of ultrasound was 85 percent, meaning that in the case of negative ultrasound findings, magnetic resonance imaging may be avoided. Teardrop sign and water droplets are the most common findings on magnetic resonance imaging. Magnetic resonance imaging should be considered the method of choice for investigating silicone gel implant rupture in postmastectomy patients, and the standardization of magnetic resonance imaging criteria may improve magnetic resonance imaging accuracy. The authors therefore suggest a strategy of screening asymptomatic women with ultrasound every year and with magnetic resonance imaging every 5 years. Diagnostic, II.

  19. 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

  20. Modified technique to improve fabrication and outcome of definitive orbital prosthesis.

    PubMed

    Aggarwal, Himanshi; Kumar, Pradeep; Singh, Saumyendra V

    2016-01-01

    Facial prostheses are generally fabricated from silicones, which provide life-like appearance and flexibility. The longevity of silicone, however, is limited because of its tendency to support fungal growth, absorb oils and grease, and edge-tearing susceptibility. Polyurethane (PU) liners have been used on the tissue-bearing surface of such prosthesis to improve tear resistance and fungal resistance. Technique sensitivity, discoloration and metamerism are significant limitations of urethane lining. Further, this liner is incorporated during processing of definitive prosthesis, which precludes try-in of tissue surface of prosthesis. This article describes an alternative lining material for fitting surface of definitive orbital prostheses, which could overcome limitations associated with all silicone or PU lined silicone prostheses.

  1. The place of subcutaneous mastectomy with immediate silicone prosthetic implantation in diseases of the breast.

    PubMed Central

    Burnand, K. G.; Bulman, A. S.; Nash, A. G.

    1980-01-01

    Subcutaneous mastectomy with immediate silicone prosthetic implantation has been performed on 32 patients. The main indications for this were severe fibrocystic disease and non-invasive carcinoma. Five patients with advanced invasive carcinoma were also included. An improved operative technique is described. The indications and results are discussed. Images FIG. 4 PMID:7436304

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

    PubMed

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

    2015-01-01

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

  3. 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

  4. 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.

  5. Nasal Prosthesis Rehabilitation after Partial Rhinectomy: A Clinical Report

    PubMed Central

    Seçilmiş, Aslı; Öztürk, A. Nilgün

    2007-01-01

    Facial defects resulting from neoplasms, congenital malformations, or trauma can be restorated with facial prostheses using different materials and retention methods to achieve a lifelike look and function. For the successful result, a lot of factors as harmony, texture, color matching, and blending of tissue interface of prosthesis is important. This clinical report describes treatment using a silicone prosthesis with a mechanical - retentined design for a patient who received a partial rhinectomy. Defects resulting from diseases as squamous cell carcinoma can be managed with the prosthetic rehabilitation so that the patient more comfortably and confidently resumed regular daily activity. Mechanical retention alone was sufficient to retain the prosthesis; thus, prosthetic adhesives were not necessary. PMID:19212487

  6. Implant-retained finger prosthesis with modified retention system.

    PubMed

    Goiato, Marcelo Coelho; dos Santos, Daniela Micheline; Amoroso, Andressa Paschoal; Gennari Filho, Humberto; Dekon, Stefan Fiuza de Carvalho

    2013-08-01

    Amputations affect both the physical and the psychological aspects of an individual, causing significant impact on self-esteem. The main causes of finger amputations are work-related accidents with dangerous machinery, road traffic accidents, and animal bites, as well as systemic diseases such as diabetes. This report aims to describe a simple technique for fabrication of implant-retained finger prosthesis with a modified base of the retention system. The O-Ring retention system was used with a modified hexagon-shaped base and a metallic capsule adapted to the acrylic resin to attach the prosthesis to the implant. The prosthesis was made with silicone, and after osseointegration, it was installed without complications, leading to a patient satisfied with the end result and encouraged to return to social life. Restoring self-esteem in the patient and static and functional rehabilitation.

  7. Enhanced enlargement of silicone ocular prostheses achieved by silicone gel (MED-361).

    PubMed

    Morris, Carrie Lynn; Singer, Matt; Fleming, James C

    2010-01-01

    Recently, silicone prostheses have been used instead of acrylic ocular prostheses. The authors sought to assess the ability of silicone gel to facilitate the growth of an ocular silicone prosthesis and to determine the best application modality to achieve maximal possible growth. Two ocular prostheses with similar baseline dimensions and contour were used for comparison of growth environment. One prosthesis was placed in an eyelid mold, while the other was placed in an open Petri dish. Silicone gel drops (MED-361; NuSil Technology, Carpinteria, CA, USA) were administered 3 times daily to both prostheses. Over the course of 41 days, an equal amount of enlargement occurred in all dimensions in both prostheses. Enlargement of a silicone prosthesis can be achieved by various modes of application of topical silicone gel.

  8. A tactile control prosthesis

    NASA Astrophysics Data System (ADS)

    Perry, James Franklin

    This research involves development and testing of a tactile control prosthesis to aid human operators in control of dynamic vehicles. Specifically, this work includes development and demonstration of a torso mounted tactile drift display that allowed helicopter pilots to hover a Blackhawk helicopter with degraded vision (equivalent to 20/200 acuity), a NASA sponsored pilot-in-the-loop simulator study for a hover display and development and analysis of a tactile control prosthesis to help pilots correctly control an airplane experiencing an engine failure on takeoff. Results of a ten-subject experiment indicate that use of a tactile display in conjunction with a visual display reduces operator delay by 65 msec (SD of 28 msec), (P < 0.001) without a significant increase in error rate. In the pilot-in-the-loop simulation experiment pilots hovered a simulated helicopter better under increased workload conditions with the tactile control prosthesis than without it. The increased workload consisted of an addition drill in which the subject had to agree or disagree with a computer generated sum. Pilots were able to hover more precisely with the tactile display (mean of 5.19, SD of 2.57 feet) than without (mean of 6.39 and SD of 3.31 feet) especially when the secondary task was required (P < 0.001). Although learning effects were exhibited throughout the trials (P < 0.001), the tactile display was of greater benefit in higher workload conditions.

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

    PubMed

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

    2016-04-18

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

  10. [Ball variance and fracture of a Smeloff-Cutter prosthesis 24 years after aortic valve replacement].

    PubMed

    Hust, M H; Klinkmüller, A; Keim, M; Momper, R; Nothwang, G

    1997-07-01

    This report documents a case of ball variance in a Smeloff-Cutter aortic prosthesis occurring 24 years after implantation. After episodes of embolic complications the patient died in acute shock. The silicone rubber ball showed several alterations including discoloration, grooving, cracking, swelling and subtotal fracture of the poppet. Terminal valvular malfunction was caused by complete thrombosis of the prosthesis. In most patients ball variance occurred during the first years after valve replacement; thus, the observed case is a very rare late complication of a ball-valve prosthesis.

  11. Functional biocompatibility testing of silicone breast implants and a novel classification system based on surface roughness.

    PubMed

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

    2017-06-27

    Increasing numbers of women undergo breast implantation for cosmetic and reconstructive purposes. Contracture of the fibrous capsule, which encases the implant leads to significant pain and reoperation. Texture, wettability and the cellular reaction to implant surfaces are poorly understood determinants of implant biocompatibility. The aim of this study was to evaluate the in-vitro characteristics of a range of commercial available implants using a macrophage based assay of implant biocompatibility and a quantitative assessment of wettability and texture. Thirteen commercially available surfaces were subjected to wettability and texture characterisation using scanning and laser confocal microscopy. THP-1 macrophages were cultured on their surfaces and assessed using Integrin αV immunocytochemistry, SEM and RT-PCR for the expression of TNF-Alpha, IL-6, IL-10 and a cytokine array for the production of TNF-alpha, IL-10, IL-1RA and IL1β; important indicators of inflammation and macrophage polarization. Textured surfaces can be accurately sub-categorized dependent upon roughness and re-entrant features into four main types (macro, micro, meso and nano-textured surfaces). Significant (P < 0.0001) differences in implant hydrophobicity and texture exist. Certain surfaces promoted poor macrophage polarization and an innate potential to foster a proinflammatory response. A subgroup analysis showed that texture had a variable effect on markers of inflammation in these surfaces. We propose a classification of implant surfaces based on roughness and present a macrophage based assay of breast implant biocompatibility with a quantitative assessment of implant wettability and texture. The breast implant surface-cell interaction is variable and sufficient to alter healing response and capsular contracture fate in-vivo. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  12. Anaplastic large cell lymphoma in a reconstructed breast using a silicone implant: a UK case report.

    PubMed

    Sørensen, K; Murphy, J; Lennard, A; Wadehra, V; Menon, G K; Collis, N

    2014-04-01

    We present case of Anaplastic Large Cell Lymphoma discovered as an incidental finding whilst revising an implant based breast reconstruction in a 55 year old woman, whom previously had undergone risk reduction mastectomies and immediate reconstruction. During the procedure a presumed seroma was present but this was macroscopically atypical giving a 'milky' coloured appearance with a pink tinge to it. The atypical fluid was sent for analysis and the diagnosis of ALCL confirmed. Treatment consisted of unilateral capsulectomy on the affected side and bilateral removal of implants with staging scans suggesting the disease being confined to the capsule. She remains in remission 12 months following the original procedure.

  13. The Evolution and Utility of the Small-Carrion Prosthesis, Its Impact, and Progression to the Modern-Day Malleable Penile Prosthesis.

    PubMed

    Martinez, Daniel R; Terlecki, Ryan; Brant, William O

    2015-11-01

    Erectile dysfunction has plagued humanity for millennia. For years, treatment had been in the hands of mental health professionals. It was not until the 1970s that urologists created a modality that was marketable, reproducible, and consistently successful at treating impotence, the Small-Carrion Penile Prosthesis. We present the evolution of the malleable/semi-rigid penile prosthesis, concentrating our efforts reviewing and critiquing the pivotal article published by Drs. Michael P. Small, Hernan M. Carrion, and Julian A. Gordon. We then discuss its continued advancement, current-day utilization, and the future of the malleable prosthesis. From the early 1900s, surgeons have been toying with the idea of creating a penile implant. These initial attempts utilized rib cartilage, and eventually synthetic materials, including acrylic, silicone, and polyethylene. In 1975, Drs. Carrion and Small presented their initial experience of 31 patients utilizing their silicone implant. In their manuscript titled, "The Small-Carrion Penile Prosthesis: New Implant for the Management of Impotence," they discuss their technique, perioperative management of complications, and results. The malleable penile prosthesis continued to evolve throughout the years to the current day Genesis and Spectra. Although the current market is dominated by the inflatable penile prosthesis, there are specific situations where the malleable is ideally utilized. The pivotal article by Drs. Carrion and Small helped pave the way for the "New Era" of penile prosthetics and still remains one of the most impactful contributions to the management of erectile dysfunction. © 2015 International Society for Sexual Medicine.

  14. 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.

  15. Intravascular large B-cell lymphoma associated with silicone breast implant, HLA-DRB1*11:01, and HLA-DQB1*03:01 manifesting as macrophage activation syndrome and with severe neurological symptoms: a case report.

    PubMed

    Moling, Oswald; Piccin, Andrea; Tauber, Martina; Marinello, Peter; Canova, Mariagrazia; Casini, Marco; Negri, Giovanni; Raffeiner, Bernd; Binazzi, Raffaella; Gandini, Latha; Vecchiato, Cinzia; Rimenti, Giovanni; Billio, Atto

    2016-09-15

    Silicone implants have been successfully used for breast augmentation and reconstruction in millions of women worldwide. The reaction to the silicone implant is highly variable; it can lead to local inflammatory symptoms, and sometimes to systemic symptoms and disease. Over 80 cases of anaplastic lymphoma kinase-negative anaplastic large cell lymphoma have been reported in patients with silicone breast implants and have been accepted as a new clinical entity. To the best of our knowledge, an intravascular large B-cell lymphoma associated with a silicone breast implant has not been reported previously. A 48-year-old Caucasian woman who presented with high fever was found to have splenomegaly on physical examination. A laboratory diagnosis revealed pancytopenia, hypertriglyceridemia, and hyperferritinemia. She developed signs of altered sensorium, hemiparesis, aphasia, and cauda equina syndrome. On further evaluation, she fulfilled the necessary five out of eight criteria for diagnosis of macrophage activation syndrome/hemophagocytic lymphohistiocytosis. Dexamethasone administration was followed by prompt improvement; however, 3 days later she again manifested high fever, which persisted despite administration of immunoglobulin and cyclosporine A. Her silicone breast implant was considered a possible contributor to her macrophage activation syndrome and was therefore removed. A histological examination of the capsule tissue showed an extensive lymphohistiocytic/giant cell foreign body reaction suggestive of autoimmune/inflammatory syndrome induced by adjuvants. However, the histological examination unexpectedly also revealed an intravascular large B-cell lymphoma. The genetic background of our patient with silicone breast implants might have predisposed her to three rare and difficult to diagnose syndromes/diseases: macrophage activation syndrome/hemophagocytic lymphohistiocytosis, autoimmune/inflammatory syndrome induced by adjuvants, and intravascular large B

  16. Breast cancer calcification measurements using direct X-ray detection in a monolithic silicon pixel detector

    SciTech Connect

    Parker, S.I.; Kenney, C.J.; Peterson, V.Z. . Dept. of Physics); Ikeda, D.M.; Backus, F.A. ); Snoeys, W.J.; Aw, C.H. . Center for Integrated Systems)

    1994-12-01

    A prototype monolithic silicon pixel detector, developed for high-precision tracking at the Superconducting Super Collider, has been used to measure, by direct detection of x-rays, aluminum oxide grains from an accreditation phantom, and calcifications from a tissue sample including a calcification with a width of 100 [mu]m (about half the diameter of the smallest ones normally seen in clinical practice). A computer model indicates that a future sensor, using the same basic structure but optimized for mammography, has the potential of improving upon the abilities of scintillator-film and scintillator-CCD systems by observing individual x-rays, thus allowing the possibility of combining high resolution digital information from more than one viewing angle or x-ray energy.

  17. Breast Augmentation

    MedlinePlus

    ... require additional, specialized views. You might need routine MRI scans. The Food and Drug Administration recommends monitoring silicone breast implants with routine MRI scans every two years, starting three years after the ...

  18. The stump and the prosthesis.

    PubMed Central

    Day, H. J.

    1980-01-01

    In performing amputations the surgeon must bear in mind the biomechanical and other constraints of the prosthesis likely to be fitted and, so far as possible, should fashion the stump accordingly. The various types of prosthesis and their features are discussed in relation to amputations of the lower and upper limbs at all levels. PMID:7377694

  19. [Safety and effectiveness of testicular prosthesis implantation for testis loss: clinical observation of 18 cases].

    PubMed

    Chen, Hui-Xing; Ning, Ye; Cai, Zhi-Kang; Ping, Ping; Huang, Mei; Xu, Di-Ping; Bo, Jun-Jie; Huang, Yi-Ran; Wang, Zhong; Li, Zheng

    2012-04-01

    To investigate the effect and safety of the implantation of a new type of testicular prosthesis in the treatment of testis loss. We recruited for this study 18 patients with testis loss treated by testicular prosthesis implantation, including 10 cases of prostate cancer, 3 cases of anorchia, 2 case of orchiatrophy, 2 cases of hermaphroditism and 1 case of cryptorchidism. The prosthesis was a hollow silicone elastomer YH-G1 made in China, selected according to the volume of the scrotum and the size of the contralateral testis. Thirteen of the patients received testicular prosthesis implantation with orchiectomy, and the other 5 underwent the procedure 6 months later. The operation time of testicular prosthesis implantation was (22.6 +/- 4.6) min, ranging from 15 to 30 minutes. All the patients were discharged after 12 hours of postoperative observation, with a mean hospital stay of (1.3 +/- 0.4) days. A follow-up after 6 months revealed no complications in 17 cases. Rejection occurred in 1 case at 3 months after the implantation, ending in the removal of the prosthesis. Of the 17 successful cases, 15 were very satisfied with the size of the prosthesis, 14 with its weight, 12 with its comfortableness, and all with the appearance of the scrotum and the position of the prosthesis, while 5 found the implant too rigid. The implantation of the new home-made silicone elastomer testicular prosthesis YH-G1 was safe and effective for the treatment of testis loss, and could meet the esthetic and psychological requirements of the patient. But further observation is needed for its long-term complications and influence on the patient's quality of life.

  20. An assistive device designed to convey independent donning of a shuttle lock trans-tibial prosthesis for a multiple limb amputee.

    PubMed

    Tamir, E; Heim, M; Oppenheim, U; Siev-Ner, I

    2003-04-01

    This contribution describes a simple device designed to convey independent donning of a shuttle lock trans-tibial prosthesis for a multiple limb amputee. The device is made of a post with a shuttle lock mechanism at one end and a plate covered by rubber at the other end. This device enables correct positioning of the silicone liner and independent attachment to the prosthesis.

  1. Photovoltaic Retinal Prosthesis with High Pixel Density

    PubMed Central

    Mathieson, Keith; Loudin, James; Goetz, Georges; Huie, Philip; Wang, Lele; Kamins, Theodore I.; Galambos, Ludwig; Smith, Richard; Harris, James S.; Sher, Alexander; Palanker, Daniel

    2012-01-01

    Retinal degenerative diseases lead to blindness due to loss of the “image capturing” photoreceptors, while neurons in the “image processing” inner retinal layers are relatively well preserved. Electronic retinal prostheses seek to restore sight by electrically stimulating surviving neurons. Most implants are powered through inductive coils, requiring complex surgical methods to implant the coil-decoder-cable-array systems, which deliver energy to stimulating electrodes via intraocular cables. We present a photovoltaic subretinal prosthesis, in which silicon photodiodes in each pixel receive power and data directly through pulsed near-infrared illumination and electrically stimulate neurons. Stimulation was produced in normal and degenerate rat retinas, with pulse durations from 0.5 to 4 ms, and threshold peak irradiances from 0.2 to 10 mW/mm2, two orders of magnitude below the ocular safety limit. Neural responses were elicited by illuminating a single 70 μm bipolar pixel, demonstrating the possibility of a fully-integrated photovoltaic retinal prosthesis with high pixel density. PMID:23049619

  2. Photovoltaic retinal prosthesis with high pixel density

    NASA Astrophysics Data System (ADS)

    Mathieson, Keith; Loudin, James; Goetz, Georges; Huie, Philip; Wang, Lele; Kamins, Theodore I.; Galambos, Ludwig; Smith, Richard; Harris, James S.; Sher, Alexander; Palanker, Daniel

    2012-06-01

    Retinal degenerative diseases lead to blindness due to loss of the `image capturing' photoreceptors, while neurons in the `image-processing' inner retinal layers are relatively well preserved. Electronic retinal prostheses seek to restore sight by electrically stimulating the surviving neurons. Most implants are powered through inductive coils, requiring complex surgical methods to implant the coil-decoder-cable-array systems that deliver energy to stimulating electrodes via intraocular cables. We present a photovoltaic subretinal prosthesis, in which silicon photodiodes in each pixel receive power and data directly through pulsed near-infrared illumination and electrically stimulate neurons. Stimulation is produced in normal and degenerate rat retinas, with pulse durations of 0.5-4 ms, and threshold peak irradiances of 0.2-10 mW mm-2, two orders of magnitude below the ocular safety limit. Neural responses were elicited by illuminating a single 70 µm bipolar pixel, demonstrating the possibility of a fully integrated photovoltaic retinal prosthesis with high pixel density.

  3. 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.

  4. 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.

  5. Retention and processing methods of nasal prosthesis.

    PubMed

    Goiato, Marcelo Coelho; Mancuso, Daniela Nardi; Zuccolotti, Bruna Carolina Rossati; Murakawa, Ana Cristina; Lima, Daniela Coelho de; Santos, Daniela Micheline dos; Andreotti, Agda Marobo

    2012-11-01

    Patients with congenital malformations, traumatic or pathological mutilation and maxillofacial developmental disorders can be restored aesthetically and emotionally by the production and use of facial prostheses. The aim of this study was to review the literature about the retention and processing methods of facial prostheses, and discuss their characteristics. A literature review on Medline (PubMed) database was performed by using the keywords "maxillofacial prosthesis, silicone, esin, pigment, cosmetic, prosthetic nose", based on articles published from 1956 to 2010. Several methods of retention, from adhesives to the placement of implants, and different processing methods such as laser, CAD/CAM and rapid prototyping technologies have been reported. There are advantages and disadvantages of each procedure, and none can be classified as better compared to others.

  6. 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.

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

    PubMed Central

    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

  8. Conus hip prosthesis.

    PubMed

    Wagner, H; Wagner, M

    2001-01-01

    50 years ago, prosthetic replacement of the hip joint ushered in a new epoch in orthopaedics. Total hip replacement made it possible to remove a severely diseased, painful hip and restore normal function and a normal quality of life to the afflicted patient. The early results of total hip replacement are almost all spectacular and hip replacement has become the most successful type of orthopaedic surgery. These good results using an approach that was technically relatively simple resulted in a temptation to implant prosthetic hip joints with ever increasing frequency in ever younger patients. This led to the emergence of new problems, which were not so clearly recognised at the outset: it emerged that the stability of prosthetic hip joints was of limited duration. This had the following consequence: If a total hip prosthesis is implanted in an elderly person whose remaining life-expectancy is shorter than the longevity of the prosthesis, hip replacement is a life-long solution. We can therefore say that, for a patient who has only 10 to 15 years left to live, their hip problem is solved by total hip replacement. For young people, who still have a long life expectancy in front of them, it is different. They will experience failure of the artificial joint and require further surgery. The commonest and most important type of failure in total hip prostheses is aseptic loosening, which is associated with resorption of bone at the site of the prosthesis. The cause of this phenomenon has only gradually been recognised in the course of the years. Initially, the unanimous opinion was that the methacrylate cement, used to fix the components of the prosthesis in the bone, was the definitive cause of aseptic loosening because fissures and fractures of the cement were almost always found during surgical revision of loosened joints. There was talk of "cement disease" and great efforts were made to improve the quality of the cement and the cementing technique. Moreover, even

  9. Design and fabrication of a finger prosthesis based on a new method of suspension.

    PubMed

    Arazpour, Mokhtar; Mardani, Mohammad Ali; Ahmadi Bani, Monireh; Zarezadeh, Fatemeh; Hutchins, Stephen William

    2013-08-01

    Finger amputation is one of the most common types of amputation. Prosthesis with adequate suspension, user-friendly design, and an aesthetic appearance can be effective in the rehabilitation of these patients. The aim of this technical note was to propose a technique for fabrication of finger prosthesis with a new suspension approach for such patients. To design and accurately fabricate the socket of finger prosthesis, the socket was reduced by 2 mm less than the original value, and a central tunnel with 4 mm width and depth with length matching the distance between the end of the stump and the nail section was provided, so that the silicone material extended to the stump to provide appreciable suspension. This study demonstrated the design and fabrication of a silicone finger prosthesis. It also showed silicone finger prosthesis with acceptable suspension, a user-friendly and light design, and a cosmetic appearance constructed for a patient with finger amputation. Patients with finger amputation usually use prostheses with a simple suspension technique, but evidence suggests that the residuum of these patients experience atrophy and subsequently loss of appropriate suspension. Therefore, this study was required to provide an alternative suspension method in patients with finger amputations.

  10. A novel technique for fabricating an ear prosthesis in a patient with congenital ear deformity.

    PubMed

    Mardani, Mohammad Ali; Aminian, Gholamreza; Tabatabaian, Farhad; Arazpour, Mokhtar; Hutchins, Stephen W; Head, John S

    2013-08-01

    Microtia is one of the forms of ear loss and deformity. A prosthesis that is simple to apply, and which has adequate suspension and acceptable aesthetics, can be useful in the rehabilitation of patients with this deficit and can improve the social and psychological effects of patients with ear amputation. The aim of this article was to describe a novel technique for fabricating ear prosthesis in a patient with congenital ear deformity. This method involves a novel method to produce an ear prosthesis using clips that were located within the layers of the final silicone ear. This study demonstrated ease of use and acceptance by the patient. Design and fabrication of silicone ear prosthesis via this new method of suspension could also be suitable for provision to children with ear microtia who are not yet suitable for surgery or would not be suited to other methods of suspension. The new method of suspension demonstrated that this approach could be used to provide low cost and acceptable silicone ear prosthesis for patients with microtia and partial ear amputation.

  11. [Tracheobronchial prosthesis in Mounier-Kuhn syndrome: New perspectives].

    PubMed

    Sauvage, M; Tiffet, O; Vergnon, J-M

    2015-05-01

    Mounier-Kuhn syndrome or tracheobronchomegaly is a rare congenital condition, the management of which is complex. We report the case of a patient who was treated with interventional endoscopy. We describe the case of a 74-year-old man with a diagnosis of tracheobronchomegaly who was admitted in 2003 with a background of deteriorating respiratory status and the occurrence of postural syncope. He initially received a tracheobronchial silicone Y prosthesis, extended with metal prostheses at the tracheal and bronchial level. This arrangement remained stable until 2011. He then began to develop episodes of asphyxia related to posterior dislocation of the tracheobronchial prosthesis, after breakage of the metallic mesh tracheal prosthesis. A new tracheobronchial prosthesis Y was then placed, custom-made from a 3D model of the airways. This was clinically and functionally effective. This case describes the management of a patient with Mounier-Kuhn syndrome by interventional bronchoscopy, with the adaptation of prosthetic materials, on an individual basis, to the anatomy of the patient's airway. Copyright © 2015 SPLF. Published by Elsevier Masson SAS. All rights reserved.

  12. Transtibial prosthesis suspension failure during skydiving freefall: a case report.

    PubMed

    Gordon, Assaf T; Land, Rebekah M

    2009-01-01

    This report describes the unusual case of an everyday-use prosthesis suspension system failure during the freefall phase of a skydiving jump. The case individual was a 53-year-old male with a left transtibial amputation secondary to trauma. He used his everyday prosthesis, a transtibial endoskeleton with push-button, plunger-releasing, pin-locking silicon liner suction suspension and a neoprene knee suspension sleeve, for a standard recreational tandem skydive. Within seconds of exiting the plane, the suspension systems failed, resulting in the complete prosthesis floating away. Several factors may have led to suspension system failure, including an inadequate seal and material design of the knee suspension sleeve and liner, lack of auxiliary suspension mechanisms, and lack of a safety cover overlying the push-button release mechanism. This is the first report, to our knowledge, to discuss prosthetic issues specifically related to skydiving. While amputees are to be encouraged to participate in this extreme sport, special modifications to everyday components may be necessary to reduce the possibility of prosthesis failure during freefall, parachute deployment, and landing.

  13. Bioelectronic retinal prosthesis

    NASA Astrophysics Data System (ADS)

    Weiland, James D.

    2016-05-01

    Retinal prosthesis have been translated to clinical use over the past two decades. Currently, two devices have regulatory approval for the treatment of retinitis pigmentosa and one device is in clinical trials for treatment of age-related macular degeneration. These devices provide partial sight restoration and patients use this improved vision in their everyday lives to navigate and to detect large objects. However, significant vision restoration will require both better technology and improved understanding of the interaction between electrical stimulation and the retina. In particular, current retinal prostheses do not provide peripheral visions due to technical and surgical limitations, thus limiting the effectiveness of the treatment. This paper reviews recent results from human implant patients and presents technical approaches for peripheral vision.

  14. 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

  15. A unique method of retaining orbital prosthesis with attachment systems - a clinical report.

    PubMed

    Guttal, Satyabodh S; Akash, N R; Prithviraj, D R; Lekha, K

    2014-06-01

    Diminution of the orbital contents post-surgical removal of a malignant tumor can have a severe psychological impact on the patient in terms of function and esthetics. Therefore, esthetic remedy should be planned subsequently, since tumor obliteration precedes cosmetic concern. A convenient option for successful rehabilitation in such patients is a simple, user-friendly, removable orbital prosthesis. Retention of the prosthesis is one of the key factors for the successful rehabilitation. Spectacle frame, conformers, adhesives, osseointegrated implants, magnets or buttons have been used to impart retention to the prosthesis. The use of semi precision attachments in maxillofacial prostheses is limited to the osseointegrated prostheses. This case report describes a conventional spectacle frame technique, to retain the silicone orbital prosthesis using two different types of stud attachments viz., dalla bona and O-ring attachment systems. Copyright © 2013 British Contact Lens Association. Published by Elsevier Ltd. All rights reserved.

  16. A new method for fabricating orbital prosthesis with a CAD/CAM negative mold.

    PubMed

    Bi, Yunpen; Wu, Shuyi; Zhao, Yimin; Bai, Shizhu

    2013-11-01

    The challenge of fabricating an orbital prosthesis is how to position the iris and pupil properly. Computer simulation can be a more effective and simpler approach to measuring and evaluating these features than the conventional method. However, transferring the optimal position of the iris determined in the virtual design procedure to the real definitive prosthesis can be difficult. The purpose of this article is to demonstrate a method of fabricating an orbital prosthesis with a negative mold designed and produced by a computer-aided design and computer-aided manufacturing technique. With this method, the iris can be designed in the most favorable position, and this position can be transferred to the silicone prosthesis correctly.

  17. 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.

  18. [Guepar anatomical trapeziometacarpal prosthesis].

