France ponders removing risky breast implants
Wednesday, December 21, 2011
PARIS (AP) — French health authorities are considering whether to suggest that an estimated 30,000 women in France get their breast implants removed, amid warnings by leading doctors about risks of rupture and possible cancer risks.
The decision could have repercussions outside France, too. Tens of thousands of women in Britain and other countries also have the pre-filled silicone gel implants made by French company Poly Implant Prothese, or PIP. British health authorities say they see no reason so far to get them systematically removed.
Experts from the French Health Ministry will meet Friday to decide what to recommend for women who have the implants, ministry officials said Wednesday.
More than 1,000 of the implants have ruptured, according to the French health and safety agency AFSSAPS, and eight women with the implants have developed cancer. The implants were taken off the market last year after French authorities discovered the company misreported what form of silicon they contain.
Friday's decision will depend partly on guidance from the French National Cancer Institute, which is studying whether there are links between the implants and the cancer cases.
Doctors studying the implants want all women to be able to remove them to avoid future problems, and want the government to foot the bill.
"We have worried for more than a year. 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 Dominique-Michel Courtois, a doctor for an association of victims of medical accidents.
He said he expects French authorities to issue a recommendation that they be removed on a voluntary basis.
Such a recommendation would impose substantial costs to France's state health care system and poses logistical challenges in finding enough surgeons to perform the operations.
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. Roughly 20 percent of French women with the implants got them for medical reasons, primarily after breast cancer.
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 €1 million ($1.3 million) a year.
Representatives for PIP, based in the southern French town of La Seyne-sur-Mer, did not immediately return phone calls or an email message seeking comment.
Some 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 would continue to work with French health authorities and "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."
Jill Lawless in London contributed to this report.