On October 14, 2010, the FDA acknowledged that the approval of an orthopedic device used in the knee was a mistake.  The FDA is conceding that pressure from Congressional lawmakers influenced the approval of ReGen Biologic’s “Menaflex” knee implant device.  The agency is taking steps to revoke the device’s approval, but will meet with ReGen officials to discuss what data would be required to prove the implant is safe and effective.

The FDA approved the knee implant device for use in December 2008, after twice rejecting its approval over concerns about the safety and effectiveness of the device.  In earlier rejections, the FDA found that the Menaflex knee implant had increased risk compared to other similar products on the market and provided little, if any, benefit to patients.

Menaflex is a collagen meniscus implant designed to guide new tissue growth using the body’s own healing process to reinforce and repair the meniscus in patients with an irreparable meniscus tear or loss of meniscus tissue.  It provides a resorbable scaffold for the growth of new tissue in the meniscus.

FDA Findings

In September 2009, the FDA found that outside pressure had influenced the approval of the Menaflex knee implant device.  The FDA internal review reports that two senators and two representatives from New Jersey, the device manufacturer’s home state, and the former FDA commissioner, exhibited an “extreme” and “unusual” amount of pressure to get the device approved.  The New York Times reports that the inquiries from the lawmakers came shortly after ReGen made campaign contributions to each of them.

Contact a Knee Implant Attorney

If you or a loved one experienced a serious side effect associated with a Menaflex knee implant device, protect your right to a legal remedy.  Contact one of the knee implant attorneys at Bernstein Liebhard LLP and schedule a free, confidential consultation.  You may be able to file a knee implant lawsuit.

Bernstein Liebhard is a nationally recognized law firm located in New York City that exclusively represents injured plaintiffs in a variety of individual and class actions nationwide.  We have been ranked among the top plaintiffs law firms in the coutry by the National Law Journal for the past nine years–an honor achieved by only one other law firm in the the United States.  Our experienced knee implant trial attorneys are standing by ready to review your case.  We represent our injured clients on a contigency fee basis, meaning that we advance all costs and do not collect any attorneys fees unless we are successful.

Published November 17, 2011 by