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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...

  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... required to be filed with the Food and Drug Administration on or before November 17, 1999, for any...

  4. 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...

  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, 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...

  7. 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...

  8. 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...

  9. 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.

  10. 21 CFR 878.3540 - Silicone gel-filled breast prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... silicone gel at time of implantation. The device is intended to be implanted to augment or reconstruct the... be implanted to augment or reconstruct the female breast. (3) Polyurethane covered silicone gel... support structure compartmentalizing the silicone gel. The device is intended to be implanted to...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... silicone gel at time of implantation. The device is intended to be implanted to augment or reconstruct the... be implanted to augment or reconstruct the female breast. (3) Polyurethane covered silicone gel... support structure compartmentalizing the silicone gel. The device is intended to be implanted to...

  12. 21 CFR 878.3540 - Silicone gel-filled breast prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... silicone gel at time of implantation. The device is intended to be implanted to augment or reconstruct the... be implanted to augment or reconstruct the female breast. (3) Polyurethane covered silicone gel... support structure compartmentalizing the silicone gel. The device is intended to be implanted to...

  13. 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.

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

    MedlinePlus

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

  15. 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- ...

  16. Breast Implants: Saline vs. Silicone

    MedlinePlus

    ... to women of any age for breast reconstruction. Silicone breast implants Silicone implants are pre-filled with ... likely be inserted at the same time. Ruptured silicone implant If a silicone breast implant ruptures, you ...

  17. 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.

  18. 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…

  19. 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

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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).

  11. 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.

  12. 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

  13. 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

  14. 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.

  15. 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.

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

    PubMed Central

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

    2016-01-01

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

  17. 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

  18. 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.

  19. [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.

  20. 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.

  1. [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.

  2. 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

  3. 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

  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. 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.

  7. 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

  8. 21 CFR 876.3750 - Testicular prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  9. 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

  10. 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

  11. 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.

  12. 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.

  13. 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

  14. 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.

  15. 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

  16. [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.

  17. 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 ...

  18. 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.

  19. 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.

  20. 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.

  1. 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...

  2. 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...

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Prosthesis Material

    NASA Technical Reports Server (NTRS)

    1995-01-01

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

  11. 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.

  12. 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

  13. 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

  14. 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%.

  15. Retinal Prosthesis

    PubMed Central

    Weiland, James D.; Humayun, Mark S.

    2015-01-01

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

  16. 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.

  17. 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

  18. 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.

  19. 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

  20. 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

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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.

  9. 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

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

    PubMed

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

    2016-11-15

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

  11. 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.

  12. 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.

  13. 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.

  14. 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

  15. 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

  16. 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.

  17. 21 CFR 888.3025 - Passive tendon prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  18. Breast Implants

    MedlinePlus

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

  19. 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.

  20. 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.

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. [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.

  6. 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.

  7. 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.

  8. 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.

  9. Risks of Breast Implants

    MedlinePlus

    ... has traveled to other parts of the body. Connective Tissue Disease The FDA has not detected any association between silicone gel-filled breast implants and connective tissue disease, breast cancer, or reproductive problems. In order ...

  10. 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.

  11. 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

  12. 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.

  13. 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.

  14. 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.

  15. 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

  16. 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.

  17. 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

  18. 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.

  19. 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

  20. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. [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.

  7. 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.

  8. [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.

  9. 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...

  10. 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...

  11. 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...

  12. 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.

  13. 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

  14. 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.

  15. 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.

  16. [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.

  17. 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

  18. 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.

  19. 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...

  20. 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...

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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....

  10. 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....

  11. 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... Drug Administration on or before July 5, 1995, for any testicular prosthesis that was in...

  12. 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....

  13. 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....

  14. 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....

  15. 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....

  16. 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....

  17. 21 CFR 878.3590 - Ear prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ear prosthesis. 878.3590 Section 878.3590 Food and 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....

  18. 21 CFR 878.3550 - Chin prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  19. 21 CFR 878.3720 - Tracheal prosthesis.

    Code of Federal Regulations, 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....

  20. 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....

  1. 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....

  2. 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....

  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 878.3720 - 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....

  5. 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....

  6. 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....

  7. 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....

  8. 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....

  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. 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.

  11. 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

  12. 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

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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 ...

  19. 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.

  20. 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

  1. 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.

  2. 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

  3. [Mechanical complications of total shoulder inverted prosthesis].

    PubMed

    Delloye, C; Joris, D; Colette, A; Eudier, A; Dubuc, J E

    2002-06-01

    Our series of inverted prosthesis included 5 patients with a mean age of 73 +/- 6 years. In 4 cases, the implant was performed as a surgical revision. The follow up was 81 +/- 15 months. Three shoulders were pain free whereas two caused a dull pain after a free interval due to mechanical complications. The mean active elevation was 72 degrees while external rotation was - 2 degrees. The adjusted Constant score passed from 32 to 60. In case of complications, the score dropped to 32. Mechanical complications were important with in one case, an unscrening of the glenosphere and in two cases, a loosening of the glenoid prosthesis. This last and major complication occurred 6 years after surgery and was promoted by the occurrence of a progressive bone erosion in the scapula. This gap represented an attempt to accomodate the medial part of the humeral prosthesis under the scapula when the arm is at rest or in adduction. The concept of an inverted prosthesis is attractive and this implant remains one of the options in cuff-tear arthropathy. Our results were not as good as those reported by others but most of ours patients had been already operated before. The occurrence of an osseous gap on pilar of scapula may lead to failure of this prosthesis. This gap remains a threath as it can progress and as such warrants a design alteration of the prosthesis.

  4. 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.

  5. 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.

  6. 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)

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 21 CFR 872.3950 - Glenoid fossa prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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.

  6. 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.

  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. 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.

  10. 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.

  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. 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.

  13. 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.

  14. 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.

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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.

  1. 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.

  2. 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.

  3. 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 ...

  4. 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.

  5. 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

  6. 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

  7. 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.

  8. 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

  9. 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,…

  10. 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.

  11. 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

  12. 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 .

  13. 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.

  14. 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

  15. 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

  16. Breast infection

    MedlinePlus

    ... female breast anatomy Breast infection Female breast References Hunt KK, Mittendorf EA. Diseases of the breast. In: ... Jacobson, MD, Professor of Obstetrics and Gynecology, Loma Linda University School of Medicine, Loma Linda Center for ...

  17. Breast cancer

    MedlinePlus

    ... of a direct link between breast cancer and pesticides. Symptoms Early breast cancer often does not cause ... breast cancer should not drink alcohol at all) Alternative Names Cancer - breast; Carcinoma - ductal; Carcinoma - lobular; DCIS; ...

  18. 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

  19. 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.

  20. 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.

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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.

  6. [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%.

  7. 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

  8. 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.

  9. 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.

  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. 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.

  12. 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.

  13. 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

  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. 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.

  16. 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.

  17. 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

  18. 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.

  19. 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

  20. 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.

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. Fibroadenoma - breast

    MedlinePlus

    Breast lump - fibroadenoma; Breast lump - noncancerous; Breast lump - benign ... The cause of fibroadenomas is not known. There may be a connection to a problem with genes. Fibroadenoma is the most common benign ...

  9. 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 ...

  10. 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 ...

  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. 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.

  14. 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

  15. 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.

  16. [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.

  17. 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.

  18. What Is Breast Cancer?

    MedlinePlus

    ... Research? Breast Cancer About Breast Cancer What Is Breast Cancer? Breast cancer starts when cells in the breast ... spread, see our section on Cancer Basics . Where breast cancer starts Breast cancers can start from different parts ...

  19. 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

  20. 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.

  1. 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.

  2. 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.

  3. Endoscopic Breast Surgery in Treating Patients With Breast Cancer

    ClinicalTrials.gov

    2014-02-05

    Male Breast Cancer; Recurrent Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer

  4. 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.

  5. Breast Diseases

    MedlinePlus

    ... bumps, and discharges (fluids that are not breast milk). If you have a breast lump, pain, discharge or skin irritation, see your health care provider. Minor and serious breast problems have similar symptoms. Although many women fear cancer, most breast problems are not cancer. Some common ...

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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

  14. 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

  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. 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.

  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. 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.

  19. 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...

  20. 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)...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 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...

  8. 21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 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...

  9. 21 CFR 888.3680 - Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 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)...

  10. 21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint carpal lunate polymer prosthesis. 888.3750 Section 888.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a...

  11. 21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a...

  12. 21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint carpal trapezium polymer prosthesis. 888.3770 Section 888.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a...

  13. 21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint carpal lunate polymer prosthesis. 888.3750 Section 888.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a...

  14. 21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a...

  15. 21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint carpal lunate polymer prosthesis. 888.3750 Section 888.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a...

  16. 21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint carpal trapezium polymer prosthesis. 888.3770 Section 888.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a...

  17. 21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint carpal trapezium polymer prosthesis. 888.3770 Section 888.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a...

  18. 21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a...

  19. 21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint carpal lunate polymer prosthesis. 888.3750 Section 888.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a...

  20. 21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint carpal trapezium polymer prosthesis. 888.3770 Section 888.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a...

  1. 21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a...

  2. 21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint carpal trapezium polymer prosthesis. 888.3770 Section 888.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a...

  3. 21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint carpal lunate polymer prosthesis. 888.3750 Section 888.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a...

  4. 21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a...

  5. 21 CFR 888.3790 - Wrist joint metal constrained cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint metal constrained cemented prosthesis... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3790 Wrist joint metal constrained cemented prosthesis. (a) Identification. A wrist joint metal constrained cemented prosthesis is...

  6. 21 CFR 888.3790 - Wrist joint metal constrained cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint metal constrained cemented prosthesis... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3790 Wrist joint metal constrained cemented prosthesis. (a) Identification. A wrist joint metal constrained cemented prosthesis is...

  7. 21 CFR 888.3790 - Wrist joint metal constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint metal constrained cemented prosthesis... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3790 Wrist joint metal constrained cemented prosthesis. (a) Identification. A wrist joint metal constrained cemented prosthesis is...

  8. 21 CFR 888.3790 - Wrist joint metal constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint metal constrained cemented prosthesis... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3790 Wrist joint metal constrained cemented prosthesis. (a) Identification. A wrist joint metal constrained cemented prosthesis is...

  9. 21 CFR 888.3790 - Wrist joint metal constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint metal constrained cemented prosthesis... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3790 Wrist joint metal constrained cemented prosthesis. (a) Identification. A wrist joint metal constrained cemented prosthesis is...

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

    PubMed Central

    Pusic, Andrea; Murphy, Diane K.

    2016-01-01

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

  11. Capsular Weakness around Breast Implant: A Non-Recognized Complication

    PubMed Central

    Arquero, Pedro Salinero; Zanata, Fabiana Cristina; Ferreira, Lydia Masako; Nahas, Fabio Xerfan

    2015-01-01

    Capsular contraction is a frequent complication following breast augmentation. On the other hand, capsular weakness, a not widely recognized complication, may occur around the implant. A weak capsule allows the migration of the prosthesis to the lateral region of the thoracic region or inferiorly, towards the abdomen, due to gravitational forces. The cause of capsular weakness remains unresolved. Implant malposition, with lateral or downward displacement, breast asymmetry, improper contour, with implants moving in the pocket that compromise the aesthetic outcome of breast augmentation and require surgical correction may be different symptoms from the same clinical problem. Capsular weakness is a short or mid-term complication of breast augmentation. Most techniques aim to correct the malposition by making sutures to increase the resistance to the displacement of the implant, rearrange the structures using the capsule as flaps to remodel the envelope of the new pocket, obtaining a more stable and reliable result. In this article, four cases of displacement of breast prosthesis with capsular weakness are described and the surgical treatment that included a capsulotomy and capsulorraphy is described. PMID:26284187

  12. 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

  13. An electronic prosthesis mimicking the dynamic vestibular function

    NASA Astrophysics Data System (ADS)

    Shkel, Andrei M.

    2006-03-01

    This paper reports our progress toward development of a unilateral vestibular prosthesis. The sensing element of the prosthesis is a custom designed one-axis MEMS gyroscope. Similarly to the natural semicircular canal, the microscopic gyroscope senses angular motion of the head and generates voltages proportional to the corresponding angular accelerations. Then, voltages are sent to the pulse generating unit where angular motion is translated into voltage pulses. The voltage pulses are converted into current pulses and are delivered through specially designed electrodes, conditioned to stimulate the corresponding vestibular nerve branch. Our preliminary experimental evaluations of the prosthesis on a rate table indicate that the device's output matches the average firing rate of vestibular neurons to those in animal models reported in the literature. The proposed design is scalable; the sensing unit, pulse generator, and the current source can be potentially implemented on a single chip using integrated MEMS technology.

