Consumer Reports published an article in September 2013 calling for medical device manufacturers to provide warranties for hip and knee implant devices. As the byline states, “Paying to replace a defective device isn’t a cost for you to bear”. Surprisingly, these devices now do not usually have warranties.
There have been a number of recalls for hip replacement devices in the last several years from medical device manufacturers including DePuy, Biomet, and Stryker. Lawsuits have been filed by patients seeking to protect their legal rights in connection with several of the recalled devices.
The Consumer Report article discusses an FDA process that allows for most medical devices to be on the market without the rigorous safety testing known as the pre-market approval process (PMA). Instead, these devices are allowed to marketed and sold based upon representations by the manufacturer that the device is substantially similar to other similar devices on the market through the fast track “510K” process.
Patient safety groups have urged Congress to require more premarket testing of these devises, but this has been opposed by the medical device industry.
Consumer Reports and Consumers Union have done an excellent job in presenting this information and raising public and patient awareness of this important health issue. Consumers Union has a campaign for warranties for medical devices at www.safepatientproject.org.