Allergan Breast Implant FAQs

Why am I hearing so much about breast implants in the news? What’s going on?

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 15-calendar day deadline provided by Health Canada.
Product Safety - There has been no new clinical evidence reviewing the benefit/risk profile of textured breast implants. 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 safety is Allergan’s highest priority. Allergan continues to collaborate with clinicians, societies and worldwide regulatory authorities to advance scientific understanding. Allergan is committed to providing all stakeholders with timely and informative updates on these issues as new information becomes available.

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 speak with you directly if they are experiencing unusual changes to their breasts, including breast pain, sudden swelling, or a lump.
Your Allergan representative can also provide you copies of our BIA-ALCL FAQ document both for Patients with Implants and Patients Considering Implants upon request.

Allergan takes every adverse event seriously. We report all adverse events to Health Canada as they are received. We exceed regulatory requirements for ALCL reporting. We do not wait and report on an annual basis as currently required under Health Canada’s 2011 Canadian Medical Devices Regulations and the Guidance for Mandatory Problem Reporting.
On April 4, 2019, Health Canada reported 28 confirmed Canadian cases of BIA-ALCL, of which 24 (86%) involve Allergan's Biocell breast implant.
Medical Information will be able to provide specific information for the patient re. BIA-ALCL, breast implant illness, connective tissue disease and rupture.
Please refer any patients directly to Allergan’s Medical Information team at MR- [email protected] or 1-800-668-6424.
Your Allergan representative can also provide you copies of our BIA-ALCL FAQ document both for Patients with Implants and Patients Considering Implants upon request.

There has been no new clinical evidence reviewing the benefit/risk profile of textured breast implants. Allergan stands behind the positive benefit/risk profile of our breast implant products.
As patient safety is Allergan’s highest priority, we actively support research, education and informative labelling to promote and advance the safest use of our textured devices. Allergan stands firmly behind the benefit/risk profile of its breast implant products, including textured breast implants.
Breast implants play a vitally important 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.

Medical Information will be able to provide specific information for the patient if they have their serial number or if their device was registered by their Healthcare Professional.
Please refer any patients directly to Allergan’s Medical Information team at MR- [email protected] or 1-800-668-6424.

Allergan provides Warranty coverage to help offset the costs associated with certain health concerns, should that become necessary. Allergan recommends patients contact their physicians to discuss any concerns they may have about their breast implants.
Full details of our warranty program and coverage can be found at: https://www.natrelle.ca/en/warranty
Your Allergan representative can also provide you copies of our Natrelle Warranty Patient Brochure upon request.
Should you have any other questions you can contact our Medical Information team at MR- [email protected] or 1-800-668-6424.

To date, there is no recommendation from Health Canada, the FDA, or any other world health authority for asymptomatic patients to have their textured implants removed or replaced prophylactically.
All breast implant patients should continue to monitor their breast health, and if there is an issue, consult with a plastic surgeon to rule out breast implant rupture or BIA-ALCL.