British Health Agency Updates Advice for Metal-on-Metal Hip Implant PatientsFeb 28, 2012 | Parker Waichman LLP
British health regulators have issued new guidance to patients fitted with metal-on-metal hip implants, amid fears that the devices may be shedding dangerous amounts of metal debris into their bloodstreams. Yesterday, the Medicines and Healthcare Regulatory Authority (MHRA) said patients with metal-on-metal hip replacement that have a head diameter of 36mm or more should be monitored annually for the life of the hip replacement.
According to a statement from the MHRA, these patients should undergo annual blood tests to ensure they don't have high levels of metal ions in their blood. Those that do test positive for metal ions in their blood should undergo MRIs to assess the condition of their implant.
As we've reported previously, the shedding of metal debris from an all-metal hip implant could cause tissue damage, premature device failure, the need for revision surgery, and even long-term health problems, including heart and nervous system damage. Most recently, preliminary findings from a study conducted by researchers at the University of Bristol in the U.K. indicated that patients fitted with all-metal hip implants may be at risk of experiencing genetic changes to the cells of the bladder that could lead to cancer.
In April 2010, the MHRA advised that patients with this type of hip replacement need only be monitored for a minimum of five years after their operation. The MHRA has not changed its advice for metal-on-metal hip implants that are smaller than 36 mms.
Concerns have been growing for some time that metal-on-metal hip implants could pose long-term health risks. 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. Problems with all-metal hip implants have also led to a growing number of lawsuits against the makers of such devices. At last count, DePuy had been named in more than 5,000 U.S. lawsuits over the recalled ASR devices. At least 900 complaints have been filed against the all-metal version of its Pinnacle hip replacement device, with plaintiffs claiming it is similar in design to the ASR implants and should have been recalled as well.