- Associated Press - Friday, December 23, 2011

PARIS (AP) - France took the costly and unprecedented step Friday of offering to pay for 30,000 women to have their breast implants removed because of mounting fears the products could rupture and leak cheap, industrial-grade silicone into the body.

Tens of thousands of other women elsewhere in Europe and in South America have the same French-made implants, but authorities there have so far refused to follow suit. The silicone-gel implants in question are not sold in the U.S.

Over the past week, the safety fears have created a public furor over something usually kept private, even in France. Women whose own families didn’t know they had their breasts enlarged marched on Paris to demand more attention to worries about what might be happening inside them. Images of leaky, blubbery implants and women having mammograms have been splashed on French TV.

More than 1,000 ruptures pushed Health Minister Xavier Bertrand to recommend that the estimated 30,000 women in France with the implants get them removed at the state’s expense.


Bertrand insisted the removals would be “preventive” and not urgent, and French health authorities said they had found nothing to link the implants to nine cases of cancer in women. The death last month of a woman who had the implants and developed a rare cancer had catalyzed worries.

The implants, made by the French company Poly Implant Prothese, were pulled from the market last year in countries around Europe and South America where they had been sold.

France’s health safety agency says the PIP implants appear to be more rupture-prone than other types. Also, investigators say PIP used industrial silicone instead of the medical variety to save money. However, the medical risks posed by industrial silicone are unclear.

PIP is being liquidated and its executives and lawyer could not be reached for comment Friday.

The financial burden of the French government’s decision falls on the state health care system, which estimated the removals could cost euro60 million ($78 million) at a time when the country is teetering on the brink of another recession and struggling with debt.

In recommending removal, the government noted the risks associated with major surgery and general anesthesia.

Because of those risks, many women may decide against removal. The government said those women should be examined every six months.

After the French decision, Britain’s Medicines and Healthcare Products Regulatory Agency announced that it doesn’t see enough proof of cancer or an excessive risk of rupture to recommend women in Britain have the implants removed. Up to 40,000 women in Britain may have had the implants, even more than in France.

Britain’s chief medical officer, Sally Davies, said women “should not be unduly worried.”

“While we respect the French government’s decision, no other country is taking similar steps because we currently have no evidence to support it,” she said.

The president of Brazil’s Plastic Surgeons Association, Jose Horacio Aboudib, said it would be premature to have women remove the implants if they are not having any problems. About 25,000 women in Brazil received PIP implants.

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