FDA admits mistake in approving knee device

Oct 14, 2010

(AP) -- The Food and Drug Administration says it made a mistake in approving a controversial knee implant against the advice of its scientific reviewers.

The unprecedented announcement comes a year after the agency first acknowledged that its decision to approve ReGen Biologics' Menaflex implant 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 devise was made despite protests by FDA scientists that Menaflex - which reinforces damaged knee tissue - provides little, if any, benefit to patients.

The FDA says 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.

Explore further: Booming mobile health app market needs more FDA oversight for consumer safety, confidence

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CarolinaScotsman
not rated yet Oct 14, 2010
FDA caving to political pressure, nothing new. FDA admitting it, world shaking.