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04.05.2019 | Responsibility

Allergan Statement Regarding Textured Breast Implants

On April 4, 2019, Health Canada issued Allergan written notice detailing a potential intent to suspend the Allergan marketing authorization for Biocell textured breast implants.  Allergan is currently reviewing this notice and intends to respond within the deadline provided by Health Canada.  Allergan will continue to cooperate and support regulatory authorities.  Patient safety is Allergan’s highest priority.  We are committed to advancing research, understanding and awareness about breast implant effectiveness and safety.

BIA-ALCL - 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.  There has been no new clinical evidence reviewing the benefit / risk profile of textured breast implants.  It is important for patients to know BIA-ALCL is not a cancer of the breast tissue.  BIA-ALCL is a type of non-Hodgkin lymphoma (a cancer that affects the immune system) that may develop many months or years after a breast implant procedure.  Breast implant patients should consult their healthcare professional if they are experiencing unusual changes to their breasts, including breast pain, sudden swelling, or a lump. 

Product Safety - The safety profile of Allergan’s breast implants is supported by extensive pre-clinical device testing, more than a decade of worldwide clinical use, as well as a large number of peer-reviewed and published studies.

Patient Needs - 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 with each patient.  With every medical procedure, there are benefits and risks.  Allergan supports informed consent for patients.  Patients are advised to have a thorough discussion with their plastic surgeon about the risks and benefits of each implant type to make a fully informed decision.  The company has included appropriate information in the surgeon Directions for Use and patient information leaflets to aid in an effective consultation and patient/physician discussion around the risks and benefits.

We encourage all breast implant patients to consult their healthcare professional if they have any questions or are experiencing unusual changes to their breasts, including breast pain, sudden swelling, or a lump.  Allergan is committed to on-going evaluation, understanding and research surrounding breast implant effectiveness and safety.