French Breast-Implant Maker Defends Unapproved Gel During Trial
Jean-Claude Mas, the founder of Poly Implant Prothese SA, a French breast implant maker whose devices leaked, continued to claim his products are “impeccable” in testimony during a fraud trial in France.
More than 5,000 women have registered as victims in the case, according to Laurent Gaudon, a lawyer for 1,600 of them. PIP’s founder, on trial alongside four of his former colleagues, could face as many as five years in prison and a fine if convicted, Gaudon said. More can join.
“They admit to cheating but they all maintain that for them, the PIP gel isn’t dangerous,” Gaudon said in a telephone interview today from Marseilles, during a pause in the hearing.
Medical authorities in France and Germany, as well as other countries, recommended women have the implants removed after reports that some had leaked industrial-grade silicone inside patients. About 400,000 PIP implants were sold worldwide, from Australia and Brazil to Germany and the U.K. They weren’t approved for use in the U.S.
The trial opened this week in a convention center in Marseilles because the southern French city’s courthouse wasn’t big enough to make room for “hundreds” of women and some 300 lawyers, Gaudon said. An investigation for possible manslaughter is still on-going, he added.
PIP is accused of using unauthorized, cheaper substances in its implants. Former employees told police they knowingly used the unapproved filler, and hid barrels of the substitute and erased evidence from computers to deceive officials during annual inspections by TUEV Rheinland Holding AG (RLV), the German company hired to certify quality control.
TUEV “was the victim of an extraordinarily organized, collective and systematic fraud,” Olivier Gutkes, TUEV’s Paris- based lawyer, said in e-mailed comments today. “The entire company, from the technicians to the management, participated intentionally in the elaboration of the fraud and in its concealment from the authorities.”
TUEV is also participating the trial as a victim alongside the women.
It’s estimated that about 30,000 women in France carried the leaky implants, according to the health-care regulator, National Medicine Security Agency, also known as ANSM. At the end of 2012, 4,061 women in France had the implants removed after detecting unwanted side effects like a ruptured implant or inflammation, ANSM says. Another 10,900 women had the implants taken out as a precaution, according to documents on ANSM’s website, and the agency had been notified of 64 cases of breast cancer among women carrying PIP implants.
One Frenchwoman with PIP implants died in 2011 of breast cancer, the regulator said in its report on the case.
Mas “won’t admit any wrongdoing,” Gaudon said. For him, “his gel is still impeccable; he couldn’t care less” about evidence to the contrary, Gaudon added.
PIP, based in Toulon, was liquidated in March 2010 after French regulators banned the company’s implants. Health authorities around the world were notified about the discovery, prompting medical device regulatory reform in Europe.
Three calls for comment to the office of Mas’s lawyer, Yves Haddad, went unanswered.
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