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02.13.2019 | Responsibility

Allergan’s Updated Statement Surrounding Breast Implants

There has been no new clinical evidence reviewing the benefit/risk profile of textured breast implants. Recent media attention and awareness about breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is believed to be the largest contributing factor to an increased reporting of BIA-ALCL cases to Health Canada.”1 BIA-ALCL is not a cancer of the breast tissue. BIA-ALCL is a serious but rare 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.

Health Canada is working with international counterparts to gather information to inform any possible regulatory updates surrounding textured breast implants. Allergan will continue to cooperate and support regulatory authorities.

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. 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.

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. Allergan supports informed consent for patients, and 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.

Patient safety is Allergan’s highest priority and we will continue to collaborate with clinicians, societies and global health authorities to advance research, understanding and awareness about breast implant effectiveness and safety.

Health Canada will be updating its safety review of breast implants. February 12, 2019