Great Britain's NHS Bans Use of 'Toxic' Metal Hip DevicesOct 29, 2013
National Health Service (NHS) hospitals are banning the use of “toxic” metal-on-metal hip replacement devices following high failure rates.
The Great Britain health regulator called for the ban after research had revealed that these devices had a failure rate of as many as four in 10 cases, according to The Daily Mail. Surgeons there expressed concern that the joints are wearing and failing prematurely, with some leaking toxic metal.
Two popular models have been removed from the market and thousands of patients who underwent implantation with the devices have been advised to undergo yearly medical exams and testing, the Daily Mail wrote. The new guidelines were issued by the National Institute for Health and Care Excellence (NICE) and follow probes by The Telegraph that revealed significant issues.
One orthopaedic surgeon told the Daily Mail that the failure rates could be likened 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 cease using any hip implant devices with failure rates greater than 5 percent at the five-year mark. This means that nearly every metal-on-metal hip implant device would be banned.
In fact, a study of all hip surgery conducted in England, Wales, and Northern Ireland found that most metal-on-metal implants had unacceptably high failure rates that fell below NICE standards. Specifically, DePuy Orthopaedics’ ASR metal hip implant was tied to revision surgery within five years of the initial implant procedure in nearly one-quarter of the cases, 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 new 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.”
In India, a probe was initiated over the way DePuy Orthopaedics recalled its ASR device. The Maharashtra Food and Drug Administration (FDA) in India issued a recommendation that the state home department submit the case concerning 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 settled another one of the nearly 11,000 lawsuits it now 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) 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 also marketed a second metal-on-metal hip implant device, under the Pinnacle brand, which is the focus of litigation as well, including an MDL in the U.S. District Court for the Northern District of Texas.