Friday, May 13, 2011

FDA Orders Makers of Hip Systems to Conduct Post Market Studies

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      On the front of its Business Day section, the New York Times (5/11, B1, Meier, Subscription Publication) reported on the "unusual move" by the FDA to direct some 20 makers of "metal-on-metal" artificial hips to do postmarket studies because of "high early failure rates and severe health effects in some patients." The companies are being told to find out if the devices "are shedding high levels of metallic debris" that account for cases of disabling "soft tissue damage." Dr. William H. Maisel, deputy director for science at the FDA's Center for Devices and Radiological Health, said the FDA wants to know "about the entire category of implants, not any single manufacturer's device." He added, "Our concern is the product, not about a manufacturer."
        Bloomberg News (5/11, Farrell, Nussbaum) said the FDA order, dated May 6, went to Johnson & Johnson, "which is already facing more than 1,000 lawsuits over hip replacements," as well as companies such as Biomet Inc., Zimmer Holdings, and Stryker Corp., which said it didn't make a metal-on-metal product. Bloomberg News added, "The request comes nine months after DePuy Orthopaedics, a unit of New Brunswick, New Jersey-based J&J, recalled a hip-replacement system that had been implanted in 93,000 patients worldwide. 
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