December 23, 2011Health minister says operations needed to prevent implant rupture, which leaks silicone gel into wearer's body.Tens of thousands of women with risky, French-made breast implants should have them removed at the state's expense, France's health minister has recommended, in an unprecedented move that could have implications across Europe and South America.
Tens of thousands of women with risky, French-made breast implants should have them removed at the state’s expense, France’s health minister has recommended, in an unprecedented move that could have implications across Europe and South America.
Xavier Bertrand said on Friday 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 $78m at a time when the country is teetering on a brink of a new recession and struggling to tame state debt.
Global police agency Interpol, meanwhile, issued a “red notice” seeking the arrest of Frenchman Jean-Claude Mas, the founder of PIP (Poly Implant Prosthese).
Investigators say the company PIP 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 only 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 US.
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 on 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.
Annie Mesnil, who had a PIP implant to replace a breast removed after cancer in 1999, said: “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 per cent of those with the PIP silicone implants have them for aesthetic reasons.
Photo by: AP/ Michel Euler