The FDA is admitting that pressure from lawmakers played a factor in the approval of the Menaflex knee replacement device by ReGen Biologics Inc., which may have unleashed an unsafe or ineffective medical device on the market.
In a preliminary internal review of its approval process over the Menaflex, a form of surgical mesh known as a collagen scaffold used in knee replacement surgery, the FDA found that it approved a device which may not be safe for consumers due to political pressure. The FDA approved the device for use in December 2008, after twice rejecting fast-track approval over concerns about the safety and complexity of the device.
In earlier rejections, FDA reviewers and scientists noted that the Menaflex had increased risk compared to other similar products on the market and involves an “unduly lengthy recovery period” of six months. They also found that there was no proof that the device provided patients with any benefits over other available products.
The FDA review division also disputed ReGen’s findings on the number of adverse events connected with the device in trials. Although ReGen counted the number of patients who had adverse events, the review division found a significantly largely number when they counted multiple problems experienced by the same patients as separate events.
After the FDA declined to approve the device, ReGen contacted several lawmakers and asked them to intervene on its behalf. The FDA internal review reports that two senators and two representatives from New Jersey, the device maker’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 RenGen made campaign contributions to each of them.
The FDA report suggests that the prior approval of the Menaflex knee replacement device should be re-evaluated.
The controversy over the FDA review process for the medical device comes amid concerns in Congress about the agency’s ability to act as an effective guardian of patient safety. In a report released earlier this summer by the Government Accountabilty Office (GAO), a review of the FDA’s oversight of medical devices was found to have a number of deficiencies that could expose the publis to potentially dangerous and defective medical devices.
Congress is currently considering the Medical Device Safety Act of 2009, which seeks to overturn a 2008 Supreme Court decision in Riegel vs. Medtronic, which provided manufacturers of some immunity from product liability lawsuits to makers of some medical devices that go through a stringent premarket approval process with the FDA.