An investigative report published in BMJ, formerly known as British Medical Journal, says thousands of hip implants made by DePuy Orthopaedics have leaked high levels of toxic cobalt and chromium ions. According to an attorney representing the plaintiffs, the industry has known about the harmful effects of cobalt for at least 25 years and left the American people in the dark about the downside of exposure to toxic levels of cobalt shed from these devices.
The toxic metals have destroyed patients’ muscle and bone, and will potentially leave some patients with long-term disability, the study says.
“Metal-on-metal hip prostheses like the DePuy ASR XL can and do create three to five-fold increases in blood levels of the heavy metals chromium and cobalt,” the lawwsuit states. "Toxicity from these metals causes metallosis, a disease that destroys the tissues surrounding the artificial joint. Left unresolved, metallosis creates irreparable harm to the patient from the progressive destruction of the joint tissues.” According to the court document, other health issues related to failure of the ASR XL hip implant includes “immediate irreparable harm from undiagnosed metal disease and the effect it has on the joint, even after revision and on other targeted organs, such as the brain, heart, liver, and kidneys.”
In addition to risk of infection and blood clots in a second implant surgery, revisions will not last as long as the 20 to 30 years the original hip implants were expected to last.
The BMJ report cites longstanding “evidence of risk from metal-on-metal hips, the manufacturers’ inadequate response, and how regulatory bodies failed to give doctors and patients the information they need to make informed decisions.”
The US Food and Drug Administration (FDA) warned in 2011 about metal ions that shed minute particles of the metal implant that migrate into the bloodstream and damage bone or tissue surrounding the implant and joint.
BMJ quotes an internal DePuy memo from July 2005 that says, “In addition to inducing potential changes in immune function, there has been concern for some time that wear debris may be carcinogenic. … One study suggested threefold risk of lymphoma and leukemia 10 years after joint replacement.”
“So-called ‘Silent Metal Disease,’ is found in upwards of 30% of patients with no symptoms. Cobalt and chromium poisoning can only be diagnosed promptly through a program of universal and comprehensive monitoring of the entire population of ASR XL patients,” according to the lawsuit.
BMJ says it’s likely there are more than 500,000 “ at risk large diameter ” metal-on-metal hips implanted in American patients since 2003 which require monitoring.
The lawsuit is asking that a class be certified and that DePuy be ordered to establish a fund to pay the costs of medical monitoring over the lifetime of all ASR XL Acetabular System hip implant patients. Those costs include annual blood and urine tests and medical imaging such as ultrasound and MRI examinations.
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Last updated on Mar-2-12