After the scare that some French breast implants may be faulty and may need removal at the government's expense the national health insurance agency will file a criminal complaint. The implants, made by now-defunct French company Poly Implant Prothese (PIP), 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.
The agency will file the complaint for deception and fraud, according to an official who spoke on condition of anonymity. 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, said. “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.”
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 $78 million. Roekeghem said insurance would also pay for replacement implants for women who had breast reconstruction surgery after cancer.
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 concerns and fears.
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.
PIP's website said it exported to more than 60 countries. The U.S. Food and Drug Administration sent an investigator to inspect a plant run by the manufacturer, Poly Implant Prothese (PIP), at La Seyne Sur Mer in southeastern France in May 2000. Shortly afterwards, the FDA sent the company's founder, Jean-Claude Mas, a warning letter saying the implants were “adulterated” and citing at least 11 deviations from good manufacturing practices.
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