Jean-Claude Mas, founder of Poly Implant Prothèse (Pip), one of the world’s leading suppliers of breast implants until it was shut down by French authorities in March 2010 for using industrial-grade silicone in its medical devices, continues to maintain that his home-brew silicone gel was no more dangerous than medical-grade materials. The trial, described as the largest in modern French history, got underway in Marseilles on 17 April amid boos from plaintiffs and spectators for Mas and the four Pip executives charged with aggravated fraud.
The septuagenarian repeated what he told gendarmes and the juge d’instruction who led the investigation, reports French daily Le Figaro. “Women who were implanted with Pip prosthetic devices were not at risk,” said Mas, according to the newspaper. “The [Pip] gel is no more dangerous than competing materials. That was shown through biocompatibility tests. All gels can cause irritation but they are not toxic,” said Mas according to Le Figaro.
As the trial continued on 22 May, auditors from the French health authority took the stand to recount their visit to the Pip factory and their discovery of the company’s fraudulent activities. As reported by French newsweekly Le Point, the visit was going well, said one of the auditors, a chemical engineer working for the government body, until he and his colleague were leaving the site and noticed, through the fence, some containers bearing a label for a material they did not recognise. They turned back, but by the time they got back into the factory for a closer inspection of the containers, the labels had been removed. They eventually found the labels, which were for Silop, an industrial-grade silicone that was used to fabricate the Pip gel.
The trial is expected to continue until 17 May.
The Pip implant scandal has had considerable influence on the drafting of Europe’s proposed new medical device regulations, which contain restrictive measures at odds with the “new approach” directives that are currently in force. Conference sessions at MEDTEC UK in London on 1 and 2 May and MEDTEC France on 15 and 16 May will explore these and related regulatory developments.
Background on the Pip implant scandal: