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FDA was pressured into approving unsafe knee implant

The New York Times today published an article detailing how the FDA succumbed to political pressure to approve a surgical implant called a "scaffold" for repairing torn medial [knee] menisici even though it deemed the device to be flawed.  The meniscus in the knee is a sort-of-pie-shaped section of cartilage that cushions the joint and provides a slippery joint surface between the tibial head and the end of the femur.  This device is intended to supplant or supplement the function of the meniscus in a damaged or worn-out knee.

According to the article, which was documented through FDA records, reports and the investigation of Senator Charles Grassley, the Menaflex device was approved on the "fast track," based on the performance of theoretically similar devices, after constant pressure was exerted by New Jersey Congressmen and the Bush-appointee who headed the Agency.  At the time, FDA examiners were concerned that the "similar" device documentation was not adequate and that the new device was not safe.  Nevertheless, succumbing to pressure from politicians, the researchers ultimately approved the device over their own concerns and it will remain on the market for the foreseeable future.

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