Did the FDA have a knee-jerk reaction to alleged pressure by four N.J. congressmen to approve a medical device that its scientists found faulty?
In a report, the agency says U.S. Sens. Robert Menendez and Frank Lautenberg, along with U.S. Reps. Frank Pallone and Steven Rothman, exerted “extreme” and “unusual” pressure for approval of the Menaflex knee implant, even though scientists said it repeatedly failed, forcing painful corrective surgery.
Although FDA administrators ignored the recommendations, approving the $3,000 device, the agency said the process is now being reviewed. Thirty patients in the U.S. and more than 3,000 in Europe have been implanted with the device, the New York Times reports.
Executives with ReGen Biologies Inc., the company that manufactures the device, donated a total of $26,000 to the lawmakers’ campaigns, the Times says records show.
The FDA report says its former commissioner, Andrew C. von Eschenbach, also pushed for approval of the device, which the Times described as “a C-shaped pad used to repair a torn or damaged meniscus, the cushion between knee bones.”
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