Allergan, a company focused on the development of branded pharmaceutical, device, biologic, surgical and regenerative medicine products, has stopped sales of textured breast implants and tissue expanders in European markets.
Image: Allergan’s site in Irvine, California. Photo: courtesy of Allergan.
The company is completely withdrawing the supply of breast implants and tissue expanders based on a compulsory recall request from French regulatory authority Agence Nationale de Sécurité du Médicament (ANSM).
Allergan has taken the suspension decision after the termination of firm’s CE mark for these products.
Allergan noted that it is fully cooperating with the ANSM even though it disagrees with the request of the authority.
ANSM has also not identified any immediate risk to the health of women with textured breast implants, said Allergan.
Allergan also intends to take part in the scientific forum, which will be conducted by ANSM in early February. At the event, all stakeholders will present and discuss regarding the data and scientific evidence for textured breast implants.
Allergan, which will continue to work with GMED to get CE mark renewal, is planning an appeal to ensure that suitable patients can access the products based on their surgeons recommend.
GMED has already renewed CE mark for Allergan’s smooth implants, which not affected and continue to be provided to the customers. The suspension decision will not have impact in the US, as it does not require the CE mark.
Allergan chief medical officer Charles Hugh-Jones said: “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.
“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.”
Based in Dublin of Ireland, Allergan markets products for various conditions, including central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women’s health, urology and anti-infective therapeutic categories.
With commercial operations in around 100 countries, Allergan works with physicians, healthcare providers and patients to develop better treatments.