    PubMed

    Masmejean, E; Alnot, J Y; Chantelot, C; Beccari, R

    2003-02-01

    A choice of surgical techniques of treatment for trapeziometacarpal (TMC) Osteo-Arthritis (OA) have been described. Total arthroplasty is often used, especially in France. Many papers have been published, presenting various prostheses. In English literature, this device is not thoroughly used. [corrected] Guepar total arthroplasty is a cemented ball-in-socket prosthesis in metal-polyethylene. It includes an anatomical stem available in 4 sizes. After failure of the conservative treatment, total arthroplasty must be reserved to elderly patients, painful, with OA Dell stage III or IV aligned or not. The trapezial height must be sufficient. The authors reports the preliminary results of 64 Guepar prostheses, anatomical new design, implanted since 1995. Results of 63 prostheses are presented. One removal had been necessary at 9 months for metacarpal loosening (failure). Mean follow-up was 29 months. Clinical results were judged excellent or good in all cases. Regarding the radiological results, no modifications has been observed in 56 cases. Six radiolucent lines without displacement of the implants has been noted, with no incidence on clinical results. In one case, a metacarpal stem penetrated into the medullary canal in the bone axis but without any clinical modifications. Clinically, in addition to pain relief, trapeziometacarpal prosthesis allows to preserve the first column length and to obtain a better opposition of the thumb as well of a better thumb-digits pinch, compared after trapeziectomy. Radiologically, as for total hip arthroplasty, the exact adaptation of an anatomical stem (new design) to the canal has probably a better prognosis at long term follow-up.

  19. [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.

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

    PubMed Central

    Picha, George J.; Murphy, Diane K.

    2016-01-01

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

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

    PubMed

    Singh, Navin; Picha, George J; Murphy, Diane K

    2016-01-01

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

  2. 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.

  3. [Fracture of macroporous hydroxyapatite prosthesis].

    PubMed

    Adetchessi, A T; Pech-Gourg, G; Metellus, P; Fuentes, S

    2012-12-01

    Different prosthesis implants are offered to perform a cranioplasty after a decompressive craniectomy when autologous bone graft cannot be used. The authors report the case of a 25-year-old man who benefited a unilateral decompressive craniectomy after a severe head trauma. Seven months later, a cranioplasty using custom macroporous hydroxyapatite prosthesis was performed. The postoperative course was marked by a generalized seizure leading to a traumatic head injury. The CT-scan showed a comminutive fracture of the prosthesis and an extradural hematoma. The patient underwent a removal of the fractured prosthesis and an evacuation of the extradural clot. The postoperative course was uneventful with a Glasgow outcome scale score at 5. A second cranioplasty using a polyether ether ketone (PEEK) implant was performed. Among cranioplasty prosthesis solutions, hydroxyapatite implants seem to have similar property to the bone. However, its weak mechanic resistance is an actual problem in patients susceptible to present generalized seizures with consecutive head impact. Hence, in patients with decompressive craniectomy who are exposed to potential brain injury, we favor the use of more resistant implant as PEEK prosthesis.

  4. Fungal colonisation in digital silicone rubber prostheses.

    PubMed

    Leow, M E; Kour, A K; Inglis, T J; Kumarasinghe, G; Pho, R W

    1997-12-01

    The fungal discolouration of silicone rubber prostheses is reported in four cases. In two of the cases, the discolouration was caused by the fungus Candida tropicalis. In the other two cases, two different fungal organisms, namely Trichoderma sp. and Scedosporium prolificans were incriminated. The non-porous silicone rubber layers create an enclosed environment in the suction cup of the prosthesis and preclude ventilation at the prosthesis-stump interface. The moisture as a result of sweat and body warmth in the stump assists fungal growth. Residual salts from the sweat, sebum from sebaceous glands and the residues from petroleum jelly (Vaseline) applied to facilitate donning, can adhere to the surfaces of the prosthesis and provide the nutrients for fungal growth. Prolonged continuous usages of the prosthesis, the presence of sweaty palms in the users, donning the prosthesis during manual physical activities which induce perspiration, washing of hands with the prosthesis on and warm humid climatic conditions have been identified as factors predisposing the prosthesis to fungal colonisation. The fungal growth caused a black discolouration and marred the aesthetic quality of the prostheses. As a preventative measure, daily immersion of the prostheses in denture cleaner such as benzalkonium chloride, or water at 60 degrees C for 15 minutes, or decontamination with 70% alcohol is recommended. Prior cleaning to remove organic matter before decontamination is emphasised.

  5. Women's quality of life and surgical long-term outcome after breast reconstruction in Poland syndrome patients.

    PubMed

    Papadopulos, Nikolaos A; Eder, Maximilian; Stergioula, Sofia; Teymouri, Hamid R; Mavroudis, Michalis C; Herschbach, Peter; Henrich, Gerhard; Papadopoulos, Othon N; Biemer, Edgar; Kovacs, Laszlo

    2011-05-01

    In the last decades, several surgical approaches have been used to improve the appearance and quality of life of female Poland syndrome patients. The aim of this study was to analyze the women's quality of life and long-term outcome after breast reconstruction. Forty-nine women with Poland syndrome who were treated surgically between 1974 and 2007 received standardized questionnaires to evaluate their quality of life and satisfaction after surgical treatment. Patient response was 65%, with 32 completed questionnaires by 16 women who had pedicled latissimus dorsi myocutaneous (LDM) flaps, 12 with tissue expander or silicone implants, and 4 who had free transverse rectus abdominis myocutaneous (TRAM) flaps. Of these patients, 16 were satisfied or highly satisfied with their postoperative appearance (13 with LDM, 2 with prosthesis, and 1 with TRAM), 16 patients would recommend the same surgery to others under similar circumstances (10 with LDM, 5 with prosthesis, and 1 with TRAM), and 18 patients would choose the same method again (14 with LDM, 3 with prosthesis, and 1 with TRAM). In our study, we found that satisfactory outcome in breast reconstruction was achieved particularly when using the LDM flap, which remains the only method that recreates the anterior axillary fold. Future studies on reconstruction methods with autogenous tissue (e.g., TRAM, deep inferior epigastric perforator [DIEP] flap) are needed, however, to analyze quality of life and long-term outcome in patients with Poland syndrome.

  6. 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

  7. Prosthesis for open pleurostomy (POP): management for chronic empyemas.

    PubMed

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

    2009-01-01

    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. 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 debridement of both pleural surfaces, the prosthesis for open pleurostomy was inserted and attached to a small recipient plastic bag. 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-pneumonectomies, 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 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.

  8. [Endourethral prosthesis. Current indications, materials and types of prosthesis].

    PubMed

    Paterlini, Juan Esteban

    2014-01-01

    To update the topic of endourethral prosthesis for the treatment of recurrent urethral stenosis comprehensively, focusing on current indications, materials and types of prosthesis in use nowadays. We used the PubMed database (1995-2013) with the terms "endourethral ", "prostheses","endourethral prosthesis "and selected the most relevant articles for this publication. Results were variable depending on the series published, with great differences among them. They are not homogeneous groups, so they are not comparable to each other. Endourethral prostheses have an important role today in the treatment of recurrent urethral stenosis. More studies are required, with longer follow up to be able to establish which one is the one with the lowest complication rates and best results in terms of urethral caliber and symptom questionnaire.

  9. [Ossiculoplasty with KURZ titanium prosthesis].

    PubMed

    Nguyen, D-Q; Morel, N; Dumas, G; Troussier, J; Lavieille, J-P; Schmerber, S

    2005-09-01

    Report the functional and anatomic results of ossicular reconstruction by titanium prosthesis. Retrospective chart reviews were performed for 111 patients who had undergone titanium ossicular implants between November 1998 and 2002 (61 PORP, 50 TORP). The anatomical and audiometric data were analyzed on average at 3 and 20 months. At 20 months, the improvement of air-bone-gap mean was 12.7 dB with better results at low frequencies. The global success rate was 66% (PORP 77%, TORP 52%). It decreased significantly in the open techniques. Extrusion rate was low (2/111) and the labyrinthization rate was 3.6%. Twenty patients required a surgical revision (18%). In 9 patients, the prosthesis was too short. At long-term follow-up, the gains were stable in 60 patients, improved in 32 patients and worsened in 19 patients. The success rate is higher in the group of the PORP with the closed technique. The stability of the TORP in open technique still remains problematic. In all cases, the risk of extrusion requires a large cartilage graft recovering the plate of the prosthesis. The high rate of luxation (9/111 prosthesis too short) has led us to increase slightly the length of the prosthesis (+1.22 mm mean).

  10. Long-term role of external breast prostheses after total mastectomy.

    PubMed

    Glaus, Simone W; Carlson, Grant W

    2009-01-01

    After total mastectomy, many women choose to wear external breast prosthesis rather than undergo breast reconstruction. The purpose of this study was to evaluate long-term satisfaction among external breast prosthesis wearers and the impact of satisfaction on prosthesis use. A questionnaire was designed to assess demographic information, prosthesis information provision, prosthesis use, and satisfaction with prosthesis. Fifty-nine women who had undergone total mastectomy without breast reconstruction completed the questionnaire. The majority of women (68%) were at least 5 years out from mastectomy. Approximately half (49%) of the women had received information about breast prostheses prior to mastectomy; 29% received information from the surgeon performing the operation. Frequent and prolonged prosthesis use was prevalent with 64% of participants reporting prosthesis use all the time, 6-7 days/week. Participants showed high rates (83%) of overall satisfaction. However, women who wore their prosthesis out in public only were less satisfied than more frequent wearers (50% versus 89%, chi(2) = 8.83, d.f. = 1, alpha = 0.05). Satisfaction increased over time, as women who were greater than 5 years out from mastectomy were more satisfied than women less that 5 years post-mastectomy (90% versus 67%, chi(2) = 4.43, d.f. = 1, alpha = 0.05). The vast majority of women are satisfied with their external breast prosthesis several years after mastectomy. Most women used their prosthesis all the time and overall satisfaction contributed to higher levels of prosthesis use. Given the long-term importance of external breast prostheses for women who have undergone mastectomy, a greater effort to inform patients about external breast prostheses prior to surgery is needed.

  11. Photovoltaic retinal prosthesis: implant fabrication and performance.

    PubMed

    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.

  12. 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.

  13. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Testicular prosthesis. 876.3750 Section 876.3750...) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3750 Testicular prosthesis. (a) Identification. A testicular prosthesis is an implanted device that consists of a solid or gel-filled...

  14. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Testicular prosthesis. 876.3750 Section 876.3750...) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3750 Testicular prosthesis. (a) Identification. A testicular prosthesis is an implanted device that consists of a solid or gel-filled...

  15. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Testicular prosthesis. 876.3750 Section 876.3750...) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3750 Testicular prosthesis. (a) Identification. A testicular prosthesis is an implanted device that consists of a solid or gel-filled...

  16. 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.

  17. Painful knee prosthesis: surgical approach

    PubMed Central

    Villano, Marco; Carulli, Christian; Puccini, Serena; Soderi, Stefano; Innocenti, Massimo

    2011-01-01

    Summary There are many conditions that may be responsible of a painful knee prosthesis. The possible causes are not always easily diagnosed. Common causes of prosthetic failure, such as aseptic loosening, infection, instability, progressive patellar arthropathy and recurrent synovitis are associated with clearly defined radiographic and/or clinical evidence. Prosthetic infection should always be considered first until any other cause has been demonstrated. In the presence of an infected prosthesis we carry out a two-step revision. Aseptic loosening needs implant revision more often with increasing prosthesis stability. Varus-valgus, anteroposterior, global and patello-femoral instability are failures often due to technical errors; superstabilized or constrained implants are needed depending on the instability entity. In presence of patello-femoral pain it is necessary to evaluate the stability of the patellar component and any alterations in its motion. Patellar progressive arthropathy can often cause late-onset knee pain; in this case patella resurfacing is needed. Altered patellar tracking, may need a lateral release but in some cases is related to misalignment of the components and the revision procedure is mandatory. Nevertheless, the diagnosis and treatment of a painful knee prosthesis can be extremely difficult if there is no clear evidence of any of the most common causes of failure. Referred pain, ligament and tendon dysfunction, cutaneous neuromas, synovitis, a patellar clunk have to be diagnosed and treated. A possible aetiological understimated factor is painful knee prosthesis due to metals sensibilization, in particular to nickel. In this event the quantity of nickel in the revision prosthesis must be minimal. PMID:22461812

  18. A comparison of retinal prosthesis electrode array substrate materials.

    PubMed

    Weiland, James D; Humayun, Mark S; Eckhardt, Helmut; Ufer, Stefan; Laude, Lucien; Basinger, Brooke; Tai, Yu-Chong

    2009-01-01

    Simulations of artificial vision suggest that 1000 electrodes may be required to restore vision to individuals with diseases of the outer retina. In order to achieve such an implant, new technology is needed, since the state-of-the-art implantable neural stimulator has at most 22 contacts with neural tissue. A critical component of this system is the multi-channel, stimulating electrode array. This array must meet very challenging, competing requirements for manufacturing, integration, surgical handling, and biocompatibility. Our lab has evaluated 3 polymers as retinal prosthesis substrates: polyimide, parylene, and silicone.

  19. Testicular prosthesis: Patient satisfaction and sexual dysfunctions in testis cancer survivors.

    PubMed

    Catanzariti, Francesco; Polito, Benedetta; Polito, Massimo

    2016-10-05

    We studied patient satisfaction about sexual activity after prosthesis implantation using validated questionnaires with the aim to discover if testicular prosthesis could be responsible of sexual dysfunctions (erectile dysfunction or premature ejaculation). We evaluated a total of 67 men who underwent radical orchiectomy for testicular cancer and a silicon testicular prosthesis implantation from January 2008 to June 2014 at our Hospital. These patients completed 5 validated questionnaires the day before orchiectomy and 6 months after surgery: the International Index of Erectile Function 5 (IIEF5), the Premature Ejaculation Diagnostic Tool (PEDT), the Body Exposure during Sexual Activities Questionnaire (BESAQ), the Body-Esteem Scale and the Rosenberg Self- Esteem Scale. We also evaluated 6 months after surgery any defects of the prosthesis complained by the patients. The questionnaires completed by patients didn't show statistically significant changes for erectile dysfunction (p > 0.05) and premature ejaculation (p > 0.05). On the contrary the psychological questionnaires showed statistically significant change for the BESAQ (p < 0.001) and the Body Esteem Scale (p < 0.001), but not for the Rosenberg Self-Esteem Scale (p > 0,05). A total of 15 patients (22.37%) were dissatisfied about the prosthesis: the most frequent complaint (8 patients; 11.94%) was that the prosthesis was firmer than the normal testis. Testicular prosthesis implantation is a safe surgical procedure that should be always proposed before orchiectomy for cancer of the testis. The defects complained by patients with testicular prosthesis are few, they don't influence sexual activity and they aren't able to cause erectile dysfunction or premature ejaculation.

  20. The transport of octamethylcyclotetrasiloxane (D4) and polydimethylsiloxane (PDMS) in lightly cross-linked silicone rubber.

    PubMed

    Wolf, C J; Jerina, K L; Brandon, H J; Young, V L

    2001-01-01

    The transport of octamethylcyclotetrasiloxane (D4), one of the major constituents of silicone fluids and rubbers, and low viscosity polydimethylsiloxane oil into a silica filled cross-linked silicone elastomeric rubber was measured as a function of temperature, cross-link density of the rubber, and concentration of the D4 in methanol solution. A small amount of material, approximately 3 wt%, is extracted from the rubber with hexane. The extraction process has a large effect upon D4 solubility in the rubber, increasing from approximately 160 to 180 wt% after extraction. The heats of solution for both penetrants into the rubber are essentially zero and the activation energies for diffusion are small, approximately 8 and 15 kJ molt(-1) for D4 and PDMS, respectively. The diffusion process is Fickian and the diffusion coefficient of D4 into silicone/silica rubbers is essentially independent of concentration over the concentration investigated, i.e. from 1 to 100 vol% D4 in methanol. The permeability, i.e. the product of the diffusion coefficient and the solubility, decreases rapidly for D4 concentrations less than 50 vol% (0.1 mol fraction). This suggests that the permeation of D4 out of any encapsulation device, such as a silicone breast implant, is linearly dependent upon the concentration of D4 in the prosthesis. Swelling is isotropic and was measured by dimensional changes in rectangular samples and correlates well with the volume of D4 sorbed.

  1. Application of carbon nanotubes layered on silicon wafer for the detection of breast cancer marker carbohydrate antigen 15-3 by immuno-polymerase chain reaction.

    PubMed

    Sadhasivam, S; Chen, Jung-Chih; Savitha, S; Chang, Chun-Wei; Lin, Feng-Huei

    2014-01-01

    A highly sensitive detection of breast cancer marker, carbohydrate antigen 15-3 (CA 15-3) by carbon nanotube (CNT) based immuno-polymerase chain reaction was reported. The study was aimed to develop a precise and sensitive method to diagnose breast cancer and its recurrence. The hydrofluoric acid (HF) treated silicon wafer layered with bundled CNT was used as the substrate. The surface was treated with HNO3/H2SO4 to graft carboxyl groups on the tips of CNT. Subsequently, polyoxyethylene bis-amine was grafted to conjugate anti human CA 15-3 antibodies. Water contact angle measurement, scanning electron microscope, Fourier transform infrared spectrometer, Raman spectrometer and sodium dodecyl sulfate polyacrylamide gel electrophoresis were employed to confirm the surface modification. The captured antibodies on the CNT were used to capture the target antigen CA 15-3 and the biotinylated secondary antibodies were subsequently bound with the target antigen. A bi-functional streptavidin was used to link biotinylated DNA to the biotinylated detection antibodies. The biotinylated target DNA was amplified by PCR, and then analyzed by agarose gel electrophoresis. The lower limit of detection of CA 15-3 by the proposed immuno-PCR system was 0.001 U/mL, which is extremely sensitive than the other bioanalytical techniques.

  2. Intraocular retinal prosthesis.

    PubMed Central

    Humayun, M S

    2001-01-01

    stimulus duration (P < .05). In all groups, short duration pulses (40, 80, and 120 microseconds) were more efficient in terms of total charge (the product of pulse amplitude and pulse duration) than longer (500 and 1,000 microseconds) pulses (P < .05). In all groups, applying a pulse train did not lead to more efficient charge usage (P < .05). Psychophysical experiments: In high-contrast tests, facial recognition rates of over 75% were achieved for all subjects with dot sizes of up to 31.5 minutes of arc when using a 25 x 25 grid with 4.5 arc minute gaps, a 30% dropout rate, and 6 gray levels. Even with a 4 x 4 array of pixels, some subjects were able to accurately describe 2 of the objects. Subjects who were able to read the 4-pixel letter height sentences (on the 6 x 10 and 16 x 16 array) seemed to have a good scanning technique. Scanning at the proper velocity tends to bring out more contrast in the lettering. The reading speed for the 72-point font is a bit slower than for the next smaller font. This may be due to the limited number of letters (3) visible in the window with this large font. CONCLUSIONS: Specific parameters needed to stimulate the retina were identified. Delineating the optimum parameters will decrease the current requirements. Psychophysical tests show that with limited pixels and image processing, useful vision is possible. Both these findings should greatly simplify the engineering of an electronic retinal prosthesis. PMID:11797315

  3. [Speech rehabilitation using Provox voice prosthesis].

    PubMed

    Morshed, Kamal; Gołabek, Wiesław; Szymański, Marcin; Olszański, Witold

    2005-01-01

    The first voice prosthesis was described in 1972 by Mozolewski. Eight years later Blom and Singer constructed the first commercial prosthesis. In 1988 another prosthesis was presented as Provox system prosthesis. The aim of the study was to describe the technique of tracheoesophageal puncture (TEP) and to present two years results of the technique performed in 21 patients. Primary TEP with immediate implantation of the Provox 2 prosthesis was applied in 16 (76%) patients. In five patients (24%) secondary TEP was performed. All the patient with primary TEP had cricopharyngeal myotomy. In 7 patients the vocal prosthesis was exchanged. In five because of leakage through the valve and in two patients the vocal prosthesis was extruded. Leakage around the prosthesis occurred in two patients with secondary TEP. The mean device-related lifetime was 216 days and ranged from 30 to 540 days. In non-radiated patients the lifetime of the prosthesis was 255 days and in patients after radiotherapy the lifetime was 150 days. In all the patients the prosthetic voice was more similar to normal voice than in patients with esophageal speech. The implantation of the voice prosthesis is a simple method of restoring of a good quality voice enabling communication.

  4. 21 CFR 878.3800 - External aesthetic restoration prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ....3800 Section 878.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... is a device intended to be used to construct an external artificial body structure, such as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with...

  5. 21 CFR 878.3800 - External aesthetic restoration prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ....3800 Section 878.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... is a device intended to be used to construct an external artificial body structure, such as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with...

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

    PubMed

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

    2016-02-01

    Several companies offer anatomically shaped breast implants but differences among manufacturers are often misunderstood. The shell texture is a crucial parameter for anatomically shaped implants to prevent rotation and to decrease the risk of capsular contracture, even though concerns have recently been raised concerning the complications associated with textured breast implants. The aim of this study was to characterize differences in terms of texture, cell adhesion, shape, and stiffness between some commonly used anatomically shaped implants from three different manufacturers. Five commercially available anatomically shaped breast implants from 3 different manufacturers (Allergan, Mentor, and Sebbin) were used. Scanning electron microscopy, X-ray microtomography, and scanning mechanical microscopy were used to characterize the shell texture. Human fibroblast adhesion onto the shells was evaluated. 3D models of the implants were obtained using CT-scan acquisitions to analyze their shape. Implant stiffness was evaluated using a tractiometer. Major differences were observed in the topography of the textures of the shells, but this was not conveyed by a statistically significant fibroblast adhesion difference. However, fibroblasts adhered better on anatomically shaped textured implants than on smooth implants (p < 0.01). Our work pointed out differences in the Biocell® texture in comparison with older studies. The 3D analysis showed significant shape differences between the anatomically shaped implants of the 3 companies, despite similar dimensions. Implant stiffness was comparable among the 3 brands. Each texture had its specific topography, and this work is the first description of Sebbin anatomic breast implant texturation. Moreover, major discrepancies were found in the analysis of the Biocell® texture when comparing our results with previous reports. These differences may have clinical implications and are discussed. This study also highlighted major shape

  7. 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

  8. Tracheostomy cannulas and voice prosthesis.

    PubMed

    Kramp, Burkhard; Dommerich, Steffen

    2009-01-01

    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.

  9. 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.

  10. 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.

  11. 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.

  12. The Salto Talaris XT Revision Ankle Prosthesis.

    PubMed

    Roukis, Thomas S

    2015-10-01

    The Salto Talaris XT Revision Ankle Prosthesis is an anatomically designed fixed-bearing prosthesis available in the United States based on the design of previous Salto systems. The Salto Talaris XT Revision Ankle Prosthesis design optimizes surface area, cortical contact, and ultrahigh-molecular-weight polyethylene conformity. Two tibial component designs, both with the same base plate dimensions, are available, the standard conical fixation plug affixed to a short keel and a long-stemmed version. The author presents an overview of the Salto Talaris XT Revision Ankle Prosthesis surgical technique and pearls for successful application.

  13. Photovoltaic retinal prosthesis: implant fabrication and performance

    PubMed Central

    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

    2012-01-01

    Objective To develop and test a photovoltaic retinal prosthesis for restoring sight to patients blinded by degenerative retinal diseases. Approach 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 (280μm, 140 μm, and 70 μm) with active electrodes of 80 μm, 40 μm and 20 μm in diameter were fabricated. Main results The turn-on voltages of one-, two- and three-series-connected photodiode structures are approximately 0.6V, 1.2V and 1.8V, respectively. The measured photo-responsivity per diode at 880 nm wavelength is ~0.36 A/W, 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. Significance 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. PMID:22791690

  14. 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.

  15. Penile prosthesis implantation: past, present and future.

    PubMed

    Simmons, M; Montague, D K

    2008-01-01

    Penile prosthesis implantation is the oldest effective treatment for erectile dysfunction. This review examines the past, present and future of penile prosthesis implantation. Advances in prosthetic design and implantation techniques have resulted today in devices that produce nearly normal flaccid and erect states, and have remarkable freedom from mechanical failure. The future of prosthetic design holds promises for even more improvements.

  16. 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 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....

  17. 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....

  18. 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....

  19. 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....

  20. 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....

  1. 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....

  2. 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....

  3. 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....

  4. 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....

  5. 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 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....

  6. 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....

  7. 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....

  8. 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....

  9. 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....

  10. 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....

  11. 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 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....

  12. 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....

  13. 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....

  14. 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. (a...

  15. 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

  16. 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....

  17. Femoral Prosthesis Infection by Rhodotorula mucilaginosa▿

    PubMed Central

    Savini, Vincenzo; Sozio, Federica; Catavitello, Chiara; Talia, Marzia; Manna, Assunta; Febbo, Fabio; Balbinot, Andrea; Di Bonaventura, Giovanni; Piccolomini, Raffaele; Parruti, Giustino; D'Antonio, Domenico

    2008-01-01

    This case report is a case history of a femoral prosthesis infection caused by Rhodotorula mucilaginosa in a human immunodeficiency virus patient. Though the pathogenicity of this organism for bone tissue has been previously reported, this is the first reported case of an orthopedic prosthesis infection by this species of the genus Rhodotorula. PMID:18753353

  18. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Testicular prosthesis. 876.3750 Section 876.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3750 Testicular prosthesis. (a...

  19. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Testicular prosthesis. 876.3750 Section 876.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3750 Testicular prosthesis. (a...

  20. Semiconstrained Distal Radioulnar Joint Prosthesis

    PubMed Central

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

    2013-01-01

    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

  1. Penile Prosthesis Implantation in Priapism.

    PubMed

    Yücel, Ömer Barış; Pazır, Yaşar; Kadıoğlu, Ateş

    2017-09-12

    Priapism is defined as a full or partial erection lasting longer than 4 hours after sexual stimulation and orgasm or unrelated to sexual stimulation. The main goal of priapism management is to resolve the episode immediately to preserve erectile function and penile length. Corporal smooth muscle necrosis is likely to have already occurred, and medically refractory erectile dysfunction is expected in patients with a protracted episode. Penile prosthesis implantation (PPI) in the early or late phase of priapism can restore erectile function. To review the literature on PPI in priapism. A PubMed search of all English-language articles published before 2017 was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement using the following search terms: penile prosthesis implantation, priapism, and corporal fibrosis. All publications reporting on PPI during or after priapism episodes were included for review. Three types of priapism were reviewed for management using PPI. Surgical techniques, outcomes, and patient satisfaction were reported. Early implantation (during the episode) is technically easier and has lower complication rates compared with delayed (electively, after the erectile dysfunction is observed) surgery. Immediate PPI also allows preservation of penile length, which is related to higher satisfaction rates. The paradigm is shifting toward immediate PPI in the management of ischemic priapism. Patients with non-ischemic priapism or recurrent priapism, even without a major ischemic episode, are at high risk for erectile dysfunction and are candidates for PPI. Yücel ÖB, Pazir Y, Kadıoğlu A. Penile Prosthesis Implantation in Priapism. Sex Med Rev 2017;X:XXX-XXX. Copyright © 2017. Published by Elsevier Inc.

  2. Light-weight ocular prosthesis.

    PubMed

    Brito Edias, R; Rezende, J R; Carvalho, J C

    1994-01-01

    The authors propose a variation of the technique for making ocular protheses for large ophthalmic cavities introducing an expanded polystyrene (styrofoam) to the acrylic resin at the time of making the prosthetic sclera, aiming at reducing the weight of the prosthesis and thus improving mobility and aesthetics. This study compares the differences in weight, absorption of water and resistance to rupture by hydrostatic pressure of the pieces made of acrylic resin, chemically activated, heat activated and cross-linked by the proposed technique and by the technique for hollow ocular prothesis. The proposed technique presents advantages in manufacturing time and handling of the material.

  3. Parametric modelling of a knee joint prosthesis.

    PubMed

    Khoo, L P; Goh, J C; Chow, S L

    1993-01-01

    This paper presents an approach for the establishment of a parametric model of knee joint prosthesis. Four different sizes of a commercial prosthesis are used as an example in the study. A reverse engineering technique was employed to reconstruct the prosthesis on CATIA, a CAD (computer aided design) system. Parametric models were established as a result of the analysis. Using the parametric model established and the knee data obtained from a clinical study on 21 pairs of cadaveric Asian knees, the development of a prototype prosthesis that suits a patient with a very small knee joint is presented. However, it was found that modification to certain parameters may be inevitable due to the uniqueness of the Asian knee. An avenue for rapid modelling and eventually economical production of a customized knee joint prosthesis for patients is proposed and discussed.

