Almost two years ago, the Food and Drug Administration ignored the advice of its scientists and approved a knee implant after being lobbied by members of Congress. On Thursday, the agency issued an unprecedented "mea culpa," saying the device should not have been approved. The agency also said it is taking steps to revoke approval of the Menaflex implant, made by ReGen Biologics. The announcement comes a year after the agency first acknowledged that its decision to approve the device was influenced by outside pressure, including lobbying by four lawmakers from the company's home state of New Jersey.
The 2008 decision to approve the implant was made despite protests by FDA scientists that Menaflex — which reinforces damaged knee tissue — provides little, if any, benefit to patients. Obama-appointed FDA officials vowed to revisit the Bush-era decision last fall after congressional investigators accused the agency of being too cozy with the companies it regulates. Since the device's approval, the top two device regulators who oversaw Menaflex's review have left the agency.
Four New Jersey Democrats — U.S. Reps. Frank Pallone and Steve Rothman and U.S. Sens. Robert Menendez and Frank Lautenberg — each had appealed to the FDA on ReGen's behalf, according to accounts last year from Rothman and spokesmen for the three others. In a statement Thursday, the FDA said it is taking steps to revoke Menaflex's approval, although it also plans to meet with the company to discuss what data would be needed to prove the device is actually safe and effective.
An FDA spokesman said the agency has revoked device approvals before, although the step is rare.
ReGen, based in Hackensack, N.J., asked the FDA in 2005 to approve its device under the so-called 510k system, which allows speedy approval for devices that are similar to products already on the market. ReGen argued that the Menaflex was comparable to shoulder joint implants sold by Johnson & Johnson, Stryker and other companies. FDA scientists rejected that argument again and again over several years, saying the device should go through a more rigorous approval pathway that requires patient testing.
The head of FDA's device division overruled those scientists in late 2008. The agency said they were actually correct and that Menaflex is "technologically dissimilar from devices already on the market." The FDA is overhauling the 510k system for approving medical devices, after several outside reports suggested high-risk devices have slipped through with little scrutiny. Earlier this year ReGen reported that about 210 patients in the U.S. and 3,000 in Europe have had the Menaflex implanted.
Since Menaflex is designed to be reabsorbed into the body, the FDA said most patients won't need to have the device removed, though it recommends patients talk to their doctors. ReGen Chief Executive Gerald Bisbee said in a statement the company is "weighing its options" for Menaflex, adding that "there has never been a safety issue associated with the device."