Jaw implants are now under scrutiny for pain issues, reports say, with the U.S. Food and Drug Administration mandating three temporomandibular joint implant makers research how long these implants before replacement.
The TMJ connects the lower jaw to the temporal bone in the skull and is used as a replacement for those suffering from previous injury, arthritis, physical abnormality, or lost mobility due to other factors.
An analysis by the FDA found that a number of implant patients suffered pain and were forced to replace the implants within three years. Because of that, the FDA has asked three manufacturers to conduct studies to determine how long implants can be used before replacement.
The manufacturers, identified by reports as TMJ Solutions, TMJ Medical, and Biomet Microfixation, are to submit a study plan which will need to be approved by the agency before any post-market studies can begin.
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