The U.S. Food and Drug Administration press release announced that, due to the extreme pain that some patients who have had a temporomandibular joint (TMJ) implant, they are ordering three device manufacturers to conduct post-surgical studies of their devices.
TMJ implants are used in patients to connect the lower jaw (mandible) to the skull. Some patients have the implant surgery because of injury, arthritis, physical abnormality and limited mobility of their jaw. Jaw implant surgery is performed after physicians have exhausted other treatment modalities including prescribing a soft diet, a jaw splint, medication, physical therapy and immobilization of the jaw.
The three approved manufacturers of TMJ devices are TMJ Solutions, TMJ Medical and Biomet Microfixation.
THE FDA is looking at adverse event ports they have received between April 30, 2004 and August 17, 2010. When looking at the data, the FDA found that there was a “substantial” number of patients who had a failure of the device within three years of the original surgery. The device was supposed to last a minimum of five years. In the case of the DePuy hip device, reports of devices failures showed the hip implants were defective but the company continued to market them.
Post market Study
Because of the higher than expected number of reports about the devices, the FDA is asking the three manufacturers to survey implant patients and collect data about the removal of the implant, the reasons why it was replaced, and the time-frame between removal and replacement.
For more information about the post market study, click here.
Concerns about TMJ implant along with DePuy ASR Hip Implant Devices highlight the fact that the United States lacks a Joint Registry system like they have in Australia, Sweden and the United Kingdom.
This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. We represent people who have suffered serious injury due to defective medical devices including the DePuy hip implant. With our help, you may recover compensation for your damages including for pain and suffering.
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Contact The Farber Law Group at 1-800-244-9087 or email@example.com to schedule a free and confidential case evaluation. We have offices in Seattle and Bellevue to assist you.