The Food and Drug Administration (“FDA”) has ordered post-market surveillance on “metal-on-metal” prosthetic hip equipment to assess safety risks associated with the devices.
The FDA’s review comes after 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.
The FDA is considering reclassifying the device – which could mean that manufacturers conduct studies to gain pre-market approval.
Last August, 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.”
Patient claims against DePuy and Johnson & Johnson for problems associated with the hip implants have been filed in courts of 19 states, and more than 139 federal cases have been filed, according to a Dec. 1, 2010 court filing by Johnson & Johnson’s attorneys.
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.