Pharmaceutical

Metal-on-metal hip implant complaints surged in 2011

A New York Times analysis of U.S. Food and Drug Administration data has found complaints about metal-on-metal hip implants have surged in recent months. The study suggests that these special devices, which once promised extra durability and longevity, continue to fail prematurely and in some cases sicken recipients with ailments linked to metal poisoning.

According to The New York Times, the FDA has received more than 5,000 complaints so far this year about metal-on-metal hip implants such as the DePuy ASR XL Acetabular system and similar devices. The total number of reports since January equals more than the FDA received in the previous four years combined. The New York Times notes that 75 percent of the complaints it reviewed concerned DePuy’s ASR XL Acetabular system.

The New York Times notes that “typically, the number of complaints filed with the F.D.A. about a product understates a problem because while companies must file reports, doctors and patients do not have to.” Therefore, the actual reported cases in all likelihood form a snapshot of a larger problem.

“The vast majority of filings appear to reflect patients who have had an all-metal hip removed, or will soon undergo such a procedure because a device failed after only a few years,” The New York Times reported. While hip implants are expected to last anywhere from 15 to 30 years, clinical studies have shown that about 13 percent of DePuy’s ASR Acetabular systems fail within the first 5 years. Other studies from the U.K. suggest the failure rate for that device and DePuy’s ASR Hip Resurfacing System, which was not approved in the U.S., could actually be much higher.

According to The New York Times, “all-metal replacement hips are on a trajectory to become the biggest and most costly medical implant problem” since 2007 – the year Medtronic recalled its Sprint Fidelis heart lead for a faulty component.

The scope of the metal-on-metal hip implant problem can be attributed to the fact that around 250,000 hip replacement surgeries are performed each year, and until the DePuy recalls announced a year ago, nearly a third of hip implant recipients opted to receive a metal-on-metal device. Since the DePuy recalls, however, about five percent of patients and surgeons choose metal-on-metal hip implants.

Source:

Hip Implant Complaints Surge, Even as the Dangers Are Studied