Here are two headlines you don’t want to read: “Medical Devices and Chinese Toys Share Same Level of Safety Checks” and “The Terrifying Story of How a Former French Butcher Earned Millions by Selling Faulty Breast Implants Made from Mattress Filling.” But millions of Guardian and Daily Mail readers did. Merci, M. Mas!
Jean-Claude Mas, as you must know, is the founder and former President of Poly Implant Prothèse (Pip). The now-infamous Pip manufactured breast implants using industrial silicone for almost 10 years until the dirty little business was brought to the attention of French authorities. Hundreds of thousands of women around the world with Pip implants are anguished, particularly in light of the fact that these products are prone to ruptures because of their thin-wall design.
Adding insult to injury, Mas is defiant. He makes no secret of the fact that the company deliberately hid the truth from Notified Body TÜV Rheinland during inspections, because, he says, the implants posed “no health risks.” Moreover, he has publicly accused women who have filed lawsuits against Pip of only “being interested in getting some money out of this.” Completely unrelated but impossible to omit: Mas reportedly is the subject of an Interpol arrest warrant for a drunk driving incident in Costa Rica. Really, you can’t make this stuff up.
| An image of PIP's old facility in France. Photo credit: Flickr user Marcovdz.
Predictably, l'affaire Pip has rekindled a debate on the safety of medical devices in general and the trustworthiness of the regulatory system. And that is how you get to a place where reporters suggest that medical devices undergo the same level of scrutiny as Chinese toys.
As Eucomed Director of Regulatory and Technical Affairs John Brennan notes in a recent blog post: “Amongst the articles in the media and in public discussions, there are many mixed reactions and unfortunately quite a few errors of fact.” He goes on to say, rightly, that there is one overall clear message: “We need a new system that readily addresses some fundamental issues.” Some of those concerns may be addressed in the spring, when the European Commission unveils its proposed new regulations on medical devices. In addition, a series of measures are being developed that, if implemented, will help prevent incidents of this kind in the future, notes Brennan.
To keep things in perspective, it is worth remembering that there are some 500,000 medical technologies currently in use, very few of which have caused harm. The New Approach directives have been remarkably successful at striking a balance between product safety and rapid access to innovative medical technologies. Fix the parts that aren’t working, certainly, but don’t be fooled into letting perfect be the enemy of good.