FDA admits mistake in approving implant

The Food and Drug Administration issued an unprecedented “mea culpa” Thursday, saying it made a mistake in approving a knee implant against the advice of its scientific reviewers.

The announcement comes a year after the agency first acknowledged that its decision to approve the Menaflex implant, made by ReGen Biologics, was influenced by outside pressure, including lobbying by four Democratic 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.

FDA officials vowed last fall to revisit the decision made under President George W. Bush, 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.

The four New Jersey Democratic lawmakers - Reps. Frank Pallone Jr. and Steven R. Rothman, and Sens. Robert Menendez and Frank R. Lautenberg - each had appealed to the FDA on ReGen’s behalf, according to accounts last year from Mr. 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.

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 repeatedly rejected that argument, saying the device should go through a more rigorous process that requires patient testing.

The head of FDA’s device division overruled those scientists in late 2008. The agency said Thursday they were actually correct and that Menaflex is “technologically dissimilar from devices already on the market.”

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.”

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