FDA admits mistake in approving knee device
15th October 2010
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 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.