Patient problems with metal-on-metal hip implants and the high number of early failures of the devices has led to a ban on most metal-on-metal hip implants in all U.K. hospitals funded by the National Health Service (NHS). As a practical matter, the ban encompasses every hospital in the U.K.
The decision to ban the devices follows new guidelines issued by the National Institute for Health and Care Excellence. The new standards recommend failure rates of five percent or lower after 10 years of use. The metal-on-metal resurfacing models found to have unacceptably high failure rates are: the Adept; Cormet 2000; Durom; Recap Magnum; and Conserve Plus. A sixth device, the Corail/Pinnacle full hip replacement using ceramic on metal, also failed to meet the standard.
Metal-on-metal hip problems include loosening and dislocation of the joint. In addition, metal components cause friction when they rub together, releasing metal ions into surrounding tissue and the bloodstream, a condition known as metallosis which can result in bone damage and tissue death if left untreated. Metallosis is treated by removing the defective device and replacing it with a new hip implant.
The Telegraph has reported that an audit of all hip surgery in England, Wales and Northern Ireland found that most types of metal-on-metal hip devices in use had failure levels below the standards NIHCE deems acceptable. The DePuy ASR, which was withdrawn when manufacturers admitted to failure rates of 13 per cent within five years, required revision surgery in almost a quarter of cases within that period. After nine years, failure rates are estimated to be 43 per cent, according to the audit.
Earlier this year, the FDA issued a new safety communication regarding metal-on-metal hip problems, which included metal exposure to the bone and surrounding tissue. The FDA recommended follow-up procedures to monitor patients for possible metal poisoning after their implant surgeries. These procedures include physical examinations and diagnostic imaging. The FDA also warned physicians to be on the lookout for symptoms of metal exposure, which might include pain or swelling near the hip joint, reduced mobility and noise from the joint.
At Heygood, Orr & Pearson, we have extensive experience litigating defective pharmaceutical and medical device lawsuits. In fact, we recently have resolved nearly 200 claims against Johnson & Johnson relating to their defective medical products. To receive a free legal consultation and find out if you are eligible to file a case, please call our toll-free number at 1-877-446-9001, or by filling out our free case evaluation form located on this page.