The FDA will meet June 27-28, 2012, to investigate the safety of metal-on-metal hip replacement devices.
Johnson and Johnson was forced to recall 93,000 implants in 2010 when it learned that one in eight hip replacements failed after five years and consumers filed complaints. Makers of Wright Conserve metal hips, BioMet M2A-Magnum metal hips, and other replacements have also been sued.
The FDA became concerned with the high failure rate and reports of metallosis, blood poisoning that occurs when metallic debris builds up in the body’s soft tissues.. In 2011, the FDA mandated that manufacturers submit post-market surveillance reports addressing these issues.
The FDA initially approved the metal-on-metal hip replacement system under its 510(k) plan, a fast track process that does not require manufacturers to conduct pre-market studies if an equivalent exists on the market. Metal-on-metal hip replacement systems are defined on the FDA website as consisting of a metal ball (femoral head), a metal femoral stem in the thighbone, and a metal cup in the hip bone.
“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,” said William Maisel, M.D., M.P.H., deputy director of science at FDA’s Center for Devices and Radiological Health (CDRH).
In the meantime, many doctors have stopped using the implants.
The FDA is accepting public comment for the committee until May 9. Electronic comments may be submitted at http://www.regulations.gov. Written comments can be mailed to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm 1061, Rockville, MD 20852. Please identify comments with Docket No. FDA-2012-N-0293.
If you or a loved one have been hurt from dangerous medical devices and implants, you should contact a attorney as soon after the accident as possible and before speaking with the press.