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Johnson & Johnson Settlement Resolves Metal Hip Lawsuits But Weak Oversight Of Medical Device Industry Leaves Hundreds of Thousands of Patients Vulnerable
Date:11/19/2013

a better understanding of how long an implant is expected to last and a clear process to follow in the event that it fails prematurely.  Ultimately, warranties will encourage companies to make their devices safer and more durable, according to Consumers Union. 

Most hip and knee implants are allowed on the market without being reviewed for safety and effectiveness by the Food and Drug Administration (FDA).  Instead, under current law, the companies simply have to demonstrate that the devices are "substantially equivalent" to a product already being sold.  Since most new hip and knee implants are similar to ones already on the market, manufacturers are able to gain approval through the FDA's fast track 510(k) clearance process without having to prove the device is safe and effective. 

Consumers Union and other patient safety groups urged Congress to require more pre-market testing of devices like hip and knee implants during last year's reauthorization of the Medical Device User Fee Act.  But those efforts were blocked by the politically powerful medical device industry. 

Over 750,000 Americans got metal on metal hip implants during the past decade, which were supposed to last longer than devices made with a combination of ceramic, metal and plastic.  But unusually high failure rates have been documented in metal hip implants in Australia, England, and Wales where devices are tracked through national registries.  The data from these countries showed that one in eight of the Johnson & Johnson DePuy ASR XL metal hip implants failed within five years. 

Some patients have experienced debilitating symptoms from metal debris that flakes off the device over time, including cardiomyopathy and neur
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SOURCE Consumers Union
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