The Food and Drug Administration is studying whether several medical devices already on the market, such as electroconvulsive therapy devices for depression and emergency defibrillators, require additional evidence to prove they’re safe.
As part of that re-evaluation, the federal agency on Thursday proposed that companies making so-called metal-on-metal artificial hip joints produce medical evidence demonstrating their safety in order to stay on the market. Also, the FDA said, any new metal-on-metal hip products will require human clinical evidence to gain approval for marketing.
The metal-on-metal hips, of which there are estimated to be hundreds of thousands implanted in patients, have tended to fail and require replacement more quickly than some other artificial hip joints, according to recent medical research. One 2012 article in the British journal Lancet concluded that “metal-on-metal total hip replacement failed at high rates” and that such devices “give poor implant survival” compared with others made of polyethylene or ceramic materials.
Diana Zuckerman, president of the National Research Center for Women & Families, said: “There are so many shortcuts at the FDA device center that they often take a shortcut and approve a product with minimal safety testing.”
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