ALLERGAN NORDEN AB
Strandbergsgatan 61
SE-112 51 Stockholm
Dear Members of SFEP
Allergan is reaching out to you to notify you of an issue regarding the availability of our textured breast implants in Sweden.
Effective immediately, Allergan is suspending sales of textured breast impants and tissue expanders and 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. Furthermore, ANSM has not identified any immediate risk to the health of women with textured breast implants.
The CE Mark for Allergan’s smooth implants has been renewed by GMED. Smooth implants are not affected and continue to be available.
Patient safety and product quality are Allergan’s highest priorities. 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.
Importantly the safety profile of textured breast implants is well-known and surgical removal is not being recommended on this information alone given the known risks removal can have for patients.
Allergan takes this situation very seriously and is committed to providing all stakeholders with timely and informative updates on this issue as more information becomes available.
If you have any questions for the Company please share them directly with me or with our Country Manager Jessica Stenberg +46 70 466 32 98 or Jessica.stenberg@allergan.com.
Maria Molén
National Sales Manager
Phone: +46 73 978 90 81 or E-mail: maria.molen@allergan.com