France’s national health insurance agency will file a criminal complaint in a breast implant scandal, an official said Saturday, after authorities recommended that women with potentially faulty implants have them removed and agreed to pay for the procedure.
The agency will file the complaint for deception and fraud in the coming days, according to the official, who spoke on condition of anonymity citing policy. It will most likely not name specific people or the company behind the implants, though specific targets could be added later.
“It now appears pretty clear that these breast implants did not meet the specifications imposed for these products,” the insurance agency’s director, Frederic Van Roekeghem, told France Info radio. “That will surely have damaging consequences for the patients ... and there will be a significant cost for social security also and so in this context it’s normal and natural for us to file a complaint.”
He added that a civil suit would also likely follow.
The implants, made by now-defunct French company Poly Implant Prothese, were pulled from the market last year in countries around Europe and South America amid fears they could rupture and leak silicone into the body.
France’s health safety agency says the implants appear to be more rupture-prone than other types. Also, investigators say PIP used industrial silicone instead of the medical variety to save money. However, the medical risks posed by industrial silicone are unclear.
The state health system has estimated the removals could cost €60 million ($78 million). Roekeghem said insurance would also pay for replacement implants; he appeared to mean for women who had breast reconstruction surgery after cancer — a procedure covered by insurance.
Fears about the safety of implants grew into a public furor over the past week, when women marched in Paris and governments spoke out about the implants.
France went the furthest, recommending Friday that the estimated 30,000 women in France with the implants get them removed after more than 1,000 ruptures.
Health Minister Xavier Bertrand insisted the removals would be “preventive” and not urgent, and French health authorities said they had found nothing to link the implants to nine cases of cancer in women. The death last month of a woman who had the implants and developed a rare cancer — anaplastic large-cell lymphoma — had catalyzed worries.
On Saturday, Bertrand said that those responsible for the implants must “answer for their acts.”
“They were looking to make money, that’s the worst thing, on the back of the health of women,” he told Europe 1 radio.
Much attention has focused on the director of the company, Jean-Claude Mas, after it was discovered that he is on Interpol’s most-wanted list. But the international policy agency clarified Saturday that its “red notice” was issued in June at the request of Costa Rica, where he faces a drunken driving charge.
“Interpol has never launched an ‘international manhunt’ for Mr. Jean-Claude Mas for the above charge or any other charge,” the agency said in a statement.
The agency said the notice was like “thousands of others” in which a member-country asks Interpol to alert other countries that a given person is wanted for arrest.
After the French decision, Britain’s Medicines and Healthcare Products Regulatory Agency announced that it doesn’t see enough proof of cancer or an excessive risk of rupture to recommend women in Britain have the implants removed.
Medical authorities in Brazil said it would be premature to recommend removal and officials in Argentina and Venezuela called closer monitoring of women who have the implants.
PIP’s website said it exported to more than 60 countries and was one of the world’s leading implant makers. The silicone-gel implants in question are not sold in the U.S.