Jaw Implants under FDA Scrutiny
Jaw implant manufacturers are apparently the latest segment of the medical device industry to experience the new get-tough stance by US regulators.
The three major manufacturers of temporomandibular joint (TMJ) implants in the US must perform new postmarket surveillance studies to address safety and device longevity concerns by the Food and Drug Administration (FDA).
The regulator has given firms TMJ Solutions, TMJ Medical and Biomet Microfixation 30 days each to submit study plans for approval prior to beginning their respective postmarket surveillances.
The FDA’s order follows an analysis the agency conducted of TMJ implant adverse event reports made between April 30, 2004 and August 17, 2010; although TMJ implant devices should have at least five-year life spans according to premarket testing, FDA investigators found that a “substantial number” of patients had their implants replaced within three years or less due to extreme pain.
Specific issues TMJ implant manufacturers must target through their postmarket surveillance studies include the length of time between a device’s initial implant and its removal; links between particular patient diagnoses and implant life span; and the life spans of replacement implants.
Manufacturers must also examine the reasons for implant removals and replacements; any associative factors between patient demographic and clinical data and rates of device removal; and assessments of implant devices that have been removed.
As of now, the FDA has not recommended any changes to the use of these devices, but manufacturers should nonetheless prepare for potential changes. The agency notes in its press release that TMJ implant manufacturers had already conducted postmarket surveillance on their devices during their initial approval processes, but those study results did not properly cover removal and replacement issues.
Possible moves the FDA is considering following the new postmarket surveillance of TMJ implants include labeling changes, new preclinical and clinical testing requirements and “other regulatory actions.”