  14. An electronic prosthesis mimicking the dynamic vestibular function.

    PubMed

    Shkel, Andrei M; Zeng, Fan-Gang

    2006-01-01

    This paper presents a functional architecture, system level design, and electronic evaluation of a unilateral vestibular prosthesis. The sensing unit of the prosthesis is a custom-designed one-axis micro-electromechanical system (MEMS) gyroscope. Similar to the natural semicircular canal, the MEMS gyroscope senses angular motion of the head and generates voltages proportional to the corresponding angular acceleration. The voltage is then converted into electric current pulses according to the physiological data relating angular acceleration to the spike count in the vestibular nerve. The current pulses can be delivered to stimulate the corresponding vestibular nerve branch. Electronic properties of the vestibular prosthesis prototype have been systematically evaluated and found to meet the design specifications. A unique feature of the present vestibular implant prototype is the scalability: the sensing unit, pulse generator, and the current source can be potentially implemented on a single chip using integrated MEMS technology.

  15. Echocardiographic features of aortic ball valve prosthesis malfunction.

    PubMed

    Weisburst, M R; Singh, A K; Riley, R S

    1982-11-01

    A case of aortic ball valve prosthesis malfunction is described in which the poppet became alternately stuck in the open and closed position. The patient experienced chest pain followed by pulmonary edema and cardiac arrest. Malfunction of prosthetic valve was diagnosed on echocardiogram and cardiopulmonary resuscitation was carried out until a Bjork-Shiley valve could be inserted in place of the faulty prosthesis. At the time of the operation, poppet migration had occurred and the poppet could not be found. Subsequent Bjork-Shiley aortic valve prosthesis dysfunction was suggested by variation in the intensity of the aortic opening sound and in the duration of the systolic ejection period. Fluoroscopy revealed the missing poppet in the left ventricle. Following surgical removal of the poppet, "normal" Bjork-Shiley valve function was restored.

  16. Development of alumina ceramic bipolar hip prosthesis and clinical application.

    PubMed

    Asada, K; Yoshida, K; Shimazu, A; Yunoki, H; Ishida, N

    1987-02-01

    The concept of the bipolar type prosthesis is that the articular motion is observed primarily between the HDP bearing insert and the inner head, thereby avoiding the greater frictional shear force between the prosthetic head and acetabulum found with the traditional one piece endoprosthesis. A newly developed ceramic bipolar hip prosthesis utilizes an outer head composed of bio-inert fine alumina ceramic rather than a metal head. The mechanical strength of this prototype bipolar hip prosthesis was tested with static load and impact force, and the dynamic fatigue strength was also tested with repeated loads. Results were judged to show that the device has strength adequate for clinical use. The hip prostheses has been clinically applied in replacement of the femoral head of a neck fracture, femoral head necrosis and osteoarthritic hip. Finally, using a mathematical model, the so-called self-centering effect due to center offset between outer and inner heads is discussed.

  17. [Tests of hand functionality in upper limb amputation with prosthesis].

    PubMed

    Bazzini, G; Orlandini, D; Moscato, T A; Nicita, D; Panigazzi, M

    2007-01-01

    The need for standardized instruments for clinical measurements has become pressing in the fields of occupational rehabilitation and ergonomics. This is particularly the case for instruments that allow a quantitative evaluation of upper limb function, and especially hand function in patients who have undergone an amputation and then application of an upper limb prosthesis. This study presents a review of the main tests used to evaluate hand function, with a critical analysis of their use in subjects with an upper limb prosthesis. The tests are divided into: tests to evaluate strength, tests to evaluate co-ordination and dexterity, tests of global or overall function, and tests proposed specifically for subjects with an upper limb prosthesis. Of the various tests presented, the authors give their preference to the Bimanual Functional Assessment, Abilhand and/or the ADL Questionnaire, because of the practical usefulness, clinimetric features, simplicity and ease of administration of these tests.

  18. Preliminary Evaluations of a Self-Contained Anthropomorphic Transfemoral Prosthesis

    PubMed Central

    Sup, Frank; Varol, Huseyin Atakan; Mitchell, Jason; Withrow, Thomas J.; Goldfarb, Michael

    2009-01-01

    This paper presents a self-contained powered knee and ankle prosthesis, intended to enhance the mobility of transfemoral amputees. A finite-state based impedance control approach, previously developed by the authors, is used for the control of the prosthesis during walking and standing. Experiments on an amputee subject for level treadmill and overground walking are described. Knee and ankle joint angle, torque, and power data taken during walking experiments at various speeds demonstrate the ability of the prosthesis to provide a functional gait that is representative of normal gait biomechanics. Measurements from the battery during level overground walking indicate that the self-contained device can provide more than 4500 strides, or 9 km, of walking at a speed of 5.1 km/h between battery charges. PMID:20054424

  19. Research, design & development project Myoelectric Prosthesis of Upper Limb

    NASA Astrophysics Data System (ADS)

    Galiano, L.; Montaner, E.; Flecha, A.

    2007-11-01

    A Research Design and Development Project was developed of a myoelectric prosthesis for a pediatric patient presenting congenital amputation of the left forearm below the elbow. A multidisciplinary work-team was formed for this goal, in order to solve the several (/various) aspects regarding this project (mechanical, ergonomics, electronics, physical). The prosthesis as an electromechanical device was divided in several blocks, trying to achieve a focused development for each stage, acording to requisites. A mechanical prototype of the prothesis was designed and built along with the circuitry needed for EMG aquisition, control logic and drivers. Having acomplished the previuos stages, the project is now dealing with the definitions of the interface between the prosthesis and the patient, with promising perspectives.

  20. 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

  1. 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.

  2. 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

  3. [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.

  4. [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.

  5. 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.

  6. Breast Biopsy System

    NASA Technical Reports Server (NTRS)

    1994-01-01

    Charge Coupled Devices (CCDs) are high technology silicon chips that connect light directly into electronic or digital images, which can be manipulated or enhanced by computers. When Goddard Space Flight Center (GSFC) scientists realized that existing CCD technology could not meet scientific requirements for the Hubble Space Telescope Imagining Spectrograph, GSFC contracted with Scientific Imaging Technologies, Inc. (SITe) to develop an advanced CCD. SITe then applied many of the NASA-driven enhancements to the manufacture of CCDs for digital mammography. The resulting device images breast tissue more clearly and efficiently. The LORAD Stereo Guide Breast Biopsy system incorporates SITe's CCD as part of a digital camera system that is replacing surgical biopsy in many cases. Known as stereotactic needle biopsy, it is performed under local anesthesia with a needle and saves women time, pain, scarring, radiation exposure and money.

  7. Aspiration of tracheoesophageal prosthesis in a laryngectomized patient

    PubMed Central

    2012-01-01

    Background The voice prosthesis inserted into a tracheoesophageal fistula has become the most widely used device for voice rehabilitation in patients with total laryngectomy. Case presentation We describe a case of tracheoesophageal prosthesis’ (TEP) aspiration in a laryngectomized patient, with permanent tracheal stoma, that appeared during standard cleaning procedure, despite a programme of training for the safe management of patients with voice prosthesis. Conclusions The definitive diagnosis and treatment were performed by flexible bronchoscopy, that may be considered the procedure of choice in these cases, also on the basis of the literature. PMID:22958961

  8. Iliopsoas tendonitis caused by overhang of a collared femoral prosthesis.

    PubMed

    Brew, Christopher J; Stockley, Ian; Grainger, Andrew J; Stone, Martin H

    2011-04-01

    Pain after total hip arthroplasty can be due to a variety of causes, one of the less common being iliopsoas tendonitis. We report an unusual case of iliopsoas tendonitis caused by overhang of the femoral calcar by a collared femoral prosthesis resulting in impingement on the iliopsoas tendon. An ultrasound-guided corticosteroid and local anesthetic diagnostic injection to the site of impingement confirmed the diagnosis with temporary symptom relief. Revision of the femoral stem to a collarless prosthesis resulted in immediate and complete resolution of symptoms.

  9. Prosthesis-preserving aortic root repair after aortic valve replacement.

    PubMed

    Hamamoto, Masaki; Kobayashi, Taira; Kodama, Hiroshi

    2015-07-01

    We describe a new technique of prosthesis-preserving aortic root replacement for patients who have previously undergone aortic valve replacement. With preservation of the mechanical prosthesis, we implant a Gelweave Valsalva graft using double suture lines. The first suture line is made between the sewing cuff of the mechanical valve and the graft, with mattress sutures of 2/0 braided polyester with pledgets. After the first sutures are tied, the second suture line is created between the graft collar and the aortic root remnant with continuous 4/0 polypropylene sutures.

  10. [Total Elbow Replacement - Implantation of the Latitude Prosthesis (Tornier)].

    PubMed

    Hackl, M; Wegmann, K; Leschinger, T; Ries, C; Burkhart, K J; Müller, L

    2015-10-01

    Due to technical progress, the indication for total elbow arthroplasty could be expanded in recent years. As a result, the demand regarding functionality and mobility of the replaced joint has risen as well. Elbow arthroplasty has to be considered as technically demanding. Only with detailed knowledge of this surgical procedure and its possible intraoperative pitfalls can one provide the best possible results. In this instructional video we explain the implantation of the Latitude elbow prosthesis (Tornier) putting emphasis on the correct approach as well as implantation of the prosthesis and subsequent wound closure.

  11. Heterotopic ossification associated with myelopathy following cervical disc prosthesis implantation.

    PubMed

    Wenger, Markus; Markwalder, Thomas-Marc

    2016-04-01

    This case report presents a 37-year-old man with clinical signs of myelopathy almost 9 years after implantation of a Bryan disc prosthesis (Medtronic Sofamor Danek, Memphis, TN, USA) for C5/C6 soft disc herniation. As demonstrated on MRI and CT scan, spinal cord compression was caused by bony spurs due to heterotopic ossification posterior to the still moving prosthesis. The device, as well as the ectopic bone deposits, had to be removed because of myelopathy and its imminent aggravation. Conversion to anterior spondylodesis was performed.

  12. Design and characterization of a powered elbow prosthesis.

    PubMed

    Bennett, Daniel A; Mitchell, Jason; Goldfarb, Michael

    2015-01-01

    This paper describes the design of a powered elbow prosthesis, which incorporates a belt and cable drive transmission with a brushless DC motor to achieve an output torque of approximately 18.4 Nm, a backdrive torque of 1.5 Nm, and a speed of up to 360 deg/s while remaining within the anthropomorphic envelope with regard to mass and size. The measured torque and speed of the prosthesis is commensurate with nominal capability of the natural limb (for purposes of performing activities of daily living).

  13. Dynamics of dental implants and orthodontics in today's periodontal prosthesis.

    PubMed

    Cheng, Y M

    2000-03-01

    Periodontal prosthesis refers to multidisciplinary efforts to stop disease progression, correct deformities created by dental diseases, and establish a therapeutic occlusion to restore the form and function of the masticatory system. These efforts are critical for the long-term prognosis and maintenance of the guarded teeth and the overall prosthesis. This article presents a functionally and esthetically challenging case, which illustrates a multidisciplinary approach--specifically implantology and orthodontics--and how they impact on each other during treatment. The role and importance of dental implants and orthodontics in setting up a case is illustrated in this article.

  14. An investigation into vascular prosthesis modified with an electron beam.

    PubMed

    Lowkis, B; Szymonowicz, M; Rutkowski, J

    1997-01-01

    The present paper shows the results of an investigation into the effect of implanted electric charge on blood platelet adhesion to woven surfaces of "Dallon" polyester vascular prosthesis. The electrets were formed using the electron beam method. The assessment of the electret effect on blood platelet adhesion was performed on the basis of microscopic studies. It was shown that an implanted negative electric charge remarkably suppresses thrombocyte adhesion to the prosthesis surface. The electret effect was found to play a significant role in the process of preparing nonthrombogenic surfaces.

  15. 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.

  16. Breast Gangrene

    PubMed Central

    2011-01-01

    Background Breast gangrene is rare in surgical practice. Gangrene of breast can be idiopathic or secondary to some causative factor. Antibiotics and debridement are used for management. Acute inflammatory infiltrate, severe necrosis of breast tissue, necrotizing arteritis, and venous thrombosis is observed on histopathology. The aim of was to study patients who had breast gangrene. Methods A prospective study of 10 patients who had breast gangrene over a period of 6 years were analyzed Results All the patients in the study group were female. Total of 10 patients were encountered who had breast gangrene. Six patients presented with breast gangrene on the right breast whereas four had on left breast. Out of 10 patients, three had breast abscess after teeth bite followed by gangrene, one had iatrogenic trauma by needle aspiration of erythematous area of breast under septic conditions. Four had history of application of belladonna on cutaneous breast abscess and had then gangrene. All were lactating female. Amongst the rest two were elderly, one of which was a diabetic who had gangrene of breast and had no application of belladonna. All except one had debridement under cover of broad spectrum antibiotics. Three patients had grafting to cover the raw area. Conclusion Breast gangrene occurs rarely. Etiology is variable and mutifactorial. Teeth bite while lactation and the iatrogenic trauma by needle aspiration of breast abscess under unsterlised conditions could be causative. Uncontrolled diabetes can be one more causative factor for the breast gangrene. Belladonna application as a topical agent could be inciting factor. Sometimes gangrene of breast can be idiopathic. Treatment is antibiotics and debridement. PMID:21854557

  17. Prosthetic Rehabilitation of a Patient with Ocular Defect using Semi-customized Prosthesis: A Case Report

    PubMed Central

    Putanikar, Nagaraj Y.; Patil, Anandkumar G.; Shetty, Pavithra K.; Nagaral, Suresh; Mithaiwala, Hatimali I.

