A U.K. government agency is taking a stand against one particularly controversial hip implant that has reportedly caused widespread medical complications in patients around the world.
High failure rates and toxicity concerns have prompted the U.K. to ban metal-on-metal hip implants in hip replacement surgeries performed at National Health Service (NHS) hospitals. The NHS is the publicly funded health care system in the U.K.
The move comes after the watchdog group, National Institute for Health and Care Excellence (NICE), issued the guidance last week to NHS hospitals following alarming results from a recent study, according to a story first reported in the U.K. publication, The Telegraph.
The study of 17,000 patients with the devices found that some of the metal-on-metal brands had failure rates as high as 43 percent. Not only do early failures require patients to get follow-up hip replacement surgeries, called revisions, but health care professionals worry the metal hips may deposit toxic metal particles in the bloodstream.
Researchers found more troubling results in one brand. DePuy, owned by Johnson & Johnson, stood out due to a 13 percent failure rate of the ASR hip implant within five years. The device required patients to have revision surgeries in nearly a quarter of the cases.
Metal-on-metal implants have received negative press in the U.S., too. Thousands of lawsuits have been filed claiming similar results reported by the NICE study.
More decisive action is being taken against the industry in the U.K.
Regulators are advising the NHS ban any implants in the future with a failure rate higher than 5 percent. Experts say this means nearly every metal-on-metal device, including the implants still on the market, would be banned in the U.K.
Metal-on-Metal Implants Spawn Thousands of Lawsuits in the US
Metal-on-metal hip implants have long been controversial in the U.S. Although there hasn’t been widespread action by any government agency, all-metal hip implants have been the focus of a slew of ongoing litigation in this country.
Last week, the first federal trial alleging that DePuy sold defective metal-on-metal hips was delayed again. Themultidistrict litigation covers 8,000 consolidated federal cases under Judge David A. Katz in Ohio. DePuy, which has recalled more than 93,000 devices worldwide, and faces additional state lawsuits from patients claiming defective devices injured them. The trial, initially set for September, may not see the light of day until late January.
DePuy settled two metal hip lawsuits in October, which could be a sign of more to come. There have been reports that Johnson & Johnson may want to settle all of the remaining lawsuits against it, which could cost the company $3 billion.
Fellow device manufacturing companies, including Stryker and Biomet, also face a number of legal complaints based on similar claims by patients who say they were injured.
Some Manufacturers Recall All-Metal Hips
Despite the lawsuits against those companies, the U.S. Food and Drug Administration has not issued a metal hip recall. However, individual manufacturers have recalled their products for various reasons, while rarely addressing the harsh allegations against them.
DePuy pulled its ASR XL Acetabular System in 2010 after the National Joint Registry of England and Wales discovered the high failure rates. But DePuy is not the only company that has pulled problematic metal-on-metal hip devices.
Last year, London-based Smith & Nephew Orthopaedics issued a “market withdrawal” for metal liners in its R3 Acetabular System due to higher than normal revision surgeries associated with that variety of hips.
Even though the FDA isn’t calling for a ban on these devices, the negative publicity and legal price tags surrounding the lawsuits seem to be steering some manufacturers out of the metal-on-metal device business.
Executives at Johnson & Johnson say the company is discontinuing its metal-on-metal and metal-on-ceramic hips by the end of 2014. Instead of blaming the costly legal headaches, the company is blaming stricter FDA guidelines and declining use of the products by medical professionals.