TORONTO, May 28, 2019 /CNW/ - Allergan Canada has made the decision to voluntarily recall textured breast implants from the Canadian market as a result of Health Canada's suspension of the BIOCELL® textured implant licence. Health Canada's decision is in contrast to public rulings and positions by other regulatory bodies and societies around the world, including the U.S. Food and Drug Administration's (FDA) recent position. Allergan continues to stand firmly behind the benefit / risk profile of its breast implant products, and the Company plans to explore options to appeal this decision with Health Canada.
As part of this voluntary recall, any unused BIOCELL saline-filled and silicone-filled textured breast implants (medical device licences 3112, 72262, 72263, 87277 and 87279) will be removed from the Canadian market and no longer be sold. NATRELLE smooth implants and tissue expanders are not impacted by this licence suspension and voluntary recall.
Patient safety is Allergan's highest priority. This decision will raise many questions for Canadians who have textured breast implants. Patients are advised to have a thorough discussion with their plastic surgeon about the risks and benefits of their implant type should they have any concerns with their implants. Allergan is committed to working with Health Canada to implement a communications plan to inform surgeons, hospitals, government organizations, medical and healthcare professional associations and patient groups to ensure patient needs are met.
Should any Canadian patients or healthcare professionals have questions about BIOCELL® textured breast implants, you can contact our Medical Information team: [email protected] or 1-800-668-6424.
Health Canada's decision is not consistent with regulatory agencies and professional societies including the FDA, the Italian Ministry of Health, Spanish Ministry of Health, the UK Medicines and Healthcare products Regulatory Agency, Brazil's National Health Surveillance Agency, Argentina's National Administration of Drugs, Foods and Medical Devices, and the British Association of Aesthetic and Plastic Surgeons (BAAPS), which have been systematically reviewing the status of textured breast implants in the context of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). These agencies and societies have determined that textured implants remain available to ensure that choice is not limited for surgeons and their patients. Specifically, they have stated that there is a need for more evidence gathering and information to make a fully informed determination regarding textured breast implants.
There continues to be no recommendation from any health authority, including Health Canadai and the FDA, for asymptomatic patients to have their textured breast implants removed or replaced prophylactically. As there is risk associated with all surgeries, patients are encouraged to discuss the risks and benefits with their healthcare professional.
BIA-ALCL has been reported in patients with an implant history that includes Allergan's and other manufacturers' textured breast implants with various surface properties, styles, and shapes. As per Health Canada, the exact cause of BIA-ALCL is unknown.i
Whether mammaplasty, breast reconstruction or breast augmentation procedures; breast implants play a vital role in a patient's physical and psychological health. Surgeons need a variety of implant types to address the variable nature of breast anatomy and pathology to meet the needs of individual patients. With every medical procedure, there are benefits and risks. Allergan supports informed consent for patients.
"The safety profile of Allergan's breast implants is supported by extensive pre-clinical device testing and more than a decade of worldwide clinical use, as well as, a large number of peer-reviewed and published studies," said Dr. Carmen Enciu, Director, Chief Medical Office, Allergan Canada. "Allergan is committed to on-going evaluation, understanding and research surrounding breast implant effectiveness and safety."
About Allergan plc
Allergan plc, 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.
For more information, visit Allergan's website at www.Allergan.com.
Forward-Looking Statement
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; uncertainty associated with financial projections, projected cost reductions, 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 March 31, 2018. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
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i http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/69520a-eng.php |
SOURCE Allergan
MEDIA CONTACTS: Jennifer Gordon, Head of Communications, Allergan Inc., T. 905-940-7003; Rob McEwan, Argyle Public Relationships, [email protected], T. 416 968-7311 ext.241
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