    2015-01-01

    Severe physical and psychological distress occurs due to disfigurement caused by loss of eye. Ocular prosthesis is the only mode of rehabilitation for the missing eye. There are different materials and techniques used for the fabrication of the same. Resin proved to be the better among the available materials. Either using the stock eye or using customized ocular prosthesis has their own advantages and disadvantages. Through our clinical report, we have fabricated a semi-customized ocular prosthesis with stock iris and customized sclera. This prosthesis had the advantages of both stock and custom ocular prosthesis providing functionally and esthetically satisfactory result. PMID:25954078

  18. Management of long span partially edentulous maxilla with fixed removable denture prosthesis

    PubMed Central

    Jeyavalan, Mahilan I.; Narasimman, M.; Venkatakrishnan, C. J.; Philip, Jacob M.

    2012-01-01

    Restoration of a long span partially edentulous maxilla with tooth supported prosthesis is challenging because of inherent anatomic limitations and unfavourable biomechanics present after the loss of teeth. A tooth supported fixed-removable prosthesis is a treatment option for restoration of such long span partially edentulous maxillary arches. This prosthesis meets the requirements for esthetics, phonetics, comfort, and hygiene, as well as favourable biomechanical stress distribution to the remaining natural tooth abutments. This article presents a procedure for fabrication of a fixed-removable prosthesis that has cement-retained custom cast bar metal substructure and a ball attachment retained removable superstructure prosthesis. PMID:23293488

  19. Penile prosthesis implantation in the era of medical treatment for erectile dysfunction.

    PubMed

    Montague, Drogo K

    2011-05-01

    Penile prosthesis implantation, the oldest of the modern treatments for erectile dysfunction (ED), still plays an important role despite the advent of less invasive alternatives. For some men with ED, penile prosthesis implantation is the only effective or acceptable treatment. Penile prosthesis implantation remains a viable option in the contemporary management of ED as evidenced by annual penile prosthesis implantation cases in the United States rising from 17,540 in 2000 to 22,420 in 2009. Improvements in prosthesis design and implantation techniques have resulted in significant increases in device survival and patient satisfaction.

  20. Breast lift

    MedlinePlus

    ... Planning to have more children Talk with a plastic surgeon if you are considering cosmetic breast surgery. ... before surgery: You may need a mammogram . Your plastic surgeon will do a routine breast exam. You ...

  1. Breast Exam

    MedlinePlus

    ... Your hormone levels fluctuate each month during your menstrual cycle, which causes changes in breast tissue. Swelling begins ... changes that occur at various points in the menstrual cycles. Finding a change or lump in your breast ...

  2. Breast Cysts

    MedlinePlus

    ... discuss your symptoms, their relation to your menstrual cycle and any other relevant information. To prepare for ... one or both breasts? How does your menstrual cycle affect the breast cyst or lump? When was ...

  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 ... who have family members with breast or ovarian cancer may wish to be tested for the genes. ...

  4. [Carcinoma of the esophagus. Palliative treatment with endoscopic prosthesis].

    PubMed

    Sala, T; Pertejo, V; Linares, M; Del Val, A

    1990-08-01

    The efficacy and safety of endoscopically inserted esophageal prosthesis was evaluated in 33 patients with non-operable carcinoma involving the esophagus. In 30 cases, the origin of the tumor was esophageal, and in 3 cases, bronchopulmonary. Esophago-pulmonary fistula was present in 9 patients. Histologic exam of the tumors revealed 11 adenocarcinomas and 22 epidermoid carcinomas. In every case, Atkinson prosthesis was used and previous esophageal dilatation was needed in 21 patients. Normal oral feeding was achieved in 29 patients. Mean hospital stay after insertion of the prosthesis was 5 days. Survival rate was 84.8% at one month, 63.6% at 4-6 months, 42.4% survived more than 6 months, and 21.2% were still alive one year after the procedure. Complications occurred in 3 patients (9%) -esophageal perforation in two cases, and pneumonia in one case. One patient died. In conclusion, in patients with advanced carcinoma involving the esophagus, palliative therapy with endoscopically inserted esophageal prosthesis is effective, relatively safe and cheap.

  5. Verge of Collapse: The Pros/thesis of Art Research

    ERIC Educational Resources Information Center

    Garoian, Charles R.

    2008-01-01

    This article explores "prosthesis" as a metaphor of embodiment in art-based research to challenge the utopian myth of wholeness and normality in art and the human body. Bearing in mind the correspondences between amputated bodies and the cultural dislocations of art, I propose "prosthetic epistemology" and "prosthetic ontology" as embodied knowing…

  6. 21 CFR 874.3495 - Total ossicular replacement prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Total ossicular replacement prosthesis. 874.3495 Section 874.3495 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... be implanted for the total functional reconstruction of the ossicular chain and facilitates...

  7. 21 CFR 874.3495 - Total ossicular replacement prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Total ossicular replacement prosthesis. 874.3495 Section 874.3495 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... be implanted for the total functional reconstruction of the ossicular chain and facilitates...

  8. 21 CFR 874.3495 - Total ossicular replacement prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Total ossicular replacement prosthesis. 874.3495 Section 874.3495 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... be implanted for the total functional reconstruction of the ossicular chain and facilitates...

  9. 21 CFR 874.3495 - Total ossicular replacement prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Total ossicular replacement prosthesis. 874.3495 Section 874.3495 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... be implanted for the total functional reconstruction of the ossicular chain and facilitates...

  10. 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 888.3025 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... flexor tendon of the hand. The device is implanted for a period of 2 to 6 months to aid growth of a...

  11. 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 888.3025 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... flexor tendon of the hand. The device is implanted for a period of 2 to 6 months to aid growth of a...

  12. 21 CFR 890.3500 - External assembled lower limb prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false External assembled lower limb prosthesis. 890.3500 Section 890.3500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices §...

  13. 21 CFR 890.3500 - External assembled lower limb prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false External assembled lower limb prosthesis. 890.3500 Section 890.3500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices §...

  14. 21 CFR 890.3500 - External assembled lower limb prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false External assembled lower limb prosthesis. 890.3500 Section 890.3500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices §...

  15. 21 CFR 870.3450 - Vascular graft prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Vascular graft prosthesis. 870.3450 Section 870.3450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3450 Vascular...

  16. 21 CFR 870.3450 - Vascular graft prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Vascular graft prosthesis. 870.3450 Section 870.3450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3450 Vascular...

  17. 21 CFR 870.3450 - Vascular graft prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Vascular graft prosthesis. 870.3450 Section 870.3450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3450 Vascular...

  18. 21 CFR 870.3450 - Vascular graft prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Vascular graft prosthesis. 870.3450 Section 870.3450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3450 Vascular...

  19. 21 CFR 890.3500 - External assembled lower limb prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false External assembled lower limb prosthesis. 890.3500 Section 890.3500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices §...

  20. 21 CFR 890.3500 - External assembled lower limb prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false External assembled lower limb prosthesis. 890.3500 Section 890.3500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices §...

  1. 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...

  2. Transfemoral prosthesis suspension systems: a systematic review of the literature.

    PubMed

    Gholizadeh, Hossein; Abu Osman, Noor Azuan; Eshraghi, Arezoo; Ali, Sadeeq

    2014-09-01

    The purpose of this study was to find the scientific evidence pertaining to various transfemoral suspension systems to provide selection criteria for clinicians. To this end, databases of PubMed, Web of Science, and ScienceDirect were explored. The following key words, as well as their combinations and synonyms, were used for the search: transfemoral prosthesis, prosthetic suspension, lower limb prosthesis, above-knee prosthesis, prosthetic liner, transfemoral, and prosthetic socket. The study design, research instrument, sampling method, outcome measures, and protocols of articles were reviewed. On the basis of the selection criteria, 16 articles (11 prospective studies and 5 surveys) were reviewed. The main causes of reluctance to prosthesis, aside from energy expenditure, were socket-related problems such as discomfort, perspiration, and skin problems. Osseointegration was a suspension option, yet it is rarely applied because of several drawbacks, such as extended rehabilitation process, risk for fracture, and infection along with excessive cost. In conclusion, no clinical evidence was found as a "standard" system of suspension and socket design for all transfemoral amputees. However, among various suspension systems for transfemoral amputees, the soft insert or double socket was favored by most users in terms of function and comfort.

  3. 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 Section 872.3940 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... and Drug Administration on or before March 30, 1999, for any total temporomandibular joint...

  4. 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 872.3950 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... or a notice of completion of a PDP is required to be filed with the Food and Drug Administration...

  5. 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 Section 872.3940 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... and Drug Administration on or before March 30, 1999, for any total temporomandibular joint...

  6. 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 implant). 872.3970 Section 872.3970 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... Food and Drug Administration on or before March 30, 1999, for any interarticular disc...

  7. 21 CFR 872.3960 - Mandibular condyle prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Mandibular condyle prosthesis. 872.3960 Section 872.3960 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... this section, a PMA or a notice of completion of a PDP is required to be filed with the Food and...

  8. Wispy Prosthesis: A Novel Method in Denture Weight Reduction

    PubMed Central

    Anne, Gopinadh; Budeti, Sreedevi; Anche, Sampath Kumar; Zakkula, Srujana; Atla, Jyothi; Jyothula, Ravi Rakesh Dev; Peddinti, Vijaya Kumar

    2016-01-01

    Introduction Stability and retention of the denture becomes at stake with the increase in weight of the denture prosthesis. As a consequence, different materials and methods have been introduced to overcome these issues but denture weight reduction still remains to be a cumbersome and strenuous procedure. Aim To introduce a novel technique for the fabrication of denture prosthesis where in the weight of the denture will not affect the retention and stability of the denture. Materials and Methods Four groups with a sample size of 10 each, were included where in one group was control and other three were study groups. The control group samples were made completely solid and the study group samples were packed with materials like bean balls, cellulose balls and polyacrylic fibers. The weight of all the samples of each study group was measured and compared with the control group. The observations were analyzed statistically by paired t-test. Results It was observed that the bean balls group produced a weight reduction of 31.3%, cellulose balls group 27.4% and polyacrylic fibers group 24.5% when compared to that of the control group. Conclusion This novel technique will eliminate the problems that were associated in creating hollowness and at the same time will reduce the weight of the prosthesis and among all the study groups, bean balls group were found to reduce maximum weight of the prosthesis. PMID:27190947

  9. Effectiveness and versatility of biological prosthesis in transplanted patients

    PubMed Central

    Vennarecci, Giovanni; Mascianà, Gianluca; De Werra, Edoardo; Sandri, Giovanni Battista Levi; Ferraro, Daniele; Burocchi, Mirco; Tortorelli, Giovanni; Guglielmo, Nicola; Ettorre, Giuseppe Maria

    2017-01-01

    AIM To emphasize the effectiveness and versatility of prosthesis, and good tolerance by patients with incisional hernia (IH). METHODS From December 2001 to February 2016, 270 liver transplantations were performed at San Camillo Hospital. IH occurred in 78 patients (28.8%). IH usually appeared early within the first year post-orthotopic liver transplantation. In the first era, fascial defect was repaired by primary closure for defects smaller than 2.5 cm or with synthetic mesh for greater defects. Recently, we started using biological mesh (Permacol™, Covidien). We present a series of five transplanted patients submitted to surgery for abdominal wall defect correction repaired with biological mesh (Permacol™, Covidien). RESULTS In our cases, the use of biological prosthesis (Permacol™, Covidien) have proven to be effective and versatile in repairing hernia defects of different kinds; patients did not suffer infections of the prosthesis and no recurrence was observed. Furthermore, the prosthesis remains intact even in the years after surgery. CONCLUSION The cases that we presented show that the use of biological mesh (Permacol™, Covidien) in transplanted patients may be safe and effective, being careful in the management of perioperative immunosuppression and renal and graft function, although the cost of the product itself has been the main limiting factor and there is need for prospective studies for further evaluations. PMID:28280694

  10. 21 CFR 874.3695 - Mandibular implant facial prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Mandibular implant facial prosthesis. 874.3695 Section 874.3695 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3695 Mandibular...

