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Link between Metal-on-Metal Hip Implants and Cancer--DePuy Orthopaedics Responds to Allegations

In March of 2012, an article was published in the British Medical Journal (BMJ) in which their investigations reporter wrote of a possible connection between the failure of metal-on-metall hip implants, such as the DePuy hip replacement,  and the risk of certain types of cancer. A press release in the same publication  published about five weeks later modified this position – based on a study funded by U.K. government health agencies with no apparent financial ties to any implant  manufacturer. However, even this press release acknowledged that the study only considered seven years' worth of data, and that because of this,  “...analysis of long-term data [would be] required over the next few decades,” as many types of cancers grow very slowly.

In any event, DePuy has decided to respond with its own article in the BMJ. Written by a mechanical engineer and a neuroscientist, both of whom are employed by DePuy Orthopaedics' U.K. Division, the response article states that while the authors “respect the BMJ’s right to rigorously investigate issues,” they insist that Deborah Cohen's article is “unnecessarily alarmist and in a number of instances factually incorrect” about the link between metal on metal hip implants and cancer.

Ms. Cohen quickly responded by stating that she and her colleagues were in fact being “necessarily alarmist,” particularly in the face of the “laxity of medical device regulation in Europe as a whole and some aspects of the US system” -- the latter referring to the FDA's 501(k) Clearance process, which allows fast approval of medical devices with little or no testing if it can be demonstrated that the new device is “substantially similar” to one that has been previously granted approval. In fact, very little testing had been done – which, according to Ms. Cohen's response, explains why the authors of the article defending the DePuy hip replacement found so little evidence of adverse effects. 

The authors of DePuy's defense article acknowledge that when it comes to revision surgery, the rates are approximately 3-5% -- but these figures are based on DePuy's own research, which can hardly be expected to be objective.

At least, not when profits are at stake...

Sources

Cohen, Deborah. “Response to Graham Isaac and Simon Sinclair of DePuy.” British Medical Journal, 2 May 2012.

Graham, Isaac and Simon Sinclair. “Re: How Safe Are Metal on Metal Hip Implants?” British Medical Journal, 12 April 2012.

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