France ‘criminal’ in advising implant removal
Paris, January 18, 2012
The founder of a French company at the heart of an international health scandal acknowledged on Wednesday that he had used unapproved silicone in breast implants, but said France's recommendation for women to have them removed was "criminal".
The scandal erupted in December when the French government advised 30,000 women to have PIP implants removed because of reports that they were more prone to rupturing than standard medical implants. Concern focused on last year's death from cancer of a French woman with PIP implants.
In a brief but defiant interview with RTL radio, Jean-Claude Mas, founder of Poly Implant Prothese (PIP), said he had never denied that his home-made silicone gel was not approved by regulators, and scoffed at the idea that it was a health risk.
Countries such as Britain, Brazil or Argentina where the protheses were also sold, did not share France's recommendation.
There was "no medical, scientific reason" to believe the industrial-grade gel PIP used to fill its protheses was toxic, Mas said, saving his harshest words for French Health Minister Xavier Bertrand.
"This man has decided to reimburse patients even though there was no medical reason to do so," said Mas. "Why pay for women's explantations where there is a real surgery risk? This decision is criminal."
France said it would cover the cost for explantations of PIP implants in French women and pay for the implantation of new protheses in women who received implants after breast cancer.
Some 300,000 implants were sold around the world by the French company located in the south of France, once the third-largest global seller of breast protheses, before regulators shut it down in March 2010. The company is now in bankruptcy.
Health officials say PIP used a non-medical grade silicone to fill its implants without disclosing that to regulators.
No one has been charged in the case, but a judicial source has told Reuters that between four to six PIP managers will face a Marseille court in October for fraud and deceptive business practices.
A separate investigation into possible involuntary homicide was opened last month following the 2010 cancer death of a woman with PIP implants.
Asked about the industrial-grade ingredients used in PIP's homemade silicone gel, Mas said "a chemical product can be used to make lots of things."
France's medical device regulator AFSSAPS has said that PIP implants ruptured at higher rates than other manufacturers' products. The silicone gel that leaked out of their coverings, or envelopes, cause irritation and inflammation, AFSSAPS said. – Reuters