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Source: Consumer Reports
And:
Metal-on-metal hip implants high risk devices
....An undercover team from the two publications created a fake large-diameter metal-on-metal total hip, which they called Changi TMH. In metal-on-metal implants, the ball and socket of the devices are both made from metal.
Its fake design was based on a device, DePuy ASR XL, that was recalled by its manufacturer for safety reasons. The undercover team presented the hip to 14 certification agencies in Europe. And even though their documentation stated that tests had shown it produced potentially toxic levels of metal ions in the body, they received approval.
This should be shocking news, considering the risks to the patients' health and the pain associated with their recovery once the device has been implanted. Revision surgeries, needed to correct the device when it fails, are more complicated. Few surgeons want to clean the manufacturer's mess, afraid they could be pulled into a lawsuit.
What does this have to do with patients in the United States?
A Consumer Reports investigation this year found lack of U.S. oversight in the approval of implants. It said that many medical devices implanted in million of Americans' bodies have never been tested for safety.
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