In response to increasing reports of failure and adverse events, and concern over defective hip replacements, the U.S. Food and Drug Administration (“FDA”) announced that it will hold a two-day expert advisory panel meeting to discuss the risks and benefits of metal-on-metal hip replacement implants. The FDA is seeking independent experts for the advisory panel meeting scheduled for June 27-28, 2012.
There are two categories of metal-on-metal hip replacements. One such category is the metal-on-metal total hip replacement system, which consists of a metal ball, metal stem in the thighbone and metal cup in the hip bone. The second category is the metal-on-metal hip resurfacing system, which consists of a trimmed femoral head capped with a metal covering and a metal cup in the hip bone.
Last May, the FDA ordered all manufacturers of these hip replacement systems to conduct post-market studies to collect additional safety data on these medical devices, including data relating to metal ion concentrations in the blood of recipients of hip implants. Currently, in an effort to minimize the distribution of defective hip replacements, the FDA is considering making metal-on-metal systems subject to more rigorous testing and premarket reviews.
William Maisal, M.D., M.P.H., deputy director of science at the FDA’s Center for Devices and Radiological Health, stated “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.”
Experts on the panel will discuss failure rates, metal ion testing, imaging methods, local and systemic complications, patient risk factors, and post-operative follow up.
Metal-on-metal hip replacements have been marketed by 21 companies including Biomet Orthopedics, DePuy, Zimmer, and Wright Medical.
Source: FDA News Release, “FDA to discuss risks and benefits of metal-on-metal hip replacements,” March 29, 2012