An FDA panel has found that there isn't enough scientific evidence to come to a firm conclusion about the benefits of ReGen Biologics' Menaflex knee implant that was approved by the FDA in 2008. Menaflex has been the subject of controversy because of alleged lobbying that may have played a large role in the device's clearance.
The chairman of the panel, John Kelly of the University of Pennsylvania, cited inadequate evidence about the effectiveness of the Menaflex implant, adding that there isn't enough information about the device's safety. "There is evidence of reasonable efficacy, but we have concerns about inadequacies of scientific proof," he noted during the meeting. He said it was the panel's opinion that the device "is reasonably safe, but it fails to pass scientific muster," according to the Wall Street Journal
Menaflex is a resorbable collagen-based surgical mesh composed primarily of type I collagen. It reinforces damaged or weakened tissue and provides a resorbable scaffold for replacement by the patient's own tissue. It is intended for use in the treatment of medial meniscus injuries.
Last week, the FDA said in briefing documents posted ahead of the meeting that ReGen hadn't provided enough data to show that Menaflex is safe. And in a report released last September, the agency went as far as to admit that there were "multiple departures" from standard procedures during the 17-year review history of the CS device. The agency also admitted that it was unable to counter accusations that lobbying on behalf of ReGen had affected its decision. ReGen maintained that its product worked as it was intended.
After the meeting, Jeffrey Shuren, the FDA device division director, said the agency could pursue several avenues, including could doing nothing, applying special controls, or reclassifying Menaflex as a high-risk device, which could require a new application, the WSJ notes.
- check out the FDA's briefing materials
- see the company's briefing materials
- read the WSJ's coverage