Allergan is suspending sales of textured breast implants and tissue expanders and is withdrawing any remaining supply in European markets.
The withdrawal decision follows a compulsory recall request from Agence Nationale de Sécurité du Médicament (ANSM), the French regulatory authority. The suspension of sales stems from the expiration of the company's CE Mark for these products.
Although Allergan disagrees with ANSM's request, the Company is fully cooperating with the authority. Allergan stands behind the benefit/risk profile of our breast implant products. The ANSM request, and this action, is not based on any new scientific evidence regarding these products. Furthermore, ANSM has not identified any immediate risk to the health of women with textured breast implants.
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare and highly treatable type of lymphoma, occurs most frequently in patients who have textured breast implants.
"Breast implants play a vital role for patients' physical and psychological health. For many patients, textured breast implants provide a critical option for surgeons to provide the right solution for each individual need," says Michael Atlan, Associate Professor, Pierre et Marie Curie Faculty of Medicine, and a Plastic Surgeon at Tenon Hospital (Assistance Publique-Hôpitaux de Paris), in a news release. "Importantly, the safety profile of textured breast implants is known and surgical removal is not being recommended on this information alone, particularly given the known risks removal can have for patients."
Allergan will be participating in the scientific forum that ANSM has scheduled for early February where the full set of data and scientific evidence for textured breast implants can be presented and thoroughly discussed by all stakeholders.
"Patient safety and product quality are Allergan's highest priorities. Allergan takes this situation very seriously and is committed to engaging with all stakeholders to ensure they have the most up to date information," says Charles Hugh-Jones, Chief Medical Officer at Allergan. "We are committed to strict adherence to all regulatory requirements, to the most rigorous scientific evidence and to the highest industry standards for our products."
Allergan will continue to work through the CE Mark renewal with GMED, and is planning an appeal to ensure that appropriate patients have access to the products that their surgeons recommend.
Importantly, the CE Mark for Allergan's smooth implants has been renewed by GMED. Smooth implants are not affected and continue to be available for patients. The United States does not require the CE Mark so it is unaffected by the action.