FDA Orders Studies of TMJ Jaw Implants after Reports of Pain and Need for Removal
The U.S. Food and Drug Administration (FDA), who approves and oversees the use of medical devices, has ordered three manufacturers of temporomandibular joint (TMJ) implants to conduct postmarket surveillance studies of these devices because of a high number of adverse event reports.
The FDA announced today that the agency has ordered TMJ Solutions, TMJ Medical and Biomet Microfixation to conduct studies to investigate an increased failure rate of the devices in which patients must have these devices removed or replaced due to pain or other reason. These companies make all the TMJ implants currently approved for use in the United States.
Physicians use TMJ implants in cases of jaw injury, arthritis, physical abnormality, mobility problems and temporomandibular disorder (TMD) to connect the lower jaw, or mandible, to the temporal bone of the skull.
“The FDA analyzed TMJ implant-related adverse event reports submitted between April 30, 2004 and Aug. 17, 2010,” the FDA said. “The analysis described a substantial number of patients who had implants replaced within three years or less after implantation because of extreme pain. This is considerably shorter than the expected minimum five-year life span of the device, based on premarket mechanical testing.”
The TMJ implant postmarket surveillance studies performed by the manufacturers must 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
After the review, the FDA will determine if labeling changes, additional preclinical and clinical testing requirements, or other regulatory actions, such as a recall, are necessary for TMJ implants.
