In 2009, Suzy Mansfield, then 57-years-old, seemed like a perfect candidate for a metal-on-metal hip implant. Mansfield’s doctor had recommended an all-metal hip replacement for the active Massachusetts woman, who according to the makers of the devices, was exactly the kind of patient for whom metal-on-metal hip implants were intended.
“He said, ‘You’re young. Metal is good for younger people. It’s going to last a lot longer,’ ” Mansfield recently told NPR.
In 2009, when Mansfield underwent her total hip replacement, 1 in 3 hip implant recipients were being fitted with a metal-on-metal device. According to NPR, that means about 80,000 patients per year were receiving an all-metal hip implant when they were at the height of their popularity. And like Mansfield, many of those patents have since discovered that their metal-on-metal hip implants were far from the best choice.
According to NPR, Mansfield ultimately received DePuy Orthopaedic’s ASR Hip Implant, which ended up being recalled in August 2010 because of its high failure rate. The worldwide recall was announced after it was found that they were failing in about 12 percent of patients within five years. Realistically, a hip implant should last around 10-15 years.
Since her original implant, Mansfield has suffered from constant, worsening pain, she told NPR. Her device also became loose. As a result, Mansfield recently underwent hip revision surgery at Massachusetts General Hospital to have her device removed and replaced. When surgeons opened her up, they discovered Mansfield’s implant was eating away at the surrounding bone and soft tissue. A reporter from NPR was allowed to observe the surgery.
“You can see here the yellowish discoloration of the tissue that is no longer functioning,” surgeon Young-min Kwon explained. The yellow tissue was once muscle, and it was dying because of exposure to toxic metal ions leaking from the implants. The operation also revealed tissue that was stained black, which Kwon said was metallosis. Metallosis, the toxic buildup of metal in the issue, causes swelling, tissue death and the kind of burning pain that Mansfield had described, according to NPR.
Since the DePuy ASR Hip implant recall, concerns about metal-on-metal hip implants have only intensified. 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. Last week, The Lancet published a study conducted by University of Bristol researchers who 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. 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.
The metal-on-metal hip implant debacle has also spawned what’s turning out to be a massive wave of litigation. 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.
Earlier this month, lawsuits involving Wright Medical Technology’s Conserve Plus metal-on-metal hip implant were consolidated in a multidistrict litigation in the U.S. District Court for the Northern District of Georgia. A number of lawsuits have also been filed around the country alleging that Biomet’s Magnum hip replacement, another all-metal device, is defective and may result in the need for revision surgery within a few years.