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FDA Issues New Metal-on-Metal Hip Implant Website

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The Food and Drug Administration (FDA) recently launched a new set of Web pages to address the risks and side effects associated with metal-on-metal hip implants.

The new pages include several different topics including how the metal-on-metal hip implant systems work, the FDA’s concerns relating to these systems and the hip systems that have been recently recalled, including the DePuy ASR total hip system.

A major concern with metal hip implants is metallosis, according to the FDA. Metallosis is the result of the body reacting to a metal implant. It occurs when the rubbing of metal-on-metal components releases increased levels of cobalt and chromium into the bloodstream. Inflammation and scarring around the implant are the result.

Other side effects associated with metal-on-metal hip implants include pain in the groin, hip or leg, swelling near the hip joint and a limp or change in walking ability.

The FDA’s new Web pages were spurred following the recent recall of DePuy hip devices in August 2010. The ASR Hip Resurfacing System and ASR XL Acetablular Systems were recalled after the devices were associated with higher failure rates than other models. A second, corrective surgery was needed in 12 to 13 percent of patients five years after the initial operation.

The new pages describe hip implants; how metal-on-metal implants differ from other implants and it also outlines information and recommendations for patients regarding the benefits and risks of these products.

Read about the FDA’s Role and Activities to further assess the safety and effectiveness of metal-on-metal hip implants.

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  1. Steve Ray says:
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    It seems crazy that their are not clear guidelines that doctors should be following to test for high levels of cobalt. I had to beg my doctor to test me. My orthopedic did not even tell me about the dangers and I had to research it on my own.