FDA orders postmarket surveillance of certain TMJ implants
MedSun: Newsletter #58, March 2011

FDA Press Release

Today the U.S. Food and Drug Administration ordered three manufacturers of temporomandibular joint (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 is not 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.

Additional Information:

FDA Press Release. FDA orders postmarket surveillance of certain TMJ implants. February 7, 2011.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm242421.htm


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