The National Agency for Health Products has sent a draft decision to manufacturers, in which it considers this sanction.
A warning, before the sanction? Seven brands of breast implants “Likely to constitute a rare but serious danger” cancer in women who carry it could be banned in France, according to a “Draft decision” of the National Agency for Health Products (ANSM) submitted to manufacturers. “No decision has been taken at this stage”, however warned the sanitary gendarme, who must make “shortly” its official decision on the matter.
In a letter revealed by AFP on Monday March 25, the ANSM’s medical devices department is however preparing the ground. Because “In view of the scientific data acquired, the opinions of experts and the recommendations of health professionals, it appears that breast implants with a macro-textured shell as well as breast implants covered with polyurethane present a risk” anaplastic large cell lymphoma.
About fifty cases identified since 2011
As well, “ANSM, as part of a risk reduction approach”, a “The intention to prohibit the marketing, distribution, advertising and use” of seven brands of implants currently used in France. Such a ban on all so-called “macro-textured” implants as well as those with a polyurethane casing would go beyond the recommendations of the committee of experts convened at the beginning of February by the ANSM after the revelations of the “Implants Files”.
This committee spoke only in favor of the prohibition of Biocell prostheses from the American manufacturer Allergan, the main model implicated in the occurrence of LAGC. Since 2011, 56 cases of this rare form of cancer have been identified in France in women with breast implants, almost all textured. Three died from it. A disease that remains rare, 500,000 women wearing implants in France.