Could Cancer Be a Possible Metal-on-Metal Hip Implant Side Effect?Feb 6, 2012 | Parker Waichman LLP
A study that could be unveiled next month in Britain is likely to raise more concerns about the safety of metal-on-metal hip implant devices. According to a report from The Telegraph, the study, conducted by researchers at the University of Bristol, reportedly found evidence linking all-metal hip implants to an increased risk of cancer.
According to The Telegraph, the study involved 72 patients with metal-on-metal hip implants, and found that 17 had sustained genetic damage to cells of the bladder. Atypical cells could be a precursor to cancer, and even more alarming, at least three patients did actually developed full-blown cancer. The study hasn't been published yet, but could be presented next month at the annual British Hip Society conference.
The Bristol University metal-on-metal hip implant study was launched after British regulators warned patients there undergo annual checks, including scans and blood tests if doctors find symptoms that suggest their hips are shedding unsafe levels of metal debris. For several years now, concern has been building that the wearing of metal debris could allow toxic metal shards to make their way into the blood stream, and cause inflammation that destroys tissue and bone.
The concerns have U.S. regulators worried as well. Last year, the U.S. Food & Drug Administration (FDA) directed 21 makers of all-metal hip implants, to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metallic debris in patients.
Several specific models of metal-on-metal hip implants have also raised safety concerns in the U.S. and abroad. For example, in August 2010, DePuy Orthopaedics issued a worldwide recall of its ASR Hip Resurfacing System and the DePuy ASR Acetabular System, after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years of receiving it. Recently, a new study - also conducted in Britain - found up to a 50 percent failure rate at six years for those who received a DePuy ASR hip implant in a total hip replacement procedure. Among those implanted with the more limited resurfacing treatment, one in four products failed within the same period, according to the study.
In the U.S., DePuy, a division of Johnson & Johnson, faces more than 3,500 product liability lawsuits over the ASR hip implants. The company faces another 900 over an all-metal version of its Pinnacle hip implant, as well.