One of the most-used joints in the body in the temporomandibular joint (TMJ), which connects the lower jaw (the mandible) to the skull. The TMJ allows two kinds of movements: Regular opening and closing, as well as side-to-side movements. The result is a wonderful ability to eat, talk, chew, and make a variety of facial expressions.
Unfortunately, just as with knees, hips, and other joints, the TMJ can wear out or become diseased. And also like knees and hips, there are medical implants available for people whose TMJ has been badly damaged by injury, arthritis, or physical abnormality.
Now, the U.S. Food and Drug Administration (FDA) is ordering the three manufacturers of TMJ implants to conduct postmarket surveillance studies to determine the length of time before the implants are removed or replaced due to pain or other reasons.
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 because of extreme pain. This is considerably shorter than the expected minimum five-year life span of the device, based on mechanical testing.
The TMJ implant postmarket surveillance studies 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
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. The FDA is not currently recommending any changes on use of the implants. The agency 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. If you have had a TMJ implant that went bad, and you would like to explore your legal options, feel free to contact HensonFuerst Attorneys at 1-800-4LAW-MED. If you have questions, HensonFuerst has answers.
