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Hundreds of Thousands May have Toxic Metal-on-Metal Hip Implants

February 28, 2012 — An investigation by the BBC and the British Medical Journal has discovered that there may be hundreds of thousands of people with hip replacements that have a flawed design that may expose them to toxic metal.

The problem is due to the “metal on metal” design. When the joint grinds together as a person walks, it can leak cobalt and chromium into the body. These substances are potentially carcinogenic and have been linked to a degenerative heart condition called cardiomyopathy. Experts are now calling for a ban of these medical devices.

The replacement hips are created by DePuy Orthopaedics, a subsidiary company of Johnson & Johnson. The team investigating these implants says that they saw an internal DePuy memo from 2005 that expressed concern about the risk of carcinogens. Even so, the investigators say that DePuy continued to sell the defective hips without warning of this potential side effect.

Since 1975, doctors have known that cobalt-chrome implants could potentially leak toxic substances into the bloodstream. This is because the tissues in contact with the implants can react to the charged ionic particles in cobalt and chromium. These charged ionic particles can leak into the bloodstream and spread to lymph nodes, spleen, liver, and kidneys. Chromium ions have been identified as a probable carcinogen.

Cobalt has been linked to a heart condition called cardiomyopathy, in which the heart muscle becomes diseased. Over time, the heart muscle becomes weaker, and is less able to pump enough blood into the body. It can also cause irregular heartbeats called arrhythmias.

In addition to concerns that DePuy ignored the risk of cancer and heart problems with the implants, the BBC-BMJ investigators were also concerned that U.S. and European health regulatory agencies had ignored the risk. The investigators said that the agencies did not respond to concerns. The agencies also did not require DePuy to monitor or follow-up with patients who had received the hip implants.

The investigators say that there are serious problems with two models of DePuy hip replacements: the ASR and the Pinnacle hip prothesis. The Pinnacle was introduced in 2010, but in 2011 British researchers found that it also could be defective.

The editor of the BMJ investigation, Deborah Cohen, called the DePuy hip implants a “large uncontrolled experiment,” and blamed health authorities for failing to protect the people. “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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