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After DePuy ASR Hip Implant Recall, FDA Orders Safety Studies for Metal-on-Metal Hips

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The U.S. Food and Drug Administration (FDA) has issued an order for DePuy Orthopaedics, maker of the recalled DePuy ASR hip implant, to undertake studies of artificial hip implant devices linked to early failure rates and severe health effects in patients.  The New York Times reports that under the order, DePuy and twenty other producers of “metal-on-metal” hip implants will conduct studies of implant recipients to determine whether the devices are shedding high levels of metallic debris.

The FDA issued a letter to manufacturers mandating post-market studies of cases where an implant device could cause serious health consequences.  The order is designed to obtain information about the entire category of metal-on-metal implants rather than single out one manufacturer’s device.  The agency allows the manufacturers to determine the method of their studies, but they are expected to collect patient data that includes blood tests detailing if implant recipients have elevated levels of metal ions.  Manufacturers will have thirty days to file proposed plans with the agency.

In 2005, DePuy Orthopaedics introduced the ASR (Articular Surface Replacement) Hip Replacement System.  The device is a metal-on-metal hip implant made of chromium and cobalt and is used in total hip replacements for those suffering from severe pain and physical disability.  The hip implant device was permitted by the FDA via a process known as 510(k) approval.  This process allows a manufacturer to obtain market approval with little, if any, clinical testing of the device.   Manufacturers can bypass human testing by proving the device is substantially similar to another product currently on the market.

In August 2010, DePuy Orthopaedics issued a worldwide voluntary recall of its ASR XL System after the National Joint Registry of England and Wales reported 1 out of 8 implant patients (12%-13%) required revision surgery.  Unlike the average hip implant which is estimated to last fifteen years, DePuy ASR implant recipients needed surgery within five years of receiving the device.  More than 93,000 patients worldwide were fitted with an ASR hip implant, and it is estimated one third are U.S. patients.

DePuy is not the only one concerned about the ASR System.  The FDA has also issued a recall on the device.  The agency will issue a recall to address a problem with a medical device to determine if the device is a health risk to recipients, defective, or both.  Since the agency’s recall, numerous DePuy ASR hip implant lawsuits have been filed in the U.S.

Due to the device’s metal components, complications linked to DePuy ASR hip implant are the cause of cobalt and chromium shavings entering a patient’s bloodstream.  This shedding can cause metallosis, which can lead to tissue breakdown, bone density loss, and non-cancerous tumors.  The process can also cause cobalt poisoning, which if left untreated, can put patients at risk of deafness, blindness, headaches, heart disease, hypothyroidism, convulsions, tinnitus, and optic nerve atrophy.

DePuy makes the claim that implant recipients prior to 2003 are not subject to the recall.  Nonetheless, medical physicians advise all DePuy ASR implant patients to have their blood cobalt levels regularly tested and to continue medical monitoring several years post-surgery.

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