France recommends removal of substandard breast implants


Dr. Maurice Mimoun, a plastic surgeon at the St. Louis hospital, holds a silicone gel breast implant made by French company Poly Implant Prothese, or PIP, that he removed from a patient because of concerns that they are unsafe. (Michel Euler/AP)
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 in a statement 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 profits.

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 in the process of 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.

The overwhelming majority of French women who had the potentially faulty implants decided on the operation for cosmetic reasons, meaning their surgery for replacements will be at their own expense. It was not known how many women in other countries had the surgery for reconstruction after accidents or cancer operations, but most women around the world decide on the surgery for aesthetic reasons.

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.

“However, the well-established risks linked to these devices are ruptures and the capacity for irritation from the gel, which could lead to inflammatory reactions that would make removal difficult,” the ministry added.

The French government health security agency, AFSSAPS, reminded the public that all breast implants are subject to the danger of rupture. But the AFSSAPS evaluation director, Jean-Claude Ghislain, told a news conference that the gel pockets made by Poly Implant Prothese were believed to be more likely than others to break open.

Women who choose not to have their implants removed, the statement said, should get breast exams every six months. “Any rupture, and suspicion of rupture or leakage from a device, should lead to its removal as well as the removal of the second device,” it said.

In Britain, the Medicines and Healthcare Products Regulatory Agency advised concerned women to consult their doctors but said there was no need for “routine removal” of Poly Implant Prothese (PIP) breast implants.

In a statement Friday, the agency said its regulators conferred with experts from France, the Netherlands, Portugal, Italy, Ireland, Hungary, Austria, Denmark and Malta. “They all agreed that there was no evidence of any increase in incidents of cancer associated with PIP breast implants and no evidence of any disproportionate rupture rates other than in France.”

In Britain, roughly 1 percent of women’s PIP breast implants have failed, compared with 5 percent in France, the agency said.

In the United States, the FDA has no information at this point on American women who may have received the implants in other countries. The agency also is unaware of any black-market sales of PIP implants in the United States, said Erica Jefferson, an FDA spokeswoman.

But women should know that silicone gel-filled breast implants of any kind are not lifelong devices, she said. The longer a woman has them, the more likely she is to experience complications. 

Women who have experienced any serious side effects related to breast implants should report their problems to the FDA’s MedWatch Adverse Event system, Jefferson said.

Correspondent Karla Adam in London and staff writer Dina ElBoghdady in Washington contributed to this report.

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