On the 17thof July 2019, the SCHEER* has received a Requestfor a scientific Opinion on the safety of breast implants in relation to anaplastic large cell lymphoma as a public health concern in the EU. Breast Implant-Associated Anaplastic Large Cell Lymphoma(BIA-ALCL) is a rare type of non-Hodgkin lymphoma that can appear as a mass adjacent to the breast implant or a delayed periprosthetic seroma.
This request was made after concerns were raised at a global level regarding this issue, and after the decision from the French Competent Authority ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) to ban certain type of breast implants linked to this rare type of cancer on the 2nd of April 2019.
After considering that sufficient scientific information was available to conduct a full risk assessment on this matter, the SCHEER will now proceed with an in-depth evaluation of the safety of textured breast implants.
The Committee is expected to publish its Opinion by the 31st of August 2020. EU and the relevant Competent Authorities will take necessary actions in case textured breast implants are found to represent a risk for public health.
If you wish to know more about the request to the SCHEER and its developments, please do not hesitate to contact us. Obelis Expert Consultants, with 30 years of experiencein EU legislation, will gladly answer your questions and assist you with your products’ compliance.
*The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) provides Opinions on questions regarding newly identified health and environmental risks for consumers safety or public health upon request of the European Commission.
Regulatory Affairs Department
September 11, 2019
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