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Friday, 23 December 2011

France recommends removal of PIP breast implants


Tens of thousands of women in France, Britain and other countries are awaiting French government guidance Friday on what to do about their breast implants, which may be unsafe.

French health authorities are expected to make an unprecedented move to urge women with silicone gel implants made by French company Poly Implant Prothese to get them removed at the state`s expense, because of the risks that they could rupture and leak a questionable type of silicone gel into their bodies.


It`s unclear how far the French recommendations will go, and how much the extreme measures could cost the government as it teeters toward a new recession.

Britain, Italy, Spain, Portugal and other countries in Europe and South America are keeping a close eye on the French decision, which could have repercussions on their health guidance, too.

Women who have had their implants burst and leading French plastic surgeons are urging the government to act. The death last month of a woman who had the implants and developed a rare cancer catalyzed worries, though authorities have not reported any confirmed link between the implants and increased cancer risk.

About 2,000 Frenchwomen given pre-filled silicone gel implants made by Poly Implant Protheses, or PIP, have filed legal complaints against the company, based in southern France. Investigators say it saved 1 million euros a year by using industrial silicone instead of more expensivfe silicone meant for medical use in the implants.

The French government ordered a halt to production 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 after cancer in 1999, and was given a PIP implant.

After the product was recalled last year, a mammogram and ultrasound did not reveal any problem with her implant. But she had it removed anyway, at her own expense, out of fear. When her surgeon took it out and studied it, "he discovered it had already burst."

Among measures being studied Friday is one ordering plastic surgeons to reduce their fees for implant removal. The state health care system only reimburses about 230 euros for such an operation, but most plastic surgeons in France are private practitioners who can charge five to 10 times more than that for a removal.

Replacement implants are also an open question. Women with implants replacing cancer-damaged breasts should get reimbursed for new ones, but they make up a minority of women with implants. Surgery for solely cosmetic purposes is not normally covered by French state health care.

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

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

The ministry`s health council also said the national health system would pay to have the implants removed if medical conditions required it, such as if they ruptured.

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

British health authorities say 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.

The implants in question were not sold in the U.S., where concerns about silicone gel implants in general led to a 14-year ban on their use. Silicone implants were brought back to the market in 2006 after research ruled out cancer, lupus and some other concerns.

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