On the 2nd April 2019, the French Competent Authority ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) adopted a decision regarding the ban of certain types of breast implants linked to cancer.
Breast implants are classified as Class III medical devices according to the Directive 93/42/EEC; the devices pertaining to this class are known to be of high risk for the health, therefore they are subject to strict surveillance by the Competent Authorities.
With the objective to protect patients’ health, the ban applies to macro-textured breast implants as well as breast implants made of polyurethane from certain manufacturers named in the decision (Allergan, Arion, Polytech, Sebbin, Eurosilicone and Nagor). According to this decision, it will be forbidden for them to market, distribute, advertise and use this type of implants. Moreover, from 5 April 2019, all the above-mentioned manufacturers must remove those from the shelves and stop making them available on the French market.
The ANSM has based its decision on a research conducted with regard to these implants and their link to several cases of Anaplastic Large Cell Lymphoma, a rare type of cancer that was conducted for several years. Only women with breast implants have been diagnosed with this type of cancer. This cancer has been identified in France in 2009, however, according to the ANSM, the number of Anaplastic Large Cell Lymphoma increased significantly since 2011. According to the experts, the texturing of breast implants and the related tissue reaction (chronic tissue inflammation) enhances the risk to develop an Anaplastic Large Cell Lymphoma.
This decision has consequences for manufacturers of similar breast implants ones mentioned in the decision, as the French Competent Authorities made it clear that the surveillance of all macro-textured and polyurethane breast implants will be strengthened.
If you wish to know more about the EU legislation regarding breast implants and would like to commercialize your medical devices Class III in France, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experience with EU legislation, will gladly answer any question you may have and assist you with your products’ compliance.