The regulatory process for reviewing medical devices in Europe is coming under fire after a controversy over leaking breast implants made in France.
That’s a big deal for U.S. medical device companies, who frequently praise the European regulatory system as faster, less burdensome and more supportive of technological innovation. Many in the device industry would like to see the U.S. Food and Drug Administration overhaul its regulatory process and emulate the Europeans.
The problem for U.S. device companies is the idea of Europe’s superiority in device regulation is now in doubt in light of concerns about the leaking implants and other device recalls.
“All the industry guys in the U.S. say, ‘We should have access to these products much sooner, like in Europe,’ ” Carl Heneghan, an Oxford University physician, told Bloomberg News. “The flip side is, the European people are being used as guinea pigs.”
There are two key differences between U.S. and European devices reviews: First, while both the European Union (EU) and U.S. require device makers to prove their products are safe, only the U.S. requires device companies to prove efficacy of their products.
Second, reviews of European devices aren’t conducted by the EU itself. Rather, reviews are carried out by one of 70 approved for-profit companies that must be accredited by one of the EU’s 27 member nations. In the U.S., the FDA handles medical device reviews.
Critics have complained that the European system creates an inherent conflict of interest in which medical device companies can simply shop around for the least-stringent reviewer, according to Bloomberg.
Of course, it would be an overreaction to point to just one case — the leaking breast implants –and say that an entire system is flawed. But the breast implants, which were never approved in the U.S., certainly aren’t the only recent European device to reach the market too quickly.
Bloomberg notes the same thing happened with a lung sealant from Covidien that was recalled in 2010. Ditto for an implant to treat elbow fractures, according to The New York Times. Neither were approved in the U.S.
The device industry will point to an industry-sponsored study by Boston Consulting Group that found little difference in the number of U.S. and European device recalls. However, that study’s methodology has been heavily criticized by the FDA and its allies, and can hardly be considered conclusive.
So, U.S. medical device companies should be careful what they wish for. With the industry already under heavy scrutiny over recalls of metal-on-metal hip implants and defibrillators, now may not be the time to push for an even less-stringent review process that could end up resulting in more recalls, more bad press for medical device companies and more harm to patients.
[Photo by flickr user Picture Perfect Pose]