Aug 01 by Andy Gillin

DePuy Hip Implants Cited in Report on FDA Medical Device Approval Process

The past few years have been marked by a shocking number of high-profile recalls of medical devices that were previously approved by the Food and Drug Administration’s abbreviated investigation process, dubbed 510(k). Last summer’s DePuy Orthopedics hip implant recall, for example, followed an abnormally high number of revision surgeries caused by thousands of artificial hips. Late last week, the journal Institute of Medicine released a report criticizing the FDA’s loopholes that allow medical devices to go to market if they are “substantially equivalent” to other models that have been approved in a complete FDA review.

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Jan 04 by Andy Gillin

Report: FDA Allowed Major Oversight Loopholes for DePuy Faulty Hip Implants

Late last year, the Food and Drug Administration announced that it would recall hip implants manufactured by DePuy Orthopedics, a division of pharmaceutical giant Johnson & Johnson due to an abnormally high number of hip implant failures, which some predicted could easily surpass 12,000. At the time, DePuy critics were quick to note that the ASR hip implant models hit the market without FDA oversight thanks to a loophole that greenlights a product if it is similar to a device already approved by the agency. Last month, the New York Times published a scathing report about DePuy and the FDA, showing just how easy it was for the J&J subsidiary to put a dangerous product on the market.

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