  11. 21 CFR 874.3730 - Laryngeal prosthesis (Taub design).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Laryngeal prosthesis (Taub design). 874.3730 Section 874.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3730 Laryngeal...

  12. 21 CFR 874.3695 - Mandibular implant facial prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mandibular implant facial prosthesis. 874.3695 Section 874.3695 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3695 Mandibular...

  13. 21 CFR 874.3730 - Laryngeal prosthesis (Taub design).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Laryngeal prosthesis (Taub design). 874.3730 Section 874.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3730 Laryngeal...

  14. 21 CFR 874.3730 - Laryngeal prosthesis (Taub design).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Laryngeal prosthesis (Taub design). 874.3730 Section 874.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3730 Laryngeal...

  15. 21 CFR 874.3695 - Mandibular implant facial prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Mandibular implant facial prosthesis. 874.3695 Section 874.3695 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3695 Mandibular...

  16. Indicators of dynamic stability in transtibial prosthesis users.

    PubMed

    Kendell, C; Lemaire, E D; Dudek, N L; Kofman, J

    2010-03-01

    An improved understanding of factors related to dynamic stability in lower-limb prosthesis users is important, given the high occurrence of falls in this population. Current methods of assessing stability are unable to adequately characterize dynamic stability over a variety of walking conditions. F-Scan Mobile has been used to collect plantar pressure data and six extracted parameters were useful measures of dynamic stability. The aim of this study was to investigate dynamic stability in individuals with unilateral transtibial amputation based on these six parameters. Twenty community ambulators with a unilateral transtibial amputation walked over level ground, uneven ground, stairs, and a ramp while plantar pressure data were collected. For each limb (intact and prosthetic) and condition, six stability parameters related to plantar center-of-pressure perturbations and gait temporal parameters, were computed from the plantar pressure data. Parameter values were compared between limbs, walking condition, and groups (unilateral transtibial prosthesis users and able-bodied subjects). Differences in parameters were found between limbs and conditions, and between prosthesis users and able-bodied individuals. Further research could investigate optimizing parameter calculations for unilateral transtibial prosthesis users and define relationships between potential for falls and the dynamic stability measures.

  17. 21 CFR 878.3750 - External prosthesis adhesive.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External...

  18. 21 CFR 878.3750 - External prosthesis adhesive.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External...

  19. 21 CFR 878.3800 - External aesthetic restoration prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false External aesthetic restoration prosthesis. 878.3800 Section 878.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices §...

  20. 21 CFR 878.3750 - External prosthesis adhesive.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External...

  1. 21 CFR 878.3750 - External prosthesis adhesive.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External...

  2. 21 CFR 878.3800 - External aesthetic restoration prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false External aesthetic restoration prosthesis. 878.3800 Section 878.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices §...

  3. 21 CFR 878.3800 - External aesthetic restoration prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false External aesthetic restoration prosthesis. 878.3800 Section 878.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices §...

  4. 21 CFR 878.3750 - External prosthesis adhesive.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External...

  5. A Custom Made Intrinsic Silicone Shade Guide for Indian Population

    PubMed Central

    Behanam, Mohammed; Ahila, S.C.; Jei, J. Brintha

    2016-01-01

    Introduction Replication of natural skin colour in maxillofacial prosthesis has been traditionally done using trial and error method, as concrete shade guides are unavailable till date. Hence a novel custom made intrinsic silicone shade guide has been attempted for Indian population. Aim Reconstruction of maxillofacial defects is challenging, as achieving an aesthetic result is not always easy. A concoction of a novel intrinsic silicone shade guide was contemplated for the study and its reproducibility in clinical practice was analysed. Materials and Methods Medical grade room temperature vulcanising silicone was used for the fabrication of shade tabs. The shade guide consisted of three main groups I, II and III which were divided based upon the hues yellow, red and blue respectively. Five distinct intrinsic pigments were added in definite proportions to subdivide each group of different values from lighter to darker shades. A total number of 15 circular shade tabs comprised the guide. To validate the usage of the guide, visual assessment of colour matching was done by four investigators to investigate the consent of perfect colour correspondence. Data was statistically analysed using kappa coefficients. Results The kappa values were found to be 0.47 to 0.78 for yellow based group I, 0.13 to 0.65 for red based group II, and 0.07 to 0.36 for blue based group III. This revealed that the shade tabs of yellow and red based hues matched well and showed a statistically good colour matching. Conclusion This intrinsic silicone shade guide can be effectively utilised for fabrication of maxillofacial prosthesis with silicone in Indian population. A transparent colour formula with definite proportioning of intrinsic pigments is provided for obtaining an aesthetic match to skin tone. PMID:27190946

  6. Development of an internally braced prosthesis for total talus replacement.

    PubMed

    Regauer, Markus; Lange, Mirjam; Soldan, Kevin; Peyerl, Steffen; Baumbach, Sebastian; Böcker, Wolfgang; Polzer, Hans

    2017-03-18

    Total loss of talus due to trauma or avascular necrosis, for example, still remains to be a major challenge in foot and ankle surgery with severely limited treatment options. Implantation of a custom made total talar prosthesis has shown promising results so far. Most important factors for long time success are degree of congruence of articular surfaces and ligamentous stability of the ankle. Therefore, our aim was to develop an optimized custom made prosthesis for total talus replacement providing a high level of primary stability. A custom made hemiprosthesis was developed using computed tomography and magnetic resonance imaging data of the affected and contralateral talus considering the principles and technology for the development of the S.T.A.R. prosthesis (Stryker). Additionally, four eyelets for fixation of artificial ligaments were added at the correspondent footprints of the most important ligaments. Two modifications can be provided according to the clinical requirements: A tri-articular hemiprosthesis or a bi-articular hemiprosthesis combined with the tibial component of the S.T.A.R. total ankle replacement system. A feasibility study was performed using a fresh frozen human cadaver. Maximum range of motion of the ankle was measured and ligamentous stability was evaluated by use of standard X-rays after application of varus, valgus or sagittal stress with 150 N. Correct implantation of the prosthesis was technically possible via an anterior approach to the ankle and using standard instruments. Malleolar osteotomies were not required. Maximum ankle dorsiflexion and plantarflexion were measured as 22-0-28 degrees. Maximum anterior displacement of the talus was 6 mm, maximum varus tilt 3 degrees and maximum valgus tilt 2 degrees. Application of an internally braced prosthesis for total talus replacement in humans is technically feasible and might be a reasonable procedure in carefully selected cases with no better alternatives left.

  7. Development of an internally braced prosthesis for total talus replacement

    PubMed Central

    Regauer, Markus; Lange, Mirjam; Soldan, Kevin; Peyerl, Steffen; Baumbach, Sebastian; Böcker, Wolfgang; Polzer, Hans

    2017-01-01

    Total loss of talus due to trauma or avascular necrosis, for example, still remains to be a major challenge in foot and ankle surgery with severely limited treatment options. Implantation of a custom made total talar prosthesis has shown promising results so far. Most important factors for long time success are degree of congruence of articular surfaces and ligamentous stability of the ankle. Therefore, our aim was to develop an optimized custom made prosthesis for total talus replacement providing a high level of primary stability. A custom made hemiprosthesis was developed using computed tomography and magnetic resonance imaging data of the affected and contralateral talus considering the principles and technology for the development of the S.T.A.R. prosthesis (Stryker). Additionally, four eyelets for fixation of artificial ligaments were added at the correspondent footprints of the most important ligaments. Two modifications can be provided according to the clinical requirements: A tri-articular hemiprosthesis or a bi-articular hemiprosthesis combined with the tibial component of the S.T.A.R. total ankle replacement system. A feasibility study was performed using a fresh frozen human cadaver. Maximum range of motion of the ankle was measured and ligamentous stability was evaluated by use of standard X-rays after application of varus, valgus or sagittal stress with 150 N. Correct implantation of the prosthesis was technically possible via an anterior approach to the ankle and using standard instruments. Malleolar osteotomies were not required. Maximum ankle dorsiflexion and plantarflexion were measured as 22-0-28 degrees. Maximum anterior displacement of the talus was 6 mm, maximum varus tilt 3 degrees and maximum valgus tilt 2 degrees. Application of an internally braced prosthesis for total talus replacement in humans is technically feasible and might be a reasonable procedure in carefully selected cases with no better alternatives left. PMID:28361015

  8. Key Parameters Evaluation for Hip Prosthesis with Finite Element Analysis

    NASA Astrophysics Data System (ADS)

    Guo, Hongqiang; Li, Dichen; Lian, Qin; Li, Xiang; Jin, Zhongmin

    2007-09-01

    Stem length and cross section are two key parameters that influence the stability and longevity of metallic hip prosthesis in the total hip arthroplasty (THA). In order to assess their influence to the stress and fatigue behavior of hip prosthesis, a series model of hip prosthesis with round-shaped or drum-shaped cross section, and with different stem lengths were created. These models were analyzed under both static and dynamic loading conditions with finite element analysis, and dynamic loading represents normal walking was used in the dynamic analysis. The stress on the metallic stem, cement, and adjacent bone were got, micromotion on the cement-metal interface were got too. Safety factors for fatigue life of the hip prothesis were calculated based on data obtained from dynamic analysis. Static analysis shows that drum-shaped cross section can decrease the displacement of the stem, that stress on drum-shaped stem focus on the corner of the femoral neck and the distal part of hip prosthesis, whereas the stress on the round-shaped stem distributes evenly over most part of the stem, and maximum stress on stem prosthesis fluctuates with stem length bottoming out at stem length range from 80 mm to 110 mm, that drum-shaped stems with drum height 8 mm generate more stress at the distal part of stem than drum-shaped stems with drum height 10 mm and round stems do. Dynamic and fatigue analysis shows that drum-shaped stem with drum height 10 mm and stem length 90 mm has the greatest safety factor therefore long fatigue life.

  9. Maxillofacial Prosthetic Materials- An Inclination Towards Silicones

    PubMed Central

    Choudhary, Sunita; Garg, Hemlata; H.G., Jagadeesh

    2014-01-01

    There have been constant searches and researches which are taking place in the field of dental materials to best suit the ideal selection criteria to satisfy the functionality, biocompatibility, aesthetics as well as the durability as a maxillofacial material. Among all the different materials, Silicone is the most popularly used, but still studies are carried out to overcome their weaknesses and to come out with a material which can be labeled as the “ideal maxillofacial prosthetic material”. This article comprises the materials which were and are in use and the reason for their unpopularity. It also gives us a scope to understand the major fields where the materials lack and thus needs improvement to render an individual with the best maxillo-facial prosthesis. PMID:25654054

  10. Prosthetic Rehabilitation of Lower Limb with RTV Silicone Using Prosthodontic Clinical and Laboratory Techniques - A Case Report

    PubMed Central

    Kumar, T. Mohan; Ravindran, Smitha; Nair, K. Chandrasekharan; Kumar, Aswini

    2016-01-01

    Amputation of all or part of a limb may be due to systemic disease, vascular disease, infection, local injury or trauma. Partially amputated lower limbs present a variety of unique clinical and prosthetic challenges, because of distinctly different amputation levels of the lower limb. A female patient with history of Partial Foot Amputation (PFA) surgery at metatarsophalangeal joint level, due to crush injury reported for prosthetic rehabilitation. This case was successfully rehabilitated using Room Temperature Vulcanizing (RTV) medical grade silicone for fabrication of foot prosthesis. Though limited in its function, it amply proves that the clinical and laboratory techniques used in fabrication of maxillofacial prosthesis can be effectively adapted for the fabrication of body prosthesis like toes and feet to enhance the quality of life of the patients. The patient was reviewed every year for three years. PMID:27656585

  11. Powered ankle-foot prosthesis for the improvement of amputee ambulation.

    PubMed

    Au, Samuel K; Herr, Hugh; Weber, Jeff; Martinez-Villalpando, Ernesto C

    2007-01-01

    This paper presents the mechanical design, control scheme, and clinical evaluation of a novel, motorized ankle-foot prosthesis, called MIT Powered Ankle-Foot Prosthesis. Unlike a conventional passive-elastic ankle-foot prosthesis, this prosthesis can provide active mechanical power during the stance period of walking. The basic architecture of the prosthesis is a unidirectional spring, configured in parallel with a force-controllable actuator with series elasticity. With this architecture, the anklefoot prosthesis matches the size and weight of the human ankle, and is also capable of delivering high mechanical power and torque observed in normal human walking. We also propose a biomimetic control scheme that allows the prosthesis to mimic the normal human ankle behavior during walking. To evaluate the performance of the prosthesis, we measured the rate of oxygen consumption of three unilateral transtibial amputees walking at self-selected speeds to estimate the metabolic walking economy. We find that the powered prosthesis improves amputee metabolic economy from 7% to 20% compared to the conventional passive-elastic prostheses (Flex-Foot Ceterus and Freedom Innovations Sierra), even though the powered system is twofold heavier than the conventional devices. This result highlights the benefit of performing net positive work at the ankle joint to amputee ambulation and also suggests a new direction for further advancement of an ankle-foot prosthesis.

