France recommends removal of risky breast implants
PARIS - December 23, 2011 (WPVI) -- Tens of thousands of women with risky, French-made breast implants should have them removed at the state's expense, France's health minister recommended Friday, in an unprecedented move that could have implications across Europe and South America.
Xavier Bertrand said the mass removals were "preventive" and not urgent, and French health officials said analyses so far have found no link between the pre-filled silicone gel implants and nine cases of cancer among women implanted with them.
But Bertrand, in a statement, cited an unusually high risk that the implants could rupture and leak a questionable type of silicone gel into the wearer's body.
Health authorities in Britain - where even more women have the implants than in France - said Friday that for now they see no reason to take similar action.
Questions remain about the logistics and final costs of the removals. Francois Godineau, a top official in the French national health service, estimated it could deplete French government coffers by euro60 million ($78 million) at a time when the country is teetering on a brink of a new recession and struggling to tame state debt.
Investigators say the company Poly Implant Prothese used cheaper industrial silicone for the implants instead of medical silicone to save money. The implants were pulled from the market last year and the company is being liquidated.
"As a preventive measure not of an urgent nature, (French authorities) recommend that the removal of these implants, even those not showing signs of deterioration, be proposed," the statement said. It added that the costs of removal would be footed by France's national health care system - presumably solely for French patients.
One reason for the drastic measure is the uncertainty about the contents of the silicone gel used and the risks it poses to internal organs. Also, standard mammograms and ultrasounds do not always indicate that an implant has ruptured, and many women may be walking around unknowingly with burst implants.
Some 30,000 of women in France, and tens of thousands more in Britain, Italy, Spain, Portugal and other countries in Europe and South America have had implants made by PIP. The implants in question were not sold in the U.S.
All breast implants are subject to rupture, especially as they get older, and patients are meant to be informed of the risks before getting them put in.
But "these implants have a particular fragility" and appear to pose risks of rupture earlier in their life spans than other implants, Jean-Claude Ghislain of French health agency AFSSAPS, told a news conference Friday.
Removal of the implants can require general anesthesia and other risks associated with major surgery. The government recommendations say women who don't want to get them removed should be examined every six months.
Leading French plastic surgeons had been urging the government to act. The death last month of a woman who had the implants and developed a rare cancer catalyzed worries.
Annie Mesnil, who had a PIP implant to replace a breast removed after cancer in 1999, said she was relieved that the Health Ministry "accepts the idea that there is a potential danger."
But, she added, "It's not enough. They will pay for the removal of the implants, but they will not pay for the replacements."
France's state health care system normally pays for implants for medical reasons, but not for cosmetic implants. About 80 percent of those with the PIP silicone implants have them for esthetic reasons.
After the PIP product was recalled last year, a mammogram and ultrasound did not reveal any problem with Mesnil's implant. But Mesnil, 62, had it removed anyway, at her own expense, out of fear. When her surgeon took it out and studied it, "he discovered it had already burst," she said.
Chantal Guerin, a 46-year-old accountant and mother of three, had her left breast removed after cancer and had PIP implants put in both breasts. In 2010, she developed cancer in her right breast.
"One cannot directly incriminate the implant, since there is no scientific proof," she said in an interview. "But we have the right to ask ourselves a lot of questions, because there is a great amount of physical pain involved."
She insisted that women who have implants for cosmetic reasons should also be protected by government health care.
Following the French announcement, Britain's Medicines and Healthcare Products Regulatory Agency said it was still not recommending that women in Britain have the implants removed. The agency says up to 40,000 women in Britain may have had the implants.
"We recognize the concern that some women who have these implants may be feeling but we currently have no evidence of any increase in incidents of cancer associated with these implants and no evidence of any disproportionate rupture rates other than in France," it said in a statement.
"We therefore do not believe that the associated risks of surgery from breast implant removal can be justified without further evidence."
In the U.S., concerns about silicone gel implants in general led to a 14-year ban on their use. Silicone implants were brought back to the market in the U.S. 2006 after research ruled out cancer, lupus and some other concerns.
Jill Lawless in London, Ingrid Rousseau and Catherine Gaschka in Paris contributed to this report.
surgery, france, healthcheck
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