While trying to dampen fears that the implants were linked to any kind of cancer, the French health minister, Xavier Bertrand, recommended that recipients have an “explant” procedure as a preventive, nonemergency measure, even if there were no clinical indications that the implants had been leaking substandard silicone. Medical experts said they were unable to think of any prior action on implants on the scale of the French decision.
The implants — made by a French company, Poly Implants Proth?ses, that was closed last year — used an inferior, industrial-grade silicone and are more likely to rupture or ooze than those made from surgical silicone. The French authorities stressed that the leaked gel carries no known link to cancer, focusing instead on how it can irritate body tissues and cause damaging inflammation.
Questions over how low-grade silicone could have gone undetected in hundreds of thousands of implants sold in Western Europe, Australia and South America come on the heels of France’s largest public health scandal in years. That involves a diabetes medication, Mediator, that was also used as a diet drug. It remained in circulation despite at least a decade of warnings, and health officials say it may have caused as many as 2,000 deaths. The maker, Servier, has been charged with defrauding the health-care system and is being investigated for consumer fraud and manslaughter.
No PIP implants were known to have been used in the United States, but there are concerns over an unknown number of women who traveled to South American for less-expensive implants. So far, no country has reported a rupture rate as high as France’s — 5 percent — and most have issued statements meant to reassure implant recipients.
Anxieties rose sharply last month when a French woman whose implant had ruptured died from a rare cancer called anaplastic large-cell lymphoma, and French media reported that she was the eighth woman with the PIP implants to have died of cancer, a figure for which the statistical significance is unclear.
On Friday, the health authorities in Britain, where some 40,000 women received the implants, said it was not recommending “routine removal. ”
“We recognize the concern that some women who have these implants may be feeling, but we currently have no evidence of any increase in incidents of cancer associated with these implants and no evidence of any disproportionate rupture rates other than in France,” the British agency said in a statement.
In Brazil, where about 25,000 implants were used, the National Agency of Sanitary Vigilance recommended that recipients be examined by their doctors. Chile’s Public Health Institute asked doctors who performed implants to contact patients to explain the emerging concerns.
The healthy ministry in Venezuela, one of the region’s largest plastic surgery markets, did not comment, nor did that in Colombia, where nearly 15,000 women have had PIP implants.
Breast implants have had a contentious history, with critics saying they are overused and that women in the pursuit of a narrowly defined ideal of beauty end up subject to uncertain dangers from silicone leaks, including auto-immune problems and what animal studies suggest are possible links to cancer. In the United States, a 14-year moratorium in the United States on all silicone implants was lifted only in 2006, after two decades of litigation in American courts failed to show a conclusive link to cancer in humans. The United States Institute of Medicine and the Food and Drug Administration eventually determined that there was no evidence that standard silicone implants were harmful.
A spokeswoman for the French health products safety agency, known as Afssaps, said it was possible that the rupture rates in other countries were lower because reporting was still low, or because complaints had not yet reached some governments.
“We began in March 2010 to alert the authorities in the countries that had imported those implants,” she said. “But the question is whether they passed on the information to the population. We don’t know.”
France will foot the bill for the implant removals, but will only pay for new implants in women who had them for reconstructive surgery after breast cancer. Women who choose not to undergo the removal should have an ultrasound examination every six months, the authorities said, and should remove any implant that ruptures.
Some foreign doctors expressed approval for the French approach.
Ravi Somaiya contributed from London, Simon Romero from S?o Paulo, and Gardiner Harris from Washington.