  12. [The endo-exo prosthesis for patients with a problematic amputation stump].

    PubMed

    Frölke, Jan Paul M; van de Meent, Henk

    2010-01-01

    Following lower limb amputation, quality of life is highly related to the ability to use a prosthetic limb. The conventional way to attach a prosthetic limb to the body is with a socket. Many patients experience serious discomfort wearing a conventional prosthesis because of pain, instability during walking, pressure sores, bad smell or skin irritation. In addition, sitting is uncomfortable and pelvic and lower back pain due to unstable gait is often seen in these patients. The main disadvantage of the current prosthesis is the attachment of a rigid prosthesis socket to a soft and variable body. The socket must fit tightly for stability during walking but should also be comfortable for sitting. The implantation of an osseointegrated, intramedullary, transcutaneously conducted prosthesis is a new procedure for attaching a limb prosthesis to the human body without the disadvantages of the conventional prosthesis. The intramedullary prosthesis is designed with a rough surface resembling cancellous bone to enable a secure solid integration with the long bone. We treated two patients with this new prosthesis, a 44-year-old man after a transfemoral amputation, and a 32-year-old woman after a lower leg amputation; both amputations were necessary because of trauma. Those two patients are now, more than one year after the operation, showing excellent functional results without infectious complications. We assume that endo-exo prosthesis may be a promising option for selected patients unable to use a conventional prosthesis because of a problematic amputation stump.

  13. Breast cancer screening

    MedlinePlus

    Mammogram - breast cancer screening; Breast exam - breast cancer screening; MRI - breast cancer screening ... performed to screen women to detect early breast cancer when it is more likely to be cured. ...

  14. Breast Cancer Overview

    MedlinePlus

    ... Cancer > Breast Cancer > Breast Cancer: Overview Request Permissions Breast Cancer: Overview Approved by the Cancer.Net Editorial Board , ... bean-shaped organs that help fight infection. About breast cancer Cancer begins when healthy cells in the breast ...

  15. Surgery for Breast Cancer

    MedlinePlus

    ... Pregnancy Breast Cancer Breast Cancer Treatment Surgery for Breast Cancer Surgery is a common treatment for breast cancer, ... Relieve symptoms of advanced cancer Surgery to remove breast cancer There are two main types of surgery to ...

  16. Biomechanical characterization of a low density silicone elastomer filled with hollow microspheres for maxillofacial prostheses.

    PubMed

    Liu, Q; Shao, L Q; Xiang, H F; Zhen, D; Zhao, N; Yang, S G; Zhang, X L; Xu, J

    2013-01-01

    An ideal material for maxillofacial prostheses has not been found. We created a novel material: silicone elastomer filled with hollow microspheres and characterized its biomechanical properties. Expancel hollow microspheres were mixed with MDX4-4210 silicone elastomer using Q7-9180 silicone fluid as diluent. The volume fractions of microspheres were 0, 5, 15, and 30% v/v (volume ratio to the total volume of MDX4-4210 and microspheres). The microspheres dispersed well in the matrix. The physical properties and biocompatibility of the composites were examined. Shock absorption was the greatest by the 5% v/v composite, and decreased with increasing concentrations of microspheres. The density, thermal conductivity, Shore A hardness, tear and tensile strength decreased with increasing concentrations of microspheres, while elongation at break increased. Importantly, the tear strength of all composites was markedly lower than that of pure silicone elastomer. Cell viability assays indicated that the composite was of good biocompatibility. The composite with a volume fraction of 5% exhibited the optimal properties for use as a maxillofacial prosthesis, though its tear strength was markedly lower than that of silicone elastomer. In conclusion, we developed a novel light and soft material with good flexibility and biocompatibility, which holds a promising prospect for clinical application as maxillofacial prosthesis.

  17. Silicon Detectors

    NASA Astrophysics Data System (ADS)

    Sadrozinski, Hartmut

    2014-03-01

    The use of silicon detectors has experienced an exponential growth in accelerator and space based experiments, similar to trends in the semiconductor industry as a whole, usually paraphrased as ``Moore's Law.'' Some of the essentials for this phenomenon will be presented, together with examples of the exciting science results which it enabled. With the establishment of a ``semiconductor culture'' in universities and laboratories around the world, an increased understanding of the sensors results in thinner, faster, more radiation-resistant detectors, spawning an amazing wealth of new technologies and applications, which will be the main subject of the presentation.

  18. Photovoltaic retinal prosthesis for restoring sight to the blind: implant design and fabrication

    NASA Astrophysics Data System (ADS)

    Wang, Lele; Mathieson, Keith; Kamins, Theodore I.; Loudin, James; Galambos, Ludwig; Harris, James S.; Palanker, Daniel

    2012-03-01

    We have designed and fabricated a silicon photodiode array for use as a subretinal prosthesis aimed at restoring sight to patients who lost photoreceptors due to retinal degeneration. The device operates in photovoltaic mode. Each pixel in the two-dimensional array independently converts pulsed infrared light into biphasic electric current to stimulate remaining retinal neurons without a wired power connection. To enhance the maximum voltage and charge injection levels, each pixel contains three photodiodes connected in series. An active and return electrode in each pixel ensure localized current flow and are sputter coated with iridium oxide to provide high charge injection. The fabrication process consists of eight mask layers and includes deep reactive ion etching, oxidation, and a polysilicon trench refill for in-pixel photodiode separation and isolation of adjacent pixels. Simulation of design parameters included TSUPREM4 computation of doping profiles for n+ and p+ doped regions and MATLAB computation of the anti-reflection coating layers thicknesses. The main process steps are illustrated in detail, and problems encountered are discussed. The IV characterization of the device shows that the dark reverse current is on the order of 10-100 pA-negligible compared to the stimulation current; the reverse breakdown voltage is higher than 20 V. The measured photo-responsivity per photodiode is about 0.33A/W at 880 nm.

  19. Breast surgery under local anesthesia: second-stage implant exchange, nipple flap reconstruction, and breast augmentation.

    PubMed

    Koumanis, Dimitri J; Colque, Alex; Eisemann, Michael L; Smith, Jenna

    2013-10-01

    Breast reconstruction can be performed safely with local anesthesia. Utilization of the star flap method in conjunction with tattooing successfully provides optimal aesthetic results without the need for an additional donor site. When tissue expander to silicon implant exchange is part of the operative plan, use of triple antibiotic irrigation as well as the Keller Funnel is recommended. Breast augmentation and breast augmentation-mastopexy can also be performed with good results under local anesthetic in a private operating room setting. All other operative conditions, including sterility and sound operative surgical techniques, should be the mainstay of any practice.

  20. [Research on point cloud smoothing in knee joint prosthesis modeling based on reverse engineering].

    PubMed

    Zhang, Guoliang; Yao, Jin; Wei, Xing; Pei, Fuxing; Zhou, Zongke

    2008-10-01

    At present, foreign standard knee joint prosthesis is mostly used in clinical practice; it can well represent the biological characteristic of knee joint on human being. So this paper adopts the reverse engineering technology in that connexion, presents novel positioning method of acquiring the point data on the surface of knee joint prosthesis, puts forward the algorithm of three-point angle method for removing the noise error and correcting the noise error based on the least squares plane to smooth point cloud. And then, the surface of knee joint prosthesis with better accuracy and smoothness can be generated. Finally, the knee joint prosthesis model can be generated. Thus, a basis is provided for the localization of knee joint prosthesis. This new algorithm is mainly used for the surface modeling based on point cloud smoothing, including the surface of knee joint prosthesis, the surface of regular shape, and the surface with gentle change in curvature.

  1. Manufacturer-provided effective orifice area index charts and the prevention of prosthesis-patient mismatch.

    PubMed

    House, Chad M; Nelson, William B; Kroshus, Timothy J; Dahiya, Ranjan; Pibarot, Philippe

    2012-01-01

    Prosthesis-patient mismatch (PPM) occurs when an implanted prosthesis is too small relative to the patient's body surface area (BSA). However, mismatch can often be prevented by indexing the expected effective orifice area (EOA) of a prosthesis to the patient's BSA and then selecting the largest implantable prosthesis to avoid mismatch. Previously, prosthesis manufacturers have attempted to simplify this process by providing charts that include the expected EOA for their prosthesis, already indexed into an array of BSA values. One caveat with these charts is that the expected EOA data must truly be reliable, or the charts will misguide the implanting surgeon. Manufacturer-provided charts could be improved by standardizing the EOA data, with one potential source being the hemodynamic data submitted to the United States Food and Drug Administration. This review discusses PPM, manufacturer-provided EOA charts, and the regulation of EOA data.

  2. A biomechanical study of two postoperative prostheses for transtibial amputees: a custom-molded and a prefabricated adjustable pneumatic prosthesis.

    PubMed

    Boucher, Henry R; Schon, Lew C; Parks, Brent; Kleeman, Jay; Dunn, Warren R; Badekas, Thanos; Noll, Kenneth; Melamed, Eyal

    2002-05-01

    We evaluated an adjustable pneumatic prefabricated prosthesis and a rigid custom-molded prosthesis for immediate postoperative use. Twelve transtibial amputations were performed on cadaver limbs. Differential variable reluctance transducers were placed subcutaneously across the wound edge medially and laterally. The limbs were then placed in either the pneumatic prosthesis (five limbs) or the rigid prosthesis (seven limbs). The specimens underwent static and cyclic loading to simulate weight bearing. The strain readings for static and cyclic loading were greater in the rigid prosthetic group. Only the mean medial strain measurement after cyclic loading was statistically significant. The results demonstrate that the pneumatic prosthesis places less strain across the wound than a rigid prosthesis.

  3. Breast Lumps

    MedlinePlus

    ... 2015. Raftery AT, et al. Breast lumps. In: Churchill's Pocketbook of Differential Diagnosis. 4th ed. Philadelphia, Pa.: Churchill Livingston Elsevier; 2014. http://www.clinicalkey.com. Accessed ...

  4. Running with a powered knee and ankle prosthesis.

    PubMed

    Shultz, Amanda H; Lawson, Brian E; Goldfarb, Michael

    2015-05-01

    This paper presents a running control architecture for a powered knee and ankle prosthesis that enables a transfemoral amputee to run with a biomechanically appropriate running gait and to intentionally transition between a walking and running gait. The control architecture consists firstly of a coordination level controller, which provides gait biomechanics representative of healthy running, and secondly of a gait selection controller that enables the user to intentionally transition between a running and walking gait. The running control architecture was implemented on a transfemoral prosthesis with powered knee and ankle joints, and the efficacy of the controller was assessed in a series of running trials with a transfemoral amputee subject. Specifically, treadmill trials were conducted to assess the extent to which the coordination controller provided a biomechanically appropriate running gait. Separate trials were conducted to assess the ability of the user to consistently and reliably transition between walking and running gaits.

  5. Designing and testing a hybrid lightweight shoulder prosthesis.

    PubMed

    Sekine, Masashi; Tsuchiya, Nobuto; Kita, Kahori; Yu, Wenwei

    2014-01-01

    Lightweight prostheses are preferred in terms of usability in daily living. However, this is not a property easy to realize, especially for shoulder prostheses. High portability, multiple degrees of freedom (DOFs) with an appropriate ROM (range of motion), sufficient end-effector power, and suitable viscoelasticity for the safe use in daily living, usually result in a heavy weight. In this paper, a hybrid shoulder prosthesis that combined servo motors and pneumatic elastic actuators, with a weight distribution scheme, was designed to meet the requirements. The prosthetic system was preliminarily tested by comparing its ADL (activities of daily living) motion data with that of an intact arm. The experiment results showed that the shoulder prosthesis could reproduce the motion of an intact arm, thus demonstrate its usability in daily living.

  6. Modified prosthesis for the treatment of malignant esophagotracheal fistula

    SciTech Connect

    Buess, G.; Schellong, H.; Kometz, B.; Gruessner, R.J.; Junginger, T.

    1988-04-15

    Esophagotracheal fistula is usually a sequela of irradiation or laser treatment of advanced carcinoma of the esophagus or the tracheobronchial tree. Resection of the tumor in these cases is not possible, and palliative bypass surgery is highly risky. The peroral placement of a prosthesis is less invasive, but conventional prostheses often fail to occlude the fistula. The authors regularly use an endoscopic multiple-diameter bougie for dilation. After dilation, a specially designed prosthesis is pushed through the tumor stenosis to block the fistula. This procedure can be done without general anesthesia. The funnels of conventional prostheses cannot cover the fistula when there is either a wide, proximal esophagus above the fistula or a high fistula. To cope with this particular situation, a special fistula funnel was developed. It perfectly occludes the fistulas in all patients. Of 21 patients, 19 were discharged without further aspiration.

