Use of so-called “toxic” metal-on-metal hip replacement devices are being banned at National Health Services (NHS) hospitals in Great Britain following unacceptably high failure rates there.
The failure rate was reported as high as four in 10 cases, according to The Daily Mail, which led to Great Britain regulator’s ban following health watchdog research. Surgeons there expressed concern that the joint devices wear and fail prematurely, with some leaking toxic metal.
Two popular models have been removed from the market and thousands of patients who have been implanted with the devices have been advised that they should undergo annual medical exams and testing, the Daily Mail wrote. The National Institute for Health and Care Excellence (NICE) issued the guidelines, which followed an investigation by The Telegraph that revealed significant issues.
An orthopaedic surgeon told the Daily Mail that failure rates were similar to “watching a car crash in slow motion—at first, you just don’t know how bad it is going to be.” The new rules say that the NHS should stop using hip implant devices with failure rates of more than five percent at the five-year mark, which means nearly every metal-on-metal hip implant device would be banned.
A study of all hip surgery conducted in England, Wales, and Northern Ireland revealed that most metal-on-metal hip devices had unacceptably high failure rates that fell below NICE standards. In fact, the DePuy Orthopaedics’ ASR was tied to a secondary, revision surgery in nearly 25 percent of the cases in the first five years following original implant surgery, according to The Telegraph. DePuy is a unit of health care giant Johnson & Johnson.
Stephen Cannon, honorary consultant surgeon for the Royal National Orthopaedic Hospital said of the ban, “I think there is a question about whether it goes far enough, but this is definitely a step in the right direction—it amounts to a ban on most of them. The figures speak for themselves—even the best metal-on-metals have four times the failure rate of the rest. This is a really significant problem because these were given to an awful lot of people.”
Meanwhile, in India, a probe was recently initiated over the way in which DePuy recalled the ASR. The Maharashtra Food and Drug Administration (FDA) there issued a recommendation that the state home department submit the case over the inappropriate recall of the DePuy ASR in India to the Central Bureau of Investigation (CBI) for further review, according to PharmaBiz.
In the United States, Johnson & Johnson recently just another of the nearly 11,000 lawsuits it faces over the ASR, according to court records. Last month, Johnson & Johnson also agreed to settle a bellwether case that is part of a multidistrict litigation (MDL) that has been organized in California state court. Other legal actions involving the DePuy in the U.S. include an MDL in New Jersey’s Bergen County Superior Court and in U.S. District Court, Northern District of Ohio.
DePuy sold a different metal-on-metal hip implant device under the Pinnacle brand, which is the focus of litigation, including an MDL in the U.S. District Court for the Northern District of Texas.