  4. Three-dimensional mapping and comparative analysis of the distal human corpus cavernosum and the inflatable penile prosthesis

    PubMed Central

    Hakky, Tariq S; Ferguson, Daniel; Spiess, Philippe E; Bradley, Paul; Lue, Tom F; Carrion, Rafael E

    2013-01-01

    The intricate anatomy of the corpus cavernosum in both the flaccid and tumescent state has not been fully elucidated. We report our experience using a three-dimensional (3D) scanner to reconstruct cadaveric casts and compare them with 3D images of two prototypes of penile prosthesis. Two different models of the Titan Coloplast inflatable penile prosthesis were analyzed using a 3D scanner. The first was the standard model and the second was a newer model with a rounder silicone tip. Two cadaveric phalluses were harvested using Smooth-Cast 300Q polyurethane molding. The molds were excised and scanned along side the penile prosthesis. 3D scans were completed and analyzed using Leios Mesh software, and GOM Inspect software. The 3D scans demonstrated the mean human corporal radii 2 mm from the distal tip to be 36.51 mm (36.01–37.0 mm), which is an obtuse angle. The standard Titan penile prosthesis spherical radius at the same level was 202.52 mm, while the new silicone tip prosthesis had a radius of 139.33 mm. 3D mapping further demonstrated the trajectory of the cavernosa appeared curvilinear and the distal ends appeared blunt. The use of cadaveric cavernosal molds in combination with the 3D scanner allowed us to accurately image the corpus cavernosum for the first time. Our findings suggest that anatomically accurate corporal tips appear to be relatively blunt and that the new Titan silicone tip penile prosthesis more closely resembles the human corporal tip. PMID:23542138

  5. Three-dimensional mapping and comparative analysis of the distal human corpus cavernosum and the inflatable penile prosthesis.

    PubMed

    Hakky, Tariq S; Ferguson, Daniel; Spiess, Philippe E; Bradley, Paul; Lue, Tom F; Carrion, Rafael E

    2013-07-01

    The intricate anatomy of the corpus cavernosum in both the flaccid and tumescent state has not been fully elucidated. We report our experience using a three-dimensional (3D) scanner to reconstruct cadaveric casts and compare them with 3D images of two prototypes of penile prosthesis. Two different models of the Titan Coloplast inflatable penile prosthesis were analyzed using a 3D scanner. The first was the standard model and the second was a newer model with a rounder silicone tip. Two cadaveric phalluses were harvested using Smooth-Cast 300Q polyurethane molding. The molds were excised and scanned along side the penile prosthesis. 3D scans were completed and analyzed using Leios Mesh software, and GOM Inspect software. The 3D scans demonstrated the mean human corporal radii 2 mm from the distal tip to be 36.51 mm (36.01-37.0 mm), which is an obtuse angle. The standard Titan penile prosthesis spherical radius at the same level was 202.52 mm, while the new silicone tip prosthesis had a radius of 139.33 mm. 3D mapping further demonstrated the trajectory of the cavernosa appeared curvilinear and the distal ends appeared blunt. The use of cadaveric cavernosal molds in combination with the 3D scanner allowed us to accurately image the corpus cavernosum for the first time. Our findings suggest that anatomically accurate corporal tips appear to be relatively blunt and that the new Titan silicone tip penile prosthesis more closely resembles the human corporal tip.

  6. Retinal prosthesis for the blind.

    PubMed

    Margalit, Eyal; Maia, Mauricio; Weiland, James D; Greenberg, Robert J; Fujii, Gildo Y; Torres, Gustavo; Piyathaisere, Duke V; O'Hearn, Thomas M; Liu, Wentai; Lazzi, Gianluca; Dagnelie, Gislin; Scribner, Dean A; de Juan, Eugene; Humayun, Mark S

    2002-01-01

    Most of current concepts for a visual prosthesis are based on neuronal electrical stimulation at different locations along the visual pathways within the central nervous system. The different designs of visual prostheses are named according to their locations (i.e., cortical, optic nerve, subretinal, and epiretinal). Visual loss caused by outer retinal degeneration in diseases such as retinitis pigmentosa or age-related macular degeneration can be reversed by electrical stimulation of the retina or the optic nerve (retinal or optic nerve prostheses, respectively). On the other hand, visual loss caused by inner or whole thickness retinal diseases, eye loss, optic nerve diseases (tumors, ischemia, inflammatory processes etc.), or diseases of the central nervous system (not including diseases of the primary and secondary visual cortices) can be reversed by a cortical visual prosthesis. The intent of this article is to provide an overview of current and future concepts of retinal and optic nerve prostheses. This article will begin with general considerations that are related to all or most of visual prostheses and then concentrate on the retinal and optic nerve designs. The authors believe that the field has grown beyond the scope of a single article so cortical prostheses will be described only because of their direct effect on the concept and technical development of the other prostheses, and this will be done in a more general and historic perspective.

  7. 21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Interarticular disc prosthesis (interpositional... disc prosthesis (interpositional implant). (a) Identification. An interarticular disc prosthesis... Food and Drug Administration on or before March 30, 1999, for any interarticular disc prosthesis...

  8. 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... prosthesis. (a) Identification. A total temporomandibular joint prosthesis is a device that is intended to be... and Drug Administration on or before March 30, 1999, for any total temporomandibular joint prosthesis...

  9. 21 CFR 872.3940 - Total temporomandibular joint prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Total temporomandibular joint prosthesis. 872.3940... prosthesis. (a) Identification. A total temporomandibular joint prosthesis is a device that is intended to be... and Drug Administration on or before March 30, 1999, for any total temporomandibular joint prosthesis...

  10. Wear testing of a DJOA finger prosthesis in vitro.

    PubMed

    Joyce, Thomas J

    2010-08-01

    Although the market for replacement of diseased metacarpophalangeal (MCP) joints is dominated by single-piece silicone prostheses, several two-piece designs have been implanted. One such is the Digital Joint Operative Arthroplasty (DJOA) which consists of a part-spherical stainless steel metacarpal component which articulates within a matching concave phalangeal component made of ultra high molecular weight polyethylene (UHMWPE). A DJOA MCP prosthesis was tested using a clinically-validated finger simulator while a second DJOA prosthesis acted as a statically-loaded soak-control. Testing ran to 7.1 million cycles of flexion-extension. It was found that the UHMWPE components, both test and control, gained in weight by a similar amount. Therefore apparently there was no wear of the test components. However, the initial and final surface finish values of the test stainless steel metacarpal head were relatively high. Calculations based on this roughness data, plus recent dynamically-loaded soak data, may explain the apparent lack of wear.

  11. Lower limb prosthesis utilisation by elderly amputees.

    PubMed

    Bilodeau, S; Hébert, R; Desrosiers, J

    2000-08-01

    The goal of prosthetic rehabilitation is to compensate for the loss of a limb by amputation by, in the case of a lower limb, encouraging walking, and to achieve the same level of autonomy as prior to the amputation. However, because of difficulties walking, elderly amputees may use their prosthesis to a greater or lesser degree or simply stop using it during the rehabilitation period. The objective of this research was to study factors such as physical and mental health, rehabilitation, physical independence and satisfaction with the prosthesis to understand why amputees use their prosthesis or not. The sample was composed of 65 unilateral vascular amputees 60 years old or over living at home. The information was collected from medical records, by telephone interview and by mail questionnaire. Prosthesis use was measured by a questionnaire on amputee activities developed by Day (1981). Eighty-one per cent (81%) of the subjects wore their prosthesis every day and 89% of this group wore it 6 hours or more per day. Less use of the prosthesis was significantly related to age, female gender, possession of a wheelchair, level of physical disability, cognitive impairment, poorer self-perceived health and the amputee's dissatisfaction. A multiple regression analysis showed that satisfaction, not possessing a wheelchair and cognitive integrity explained 46% of the variance in prosthesis use.

  12. Development of an inductively coupled epiretinal vision prosthesis.

    PubMed

    Stieglitz, T; Haberer, W; Lau, C; Goertz, M

    2004-01-01

    Electrical stimulation of the retina elicits visual perception in patients with retinitis pigmentosa. Using the potentials of microsystem technology, neural prostheses to restore vision become feasible that are completely implantable in the eye. In this paper, we describe the development of an inductively coupled epiretinal vision prosthesis. Microelectronic chips for data encoding and stimulation were assembled on flexible substrates with an integrated electrode array. The system was encapsulated with parylene C and silicone rubber. The receiver part was placed into an artificial intraocular lens. Microcables led to the stimulation array in the macula region. This prototype elicited spatio-temporal patterns in the visual cortex after electrical stimulation of the retina in the cat.

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

    PubMed

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

    2013-06-01

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

  14. Prosthesis

    MedlinePlus

    ... work better. Diseased or missing eyes, arms, hands, legs, or joints are commonly replaced by prosthetic devices. False teeth are known as dental prostheses. An artificial replacement of the jaw bone is called a ...

  15. Treatment of large persistent tracheoesophageal peristomal fistulas using silicon rings.

    PubMed

    Erdim, Ibrahim; Sirin, Ali Ahmet; Baykal, Bahadir; Oghan, Fatih; Guvey, Ali; Kayhan, Fatma Tulin

    Tracheoesophageal peristomal fistulae can often be solved by reducing the size of the fistula or replacing the prosthesis; however, even with conservative techniques, leakage around the fistula may continue in total laryngectomy patients. Also, several techniques have been developed to overcome this problem, including injections around the fistula, fistula closure with local flaps, myofascial flaps, or free flaps and fistula closure using a septal perforation silicon button. To present the results of the application of silicon ring expanding the voice prosthesis in patients with large and persistent peri-prosthetic fistula. A voice prosthesis was fitted to 42 patients after total laryngectomy. Leakage was detected around the prosthesis in 18 of these 42 patients. Four patients demonstrated improvement with conservative methods. Eight of 18 patients who couldn't be cured with conservative methods were treated by using primary suture closure and 4 patients were treated with local flaps. As silicon ring was applied as a primary treatment in the 2 remaining patients and also, applied to 2 patients who had recurrence after suture repair and to 2 patients who had recurrence after local flap implementation. Silicon rings were used in a total of 6 patients due to the secondary trachea-esophageal fistula. Patients were treated with provox-1 initially and later with provox-2. At the time of leakage around the fistula, 6 patients had provox-2. Fistulae were treated successfully in 6 patients, and effective speech of patients was preserved. Patients experienced no adaptation problem. Prosthesis changing time was not different between silicon rings expanded and normal prosthesis applied patients. Silicon ring combined voice prosthesis was used 26 times; there was no recurrence in fistula complication during 29±6 months follow up. Silicon rings for modified expanded voice prosthesis seems to be an effective treatment for persistent peri-prosthetic leakage, for both, fistula

  16. Prosthetic rehabilitation of a patient with finger amputation using silicone material.

    PubMed

    Goyal, Amita; Goel, Hemant

    2015-08-01

    Finger and partial finger amputations are commonly due to traumatic injuries; digit loss may also be attributed to congenital malformations and disease. Finger prostheses are difficult to fabricate as they demand both aesthetic and function. When dealing with these types of prostheses, the only method of gaining successful retention is to sleeve the remnant stump with thin silicone. A 28-year-old man reported with a chief complaint of unaesthetic look due to amputated ring finger of left hand. In this case, the remnant stump was missing, the adjacent ring finger was splinted and an adhesive retained prosthesis instead of ring retained or glove-on prosthesis was planned. The retention was achieved by extending the prosthesis to palmar crease. This article describes the rehabilitation of a finger with prosthesis, which is simple to construct, aesthetic, retentive and easy to maintain. The prosthesis thus fabricated merged with the adjacent tissues providing desired aesthetics and psychological boost to the patient. Final prosthesis was found with adequate retention. The patient was satisfied with the aesthetic of the prosthesis. Because of the missing residual stump, functional limitations were also there. This clinical report describes a technological process of designing and manufacturing a silicone rubber prosthesis for a patient who has a finger loss caused due to trauma. © The International Society for Prosthetics and Orthotics 2014.

  17. Automated lower limb prosthesis design

    NASA Astrophysics Data System (ADS)

    Bhatia, Gulab H.; Commean, Paul K.; Smith, Kirk E.; Vannier, Michael W.

    1994-09-01

    The design of lower limb prostheses requires definitive geometric data to customize socket shape. Optical surface imaging and spiral x-ray computed tomography were applied to geometric analysis of limb residua in below knee (BK) amputees. Residua (limb remnants after amputation) of BK amputees were digitized and measured. Surface (optical) and volumetric (CT) data of the residuum were used to generate solid models and specify socket shape in (SDRC I-DEAS) CAD software. Volume measurements on the solid models were found to correspond within 2% of surface models and direct determinations made using Archimedean weighing. Anatomic 3D reconstruction of the residuum by optical surface and spiral x-ray computed tomography imaging are feasible modalities for prosthesis design.

  18. 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.

  19. Visuomotor behaviours when using a myoelectric prosthesis

    PubMed Central

    2014-01-01

    Background A recent study showed that the gaze patterns of amputee users of myoelectric prostheses differ markedly from those seen in anatomically intact subjects. Gaze behaviour is a promising outcome measures for prosthesis designers, as it appears to reflect the strategies adopted by amputees to compensate for the absence of proprioceptive feedback and uncertainty/delays in the control system, factors believed to be central to the difficulty in using prostheses. The primary aim of our study was to characterise visuomotor behaviours over learning to use a trans-radial myoelectric prosthesis. Secondly, as there are logistical advantages to using anatomically intact subjects in prosthesis evaluation studies, we investigated similarities in visuomotor behaviours between anatomically intact users of a trans-radial prosthesis simulator and experienced trans-radial myoelectric prosthesis users. Methods In part 1 of the study, we investigated visuomotor behaviours during performance of a functional task (reaching, grasping and manipulating a carton) in a group of seven anatomically intact subjects over learning to use a trans-radial myoelectric prosthesis simulator (Dataset 1). Secondly, we compared their patterns of visuomotor behaviour with those of four experienced trans-radial myoelectric prosthesis users (Dataset 2). We recorded task movement time, performance on the SHAP test of hand function and gaze behaviour. Results Dataset 1 showed that while reaching and grasping the object, anatomically intact subjects using the prosthesis simulator devoted around 90% of their visual attention to either the hand or the area of the object to be grasped. This pattern of behaviour did not change with training, and similar patterns were seen in Dataset 2. Anatomically intact subjects exhibited significant increases in task duration at their first attempts to use the prosthesis simulator. At the end of training, the values had decreased and were similar to those seen in Dataset

  20. Intraoral angiosarcoma: treatment with a brachytherapy prosthesis.

    PubMed

    Rosen, Evan B; Ko, Eugene; Wolden, Suzanne; Huryn, Joseph M; Estilo, Cherry L

    2015-03-01

    Angiosarcomas are rare, malignant neoplasms of vascular origin that account for less than 1% of all soft tissue tumors. Angiosarcomas of the oral cavity are especially rare, and brachytherapy may be prescribed as a localized treatment to manage these malignancies. Intraoral brachytherapy requires collaboration between the radiation oncologist and a dental professional for the fabrication of the brachytherapy delivery prosthesis. This clinical report describes an intraoral angiosarcoma and the fabrication of an intraoral brachytherapy prosthesis to manage this malignancy.

  1. Comparison of mechanical properties of silicone and PVC (polyvinylchloride) cosmetic gloves for articulating hand prostheses.

    PubMed

    Smit, Gerwin; Plettenburg, Dick H

    2013-01-01

    Current articulating electric and body-powered hands have a lower pinch force (15-34 N) than electric hands with stiff fingers (55-100 N). The cosmetic glove, which covers a hand prosthesis, negatively affects the mechanical efficiency of a prosthesis. The goal of this study is to mechanically compare polyvinylchloride (PVC) and silicone cosmetic gloves and quantify the stiffness of the finger joints, the required actuation energy, and the energy dissipation during joint articulation. Six cosmetic gloves, identical in size but made from different materials, were mechanically tested: three PVC and three silicone. The silicone gloves required less work and dissipated less energy during flexing. They also had a lower joint stiffness and required a lower maximum joint torque. Based on energy requirements, joint stiffness, and required joint torque, the tested silicone glove is most suitable for application on an articulating hand prosthesis.

  2. Silicone metalization

    SciTech Connect

    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.

  3. Silicone metalization

    SciTech Connect

    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.

  4. 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.

  5. Experimental total wrapping of breast implants with acellular dermal matrix: a preventive tool against capsular contracture in breast surgery?

    PubMed

    Schmitz, Marweh; Bertram, Martin; Kneser, Ulrich; Keller, Andrea K; Horch, Raymund E

    2013-10-01

    Capsular contracture remains a hitherto unsolved complication after implantation of silicone gel-filled breast prostheses. Based on clinical and experimental data, the use of an acellular dermal matrix as a sheath around implants may lead to lesser capsular contracture acting as a proposed biological environment mimicking wound bed tissue. The aim of our study was to analyse the tissue reaction after implantation of silicone prosthesis with and without an envelope of acellular dermal matrix. Implantation of 60 silicone prostheses in the back of Lewis rats were carried out, randomly paired taking one rat from group A and one from group B. Group A included implants completely enveloped with xenogenic acellular dermis and group B undraped silicone implants. At 3, 6 and 12 weeks postoperatively, the samples were explanted and subjected to histological and immunohistochemical evaluation. A new myofibroblast tissue layer was identified in proximity to the implant in both groups. The thickness of the layer in group A was continuously thinner than in group B regarding the different explantation time points. Implants completely wrapped with acellular dermal matrix showed significantly lesser inflammatory signs at 3 and 12 weeks after implantation compared to controls. Cell proliferation after 12 weeks was significantly decreased in group A. The slight myofibroblast layer and reduced rate of inflammation and proliferation in the treatment group show a positive effect of total acellular dermal matrix envelope and hypothesise the decrease of capsular contracture in long-term periods. Copyright © 2013 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

  6. 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.

  7. Design and manufacturing of ear prosthesis by means of rapid prototyping technology.

    PubMed

    De Crescenzio, F; Fantini, M; Ciocca, L; Persiani, F; Scotti, R

    2011-03-01

    In this paper, the complete procedure to design and construct reusable moulds for implant-based ear prosthesis and manufacture substructures by means of a computer aided design-computer aided manufacturing (CAD-CAM) procedure and rapid prototyping (RP) technology is presented. The scan of the healthy ear, the virtual superimposition of its mirrored image on to the defective side, and the rapid manufacturing of the substructure and of the mould eliminate several steps of traditional procedures (wax, stone, try-in). Moreover, the precise design and customization of the substructure is presented, with the original and engineered shape for the retention of the silicone. The time and cost saving results of this protocol are presented together with a discussion of the main design features that make the prosthesis a stable and reproducible system to improve rehabilitation of patients with auricular defects or absence.

  8. The Timing of Implant Exchange in the Development of Capsular Contracture After Breast Reconstruction

    PubMed Central

    Weintraub, Jennifer L.; Kahn, David M.

    2008-01-01

    Objective: Capsular contracture is a common complication associated with reconstructive breast surgery. The optimal time interval between the completion of tissue expansion and placement of the permanent implant is arbitrary and incompletely studied in the literature. The aim of the study was to determine whether the time interval between completion of expansion and placement of the permanent implant would affect the incidence of capsular contracture. Methods: We conducted a retrospective study of 112 patients with breast cancer, including 140 breasts, who underwent postmastectomy tissue expander placement between 1997 and 2004. All patients underwent replacement of tissue expander with a permanent prosthesis. Data were collected retrospectively, including whether the patient smoked, underwent radiation therapy, had saline or silicone implant reconstruction, required reoperation after tissue expander placement or after permanent implant placement, Baker classification, and the interval between completion of expansion and placement of permanent implant. Results: We used a logistic regression model to incorporate the predictors of capsular contracture. Keeping all other predictors constant, we found that the time interval between implant exchange had no effect on capsular contracture. The only significant predictor of capsular contracture was whether the patient required a reoperation after the permanent implant was placed (P = .0001). Conclusions: Allowing the capsule around a tissue expander to mature does not significantly affect development of capsular contracture. However, a complication that necessitates disrupting the periprosthetic capsule of the permanent implant with an operation significantly increases odds of developing contracture. PMID:18587490

  9. Current status of breast reconstruction after mastectomy.

    PubMed

    Handel, N

    1991-11-01

    Breast reconstruction after mastectomy can make an important contribution to the quality of life of women with breast cancer. Reconstruction eliminates the need for a cumbersome external prosthesis, allows greater freedom in the selection of clothing styles, and makes a woman more comfortable undressing in front of others. Reconstruction also reduces anxiety and depression and helps a woman regain a sense of wholeness and femininity. Advances in breast reconstruction include improved types of implants, use of autogenous tissues, and refinements in nipple reconstruction. This article summarizes the "state of the art" in breast reconstruction, the various surgical techniques available, their indications, advantages, and potential drawbacks.

  10. 21 CFR 872.3950 - Glenoid fossa prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3950 Glenoid fossa prosthesis. (a) Identification. A glenoid fossa prosthesis is a device that is intended to be implanted in the temporomandibular...

  11. BELOW-ELBOW COSMETIC CONDYLE-SUSPENDED PROSTHESIS

    DTIC Science & Technology

    particular appeal to those amputees who desire a prosthesis for cosmetic reasons. However this type of prosthesis can be so built to provide a means for operating the active mechanical terminal device. (Author)

  12. 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.

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

    PubMed

    Handford, Matthew L; Srinivasan, Manoj

    2016-02-09

    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.

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

    NASA Astrophysics Data System (ADS)

    Handford, Matthew L.; Srinivasan, Manoj

    2016-02-01

    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.

  15. 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

  16. 21 CFR 872.3950 - Glenoid fossa prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Glenoid fossa prosthesis. 872.3950 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3950 Glenoid fossa prosthesis. (a) Identification. A glenoid fossa prosthesis is a device that is intended to be implanted in the...

  17. 21 CFR 872.3960 - Mandibular condyle prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Mandibular condyle prosthesis. 872.3960 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3960 Mandibular condyle prosthesis. (a) Identification. A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw...

  18. 21 CFR 872.3960 - Mandibular condyle prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mandibular condyle prosthesis. 872.3960 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3960 Mandibular condyle prosthesis. (a) Identification. A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw...

  19. 21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Interarticular disc prosthesis (interpositional... disc prosthesis (interpositional implant). (a) Identification. An interarticular disc prosthesis... Food and Drug Administration on or before March 30, 1999, for any interarticular disc...

  20. 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... prosthesis. (a) Identification. A total temporomandibular joint prosthesis is a device that is intended to be... and Drug Administration on or before March 30, 1999, for any total temporomandibular joint...

  1. 21 CFR 872.3950 - Glenoid fossa prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Glenoid fossa prosthesis. 872.3950 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3950 Glenoid fossa prosthesis. (a) Identification. A glenoid fossa prosthesis is a device that is intended to be implanted in the...

  2. 21 CFR 872.3950 - Glenoid fossa prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Glenoid fossa prosthesis. 872.3950 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3950 Glenoid fossa prosthesis. (a) Identification. A glenoid fossa prosthesis is a device that is intended to be implanted in the...

  3. 21 CFR 872.3960 - Mandibular condyle prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Mandibular condyle prosthesis. 872.3960 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3960 Mandibular condyle prosthesis. (a) Identification. A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw...

  4. 21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Interarticular disc prosthesis (interpositional... disc prosthesis (interpositional implant). (a) Identification. An interarticular disc prosthesis... Food and Drug Administration on or before March 30, 1999, for any interarticular disc...

  5. 21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Interarticular disc prosthesis (interpositional... disc prosthesis (interpositional implant). (a) Identification. An interarticular disc prosthesis... Food and Drug Administration on or before March 30, 1999, for any interarticular disc...

  6. 21 CFR 872.3960 - Mandibular condyle prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3960 Mandibular condyle prosthesis. (a) 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 human...

  7. 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... § 884.3650 Fallopian tube prosthesis. (a) Identification. A fallopian tube prosthesis is a device designed to maintain the patency (openness) of the fallopian tube and is used after reconstructive...

  8. 21 CFR 884.3650 - Fallopian tube prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Fallopian tube prosthesis. 884.3650 Section 884... § 884.3650 Fallopian tube prosthesis. (a) Identification. A fallopian tube prosthesis is a device designed to maintain the patency (openness) of the fallopian tube and is used after reconstructive...

  9. 21 CFR 884.3650 - Fallopian tube prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Fallopian tube prosthesis. 884.3650 Section 884... § 884.3650 Fallopian tube prosthesis. (a) Identification. A fallopian tube prosthesis is a device designed to maintain the patency (openness) of the fallopian tube and is used after reconstructive...

  10. 21 CFR 884.3650 - Fallopian tube prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Fallopian tube prosthesis. 884.3650 Section 884... § 884.3650 Fallopian tube prosthesis. (a) Identification. A fallopian tube prosthesis is a device designed to maintain the patency (openness) of the fallopian tube and is used after reconstructive...

  11. 21 CFR 884.3650 - Fallopian tube prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Fallopian tube prosthesis. 884.3650 Section 884... § 884.3650 Fallopian tube prosthesis. (a) Identification. A fallopian tube prosthesis is a device designed to maintain the patency (openness) of the fallopian tube and is used after reconstructive...

  12. 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...

  13. 21 CFR 872.3950 - Glenoid fossa prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Glenoid fossa prosthesis. 872.3950 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3950 Glenoid fossa prosthesis. (a) Identification. A glenoid fossa prosthesis is a device that is intended to be implanted in the temporomandibular...

  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 888.3720 - 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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 of...

  1. 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 of...

  2. 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 of...

  3. 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... 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 intended...

  4. 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 intended...

  5. 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 intended...

  6. 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..., and to provide vascular access. It is commonly constructed of materials such as...

  7. Fabrication of a provisional nasal prosthesis.

    PubMed

    Rosen, Evan B; Golden, Marjorie; Huryn, Joseph M

    2014-11-01

    A technique for making a provisional nasal prosthesis for interim use after the ablation of a midface tumor is described. The technique is especially useful for the re-creation of a nasal form in an expedient and cost-effective manner. A preoperative definitive cast, or moulage, of the patient that includes a nasal form is used to fabricate a vacuum form of the midface. The vacuum form is evaluated on the patient, the extension is adjusted, and an external adhesive knit liner is applied to give the appearance of a contoured nasal bandage. The provisional nasal prosthesis is attached with medical adhesive tape and removed daily by the patient. The prosthesis is easily replaced during the course of treatment and has been found to be functional and esthetically acceptable to those patients receiving care from the Dental Service at Memorial Sloan Kettering Cancer Center.

  8. 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.

  9. Acrylic Finger Prosthesis: A Case Report

    PubMed Central

    Bandela, Vinod; M, Bharathi; S V, Giridhar Reddy

    2014-01-01

    Hands basic function is to grasp, hold and manipulate items. Hand gesture is perhaps the most blatant example of non-verbal communication. Finger and partial finger amputations are most frequently encountered forms of partial hand loss. Common causes are traumatic injuries, congenital absence or malformations present great clinical challenges. In addition to immediate loss of grasp strength, finger absence may cause marked psychological trauma. Individuals who desire finger replacement usually have high expectation for the appearance of prosthesis. This clinical report portrays simple method to retain acrylic finger prosthesis. PMID:25302271

  10. A running controller for a powered transfemoral prosthesis.

    PubMed

    Huff, Amanda M; Lawson, Brian E; Goldfarb, Michael

    2012-01-01

    This paper describes a running controller for a powered knee and ankle prosthesis. The running controller was implemented on a powered prosthesis prototype and evaluated by a transfemoral amputee subject running on a treadmill at a speed of 2.25 m/s (5.0 mph). The ability of the prosthesis and controller to provide the salient features of a running gait was assessed by comparing the kinematics of running provided by the powered prosthesis to the averaged kinematics of five healthy subjects running at the same speed. This comparison indicates that the powered prosthesis and running controller are able to provide essential features of a healthy running gait.

  11. 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

  12. 21 CFR 878.3610 - Esophageal prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. Simplified, low cost below-knee prosthesis.

    PubMed

    Kijkusol, D

    1986-08-01

    Problems are encountered in using standard prostheses in developing countries, especially when the prostheses need repair and the amputees cannot come back to the workshop. Very simple, low cost and durable prostheses can solve this problem. The solution described has worked well with villagers in some rural areas of Thailand, where the inexpensive prosthesis permits walking bare-foot and through water and mud.

  18. Evolution of the reverse total shoulder prosthesis.

    PubMed

    Jazayeri, Reza; Kwon, Young W

    2011-01-01

    Over the last decade, reverse total shoulder arthroplasty has gained significant popularity due to its ability to address difficult reconstructive shoulder problems that could not be adequately treated in the past. The concept of the reverse shoulder prosthesis was introduced in the 1970s, but the initial attempts were associated with high complication and implant failure rates. The pioneering work of Paul Grammont (shifting the center of rotation medially and distally) and the development of the DELTA prosthesis have been fundamental to all subsequent reverse shoulder arthroplasty systems. These semiconstrained prostheses utilize the deltoid to improve function and stability of the shoulder joint by coupling a convex glenoid with a concave humeral component. Modern generations of reverse shoulder prosthesis continue to evolve on the fundamentals of Grammont. Though results of these new prosthesis demonstrate promising outcomes, many controversies and challenges continue to be refined. An historical review of the evolution of reverse shoulder arthroplasty is presented, as well as the currently expanding indications for its application.

  19. 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.