  7. A cognitive prosthesis for complex decision-making.

    PubMed

    Tremblay, Sébastien; Gagnon, Jean-François; Lafond, Daniel; Hodgetts, Helen M; Doiron, Maxime; Jeuniaux, Patrick P J M H

    2017-01-01

    While simple heuristics can be ecologically rational and effective in naturalistic decision making contexts, complex situations require analytical decision making strategies, hypothesis-testing and learning. Sub-optimal decision strategies - using simplified as opposed to analytic decision rules - have been reported in domains such as healthcare, military operational planning, and government policy making. We investigate the potential of a computational toolkit called "IMAGE" to improve decision-making by developing structural knowledge and increasing understanding of complex situations. IMAGE is tested within the context of a complex military convoy management task through (a) interactive simulations, and (b) visualization and knowledge representation capabilities. We assess the usefulness of two versions of IMAGE (desktop and immersive) compared to a baseline. Results suggest that the prosthesis helped analysts in making better decisions, but failed to increase their structural knowledge about the situation once the cognitive prosthesis is removed.

  8. Midterm clinical results of the Autocentric II patellofemoral prosthesis

    PubMed Central

    Speigner, B.; Gosens, T.; de Waal Malefijt, J.

    2009-01-01

    We studied the outcome of patellofemoral arthroplasties using the Autocentric prosthesis implanted in our clinic between 1994 and 2004. New insight on indications and contraindications motivated us to find risk factors in the failure of this prosthesis. Twenty-four patients had surgery for patellofemoral arthritis not responding to exhaustive nonoperative measures. The mean age at the time of patellofemoral arthroplasty (PFA) was 63.4 (SD 11.3, range 38–81) years with a mean follow-up of 4.8 (SD 2.9, range 2–11) years. Additional interventions were necessary in 21 knees during follow-up in our population, and seven knees required total knee arthroplasty (TKA) mainly due to progressive tibiofemoral osteoarthritis and maltracking of the patella. The patient outcomes and quality of life scores showed disappointing results, even after revision to TKA. This retrospective analysis underlines the importance of strict indications for patellofemoral arthroplasty and, in particular, of contraindications. PMID:19224212

  9. AMS 700 inflatable penile prosthesis with InhibiZone.

    PubMed

    McKim, Stephen E; Carson, Culley C

    2010-05-01

    Inflatable penile prostheses are the definitive therapy for erectile dysfunction refractory to medical therapy. For years mechanical malfunction was the most common cause of device failure, but recent advances in design have largely eliminated this, and now infection is the most significant problem with these implants. Antibiotic-coated medical devices, such as central venous and bladder catheters, have proven effective in reducing bacterial colonization and biofilm formation, leading to decreased rates of infection. In 2001, American Medical Systems (AMS) released its AMS 700 series penile prosthesis impregnated with a proprietary combination of the antibiotics rifampin and minocycline, called InhibiZone. Multiple studies have found that this device significantly reduces infection rates in men receiving penile prostheses. In July 2009, the US FDA approved the AMS 700 with InhibiZone as the only inflatable penile prosthesis with clinical evidence showing significant reduction in the rate of revision surgery due to infection.

  10. A case of TURBT after penile prosthesis implantation.

    PubMed

    Senda, Motohiro; Otani, Toshikazu; Ito, Yuichi

    2006-08-01

    The patient was a 66-year-old man who had undergone implantation of a penile prosthesis for organic erectile dysfunction 7 years prior to consulting our hospital with a complaint of gross hematuria. Since a pedunculated, superficial tumor 1 cm in diameter was noted lateral to the left ureteral orifice, transurethral resection of the bladder tumor (TURBT) was performed. In this patient, we were able to insert the sheath with no difficulty, and the surgical procedure was done smoothly, resulting in complete resection of the tumor. However, the location of the tumor in the anterior or posterior wall of the bladder predicted difficulty of the tumor resection. Therefore, we consider it important to sufficiently evaluate the feasibility of complete TURBT before surgery and to thoroughly examine the patient for benign prostatic hyperplasia and bladder cancer, which can cause difficulty with post-implantation ransurethral procedures, and to perform transurethral surgery before implantation, if prosthesis implantation is planned.

  11. Research and development of a versatile portable speech prosthesis

    NASA Technical Reports Server (NTRS)

    1981-01-01

    The Versatile Portable Speech Prosthesis (VPSP), a synthetic speech output communication aid for non-speaking people is described. It was intended initially for severely physically limited people with cerebral palsy who are in electric wheelchairs. Hence, it was designed to be placed on a wheelchair and powered from a wheelchair battery. It can easily be separated from the wheelchair. The VPSP is versatile because it is designed to accept any means of single switch, multiple switch, or keyboard control which physically limited people have the ability to use. It is portable because it is mounted on and can go with the electric wheelchair. It is a speech prosthesis, obviously, because it speaks with a synthetic voice for people unable to speak with their own voices. Both hardware and software are described.

  12. Hip arthroplasty. Part 1: prosthesis terminology and classification.

    PubMed

    Pluot, E; Davis, E T; Revell, M; Davies, A M; James, S L J

    2009-10-01

    Hip arthroplasty is an extremely common orthopaedic procedure and there is a wide array of implants that are in current use in the UK. The follow-up of patients who have undergone insertion of a hip prosthesis is shifting from a consultant-lead hospital service towards primary care. As this change in patient care continues it becomes increasingly important that an accurate description of the radiographic features is communicated to the primary-care practitioner so appropriate specialist input can be triggered. This review focuses on the terminology and classification of hip prostheses. This acts as a precursor for Part 2 of this series, which describes the normal and abnormal radiographic findings following hip prosthesis insertion.

  13. The method of manufacture of nylon dental partially removable prosthesis using additive technologies

    NASA Astrophysics Data System (ADS)

    Kashapov, R. N.; Korobkina, A. I.; Platonov, E. V.; Saleeva, G. T.

    2014-12-01

    The article is devoted to the topic of creating new methods of dental prosthesis. The aim of this work is to investigate the possibility of using additive technology to create nylon prosthesis. As a result of experimental studies, was made a sample of nylon partially removable prosthesis using 3D printing has allowed to simplify, accelerate and reduce the coat of manufacturing high-precision nylon dentures.

  14. False-positive indium-111 labeled leukocyte scintigram in a patient with a painful hip prosthesis

    SciTech Connect

    Feldman, N.; Makler, P.T. Jr.; Alavi, A.

    1986-01-01

    A Tronzo hip prosthesis is designed to elicit an inflammatory reaction in order to promote prosthesis stability. A three-phased bone scan and Ga-67 imaging in conjunction with physical examination and laboratory findings failed to demonstrate evidence for osteomyelitis in a patient with a painful hip prosthesis, in whom images obtained with In-111-labeled leukocytes were positive. This observation demonstrated that the interpretation of the latter technique in demonstrating inflammation can cause a false impression of an infectious process.

  15. Magnetic resonance imaging compatibility test of a cranial prosthesis with titanium screws

    NASA Astrophysics Data System (ADS)

    Jimenez, R.; Benavides, A.; Flores, D.; Hidalgo, S. S.; Solis, S. E.; Uribe, E.; Rodriguez, A. O.

    2012-10-01

    The follow-up of patients with skull prosthesis is necessary to provide adequate medical care. Skull prostheses for cranioplasty have been developed at the Faculty of Odontology of Universidad Nacional Autonoma de Mexico. We built a skull prosthesis phantom and tested for compatibility with standard magnetic resonance imaging procedures. Results showed full compatibility but susceptibility artefacts occurred due to titanium used to fix the prosthesis to the skull.

  16. Task-Oriented Gaming for Transfer to Prosthesis Use.

    PubMed

    van Dijk, Ludger; van der Sluis, Corry K; van Dijk, Hylke W; Bongers, Raoul M

    2016-12-01

    The aim of this study is to establish the effect of task-oriented video gaming on using a myoelectric prosthesis in a basic activity of daily life (ADL). Forty-one able-bodied right-handed participants were randomly assigned to one of four groups. In three of these groups the participants trained to control a video game using the myosignals of the flexors and extensors of the wrist: in the Adaptive Catching group participants needed to catch falling objects by opening and closing a grabber and received ADL-relevant feedback during performance. The Free Catching group used the same game, but without augmented feedback. The Interceptive Catching group trained a game where the goal was to intercept a falling object by moving a grabber to the left and right. They received no additional feedback. The control group played a regular Mario computer game. All groups trained 20 minutes a day for four consecutive days. Two tests were conducted before and after training: one level of the training game was performed, and participants grasped objects with a prosthesis simulator. Results showed all groups improved their game performance over controls. In the prosthesis-simulator task, after training the Adaptive Catching group outperformed the other groups in their ability to adjust the hand aperture to the size of the objects and the degree of compression of compressible objects. This study is the first to demonstrate transfer effects from a serious game to a myoelectric prosthesis task. The specificity of the learning effects suggests that research into serious gaming will benefit from placing ADL-specific constraints on game development.

  17. Molecular Identification of a Dietzia maris Hip Prosthesis Infection Isolate

    PubMed Central

    Pidoux, O.; Argenson, J.-N.; Jacomo, V.; Drancourt, M.

    2001-01-01

    Dietzia maris, an environmental actinomycete, has been implicated only once in human disease. We herein report the first D. maris isolate from a bone biopsy specimen in a patient hospitalized for a total hip prosthesis replacement. Cell wall fatty acid analysis and 16S ribosomal DNA gene sequencing were utilized to achieve its definite identification. This case report illustrates the usefulness of such methods for the accurate identification of actinomycetes. PMID:11427581

  18. Using a Visible Light-Polymerized Resin to Fabricate an Interim Partial Removable Dental Prosthesis.

    PubMed

    Segal, Aaron; Yu, Hui Wen; Elkassaby, Heba

    2017-02-01

    An interim partial removable dental prosthesis (RDP) is any dental prosthesis that replaces some teeth in a partially dentate arch designed to enhance esthetics, stabilization, and/or function for a limited period of time, after which it is to be replaced by a definitive dental prosthesis. This article describes a technique that uses a visible light-polymerized (VLP) resin as the base material for an interim partial RDP. This technique can be easily accomplished in a dental office or laboratory and results in a predictable dental prosthesis. This technique eliminates the need for laboratory processing.

  19. Penile prosthesis implant: scientific advances and technological innovations over the last four decades

    PubMed Central

    2017-01-01

    Despite introduction of oral phosphodiesterase type 5 inhibitors and intracavernosal vasoactive agents, penile prosthesis implant remains a relevant and desired option with sales of penile prostheses continue to stay high, as many men became refractory to medical therapy and/or seeking a more effective and permanent therapy. There are two types of penile prosthesis implants: inflatable and non-inflatable types, and the inflatable penile implants can be subdivided into single-, two- and three-piece devices. Non-inflatable penile prosthesis (non-IPP) may be referred to as semi-rigid rod or malleable prosthesis. IPP is considered a superior option to malleable prosthesis as it produces penile rigidity and flaccidity that closely replicates a normal penile erectile function. Since the introduction of IPP by Scott in 1973, surgical landscape for penile prosthesis implantation has changed dramatically. Advances in prosthesis design, device technologies and surgical techniques have made penile prosthesis implant a more natural, durable and reliable device. The following article reviews the scientific advances and technological innovation in modern penile prosthesis implants over the last four decades. PMID:28217449

  20. Penile prosthesis implant: scientific advances and technological innovations over the last four decades.

    PubMed

    Chung, Eric

    2017-02-01

    Despite introduction of oral phosphodiesterase type 5 inhibitors and intracavernosal vasoactive agents, penile prosthesis implant remains a relevant and desired option with sales of penile prostheses continue to stay high, as many men became refractory to medical therapy and/or seeking a more effective and permanent therapy. There are two types of penile prosthesis implants: inflatable and non-inflatable types, and the inflatable penile implants can be subdivided into single-, two- and three-piece devices. Non-inflatable penile prosthesis (non-IPP) may be referred to as semi-rigid rod or malleable prosthesis. IPP is considered a superior option to malleable prosthesis as it produces penile rigidity and flaccidity that closely replicates a normal penile erectile function. Since the introduction of IPP by Scott in 1973, surgical landscape for penile prosthesis implantation has changed dramatically. Advances in prosthesis design, device technologies and surgical techniques have made penile prosthesis implant a more natural, durable and reliable device. The following article reviews the scientific advances and technological innovation in modern penile prosthesis implants over the last four decades.

