France suggests removal of risky breast implants

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 on Friday, adding that such removals were "preventive" and not urgent.

While implants made by Poly Implant Prothese SA (PIP) have not been linked to an increased incidence of cancer, the risk that they could rupture and leak a questionable type of silicone gel has been shown, Xavier Bertrand said in a statement.

"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 will be footed by France's national healthcare system - presumably solely for French patients.

Some 30,000 of women in France, Britain, Italy, Spain, Portugal and other countries in Europe and South America have received PIP implants. Health authorities in those countries have been following the French decision closely and could possibly make similar recommendations. The implants in question were not sold in the United States.

Women who have had their implants burst 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 concerns.

About 2,000 French women who were given pre-filled silicone gel implants that were made by PIP have filed legal complaints against the company. Investigators said PIP saved 1 million euros ($1.3 million) a year by using industrial silicone instead of the more expensive silicone meant for medical use.

The French government ordered a production halt of the implants last year and the company is being liquidated.

The main concern of doctors and patients is the uncertainty surrounding the risks of the silicone used.

"I don't know what might be inside of me," said Annie Mesnil, 62, who had a breast removed because of cancer in 1999 and was given a PIP implant.

After the product was recalled last year, a mammogram and ultrasound did not reveal any problems with her implant. She had it removed anyway, at her own expense, out of fear.

When her surgeon took it out and studied it, "he discovered that it had already burst".

Health officials from several European countries held a conference call on Wednesday to discuss the implants.

Italy's health council held an emergency session on Thursday to discuss the pending French decision and asked hospitals to track down women who had received silicone implants that were made by PIP. The ministry estimates that about 4,000 PIP implants were used in Italy.

The health council also said the national health system will pay to have the implants removed if medical conditions required it.

While saying there was no proof of a greater risk of cancer among women with PIP implants, the council suggested that women with the implants contact their surgeons because of a "greater probability of rupture and inflammatory reaction".

British health authorities said they see 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 US, concerns about silicone gel implants in general led to a 14-year ban on their use. However, silicone implants were brought back to the US market in 2006 after research ruled out cancer, lupus and some other concerns.

Associated Press