– Action Being Taken Following CE Mark Expiration and Compulsory Recall Request by Agence Nationale de Sécurité du Médicament (ANSM) –
DUBLIN, Dec. 19, 2018 /CNW/ -- Allergan plc (NYSE: AGN), a leading global biopharmaceutical company, today 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 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 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," said Michael Atlan, Associate Professor, Pierre et Marie Curie Faculty of Medicine, and a Plastic Surgeon at Tenon Hospital (Assistance Publique-Hôpitaux de Paris). "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."
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.
"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," said 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. It is also important to note that the United States does not require the CE Mark so it is unaffected by the action.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical leader. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry.
Allergan's success is powered by our global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; uncertainty associated with financial projections, projected cost reductions, projected debt reduction, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2017 and Allergan's Quarterly Report on Form 10-Q for the period ended June 30, 2018. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.