Regulatory Focus™ > News Articles > French Executive Released from Prison to Await Trial over Regulatory Fraud

French Executive Released from Prison to Await Trial over Regulatory Fraud

Posted 30 October 2012 | By

The former executive of a French medical device company accused of manufacturing and selling breast implant products manufactured with sub-standard industrial-grade silicone has been released from jail to await charges of causing involuntary bodily harm and aggravated fraud, reports Reuters.

Jean-Claude Mas, the former head of the now-defunct implant manufacturer Poly Implant Prothese (PIP), was among several executives arrested earlier in the year after regulators linked breast implant products manufactured by the company to higher rates of rupture.

An investigation conducted by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) found, for instance, that the implants were between 200% and 600% more likely to rupture than other approved implants. The difference in rupture rate depended on several factors, the more notable being the age of the implant.

At the time of Mas' arrest, officials said they were considering charging him with manslaughter, but never did.

Still, Mas and six other PIP executives could receive prison sentences of up to five years and court-imposed penalties, to say nothing of the civil suits filed by thousands of affected patients, explained Reuters. Many regulators have urged patients implanted with the company's devices to have them surgically removed or replaced in light of a heightened risk for rupture, though additional testing has not substantiated initial fears that the industrial-grade silicone could be genotoxic.

The trial against the executives could be massive. Reuters reports the facility set to contain the trial can fit between 4,000 and 10,000 people-as much a public spectacle as a trial.

The high level of interest-and shock-in PIP's behavior has also fueled calls for regulatory reforms across the EU. In September 2012, the European Commission released two proposed regulations which would overhaul the way medical devices-and in particular implanted devices-are regulated.

"Just a few months ago, everybody was shocked by the scandal involving fraudulent breast implants which affected tens of thousands of women in Europe and around the world," said then-EU Health Commissioner John Dalli in a statement announcing the changes. "As policy makers, we must do our best never to let this happen again."

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