February 28, 2012 — The British Medical Journal and the BBC have led an investigation into potentially toxic hip implants. Investigators warn that the metal-on-metal implants can leak chromium and cobalt into a person’s bloodstream, potentially increasing the risk of cancer and a degenerative heart muscle disease called cardiomyopathy. The investigation revealed evidence that the company responsible for the implants, DePuy Orthopaedics, ignored warnings from experts. Now, there may be hundreds of thousands of people may be fitted with toxic hip implants.
The company responsible for the hip implants is DePuy Orthopaedics, a subsidiary of Johnson & Johnson. The joint BMJ-BBC investigation team reports that they reviewed an internal document from DePuy that was written in 2005. In the document, experts warned about the risk of carcinogens with metal-on-metal hip implants. Despite the warning sign, DePuy did not warn consumers of this risk when they marketed the hip implants.
DePuy has created two types of metal-on-metal hip implants: ASR and Pinnacle. The Pinnacle hip implant was introduced in 2010. One year later, British researchers warned that it could also be defective.
Doctors and researchers have known about the risk of chromium-cobalt implants since 1975, when they discovered that tissue that comes in contact with this metal can react with the charged ions in cobalt and chromium. These ions could then leak into a person’s bloodstream and then travel to the lymph nodes, spleen, liver, and kidneys. Researchers have found that chromium ions are probably carcinogenic.
Carcinogenic chromium is not the only problem. Researchers have also linked cobalt to cardiomyopathy, a severe heart disease that occurs when the heart muscle degenerates. The muscle becomes weaker over time. A weakened heart muscle cannot supply enough blood to the body, may develop irregular heart rhythms, and can lead to congestive heart failure and death.
The BBC-BMJ investigative team was not just concerned about the risk of cancer and heart disease. They were also concerned about lax oversight from U.S. and European health regulatory agencies. The investigative team alleged that these agencies did not provide adequate oversight, respond to concerns from experts, or require DePuy to monitor patients who had received the implants.
As a result, “Despite the fact that these risks have been known and well documented for decades, patients have been kept in the dark about their participation in what has effectively been a large uncontrolled experiment,” says BMJ investigations editor Deborah Cohen.
Ms. Cohen went on to blame health authorities for failures to protect the people from dangerous medical devices, saying, “This isn’t the unlucky failure to spot the misdemeanours of one rogue company or the occasional unforeseen breakdown of a small number of devices. It is the inability to prevent a whole class of failing hip implant from being used in hundreds of thousands of people globally.”
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