  20. Catastrophic failure of a monolithic zirconia prosthesis.

    PubMed

    Chang, Jae-Seung; Ji, Woon; Choi, Chang-Hoon; Kim, Sunjai

    2015-02-01

    Recently, monolithic zirconia restorations have received attention as an alternative to zirconia veneered with feldspathic porcelain to eliminate chipping failures of veneer ceramics. In this clinical report, a patient with mandibular edentulism received 4 dental implants in the interforaminal area, and a screw-retained monolithic zirconia prosthesis was fabricated. The patient also received a maxillary complete removable dental prosthesis over 4 anterior roots. At the 18-month follow-up, all of the zirconia cylinders were seen to be fractured, and the contacting abutment surfaces had lost structural integrity. The damaged abutments were replaced with new abutments, and a new prosthesis was delivered with a computer-assisted design and computer-assisted manufacturing fabricated titanium framework with denture teeth and denture base resins. At the 6-month recall, the patient did not have any problems. Dental zirconia has excellent physical properties; however, care should be taken to prevent excessive stresses on the zirconia cylinders when a screw-retained zirconia restoration is planned as a definitive prosthesis.

  1. Implant-Supported Auricular Prosthesis - An Overview.

    PubMed

    Sharma, Ashu; Rahul, G R; T Poduval, Soorya; Shetty, Karunakar

    2012-08-22

    Abstract Auricular defects can result from tumor resection, congenital malformations, and trauma. These defects lack hard or soft tissue undercuts, and prosthesis retention is obtained primarily by the use of skin adhesives. There are significant disadvantages to the use of skin adhesives.The margins of the facial prosthesis may be damaged by repeated application and removal of the adhesive, and occasionally a patient will have a toxic skin reaction. The retentive capacity of adhesives may be insufficient in mobile tissues or in moist environments. The presence of hair also complicates the use of skin adhesives. The use of craniofacial titanium implants for restoring auricular defects may provide many benefits. The quality of retention provided far exceeds that obtained with adhesives, and skin-penetrating osseointegrated implants have demonstrated an excellent level of predictability when placed in bone in the auricular area.The aim of this paper is to present concept and principles of maxillofacial implants, history, literature review , advantages and disadvantages, considerations in treatment planning, finally the treatment phases of an implant-supported auricular prosthesis in particular and prospective developments for ear prosthesis.

  2. Practical management of periprosthetic leakage in patients rehabilitated with a Provox® 2 voice prosthesis after total laryngectomy.

    PubMed

    Friedlander, Eviatar; Pinacho Martínez, Paloma; Poletti Serafini, Daniel; Martín-Oviedo, Carlos; Martínez Guirado, Tomás; Scola Yurrita, Bartolomé

    Periprosthetic leakage of liquids is a common complication in patients rehabilitated with voice prostheses. Our objective was to describe and review the results of procedures for treating periprosthetic leakage. This was a retrospective analysis of 41 patients rehabilitated with Provox® 2 voice prostheses between 1997 and 2015. We describe 3 techniques: periprosthetic silicon collar placement, injection of hyaluronic acid into the tracheoesophageal wall and the combination of the 2 techniques. We present a method to reduce the diameter of the tracheoesophageal fistula by removing the voice prosthesis and placing a nasogastric tube through the fistula. In the 3 groups treated with silicone collar (n=5, 13 procedures), hyaluronic acid injection (n=5, 9 procedures) and the combination of both techniques (n=3, 5 procedures), we observed an increase in prosthesis lifespan of an average of 56 days (range 7-118 days), 32 days (range 3-55 days) and 63 days (range 28-136 days), respectively. The tracheoesophageal fistula diameter reduction was performed in 100% (n=6) of patients. The use of silicone collars, injection of hyaluronic acid into the tracheoesophageal wall and the combination of both techniques for the treatment of periprosthesis leakage increase the lifespan of the prosthesis. Temporary prosthesis removal and placement of nasogastric tube has also been shown effective in our experience. These techniques are simple, inexpensive and reproducible, thereby reducing healthcare costs. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello. All rights reserved.

  3. Hearing results using the SMart piston prosthesis.

    PubMed

    Fayad, Jose N; Semaan, Maroun T; Meier, Josh C; House, John W

    2009-12-01

    SMart, a newly introduced piston prosthesis for stapedotomy, is a nitinol-based, heat-activated, self-crimping prosthesis. We review our hearing results and postoperative complications using this self-crimped piston prosthesis and compare them with those obtained using stainless steel or platinum piston prostheses. Audiometric results using the SMart piston are identical to those obtained using a conventional piston prosthesis. Retrospective chart review. Private neurotologic tertiary referral center. The 416 ears reviewed included 306 with a SMart prosthesis and 110 conventional prostheses. 61% were women. Mean follow-up time was 5.6 (standard deviation [SD], 6.3 mo) and 6.9 months (SD, 7.0 mo) for the 2 groups, respectively. Stapedotomy using the SMart or a conventional (non-SMart) prosthesis. Audiometric hearing results, including pure-tone average (PTA) and air-bone gap (ABG), and prevalence of postoperative complications. Mean postoperative PTA was 32.6 (SD, 16.8) dB for the SMart group and 29.4 (SD, 13.5) dB for the non-SMart group, with ABGs of 7.6 (SD, 8.9) and 6.0 (SD, 5.2) dB, respectively. Mean change (decrease) in ABG was 18.7 (SD, 13.1) dB for the SMart group and 19.9 (SD, 10.3) dB for the non-SMart group. High-frequency bone PTAs showed overclosure of 2.0 (SD, 7.9) dB for the SMart group and 3.6 (SD, 8.6) dB for the non-SMart group. Postoperative vertigo and tinnitus were infrequent. No significant differences in these audiometric outcomes or complication rates were noted between groups. There was no significant difference in rate of gap closure to within 10 dB (78.3 versus 84.2%, SMart and non-SMart, respectively) or 20 dB (94.2 and 98.0%). Compared with conventional stapes prostheses, the nitinol-based SMart is a safe and reliable stapes prosthesis that eliminates manual crimping without significantly altering the audiometric outcome. Complications are rare, but longer follow-up is needed before establishing long-term stability.

  4. Reading visual braille with a retinal prosthesis.

    PubMed

    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.

  5. 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.

  6. Grammont reverse prosthesis: design, rationale, and biomechanics.

    PubMed

    Boileau, Pascal; Watkinson, Duncan J; Hatzidakis, Armodios M; Balg, Frederic

    2005-01-01

    Combined destruction of the rotator cuff and the glenohumeral joint may lead to a painful and pseudo-paralyzed shoulder. In this situation a nonconstrained shoulder prosthesis yields a limited functional result or may even be contraindicated. Previous constrained prostheses (ball-and-socket or reverse ball-and-socket designs) have failed because their center of rotation remained lateral to the scapula, which limited motion and produced excessive torque on the glenoid component, leading to early loosening. The reverse prosthesis designed by Paul Grammont, unlike any previous reverse ball-and-socket design, has introduced 2 major innovations that have led to its success: (1) a large glenoid hemisphere with no neck and (2) a small humeral cup almost horizontally oriented with a nonanatomic inclination of 155 degrees, covering less than half of the glenosphere. This design medializes and stabilizes the center of rotation, minimizes torque on the glenoid component, and helps in recruiting more fibers of the anterior and posterior deltoid to act as abductors. Furthermore, the humerus is lowered relative to the acromion, restoring and even increasing deltoid tension. The Grammont reverse prosthesis imposes a new biomechanical environment for the deltoid muscle to act, thus allowing it to compensate for the deficient rotator cuff muscles. The clinical experience does live up to the biomechanical concept: the reverse prosthesis restores active elevation above 90 degrees in patients with a cuff-deficient shoulder. However, external rotation often remains limited, particularly in patients with an absent or fat-infiltrated teres minor. Internal rotation is also rarely restored after a reverse prosthesis. Failure to restore sufficient tension in the deltoid may result in prosthetic instability. The design does appear to protect against early loosening of the glenoid component, but impingement of the humeral cup on the scapular neck can lead to scapular notching and polyethylene

  7. 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.

  8. 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.

  9. Wise pattern mastectomy with immediate breast reconstruction.

    PubMed

    Prathap, P; Harland, R N L

    2004-12-01

    A new technique of immediate breast reconstruction is presented. This technique uses a silicone implant placed in a subpectoral pocket, using de-epithelialised skin from the lower breast to augment the submuscular pocket, thus producing a compound myodermal flap. The technique is simple, and the resulting scar is cosmetically satisfactory; when combined with reduction mammoplasty on the opposite breast, this technique produces satisfactory breast symmetry.

  10. Tracheobronchial Foreign Body Aspiration: Dental Prosthesis

    PubMed Central

    Köse, Ataman; Kostak, Dilek; Aramagan, Erol; Durak, Aslıhan; Seçkin, Nur Sezin; Dönmez, Serdar Süha; Melek, Hüseyin

    2014-01-01

    It is important to extract foreign bodies for avoiding life-threatening complications. They can lead to death if they are not treated. Different signs and symptoms could occur according to the complete or partial airway obstruction. Foreign body aspiration is a rare incident in adults. The organic foreign materials such as foods are found to be aspirated more commonly and are usually settled in the right bronchial system. However, dental prosthesis and teeth aspirations are rare in literature. In our study, a 52-year-old male patient who had aspirated the front part of his lower dental prosthesis accidentally is presented and the foreign body is extracted by using rigid bronchoscopy. There are many causes of aspiration but dental prosthetic aspirations should be kept in mind during sleep. For this reason, dental apparatus must be taken out while asleep. PMID:25165606

  11. Multigrasp Myoelectric Control for a Transradial Prosthesis

    PubMed Central

    Dalley, Skyler A.; Varol, Huseyin Atakan; Goldfarb, Michael

    2012-01-01

    This paper presents the design and preliminary experimental verification of a multigrasp myoelectric controller. The controller enables the direct and proportional control of a multigrasp transradial prosthesis through a set of nine postures using two surface EMG electrodes. Five healthy subjects utilized the multigrasp controller to manipulate a virtual prosthesis to experimentally quantify the performance of the controller in terms of real time performance metrics. For comparison, the performance of the native hand was also characterized using a dataglove. The average overall transition times for the multigrasp myoelectric controller and the native hand with the dataglove were found to be 1.49 and 0.81 seconds, respectively. The transition rates for both were found to be the same (99.2%). PMID:22275677

  12. Development and clinical application of a new testicular prosthesis

    PubMed Central

    Ning, Ye; Cai, Zhikang; Chen, Huixing; Ping, Ping; Li, Peng; Wang, Zhong; Li, Zheng

    2011-01-01

    A new type of testicular prosthesis made of silastic with an elliptical shape to mimic a normal testis was developed by our team and submitted for patenting in China. The prosthesis was produced in different sizes to imitate the normal testis of the patient. To investigate the effects and safety of the testicular prosthesis, 20 patients receiving testicular prosthesis implantation were recruited for this study. Follow-up after 6 months revealed no complications in the patients. All the patients answered that they were satisfied with their body image and the position of the implants, 19 patients were satisfied with the size and 16 patients were satisfied with the weight. These results show that the testicular prosthesis used in this study can meet patient's expectations. Patients undergoing orchiectomy should be offered the option to receive a testicular prosthesis implantation. The dimensions and weight of the available prosthetic implants should be further addressed to improve patient satisfaction. PMID:21927041

  13. 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

  14. Design and Control of a Powered Transfemoral Prosthesis.

    PubMed

    Sup, Frank; Bohara, Amit; Goldfarb, Michael

    2008-02-01

    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.

  15. [The esthetics of lower limb prosthesis].

    PubMed

    Gardrat, Franck

    2015-01-01

    The amputation, which is upper or lower limb, entails important consequences and often traumatic into subject amputee from a physical, psychological, interpersonal and social point of view. It acts on the body image unleashing different psychological disorders and alterations in the social and professional reality. The aesthetic prosthesis can be considered a good support to help the person regain a new body image of themselves, facilitating the process of physical rehabilitation and social integration.

  16. Control of dental prosthesis system with microcontroller.

    PubMed

    Kapidere, M; Müldür, S; Güler, I

    2000-04-01

    In this study, a microcontroller-based electronic circuit was designed and implemented for dental prosthesis curing system. Heater, compressor and valve were controlled by 8-bit PIC16C64 microcontroller which is programmed using MPASM package. The temperature and time were controlled automatically by preset values which were inputted from keyboard while the pressure was kept constant. Calibration was controlled and the working range was tested. The test results showed that the system provided a good performance.

  17. 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

  18. [Replacement of tracheo-esophageal Provox prosthesis].

    PubMed

    Biacabe, B; Laccourreye, O; Ménard, M; Hans, S; Brasnu, D

    2000-02-01

    To compare anesthesic techniques used between 1992 and 1997 at Laënnec Hospital for replacement by tracheo-esophageal Provox prosthesis: local and general anesthesia. Theoretical financial cost for replacement was estimated according to anaesthetic techniques. Provox in situ lifetime was calculated in 58 patients who underwent 115 and 49 replacements under general and local anaesthesia respectively. Age, sex, surgical and radiotherapy backgrounds, complications and anaesthetic techniques were studied as potential factors correlated with Provox in situ lifetime. Theoretical financial cost for replacement was estimated according to anaesthetic techniques. In 1992, 12% of Provox prosthesis were inserted under local anaesthesia and 54% in 1997. Provox in situ lifetime was either not influenced by anaesthetic techniques or other factors under analysis. The theoretical financial cost was estimated at 14, 341 FFrs and 6,048 FFrs for replacement under general and local anaesthesia respectively. Due to increased control of health care costs, we advocated local anaesthesia for Provox prosthesis replacement if control endoscopy is not required.

  19. A New Distal Radioulnar Joint Prosthesis

    PubMed Central

    Schuurman, Arnold H.

    2013-01-01

    Pain and instability of the distal radioulnar joint (DRUJ) are common sequelae following a fracture of the distal radius. Many soft tissue procedures have been described, not all of which are successful. Ulnar head replacement prostheses are available but do not always provide stability. We designed a two-part, easy to implant, distal radioulnar prosthesis and implanted it in 19 patients. The first prototype was inserted in 2002 and is still in place. During the study, the design was changed twice, resulting in three groups with four patients in group A, five in group B, and ten in group C. Unfortunately all five prostheses in group B had to be removed because of loosening, while only two prostheses in group C had to be removed, for nonprosthetic reasons. For the 12 patients who retained their prosthesis, forearm function increased while grip strength increased significantly. Pain scores decreased and the Disabilities of the Arm, Shoulder, and Hand (DASH) score improved but remained high. We conclude that the prosthesis offers a new treatment option for ulnar instability following distal ulnar resection. PMID:24436843

  20. Longitudinal performance of an implantable vestibular prosthesis.

    PubMed

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

    2015-04-01

    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. This article is part of a Special Issue entitled .

  1. 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

  2. Rehabilitation of Nose following Chemical Burn Using CAD/CAM Made Substructure for Implant Retained Nasal Prosthesis: A Clinical Report

    PubMed Central

    Bhagat, Tushar; Verma, A. K.; Gurumurthy, Vishwanath; Ali, Mariyam; Vadhwani, Preeti

    2017-01-01

    Insufficient knowledge of medical chemicals and their improper use have destructive effects. Accidental exposure to chemicals on facial tissue may result in large facial defect. For ages the tradition of piercing nose is common but improper use of unknown chemical for piercing has deleterious effect. Mostly rhinectomy defects are acquired caused by trauma or malignant diseases. Prosthetic rehabilitation is the preferred treatment of choice for any large rhinectomy defects as medical and surgical interventions are ineffective in developing esthetics. Main concern with the prosthesis for such defects is retention. This article describes rehabilitation of a patient with large size nasal defect created by chemical burn in childhood during piercing. Implant retained customized silicone nasal prosthesis was fabricated using simple O-ring attachments and innovative modified polyamide acrylic resin substructure acting as skeleton. PMID:28702265

  3. [Sarcoma of the breast].

    PubMed

    Haberthür, F; Almendral, A C; Feichter, G; Torhorst, J K

    1992-05-01

    Sarcoma of the breast represents only 0.2-1% of all mammary malignancies. This study reports 5 such cases, including 2 osteosarcomas, 1 fibro-, 1 lipo-, and 1 malignant fibrous sarcoma. The treatment used was mastectomy in 3 cases with excision of axillary lymph nodes. The remaining 2 patients were treated by simple mastectomy whereby 1 of these received a immediate reconstruction with a prosthesis. 1 patient demonstrated local recurrence and died. The remaining 4 patients did not develop neither metastases nor local recurrence and are still alive after an observing period between 12 months up to 17 years. Today, first-line treatment is wide local excision or simple mastectomy. Excision of the axillary lymphatics, adjuvant radiotherapy, and chemotherapy have been disappointing in the treatment of breast sarcoma.

  4. Enucleated eye model for intraocular retinal prosthesis implantation.

    PubMed

    Ratanapakorn, Tanapat; Ameri, Hossein; Humayun, Mark S; Weiland, James D

    2006-01-01

    An enucleated porcine eye model was developed to assess intraocular retinal prosthesis implantation surgery. The surgical technique consists of corneal and crystalline lens removal, keratoprosthesis replacement, and vitrectomy. To test the eye model, the scleral incision was increased to 5 mm and a 10-mm wide retinal prosthesis folded and inserted. One retinal tack was used to fix the prosthesis to the retina. A retinal prosthesis array was inserted without significant damage to the array and conformed to the curvature of the eye. Fundus photography and optical coherence tomography were performed at the end of surgery.

  5. Hearing results after stapedotomy with a nitinol piston prosthesis.

    PubMed

    Brown, Kevin D; Gantz, Bruce J

    2007-08-01

    To compare the hearing results in patients with otosclerosis who underwent a stapedotomy with either a platinum wire prosthesis or a commercially available, heat-activated nitinol stapes piston prosthesis. Retrospective medical chart review. Academic tertiary care medical center. Seventy-nine consecutive patients diagnosed as having otosclerosis who underwent primary stapedotomy (33 men and 46 women) were included in this study (41 ears per group). Stapedotomy. The operative records of the senior surgeon (B.J.G.) were retrospectively reviewed, and hearing results were obtained. The hearing results of the patients who received a platinum wire prosthesis were compared with those who received a nitinol prosthesis. Results for the platinum wire prosthesis group revealed a postoperative mean (SD) air-bone gap (ABG) of 7 (6) dB, a mean (SD) ABG closure of 21 (12) dB, and a postoperative mean (SD) speech reception threshold of 25 (16) dB. Results for the nitinol prosthesis group revealed a postoperative ABG of 8 (6) dB, an ABG closure of 25 (10) dB, and a postoperative speech reception threshold of 25 (12) dB. These data show that the nitinol prosthesis is equivalent to the platinum wire prosthesis in closing the ABG in patients with otosclerosis. Comparable efficacy combined with the ease and safety of heat-activated crimping supports the continued use of this prosthesis for stapes surgery.

  6. Improved comfort and function of arm prosthesis after implantation of a Humerus-T-Prosthesis in trans-humeral amputees.

    PubMed

    Witsø, Eivind; Kristensen, Tomm; Benum, Pål; Sivertsen, Svein; Persen, Leif; Funderud, Are; Magne, Tordis; Aursand, Hans Petter; Aamodt, Arild

    2006-12-01

    The use of arm prosthesis in trans-humeral amputees is limited; due to the cone form of the amputation stump. A Humerus-T-Prosthesis was implanted in three patients to create artificial humerus condyles. Two of the patients were successfully rehabilitated with the application of a new type trans-humeral arm prosthesis. This arm prosthesis had a socket which is suspended and stabilized by the humerus and implant only. Traction and rotational stability were secured by adjustable pressure adaptation around the artificial condyles. The third patient developed a pressure wound over the lateral part of the artificial condyle that later healed. He also was subject to a new trauma with a fracture of the ipsilateral scapula and until now has had limited the use of his new arm prosthesis. It was concluded that this new concept for prosthesis fitting of trans-humeral amputees looks promising, but alternative designs of the implant should be tested.

  7. Preliminary silicone putty casts: diagnosis to final impression for complete dentures.

    PubMed

    Kinderknecht, K E; Dominici, J T; Clark, E P

    1996-04-01

    Silicone putty casts are useful for articulating existing dentures for evaluation and problem solving before relining procedures are performed or a new prosthesis is made. Tissue health may require significant modification of the existing dentures and treatment with tissue-conditioning material before final impressions are made. This practical procedure uses a functional impression that substitutes for a quality preliminary impression and combines tissue conditioning, a functional impression, silicone putty cast, custom final impression tray, and a final impression for a complete denture.

  8. 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 ...

  9. Breast infection

    MedlinePlus

    ... slowly, over several weeks, rather than quickly stopping breastfeeding Alternative Names Mastitis; Infection - breast tissue; Breast abscess Images Normal female breast anatomy Breast infection Female breast References Hunt KK, Mittendorf ...

  10. Low Risk of Skin and Nipple Sensitivity and Lactation Issues After Primary Breast Augmentation with Form-Stable Silicone Implants: Follow-Up in 4927 Subjects

    PubMed Central

    Lund, Herluf G.; Turkle, Janet; Jewell, Mark L.; Murphy, Diane K.

    2016-01-01

    Background Natrelle 410 implants (Allergan, Inc., Irvine, CA) are approved in the United States for breast augmentation, reconstruction, and revision. Objectives To assess the risk of nipple and skin sensation changes and lactation issues in subjects receiving implants for primary breast augmentation and ascertain whether differences based on incision site exist. Methods We used 410 Continued Access study data to assess safety and effectiveness of devices implanted via inframammary or periareolar incision sites. Subjects were evaluated preoperatively and at 4 weeks, 6 months, and annually up to 10 years postoperatively. Lactation issues and nipple and skin sensation changes (hypersensitivity/paresthesia, loss of sensation) were assessed. Results The inframammary and periareolar cohorts comprised 9217 and 610 implanted devices, with mean follow-up of 4.1 years (range, 0-10.1 years) and 4.8 years (range, 0-10.1 years), respectively. In the inframammary cohort, risk of first occurrence of nipple sensation changes was 0.3% (95% CI: 0.2-0.5) at week 4 and month 6, and 0.4% (0.3-0.7) at year 10. Risk of skin sensation changes was 0.0% (95% CI: 0.0-0.2) at week 4, 0.1% (0.0-0.2) at month 6, and 0.1% (0.0-0.3) at all subsequent time points. No nipple or skin changes occurred in the periareolar cohort. Incidence of lactation issues was similar to that reported in postpartum women who did not have breast implants. Conclusions We found that the risk of nipple or skin sensation changes and lactation issues is low and provide long-term safety and effectiveness data on subjects receiving implants for primary breast augmentation. Level of Evidence: 3 Therapeutic PMID:27118002

  11. Low Risk of Skin and Nipple Sensitivity and Lactation Issues After Primary Breast Augmentation with Form-Stable Silicone Implants: Follow-Up in 4927 Subjects.

    PubMed

    Lund, Herluf G; Turkle, Janet; Jewell, Mark L; Murphy, Diane K

    2016-06-01

    Natrelle 410 implants (Allergan, Inc., Irvine, CA) are approved in the United States for breast augmentation, reconstruction, and revision. To assess the risk of nipple and skin sensation changes and lactation issues in subjects receiving implants for primary breast augmentation and ascertain whether differences based on incision site exist. We used 410 Continued Access study data to assess safety and effectiveness of devices implanted via inframammary or periareolar incision sites. Subjects were evaluated preoperatively and at 4 weeks, 6 months, and annually up to 10 years postoperatively. Lactation issues and nipple and skin sensation changes (hypersensitivity/paresthesia, loss of sensation) were assessed. The inframammary and periareolar cohorts comprised 9217 and 610 implanted devices, with mean follow-up of 4.1 years (range, 0-10.1 years) and 4.8 years (range, 0-10.1 years), respectively. In the inframammary cohort, risk of first occurrence of nipple sensation changes was 0.3% (95% CI: 0.2-0.5) at week 4 and month 6, and 0.4% (0.3-0.7) at year 10. Risk of skin sensation changes was 0.0% (95% CI: 0.0-0.2) at week 4, 0.1% (0.0-0.2) at month 6, and 0.1% (0.0-0.3) at all subsequent time points. No nipple or skin changes occurred in the periareolar cohort. Incidence of lactation issues was similar to that reported in postpartum women who did not have breast implants. We found that the risk of nipple or skin sensation changes and lactation issues is low and provide long-term safety and effectiveness data on subjects receiving implants for primary breast augmentation. LEVEL OF EVIDENCE 3: Therapeutic. © 2016 The American Society for Aesthetic Plastic Surgery, Inc.

  12. Hypoplasty of the breast due to x-ray irradiation

    SciTech Connect

    Wada, H.; Jinnai, K.; Urabe, H.

    1986-01-01

    We treated five women with hypoplasty of the breast induced by radiation. Only one of these women underwent mammaplasty with the use of a latissimus dorsi muscle flap and prosthesis. Hypoplasty of the breast is considered a result of imprudent utilization of x-ray irradiation of young patients with benign skin diseases. To prevent underdevelopment and hypoplasty, attention must be directed to the risk involved in radiation therapy for benign diseases.

  13. Silicone implant incompatibility syndrome (SIIS): a frequent cause of ASIA (Shoenfeld's syndrome).

    PubMed

    Cohen Tervaert, J W; Kappel, R M

    2013-07-01

    Silicon has a molecular mass of 28 daltons. In nature, silicon is found as silicon dioxide (silica) or in a variety of silicates (e.g., in talc or asbestos). Furthermore, silicon is present in silicones, polymerized siloxanes, which are often used as medical silicones in breast implants. Silicon exposure is associated with different systemic autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, progressive systemic sclerosis, and vasculitis. Remarkably, silicon in silicone-filled breast implants is considered to be safe, not increasing the risk of developing autoimmune diseases. We analyzed the impact of silicone-filled breast implants on the immune system in 32 consecutive patients attending a specialized autoimmunity clinic. All 32 patients had silicone implant incompatibility syndrome and complaints fulfilling the diagnostic criteria of ASIA (autoimmune/inflammatory syndrome induced by adjuvants). Furthermore, in 17 of the 32 patients, a systemic autoimmune disease was diagnosed, and 15 of the 32 patients had an impaired humoral immune system. Patients developed symptoms and signs after long-term follow-up, suggesting that these symptoms and signs started after implant aging and/or rupture. We postulate that silicon in silicone-filled breast implants may increase the risk of developing (auto) immune diseases and immune deficiencies.

  14. Prosthesis Socket Pressure Tools v. 1.0

    SciTech Connect

    Janik, Gregory

    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 on 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.

  15. 21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... implant). 872.3970 Section 872.3970 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3970 Interarticular disc prosthesis (interpositional implant). (a) Identification. An interarticular disc prosthesis...

  16. Novel knee joint mechanism of transfemoral prosthesis for stair ascent.

    PubMed

    Inoue, Koh; Wada, Takahiro; Harada, Ryuchi; Tachiwana, Shinichi

    2013-06-01

    The stability of a transfemoral prosthesis when walking on flat ground has been established by recent advances in knee joint mechanisms and their control methods. It is, however, difficult for users of a transfemoral prosthesis to ascend stairs. This difficulty is mainly due to insufficient generation of extension moment around the knee joint of the prosthesis to lift the body to the next step on the staircase and prevent any unexpected flexion of the knee joint in the stance phase. Only a prosthesis with an actuator has facilitated stair ascent using a step-over-step gait (1 foot is placed per step). However, its use has issues associated with the durability, cost, maintenance, and usage environment. Therefore, the purpose of this research is to develop a novel knee joint mechanism for a prosthesis that generates an extension moment around the knee joint in the stance phase during stair ascent, without the use of any actuators. The proposed mechanism is based on the knowledge that the ground reaction force increases during the stance phase when the knee flexion occurs. Stair ascent experiments with the prosthesis showed that the proposed prosthesis can realize stair ascent without any undesirable knee flexion. In addition, the prosthesis is able to generate a positive knee joint moment power in the stance phase even without any power source.

  17. 21 CFR 874.3730 - Laryngeal prosthesis (Taub design).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3730 Laryngeal prosthesis (Taub design). (a) Identification. A laryngeal prosthesis (Taub design) is a device intended to direct... device is interposed between openings in the trachea and the esophagus and may be removed and...

  18. 21 CFR 874.3695 - Mandibular implant facial prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3695 Mandibular implant facial prosthesis. (a) Identification. A mandibular implant facial prosthesis is a device that is intended to be implanted for use in the functional reconstruction of mandibular deficits. The device...

  19. 21 CFR 874.3730 - Laryngeal prosthesis (Taub design).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3730 Laryngeal prosthesis (Taub design). (a) Identification. A laryngeal prosthesis (Taub design) is a device intended to direct... device is interposed between openings in the trachea and the esophagus and may be removed and...

  20. 21 CFR 874.3695 - Mandibular implant facial prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3695 Mandibular implant facial prosthesis. (a) Identification. A mandibular implant facial prosthesis is a device that is intended to be implanted for use in the functional reconstruction of mandibular deficits. The device...

  1. 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

  2. Active prosthesis dependent functional cortical reorganization following stroke.

    PubMed

    Merkel, Christian; Hausmann, Janet; Hopf, Jens-Max; Heinze, Hans-Jochen; Buentjen, Lars; Schoenfeld, Mircea Ariel

    2017-08-17

    The present study investigated the neural correlates associated with gait improvements triggered by an active prosthesis in patients with drop-foot following stroke during the chronic stage. Eleven patients took part in the study. MEG recordings in conjunction with somatosensory stimulation of the left and right hand as well as gait analyses were performed shortly before or after prosthesis implantation surgery and 3-4 months later. Plastic changes of the sensorimotor cortex of the ipsi- and contralesional hemisphere were revealed. Gait analysis indicated that all patients improved their gait with the active prosthesis. Patients with larger plastic changes within the lesioned hemisphere maintained their improved gait performance even when the prosthesis was turned off. Patients with larger contralesional changes also improved their gait with the active prosthesis. However, their gait measures decreased when the prosthesis was turned off. The current data provide the neural basis of gait improvement triggered by an active prosthesis and has important implications with respect to the choice of the type of active prosthesis (implantable vs removable) and to the selection procedure of the patients (length of testing period).

