FDA admits it was a mistake to approve a knee treatment device
The U.S. Food and Drug Administration, or FDA, said on Thursday its 2008 decision of approving the sales of the device called the Menaflex Collagen Scaffold shouldn’t have been approved. FDA admitted its mistake of wrongly approving the device ignoring the advice of its own scientific advisors.
The FDA mentioned in a statement that it will take action to eliminate the device from the market, but also will get together with the company that produces it, ReGen Biologics Inc to see if there is a process through which the implant could gain approval in a new application.
The approval happened over the opposition of FDA scientific staff who said the Menaflex device did only a little benefit over current treatments.
It’s not likely that patients who have already received the device will require having it removed since they are designed to be reabsorbed by the body said the FDA.
Menaflex is a collagen scaffold used in surgery to fix a torn medial meniscus, the most universal form of knee injury. The scaffold strengthens and repairs damaged tissue.
According to the FDA statement, “patients who have had the Menaflex device implanted should consult with their surgeon about what, if any, action should be taken.”