A knee implant that was approved by the U.S. Food and Drug Administration in 2008 is opening eyes to possibly corruption in the agency.
Medical devices sold and used in the United States have to be approved by the FDA before being marketable, but some devices don’t have to be fully examined on a trial bases. Such is the case with ReGen Biologics Inc.’s C-shaped, cow collagen implant, the Menaflex, and DePuy Orthopaedic’s ASR hip implant. Devices ruled similar to already approved devices may receive fast-track approval with the FDA’s 510(k) clearance.
But, in the case with Menaflex, FDA whistleblowers say the FDA was lobbied to approve the device when it shouldn’t have.
In 2004, ReGen Biologics Inc. submitted a C-shaped, cow collagen implant, Menaflex, to the FDA for approval. Intended to replace the cushion between human knee bones, the company claimed the device was a similar to a shoulder implant also made by ReGen. But the FDA rejected the comparison to the shoulder implant, saying knees are weight bearing and subject to vastly different motions and wear patterns than shoulder joints.
After the second rejection, the company then turned to four Congressmen from New Jersey for help. The congressmen worked with then FDA Commissioner who set up an outside panel to review the device. The new review group was comprised of sports doctors recommended by ReGen.
The four members of Congress, all of whom received campaign contributions from ReGen, remained involved in the process, while previous committee were forbidden to interact with them. In December, the Menaflex device was approved, claiming the decision represented a unanimous committee decision.
For more, read Part 2 by a personal injury lawyer .