The National Institute for Health and Care Excellence (NICE) has drafted new regulations to monitor the use of metal-on-metal hip devices in European National Health Services (NHS) hospitals following studies that report unacceptably high failure rates in these implants.
Even the best metal-on-metals have four times the failure rate of the rest.
NICE’s new regulations will prohibit NHS hospitals from using any hip implants that have displayed a failure rate higher than five percent after five years, banning the muse of almost every metal hip implant in these hospitals, according to The Telegraph.
Patients with metal-on-metal hip implants have previously reported premature failure in the devices, as well as tissue damage surrounding the implant. Concerns have also been raised about the possibility of metal poisoning, since friction between the metal ball and metal socket has been shown to release small metal particles into the bloodstream. In the United States, metal-on-metal hip implant manufacturers are facing thousands of lawsuits alleging a link between the products and metal toxicity, among other injuries.
An audit of all hip surgeries performed in England, Wales, and Northern Ireland spurred NICE’s new regulations. Researchers found unacceptably high rates of failure in the implants and predict even higher rates will be reported in the coming years. DePuy’s ASR metal-on-metal hip implant has a 13 percent failure rate after five years, according to the device’s manufacturer. Using this information, researchers estimate that the ASR implant could have failure rates as high as 43 percent after nine years. Some metal hip resurfacing implants had similar failure rates of 14 percent after five years, and an estimated 36 percent after nine years. These devices have been implanted in nearly 6,000 patients, while some 11,000 patients were implanted with metal-on-metal or metal-on-ceramic resurfacing devices with five percent failure rates after five years; researchers estimate this number will jump to 16 percent after nine years.
“The figures speak for themselves – even the best metal-on-metals have four times the failure rate of the rest,” an honorary consultant surgeon for the Royal National Orthopaedic Hospital Stephen Cannon said. Aside from the fact that metal hips are substandard to traditional implants, the high failure rates alone should constitute a ban on all metal implants, surgeons told The Telegraph.