Synthetic jaw implants already on the market prior to the 1976 Federal law requiring medical devices be proven safe and effective were exempt and continued to be sold after 1976 without proof of safety. Teflon implants made by Vitek, and silicone ones made by Dow Corning, raised the most concern. Vitek-Kent Proplast-Teflon partial & total prosthesis were manufactured from 1982 to 1990 in Houston TX. TMJ prostheses became popular with the introduction of Vitek, but evidence that the implants could cause debilitating reactions including pain, malocclusion, and foreign-body giant cell reaction (FBGCR) resulting in degeneration of the surrounding tissue led to a recall by the FDA on 1/7/91. Since Vitek declared bankruptcy in June 1990 and the owner fled the country, the FDA was left to handle the recall, which they did by sending out a safety alert and public health advisory. Otherwise, there was next to no follow-up on the recall. Silastic silicone TMJ Implants produced by Dow Corning became popular during the 1970s, but reports of widespread mechanical failure with wear, tearing, and fracture began to surface. Debris and fragments led to an inflammatory response, joint degeneration, bony ankylosis, and lymph node swelling. Marketing of Silastic for use in the TMJ was discontinued on 6/15/93 after warnings from the FDA and the American Association of Oral and Maxillofacial Surgeons URL The Hoffman-Pappas Total TMJ Replacement System produced by Endotech has been in use since 1995 while awaiting final FDA approval. Working with Dr. Mike Pappas, Dr. David Hoffman of Staten Island University Hospital received approval by the FDA to undertake a national study to investigate a clinical trial on the prosthetic joint URL
Synthetic jaw implants already on the market prior to the 1976 Federal law requiring medical devices be proven safe and effective were exempt and continued to be sold after 1976 without proof of safety. Teflon implants made by Vitek, and silicone ones made by Dow Corning, raised the most concern. Vitek-Kent Proplast-Teflon partial & total prosthesis were manufactured from 1982 to 1990 in Houston TX. TMJ prostheses became popular with the introduction of Vitek, but evidence that the implants could cause debilitating reactions including pain, malocclusion, and foreign-body giant cell reaction (FBGCR) resulting in degeneration of the surrounding tissue led to a recall by the FDA on 1/7/91. Since Vitek declared bankruptcy in June 1990 and the owner fled the country, the FDA was left to handle the recall, which they did by sending out a safety alert and public health advisory. Otherwise, there was next to no follow-up on the recall. Silastic silicone TMJ Implants produced by Dow Corning became popular during the 1970s, but reports of widespread mechanical failure with wear, tearing, and fracture began to surface. Debris and fragments led to an inflammatory response, joint degeneration, bony ankylosis, and lymph node swelling. Marketing of Silastic for use in the TMJ was discontinued on 6/15/93 after warnings from the FDA and the American Association of Oral and Maxillofacial Surgeons (AAOMS). The Hoffman-Pappas Total TMJ Replacement System produced by Endotech has been in use since 1995 while awaiting final FDA approval. Working with Dr. Mike Pappas, Dr. David Hoffman of Staten Island University Hospital received approval by the FDA to undertake a national study to investigate a clinical trial on the prosthetic joint system.
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