FRENCH health authorities say 20 cases of cancer have been uncovered in women with allegedly faulty French-made breast implants, but insisted there was still no proven link with the disease.
The announcement came as France’s state health insurance fund said it had filed a fraud complaint against manufacturer Poly Implant Prothese (PIP), which sold hundreds of thousands of implants made with sub-standard silicone gel around the world.
French consumer health agency AFSSAPS said that as of December 28 it had registered 15 cases of breast adenocarcinoma, the most frequent form of breast cancer; one case of breast lymphoma; two cases of other lymphoma; one case of lung cancer; and one case of acute myelogenous leukaemia in women with the implants.
French authorities earlier this month advised 30,000 women to have PIP implants removed because of an increased risk of rupture, but said no direct link with cancer had been found.
AFSSAPS stressed again on Friday: “No link has to this day been established between cases of cancer and having PIP implants.”
Health officials had earlier said eight cases of cancer had been registered in women with the implants, including one woman who died from a rare form of large cell lymphoma.
AFSSAPS said it had also registered 1143 ruptures and 495 inflammatory reactions in PIP implants.
Between 300,000 and 400,000 women in 65 countries from Europe to Latin America have received implants made by PIP, once the world’s third-largest producer of silicone implants.
PIP was shut down and its products banned in April 2010 after it was revealed to have been using non-authorised silicone gel that caused abnormally high implant rupture rates.
Prosecutors in Marseille said France’s National Health Insurance Fund (CNAM) had filed a complaint for aggravated fraud over the scandal.
The prosecutors’ office said the case being taken by the CNAM would allow it “to possibly demand compensation”, adding that its complaint would be jointly investigated with others.
Prosecutors in Marseille, near PIP’s laboratory at Seyne-sur-Mer on the Mediterranean, have received more than 2500 complaints from French women who received the implants and are pursuing a criminal investigation.
French authorities have agreed to pay to have the implants removed and said the cost could reach 60 million euros ($A77 million).
In Italy, where an estimated 5000 women received PIP implants, prosecutors in Turin have also opened a criminal investigation against firm founder Jean-Claude Mas.
Mas, 72, is under investigation on charges of “commercial fraud” and “sale of products hazardous to health”, the ANSA news agency reported.
It also emerged on Friday that Mas and his children were in the process of creating a new company to take over PIP’s operations when the implant scandal erupted.
Local newspaper Nice-Matin reported that Mas and his children, Nicolas and Peggy Lucciardi, had in June founded a new company to restart the implant manufacturing business.
France Implant Technologie (FIT) was registered under the names of Nicolas Lucciardi, 27, and Peggy Lucciardi, 24, at the address of their mother, Dominique Lucciardi, who was Mas’s former civil partner.
In a business plan for FIT obtained by Nice-Matin, Mas is named as a “technical-commercial consultant” to the company and its objectives are listed as exporting implants on the “European, South American and Chinese markets”.
According to PIP’s 2010 bankruptcy filing, it had exported 84 per cent of its annual production of 100,000 implants.
Authorities in other countries have advised women to consult their doctors over the implants, while some nations, including Bolivia and Venezuela, have said that in some cases the implants will be removed for free.
In Brazil, the National Agency for Sanitary Surveillance (ANVISA) on Friday withdrew its health authorisation for the implants, the sale of which had already been suspended since 2010.
Brazil had imported 34,631 of the implants, including 24,534 sold before the 2010 suspension.
Mas has admitted through his lawyer that the company used non-standard silicone gel but insisted there is no evidence of any health risk.