FDA says it was wrong to OK implant

Associated Press / October 15, 2010

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WASHINGTON — The Food and Drug Administration issued an unprecedented mea culpa yesterday, 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 lawmakers from the company’s home state of New Jersey.

The 2008 decision was made despite protests by FDA scientists that Menaflex provides little benefit.

Obama-appointed FDA officials vowed to revisit the Bush-era decision after congressional investigators accused the agency of being too cozy with the companies it regulates.

The FDA is taking steps to revoke Menaflex’s approval, although it will meet with the company to discuss what data would be needed to prove the device is safe and effective.

ReGen’s chief executive, Gerald Bisbee, said the company is weighing its options, adding that “there has never been a safety issue associated with the device.’’