We had previously blogged about the sorry state of regulatory oversight of manufacturers of temporomandibular joint (TMJ) implants.
The good news is that the FDA announced last week that it had ordered three manufacturers of TMJ implants to conduct postmarket surveillance studies to determine the length of time before the implants are removed or replaced due to pain or other reasons.
The three manufacturers, TMJ Solutions, TMJ Medical, and Biomet Microfixation, that were the subject of the FDA’s order make all of the currently approved TMJ devices marketed in the United States.
The companies will have 30 days to submit a study plan which will need to be approved by the agency before any postmarket studies can begin.
The FDA’s order was prompted by reports of a substantial number of patients who had TMJ implants replaced within three years or less after implantation because of extreme pain, which is a considerably shorter timeframe than the expected minimum five-year life span of the device.
