FDA orders studies of TMJ implants after finding some are removed early because of pain

First breast implants, now jaw implants. The implant news just keeps on coming.

The Food and Drug Administration on Monday ordered three manufacturers of temporomandibular joint, or TMJ, implants to study the length of time these jaw implants remain effective before they are removed or replaced because of pain or other reasons.

The federal agency reviewed what it called “TMJ implant-related adverse event reports” and found that a substantial number of patients had implants replaced within three years or less. That number falls short of the expected five-year life span of the devices.

At this point, the FDA isn’t recommending changes but wants to see what the new clinical data will show. TMJ Solutions, TMJ Medical and Biomet Microfixation have 30 days to design a study plan that requires agency approval. Here’s the FDA’s statement about the action.

Earlier this month, the FDA issued a warning about breast implants and their possible link to a rare form of cancer called anaplastic large-cell lymphoma, or ALCL, among a minuscule number of women worldwide. This Los Angeles Times article explains the safety history of breast implants.

Of course, a greater number of people have breast implants (5 million to 10 million women globally) than have jaw implants.

Still, any medical device that may pose an unintended health risk catches our attention -- no matter what kind of implant it might be.