The National Agency for Health Products (ANSM) has sent a “draft decision” to the manufacturers of seven brands of macro-textured breast implants, in which it recognizes “a rare but serious danger” for the health of women who carry. They could soon be banned in France.
After hearing health professionals and patients to rule on the safety of macro-textured breast implants, the National Agency for Health Products (ANSM) has decided. In a “draft decision” made public on Monday March 25 by AFP, she recognizes that these implants are “likely to constitute a rare but serious danger” in women who wear them. In this sense, it now plans to ban seven of the brands that manufacture these medical devices. The health agency, however, specifies “that no decision has been taken at this stage” and that it will “soon” give its final opinion on the subject.
56 cases of lymphoma identified since 2011
In question, according to the ANSM: the suspicion that these breast implants pose on the risk of development of anaplastic large cell lymphoma (AIM-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 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.
“In view of the scientific data acquired, national vigilance data, expert opinions and national and international recommendations from health professionals, it appears that breast implants with a macro-textured envelope as well as breast implants covered with polyurethane present a risk of occurrence of LAGC-AIM”, notes the ANSM in its letter.
7 models of prostheses in the viewfinder
Also, “as part of a risk reduction approach”, the ANSM explains that it “intends to ban the marketing, distribution, advertising and use” of seven brands of breast implants marketed today in France.
In addition to the macro-textured Biocell prostheses from the American manufacturer Allergan – withdrawn from the French market following the Implant files scandal, six other models are in the sights of the ANSM: LSA from the Sebbin laboratory, Polytext from Polytech and Arion, as well as implants Cristalline and Nagotex from the GC Aesthetics group. The polyurethane envelope implants targeted by a possible ban are those of the Microthane (Polytech) brand.
Such a ban on all macro-textured implants and those with a polyurethane envelope would go 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 Allergan’s Biocell prostheses, the main model implicated in the occurrence of LAGC-AIM.
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