Reports indicate that problems associated with the DePuy ASR metal-on-metal hip implants are on the rise.
According to recent report, the Food and Drug Administration ("FDA") received more complaints related to failure of metal-on-metal hips in the first six months of 2011 than the prior four years combined. And the National Joint Registry for England and Wales is reporting that nearly one out of three ASR hip systems implanted in patients six years ago have failed.
The reports follow a spate of lawsuits challenging metal-on-metal devices manufactured and marketed by DePuy Orthopedics. The lawsuits allege that the metal-on-metal devices can shed tiny particles damaging to bone, muscle, and nerve, complicating revision surgeries.
The FDA is now reviewing the risk-benefit profile and revision surgery rates of hip prostheses by 21 manufacturers. The metal-on-metal devices include a metal ball and socket parts. Other designs are plastic or ceramic, to avoid metal-on-metal contact and wear.
Metal-on-metal hip systems were marketed in the U.S. prior to 1976 legislation that gave the FDA premarket authority over medical devices. These so-called “pre-amendment devices” were automatically designated as Class III (higher risk)devices, but they were regulated under the less rigorous 510(k) premarket notification program.
In August 2010, DePuy Orthopedics recalled its ASR™ XL Acetabular hip system after researchers found 13 percent of patients required a revision surgery to fix problems within five years of the surgery. The New York Times characterized the rate of failure as “unusually high.”
Any patient with a hip replacement should contact their orthopedic surgeon to determine whether they received a DePuy device.
Sheller, P.C. represents clients nationwide with the recalled hip implant. If you or someone you know has been injured by one of these products, see www.hiprecallhelp.com, or call 1(800)883-2299.