  1. Dental prosthesis aspiration: An uncommon cause of respiratory distress.

    PubMed

    De Wilde, Belphine A L; Malfait, Thomas L; Bonte, Katrien; Malfait, Thomas L A

    2016-12-01

    We present a case of a 66-year-old Caucasian man with acute respiratory distress. The patient had a history of multiple cerebrovascular accidents which resulted in left hemiplegia, swallowing problems, and aphasia. He was tentatively diagnosed with aspiration pneumonia. However, because of clinical deterioration further investigations concluded to the aspiration of a dental prosthesis. After intubation and stabilization, the prosthesis could be manually extracted. However, the patient developed a Staphylococcus epidermidis sepsis and despite adequate antibiotic therapy, he eventually died. Dental prosthesis aspiration is a medical situation associated with a higher morbidity and mortality rate compared to ingested foreign bodies. It requires a high level of suspicion to ensure a timely diagnosis and life-saving treatment. Thorough history taking is of great importance in case of tracheobronchial aspiration, which is in the adult population mostly secondary to an underlying disorder. In impaired adults with missing dental prostheses there should be extra awareness for this problem. This case report illustrates the importance of a detailed history in case of tracheobronchial aspiration and shows the limitations in the diagnostic usefulness of bedside chest radiography.

  2. Abiotrophia defectiva knee prosthesis infection: A case report

    PubMed Central

    2011-01-01

    Background Abiotrophia species have rarely been implicated in osteoarticular infections. We report one case of an A. defectiva knee prosthesis infection. Case presentation A 71-year-old man of Italian origin presented with pain and swelling of the knee four years after the implantation of a total knee replacement prosthesis. While standard culturing of the synovial fluid resulted in no isolation of microorganisms, the direct inoculation of the synovial fluid into a rich culture medium resulted in the identification of A. defectiva by polymerase chain reaction sequencing. Repeated attempts of culturing microorganisms from blood were negative, and echocardiograms and colonoscopies were unremarkable. High-dose amoxicillin for nine months and a two-stage replacement of the knee prosthesis led to full patient recovery by the time of the 12-month follow-up examination. Conclusions Because Abiotrophia spp. are fastidious microorganisms, it is likely that cases of Abiotrophia orthopedic infection are misdiagnosed as culture-negative infections. Direct inoculation of synovial fluids into rich broth medium and further polymerase chain reaction-based detection of culture-negative synovial fluids are key tests for accurate documentation and detection of these infections. PMID:21896178

  3. Visual prosthesis wireless energy transfer system optimal modeling

    PubMed Central

    2014-01-01

    Background Wireless energy transfer system is an effective way to solve the visual prosthesis energy supply problems, theoretical modeling of the system is the prerequisite to do optimal energy transfer system design. Methods On the basis of the ideal model of the wireless energy transfer system, according to visual prosthesis application condition, the system modeling is optimized. During the optimal modeling, taking planar spiral coils as the coupling devices between energy transmitter and receiver, the effect of the parasitic capacitance of the transfer coil is considered, and especially the concept of biological capacitance is proposed to consider the influence of biological tissue on the energy transfer efficiency, resulting in the optimal modeling’s more accuracy for the actual application. Results The simulation data of the optimal model in this paper is compared with that of the previous ideal model, the results show that under high frequency condition, the parasitic capacitance of inductance and biological capacitance considered in the optimal model could have great impact on the wireless energy transfer system. The further comparison with the experimental data verifies the validity and accuracy of the optimal model proposed in this paper. Conclusions The optimal model proposed in this paper has a higher theoretical guiding significance for the wireless energy transfer system’s further research, and provide a more precise model reference for solving the power supply problem in visual prosthesis clinical application. PMID:24428906

  4. TOTAL ANKLE ARTHROPLASTY: BRAZILIAN EXPERIENCE WITH THE HINTEGRA PROSTHESIS.

    PubMed

    Nery, Caio; Fernandes, Túlio Diniz; Réssio, Cibele; Fuchs, Mauro Luiz; Godoy Santos, Alexandre Leme de; Ortiz, Rafael Trevisan

    2010-01-01

    Ankle arthrosis is becoming more and more common. The search for solutions that preserve joint function has led to a new generation of prosthesis with three components and more degrees of freedom. This paper presents the results achieved for ten patients treated with the HINTEGRA Prosthesis (Integra, New Deal), through collaborative action between the Foot and Ankle Groups of the Orthopedics and Traumatology divisions of Escola Paulista de Medicina, Unifesp, and the School of Medicine of the University of São Paulo (USP). The ten patients (six women and four men, aged between 29 and 66 years), underwent a surgical procedure consisting of Hintermann's technique, between January and June 2005. They were evaluated at prearranged intervals, and the data were subjected to statistical analysis. The surgery led to a significant improvement in ankle mobility. Radiological evaluation showed no signs of loosening or failure in the prosthetic components in any of the patients studied. Although the complication rate in our sample was high, it was equivalent to the rates found by other authors, and directly represents the learning curve associate with this kind of procedure. Four years after the procedure, it was found that the patients pain levels had significantly decreased, and that their functional patterns had significantly improved, with AOFAS and Hintermann scores indicating results that were excellent for 20%, good for 70% and poor for 10%. Treatment of ankle arthritis by means of total arthroplasty using the HINTEGRA prosthesis was capable of providing good results over an average observation period of four years.

  5. Literature Review on Needs of Upper Limb Prosthesis Users

    PubMed Central

    Cordella, Francesca; Ciancio, Anna Lisa; Sacchetti, Rinaldo; Davalli, Angelo; Cutti, Andrea Giovanni; Guglielmelli, Eugenio; Zollo, Loredana

    2016-01-01

    The loss of one hand can significantly affect the level of autonomy and the capability of performing daily living, working and social activities. The current prosthetic solutions contribute in a poor way to overcome these problems due to limitations in the interfaces adopted for controlling the prosthesis and to the lack of force or tactile feedback, thus limiting hand grasp capabilities. This paper presents a literature review on needs analysis of upper limb prosthesis users, and points out the main critical aspects of the current prosthetic solutions, in terms of users satisfaction and activities of daily living they would like to perform with the prosthetic device. The ultimate goal is to provide design inputs in the prosthetic field and, contemporary, increase user satisfaction rates and reduce device abandonment. A list of requirements for upper limb prostheses is proposed, grounded on the performed analysis on user needs. It wants to (i) provide guidelines for improving the level of acceptability and usefulness of the prosthesis, by accounting for hand functional and technical aspects; (ii) propose a control architecture of PNS-based prosthetic systems able to satisfy the analyzed user wishes; (iii) provide hints for improving the quality of the methods (e.g., questionnaires) adopted for understanding the user satisfaction with their prostheses. PMID:27242413

  6. Three-dimensional printed calcaneal prosthesis following total calcanectomy☆

    PubMed Central

    Imanishi, Jungo; Choong, Peter F.M.

    2015-01-01

    Introduction The majority of patients with extremity sarcoma can be surgically treated without amputation. However, limb-salvage surgery for foot sarcomas including the calcaneus remains challenging. Presentation of case A 71-year-old man presented with a 5-year history of right heel persistent pain. Imaging studies revealed an osteolytic, destructive and highly metabolic lesion in the right calcaneus. Computed tomography guided core needle biopsy confirmed the diagnosis of grade 2 chondrosarcoma. A total calcanectomy was performed, and the defect was reconstructed with a patient matched three-dimensional printed titanium calcaneal prosthesis. Intra-operatively, ligaments including the Achilles tendon, and plantar fascia were reattached. The post-operative course was uneventful, and at the 5-month clinical follow-up, the patient was fully weightbearing, with a mobile ankle without pain. Discussion This case is the first to use additive manufacturing to create a prosthetic calcaneus. The complex peri-calcaneal articular surfaces and reattachment of tendinous structures facilitate efforts to stabilize the prosthesis in situ. Conclusion Three-dimensional-printed prosthesis of the calcaneus is a viable alternative to amputation. PMID:25827294

  7. [Prevention of postenucleation syndrome: the hydroxylapatite silicone implant. Preliminary experimental studies and initial clinical experiences].

    PubMed

    Guthoff, R; Vick, H P; Schaudig, U

    1995-04-01

    An orbital implant after enucleation compensates for volume deficiency and increases prosthesis motility. In the literature, however, an extrusion rate of orbital implant between 10 and 25% is reported. Since the introduction of hydroxylapatic ceramics (HAC), these numbers have been reduced considerably. The HAC, which is derived from corals, has a rough surface and requires a scleral covering for implantation. The HAC, which is made in the laboratory, can be produced with smoother surfaces, so that a homoplastic covering is no longer mandatory. A composite implant was developed to improve prosthesis motility further. This consists of artificial HAC at its anterior surface to guarantee safe tissue integration; the posterior part of the implant is manufactured from silicon rubber to create a jointlike structure in Tenon's capsule. Integration of the porous HAC in the orbital soft tissues has been tested and confirmed by animal experiments. After 30 full HAC implants and 25 composite implants, only one extrusion occurred. In all other cases, compatibility proved to be excellent; transmission of the motility to the prosthesis was moderate to good. Examinations comparing prosthesis motility and computer tomographically evaluated implant motility enabled the analysis of deficits in motility transmission of the implant for the artificial eye.

  8. Silicon carbide

    SciTech Connect

    Ault, N.N.; Crowe, J.T. )

    1991-05-01

    This paper reports that, since silicon carbide (SiC) does not occur in nature, it must be synthesized by a high-temperature chemical reaction. The first commercial production began at the end of the 19th century when Acheson developed a process of reacting sand and coke in a resistance furnace. This process is still the basic SiC manufacturing process used today. High-quality silica sand (99.5% SiO{sub 2}), low-sulfur petroleum coke, and electricity (23.8 MJ/kg) are the major ingredients in the production of SiC. The reaction takes place in a trough-like furnace with a removable refractory side (or some similar configuration) and with permanent refractory ends holding carbon electrodes. When the furnace is started, the carbon electrodes are joined by the graphite core laid the length of the furnace near the center of the mixture which fills the furnace.

  9. [Radiotherpay and immediate breast reconstruction with myocutaneous flap in breast cancer of reserved prognosis].

    PubMed

    Missana, M C; Levy, C; Barreau-Pouhaer, L; Janin, N

    2000-04-01

    In France, immediate breast reconstruction (IBR) for infiltrating carcinoma remains controversial. Many teams advocate the possible event of a post mastectomy radiotherapy and its negative effect on IBR. In our Institute we do not exclude infiltrating breast cancer patient from IBR. In the poor prognostic patients who wish IBR, we recommend autologous IBR to obtain the best aesthetic result with minimum revision procedures and best tolerance to adjuvant radiotherapy. From January 1993 to December 1997, we performed 687 IBR with myocutaneous flap for infiltrating carcinomas. In this group only 68 patients needed postoperative chest wall radiotherapy (45 Gy): 27 TRAM flap, 41 latissimus flap. Only one of the TRAM but 39 of latissimus flaps were associated with a prosthesis. The mean follow-up was 24 months. Fourteen patients developed metastatic disease, and ten were dead at the time of the chart revue. The autogenous TRAM flap tolerate radiation quite well and remain soft and mobile. The latissimus flap associated with a prosthesis developed capsular contracture (BAKER II or III) in 71% of cases. In all cases the cosmetic impairment was not important and the result after capsulectomy remained soft. We concluded that IBR could be offered to motivated patients in all stages of the disease regardless of the subsequent chest wall radiotherapy, and we recommend its use for possible autologous reconstruction.

  10. Thin silicon solar cells

    SciTech Connect

    Hall, R.B.; Bacon, C.; DiReda, V.; Ford, D.H.; Ingram, A.E.; Cotter, J.; Hughes-Lampros, T.; Rand, J.A.; Ruffins, T.R.; Barnett, A.M.

    1992-12-01

    The silicon-film design achieves high performance by using a dun silicon layer and incorporating light trapping. Optimally designed thin crystalline solar cells (<50 microns thick) have performance advantages over conventional thick devices. The high-performance silicon-film design employs a metallurgical barrier between the low-cost substrate and the thin silicon layer. Light trapping properties of silicon-film on ceramic solar cells are presented and analyzed. Recent advances in process development are described here.

  11. Duocentric® reversed shoulder prosthesis and Personal Fit® templates: innovative strategies to optimize prosthesis positioning and prevent scapular notching.

    PubMed

    Trouilloud, P; Gonzalvez, M; Martz, P; Charles, H; Handelberg, F; Nyffeler, R W; Baulot, E

    2014-05-01

    We describe our experience with a new system of patient-specific template called Personal Fit(®), which is unique in shoulder surgery and used in combination with Duocentric(®) prosthesis. The reverse prosthesis's concept is the invention of Paul Grammont, developed with Grammont's team of Dijon University as from 1981, which led to the first reversed total shoulder prosthesis called Trumpet in 1985. The Duocentric(®) prosthesis developed in 2001 is the third-generation prosthesis, coming from the Trumpet and the second-generation prosthesis Delta(®) (DePuy). This prosthesis provides a novel solution to the notching problem with an inferior overhang integrated onto the glenoid baseplate. Personal Fit(®) system is based on reconstructing the shoulder joint bones in three dimensions using CT scan data, placing a landmark on the scapula and locating points on the glenoid and humerus. That will be used as a reference for the patient-specific templates. We study the glenoid position planned with Personal Fit(®) software relative to native glenoid position in 30 cases. On average, the difference between the planned retroversion (or anteversion in one case) and native retroversion was 8.6°.

