Bernard James, a grandfather living in Wales, recently came forward to detail his gruesome experience with a failed metal-on-metal hip implant. According to a report from Wales Online, James went into the hospital to be treated for what was thought to be a muscle hernia, only to learn an all-metal hip implant which had been leeching cobalt and chromium into the surrounding tissue was actually responsible for his pain and suffering.
“When I had the right-hand hip removed they actually found there was a piece of muscle that had been eaten away by the grey fluid.” Bernard James told Wales Online.
James was referring to grey fluid that was contained in a cyst near his hip implant, a reaction caused by the metal ions that had leaked from the device.
According to Wales Online, James, had both his left and right hips replaced in separate operations in 2006. Initially, he did well. But over time, he began experiencing pain from his implants.
James has had his right hip replace. According to Wales Online, he is now waiting on the results of blood tests to see if this has solved the problem or whether the left hip is also leeching metal.
“Obviously the thought is bothering you at times, is the left one going to give me the same trouble as the right?” he said.
When James first received his hip implants, he and his doctors expected the devices to last for 15 years.
James is just one of thousands of patients throughout the world who have experienced problems with all-metal hip implants. Metal-on-metal hip implants include DePuy Orthopaedics’ ASR Hip Resurfacing System and the DePuy ASR Acetabular System, which were recalled in 2010 because of an unusually high premature failure rate. DePuy, a division of Johnson & Johnson, currently faces more than 5,000 U.S. lawsuits over its defective ASR hip implants. At least 900 lawsuits are pending in the U.S. over an 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.
Just yesterday, The Lancet published a study conducted by University of Bristol researchers who analyzed data from the National Joint Registry of England and Wales covering more than 400,000 hips replacements, including 31,171 all-metal ones, that occurred between 2003 and 2011. They found that people with metal-on-metal hip implants were twice as likely to experience early failure of their device compared to those fitted with other types of implants. The authors of the study asserted the devices should no longer be used.
Just last month, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) announced that blood tests should be conducted yearly to check cobalt and chromium blood levels in some all-metal hip implant recipients, those with bearings of 36 mm or above. Those who do exhibit high metal ion levels should be subjected to MRI to check for damage near the implanted joint, the agency said. Only last week, the British Hip Society advised that larger metal hip implants be used in total hip replacement surgery.
Metal-and-metal hip implants have sparked concerns in the U.S. as well. Last May, the U.S. Food & Drug Administration (FDA) directed 21 companies that market all-metal hip replacement devices to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metallic debris in patients. The shedding of metal debris may cause tissue damage, the development of cysts and pseudotumors, premature device failure, the need for revision surgery, and other long-term health problems, according to the agency.
Late last month, the British Medical Journal revealed that metal-on-metal hip implant manufacturers were aware of mounting evidence linking metal-on-metal hip replacement devices to serious, long-term health consequences, but for years failed to warn the public about these dangers.