  3. [Aortoenteric fistula secondary to aortobifemoral prosthesis infection].

    PubMed

    Gabriel Botella, F; Labiós Gómez, M; Ibáñez Gadea, L; Fácila Rubio, L; Carbonell Cantí, C

    2002-05-01

    We present the case of a 76 year-old man, intervened of an obstruction bilateral iliac by means of placement of a prosthesis aortobifemoral that presented pain in the grave left iliac and fever in needles of 39 degrees C to the five years of the intervention. In the physical exploration it highlighted a painful abdomen in the grave left iliac with signs of peritoneal irritation. In the laboratory tests a leukocytosis was detected with neutrophilia and negative culture. The computed thomography (CT) show the presence of gas bubbles around the prosthesis, as well as a liquid collection with areas necrotics in their interior that affected to the psoas and iliac muscles. In the same exploration the aspirative puncture with drainage of the absces demonstrated in the cultivations carried out in aerobic means the presence of Enterococcus faecalis and Enterobacter cloacae. When presenting a high gastrointestinal hemorrhage abruptly, he was practiced and gastroduodenal endoscope in which a aortoduodenal fistula was evidenced with having bled active. When a bypass extra-anatomic, the sick person will practice it died when presenting a shock abrupt hipovolemic that he didn't respond to the pertinent treatment. We analyze the approaches current diagnoses of infection of the vascular prosthesis and their more serious complication, the aortoenteric fistula (AEF) that either appears in the 0.3-5.9% of the patients who undergo prosthetic reconstruction of the abdominal aorta, for occlusive or aneurismal disease. We highlight the importance of carrying out a precocious diagnosis of the infection of the portion retroperitoneal of the vascular graft that, often, it is manifested with subtle and not specific clinical signs, with the techniques at the moment available as: the CT, fine needle aspiration guided by her, and to diminish the rates of mortality, from the current of 43%, until the most optimistic estimated in 19%.

  4. Auricular Prosthesis-A Case Report

    PubMed Central

    Ravuri, Rajyalakshmi; Bheemalingeshwarrao; Tella, Suchita; Thota, Kiran

    2014-01-01

    Loss of facial organs in an individual may be developmental anomalies or acquired. The missing parts of the face ear, eyes and nose are considered as maxillofacial defects which can be rehabilitated by the prosthesis and/or cosmetic surgeries. This art of science has developed into a more reliable and predictable process due to ever increasing development of materials and equipments used in the procedure. This article describes a simple technique to rehabilitate patients with auricular defects which are both aesthetically acceptable and economical for the individual. PMID:24596801

  5. Belgian experience with the Vibrant Soundbridge prosthesis.

    PubMed

    Thill, M P; Gérard, J M; Garin, P; Offeciers, E

    2002-01-01

    The Belgian Experience with the Vibrant Soundbridge Prosthesis. The authors present the first results obtained with 13 patients implanted with the Vibrant Soundbridge, a semi-implantable electromagnetic hearing device. The first patient was implanted in October 1998. The results show that there were no significant modifications of the hearing thresholds after implantation. The average functional gain was 30 dB in tonal audiometry and 25.6 dB in vocal audiometry. All the patients are satisfied with the device and wear it daily.

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

    PubMed

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

    2013-10-03

    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.

  7. 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

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

    PubMed Central

    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

  9. Clinical Appraisal of Indigenous Below Knee Endoskeletal Carbon Fibre Prosthesis.

    PubMed

    Pithawa, A K; Singh, Gurjit; Ravindranath, G

    2006-04-01

    Amputation is a catastrophe, which results in physical, social, psychological and economic handicap. Provision of suitable prosthesis (artificial limb) is a major step towards rehabilitation of these patients. With an aim to provide comfortable, prosthesis to these patients, Artificial Limb Centre (ALC) Pune, developed Below Knee Carbon Fibre Shaft Endo-Skeletal (BK ES CF) Prosthesis in collaboration with DEBEL, Bangalore, a DRDO establishment. 815 Below Knee Amputee patients have been provided with the newly developed Endo-skeletal prostheses at ALC Pune till 31 Dec 2003. New BK ESCF prosthesis was evaluated for its performance by feedback received from 500 patients. More than 86% patients were satisfied with the performance of new prosthesis and they achieved almost normal gait. The performance of new BK ESCF prostheses was excellent and it achieved good clientele satisfaction.

  10. 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

  11. Porosity and color of maxillofacial silicone elastomer.

    PubMed

    Hatamleh, Muhanad M; Watts, David C

    2011-01-01

    Prosthesis color production and stability as a result of pore entrapment during mixing has not been investigated for maxillofacial silicone prostheses. The purpose of this study was to investigate pore numbers and percentages of a maxillofacial silicone elastomer mixed by two different techniques, using X-ray microfocus computerized tomography (Micro-CT), and to investigate the effect of porosity on color reproducibility and stability after two different aging conditions. Sixty-four disk-shaped specimens were prepared (8-mm diameter, 3-mm thick) by mixing TechSil S25 silicone elastomer (Technovent, Leeds, UK) following two techniques: manual mixing (n = 32) and mechanical mixing under vacuum (n = 32). Half the specimens in each group were intrinsically pigmented, and the other half remained unpigmented. Pore numbers, volumes, and percentages were calculated using the Micro-CT, and then specimens of each subgroup were stored in simulated sebum for 6 months (n = 8), and exposed to accelerated daylight aging for 360 hours (n = 8). Color change (ΔE) was measured at the start and end of conditioning. Pore numbers and percentages were analyzed using one-way Analysis of Variance (ANOVA) and Dunnett's-T3 post-hoc tests (p < 0.05). Independent t-test was used to detect differences (p < 0.05) in ΔE between manually and mechanically mixed specimens, in both unpigmented and pigmented states and to detect differences (p < 0.05) in ΔE before and after conditioning within each mixing method. Mechanical mixing under vacuum reduced the number and percentage of pores in comparison to manual mixing, within pigmented and unpigmented silicone specimens (p < 0.05). Perceptible ΔE between manual and mechanical mixing techniques were 5.93 and 5.18 for both unpigmented and pigmented specimens, respectively. Under sebum storage, manually mixed unpigmented specimens showed lower ΔE (p < 0.05) than those that were mechanically mixed; however, pigmented silicone specimens showed the same

  12. 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,…

  13. 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,…

  14. Linguine sign in musculoskeletal imaging: calf silicone implant rupture.

    PubMed

    Duryea, Dennis; Petscavage-Thomas, Jonelle; Frauenhoffer, Elizabeth E; Walker, Eric A

    2015-08-01

    Imaging findings of breast silicone implant rupture are well described in the literature. On MRI, the linguine sign indicates intracapsular rupture, while the presence of silicone particles outside the fibrous capsule indicates extracapsular rupture. The linguine sign is described as the thin, wavy hypodense wall of the implant within the hyperintense silicone on T2-weighted images indicative of rupture of the implant within the naturally formed fibrous capsule. Hyperintense T2 signal outside of the fibrous capsule is indicative of an extracapsular rupture with silicone granuloma formation. We present a rare case of a patient with a silicone calf implant rupture and discuss the MRI findings associated with this condition.

  15. Satisfaction and problems experienced with wrist movements: comparison between a common body-powered prosthesis and a new biomechatronics prosthesis.

    PubMed

    Abd Razak, N A; Abu Osman, N A; Kamyab, M; Wan Abas, W A B; Gholizadeh, H

    2014-05-01

    This report compares wrist supination and pronation and flexion and extension movements with the common body-powered prosthesis and a new biomechatronics prosthesis with regard to patient satisfaction and problems experienced with the prosthesis. Fifteen subjects with traumatic transradial amputation who used both prosthetic systems participated in this study. Each subject completed two questionnaires to evaluate their satisfaction and problems experienced with the two prosthetic systems. Satisfaction and problems with the prosthetic's wrist movements were analyzed in terms of the following: supination and pronation; flexion and extension; appearance; sweating; wounds; pain; irritation; pistoning; smell; sound; durability; and the abilities to open a door, hold a cup, and pick up or place objects. This study revealed that the respondents were more satisfied with the biomechatronics wrist prosthesis with regard to supination and pronation, flexion and extension, pain, and the ability to open a door. However, satisfaction with the prosthesis showed no significant differences in terms of sweating, wounds, irritation, pistoning, smell, sound, and durability. The abilities to hold a cup and pick up or place an object were significantly better with the body-powered prosthesis. The results of the survey suggest that satisfaction and problems with wrist movements in persons with transradial amputation can be improved with a biomechatronics wrist prosthesis compared with the common body-powered prosthesis.

  16. Dimensional accuracy of 3 silicone dental impression materials.

    PubMed

    Hassan, A K

    2006-09-01

    This study was carried out to measure the dimensional changes in silicone impression material, which can affect the fitness of the prosthesis. Using both single and double mix techniques, 20 impression samples for each of 3 different proprietary silicones, Xantopren-H, President and Fulldent, were made. Selected measurements were made on the stone casts made from each impression. In all 3 cases, the single mix gave more accurate casts than the double mix technique. The Xantopren-H impressions had the most accurate dimensions.

  17. Silicon spintronics.

    PubMed

    Jansen, Ron

    2012-04-23

    Worldwide efforts are underway to integrate semiconductors and magnetic materials, aiming to create a revolutionary and energy-efficient information technology in which digital data are encoded in the spin of electrons. Implementing spin functionality in silicon, the mainstream semiconductor, is vital to establish a spin-based electronics with potential to change information technology beyond imagination. Can silicon spintronics live up to the expectation? Remarkable advances in the creation and control of spin polarization in silicon suggest so. Here, I review the key developments and achievements, and describe the building blocks of silicon spintronics. Unexpected and puzzling results are discussed, and open issues and challenges identified. More surprises lie ahead as silicon spintronics comes of age.

  18. Effects of image and education on the precision of the measurement method for evaluating prosthesis misfit.

    PubMed

    Mai, Hang-Nga; Eun Lee, Kyeong; Ha, Jung-Hong; Lee, Du-Hyeong

    2017-08-04

    Various methods for measuring prosthesis misfit have been suggested. Although the cross-sectional images between the crown and abutment are used to evaluate the misfit, the effects of the image and the observer's knowledge on the precision of measurement are unknown. The purpose of this in vitro study was to investigate the effects of the image and of education on the precision of prosthesis misfit measurement methods using inter- and intraobserver variability analyses. The cross-sectional images in the margin were obtained using the computer-aided replica technique (CART), silicone replica technique (RT), and sectioning technique (ST). Twenty-five observers measured the absolute marginal discrepancy values in the images obtained from each group 4 times at an interval of 2 weeks; the observers went through different education sessions regarding the selection of the measurement points. The precision of measurement was determined and compared using the likelihood-ratio test statistic (α=.05) and the intraclass correlation coefficient with the linear mixed-effects model. The CART group exhibited the smallest deviations in the measurement variations, followed by the ST and RT groups (P<.001). Additional education on misfit measurements generally decreased the deviation values in all the groups, but without any significant differences. The cross-sectional image obtained from the measurement methods and education on the evaluation method affected the precision of the prosthesis misfit measurement. Digital methods might be a useful tool to significantly enhance the precision of the measurements. Copyright © 2017 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  19. Management of Implant Exposure in One-Stage Breast Reconstruction Using Titanium-Coated Polypropylene Mesh: Sub-Mammary Intercostal Perforator Flap.

    PubMed

    De Riggi, Michele Antonio; Rocco, Nicola; Gherardini, Giulio; Esposito, Emanuela; D'Aiuto, Massimiliano

    2016-12-01

    One-stage implant-based breast reconstruction using titanium-coated polypropylene mesh is a novel approach widely used in Europe. Complication rates in breast reconstruction with the use of titanium-coated meshes seem to be comparable to those in patients with implant-based breast reconstruction alone. However, the use of synthetic meshes in implant-based breast reconstructive surgery leads to new clinical scenarios with the need for the breast surgeon to face new complications. We present an innovative treatment of implant exposure in the absence of infection in patients who underwent nipple-sparing mastectomy and immediate breast reconstruction with silicone implants and titanium-coated polypropylene mesh by using a pedicled sub-mammary intercostal perforator flap. Four patients who experienced implant exposure without infection have been treated with the use of a sub-mammary intercostal perforator flap. Whole coverage of the exposed implant/mesh with a sub-mammary intercostal perforator flap was obtained in all cases. No post-operative complications have been observed, whereas a pleasant aesthetic result has been achieved. Patients' post-operative quality of life and satisfaction levels were measured by the European Organisation for Research and Treatment of Cancer breast cancer-specific quality of life QLQ-BR23 questionnaire and showed an average good satisfaction with the post-operative outcomes (mean QLQ-BR23 score 1.9). For the first time, a sub-mammary intercostal perforator flap has been used with the aim of treating implant exposures without removing the prosthesis even in the presence of synthetic meshes, when wound infection was excluded. Although tested on a small series, the sub-mammary intercostal perforator flap might represent a simple, versatile and cost-effective procedure for the management of implant exposure following nipple-sparing mastectomy and immediate reconstruction with silicone implants and synthetic meshes. It should be considered to

  20. Fibroadenoma - breast

    MedlinePlus

    ... fibroadenoma; Breast lump - noncancerous; Breast lump - benign References Hacker NF, Friedlander ML. Breast disease: a gynecologic perspective. In: Hacker NF, Gambone JC, Hobel CJ, eds. Hacker and ...

  1. Care of the breast and support of breast-feeding.

    PubMed

    Bedinghaus, J M

    1997-03-01

    Primary care physicians can integrate care of the breasts through a woman's life cycle. Early and frequent nursing and careful attention to the infant's suckling position during the postpartum period can prevent several common problems. Neonatal jaundice, poor weight gain, mastitis, and candidiasis should be recognized and managed correctly. Outside the puerperium, fibrocystic change, nonlactational mastitis, and benign breast masses are encountered commonly. Problems related to silicone augmentation are discussed briefly.

  2. Protection of the small intestine against irradiation by means of a removable prosthesis

    SciTech Connect

    Sezeur, A.; Abbou, C.; Chopin, D.; Rey, P.; Leandri, J. )

    1990-07-01

    In radiation therapy of tumors, several techniques are used to prevent injury of the intestinal loops. Their purpose is to drive the intestine out of the external beam. Understanding the disadvantages they present, a temporary prosthesis which effectively protects the small bowel, and is easy to remove, has been developed. The device is a 600 to 1,000 ml, silicone rubber, expandable balloon. When implanted in the pelvis or retroperitoneal cavity, and filled, this balloon displaces the intestinal loops out of the pelvic irradiation field. It may remain either filled or empty between each irradiation session. Due to its particular elliptical shape, once empty, the balloon can be removed through a 3 cm incision under local or peridural anesthesia at the completion of radiotherapy. Eleven patients with recurrent (8) or primary (3) cancer have been implanted. The protective effect has been evaluated on successive biologic tests, performed during treatment. No problem related to the prosthesis, no alteration of the biologic tests, nor bowel injury have been observed after several months follow-up. This device is suitable for preventing intestinal complications during therapy, allowing a higher dose of radiations in some cases.

  3. A wide-field suprachoroidal retinal prosthesis is stable and well tolerated following chronic implantation.

    PubMed

    Villalobos, Joel; Nayagam, David A X; Allen, Penelope J; McKelvie, Penelope; Luu, Chi D; Ayton, Lauren N; Freemantle, Alexia L; McPhedran, Michelle; Basa, Meri; McGowan, Ceara C; Shepherd, Robert K; Williams, Chris E

    2013-05-01

    The safety of chronic implantation of a retinal prosthesis in the suprachoroidal space has not been established. This study aimed to determine the safety of a wide-field suprachoroidal electrode array following chronic implantation using histopathologic techniques and electroretinography. A platinum electrode array in a wide silicone substrate was implanted unilaterally in the suprachoroidal space in adult cats (n = 7). The lead and connector were tunneled out of the orbit and positioned subcutaneously. Postsurgical recovery was assessed using fundus photography and electroretinography (ERG). Following 3 months of passive implantation, the animals were terminated and the eyes assessed for the pathologic response to implantation. The implant was mechanically stable in the suprachoroidal space during the course of the study. The implanted eye showed a transient increase in ERG response amplitude at 2 weeks, which returned to normal by 3 months. Pigmentary changes were observed at the distal end of the implant, near the optic disc. Histopathologic assessment revealed a largely intact retina and a thin fibrous capsule around the suprachoroidal implant cavity. The foreign body response was minimal, with sporadic presence of macrophages and no active inflammation. All implanted eyes were negative for bacterial or fungal infections. A midgrade granuloma and thick fibrous buildup surrounded the extraocular cable. Scleral closure was maintained in six of seven eyes. There were no staphylomas or choroidal incarceration. A wide-field retinal prosthesis was stable and well tolerated during long-term suprachoroidal implantation in a cat model. The surgical approach was reproducible and overall safe.

  4. A different wax sculpture technique for implant-retained auricular prosthesis

    PubMed Central

    Demir, Necla; Cevik, Pınar; Okutan, Yener; Ozturk, A. Nilgun; Colpan, Bahar

    2015-01-01

    Replacement of missing ears is a challenging task in which extensive array of materials and techniques have been employed. This article describes a different and simplified procedure for fabricating auricular prostheses very similar to the intact left ear of the patient. A 65-year-old male patient was referred to the Department of Prosthodontics with the loss of the right ear. In this case, the impression was made using hydrocolloid material (alginate) from the both defected and the opposite side. After hardening of the stone casts, a custom-made transparent splint plate was designed for the left auricular side. The splint was reversed and a cast model of the right auricular side was obtained as pouring the dental stone into transparent orthodontic splint. After getting the impression from cast model, conventional wax pattern and try on process was done. Finally, silicone elastomer was polymerized and the retention of the prosthesis acquired with the magnetic attachments. The technique described is economical, conventional, and time-saving. Furthermore, the prosthesis imitates the patient's intact auricular tissue. PMID:26430376

  5. Proximal tendon-prosthesis junction for active tendon implants of the hand: a biomechanical comparison of 2 techniques.

    PubMed

    Thompson, Matthew J; Owen, John R; McDowell, Charles L; Wayne, Jennifer S

    2015-01-01

    To study the biomechanical characteristics (percent stretch, stiffness, and ultimate load) of 2 tendon-prosthesis techniques used to connect the proximal tendon stump to silicone active tendon implants used in reconstruction of flexor tendons. We evaluated percent stretch following cyclic loading and at failure, stiffness during load to failure, and ultimate load of 16 tendon-prosthesis junctions using cadaveric canine flexor digitorum profundus tendons to re-create 2 junction techniques: the tendon loop (TL) and the polyester weave (PW). The TL junction showed greater percent stretch at a static load of 2 N, following 500 cycles of loading between 2 N and 50 N, and at peak load. The PW junction displayed greater stiffness from 50 to 150 N during load to failure. Both junctions failed at a mean ultimate load greater than 220 N. The described proximal junction techniques for active tendon implants were strong enough to resist early active motion in the immediate postoperative period without significant elongation. The PW technique displayed greater stiffness and ultimate load compared with the TL. Data on tendon-prosthesis characteristics of these 2 methods may aid the surgeon in choosing which junction technique to use, during surgical tensioning decisions, and in considering activity protocols after surgery. These data may also serve as a baseline for further investigations regarding active tendon implants. Copyright © 2015 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

  6. Impact of Prior Tissue Expander/Implant on Postmastectomy Free Flap Breast Reconstruction.

    PubMed

    Roostaeian, Jason; Yoon, Alfred P; Ordon, Shannon; Gold, Chris; Crisera, Christopher; Festekjian, Jaco; Da Lio, Andrew; Lipa, Joan E

    2016-04-01

    Implant-based breast reconstructions can result in unsatisfactory results requiring surgical revision or salvage reconstructive surgery with autologous tissue. This study compares the outcomes and complications of salvage (tertiary) flap reconstruction after failed prosthesis placement to those of primary/secondary flap reconstruction. All patients undergoing free flap breast reconstruction after failed prosthesis between July 1, 2005, and June 30, 2014, were identified. A matched number of patients who underwent a de novo free flap breast reconstruction were selected randomly for review. The indication for prosthesis removal, demographic and operative data, flap type and inset, and complication rates were evaluated. Eighty-nine women with a history of failed implant-based reconstruction required free flap reconstruction for salvage in 121 breasts. Capsular contracture was the most common indication for prosthesis removal (62.0 percent). Recipient vessel scarring was 5.23 times more likely to occur in the prior prosthesis group (p < 0.001). Alternate flap types other than deep inferior epigastric perforator and transverse rectus abdominis myocutaneous flaps were more frequently used in this cohort. Major complications requiring operative management were more common in the experimental group (17.4 percent versus 8.1 percent; p = 0.035). No difference was noted in flap loss rates, operative take back, or operative time. Salvage breast reconstruction with autologous tissue after failed prosthesis can be safely performed, with success rates similar to those of primary free flap breast reconstruction. However, these procedures may have increased complexity because of recipient vessel scarring, higher rates of prior radiation therapy, and major complications, which may warrant appropriate preoperative planning and patient counseling. Therapeutic, III.

  7. Categorization of compensatory motions in transradial myoelectric prosthesis users.

    PubMed

    Hussaini, Ali; Zinck, Arthur; Kyberd, Peter

    2017-06-01

    Prosthesis users perform various compensatory motions to accommodate for the loss of the hand and wrist as well as the reduced functionality of a prosthetic hand. Investigate different compensation strategies that are performed by prosthesis users. Comparative analysis. A total of 20 able-bodied subjects and 4 prosthesis users performed a set of bimanual activities. Movements of the trunk and head were recorded using a motion capture system and a digital video recorder. Clinical motion angles were calculated to assess the compensatory motions made by the prosthesis users. The video recording also assisted in visually identifying the compensations. Compensatory motions by the prosthesis users were evident in the tasks performed (slicing and stirring activities) as compared to the benchmark of able-bodied subjects. Compensations took the form of a measured increase in range of motion, an observed adoption of a new posture during task execution, and prepositioning of items in the workspace prior to initiating a given task. Compensatory motions were performed by prosthesis users during the selected tasks. These can be categorized into three different types of compensations. Clinical relevance Proper identification and classification of compensatory motions performed by prosthesis users into three distinct forms allows clinicians and researchers to accurately identify and quantify movement. It will assist in evaluating new prosthetic interventions by providing distinct terminology that is easily understood and can be shared between research institutions.

  8. Vitamin D deficiency as a risk factor for the development of autoantibodies in patients with ASIA and silicone breast implants: a cohort study and review of the literature.

    PubMed

    Colaris, Maartje J L; van der Hulst, Rene R; Tervaert, Jan Willem Cohen

    2017-03-17

    The development of autoimmunity and/or autoimmune diseases is multifactorial. Vitamin D is one of the factors that might play a role. We postulated that both the presence of adjuvants and insufficient levels of vitamin D may result in the development of autoimmunity in patients with autoimmune/inflammatory syndrome induced by adjuvants (ASIA) in relation to silicone implant incompatibility. We measured vitamin D levels in 135 patients with ASIA in relation to silicone implant incompatibility and related findings to the presence of autoantibodies that are commonly used to diagnose systemic autoimmune diseases. Furthermore, we systematically reviewed the literature regarding vitamin D deficiency as a risk factor for the development of autoantibodies. Vitamin D measurements were available for analysis in 131 of 135 patients with ASIA in relation to SIIS. Twenty-three patients (18%) tested positive for autoantibodies, from which 18 patients (78%) had either a vitamin D deficiency or insufficiency (median vitamin D level 60.5 mmol/L), whereas five patients (22%) had sufficient vitamin D levels. The risk to develop autoantibodies was significantly increased in vitamin D deficient and/or insufficient patients [RR 3.14; 95% CI, 1.24-7.95; p = 0.009]. Reviewed literature suggested an association between vitamin D levels and the presence and/or titer levels of autoantibodies in different autoimmune diseases. From our current study and from our review of the literature, we conclude that vitamin D deficiency is related to the presence of autoantibodies. Whether vitamin D supplementation results in a decrease of autoimmunity needs to be studied prospectively.

  9. Stumble detection and classification for an intelligent transfemoral prosthesis.

    PubMed

    Lawson, Brian E; Atakan Varol, H; Sup, Frank; Goldfarb, Michael

    2010-01-01

    This paper describes an approach for the real-time detection of stumble for use in an intelligent lower limb prosthesis, using accelerometers mounted on the prosthesis, and also describes an algorithm that classifies the stumble response as either an elevating or lowering type response. In order to validate the proposed approach, the investigators collected stumble data on 10 healthy subjects using accelerometers affixed to the subjects in a manner consistent with similar instrumentation on a transfemoral prosthesis. The proposed algorithms were shown to correctly identify stumbling and correctly classify the stumble response for all 19 stumbles and 34 control strides collected in the experiments.

  10. [Old and new materials in the hip prosthesis].

    PubMed

    Kowalczewski, Jacek B; Milecki, Marcin; Marczak, Dariusz

    2006-01-01

    Since the second half of the XX century a steady evolution of hip prosthesis design is taking place. Implant shape, fixation systems and materials are constantly evolving. The paper presents the materials combinations most commonly used in hip prosthesis (metal-metal, metal-polyethylene and ceramic). All the above mentioned materials have been in used for over 25 years, and thanks to minor modification and better quality are widely used all over the world. The authors basing on biochemical studies, clinical observations and personal experience present problems related to materials used in hip prosthesis.

  11. Radiological and clinical effect of prosthesis design in varus knees?

    PubMed Central

    Isyar, Mehmet; Guler, Olcay; Cakmak, Selami; Kara, Adnan; Yalcin, Sercan; Mahirogullari, Mahir

    2015-01-01

    Purpose The aim of the study is to investigate the efficacy of the prosthesis design used in total knee arthroplasty in patients with varus malalignment. Methods After exclusion criteria we classified 90 patients underwent total knee arthroplasty according to prosthesis used into two groups: posterior cruciate ligament substituting and retaining. Mean follow up period was 25–98 months. We evaluated preoperative and postoperative radiological and as well as clinical parameters such as pain, knee function, flexion deformity. Results We found statistically significant difference in both groups in terms of deformity correction (p = 0.000). Conclusion Prosthesis design affects radiological outcomes in varus knees. PMID:26566321

  12. The bionic eye (electronic visual prosthesis): a review.

    PubMed

    Suaning, G J; Lovell, N H; Schindhelm, K; Coroneo, M T

    1998-08-01

    The concept of a visual prosthesis for the blind or partially sighted is not a new one. Indeed, for more than three decades this technology based treatment for blindness has appeared imminent. Despite the concerted efforts of numerous physicians, scientists and engineers, the successful application of a useful visual prosthesis remains elusive. The present review will endeavour to describe past efforts, investigate the present state of the art and indicate the obstacles that must be overcome in order to bring an electronic visual prosthesis to fruition.

  13. [Total hip prosthesis for chronic juvenile arthritis. A review of a series of 34 prosthesis].

    PubMed

    Journeau, P; Mabesoone, F; Touzet, P; Prieur, A M; Rigault, P

    1996-01-01

    The purpose of this study was to analyse the results of total hip arthroplasty for chronic juvenile arthritis in order to evaluate risks, problems and benefits of this procedure. Between 1984 and 1992, 34 total hip prostheses were implanted for chronic juvenile arthritis in 20 patients. Most prosthesis were Zweymuller cementless prosthesis. Mean follow up was 5 years. Results were good. In 85 per cent of cases, patients had a normal activity recovery. Pain relief was very good since in 80 per cent cases patients had a total indolence. Beyond these good clinical results at this mean follow-up, the main interest of this study is to characterize two different periods in the surgical technique. The first period when cemented prosthesis was employed and the second one when cementless femoral implants with screwed acetabular component were used. Cementless prostheses appear to be a satisfying solution in this disease, preserving bones and showing very good radiological and functional results. Furthermore, the very low complication rate despite general discomfort may prompt us to use total hip arthroplasty for the treatment of chronic juvenile arthritis.

  14. Thoracic Outlet Syndrome Following Breast Implant Rupture

    PubMed Central

    Caplash, Yugesh; Giri, Pratyush; Kearney, Daniel; Wagstaff, Marcus

    2015-01-01

    Summary: We present a patient with bilateral breast implant rupture who developed severe locoregional silicone granulomatous lymphadenopathy. Poly Implant Prothese silicone implants had been used for bilateral breast augmentation 5 years prior. Extracapsular implant rupture and bilateral axillary lymphadenopathy indicated explantation, capsulectomy, and selective lymph node excision. Histology demonstrated silicone lymphadenopathy with no evidence of malignancy. Over the subsequent 12 months, she developed progressive locoregional lymphadenopathy involving bilateral cervical, axillary, and internal mammary groups, resulting in bilateral thoracic outlet syndrome. We report the unusual presentation, progression, and the ultimate surgical management of this patient. PMID:25878942

  15. Breast Reconstruction

    MedlinePlus

    ... rebuild the shape of the breast. Instead of breast reconstruction, you could choose to wear a breast form ... one woman may not be right for another. Breast reconstruction may be done at the same time as ...

