Allergan Suspends Sales, Withdraws Supply Of Textured Breast Implants In Europe

(RTTNews) - Allergan plc (AGN) said that it 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 Sécurité du Médicament or ANSM, the French regulatory authority.

The suspension of sales stems from the expiration of the company's CE Mark for these products.

Allergan said, "Although Allergan disagrees with ANSM's request, the Company is fully cooperating with the authority. Allergan stands behind the benefit/risk profile of breast implant products. The ANSM request 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."

Allergan noted that it 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.