France tells women to get faulty implants removed

Edward Cody, Washington Post

Friday, December 23, 2011

The French Health Ministry recommended Friday that women with breast implants reported to contain substandard silicone should get them removed, a ruling that affects 30,000 women in France and raises questions for thousands more in other countries.

The ministry said that the operations would be "a preventive measure without an urgent nature" but would be paid for by the French national health system. Replacements also would be paid for if the original implants had been part of reconstruction, such as after cancer surgery, but not if they were done for cosmetic reasons, it said.

The decision by Health Minister Xavier Bertrand came in response to growing concern among plastic surgeons and their patients over breast surgery using implants produced by a now-defunct company in southern France called Poly Implant Prothese. According to French investigators, the company used a relatively cheap industrial silicone for some of its implants to enhance profit.

The substandard pockets of gel were removed from the market last year when the substitution was discovered. Since then, the once-flourishing company has come under attack and is filing for bankruptcy.

It was unclear how many questionable gel pockets were put into circulation around the world, but an estimated 30,000 French women received the suspect implants, authorities said. A group of patients who have investigated the company said tens of thousands were exported to other European countries and South America before the recall was ordered.

The U.S. Food and Drug Administration reported in June that silicone breast implants appeared to be relatively safe for most women, although recipients often have them removed because of leaks, infections and other problems.

The FDA said Friday that Poly Implant Prothese never applied for permission to market its silicone gel-filled implants in the United States. Those implants therefore are not approved for U.S. surgeries, and neither are the company's saline breast implants, the agency said.

Concern flared last month after a French woman who had the questionable implants died of a rare kind of cancer. But the ministry said there was no proof so far that the implants created a greater risk of cancer compared with other types of gel pockets.

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