According to a letter from the National Agency for Health Products (ANSM), France will ban some breast implants suspected of promoting a rare form of cancer.
France will ban several models of breast implants suspected of promoting a rare form of cancer, according to a letter from the National Agency for Health Products (ANSM) unveiled Wednesday 3rd April, 2019 by Le Monde and Radio France .
The prostheses concerned have an outer surface made of “macro-textured”, that is to say, rough, silicone or polyurethane. Their withdrawal was decided “given the rare but serious danger that their implementation is likely to constitute”, according to this letter.
56 cases detected
Contacted by AFP, the ANSM did not wish to confirm the authenticity of this letter. She has to announce her decision at a press conference on Thursday morning.
Prohibited prostheses include several models from the American manufacturer Allergan Biocell type. This texture is the main cause in the occurrence of anaplastic large cell lymphoma (ACG) in some women.
Since 2011, 56 cases of this rare form of cancer have been reported in France in women with breast implants, textured for almost all. Three have died. However, this disease remains rare, with 500,000 women wearing implants in France.
Block all textured breast implants?
Other banned models are manufactured by the brands Arion, Sebbin, Nagor, Eurosilicone and Polytech.
By pronouncing these prohibitions, the ANSM went further than the committee of experts it had mandated at the beginning of February.
This committee was only in favor of banning Allergan’s Biocell prostheses.
On the other hand, the ANSM has not opted for the most radical solution, which would have been to ban all the textured breast implants together.
Silicone breast implants are classified according to the appearance of the film that surrounds them, between smooth and textured (microtextured or macrotextured, depending on the degree of roughness).
85% of the market
In France, textured prostheses (macro and micro combined) account for 85% of the market. They are known to remain better in place than smooth surface dentures and cause fewer “shells” (hardening of tissue around the implant).
According to some scientists, inflammation caused by friction may, however, be at the origin of the LAGC.
Finally, implants with an outer shell of polyurethane are marginal on the market. The foam they are covered with is porous, which allows the tissues of the breast to hang on it.