PARIS (Reuters) - The French government urged 30,000 women in France on Friday to seek removal of defective breast implants that a now-defunct company exported worldwide but it said there was no evidence that the product raised the risk of cancer.
The government said public healthcare funds would be used to finance the removals, which were recommended because of the risk of ruptures that could cause inflammation and irritation, at a cost which health officials estimated at 60 million euros.
Around 30,000 women in France have had breast implants made by the company Poly Implant Prothese SA (PIP), which is accused of using industrial-grade silicone normally used in anything from computers to cookware.
PIP, founded by one-time butcher Jean-Claude Mas, produced about 100,000 implants a year before its products were ordered off the market in early 2010.
As many as 300,000 women worldwide may have received PIP implants, which were exported to Latin American countries such as Brazil and Argentina, and Western European markets such as Britain, Germany, Spain and Italy.
Britain said on Friday it was not following the French recommendation and played down any cancer risks.
France has had reports of eight cases of cancer in women with breast implants made by PIP, but health officials stressed at a news conference that the product was not suspected of increasing cancer risk.
A health ministry statement said advice from medical experts showed that: “There is as of now no increased risk of cancer for women using implants of the PIP brand versus other implants.”
The statement addressed to French women said new implants would be paid from public funds in cases where the initial implant was inserted for medical reasons, typically for reconstruction after breast cancer treatments.
Associations representing women with PIP implants have been demanding that all replacements, including cases of implants that were purely cosmetic, be publicly funded.
“This announcement is just a smokescreen and the victims of PIP are angry,” said Alexandra Blachere, head of the association of PIP implant users in France. “PIP implants are dangerous even excluding cancer. The state can’t simply order them to be removed and then leave women to get by afterwards.”
Philippe Courtois, a lawyer for a French association of PIP implant users, gave a cautious welcome to Friday’s government announcement, saying: “It’s a common sense decision even if it unfortunately comes a bit late.”
PIP was placed into liquidation in March 2010 with losses of 9 million euros after the French medical safety agency, AFSSAPS, recalled its implants when surgeons reported abnormally high rupture rates.
During a subsequent inspection of its manufacturing site, officials found PIP was using a type of silicone that was not approved by health authorities, but was about 10 times cheaper.
An investigation found a majority of implants made by PIP since 2001 contained the unapproved gel.
A spokesman for the German company TUV Rheinland which provided quality certification of PIP’s production facilities until March 2010 said its remit was to check the production process not the content of the silicone.
TÜV Rheinland sued PIP in February 2011, claiming it was “thoroughly and continuously misled” by PIP about a change in the silicone that was used.
Authorities in Britain, where women using PIP implants have also announced a court case, also played down any cancer risk.
“Women with PIP implants should not be unduly worried. We have no evidence of a link to cancer or an increased risk of rupture. If women are concerned they should speak to their surgeon,” British Chief Medical Officer Dame Sally Davies said.
More than 2,000 women in France have filed legal complaints and another 250 women have recently done likewise in Britain, where the authorities have stopped short of recommending implant removals and sought to reassure on cancer risks too on Friday.
Several as yet unidentified executives of the company founded by Mas, are expected to face charges of aggravated fraud in an ongoing court case in France, which exposes them to possible sentences of up to five years in prison. French judicial inquiries tends to be extremely protracted and often highly secretive affairs.
The PIP scandal was rekindled in recent weeks by the death of a cancer victim who had such implants, prompting prosecutors to open another preliminary inquiry that will assess whether there are grounds for more serious charges of involuntary manslaughter.
Additional reporting by Alexandria Sage in Paris, Jean Francois Rosnoblet in Marseilles, Kate Kelland in Britain, Ludwig Burger in Frankfurt