TMJ Implants Face Scrutiny

<"">Defective medical devices, sadly, are nothing new. Now, jaw implants are under scrutiny for pain issues. The LA Times just reported that the U.S. Food and Drug Administration (FDA) has mandated that three temporomandibular joint—TMJ—implant makers study how long these implants are effective before they must be removed due to TMJ implant pain, TMJ implant injuries, and other problems.

The FDA analyzed TMJ implant-related adverse event reports submitted between April 30, 2004 and August 17, 2010. The analysis described a substantial number of patients who had implants replaced within three years or less after implantation over extreme pain. This is considerably shorter than the expected minimum five-year life span of the device, based on pre-market mechanical testing.

The FDA has asked the three manufacturers to conduct post-market surveillance studies to determine the length of time before implants must be removed or replaced due to pain or other reasons. The LA Times noted that the agency is seeking an understanding of what this data will reveal and is not recommending any changes at this point. Three manufacturers; TMJ Solutions, TMJ Medical, and Biomet Microfixation have been given 30 days to submit a study plan which will need to be approved by the agency before any post-market studies can begin.

The FDA explained that the TMJ connects the lower jaw (mandible) to the temporal bone in the skull. A person may have an implant to replace the socket in the temporal bone or the rounded edge of the lower jaw that glides in the temporal bone socket because of an injury, arthritis, physical abnormality, or lost mobility.

TMJ implants also can be used to treat temporomandibular disorder (TMD) that has not responded to more conservative treatments such as limiting jaw movement, soft diet, jaw splint or adjustments, medicine to reduce pain, or physical therapy.

The FDA may revise its recommendations or issue other recommendations after reviewing additional clinical data from the studies. Patients who have or are considering a TMJ implant should consult with their health care professional.

TMJ implant manufacturers are required to collect post-market data on their implants as part of the approval process; however, the data collected did not adequately address the timing or reasons for replacement, and the studies lost contact over the years with many of the enrolled patients.

The TMJ implant post-market surveillance studies must, now, address the following:

• Time between initial implant and removal/replacement.

• Association between patient diagnosis and the timeframe between implant and removal/replacement.

• For replacement implants, the time between implant and subsequent removal/replacement.

• Reasons for removal/replacement of the implant.

• Associations between patient demographic and clinical data and the need or removal/replacement.

• Assessment of devices that have been removed from patients.

As part of its review, the FDA will consider whether labeling changes, additional preclinical and clinical testing requirements, or other regulatory actions are necessary for these devices.

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