The Food & Drug Administration is ordering all three U.S. manufacturers of a type of jaw implant to run post-market surveillance on the devices to track the rate of removal or replacement.
The federal watchdog agency is forcing TMJ Solutions, TMJ Medical and Biomet Microfixation, the only manufacturers cleared by the FDA to put temporomandibular joint implants on the U.S. market, run additional after-market studies. The devices are designed to replace the jaw’s "hinge," connecting the jawbone to the skull’s temporal bone.
The FDA said the trio have 30 days to submit designs for the new studies for its approval. The mandate was prompted by an agency study of TMJ implant-related adverse events between May 2004 and August 2010.
"The analysis described a substantial number of patients who had implants replaced within three years or less after implantation because of extreme pain," according to a press release. "This is considerably shorter than the expected minimum five-year life span of the device, based on pre-market mechanical testing."
No changes to the devices are being mulled yet, but the agency said it may revise its stance to add labeling changes, additional pre-clinical and clinical data requirements or other actions based on data from the post-market surveillance. That data must include:
- Time between initial implant and removal or replacement;
- Association between patient diagnosis and the time frame between implant and removal or replacement;
- For replacement implants, the time between implant and subsequent removal or replacement;
- Reasons for removal or replacement of the implant;
- Associations between patient demographic and clinical data and the need or removal or replacement;
- Assessment of devices that have been removed from patients.