The Food and Drug Administration made a mistake in approving a knee implant against the advice of its scientific reviewers. It has now admitted that it shouldn’t have approved the device. 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 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. The FDA says it’s taking steps to revoke Menaflex’s approval.
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