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FDA Exercises Poor Oversight Over TMJ Device Manufacturers and Patients With TMJ Implants Suffer the Painful Consequences
Monday, November 29th, 2010

More than 10 million Americans suffer from a condition known temporomandibular joint disorder, or TMJ, which causes varying levels of dysfunction and pain in and around the joint connecting the jaw to the head. Surgeons have sought to alleviate the condition by implanting artifical jaw joints in patients. But frequently these TMJ implants have broken down, resulting in more surgeries, and pain and suffering, for patients.

In a recent report, MedPage Today concludes that the fiasco surrounding TMJ implants is due to poor oversight by the FDA over TMJ device manufacturers. Initially, the FDA did not require TMJ implant makers to submit their devices for review, a decision that allowed thousands of devices to be marketed with disastrous effects.

Then the FDA shifted gears and directed TMJ implant manufacturers to submit their devices to the FDA for review and pre-market approval. Four TMJ devices went through that formal review process, and the FDA approved all four despite weak scientific support for the devices, and reliance on clinical trials being run by doctors with financial conflicts, and suffering from flaws such as small numbers of patients with limited follow-up, and sloppy record-keeping and inadequate oversight (in the case of one TMJ device submitted for review, the FDA approved the device despite a panel recommendation against approval).

The FDA approvals also appear to have been a product of political pressure exerted by Congressman representing districts in which the TMJ device manufacturers were located.

Click here to read the full report on MedPage Today.

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