PARIS — 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 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. Questions remain about the logistics and final costs of the removals.
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. Health authorities in those countries have been following the French decision closely and could make similar recommendations, too. 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.
Women who have had problems with PIP implants and 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.
Lawyer Philippe Courtois, who represents several women who filed a legal complaint against the company, said Friday's announcement is "a decision that makes sense, even if we've been waiting for it since last year."
"I don't know what might be inside of me," said Annie Mesnil, 62, who had a breast removed after cancer in 1999, and was given a PIP implant.
After the product was recalled last year, a mammogram and ultrasound did not reveal any problem with her implant. But she 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."
Health officials from several European countries held a conference call Wednesday to discuss the implants.
The health council of Italy's health ministry held an emergency session Thursday and asked hospitals to track down women who received silicone implants made by PIP. The ministry estimates that about 4,000 PIP implants are in use in Italy.
The ministry's health council also said the national health system would pay to have the implants removed if medical conditions required it, such as if they ruptured.
British health authorities said earlier this week they saw no reason so far to have the French-made implants systematically removed, and have said that there is not enough evidence of a link between silicone implants and cancer.
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.