Five executives from the defunct French breast implant company Poly Implant Prothèse (PIP) have been sentenced for their roles in concealing a substandard product, a practice that that led to global hysteria and Europe's movement toward tougher medical device regulation once word got out.
As Reuters reported, disgraced PIP founder and CEO Jean-Claude Mas got the worst punishment--four years in prison--following a two-month trial in April and May that accommodated thousands of plaintiffs, 300 lawyers and plenty of jeers when Mas testified.
It's not as if Mas denied wrongdoing. According to the story, he acknowledged the company's silicone never obtained regulatory approval for medical use, though it was, in fact, much cheaper. Reuters noted that he insisted the gel was safe, though police eventually determined that PIP intentionally concealed the ingredients used to make the silicone. Besides Mas, four other executives have also been sentenced. Prison terms for them range from one and a half to three years in prison. The article explained that some defendants were given suspended sentences and also fined.
While health experts have downplayed the risk of PIP implants causing breast cancer, thousands of women in countries around the world have rushed to have those implants removed. Reuters said that close to 15,000 women in France, for example, have had their PIP implants taken out, as per French regulatory recommendations, and 25% had already ruptured. France and Venezuela health officials said that women who had their PIP implants taken out could obtain reimbursement, Reuters said. In Britain, regulators have simply urged patients to get their implants checked, but some are pressing for a stronger response as in the other countries.
In France, a recent investigation slammed French regulators for not taking the substandard breast implants off the market as early as 2007, three years before they actually did. The PIP scandal also sparked a Europe-wide movement to toughen the region's medical device regulatory process. Those proposed changes are now working their way through the EU's legislative systems and bureaucracy.
- read the Reuters story