An article about metal-on-metal (MoM) hip implants that was published in the British Medical Journal (BMJ) in February continues to stir controversy. The article has resulted in a heated debate between BMJ and DePuy. DePuy claims that the article was “unnecessarily alarmist” and included several incorrect facts, while omitting other essential information. BMJ defended the article in a detailed response to the criticism.
Last week, the author of the article, BMJ Investigations Editor Deborah Cohen, responded to DePuy’s comments, accusing DePuy of sidestepping the issue of metal hip safety. Cohen claims that the article “provided a necessarily alarming portrait of the state of medical device regulation today.” Cohen also said that the main point of her article was to point out “the laxity of medical device regulation in Europe as a whole and some aspects of the US system.”
As the European Commission drafts its proposal for the revision of the Medical Device Directives, the controversy is likely to impact the outcome. The Pip resolution, which was passed in April, already included references to the controversy, using it as an example of the failure of the European regulatory system. The resolution is not binding and only expresses the views of the European Parliament, but it demonstrates the prevailing view in the Parliament that Europe’s medtech regulations are not strict enough to prevent similar incidents (see this medtechinsider post for more information and for Eucomed’s response to this argument).Camilla Andersson