Allergan suspends sales of textured breast implants in European markets
Allergan announced that the company has suspended 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 Securite du Medicament, 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. The Company looks forward to 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. 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. It is also important to note that the United States does not require the CE Mark so it is unaffected by the action.