FDA: We Made Approval Mistake with Knee Device

The U.S. Food and Drug Administration has concluded in a report released this week that even though its own scientists recommended against the approval of a knee repair device last year, it was still given the green light, thereby violating agency rules.

The device, Menaflex, a collagen meniscus implant manufactured by Franklin Lakes, N.J.-headquartered ReGen Biologics, is used to help surgically repair knee damage.

“There were numerous departures from processes, procedures and practices, and there were problems with the review process for the device,” said Dr. Joshua Sharfstein, an FDA deputy commissioner, during a teleconference.

In addition, the FDA report pointed out that Democratic Sens. Robert Menendez and Frank Lautenberg, and Congressmen Frank Pallone Jr. and Steven R. Rothman, all representing New Jersey, made inquiries to agency officials about the device’s approval status.

“Members of the delegation apparently had conversations with the [FDA] commissioner and at least one conversation with the [former] principal deputy commissioner,” the report said.

The FDA plans to review the process by which such medical devices are approved, Sharfstein said; however, Menaflex will stay on the market for now, according to the agency.

“What we have concluded is that the integrity of our process for reaching a decision was compromised in this case, so we are revisiting and evaluating the record and the bases for making that decision,” said Dr. Jeffrey Shuren, acting director of the FDA’s Center for Devices and Radiological Health.

In response to criticism, the FDA has asked the U.S. Institute of Medicine to examine the approval process for certain medical devices, specifically the 510(k) review procedure, the process by which Menaflex was approved.

ReGen is defending its Menaflex device.

“ReGen stands behind Menaflex and believes that the scientific evidence for its collagen scaffold is solid,” said Gerald E. Bisbee, Jr., Ph.D., chairman and CEO of ReGen. He cited the results of a multicenter clinical trial published in The Journal of Bone and Joint Surgery in July 2008 and the nearly 3,000 patients in Europe and the U.S. who have had successful Menaflex surgery.