A decision by the Food & Drug Administration, which led to a very public mea culpa by the agency and more than a few bloody noses, will get a second look later this month.
The Menaflex knee implant, manufactured by ReGen Biologics Inc., will go back before the Orthopaedic and Rehabilitation Devices Panel on March 23, according to a press release from the Center for Devices and Radiological Health.
The knee implant, which was cleared for sale by regulators in December 2008, over the objections of FDA scientists, set off a high-profile maelstrom that ended in the watchdog agency admitting it had erred in clearing the device and that the FDA’s former director and four New Jersey legislators had pressured investigators to push the product through the system.
The clearance came despite the fact that the device, used to repair torn knee cartilage, often failed and required second operations. An FDA report called pressure from four New Jersey Democrats — Sens. Robert Menendez and Frank Lautenberg and Reps. Frank Pallone Jr. and Steven Rothman, all of whom received “significant” campaign contributions from New Jersey-based ReGen, according to the New York Times — extreme, unusual and persistent and said it helped lead agency managers to overrule the agency’s scientists.
The legislators all said they had acted appropriately and were not influenced by the money. Former commissioner Andrew von Eschenbach also denied any impropriety.
“My responsibility as that process was coming to a close was to make sure that it was continued in an orderly and appropriate fashion, and that’s what I believe I did,” he told the Times.
Gerald Bisbee Jr., chairman and CEO of ReGen, insisted that the Menaflex was safe and denied many of the allegations made by the FDA.
The dust-up was the first time the FDA has gone public with questions about its own approval process and admitted that politics played a part in approving a device or drug. It also set off a call to further investigate the 510(k) clearance process, by which a majority of medical devices are cleared for sale in the United States.
The agency said it will release more information two days before the review panel is set to meet.
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