TORONTO: 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: MR-MedicalInformation@Allergan.com 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.
Find any Critical Errors? Please Report It!