  16. 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 ...

  17. Silicon nitride/silicon carbide composite powders

    DOEpatents

    Dunmead, Stephen D.; Weimer, Alan W.; Carroll, Daniel F.; Eisman, Glenn A.; Cochran, Gene A.; Susnitzky, David W.; Beaman, Donald R.; Nilsen, Kevin J.

    1996-06-11

    Prepare silicon nitride-silicon carbide composite powders by carbothermal reduction of crystalline silica powder, carbon powder and, optionally, crystalline silicon nitride powder. The crystalline silicon carbide portion of the composite powders has a mean number diameter less than about 700 nanometers and contains nitrogen. The composite powders may be used to prepare sintered ceramic bodies and self-reinforced silicon nitride ceramic bodies.

  18. Rehabilitation of post-traumatic total nasal defect using silicone and acrylic resin

    PubMed Central

    Aggarwal, Vikas; Datta, Kusum; Kaur, Sukhjit

    2016-01-01

    Facial defects resulting from neoplasms, congenital abnormalities or trauma can affect the patient esthetically, psychologically, and even financially. Surgical reconstruction of large facial defects is sometimes not possible and frequently demands prosthetic rehabilitation. For success of such prosthesis, adequate replication of natural anatomy, color matching and blending with tissue interface are important criteria. Variety of materials and retention methods are advocated to achieve a functionally and esthetically acceptable restoration. Silicones are the most commonly used materials because of flexibility, lifelike appearance and ability to be used in combination with acrylic resin which is hard, provides body and helps in achieving retention to the prosthesis by engaging mechanical undercuts. Furthermore, the acrylic portion can be relined easily, thus helping comfortable wear and removal of the prosthesis by patient without traumatizing nasal mucosa. This case report describes time saving and cost effective prosthetic rehabilitation of a patient with total nasal defect using custom sculpted nasal prosthesis made up of silicone elastomer and acrylic resin, which is retained by engaging mechanical undercut and use of biocompatible silicone adhesive. PMID:27134434

  19. Natural tooth as an interim prosthesis

    PubMed Central

    Dhariwal, Neha S.; Gokhale, Niraj S.; Patel, Punit; Hugar, Shivayogi M.

    2016-01-01

    A traumatic injury to primary maxillary anterior tooth is one of the common causes for problems with the succedaneous tooth leading to it noneruption. A missing anterior tooth can be psychologically and socially damaging to the patient. Despite a wide range of treatment options available, sometimes, it is inevitable to save the natural tooth. This paper describes the immediate replacement of a right central incisor using a fiber-composite resin splint with the natural tooth crown as a pontic following surgical extraction of the dilacerated impacted permanent maxillary central incisor. The abutment teeth can be conserved with minimal or no preparation, thus keeping the technique reversible and can be completed at chair side thereby avoiding laboratory costs. It can be used as an interim measure until a definitive prosthesis can be fabricated as the growth is still incomplete. PMID:27433074

  20. Interim Prosthesis Options for Dental Implants.

    PubMed

    Siadat, Hakimeh; Alikhasi, Marzieh; Beyabanaki, Elaheh

    2016-01-24

    Dental implants have become a popular treatment modality for replacing missing teeth. In this regard, the importance of restoring patients with function during the implant healing period has grown in recent decades. Esthetic concerns, especially in the anterior region of the maxilla, should also be considered until the definitive restoration is delivered. Another indication for such restorations is maintenance of the space required for esthetic and functional definitive restorations in cases where the implant site is surrounded by natural teeth. Numerous articles have described different types of interim prostheses and their fabrication techniques. This article aims to briefly discuss all types of implant-related interim prostheses by different classification including provisional timing (before implant placement, after implant placement in unloading and loading periods), materials, and techniques used for making the restorations, the type of interim prosthesis retention, and definitive restoration. Furthermore, the abutment torque for such restorations and methods for transferring the soft tissue from interim to definitive prostheses are addressed.

  1. Predicting Visual Sensitivity in Retinal Prosthesis Patients

    PubMed Central

    Horsager, Alan; Greenwald, Scott H.; Weiland, James D.; Humayun, Mark S.; Greenberg, Robert J.; McMahon, Matthew J.; Boynton, Geoffrey M.; Fine, Ione

    2009-01-01

    PURPOSE With the long-term goal of restoring functional vision in patients with retinal degenerative diseases, the eyes of blind human subjects were implanted chronically with epiretinal prostheses consisting of two-dimensional electrode arrays that directly stimulated cells of the neural retina. METHODS Psychophysical techniques were used to measure the brightness of electrically generated percepts on single electrodes using a variety of electrical stimulation patterns. RESULTS It was possible to predict the sensitivity of the human visual system to a wide variety of retinal electrical stimulation patterns using a simple and biologically plausible model. CONCLUSIONS This is the first study to demonstrate that, on the single-electrode level, retinal electrical stimulation in humans can produce visual qualia that are predictable using a quantitative model, a prerequisite for a successful retinal prosthesis. PMID:19098313

  2. Galvanic gold plating for fixed dental prosthesis.

    PubMed

    Ozcelik, Tuncer Burak; Yilmaz, Burak

    2013-07-01

    Metal ceramic partial fixed dental prostheses have been commonly used for the replacement of missing teeth for many years. Because of an increase in the price of gold, base metal alloys have been the choice of alloy for the fabrication of metal ceramic restorations in many dental clinics. Some major disadvantages of base metals are their corrosion and the dark coloration they may cause at the crown margins. This article describes a galvanic gold-plating technique, which is used to minimize corrosion and improve the esthetics of metal ceramic restorations fabricated with Cr-Co base metal alloys. This technique involves the deposition of a 6 μm to 8 μm 24 K gold layer directly onto the Cr-Co cast prosthesis framework. The technique improves metal surface properties, making them more biocompatible and usable, however, requires additional equipment and experienced laboratory technicians. Clinical studies should be performed to corroborate the long term success of this technique.

  3. Development of a micromachined epiretinal vision prosthesis.

    PubMed

    Stieglitz, Thomas

    2009-12-01

    Microsystems engineering offers the tools to develop highly sophisticated miniaturized implants to interface with the nervous system. One challenging application field is the development of neural prostheses to restore vision in persons that have become blind by photoreceptor degeneration due to retinitis pigmentosa. The fundamental work that has been done in one approach is presented here. An epiretinal vision prosthesis has been developed that allows hybrid integration of electronics on one part of a thin and flexible substrate. Polyimide as a substrate material is proven to be non-cytotoxic. Non-hermetic encapsulation with parylene C was stable for at least 3 months in vivo. Chronic animal experiments proved spatially selective cortical activation after epiretinal stimulation with a 25-channel implant. Research results have been transferred successfully to companies that currently work on the medical device approval of these retinal vision prostheses in Europe and in the USA.

  4. Development of a micromachined epiretinal vision prosthesis

    NASA Astrophysics Data System (ADS)

    Stieglitz, Thomas

    2009-12-01

    Microsystems engineering offers the tools to develop highly sophisticated miniaturized implants to interface with the nervous system. One challenging application field is the development of neural prostheses to restore vision in persons that have become blind by photoreceptor degeneration due to retinitis pigmentosa. The fundamental work that has been done in one approach is presented here. An epiretinal vision prosthesis has been developed that allows hybrid integration of electronics on one part of a thin and flexible substrate. Polyimide as a substrate material is proven to be non-cytotoxic. Non-hermetic encapsulation with parylene C was stable for at least 3 months in vivo. Chronic animal experiments proved spatially selective cortical activation after epiretinal stimulation with a 25-channel implant. Research results have been transferred successfully to companies that currently work on the medical device approval of these retinal vision prostheses in Europe and in the USA.

  5. Adherence of Candida albicans to silicone is promoted by the human salivary protein SPLUNC2/PSP/BPIFA2.

    PubMed

    Holmes, A R; Rodrigues, E; van der Wielen, P; Lyons, K M; Haigh, B J; Wheeler, T T; Dawes, P J D; Cannon, R D

    2014-04-01

    Interactions between Candida albicans, saliva and saliva-coated oral surfaces are initial events in the colonization of the oral cavity by this commensal yeast, which can cause oral diseases such as candidiasis and denture stomatitis. Candida albicans also colonizes silicone voice prostheses, and the microbial biofilm formed can impair valve function, necessitating frequent prosthesis replacement. We have previously shown that saliva promoted binding of C. albicans cells to silicone in vitro, and that the selective binding of specific salivary proteins to voice prosthesis silicone mediated attachment of C. albicans cells. The C. albicans cells adhered to a polypeptide (or polypeptides) of ~36 kDa eluted from saliva-treated silicone. We show here that a protein of similar size was identified in replicate blots of the eluate from saliva-treated silicone when the blots were probed with antibodies to human SPLUNC2, a salivary protein with reported microbial agglutination properties. In addition, SPLUNC2 was depleted from saliva that had been incubated with silicone coupons. To determine whether SPLUNC2 is a yeast-binding protein, SPLUNC2 cDNA was expressed in Escherichia coli. Purified recombinant His-tagged protein (SPLUNC2r) bound to silicone as demonstrated by immunoblot analysis of an eluate from SPLUNC2r-treated silicone coupons and (35) S-radiolabelled C. albicans cells adhered in a dose-dependent manner to SPLUNC2r-coated silicone. We conclude that SPLUNC2 binds to silicone and acts as a receptor for C. albicans adherence to, and subsequent colonization of, voice prosthesis silicone.

  6. Comprehensive prosthetic rehabilitation of a patient with partial finger amputations using silicone biomaterial: A technical note.

    PubMed

    Kini, Ashwini Y; Byakod, Preeti P; Angadi, Gangadhar S; Pai, Umesh; Bhandari, Aruna J

    2010-12-01

    Finger and partial finger amputations are some of the most frequently encountered forms of partial hand loss. A high quality aesthetic prosthesis with passive function can be helpful to the patient since loss or congenital absence or malformation have both a social and psychological impact on the patient. Prosthetics is an art and science which provides a lifelike appearance to the lost structures of the patient. This case report presents the fabrication of a silicone finger prosthesis which had good suspension, adequate function, was comfortable to use and aesthetically acceptable to the patient.

  7. [Results after replacement of femoral neck prostheses - thrust plate prosthesis (TPP) versus ESKA cut prosthesis].

    PubMed

    Ishaque, B A; Gils, J; Wienbeck, S; Donle, E; Basad, E; Stürz, H

    2009-01-01

    The aim of this study was to analyse and evaluate comparatively loosening mechanisms, failure frequency, surgical changing strategies and results after replacement of thrust plate prostheses (TPP) and ESKA Cut prostheses. Between 1993 und 2007, 465 TPP and in the years 2000 and 2001 82 ESKA Cut prostheses were performed and evaluated prospectively. Until 2007 46 change interventions of the TPP and 35 of the CUT prosthesis became necessary. All patients who received a stem revision procedure in our hospital were included within this study. Besides the evaluation of clinical results according to the criteria of the Harris Hip Score on the average at 15.6 months (+/- 14.4) postoperatively, radiological loosening processes and surgical difficulties were registered. Furthermore, an analysis of perioperative data was performed according to some criteria of the German Federal Office of Quality Assurance (BQS), such as duration of the surgery, intraoperative blood loss and complications. Statistical investigations for comparative analysis as well as survival analysis of both groups were calculated using SPSS for Windows 13.0. The mean age of the 46 patients who had to undergo revision surgery after TPP was 60.1 years, that of 35 patients in whom revision surgery was necessary after receiving an ESKA Cut femoral neck stem was 56.6 years. The survival rate analysis according to Kaplan-Meier at 13 years was 89.4 % (TPP) and 53.6 % at 66 months (ESKA Cut). In all cases the partial osteointegration of the tripod surface of the loosened Cut prosthesis complicated the explantation. It led on the one hand to a significant difference of the surgery duration and on the other hand to an increased frequency of fractures of the trochanteric region. The conversion of the TPP on standard type stems was usually free of problems. The HHS increased significantly to the averages of 86.6 (TPP) or, respectively, 91.69 (ESKA Cut) after revision. In comparison with the usually problem

  8. External breast prostheses: misinformation and false beliefs.

    PubMed

    Healey, Irene R

    2003-09-08

    This article discusses common myths associated with the use of external breast prostheses and the impact this misinformation may have on the quality of life of women after mastectomy. A review of the literature reveals that very little research has been conducted on this subject. The majority of information on breast prostheses is provided by the manufacturers and tacitly accepted by healthcare providers and the media in general. Claims regarding the medical necessity of a weighted prosthesis and the suitability of gel fillings are examined and found wanting. Widespread acceptance of these myths may be preventing women from pursuing healthy lifestyle options and restricting the development of more suitable prosthetic products. The article concludes that a rigorous, evidence-based approach to the evaluation of external breast prostheses would enhance both the development of this noninvasive and cost-effective sector of post-mastectomy care, as well as the adjustment, well being and quality of life of breast cancer survivors.

  9. 21 CFR 872.3960 - Mandibular condyle prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Identification. A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw to... jaw for temporary reconstruction of the mandibular condyle in patients who have undergone resective...

  10. Virginal Breast Hypertrophy and Symptomatic Treatment: A Case Report

    PubMed Central

    Menekşe, Ebru; Önel, Safa; Karateke, Faruk; Daş, Koray; Bali, İlhan; Bozkurt, Hilmi; Sözen, Selim; Özdoğan, Mehmet

    2014-01-01

    Virginal breast hypertrophy is a rare benign disease. It is characterized by rapid and excessive growth of one or two breasts during peripubertal period. There is no specific treatment algorithm, subcutaneous mastectomy and prosthesis replacement, reduction mammoplasty, medical treatment with particularly tamoxifen are all recommended in the literature. Unfortunately, all treatment methods have some disadvantages in this patient group who have not completed their sexual and physical maturation. Although these treatments are usually required, it should be noted that spontaneous remission could rarely be seen in virginal hypertrophy. We aimed to present a case of virginal hypertrophy, in whom symptomatic treatment has been used and breast growth regressed spontaneously.

  11. Microfluidic neurotransmiter-based neural interfaces for retinal prosthesis.

    PubMed

    Iezzi, Raymond; Finlayson, Paul; Xu, Yong; Katragadda, Rakesh

    2009-01-01

    Natural inter-neuronal communication is mediated primarily via neurotransmitter-gated ion channels. While most of the methods for neural interfacing have been based upon electrical stimulation, neurotransmitter-based approaches for the spatially and temporally controlled delivery of neurotransmitters are relatively new. Methods of neurotransmitter stimulation retinal prosthesis may provide new ways to control neural excitation. Experimental results for retinal ganglion cell stimulation demonstrate the feasibility of a neurotransmitter-based retinal prosthesis.

  12. Towards a Completely Implantable, Light-Sensitive Intraocular Retinal Prosthesis

    DTIC Science & Technology

    2007-11-02

    electronic retinal prosthesis is under development to treat retinitis pigmentosa and age-related macular degeneration, two presently incurable...34Preservation of the inner retina in retinitis pigmentosa . A morphometric analysis," Arch Ophthalmol, vol. 115, no. 4, pp. 511-515, Apr.1997...Towards a completely implantable, light-sensitive intraocular retinal prosthesis. M.S. Humayun, J.D. Weiland, B. Justus1, C. Merrit1, J. Whalen, D

  13. Validated finite element analysis of the maverick total disc prosthesis.

    PubMed

    Le Huec, Jean-Charles; Lafage, Virginie; Bonnet, Xavier; Lavaste, François; Josse, Loic; Liu, Minglyan; Skalli, Wafa

    2010-06-01

    Combining in vitro tests and finite element analysis to provide a more complete picture of the role that a disc prosthesis implant would play in the biomechanics of the spine. Analysis of the disc function after total disc prosthesis insertion with and without antero-posterior or lateral offset and in combination with adjacent fusion. To avoid the risk of degenerative cascade the total disc replacement may be considered as an alternative. Few finite element analysis combined with cadaver testing under loading conditions have been published today. In vitro tests were performed using 6 fresh human cadaver specimens to quantify the load-displacement behaviors before and after insertion of a total disc replacement (Maverick, Memphis) implant. A finite element (FE) spine model was validated with the data from the in vitro tests. This model is built on the basis of ANSYS software. The effect of the prosthesis positioning on the motion behavior at L4-L5 and on the inner loads over facets was evaluated in 4 configurations. The study showed that the motion behavior at the levels adjacent to the Maverick prosthesis remained the same as the intact spine, unlike a single level fusion at L5-S1. In the biomechanical study settings, Maverick prosthesis, once properly positioned, does not modify the motion behavior of the spine as compared with its intact state. The less-than-ideal positioning of the prosthesis, especially with anterior offset, affect significantly the range of motion of the spine segment and cause increase of inner load in the facets. Those results indicated a good reliability of the finite element model in representing both intact and instrumented spine segments. The in vitro test results demonstrated that Maverick disc prosthesis provides near physiologic function of a natural disc restores stability of the spine and preserves the segmental motion without undue stress on adjacent segments.To our knowledge, this study suggested for the first time the importance

  14. Intraoral-extraoral combination prosthesis: improving retention using interconnecting magnets.

    PubMed

    Engelen, Marloes; van Heumen, Celeste C M; Merkx, Matthias A W; Meijer, Gert J

    2014-01-01

    Osseointegrated implants have been well documented for retaining an obturator prosthesis as well as a facial prosthesis. However, when the defect extends to both the facial area and the maxilla, it is difficult to rehabilitate those defects to the satisfaction of the patient, especially in cases where implants cannot be placed on both sites. This case report describes the use of magnets to connect two prostheses, thereby increasing retention and patient comfort.

  15. Septic complication following porous hydroxyapatite cranioplasty: prosthesis retention management.

    PubMed

    Iaccarino, Corrado; Mattogno, Pier P; Zanotti, Bruno; Bellocchi, Silvio; Verlicchi, Angela; Viaroli, Edoardo; Pastorello, Giulia; SGULò, Francesco; Ghadirpour, Reza; Servadei, Franco

    2016-05-13

    After failing of autologous cranioplasty or when the bone flap is unavailable, the alloplastic (heterologous) materials are the choice for cranial reconstruction. No agreement has been reported about the material with a significant lower risk of septic complications. This is due to extremely heterogeneous prognostic factors related not only to the material used but also to the surgical procedures and/or to the timing of the procedure. More attention should be focused on the material whose characteristic could enable a delay in bacterial colonization, where an antibiotic therapy could be effective, without need of prosthesis removal. Four cases of severe septic complication following cranioplasty with porous hydroxyapatite (HA) prosthesis are presented. Patients were conservatively treated, without heterologous bone flap removal. All of our patients presented reasons for delaying HA cranioplasty removal: Patients 1, 3 and 4 had an associated shunted hydrocephalus and the need for non- removing the prosthesis was related to the predictable recurrence of overshunting and/or sinking skin flap syndrome. In case 4 the revision surgery would have also damaged the microvascular flap with latissimus dorsi muscle used by plastic surgeon for skin reconstruction. In case 2 the patient refused revision surgery. In all cases systemic and/or radiological signs of infection were observed. In Case 2 the infective process surrounded completely the HA prosthesis, while it was located in the epidural region in Case 1 and 4. In Case 3 a surgical curettage of the infected wound was performed over the HA prosthesis. Following prosthesis retention management with antibiotic therapy, all patients revealed systemic and/or radiological signs of sepsis resolution at follow-up. The possibility to avoid a prosthesis removal with effective antibiotic treatment is mainly due to the combination of three factors: targeted antibiotic therapy, good anatomical area revascularization (resulting of an

  16. Kinematic Analysis of a Posterior-stabilized Knee Prosthesis

    PubMed Central

    Zhao, Zhi-Xin; Wen, Liang; Qu, Tie-Bing; Hou, Li-Li; Xiang, Dong; Bin, Jia

    2015-01-01

    Background: The goal of total knee arthroplasty (TKA) is to restore knee kinematics. Knee prosthesis design plays a very important role in successful restoration. Here, kinematics models of normal and prosthetic knees were created and validated using previously published data. Methods: Computed tomography and magnetic resonance imaging scans of a healthy, anticorrosive female cadaver were used to establish a model of the entire lower limbs, including the femur, tibia, patella, fibula, distal femur cartilage, and medial and lateral menisci, as well as the anterior cruciate, posterior cruciate, medial collateral, and lateral collateral ligaments. The data from the three-dimensional models of the normal knee joint and a posterior-stabilized (PS) knee prosthesis were imported into finite element analysis software to create the final kinematic model of the TKA prosthesis, which was then validated by comparison with a previous study. The displacement of the medial/lateral femur and the internal rotation angle of the tibia were analyzed during 0–135° flexion. Results: Both the output data trends and the measured values derived from the normal knee's kinematics model were very close to the results reported in a previous in vivo study, suggesting that this model can be used for further analyses. The PS knee prosthesis underwent an abnormal forward displacement compared with the normal knee and has insufficient, or insufficiently aggressive, “rollback” compared with the lateral femur of the normal knee. In addition, a certain degree of reverse rotation occurs during flexion of the PS knee prosthesis. Conclusions: There were still several differences between the kinematics of the PS knee prosthesis and a normal knee, suggesting room for improving the design of the PS knee prosthesis. The abnormal kinematics during early flexion shows that the design of the articular surface played a vital role in improving the kinematics of the PS knee prosthesis. PMID:25591565

  17. [Research progress of tracheal prosthesis in reconstructing trachea].

    PubMed

    Xu, Hong; Shi, Hongcan; Chen, Huimin

    2007-05-01

    To review the recent research progress of base and clinical application of tracheal replacement. Literature concerning tracheal prosthesis and the current achievements were extensively and comprehensively reviewed. Most tracheal lesions can be resected and achieve primary reconstruction, but the resectable length was limited. Tracheal replacement was an efficient and feasible way to substitute the defects resulting from extended resection. New techniques such as tissue engineering, tracheal transplantation, new tracheal prosthesis of biomaterials break fresh ground for the more rapid development of tracheal surgery.

  18. Magnet-Retained Orbital Prosthesis Using a Dental Implant.

    PubMed

    Kim, Soung Min

    2016-12-30

    The loss of an eye and the associated facial disharmony has major physical, psychological, and social consequences for patients undergoing orbital exenteration. A magnet-retained prosthesis with an implant has various advantages over both adhesive and spectacle-retained prostheses for reconstruction of the exenterated orbit.The author demonstrates one representative patient with our orbital reconstruction patients with magnetic implants, which will be applied to various maxillofacial prosthesis strategies in the near future.

  19. Penile Prosthesis Implantation in Acute and Chronic Priapism.

    PubMed

    Garaffa, Giulio; Ralph, David J

    2013-07-01

    To review the current literature regarding penile prosthesis implantation in acute and chronic priapism. A nonstructured Pubmed base search using the terms ischemic priapism, penile prosthesis, and refractory erectile dysfunction has been carried out. Surgical outcome and patient satisfaction following penile prosthesis implantation are reported. Implantation of a penile prosthesis in acute and chronic ischemic priapism is associated with increased complication rates, when compared with virgin implants. Implantation in acute priapism allows the painful priapic episode to settle and to preserve penile length, while implantation in chronic priapism is technically much more challenging and often requires the use of downsized shorter cylinders. Implantation of a penile prosthesis in acute refractory ischemic priapism should be the solution of choice, as the dilatation is easier and allows the preservation of penile length, which is one of the main factors influencing postoperative patient's satisfaction in prosthetic surgery. Garaffa G and Ralph D. Penile prosthesis implantation in acute and chronic priapism. Sex Med Rev 2013;1:76-82. Copyright © 2013 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

  20. Ischemic Gangrene of the Glans following Penile Prosthesis Implantation

    PubMed Central

    García Gómez, Borja; Romero Otero, Javier; Díez Sicilia, Laura; Jiménez Alcaide, Estibaliz; García-Cruz, Eduardo; Rodríguez Antolín, Alfredo

    2013-01-01

    The development of ischemic gangrene of the penis following implantation of prosthesis is unusual, and very few cases are available in the literature. As a result, no established treatment protocol is available. We report our experience within a case of gangrene of the glans following implantation of a three-component prosthesis. We present a 53-year-old male, smoker with diabetes and hypercholesterolemia, who underwent surgery for the insertion of a penile prosthesis with 3 components to correct his erectile dysfunction and severe Peyronie's disease. The procedure was carried out without incidents. During the postoperative period, the patient began to complain from penile and perineal pain. He developed avascular necrosis of the glans. The necrosed area was excised. Four weeks later, he developed fever and perineal pain arriving to the emergency room with the prosthesis extruding through the glans. He had emergency surgery to remove the prosthesis plus surgical lavage and was prescribed broad-spectrum antibiotic therapy. Four weeks later, the penis was completely revascularized and reepithelialized. Ischemic gangrene following penile prosthesis implantation takes place in patients with poor peripheral vascularisation. Diabetes mellitus has been the common denominator to all of the reported cases. PMID:23956919

  1. Glans Necrosis Following Penile Prosthesis Implantation: Prevention and Treatment Suggestions.

    PubMed

    Wilson, Steven K; Mora-Estaves, Cesar; Egydio, Paulo; Ralph, David; Habous, Mohamad; Love, Christopher; Shamsodini, Ahmad; Valenzuela, Robert; Yafi, Faysal A

    2017-09-01

    To examine possible etiology and treatment outcomes in 21 patients with glans necrosis following penile prosthesis implantation. Glans necrosis typically presented with a dusky glans on the first postoperative day following prosthesis implantation. The blood supply to the glans penis consists of the dorsal arteries and the terminal branches of the spongiosal arteries. Using the cohort in our study, we compiled preoperative comorbidities and adjunctive surgical maneuvers that might compromise glans vascularity, leading to glans necrosis. Preoperative risk factors were arteriosclerotic cardiovascular disease (90%), diabetes mellitus (81%), smoking (81%), previous prosthesis explantation (57%), and previous radiation therapy (48%). The most prevalent intraoperative and postoperative factor was subcoronal incision for reasons as simple as coincident circumcision or as complex as for penile degloving (86%). Other factors detected were penile wrapping with an occlusive elastic bandage (62%), use of a sliding technique for penile lengthening (33%), and coincident distal urethral injury repair (29%). Seventeen patients (81%) managed expectantly with preservation of implanted prosthesis sustained significant glandular loss. Four patients managed with immediate prosthesis removal healed without sequelae. Patients with preoperative risk factors undergoing penile prosthesis implantation should avoid high-risk adjunctive surgical maneuvers. Upon development of signs of glans necrosis postoperatively, in the setting of these high-risk factors, immediate implant removal may prevent subsequent glans necrosis. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. [Penile prosthesis for the treatment of erectile dysfunction].

    PubMed

    Atienza Merino, G

    2006-02-01

    The erectile dysfunction is a pathology that, with different degrees of intensity, affects nearly the 20% of the spanish adult men. The treatment is usually performed in stages, reserving the penile prosthesis for when other previous treatments have failed. The aim of this work is to evaluate, according to the state of present knowledge, the effectiveness and security of the penile prosthesis for the treatment of the erectile dysfunction. With this purpose 52 articles were selected, observing a 5 years prosthesis survival of 78-91% and a 3-8% of surgical complications. Mechanical failures and infection percentages were smaller in the semi-rigid prosthesis that in the inflatable ones, with high levels of postoperative satisfaction in patients as well as in their couples, even greater than in other treatments available at the present time. The penile prosthesis implantation must be reserved for the organic erectile dysfunction when previous treatments have failed, evaluating the risk-benefit relation and informing the patient of the results that are hoped to be obtained and of the possible complications that can arise. In view of the great concern of our society with the erectile function and the availability of effective drugs, an increase in the demand of penile prosthesis implantation is predictable in those patients highly motivated, but refractory to the less invasive treatments.

