FDA Advisors to Review Metal-on-Metal Hip Implant Problems in JuneMar 30, 2012 | Parker Waichman LLP
The U.S. Food & Drug Administration (FDA) has decided the problems associated with metal-on-metal hip implants need more scrutiney, and is calling in outside medical experts to recommend what should be done about the controversial devices. According to an announcement posted yesterday on the FDA website, the agency's Orthopaedic and Rehabilitation Devices Panel will meet over June 27 and 28 to discuss the risks and benefits of metal-on-metal hip replacement devices.
The advisory panel will discuss both metal-on-metal hip implants used in total hip replacement surgeries, as well as hip resurfacing. Failure rates and modes; metal ion testing; imaging methods; local and systemic complications; patient risk factors; andc onsiderations for follow-up after surgery.
“We are asking outside scientific and medical experts to discuss recent information on these devices so that the agency can continue to make reliable safety recommendations to patients and their health care providers,” William Maisel, M.D., M.P.H., deputy director of science at FDA’s Center for Devices and Radiological Health (CDRH), said in a statement from the agency.
The panel could vote to recommend that the FDA impose new testing standards and review requirements to be met before a device can be sold in the United States. The FDA is not legally obligated to follow the recommendations of its advisory panels, but usually does so.
Last May, the FDA directed 21 companies that market all-metal hip replacement to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metallic debris in patients.