The national drug and health safety agency, ANSM, said that despite measures taken to avoid a repeat of the recent global healthcare sparked by faulty French implants, the industry could do a lot more to improve safety and inform women of the potential dangers.
And it said it had ordered a French and a South Korean breast implant company to stop selling their products in France as they did not meet safety standards.
The report, carried exclusively by Le Parisien newspaper, said that 2,169 women had since 2010 reported that their breast implants had ruptured.
It said this figure was separate from the cases of women who had implants made by the French firm PIP.
Some 300,000 women in 65 countries are believed to have received PIP implants made from industrial-grade silicone. More than 7,500 women have reported ruptures in the implants and in France alone 15,000 have had the PIP implants replaced.
The ANSM report said the breast implants on offer by various companies lasted on average 7.6 years, and not the ten years promised by their manufacturers.
It also said that women who had implants suffered more frequently from lymphatic cancer than the general population.
Firms ordered to close until standards improved
ANSM inspected all 11 sites in France where implants are made as well as the various distribution centres.
The health agency’s boss, François Hébert, told Le Parisien that ANSM subsequently ordered two companies, Cereplas of France and Hans Biomed Corporation, a South Korean firm, to suspend their activities until they improved their standards to meet European norms.
Hébert said that cosmetic surgeons needed to provide better information to the women who want implants for cosmetic reasons or after having had breast cancer.
“Surgeons absolutely have to tell them, more clearly than they do today, about the risks involved,” he said.
Breast implants have become hugely popular in France in recent years. Eighty percent of French women opting for breast enhancement do so for cosmetic reasons, with the remaining 20 percent having surgery after breast cancer.
PIP, which has now been liquidated, had been the third-largest global supplier of implants, but came under the spotlight when plastic surgeons began reporting an unusual number of ruptures in its products.
Health authorities later discovered the firm was saving millions of euros by using industrial-grade gel in 75 percent of the implants.
PIP had exported more than 80 percent of its implants, with about half going to Latin America, about a third to other countries in western Europe, about 10 percent to eastern Europe and the rest to the Middle East and Asia.
PIP's founder Jean-Claude Masa, who was dubbed "the sorcerer's apprentice of implants" was jailed last year for fraud.
by Rory Mulholland