France has banned several types of textured breast implants that have been linked to a rare form of cancer. The ban, which covers macro-textured and polyurethane implants, took effect Friday. It was announced this week by France’s National Agency for Safety of Medicines and Health Products, or ANSM, in a letter to manufacturers.
The implants, characterized by a textured, Velcrolike surface that adheres to the breast tissue, are suspected of being linked to anaplastic large-cell lymphoma, a rare form of cancer. Since 2011, 59 cases have been recorded in France, according to the ANSM, and most women affected by the disease had textured breast implants. Although the safety agency did not find a causal link between the cancer and the implants, it said it was imposing the ban as a “precautionary measure.”
In December, Allergan, one of the makers of textured implants, halted European sales after its certification expired. The French safety agency had asked for additional data on the implants, but the company said it could not provide it before the expiration date. At the time, the ANSM said it had not “identified any immediate risk for the health of women carrying the implants concerned,” and it did not mention the unusual cancer.
France’s decision this week has set off a chain reaction in regulators across continents, with Canada and the Netherlands announcing similar plans to suspend the sale of textured breast implants. In the United States, the Food and Drug Administration held public hearings on the subject on March 25 and 26. It said it would announce a decision “in the coming weeks.”
The prohibition followed a series of media investigations last year, coordinated by the International Consortium of Investigative Journalists, that found poorly designed breast implants had led to health issues for patients globally. In the ANSM letter this week, which the French newspaper Le Monde published on its website, Dr Christelle Ratignier-Carbonneil, deputy director-general of the agency, asked manufacturers to remove their implants from the market, “in view of the rare but serious danger that their implantation is likely to constitute.”
Nearly 500,000 women have breast implants in France. In 2018, macro-textured and polyurethane implants represented 27 per cent of sales, according to the ANSM. Over the past five years, some 70,000 women are thought to have received the implants, which do not slip out of place or rotate, unlike smooth ones. They are also less likely than smooth ones to cause thick scarring around the implant, which is common and requires more surgery.
Joëlle Manighetti, a French activist who started a blog on breast implants after suffering from faulty ones, praised the decision as going “beyond our recommendations.”
“I now hope that there will be a serious follow-up of the other breast implants still on the market,” she said.
Breast implants came under scrutiny in France in the last decade, in a landmark case involving the company Poly Implant Prothèse, which was accused of selling hundreds of thousands of defective implants in 65 countries.
After a trial that involved more than 7,000 defendants, the company’s founder, Jean-Claude Mas, and four former employees were found guilty of aggravated fraud in 2012. Mas, who died Thursday at age 79, was later sentenced to four years in prison.