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Metal-on-Metal Hip Problems Lead to Ban of Devices in U.K.

Reports of serious metal-on-metal hip problems and early failure of these 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).

The decision follows new guidelines issued by the National Institute for Health and Care Excellence (NICE), which has changed the standards by which hip implants should be evaluated. These new guidelines would impact nearly all manufacturers of metal-on-metal devices, since few of these implants would meet the new standards.

Study shows high rates of metal on metal hip problems

According to a report at the Telegraph, the decision to ban metal-on-metal hip implants was made after a study showed unacceptably high failure rates among the devices implanted in 17,000 patients. The previous standards set by NICE recommend failure rates of 10 percent or lower after 10 years of use. New standards, based on information on how long artificial hips can and should last, recommend failure rates of five percent or lower after 10 years of use.

Currently, there are no metal-on-metal implants that boast this type of failure rate. 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. This condition, known as metallosis, can result in bone damage and tissue death if left untreated. Unfortunately, the only way to address metallosis is through hip revision surgery, which involves removal of the defective device and replacement with a new hip implant.

The new ruling by the United Kingdom would require hospitals funded by the NHS to stop using hip implants that do not fall within the new guidelines immediately. Since the U.K. has a public health system fully funded by the NHS, this ban would encompass every hospital in the country. Metal-on-metal devices listed in the ban include DePuy ASR and Pinnacle implants, Zimmer Durom Cup devices and the Biomet Recap-Magnum.

DePuy hip recall preceded report of high failure rate

Just before the new guidelines were issued by NICE, a report came out suggesting the DePuy ASR hip device had a failure rate of nearly 40 percent after 10 years of use.  A DePuy hip recall was issued for the ASR system in 2010 in the United States. Since that time, many who were injured by the ASR hip implant have filed lawsuits against DePuy, seeking damages from the company for their injuries.

In early 2013, the FDA issued a new safety communication regarding metal-on-metal hip problems, which included metal exposure to the bone and surrounding tissue. The agency 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 warns 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.

Stephen Cannon, an honorary consultant surgeon at the Royal National Orthopedic Hospital, told the Telegraph, “The figures speak for themselves – even the best metal-on-metals have four times the failure rate of the rest. This is really a significant problem, because these were given to an awful lot of people.”

Hip implant lawsuits continue to mount

In the United States, where metal-on-metal implants continue to be used at this time, an increasing number of hip replacement lawsuits have been filed against manufacturers of the devices like Zimmer, DePuy and Stryker. Plaintiffs in these cases claim their hip implants led to serious complications, including pain, reduced mobility and metallosis. Many of these plaintiffs had to undergo risky revision surgery in just a few short years to remove the defective devices and replace them with new implants.