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Monday, May 16, 2011

FDA Orders Surveillance of Hip Implants

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Hip replacements are utilized through the workers' compensation medical delivery system in an effort to cure and relieve medical conditions arising out of employment injuries and exposures. The US Food and Drug Administration (FDA) has recently announced that it is widening its roll in monitoring the hip implants. This follows a recent recall of defective hip implants.
"The FDA is continuing to gather and review all available information about currently marketed metal-on-metal hip systems, including information related to adverse events that may be associated with increase levels of cobalt and chromium in the bloodstream. To that end, on May 6, 2011 the FDA issued orders for postmarket surveillance studies to manufacturers of metal-on-metal hip systems. The FDA sent 145 orders to 21 manufacturers. Manufacturers will be required to submit a research protocol to the FDA that addresses specific safety issues related to these devices. Data from the studies conducted will enable the agency to better understand these devices and their safety profiles.