FDA Orders 21 Hip Reserve Makers To Study Defects

Law360, New York (May 10, 2011, 10:09 PM EDT) -- The U.S. Food and Drug Administration on Friday ordered 21 manufacturers of metal-on-metal hip replacement systems to conduct post-market surveillance studies to determine whether their devices were associated with a dangerous increase in levels of metals in patients' bloodstreams.

“Data from the studies conducted will enable the agency to better understand these devices and their safety profiles,” the FDA said in a notice on its website.

The makers of the artificial hips will be required to submit research protocol to the FDA that addresses specific safety...
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