  3. Function of obturator prosthesis after maxillectomy and prosthetic obturator rehabilitation.

    PubMed

    Chen, Cheng; Ren, Wenhao; Gao, Ling; Cheng, Zheng; Zhang, Linmei; Li, Shaoming; Zhi, Pro Ke-qian

    2016-01-01

    Maxillary defects are usually rehabilitated by a prosthetic obturator. This study aimed to evaluate the functioning of obturators prosthesis in patients with unilateral defects after maxillectomy. Of 49 patients, 28 underwent to maxillectomy as a result of tumor ablative surgery, and acquired unilateral maxillary defects. Evaluation of the function was performed by applying the Obturator Functional Scale (OFS). From a total of 49 patients, 28 were treated as follows: 9 with a conventional retained obturator prosthesis (COP), 11 (39%) with an enhanced retentive obturator prosthesis with stud attachment (POP) and 8 (28%) with an enhanced retentive obturator prosthesis with magnetic attachment (POM). The mean OFS score was 80. Scores on functions of speech, swallowing and chewing reached statistical significances (p<0.05) among these three subgroups. Comparing COP and MOP groups, the scores of OFS in the domains of "Speech-ability to speak in public" and "Swallowing-leakage with liquids" were significantly higher in AOP group. Comparing COP group, the scores of OFS in "Swallowing-leakage with solid" and "Chewing/eating" domains were increased significantly (p<0.05) both in MOP and AOP groups. Obturator prosthesis improves oral function of patients after maxillary defects; the retention of the obturator prosthesis enhanced by the addition of attachments showed more benefits in oral function. Copyright © 2015 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

  4. Mastication improvement after partial implant-supported prosthesis use.

    PubMed

    Gonçalves, T M S V; Campos, C H; Gonçalves, G M; de Moraes, M; Rodrigues Garcia, R C M

    2013-12-01

    Partially edentulous patients may be rehabilitated by the placement of removable dental prostheses, implant-supported removable dental prostheses, or partial implant fixed dental prostheses. However, it is unclear the impact of each prosthesis type over the masticatory aspects, which represents the objective of this paired clinical trial. Twelve patients sequentially received and used each of these 3 prosthesis types for 2 months, after which maximum bite force was assessed by a strain sensor and food comminution index was determined with the sieving method. Masseter and temporal muscle thicknesses during rest and maximal clenching were also evaluated by ultrasonography. Each maxillary arch received a new complete denture that was used throughout the study. Data were analyzed by analysis of variance for repeated measures, followed by the Tukey test (p < .05). Maximum bite force and food comminution index increased (p < .0001) after implant-supported dental prosthesis and implant fixed dental prosthesis use, with the higher improvement found after the latter's use. Regardless of implant-retained prosthesis type, masseter muscle thickness during maximal clenching also increased (p < .05) after implant insertion. Partial implant-supported prostheses significantly improved masseter muscle thickness and mastication, and the magnitude of this effect was related to prosthesis type.

  5. Mastication Improvement After Partial Implant-supported Prosthesis Use

    PubMed Central

    Gonçalves, T.M.S.V.; Campos, C.H.; Gonçalves, G.M.; de Moraes, M.; Rodrigues Garcia, R.C.M.

    2013-01-01

    Partially edentulous patients may be rehabilitated by the placement of removable dental prostheses, implant-supported removable dental prostheses, or partial implant fixed dental prostheses. However, it is unclear the impact of each prosthesis type over the masticatory aspects, which represents the objective of this paired clinical trial. Twelve patients sequentially received and used each of these 3 prosthesis types for 2 months, after which maximum bite force was assessed by a strain sensor and food comminution index was determined with the sieving method. Masseter and temporal muscle thicknesses during rest and maximal clenching were also evaluated by ultrasonography. Each maxillary arch received a new complete denture that was used throughout the study. Data were analyzed by analysis of variance for repeated measures, followed by the Tukey test (p < .05). Maximum bite force and food comminution index increased (p < .0001) after implant-supported dental prosthesis and implant fixed dental prosthesis use, with the higher improvement found after the latter’s use. Regardless of implant-retained prosthesis type, masseter muscle thickness during maximal clenching also increased (p < .05) after implant insertion. Partial implant-supported prostheses significantly improved masseter muscle thickness and mastication, and the magnitude of this effect was related to prosthesis type (International Clinical Trial Registration RBR-9J26XD). PMID:24158344

  6. Breast implant foreign body reaction mimicking breast cancer recurrence on FDG PET/CT.

    PubMed

    Ulaner, Gary A; D'Andrea, Gabriella; Cody, Hiram S

    2013-06-01

    A woman with bilateral breast cancer treated with bilateral mastectomies, implant reconstructions, chemotherapy, and hormonal therapy underwent FDG PET/CT imaging. Imaging demonstrated sternal, nodal, and lung lesions which were stable or slowly increasing, as well as a parasternal chest wall mass which was enlarging much more rapidly and was excised. Pathology of the chest wall mass demonstrated only benign soft tissue with fat necrosis and foreign body giant cell reaction, without evidence of malignancy or implant rupture. This case demonstrates how a benign FDG-avid foreign body reaction, induced by an intact breast prosthesis, could easily be mistaken for malignancy.

  7. Fabrication of an Implant-Supported Fixed Interim Prosthesis Using a Duplicate Denture: An Alternative Technique.

    PubMed

    Al-Thobity, Ahmad M

    2016-06-22

    The fabrication of an implant-supported fixed complete denture prosthesis involves multiple clinical and laboratory steps. One of the main steps is to provide the patient with an interim fixed prosthesis to evaluate the patient's esthetic and functional needs as well as to enhance the patient's psychology before proceeding to the definitive prosthesis. Different techniques for fabricating interim prostheses have been described in the literature. This report describes an alternative technique that uses a duplicate denture made of self-curing acrylic resin to fabricate an implant-supported fixed interim prosthesis. The interim prosthesis was later used as a blueprint for the definitive implant-supported hybrid prosthesis.

  8. 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

  9. Automated estimation of hip prosthesis migration: a feasibility study

    NASA Astrophysics Data System (ADS)

    Vandemeulebroucke, Jef; Deklerck, Rudi; Temmermans, Frederik; Van Gompel, Gert; Buls, Nico; Scheerlinck, Thierry; de Mey, Johan

    2013-09-01

    A common complication associated with hip arthoplasty is prosthesis migration, and for most cemented components a migration greater than 0.85 mm within the first six months after surgery, are an indicator for prosthesis failure. Currently, prosthesis migration is evaluated using X-ray images, which can only reliably estimate migrations larger than 5 mm. We propose an automated method for estimating prosthesis migration more accurately, using CT images and image registration techniques. We report on the results obtained using an experimental set-up, in which a metal prosthesis can be translated and rotated with respect to a cadaver femur, over distances and angles applied using a combination of positioning stages. Images are first preprocessed to reduce artefacts. Bone and prosthesis are extracted using consecutive thresholding and morphological operations. Two registrations are performed, one aligning the bones and the other aligning the prostheses. The migration is estimated as the difference between the found transformations. We use a robust, multi-resolution, stochastic optimization approach, and compare the mean squared intensity differences (MS) to mutual information (MI). 30 high-resolution helical CT scans were acquired for prosthesis translations ranging from 0.05 mm to 4 mm, and rotations ranging from 0.3° to 3° . For the translations, the mean 3D registration error was found to be 0.22 mm for MS, and 0.15 mm for MI. For the rotations, the standard deviation of the estimation error was 0.18° for MS, and 0.08° for MI. The results show that the proposed approach is feasible and that clinically acceptable accuracies can be obtained. Clinical validation studies on patient images will now be undertaken.

  10. Particle shedding and migration from silicone genitourinary prosthetic devices

    SciTech Connect

    Barrett, D.M.; O'Sullivan, D.C.; Malizia, A.A.; Reiman, H.M.; Abell-Aleff, P.C. )

    1991-08-01

    Of 26 patients undergoing revision of genitourinary prostheses the surrounding reactive fibrous capsule was biopsied in 25 and the draining lymph nodes also were biopsied in 4. The prostheses included 16 inflatable and 14 flexible penile devices, and 10 artificial urinary sphincters. Tissue was examined by light and transmission electron microscopy. X-ray microanalysis was done on intracellular and extracellular foreign material from each specimen. Silicone was found in 18 of the 25 periprosthetic specimens and in all 4 lymph nodes. Foreign body granulomas were identified in 14 of these 29 specimens. Examination of new and explanted versions of each prosthesis by scanning electron microscopy revealed free particles of silicone or silicates on the surface of most devices. Pitting and microfissuring were seen on a few of the new devices and on nearly all of the used ones. Thus, genitourinary prostheses shed silicone particles that can be found in the fibrous capsule and draining lymph nodes.

  11. Association between dental prosthesis need, nutritional status and quality of life of elderly subjects.

    PubMed

    Pillai, Rajath Sasidharan; Mathur, Vijay Prakash; Jain, Veena; Shah, Naseem; Kalra, Sandeep; Kumar, Pravesh; Dey, A B

    2015-12-01

    To determine the effect of prosthesis need on nutritional status and oral health-related quality of life (OHrQoL) in elderly and to check the disparity between prosthesis need and prosthesis want in the Indian elderly. A total of 946 geriatric participants reporting to a geriatric medicine clinic were recruited in the study. Mini-nutritional assessment (MNA), geriatric oral health assessment (GOHAI) indices, prosthesis need according to WHO criteria, and prosthesis want was recorded along with age, gender, socioeconomic status and posterior occluding pair. Significant associations exist between prosthesis need and age (p = 0.005), MNA (p = 0.006) and GOHAI (p = 0.000). Prosthesis demand too was influenced by age (p = 0.004), posterior occluding pairs (p = 0.000), MNA (p = 0.012) and GOHAI (p = 0.000). GOHAI was negatively correlated with upper (r = -0.445) and lower prosthesis need (r = -0.460). Participants with some prosthesis need had significantly lower MNA and GOHAI scores as compared to those with no prosthesis need. Though prosthesis need was high (79.7 %), demand was low (39.3 %). Prosthesis need affects nutritional status and OHrQoL in elderly, and a wide gap exists between need and want of prosthesis.

  12. Biomedical and psychosocial factors influencing transtibial prosthesis fit: a Delphi survey among health care professionals.

    PubMed

    Baars, Erwin C; Schrier, Ernst; Geertzen, Jan H; Dijkstra, Pieter U

    2015-01-01

    We aimed to reach consensus among professionals caring for prosthesis users, on definitions of biomedical and psychosocial factors, to assess their influence on fit of transtibial prosthesis and to identify new factors. A three-round, internet-based, Delphi survey was conducted among experts recruited via the Dutch National Amputee and Prosthesis Work Group. The main outcome measure was consensus among care professionals on statements concerning new and presented biomechanical and psychosocial factors that influence transtibial prosthesis fit. Fifty-four experts participated in the survey, and consensus was reached on 67% (46/69) of all statements. Consensus on statements relevant for good prosthesis fit was reached in most of the statements concerning psychosocial factors and on statements concerning the biomedical factors "prosthesis support and suspension". Least consensus was reached on statements concerning the biomedical factor "skin problems and pain in the residual limb". Biomedical and psychosocial factors influence transtibial prosthesis fit. Consensus was reached among care professionals in a majority of the presented statements concerning these factors. Implications for Rehabilitation Prosthesis fit and comfort is suboptimal in many prosthesis users. Both biomedical and psychosocial factors influence fit. Biomedical and psychosocial factors should be checked during transtibial prosthesis prescription to achieve and maintain an optimal fit. Consensus on many factors influencing prosthesis fit is achieved among care professionals. Consensus was largest regarding prosthesis support and suspension and least regarding skin problems and pain in the residual limb. This consensus contributes to systematic assessment of prosthesis fit.

  13. Silicon microdosimetry.

    PubMed

    Agosteo, Stefano; Pola, Andrea

    2011-02-01

    Silicon detectors are being studied as microdosemeters since they can provide sensitive volumes of micrometric dimensions. They can be applied for assessing single-event effects in electronic instrumentation exposed to complex fields around high-energy accelerators or in space missions. When coupled to tissue-equivalent converters, they can be used for measuring the quality of radiation therapy beams or for dosimetry. The use of micrometric volumes avoids the contribution of wall effects to the measured spectra. Further advantages of such detectors are their compactness, cheapness, transportability and a low sensitivity to vibrations. The following problems need to be solved when silicon devices are used for microdosimetry: (i) the sensitive volume has to be confined in a region of well-known dimensions; (ii) the electric noise limits the minimum detectable energy; (iii) corrections for tissue-equivalency should be made; (iv) corrections for shape equivalency should be made when referring to a spherical simulated site of tissue; (v) the angular response should be evaluated carefully; (vi) the efficiency of a single detector of micrometric dimensions is very poor and detector arrays should be considered. Several devices have been proposed as silicon microdosemeters, based on different technologies (telescope detectors, silicon on insulator detectors and arrays of cylindrical p-n junctions with internal amplification), in order to satisfy the issues mentioned above.

  14. Metabolic Prosthesis for Oxygenation of Ischemic Tissue

    SciTech Connect

    Greenbaum, Elias

    2009-01-01

    This communication discloses new ideas and preliminary results on the development of a "metabolic prosthesis" for local oxygenation of ischemic tissue under physiological neutral conditions. We report for the first time the selective electrolysis of physiological saline by repetitively pulsed charge-limited electrolysis for the production of oxygen and suppression of free chlorine. For example, using 800 A amplitude current pulses and <200 sec pulse durations, we demonstrated prompt oxygen production and delayed chlorine production at the surface of a shiny 0.85 mm diameter spherical platinum electrode. The data, interpreted in terms of the ionic structure of the electric double layer, suggest a strategy for in situ production of metabolic oxygen via a new class of "smart" prosthetic implants for dealing with ischemic disease such as diabetic retinopathy. We also present data indicating that drift of the local pH of the oxygenated environment can be held constant using a feedback-controlled three electrode electrolysis system that chooses anode and cathode pair based on pH data provided by local microsensors. The work is discussed in the context of diabetic retinopathy since surgical techniques for multielectrode prosthetic implants aimed at retinal degenerative diseases have been developed.

  15. Zirconia in fixed prosthesis. A literature review

    PubMed Central

    Román-Rodríguez, Juan L.; Ferreiroa, Alberto; Solá-Ruíz, María F.; Fons-Font, Antonio

    2014-01-01

    Statement of problem: Evidence is limited on the efficacy of zirconia-based fixed dental prostheses. Objective: To carry out a literature review of the behavior of zirconium oxide dental restorations. Material and Methods: This literature review searched the Pubmed, Scopus, Medline and Cochrane Library databases using key search words “zirconium oxide,” “zirconia,” “non-metal restorations,” “ceramic oxides,” “veneering ceramic,” “zirconia-based fixed dental prostheses”. Both in vivo and in vitro studies into zirconia-based prosthodontic restoration behavior were included. Results: Clinical studies have revealed a high rate of fracture for porcelain-veneered zirconia-based restorations that varies between 6% and 15% over a 3- to 5-year period, while for ceramo-metallic restorations the fracture rate ranges between 4 and 10% over ten years. These results provoke uncertainty as to the long-term prognosis for this material in the oral medium. The cause of veneering porcelain fractures is unknown but hypothetically they could be associated with bond failure between the veneer material and the zirconia sub-structure. Key words:Veneering ceramic, zirconia-based ceramic restoration, crown, zirconia, tooth-supported fixed prosthesis. PMID:24596638

  16. Amputation and prosthesis fitting in paediatric patients.

    PubMed

    Griffet, J

    2016-02-01

    Amputation of a limb is always perceived as a catastrophe. The principles underlying creation of a stump adapted to modern prosthetic fittings must be fully understood and the patient managed by a multidisciplinary team. In paediatric patients, preserving residual limb length is a crucial point that should be assessed according to the expected growth potential. Advances in prosthetic fittings have led to changes in the overall concept of socket design, which seeks to achieve three objectives: to maximise the weight-bearing surface area, to eliminate friction of the skin on the socket, and to eliminate lever-arm effects. The introduction on the market of new materials has contributed substantially to advances in prosthetic fittings. These advances require the use of new criteria for stump quality and optimisation, which exert a considerable influence on prosthesis function. Prosthetic fitting and specific management of psychological and social problems are provided during an inpatient stay in a physical medicine department, by a team of physicians, other healthcare professionals, social workers, and educators. Three-dimensional imaging and gait analysis provide valuable information.

  17. [Are the cobalt hip prosthesis dangerous?].

    PubMed

    Mistretta, Virginie; Kurth, William; Charlier, Corinne

    The placement of a hip prosthesis is one of the most common orthopedic surgical procedures. Some implants contain metal and are therefore capable of releasing metal particles like cobalt in patients who wear metal prostheses. Cobalt can be responsible of local toxicity (including metallosis, hypersensitivity reaction, and benign tumor) or systemic toxicity (including cardiomyopathy, polycythemia, hypothyroidism, and neurological disorders). To monitor potential toxicity of metal hip prostheses, an annual monitoring of patients implanted is recommended and includes clinical examination, radiological examination and blood cobalt determination. The cobalt concentration in blood allows to estimate the risk of toxicity and to evaluate the performance of the implant. The currently recommended threshold value is equal to 7 µg of cobalt per liter of blood. Our study, conducted on 251 patients over a period of 4 years, has shown that the cobalt concentration average was 2.51 µg/l in blood, with 51 patients having a cobaltemia higher than the threshold of 7 µg/l. © 2016 médecine/sciences – Inserm.

  18. Optoelectronic retinal prosthesis: system design and performance.

    PubMed

    Loudin, J D; Simanovskii, D M; Vijayraghavan, K; Sramek, C K; Butterwick, A F; Huie, P; McLean, G Y; Palanker, D V

    2007-03-01

    The design of high-resolution retinal prostheses presents many unique engineering and biological challenges. Ever smaller electrodes must inject enough charge to stimulate nerve cells, within electrochemically safe voltage limits. Stimulation sites should be placed within an electrode diameter from the target cells to prevent 'blurring' and minimize current. Signals must be delivered wirelessly from an external source to a large number of electrodes, and visual information should, ideally, maintain its natural link to eye movements. Finally, a good system must have a wide range of stimulation currents, external control of image processing and the option of either anodic-first or cathodic-first pulses. This paper discusses these challenges and presents solutions to them for a system based on a photodiode array implant. Video frames are processed and imaged onto the retinal implant by a head-mounted near-to-eye projection system operating at near-infrared wavelengths. Photodiodes convert light into pulsed electric current, with charge injection maximized by applying a common biphasic bias waveform. The resulting prosthesis will provide stimulation with a frame rate of up to 50 Hz in a central 10 degrees visual field, with a full 30 degrees field accessible via eye movements. Pixel sizes are scalable from 100 to 25 microm, corresponding to 640-10,000 pixels on an implant 3 mm in diameter.

  19. Toward Wide-Field Retinal Prosthesis

    PubMed Central

    Ameri, Hossein; Ratanapakorn, Tanapat; Ufer, Stefan; Eckhardt, Helmut; Humayun, Mark S.; Weiland, James D.

    2010-01-01

    The purpose of this article is to present a wide field electrode array that may increase the field of vision in patients implanted with a retinal prosthesis. Mobility is often impaired in patients with low vision, particularly in those with peripheral visual loss. Studies on low vision patients as well as simulation studies on normally sighted individuals have indicated a strong correlation between the visual field and mobility. In addition, it has been shown that increased visual field is associated with a significant improvement in visual acuity and object discrimination. Current electrode arrays implanted in animals or human vary in size; however, the retinal area covered by the electrodes has a maximum projected visual field of about 10°. We have designed wide field electrode arrays that could potentially provide a visual field of 34°, which may significantly improve the mobility. Tests performed on a mechanical eye model showed that it was possible to fix flexible polyimide dummy electrode arrays of 10 mm wide onto the retina using a single retinal tack. They also showed that the arrays could conform to the inner curvature of the eye. Surgeries on an enucleated porcine eye model demonstrated feasibility of implantation of 10 mm wide arrays through a 5 mm eye wall incision. PMID:19458405

  20. Fixation of the reversed shoulder prosthesis.

    PubMed

    Hopkins, Andrew R; Hansen, Ulrich N; Bull, Anthony M J; Emery, Roger; Amis, Andrew A

    2008-01-01

    The last decade has seen an increased interest in reversed shoulder prostheses. Success rates with these designs have been varied, with initial performance marred by failures resulting from improper implant alignment and an emerging engineering understanding. Competitor products to the well-documented Grammont design have yielded increasingly high success rates. Understanding the relationships between implant design, surgical procedure, and clinical outcome is important so that current results can be improved upon. This study considers the performance of 3 different reversed shoulder designs from the perspective of osseointegration, with the results broadly validated through comparison with experimental data. Finite element modeling was used to clarify the relationships between lateral offset of the center of rotation, screw insertion angle, screw length, screw diameter, bone material quality, and the potential for interdigitation of the supporting bone onto the reversed prosthesis. The results indicate that screw length, insertion angle, and diameter, when maximized, allow the least relative motion between the implant and underlying bone. When the bone is stiffer, the relative motion of the implant is lower. In almost all scenarios modeled, the interface micromotion was small enough to suggest that the glenoid was stable enough to encourage bone ingrowth across the majority of the bone-implant interfaces.

  1. Golf hand prosthesis performance of transradial amputees.

    PubMed

    Carey, Stephanie L; Wernke, Matthew M; Lura, Derek J; Kahle, Jason T; Dubey, Rajiv V; Highsmith, M Jason

    2015-06-01

    Typical upper limb prostheses may limit sports participation; therefore, specialized terminal devices are often needed. The purpose of this study was to evaluate the ability of transradial amputees to play golf using a specialized terminal device. Club head speed, X-factor, and elbow motion of two individuals with transradial amputations using an Eagle Golf terminal device were compared to a non-amputee during a golf swing. Measurements were collected pre/post training with various stances and grips. Both prosthesis users preferred a right-handed stance initially; however, after training, one preferred a left-handed stance. The amputees had slower club head speeds and a lower X-factor compared to the non-amputee golfer, but increased their individual elbow motion on the prosthetic side after training. Amputees enjoyed using the device, and it may provide kinematic benefits indicated by the increase in elbow flexion on the prosthetic side. The transradial amputees were able to swing a golf club with sufficient repetition, form, and velocity to play golf recreationally. Increased elbow flexion on the prosthetic side suggests a potential benefit from using the Eagle Golf terminal device. Participating in recreational sports can increase amputees' health and quality of life. © The International Society for Prosthetics and Orthotics 2014.

  2. Galvanic gold plating for fixed dental prosthesis

    PubMed Central

    Ozcelik, Tuncer Burak; Yilmaz, Burak

    2013-01-01

    Metal ceramic partial fixed dental prostheses have been commonly used for the replacement of missing teeth for many years. Because of an increase in the price of gold, base metal alloys have been the choice of alloy for the fabrication of metal ceramic restorations in many dental clinics. Some major disadvantages of base metals are their corrosion and the dark coloration they may cause at the crown margins. This article describes a galvanic gold-plating technique, which is used to minimize corrosion and improve the esthetics of metal ceramic restorations fabricated with Cr-Co base metal alloys. This technique involves the deposition of a 6 μm to 8 μm 24 K gold layer directly onto the Cr-Co cast prosthesis framework. The technique improves metal surface properties, making them more biocompatible and usable, however, requires additional equipment and experienced laboratory technicians. Clinical studies should be performed to corroborate the long term success of this technique. PMID:24926220

  3. Breast Cancer

    MedlinePlus

    Breast cancer affects one in eight women during their lives. No one knows why some women get breast cancer, but there are many risk factors. Risks that ... age 35, and having dense breasts. Symptoms of breast cancer may include a lump in the breast, a ...

  4. Silicon surface passivation by silicon nitride deposition

    NASA Technical Reports Server (NTRS)

    Olsen, L. C.

    1984-01-01

    Silicon nitride deposition was studied as a method of passivation for silicon solar cell surfaces. The following three objectives were the thrust of the research: (1) the use of pecvd silicon nitride for passivation of silicon surfaces; (2) measurement techniques for surface recombination velocity; and (3) the importance of surface passivation to high efficiency solar cells.

  5. Practical do-it-yourself device for accurate volume measurement of breast.

    PubMed

    Tezel, E; Numanoğlu, A

    2000-03-01

    A simple and accurate method of measuring differences in breast volume based on Archimedes' principle is described. In this method, a plastic container is placed on the breast of the patient who is lying in supine position. While the breast occupies part of the container, the remaining part is filled with water and the volume is measured. This method allows the measurement of the volume differences of asymmetric breasts and also helps the surgeon to estimate the size of the prosthesis to be used in augmentation mammaplasty.

  6. Submuscle saline breast augmentation: are we making sense in the new millenium?

    PubMed

    Hudson, Donald A

    2002-01-01

    Historically, it appears that the problems of capsule contracture, the alleged risk of human adjuvant disease, and the problems due to migration of smooth walled breast prosthesis have had a major impact on the techniques used in breast augmentation. As a consequence of the above, the primary cosmetic goal may have been lost (a naturally enlarged aesthetic breast). It is suggested, that from a purely cosmetic point of view, that the best result is obtained with a subglandular textured gel prosthesis. Reasons for selecting this method are advanced and well documented limitations to the submuscle pocket are highlighted. Various incisions are also discussed. The inframammary fold is a critical landmark of the breast and should not be violated in a cosmetic procedure.

  7. [Surgery of the breast on transgender persons].

    PubMed

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

    2015-01-01

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

  8. A comparison of tumor prosthesis implantation and pasteurized autograft-prosthesis composite for proximal tibial tumor.

    PubMed

    Song, Won Seok; Cho, Wan Hyeong; Jeon, Dae-Geun; Kong, Chang-Bae; Duo, Jian; Lee, Soo-Yong

    2012-07-01

    Although previous reports on composite biologic reconstruction in the proximal tibial location vary, we hypothesized that this type of reconstruction may reduce the late infection rate and have advantages in terms of longevity by restoring bone stock. Primary analysis addressed differences between 62 tumor prosthesis (TP) and 25 pasteurized autograft-prosthesis composite (PPC) reconstructions in terms of survival rates, functional outcomes, and temporal patterns of infection. The 10-year survival rates of the TP and PPC groups were 73.9 ± 11.7 and 68.7 ± 20.1 %, respectively (P = 0.64). Reconstructive failure occurred in 16 (25.8 %) in the TP and in 7 (28 %) in the PPC group. The cause of failures in the TP group was infection (16), whereas those of PPC group were infection (5), loosening (1), and local recurrence (1). The mean functional scores of TP (52) and PPC (20) patients that maintained a mobile joint were 24.2 (81 %) and 25.1 (83.6 %), respectively. Infection rates in the two groups were similar (P = 0.328), but infections occurred earlier in the PPC group (P = 0.011). This comparative study suggests composite biological reconstruction shows a comparable long-term survival rate to TP reconstruction; however, the composite method has a tendency to a lower rate of late infection.

  9. Breast reconstruction after mastectomy for breast cancer: comparative analysis of early and delayed reconstruction.

    PubMed

    Seidel, William; Bins-Ely, Jorge; Ongaratto Barazzetti, Daniel; Della Giustina, Renata; Walter, Gustavo P; Ferri, Thiago A; Maurici, Rosemeri; Narciso-Schiavon, Janaína L

    2017-06-01

    Early reconstruction after mastectomy for breast cancer with definitive implants has been widely used, especially with the evolution of conservative surgical breast cancer treatments. We aimed to identify different characteristics associated with plastic surgery, based on immediate or delayed reconstruction time and evaluate quality of life in patients undergoing mastectomy for cancer. This is a cross-sectional analytical study that evaluated adult patients undergoing mastectomy for breast cancer and breast reconstruction in Plastic Surgery Service at a tertiary hospital. Between March 2011 and November 2015, 58 patients who underwent mastectomy were included, with a mean age of 51.6±10.6 years and 98.3% of them being women. Eighty percent of the patients underwent a radical mastectomy and 20% underwent segmentectomies. Immediate and delayed surgical reconstructions occurred in 22.4% and 77.6% of the cases, respectively, including immediate reconstruction with the local flap trade (15.5%), immediate reconstruction with prosthesis (6.9%), transverse rectus abdominis myocutaneous (TRAM) flap (6.9%), delayed reconstruction with local flap (8.6%), expander and prosthesis (35.7%), and reconstruction with latissimus dorsi flap and prosthesis (22.4%). When comparing subjects undergoing reconstructive surgery based on timing of reconstruction, it was observed that patients undergoing delayed breast reconstruction surgery presented a higher proportion of radical mastectomy (90.7% vs. 41.7%; P=0.001) and the need for two or more surgical interventions (64.1% vs. 20.0%; P=0.029). There was no difference in the quality of life according to reconstruction time. The characteristics associated with postmastectomy reconstruction timing are related to preoperative factors such as the procedure employed and the number of interventions performed and have no influence on complications or the quality of life.

  10. Implementation of machine learning for classifying prosthesis type through conventional gait analysis.

    PubMed

    LeMoyne, Robert; Mastroianni, Timothy; Hessel, Anthony; Nishikawa, Kiisa

    2015-01-01

    Current forecasts imply a significant increase in the quantity of lower limb amputations. Synergizing the capabilities of a conventional gait analysis system and machine learning facilitates the capacity to classify disparate types of transtibial prostheses. Automated classification of prosthesis type may eventually advance rehabilitative acuity for selecting an appropriate prosthesis for a given aspect of the rehabilitation process. The presented research utilized a force plate as a conventional gait analysis device to acquire a feature set for two types of prosthesis: passive Solid Ankle Cushioned Heel (SACH) and the iWalk BiOM powered prosthesis. The feature set consists of both temporal and kinetic data with respect to the force plate signal during stance. Intuitively a passive prosthesis and powered prosthesis generate distinctively different force plate recordings. A support vector machine, which is type of machine learning application, achieves 100% classification between a passive prosthesis and powered prosthesis regarding the feature set derived from force plate recordings.