  12. Ocular prosthesis incorporating IPS e-max press scleral veneer and a literature review on non-integrated ocular prosthesis

    PubMed Central

    Da Costa, Godwin Clovis; Aras, Meena Ajay; Chalakkal, Paul; Da Costa, Michelle Clovis

    2017-01-01

    The article highlights a new method for the fabrication of an ocular prosthesis by the incorporation of a ceramic scleral veneer. The steps of fabrication include impression making, wax try-in, performing a “cut-back” on a selected stock eye, insertion of the IPS e-max press scleral veneer, finishing and insertion. It also includes a detailed review on non-integrated ocular prostheses. PMID:28149792

  13. Ocular prosthesis incorporating IPS e-max press scleral veneer and a literature review on non-integrated ocular prosthesis.

    PubMed

    Da Costa, Godwin Clovis; Aras, Meena Ajay; Chalakkal, Paul; Da Costa, Michelle Clovis

    2017-01-01

    The article highlights a new method for the fabrication of an ocular prosthesis by the incorporation of a ceramic scleral veneer. The steps of fabrication include impression making, wax try-in, performing a "cut-back" on a selected stock eye, insertion of the IPS e-max press scleral veneer, finishing and insertion. It also includes a detailed review on non-integrated ocular prostheses.

  14. Breast Tomosynthesis

    MedlinePlus

    ... mammography, that uses a low-dose x-ray system and computer reconstructions to create three-dimensional images of the ... Breast tomosynthesis uses a low-dose x-ray system, electronics and a computer to convert x-ray images of the breast ...

  15. Breast Feeding.

    ERIC Educational Resources Information Center

    International Children's Centre, Paris (France).

    This set of documents consists of English, French, and Spanish translations of four pamphlets on breast-feeding. The pamphlets provide information designed for lay persons, academics and professionals, health personnel and educators, and policy-makers. The contents cover health-related differences between breast and bottle milk; patterns of…

  16. Buried oxide layer in silicon

    DOEpatents

    Sadana, Devendra Kumar; Holland, Orin Wayne

    2001-01-01

    A process for forming Silicon-On-Insulator is described incorporating the steps of ion implantation of oxygen into a silicon substrate at elevated temperature, ion implanting oxygen at a temperature below 200.degree. C. at a lower dose to form an amorphous silicon layer, and annealing steps to form a mixture of defective single crystal silicon and polycrystalline silicon or polycrystalline silicon alone and then silicon oxide from the amorphous silicon layer to form a continuous silicon oxide layer below the surface of the silicon substrate to provide an isolated superficial layer of silicon. The invention overcomes the problem of buried isolated islands of silicon oxide forming a discontinuous buried oxide layer.

  17. [Analysis of sources of treatment-related knowledge in women undergoing mastectomy for breast cancer and review of literature].

    PubMed

    Wysocki, Wojciech M; Komorowski, Andrzej L; Mituś, Jerzy

    2011-01-01

    Recent development in the surgical technique, reduced invasiveness and extensiveness of surgery, improvement in the safety of surgery was not accompanied by significant progress of preoperative psychological care. Still many cancer patients complain on unsatisfactory communication with health care professionals and suboptimal information. The aim of the study was to analyze sources of knowledge on the disease and treatment and to assess the efficacy of physician-patient communication. Additional aim of the study was to evaluate the willingness to use breast prosthesis and to undergo breast reconstruction etc. The study population consisted of 58 consecutive women admitted for mastectomy for breast cancer. Nurses and female doctors were excluded, as well as patients treated for other malignancies in the past. Main source of knowledge about disease and surgery among participants was the cancer surgeon (ca. 75%). It needs to be underlined that family doctors were only marginally pointed out as sources of oncological information (< 10%). On the other hand significant proportion of participants pointed out mass media as the source of information (ca. 40%). On the day before surgery most of the participants (95%) correctly described surgery ("removal of breast and armpit lymph nodes"). Significantly less women correctly listed all major treatment option for breast cancer (surgery, chemotherapy, radiotherapy, hormonal therapy). It was observed, that most the patients (87%) declared will to use breast prosthesis. Additionally it was noted, that most of participants (68%) was not planning to undergo breast reconstruction.

  18. Silicone granulomas: report of three cases and review of the literature.

    PubMed

    Travis, W D; Balogh, K; Abraham, J L

    1985-01-01

    Since silicone is rapidly becoming one of the most commonly used biomaterials in modern medicine, pathologists will be observing increasing numbers of cases of silicone-related disease. Although numerous case reports have established that silicone elicits a characteristic response in tissues, the varying tissue reactions to silicone gels, liquids, and elastomers (rubber) have not been emphasized. Three cases are reported, and the literature is reviewed to illustrate the varying features of tissue reaction to silicone in its different forms. The first case is an example of silicone lymphadenopathy in an inguinal lymph node. This case demonstrates exuberant foreign body granuloma formation in response to particles of silicone elastomer. The second case involves a patient who had facial subcutaneous liquid silicone injections, and the third case is that of a woman in whom breast carcinoma developed 13 years after mammary augmentation with liquid silicone injections. These two cases illustrate the characteristic reaction to silicone liquid, with numerous cystic spaces and vacuoles in the soft tissues but minimal or no foreign body giant cell reaction. Scanning electron microscopy and energy dispersive x-ray analysis were performed in the first two cases, confirming the presence of silicon. Silicone migration and the clinical significance of various silicone-induced lesions are discussed.

  19. A Fixed Telescopic Prosthesis Designed to Retrieve and Convert to Fixed-Removable Combination Case: A Clinical Report

    PubMed Central

    Panagiota, Spyropoulou; Polyzois, Gregory

    2015-01-01

    This clinical report describes a fixed maxillary telescopic dental prosthesis (FTDP) employing milled base metal copings and a metal superstructure veneered with composite resin, for the restoration in a periodontally compromised patient with uncontrolled diabetes. The telescopic prosthesis framework design incorporated occlusal rest seats in key positions along the arch in case of future posterior tooth loss, in order to be converted to fixed - removable combination prosthesis. The mandible was restored with a conventional fixed ceramo-metal dental prosthesis. PMID:27688397

  20. Purified silicon production system

    DOEpatents

    Wang, Tihu; Ciszek, Theodore F.

    2004-03-30

    Method and apparatus for producing purified bulk silicon from highly impure metallurgical-grade silicon source material at atmospheric pressure. Method involves: (1) initially reacting iodine and metallurgical-grade silicon to create silicon tetraiodide and impurity iodide byproducts in a cold-wall reactor chamber; (2) isolating silicon tetraiodide from the impurity iodide byproducts and purifying it by distillation in a distillation chamber; and (3) transferring the purified silicon tetraiodide back to the cold-wall reactor chamber, reacting it with additional iodine and metallurgical-grade silicon to produce silicon diiodide and depositing the silicon diiodide onto a substrate within the cold-wall reactor chamber. The two chambers are at atmospheric pressure and the system is open to allow the introduction of additional source material and to remove and replace finished substrates.

  1. Breast augmentation surgery

    MedlinePlus

    ... the shape of your breasts. Talk with a plastic surgeon if you are considering breast augmentation. Discuss ... mammograms or breast x-rays before surgery. The plastic surgeon will do a routine breast exam. Several ...

  2. Learning about Breast Cancer

    MedlinePlus

    ... genetic terms used on this page Learning About Breast Cancer What do we know about heredity and breast ... Cancer What do we know about heredity and breast cancer? Breast cancer is a common disease. Each year, ...

  3. Breast reconstruction - natural tissue

    MedlinePlus

    ... After a mastectomy , some women choose to have cosmetic surgery to remake their breast. This type of surgery ... augmentation surgery Breast reconstruction - implants Mastectomy Patient Instructions Cosmetic breast surgery - discharge Mastectomy and breast reconstruction - what to ask ...

  4. Treatment of an old infection in a total hip replacement with an interim spacer prosthesis.

    PubMed

    Zilkens, K W; Casser, H R; Ohnsorge, J

    1990-01-01

    When treating a septic hip-joint prosthesis with bone loss of the proximal femur secondary to osteomyelitis, we implanted a specially designed prosthesis to act as a local antibiotic and spacer between the acetabulum and femur until the infection abated. Arthroplasty could then be carried out with no trouble and there was no recurrence of infection.

  5. 21 CFR 888.3100 - Ankle joint metal/composite semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ankle joint metal/composite semi-constrained... Ankle joint metal/composite semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/composite semi-constrained cemented prosthesis is a device intended to be implanted to replace...

  6. 21 CFR 888.3100 - Ankle joint metal/composite semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ankle joint metal/composite semi-constrained... Ankle joint metal/composite semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/composite semi-constrained cemented prosthesis is a device intended to be implanted to replace...

  7. 21 CFR 888.3100 - Ankle joint metal/composite semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ankle joint metal/composite semi-constrained... Ankle joint metal/composite semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/composite semi-constrained cemented prosthesis is a device intended to be implanted to replace...

  8. 21 CFR 888.3500 - Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint femorotibial metal/composite semi... § 888.3500 Knee joint femorotibial metal/composite semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/composite semi-constrained cemented prosthesis is a...

  9. 21 CFR 888.3490 - Knee joint femorotibial metal/composite non-constrained cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint femorotibial metal/composite non... § 888.3490 Knee joint femorotibial metal/composite non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/composite non-constrained cemented prosthesis is a...

  10. 21 CFR 888.3490 - Knee joint femorotibial metal/composite non-constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Knee joint femorotibial metal/composite non... § 888.3490 Knee joint femorotibial metal/composite non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/composite non-constrained cemented prosthesis is a...

  11. 21 CFR 888.3490 - Knee joint femorotibial metal/composite non-constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint femorotibial metal/composite non... § 888.3490 Knee joint femorotibial metal/composite non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/composite non-constrained cemented prosthesis is a...

  12. 21 CFR 888.3500 - Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Knee joint femorotibial metal/composite semi... § 888.3500 Knee joint femorotibial metal/composite semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/composite semi-constrained cemented prosthesis is a...

  13. 21 CFR 888.3100 - Ankle joint metal/composite semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ankle joint metal/composite semi-constrained... Ankle joint metal/composite semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/composite semi-constrained cemented prosthesis is a device intended to be implanted to replace...

  14. 21 CFR 888.3500 - Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Knee joint femorotibial metal/composite semi... § 888.3500 Knee joint femorotibial metal/composite semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/composite semi-constrained cemented prosthesis is a...

  15. 21 CFR 888.3500 - Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint femorotibial metal/composite semi... § 888.3500 Knee joint femorotibial metal/composite semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/composite semi-constrained cemented prosthesis is a...

  16. 21 CFR 888.3490 - Knee joint femorotibial metal/composite non-constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Knee joint femorotibial metal/composite non... § 888.3490 Knee joint femorotibial metal/composite non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/composite non-constrained cemented prosthesis is a...

  17. "Wrap technique": a new operative procedure using a self-adhesive prosthesis for laparoscopic ventral rectopexy.

    PubMed

    Gravié, J-F; Maigné, C

    2015-06-01

    The aim of the present study was to describe and assess a new method of fixation using a self-adhesive prosthesis (Adhesix(™)) in laparoscopic ventral rectopexy (LVR). The technical principles are based on a very low dissection and the adhesive properties of the prosthesis which can be applied to the rectum without stitches or staples. The prosthesis is made from polypropylene coated with a synthetic hydrogel. The binding of the prosthesis to rectum and vagina takes place in a wet environment after a few minutes and enables the shaping of the mesh on the surface of the rectum (wrap effect). Between March 2010 and March 2013, 41 patients were operated on using LVR with a self-adhesive prosthesis. The effectiveness of prosthesis fixation was evaluated in a subset of 27 patients suffering from complete rectal prolapse. With a median follow-up of 30 months, there were no major complications and no recurrence. In this initial experience, LVR with a self-adhesive prosthesis does not increase the risk of recurrence. No undesirable effects were associated with the prosthesis.

  18. 21 CFR 888.3590 - Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Knee joint tibial (hemi-knee) metallic resurfacing... Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis. (a) Identification. A knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis is a device intended to be...

  19. 21 CFR 888.3590 - Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint tibial (hemi-knee) metallic resurfacing... Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis. (a) Identification. A knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis is a device intended to be...

  20. 21 CFR 888.3580 - Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Knee joint patellar (hemi-knee) metallic... § 888.3580 Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis. (a) Identification. A knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis is a device made...