Dec. 21, 2011
France ponders removing recalled breast implants
by ANGELA CHARLTON - The Associated Press
PARIS - Emmanuelle Maria's breasts were burning and globules of silicone gel were protruding into her armpits. Her implants had ruptured. Yet her doctors, she says, told her nothing was wrong.
Now she and a group of leading plastic surgeons want the French government to tell 30,000 women to get their implants removed , at the state's expense.
Prompted by the calls, French health authorities are considering an unprecedented move: recommending that all women with the now-banned breast implants undergo surgery to remove them. Investigators say the implants were made with cheap industrial silicone whose medical dangers remain unclear.
Governments around Europe are awaiting France's decision Friday. Tens of thousands more women in Britain, Italy, Spain and other European nations are walking around with the same implants, made by the now-defunct French company Poly Implant Prothese, or PIP.
The main concern in France is the risk of rupture, as well as uncertainty over what risks the suspected industrial silicone gel could pose when it leaks inside the body. Of the more than 30,000 women who have the implants, more than 1,000 have suffered ruptures, according to the French health safety agency AFSSAPS.
Eight cases of cancer among women with the implants, including one who died in November, have heightened pressure on the government to act, and Friday's decision will depend partly on guidance from the French National Cancer Institute.
The implants in question were not sold in the United States, where concerns about silicone gel implants overall led to a 14-year ban on their use. Silicone implants were brought back on the market in 2006 after research ruled out cancer, lupus and some other concerns.
All implants , not just this brand , have a risk of rupture. The U.S. Food and Drug Administration recommends regular MRI checks for ruptures and French health officials also recommend regular screening.
PIP implants were taken off the market last year after French authorities discovered the company misreported the type of silicone used.
British health officials say they see no reason so far to have the French-made implants systematically removed, and have said 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.
Dr. Maurice Mimoun, a leading plastic surgeon at Paris' Saint Louis Hospital, said a rupture could cause silicone gel to leak to other parts of the body.
"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 said 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 say the company used cheaper industrial silicone instead of silicone meant for medical use in the implants, cutting costs by up to $1.3 million (euro1 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.
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 said.
She then went to two other doctors who confirmed that both implants had ruptured. She had them removed, and paid for two new ones , 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."
"We have been trying for more than a year to ensure that women with these implants can have them removed without having financial difficulties," said Dr. Dominique-Michel Courtois, a medical adviser to an association created to help women like Maria who have had problems with PIP implants.
Tina, a retiree 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.
She said she was 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 no one outside her immediate family knows that she had her breasts augmented.
Recommending implant removal for all 30,000 women in France with these artificial breasts would impose substantial costs to France's state health care system.
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.
Health officials from several European countries held a conference call Wednesday to discuss the issue, Portugal's director-general of health, Dr. Francisco Jorge, told the AP.
About 40,000 women in Britain are believed to have PIP implants. Britain's Medicines and Healthcare Products Regulatory Agency said its own testing had found no evidence of toxicity in the 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."
"Surgeons will be in contact with any patient who has received this type of implant if any action is required," the British Association for Plastic, Reconstructive and Aesthetic Surgeons said. "If women are worried or believe that their implants may have ruptured, they should contact their implanting surgeon."
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.
PIP 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 and Barry Hatton in Lisbon contributed to this report.
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