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PARIS – France has banned several types of textured breast implants that have been linked to a rare form of cancer.
The ban, which concerns macro-texture and polyurethane implants, came into effect on Friday. It has been announced the National Agency for the Safety of Medicines and Health Products, or ANSM, in a letter to the manufacturers.
Implants, characterized by a velcro-like textured surface that adheres to breast tissue, are suspected to be related to large cell anaplastic lymphoma, a rare form of cancer. Since 2011, 59 cases have been recorded in France, according to ANSM, and most women affected by the disease had textured breast implants.
Although the safety agency did not find a causal link between cancer and implants, she said it imposed the ban as a "precautionary measure."
In December, Allergan, one of the textured implant manufacturers, interrupted European sales after the expiry of its certification. The French safety agency had requested additional data on the implants, but the company said it could not provide them before the expiry date.
At the time, the ANSM stated that it did not "identify an immediate risk to the health of women wearing the implants concerned" and not mention the unusual cancer.
France's decision this week triggered a chain reaction from regulators from all continents, with Canada and the Netherlands having announced 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. She announced that she would announce a decision "in the coming weeks".
This ban followed a series of media inquiries conducted last year, coordinated by the International Consortium of Investigative Journalists, which revealed that poorly designed breast implants had resulted in health problems for women. patients all over the world.
In this week's letter from the ANSM, that French newspaper Le Monde has posted on its website, Mrs. Christelle Ratignier-Carbonneil, deputy general manager of the agency, asked manufacturers to remove their implants from the market, "given the rare but serious danger that their implantation is likely to represent".
Nearly 500,000 women have breast implants in France. In 2018, macro and polyurethane implants accounted for 27% of sales, according to ANSM. In the last five years, some 70,000 women have received implants that did not slip or rotate, unlike smooth implants. They are also less likely than smooth to cause thick scars around the implant, which is common and requires more surgery.
Joëlle Manighetti, a French activist who launched a blog about breast implants after having made mistakes, welcomed this decision, going beyond our recommendations.
"I now hope that there will be a serious follow-up of other breast implants still on the market," she said.
Breast implants have been the subject of close scrutiny in France over the last decade, in a landmark case involving the company Poly Implant Prosthesis, accused of having sold hundreds of thousands of dollars. 39, defective implants in 65 countries.
After a lawsuit involving more than 7,000 defendants, the company's founder, Jean-Claude Mas, and four former employees were convicted of aggravated fraud in 2012. Mr. Mas, who died Thursday at age 79, was later sentenced to four years in prison. jail.
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