This file should allow better follow-up of patients. A few days ago, nearly a hundred prostheses were banned by the ANSM.
It was a request from patients and cosmetic surgeons: the General Directorate of Health (DGS) announced the establishment of a national register of breast prostheses this summer. This decision follows the announcement last week, by the National Agency for the Safety of Medicines and Health Products (ANSM), of the banning of 95 models of prostheses, likely to cause anaplastic large cell lymphoma ( ALCL), cancer of the lymph nodes.
A file ready for three years
According to AFP, the register had been ready for three years, pending validation by the CNIL. It identifies all women with a breast prosthesis to guarantee them better follow-up. The DGS also announced that the information documents provided to patients by their doctor before the installation will be updated.
56 cases of cancer
95 models of mammary prostheses in macro-textured silicone, that is to say rough to the touch and wrapped in polyurethane, marketed by six different brands, have been banned. The decision was taken in view of the “rare but serious danger that their establishment is likely to constitute”, specifies a letter from the ANSM.
Textured implants represent 85% of the market
The ANSM decided to go beyond the opinion delivered by the committee of experts it had requested. Patients, health professionals and other players in the sector met on February 7 and 8 to take stock of these implants. They had declared themselves in favor of the prohibition of Biocell prostheses of the Allergan brand.
Since 2011, 56 cases of ALCL associated with the wearing of one of these prostheses have been listed. Textured implants represent 85% of the market in France, some remain authorized by the ANSM. However, the agency recommends that health professionals maintain enhanced surveillance of this type of prosthesis. For patients, a toll-free number is available to answer any questions: 0800 71 02 35. Approximately 500,000 women wear breast prostheses in France.
