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Consumers Union Calls On Medical Device Makers to Provide Warranties for Hip & Knee Implants
Date:9/10/2013

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. 

"Medical device companies claim that current law provides adequate protection for patients and that their implants are dependable and safe," said McGiffert.  "If that's the case, they should have no objection to offering warranties to back up those claims.  Patients and taxpayers shouldn't be on the hook for the cost of replacing devices when they fail."

When implants turn out be defective, the cost for additional surgery and a replacement device is now largely paid by patients or their insurance companies, including Medicare.  Revision surgery costs more, results in longer hospital stays and can often lead to additional surgeries.  An estimated 18 percent of hip replacements and 8 percent of knee replacements in the U.S. are for revisions and the cost for these procedures is likely in the hundreds of millions of dollars per year.  

In letters sent to Biomet, Inc., DePuy Synthes, Smith & Nephew, Stryker Corporation, Wright Medical Technology, Inc, and Zimmer Holdings Inc., earlier this summer, Consumers Union urged the companies to provide a 20 year warranty and outlined the terms of
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SOURCE Consumers Union
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