  11. Design and Control of a Pneumatically Actuated Transtibial Prosthesis

    PubMed Central

    Zheng, Hao; Shen, Xiangrong

    2015-01-01

    This paper presents the design and control of a pneumatically actuated transtibial prosthesis, which utilizes a pneumatic cylinder-type actuator to power the prosthetic ankle joint to support the user's locomotion. The pneumatic actuator has multiple advantages over the traditional electric motor, such as light weight, low cost, and high power-to-weight ratio. The objective of this work is to develop a compact and lightweight transtibial prosthesis, leveraging the multiple advantages provided by this highly competitive actuator. In this paper, the design details of the prosthesis are described, including the determination of performance specifications, the layout of the actuation mechanism, and the calculation of the torque capacity. Through the authors’ design calculation, the prosthesis is able to provide sufficient range of motion and torque capacity to support the locomotion of a 75 kg individual. The controller design is also described, including the underlying biomechanical analysis and the formulation of the finite-state impedance controller. Finally, the human subject testing results are presented, with the data indicating that the prosthesis is able to generate a natural walking gait and sufficient power output for its amputee user. PMID:26146497

  12. Design and Testing of a Bionic Dancing Prosthesis.

    PubMed

    Rouse, Elliott J; Villagaray-Carski, Nathan C; Emerson, Robert W; Herr, Hugh M

    2015-01-01

    Traditionally, prosthetic leg research has focused on improving mobility for activities of daily living. Artistic expression such as dance, however, is not a common research topic and consequently prosthetic technology for dance has been severely limited for the disabled. This work focuses on investigating the ankle joint kinetics and kinematics during a Latin-American dance to provide unique motor options for disabled individuals beyond those of daily living. The objective of this study was to develop a control system for a bionic ankle prosthesis that outperforms conventional prostheses when dancing the rumba. The biomechanics of the ankle joint of a non-amputee, professional dancer were acquired for the development of the bionic control system. Subsequently, a professional dancer who received a traumatic transtibial amputation in April 2013 tested the bionic dance prosthesis and a conventional, passive prosthesis for comparison. The ability to provide similar torque-angle behavior of the biological ankle was assessed to quantify the biological realism of the prostheses. The bionic dancing prosthesis overlapped with 37 ± 6% of the non-amputee ankle torque and ankle angle data, compared to 26 ± 2% for the conventional, passive prosthesis, a statistically greater overlap (p = 0.01). This study lays the foundation for quantifying unique, expressive activity modes currently unavailable to individuals with disabilities. Future work will focus on an expansion of the methods and types of dance investigated in this work.

  13. Estimation of crank angle for cycling with a powered prosthesis.

    PubMed

    Lawson, B E; Shultz, A; Ledoux, E; Goldfarb, M

    2014-01-01

    In order for a prosthesis to restore power generation during cycling, it must supply torque in a manner that is coordinated with the motion of the bicycle crank. This paper outlines an algorithm for the real time estimation of the angular position of a bicycle crankshaft using only measurements internal to an intelligent knee and ankle prosthesis. The algorithm assumes that the rider/prosthesis/bicycle system can be modeled as a four-bar mechanism. Assuming that a prosthesis can generate two independent angular measurements of the mechanism (in this case the knee angle and the absolute orientation of the shank), Freudenstein's equation can be used to synthesize the mechanism continuously. A recursive least-squares algorithm is implemented to estimate the Freudenstein coefficients, and the resulting link lengths are used to reformulate the equation in terms of input-output relationships mapping both measured angles to the crank angle. Using two independent measurements allows the algorithm to uniquely determine the crank angle from multi-valued functions. In order to validate the algorithm, a bicycle was mounted on a trainer and configured with the prosthesis using an artificial hip joint attached to the seat post. Motion capture was used to monitor the mechanism for forward and backward pedaling and the results are compared to the output of the presented algorithm. Once the parameters have converged, the algorithm is shown to predict the crank angle within 15° of the externally measured value throughout the entire crank cycle during forward rotation.

  14. A digital patient for computer-aided prosthesis design

    PubMed Central

    Colombo, Giorgio; Facoetti, Giancarlo; Rizzi, Caterina

    2013-01-01

    This article concerns the design of lower limb prosthesis, both below and above knee. It describes a new computer-based design framework and a digital model of the patient around which the prosthesis is designed and tested in a completely virtual environment. The virtual model of the patient is the backbone of the whole system, and it is based on a biomechanical general-purpose model customized with the patient's characteristics (e.g. anthropometric measures). The software platform adopts computer-aided and knowledge-guided approaches with the goal of replacing the current development process, mainly hand made, with a virtual one. It provides the prosthetics with a set of tools to design, configure and test the prosthesis and comprehends two main environments: the prosthesis modelling laboratory and the virtual testing laboratory. The first permits the three-dimensional model of the prosthesis to be configured and generated, while the second allows the prosthetics to virtually set up the artificial leg and simulate the patient's postures and movements, validating its functionality and configuration. General architecture and modelling/simulation tools for the platform are described as well as main aspects and results of the experimentation. PMID:24427528

  15. Design and Testing of a Bionic Dancing Prosthesis

    PubMed Central

    Rouse, Elliott J.; Villagaray-Carski, Nathan C.; Emerson, Robert W.; Herr, Hugh M.

    2015-01-01

    Traditionally, prosthetic leg research has focused on improving mobility for activities of daily living. Artistic expression such as dance, however, is not a common research topic and consequently prosthetic technology for dance has been severely limited for the disabled. This work focuses on investigating the ankle joint kinetics and kinematics during a Latin-American dance to provide unique motor options for disabled individuals beyond those of daily living. The objective of this study was to develop a control system for a bionic ankle prosthesis that outperforms conventional prostheses when dancing the rumba. The biomechanics of the ankle joint of a non-amputee, professional dancer were acquired for the development of the bionic control system. Subsequently, a professional dancer who received a traumatic transtibial amputation in April 2013 tested the bionic dance prosthesis and a conventional, passive prosthesis for comparison. The ability to provide similar torque-angle behavior of the biological ankle was assessed to quantify the biological realism of the prostheses. The bionic dancing prosthesis overlapped with 37 ± 6% of the non-amputee ankle torque and ankle angle data, compared to 26 ± 2% for the conventional, passive prosthesis, a statistically greater overlap (p = 0.01). This study lays the foundation for quantifying unique, expressive activity modes currently unavailable to individuals with disabilities. Future work will focus on an expansion of the methods and types of dance investigated in this work. PMID:26285201

  16. Biomechanical evaluation of an adjustable patellar tendon bearing prosthesis.

    PubMed

    Mizrahi, J; Susak, Z; Bahar, A; Seliktar, R; Najenson, T

    1985-01-01

    The purpose of this study was to determine the relation between geometry of the patellar tendon (PT) insertion in the socket and the dynamic load transmitted through the PT, in a patellar tendon bearing (PTB) prosthesis. The dynamic load was measured by a specially constructed two-component load cell, which was mounted on the experimental prosthesis. Geometry of the PT insertion relative to the socket was altered by adjusting the location of the mounting frame-load cell assembly. Evaluation of performance of the prosthesis in the range of geometries investigated was made objectively by gait analysis of the patients. The latter was performed on a 10 m walkpath, including at halfway two forceplates, from which the foot-ground forces were recorded. Simultaneously, the PT forces on the prosthesis, as sensed by the load cell were monitored. Computer processing of the data included full analysis of the force-trace and the determination of criteria for optimization of the PT insertion. The resulting criteria were those which expressed minimization of abnormalities in the foot-ground forces of each patient, such as vertical and braking forces and their timings. The complete optimization procedure, which was undertaken for two below-knee male amputees, indicated the correct positioning of the PT insertion, actually taken in the final fitting procedure of the socket of the prosthesis.

  17. Split-Framework in Mandibular Implant-Supported Prosthesis

    PubMed Central

    2015-01-01

    During oral rehabilitation of an edentulous patient with an implant-supported prosthesis, mandibular flexure must be considered an important biomechanical factor when planning the metal framework design, especially if implants are installed posterior to the interforaminal region. When an edentulous mandible is restored with a fixed implant-supported prosthesis connected by a fixed full-arch framework, mandibular flexure may cause needless stress in the overall restorative system and lead to screw loosening, poor fit of prosthesis, loss of the posterior implant, and patient's discomfort due to deformation properties of the mandible during functional movements. The use of a split-framework could decrease the stress with a precise and passive fit on the implants and restore a more natural functional condition of the mandible, helping in the longevity of the prosthesis. Therefore, the present clinical report describes the oral rehabilitation of an edentulous patient by a mandibular fixed implant-supported prosthesis with a split-framework to compensate for mandibular flexure. Clinical Significance. The present clinical report shows that the use of a split-framework reduced the risk of loss of the posterior implants or screws loosening with acceptable patient comfort over the period of a year. The split-framework might have compensated for the mandibular flexure during functional activities. PMID:26770841

  18. Partial breast brachytherapy

    MedlinePlus

    ... brachytherapy; Accelerated partial breast irradiation - brachytherapy; Partial breast radiation therapy - brachytherapy; Permanent breast seed implant; PBSI; Low-dose radiotherapy - breast; High-dose radiotherapy - breast; Electronic balloon ...

  19. Breast Pain

    MedlinePlus

    ... before your period and sometimes continuing through your menstrual cycle. The pain may be moderate or severe, and ... breasts. Throughout the month, not related to your menstrual cycle. Postmenopausal women sometimes have breast pain, but breast ...

  20. Breast ultrasound

    MedlinePlus

    ... Sonogram of the breast Images Female breast References Hacker NF, Friedland ML. Breast disease. In: Hacker NF, Gambone JC, Hobel CJ, eds. Hacker and Moore's Essentials of Obstetrics and Gynecology . 6th ...

  1. Complications of acellular dermal matrices in breast surgery.

    PubMed

    Israeli, Ron

    2012-11-01

    Acellular dermal matrices have been used in breast surgery for a decade. They are widely used in implant-based breast reconstruction to provide coverage of the inferolateral aspects of the prosthesis. Numerous benefits have been reported with this approach including improved fold control, better support and control of the implant pocket with concomitant reduced risk of malposition, and improved lower pole expansion. Seroma, infection, mastectomy skin necrosis, and expander/implant loss are the most commonly reported complications with this approach, and the incidences vary widely among studies. Patient selection and adherence to established intraoperative technique principles related to acellular dermal matrix use are both critical to minimizing the risk of complications. Acellular dermal matrices are also being used in aesthetic breast surgery, revision breast surgery, and nipple reconstruction, but clinical experience is limited. This article reviews the complications associated with the use of matrices in breast surgery from the published literature.

  2. Maxillary cement retained implant supported monolithic zirconia prosthesis in a full mouth rehabilitation: a clinical report

    PubMed Central

    Liu, Perng-Ru; Aponte-Wesson, Ruth; O'Neal, Sandra J

    2013-01-01

    This clinical report presents the reconstruction of a maxillary arch with a cement retained implant supported fixed prosthesis using a monolithic zirconia generated by CAD/CAM system on eight osseointegrated implants. The prosthesis was copy milled from an interim prosthesis minimizing occlusal adjustments on the definitive prosthesis at the time of delivery. Monolithic zirconia provides high esthetics and reduces the number of metal alloys used in the oral cavity. PMID:23755349

  3. Interim results from the international trial of Second Sight's visual prosthesis.

    PubMed

    Humayun, Mark S; Dorn, Jessy D; da Cruz, Lyndon; Dagnelie, Gislin; Sahel, José-Alain; Stanga, Paulo E; Cideciyan, Artur V; Duncan, Jacque L; Eliott, Dean; Filley, Eugene; Ho, Allen C; Santos, Arturo; Safran, Avinoam B; Arditi, Aries; Del Priore, Lucian V; Greenberg, Robert J

    2012-04-01

    This study evaluated the Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc., Sylmar, CA) in blind subjects with severe outer retinal degeneration. Single-arm, prospective, multicenter clinical trial. Thirty subjects were enrolled in the United States and Europe between June 6, 2007, and August 11, 2009. All subjects were followed up for a minimum of 6 months and up to 2.7 years. The electronic stimulator and antenna of the implant were sutured onto the sclera using an encircling silicone band. Next, a pars plana vitrectomy was performed, and the electrode array and cable were introduced into the eye via a pars plana sclerotomy. The microelectrode array then was tacked to the epiretinal surface. The primary safety end points for the trial were the number, severity, and relation of adverse events. Principal performance end points were assessments of visual function as well as performance on orientation and mobility tasks. Subjects performed statistically better with the system on versus off in the following tasks: object localization (96% of subjects), motion discrimination (57%), and discrimination of oriented gratings (23%). The best recorded visual acuity to date is 20/1260. Subjects' mean performance on orientation and mobility tasks was significantly better when the system was on versus off. Seventy percent of the patients did not have any serious adverse events (SAEs). The most common SAE reported was either conjunctival erosion or dehiscence over the extraocular implant and was treated successfully in all subjects except in one, who required explantation of the device without further complications. The long-term safety results of Second Sight's retinal prosthesis system are acceptable, and most subjects with profound visual loss perform better on visual tasks with system than without it. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

  4. Interim Results from the International Trial of Second Sight’s Visual Prosthesis

    PubMed Central

    Humayun, Mark S.; Dorn, Jessy D.; Cruz, Lyndon da; Dagnelie, Gislin; Sahel, José-Alain; Stanga, Paulo E.; Cideciyan, Artur V.; Duncan, Jacque L.; Eliott, Dean; Filley, Eugene; Ho, Allen C.; Santos, Arturo; Safran, Avinoam B.; Arditi, Aries; Del Priore, Lucian V.; Greenberg, Robert J.

    2011-01-01

    Purpose This study evaluates the Argus™ II Retinal Prosthesis System in blind subjects with severe outer retinal degeneration. Design The study design is a single arm, prospective, multicenter clinical trial. Participants Thirty subjects were enrolled in the United States and Europe between 6 June 2007 and 11 August 2009. All subjects were followed for a minimum of six months and up to 2.7 years. Methods The electronic stimulator and antenna of the implant was sutured onto the sclera using an encircling silicone band. Next, a pars plana vitrectomy was performed and the electrode array and cable were introduced into the eye via a pars plana sclerotomy. The microelectrode array was then tacked to the epiretinal surface. Main Outcome Measures The primary safety endpoint for the trial was the number, severity, and relation of adverse events. Principal performance endpoints were assessments of visual function as well as performance on orientation and mobility tasks. Results Subjects performed statistically better with system ON vs. OFF in the following tasks: object localization (96% of subjects); motion discrimination (57%); and discrimination of oriented gratings (23%). The best recorded visual acuity to date is 20/1260. Subjects’ mean performance on Orientation and Mobility tasks was significantly better when the System was ON vs. OFF. Seventy percent of the patients did not have any serious adverse events (SAEs). The most common SAE reported was either conjunctival erosion or dehiscence over the extraocular implant and was successfully treated in all subjects except in one which required explantation of the device without further complications. Conclusions The long-term safety results of Second Sight’s retinal prosthesis system are acceptable and the majority of subjects with profound visual loss perform better on visual tasks with system than without. PMID:22244176

  5. The Malleable Implant Salvage Technique: Infection Outcomes after Mulcahy Salvage Procedure and Replacement of Infected Inflatable Penile Prosthesis with Malleable Prosthesis.

    PubMed

    Gross, Martin S; Phillips, Elizabeth A; Balen, Alejandra; Eid, J Francois; Yang, Christopher; Simon, Ross; Martinez, Daniel; Carrion, Rafael; Perito, Paul; Levine, Laurence; Greenfield, Jason; Munarriz, Ricardo

    2016-03-01

    Since its introduction in 1996 Mulcahy salvage has significantly improved outcomes for the removal and replacement of infected inflatable penile prostheses. Long-term followup data of Mulcahy salvage show an infection-free rate of 82%. A multicenter retrospective analysis of the malleable implant salvage technique was conducted to assess infection outcomes and the feasibility of conversion from malleable device back to inflatable penile prosthesis. This is a retrospective, institutional review board exempt, multi-institution study of 58 patients who underwent Mulcahy salvage with inflatable penile prosthesis removal and replacement with malleable prosthesis. Patient operative notes and charts were extensively reviewed to compile study data. Between 2002 and 2014 a total of 58 patients underwent infected inflatable penile prosthesis removal and replacement with a malleable prosthesis via Mulcahy salvage. Of these patients 54 (93%) have remained infection-free postoperatively. Average patient age was 56.4 years and average operative time was 148 minutes. Postoperative followup (as of May 2015) ranged from 1 month to 84 months. Of the 54 patients 37 retained the malleable prosthesis and 17 (31%) subsequently underwent replacement with an inflatable penile prosthesis. This occurred on average 6.7 months after Mulcahy salvage. Four patients had persistent infection after Mulcahy salvage with the malleable prosthesis and underwent explantation. This retrospective analysis of Mulcahy salvage procedure and replacement of inflatable penile prosthesis with malleable prosthesis shows a high infection-free rate. Additionally, 17 of the 54 patients who remained infection-free were able to successfully undergo subsequent removal of the malleable prosthesis and replacement with an inflatable penile prosthesis. Further prospective studies are needed to compare salvage with malleable vs inflatable penile prosthesis. Copyright © 2016 American Urological Association Education

  6. [Ankle joint prosthesis for bone defects].

    PubMed

    Lampert, C

    2011-11-01

    Large defects of the talus, i.e. due to tumors, large areas of osteolysis in total ankle replacement (TAR) and posttraumatic talus body necrosis are difficult to manage. The gold standard in these circumstances is still tibiocalcaneal arthrodesis with all the negative aspects of a completely rigid hindfoot. We started 10 years ago to replace the talus by a custom-made, all cobalt-chrome implant (laser sintering). The first patient with a giant cell tumor did very well but the following patients showed all subsidence of the metal talus into the tibia due to missing bony edges. Therefore, we constructed a custom-made talus (mirrored from the healthy side) and combined it with a well functioning total ankle prosthesis (Hintegra). So far we have implanted this custom-made implant into 3 patients: the first had a chondrosarcoma of the talus (1 year follow-up), the second had massive osteolysis/necrosis of unknown origin (6 months follow-up) and the third massive osteolysis following a correct TAR (2 months follow-up). The results are very encouraging as all of the patients are practically pain free and have a good range of movement (ROM): D-P flexion 15°-0-20° but less motion in the lower ankle joint: ROM P-S 5°-0-5°. No subsidence was detected in the tibia or the calcaneus. The custom-made talus combined with the Hintegra total ankle replacement will probably be an interesting alternative to a tibiocalcaneal arthrodesis in selected cases with massive defects of the talus.

  7. The making of indigenous vascular prosthesis

    PubMed Central

    Unnikrishnan, Madathipat; Viswanathan, Sidharth; Balasubramaniam, K.; Muraleedharan, C.V.; Lal, Arthur Vijayan; Mohanan, P.V.; Mohanty, Meera; Kapilamoorthy, Tirur Raman

    2016-01-01

    Background & objectives: Vascular illnesses are on the rise in India, due to increase in lifestyle diseases and demographic transition, requiring intervention to save life, organ or limbs using vascular prosthesis. The aim of this study was to develop indigenous large diameter vascular graft for treatment of patients with vascular pathologies. Methods: The South India Textile Research Association, at Coimbatore, Tamil Nadu, India, developed seamless woven polyester (Polyethylene terephthalate) graft at its research wing. Further characterization and testing followed by clinical trials were conducted at Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala, India. Fifteen in vivo experiments were carried out in 1992-1994 in pigs as animal model. Controlled (phase I) clinical trial in ten patients was performed along with control graft. Thereafter, phase II trial involved 22 patients who underwent multi-centre clinical trial in four centres across India. Results: Laboratory testing showed that polyester graft was non-toxic, non-leeching and non-haemolytic with preserved long-term quality, further confirming in pigs by implanting in thoracic aorta, comparable to control Dacron grafts. Perigraft incorporation and smooth neointima formation which are prime features of excellent healing characteristics, were noted at explantation at planned intervals. Subsequently in the phase I and II clinical trials, all patients had excellent recovery without mortality or device-related adverse events. Patients receiving the test graft were followed up for 10 and 5 years, respectively. Serial clinical, duplex scans and CT angiograms performed periodically confirmed excellent graft performance. Interpretation & conclusions: Indigenously developed Chitra vascular graft was comparable to commercially available Dacron graft, ready for clinical use at affordable cost to patients as against costly imported grafts. PMID:27748302

  8. [Avoidance of patient-prosthesis mismatch].

    PubMed

    Sakamoto, Y; Hashimoto, K

    2006-04-01

    To minimize the incidence of patient-prosthesis mismatch (PPM), we have routinely adopted aortic root enlargement to avoid PPM for patients with small aortic annulus. The aim of this study was to review our strategy of avoiding PPM. The Carpentier-Edwards Perimount (CEP) valves were implanted in 53 patients who were mostly aged over 65 and the St. Jude Medical (SJM) mechanical valves were used in 128 patients aged under 65. A standard 21-mm SJM valve was used in only 3 patients and no 19-mm valves were employed. However, 19-mm CEP valves were used in 12 patients with a small body surface area (1.43 +/- 0.14 m2). Of these, 26 patients (14.4%) who had a small aortic annulus and 24 patients aged under 65 underwent aortic root enlargement. No patient receiving an SJM valve had an projected indexed effective orifice area (EOAI) < or = 0.85 cm2/m2 because of performing aortic valve replacement (AVR) with annular enlargement and only 2 (3.8%) out of 53 patients receiving CEP valves developed PPM. Consequently, the prevalence of PPM was 1.1% in this series. The prevalence of PPM was low in patients over 65 years old with a relatively small body size who received bioprosthetic valves. A pericardial bioprosthesis was considered to be an appropriate valve in older population with regard to avoiding PPM. In patients under 65 years old with a small annulus, the first choice for avoiding PPM is aortic annular enlargement, which may be avoided by high performance mechanical valves with larger EOA.

  9. In vivo performance of photovoltaic subretinal prosthesis

    NASA Astrophysics Data System (ADS)

    Mandel, Yossi; Goetz, George; Lavinsky, Daniel; Huie, Phil; Mathieson, Keith; Wang, Lele; Kamins, Theodore; Manivanh, Richard; Harris, James; Palanker, Daniel

    2013-02-01

    We have developed a photovoltaic retinal prosthesis, in which camera-captured images are projected onto the retina using pulsed near-IR light. Each pixel in the subretinal implant directly converts pulsed light into local electric current to stimulate the nearby inner retinal neurons. 30 μm-thick implants with pixel sizes of 280, 140 and 70 μm were successfully implanted in the subretinal space of wild type (WT, Long-Evans) and degenerate (Royal College of Surgeons, RCS) rats. Optical Coherence Tomography and fluorescein angiography demonstrated normal retinal thickness and healthy vasculature above the implants upon 6 months follow-up. Stimulation with NIR pulses over the implant elicited robust visual evoked potentials (VEP) at safe irradiance levels. Thresholds increased with decreasing pulse duration and pixel size: with 10 ms pulses it went from 0.5 mW/mm2 on 280 μm pixels to 1.1 mW/mm2 on 140 μm pixels, to 2.1 mW/mm2 on 70 μm pixels. Latency of the implant-evoked VEP was at least 30 ms shorter than in response evoked by the visible light, due to lack of phototransduction. Like with the visible light stimulation in normal sighted animals, amplitude of the implant-induced VEP increased logarithmically with peak irradiance and pulse duration. It decreased with increasing frequency similar to the visible light response in the range of 2 - 10 Hz, but decreased slower than the visible light response at 20 - 40 Hz. Modular design of the photovoltaic arrays allows scalability to a large number of pixels, and combined with the ease of implantation, offers a promising approach to restoration of sight in patients blinded by retinal degenerative diseases.

  10. Auditory Prosthesis with a Penetrating Nerve Array

    PubMed Central

    Snyder, Russell L.

    2007-01-01

    Contemporary auditory prostheses (“cochlear implants”) employ arrays of stimulating electrodes implanted in the scala tympani of the cochlea. Such arrays have been implanted in some 100,000 profoundly or severely deaf people worldwide and arguably are the most successful of present-day neural prostheses. Nevertheless, most implant users show poor understanding of speech in noisy backgrounds, poor pitch recognition, and poor spatial hearing, even when using bilateral implants. Many of these limitations can be attributed to the remote location of stimulating electrodes relative to excitable cochlear neural elements. That is, a scala tympani electrode array lies within a bony compartment filled with electrically conductive fluid. Moreover, scala tympani arrays typically do not extend to the apical turn of the cochlea in which low frequencies are represented. In the present study, we have tested in an animal model an alternative to the conventional cochlear implant: a multielectrode array implanted directly into the auditory nerve. We monitored the specificity of stimulation of the auditory pathway by recording extracellular unit activity at 32 sites along the tonotopic axis of the inferior colliculus. The results demonstrate the activation of specific auditory nerve populations throughout essentially the entire frequency range that is represented by characteristic frequencies in the inferior colliculus. Compared to conventional scala tympani stimulation, thresholds for neural excitation are as much as 50-fold lower and interference between electrodes stimulated simultaneously is markedly reduced. The results suggest that if an intraneural stimulating array were incorporated into an auditory prosthesis system for humans, it could offer substantial improvement in hearing replacement compared to contemporary cochlear implants. PMID:17265124

  11. Spatiotemporal Interactions in Retinal Prosthesis Subjects

    PubMed Central

    Greenberg, Robert J.; Fine, Ione

    2010-01-01

    Purpose. Vision loss due to retinitis pigmentosa affects an estimated 15 million people worldwide. Through collaboration between Second Sight Medical Products, Inc., and the Doheny Eye Institute, six blind human subjects underwent implantation with epiretinal 4 × 4 electrode arrays designed to directly stimulate the remaining cells of the retina, with the goal of restoring functional vision by applying spatiotemporal patterns of stimulation. To better understand spatiotemporal interactions between electrodes during synchronous and asynchronous stimulation, the authors investigated how percepts changed as a function of pulse timing across the electrodes. Methods. Pulse trains (20, 40, 80, and 160 Hz) were presented on groups of electrodes with 800, 1600, or 2400 μm center-to-center separation. Stimulation was either synchronous (pulses were presented simultaneously across electrodes) or asynchronous (pulses were phase shifted). Using a same-different discrimination task, the authors were able to evaluate how the perceptual quality of the stimuli changed as a function of phase shifts across multiple electrodes. Results. Even after controlling for electric field interactions, subjects could discriminate between spatiotemporal pulse train patterns based on differences of phase across electrodes as small as 3 ms. These findings suggest that the quality of the percept is affected not only by electric field interactions but also by spatiotemporal interactions at the neural level. Conclusions. During multielectrode stimulation, interactions between electrodes have a significant influence on the quality of the percept. Understanding how these spatiotemporal interactions at the neural level influence percepts during multielectrode stimulation is fundamental to the successful design of a retinal prosthesis. PMID:19741248

  12. Active Bone Conduction Prosthesis: Bonebridge(TM).

    PubMed

    Zernotti, Mario E; Sarasty, Andrea Bravo

    2015-10-01

    Introduction Bone conduction implants are indicated for patients with conductive and mixed hearing loss, as well as for patients with single-sided deafness (SSD). The transcutaneous technology avoids several complications of the percutaneous bone conduction implants including skin reaction, skin growth over the abutment, and wound infection. The Bonebridge (MED-EL, Austria) prosthesis is a semi-implantable hearing system: the BCI (Bone Conduction Implant) is the implantable part that contains the Bone Conduction-Floating Mass Transducer (BC-FMT), which applies the vibrations directly to the bone; the external component is the audio processor Amadé BB (MED-EL, Austria), which digitally processes the sound and sends the information through the coil to the internal part. Bonebridge may be implanted through three different approaches: the transmastoid, the retrosigmoid, or the middle fossa approach. Objective This systematic review aims to describe the world́s first active bone conduction implant system, Bonebridge, as well as describe the surgical techniques in the three possible approaches, showing results from implant centers in the world in terms of functional gain, speech reception thresholds and word recognition scores. Data Synthesis The authors searched the MEDLINE database using the key term Bonebridge. They selected only five publications to include in this systematic review. The review analyzes 20 patients that received Bonebridge implants with different approaches and pathologies. Conclusion Bonebridge is a solution for patients with conductive/mixed hearing loss and SSD with different surgical approaches, depending on their anatomy. The system imparts fewer complications than percutaneous bone conduction implants and shows proven benefits in speech discrimination and functional gain.

  13. 21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... uncemented prosthesis. 888.3690 Section 888.3690 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. (a) Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as...

  14. 21 CFR 888.3680 - Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... cemented prosthesis. 888.3680 Section 888.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis. (a) Identification. A shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis is a device that has a glenoid (socket)...

  15. 21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... uncemented prosthesis. 888.3690 Section 888.3690 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. (a) Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as...

  16. 21 CFR 888.3180 - Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... uncemented prosthesis. 888.3180 Section 888.3180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis. (a) Identification. An elbow joint humeral (hemi-elbow) metallic uncemented prosthesis is a device intended to be implanted made of...

  17. 21 CFR 888.3180 - Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... uncemented prosthesis. 888.3180 Section 888.3180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis. (a) Identification. An elbow joint humeral (hemi-elbow) metallic uncemented prosthesis is a device intended to be implanted made of...

  18. 21 CFR 888.3180 - Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... uncemented prosthesis. 888.3180 Section 888.3180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis. (a) Identification. An elbow joint humeral (hemi-elbow) metallic uncemented prosthesis is a device intended to be implanted made of...

  19. 21 CFR 888.3180 - Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... uncemented prosthesis. 888.3180 Section 888.3180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis. (a) Identification. An elbow joint humeral (hemi-elbow) metallic uncemented prosthesis is a device intended to be implanted made of...

  20. 21 CFR 888.3180 - Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... uncemented prosthesis. 888.3180 Section 888.3180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis. (a) Identification. An elbow joint humeral (hemi-elbow) metallic uncemented prosthesis is a device intended to be implanted made of...