DUBLIN, IRELAND – August 15, 2019 – Allergan plc (NYSE: AGN) has launched an online resource at www.BIOCELLinformation.com
for patients, surgeons and healthcare professionals related to the voluntary global recall of BIOCELL® textured breast implants and tissue expanders announced on July 24, 2019.
The easy-to-navigate website offers detailed information and specific guidance about the recent announcement, including the latest resources on the BIOCELL® withdrawal and warranty information.
“Patient safety is a priority for Allergan,” said Charles Hugh-Jones MD, FRCP, Allergan’s Chief Medical Officer. “We are committed to providing patients, surgeons and healthcare providers with the very latest information about the BIOCELL® withdrawal with this new site.”
includes features such as tools and visuals to help patients understand what a textured implant is and how to read patient implant cards.
Healthcare providers will find tools to help guide the identification of patients with BIOCELL® textured devices, including a video resource and directions how to find patient information, and instructions how to return unused BIOCELL® implants.
Allergan voluntarily withdrew BIOCELL® implants as a precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provided by the Food & Drug Administration (FDA).
Importantly, the FDA and other health authorities have not recommended removal or replacement of textured breast implants or tissue expanders in asymptomatic patients.
Patients are advised to speak with a board-certified plastic surgeon about the risks and benefits of their implant type and address any concerns they may have.
Please visit www.BIOCELLinformation.com
for a complete list of affected styles and products.
For more information on the withdrawal and warranties in the U.S., please contact Allergan Medical Information at 1-800-678-1605 option #2 or email IR-Medcom@allergan.com. For all other countries, please refer to the Allergan Global Medical Information Contacts
or go to www.allergan.com.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader 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 primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.
With colleagues and commercial operations located 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.
For more information, visit Allergan’s website at www.Allergan.com
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; risks related to impairments; 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, 2018 and Allergan's Quarterly Report on Form 10-Q for the period ended June 30, 2019. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.