Summary Box: FDA to review already-approved knee implant, but device maker fights back
By APFriday, March 19, 2010
Summary Box: FDA to review already-OK’d device
WHAT HAPPENED: In a rare move, the Food and Drug Administration has decided it will again review Menaflex, a knee implant it had approved in 2008. The agency plans to convene a panel of experts next week to revisit the safety and effectiveness of the device.
THE BACKGROUND: FDA leadership concluded the implant was approved, despite objections by FDA staff scientists, due to pressure from lawmakers in the device maker’s home state, New Jersey.
WHO’S AFFECTED: Approximately 210 patients in the U.S. have had Menaflex implanted.
YOUR VIEW POINT
