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French firm linked to cheap, risky breast implants

Emmanuelle Maria's breasts were burning and globules of silicone gel were protruding into her armpits. Her implants had exploded inside her. Yet her doctors, she says, told her nothing was wrong.
Dr. Maurice Mimoun, a plastic surgeon at the St Louis hospital, holds silicone gel breast implants made by French company Poly Implant Prothese, or PIP, that he removed from a patient because of concerns that they are unsafe.
Dr. Maurice Mimoun, a plastic surgeon at the St Louis hospital, holds silicone gel breast implants 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
/ Source: The Associated Press

Emmanuelle Maria's breasts were burning and globules of silicone gel were protruding into her armpits. Her implants had exploded inside her. Yet her doctors, she says, told her nothing was wrong.

Now, she wants the French government to tell 30,000 women to get their implants removed — at the state's expense — to call attention to their risks and save others from potential pain and indignity.

Prompted by calls from implant wearers and leading doctors, French health authorities are considering a drastic and unprecedented move: recommending mass surgery to rid the country of a type of breast implant that investigators say was secretly made with cheap industrial silicone whose medical dangers remain unclear.

Governments around Europe are hanging on France's decision Friday. Tens of thousands more women in Britain, Italy, Spain and other European nations are walking around with the same pre-filled implants, made by the now-defunct French company Poly Implant Prothese, or PIP.

Health officials from several European countries held a conference call Wednesday to discuss the implants, Portugal's Director-General of Health, Dr. Francisco Jorge, told The Associated Press. European Commission spokesman Frederic Vincent said no decisions were made, but France informed the others of the situation.

The main concern in France is the risk of rupture — more than 1,000 of the 30,000 such implants in France have burst, according to the French health safety agency AFSSAPS — and uncertainty over what risks the suspected industrial silicone gel could pose when it leaks inside the body.

Meanwhile, eight cases of cancer among women with the implants, including one who died in November, have crystallized concerns and heightened pressure on the government to take action. Friday's government decision will depend partly on guidance from the French National Cancer Institute.

The implants in question were not sold in the U.S., where concerns about silicone gel implants overall 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.

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. Italy's Health Ministry is holding a meeting Thursday to discuss the French-made implants.

Experts from the French Health Ministry will meet Friday to decide what to recommend for women who have the implants. The implants were taken off the market last year after French authorities discovered the company misreported the type of silicone used.

Plastic surgeon Maurice Mimoun of Paris' Saint Louis Hospital said a rupture could leak the silicone gel internally. That in turn could require surgery on other parts of the body to remove it.

"The problem is that these implants are made with a gel that we don't know," he said in an interview. "Once these implants are removed, the story is not over ... we don't know" if there might be other consequences, he said.

Mimoun has recommended that the government push for implant removals, but insisted that the operations needn't be carried out in haste.

Women have filed more than 2,000 legal complaints since the implants were recalled last year, and an investigation into officials at PIP is under way. Investigators suspect the company used cheaper industrial silicone instead of silicone meant for medical use in the implants, cutting costs by up to euro1 million ($1.3 million) a year.

The company has suspended its activities and is being liquidated. Its phones are no longer functioning and emails sent to its staff were not answered.

Implant wearer Maria described wanting new breasts to improve her self-image after an adolescence troubled by a bone disease that left her covered in scars.

She was given the PIP silicone implants in 2007, and started developing burning pains in early 2010. She consulted her surgeon and another specialist he recommended. "They told me, 'There's nothing wrong,'" she recounted.

She then went to two other doctors who confirmed that both implants had burst. She had them removed, and at her own expense, had two new ones implanted — made by another company.

"The product is dangerous. They told us there was nothing toxic," she told The Associated Press by telephone from her office in La Seyne-sur-Mer in southern France — the same town where PIP was based.

She accused the company and surgeons of "playing Russian roulette with the health of others."

Tina, a retired Frenchwoman who had her PIP implants removed earlier this year, didn't experience any pain when they ruptured, but said she now worries about what might have leaked into her body in the months she lived unwittingly with the burst implants.

"It's time for surgeons to admit that these implants pose special risks. What we need is a bit of humanity," she said, embarrassed by her ignorance of the dangers and frustrated that doctors didn't warn her about the PIP implants after they were recalled last year.

She didn't want her last name used because some people in her entourage do not know that she had her breasts augmented.

Recommending implant removal for all 30,000 Frenchwomen with these artificial breasts would impose substantial costs to France's state health care system and pose logistical challenges in finding enough surgeons to perform the operations.

The French health system does not pay for cosmetic breast implants, which make up the majority of breast operations, but government spokeswoman Valerie Pecresse said state health care would pay for implant removal operations "if it involves a health and public safety emergency."

It is unclear, however, whether the state would pay for replacement implants. About 40,000 women in Britain are believed to have the PIP implants as well. Britain's Medicines and Healthcare Products Regulatory Agency said its own testing had found no evidence of toxicity in the PIP implants and no evidence to suggest that women should have them removed.

But the agency said in a statement it "will consider any new evidence which comes to light as a priority."

The British Association for Plastic, Reconstructive and Aesthetic Surgeons said the expected announcement by French medical authorities was "a precautionary measure."

"Surgeons will be in contact with any patient who has received this type of implant if any action is required," it said. "If women are worried or believe that their implants may have ruptured, they should contact their implanting surgeon."

The Italian Health Ministry says it is monitoring the "possible health risks linked to the PIP implants signaled by the French authorities" and it has convened a meeting of its top level health experts for Thursday.

Portugal's General Directorate for Health estimates 1,500-2,000 Portuguese women had the implants and is advising them to visit their doctor for a checkup, Jorge said.

In Denmark, authorities says less than 100 women had these breast implants and the Danish Medicines Agency is in close contact with French authorities.

The French company used to sell saline-filled implants in the United States but its authorization was revoked after a re-evaluation by the Food and Drug Administration in 2000, mainly because of what the FDA deemed incomplete studies.


Lauran Neergaard in Washington, Jill Lawless in London, Frances D'Emilio in Rome, Barry Hatton in Lisbon, Ciaran Giles in Madrid, Jan Olsen in Copenhagen contributed to this report.