France has decided to ban 95 models of macro-textured silicone and polyurethane breast implants, marketed by 6 brands.
These are the prostheses that are most popular with patients. However, nearly 95 so-called “macro-textured” models, that is to say with a rough feel and a polyurethane envelope, will soon be banned in France. This is what the National Health Products Agency (ANSM) decided. In a letter unveiled on Wednesday April 3 by The world and the investigations unit of French Radiothe health agency explains that it took this decision “in view of the rare but serious danger that their establishment is likely to constitute”.
Letter from the ANSM anno… by on Scribd
56 cases of lymphoma since 2011
In question, according to the ANSM: the suspicion of the risk posed by these breast implants on the risk of development of anaplastic large cell lymphoma (ALCL), a rare but aggressive cancer affecting the lymph nodes and organs.
Since 2011 in France, 56 cases of anaplastic large cell lymphoma have indeed been associated with macro-textured breast implants. Among these 56 patients, five died, three of them related to progression of BIA-ALCL. For the other two patients, imputability remains uncertain. The average age of the patients at the time of diagnosis was 58.4 years (minimum: 29 years; maximum: 83 years). The average duration of implantation between the last implanted breast prosthesis and the diagnosis of ALCL is 7 years, with a minimum of 3 months and a maximum of 25 years of implantation on the last breast prosthesis.
95 prohibited references
Already on March 25, the ANSM had made public a “draft decision” which suggested a ban on these breast prostheses. In addition to the macro-textured prostheses Biocell of the American manufacturer Allergan – withdrawn from the French market following the scandal of the Implant files, six other manufacturers are affected by this ban. These are 95 references marketed by the brands Arion, Sebbin, Nagor, Eurosilicone, as well as Polytech, which also markets prostheses with a polyurethane envelope.
This ban even goes beyond the recommendations of the expert committee convened by the ANSM. On February 7 and 8, the latter was given the task of interviewing patients, health professionals and other players concerned in order to benefit from an overall perspective on the use of these implants. He had simply spoken out for the prohibition of Biocell prostheses from Allergan, the main model implicated in the occurrence of ALCL.
On the other hand, the ANSM has not decided to ban all textured implants marketed in France, but recommends “maintaining, as a precaution, reinforced monitoring of other breast implants with a textured envelope, as well as other breast implants polyurethane”. It is estimated that 500,000 women today wear breast prostheses in France. Textured breast implants represent nearly 85% of the French market. To answer questions from women wearing these prostheses, a toll-free number has been made available: 0800 71 02 35.
