The US Food and Drug Administration (FDA) has ordered three manufacturers of temporomandibular joint (TMJ) implants to conduct postmarket surveillance studies due to the occurrence of high number of implant replacements.
The FDA had analysed TMJ implant-related adverse event reports submitted between 30 April 2004 and 17 August 2010.
The analysis showed that there were high number of patients who had implants replaced within three years or less after implantation because of extreme pain.
According to the FDA, this period is significantly shorter than the expected minimum five-year life span of the device, based on premarket mechanical testing.
The FDA has asked three manufacturers, TMJ Solutions, TMJ Medical, and Biomet Microfixation, to submit a study plan which will need to be approved by the agency before the postmarket studies can begin.
The postmarket studies will address aspects such association between patient diagnosis and the timeframe between implant and removal/replacement, reasons for replacement/removal, and assessment of devices that have been removed.
As a part of the review, FDA will consider whether labeling changes, additional preclinical and clinical testing requirements, or other regulatory actions are required for these devices.