The Poly Implant Prothèse scandal left more than 400,000 women with toxic breast implants and sparked medical device regulatory reforms across the EU, and now 5 of the company's former execs are enduring boos and hisses from wronged patients as their trial gets under way in France.
Former PIP CEO Jean-Claude Mas was greeted with jeers and a shout of "bastard" when he was introduced in court Thursday, standing before 310 former patients packed into a Marseille courthouse, The Times reports. There are 5,127 plaintiffs in total, the paper reports, from across the EU and Latin America.
Mas and company are charged with aggravated fraud and accused of passing off industrial-grade silicone as safe for patient use, leading to at least 4,000 implant ruptures. Each former exec from the now-bankrupt PIP faces a maximum of 5 years.
But the trial, colorful though it may be, has less impact on the medical device industry than the galvanizing effects of the initial scandal.
Since the 2011 revelation of PIP's fraud, the scattershot regulatory processes of the EU have come under intense scrutiny. As it stands, implants are vetted and cleared for sale by third-party groups, a process the European Commission claims is ineffective.
However, industry is pushing back, warning that clamping down too hard on the currently speedy CE mark process could overburden device developers and slow important treatments' paths to market. Many devicemakers go straight to the EU with their innovative products, securing CE marks and amassing post-approval data for future FDA applications.
- read the Times story (sub. req.)