Health Canada suspends Allergan's licences for its Biocell breast implants after safety review concludes an increased risk of cancer

Starting date:

May 28, 2019

Type of communication:

Information Update

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public, Healthcare Professionals

Identification number:

RA-70045

Last updated: 2019-05-28

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OTTAWA – Health Canada has completed an update to a 2017 safety review on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and has found that the rate of BIA-ALCL in Canada is significantly higher in patients with macro-textured breast implants compared to other implants. As a result, because the potential risks associated with the implants outweigh their benefits, including the rare but serious risk of BIA-ALCL, Health Canada has suspended the licences for Allergan’s Biocell breast implants (the only macro-textured implants available in Canada).

This means that no one can sell Allergan’s Biocell breast implants in Canada or import them into the country (Set out in the chart below). At Health Canada’s request, Allergan has agreed to voluntarily recall unused Biocell devices from the Canadian market. Allergan’s other breast implant products are not affected by this decision.

The license suspensions follow Health Canada’s announcement on April 4, 2019, that it intended to suspend Allergan’s Biocell licences unless the company could provide evidence within two weeks to support that the benefits of the use of the devices outweighed the risks.

Health Canada received a response from Allergan on April 17, 2019, which departmental experts reviewed. It was determined that the information provided by the manufacturer was insufficient to support the ongoing licensing of the devices. The department concluded that the potential risks associated with the devices outweigh the potential benefits.

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. It is not a cancer of the breast tissue. BIA-ALCL usually presents as an accumulation of fluid (known as seroma fluid) between the implant and the surrounding tissue. While the cause is unknown, possible risk factors and causes for the disease include the high surface area of the implants, genetic factors, and long-term (chronic) inflammation around the implant triggered by factors such as bacteria around the implant.

Health Canada has been notified of 26 confirmed Canadian cases of BIA-ALCL, of which 22 (85%) involve Allergan's Biocell breast implants. Based on Canadian confirmed case data and devices sales data provided by the manufacturers, Health Canada estimates that the risks of BIA-ALCL are 1 in 3,565 for Allergan Biocell macro-textured breast implants and 1 in 16,703 for Mentor Siltex micro-textured breast implants. No cases of BIA-ALCL have been reported in Canada with any smooth surface implants.

Health Canada takes patient health and safety very seriously. As a result of the safety review findings, the Department will also:

• work with all breast implant manufacturers to strengthen the “Instructions for Use” of all breast implants on the risk of BIA-ALCL;
• work with stakeholders to develop new information tools to support informed decision-making for individuals considering breast implants;
• continue to monitor for newly reported Canadian cases of BIA-ALCL, including a yearly follow-up with manufacturers of breast implants; and
• take appropriate and timely action if any new health risks are identified related to breast implants.

If you have an Allergan Biocell breast implant or another type of breast implant:

• Removing your breast implants is not recommended if you do not have any signs or symptoms suggesting BIA-ALCL. Patients should discuss the risks and benefits of removal with their healthcare professional.
• If you don’t know what type of breast implant you have, you should speak with the healthcare provider who did your surgery.
• Conduct regular breast self-exams and see your healthcare professional for periodic follow-ups.
• If you experience unusual changes to your breasts, including breast pain, sudden swelling, or a lump, consult a healthcare professional.
• You can find helpful information on the risks associated with breast implants, including the risk of BIA-ALCL, by visiting the breast implant section on Canada.ca.

If you are considering getting breast implants:

• You should get information about the risks and benefits of getting breast implants, and discuss them with a healthcare professional.
• If you do decide to get breast implants, have a conversation with your healthcare professional about which type of implant is the best choice for you.
• You can find helpful information about breast implants, including what you should ask the surgeon, by visiting the breast implant section on Canada.ca.

Information for healthcare professionals

• Provide patients with the appropriate information about the risks, including the risk of BIA ALCL, and benefits associated with their options, so that they can make an informed decision before a breast implant procedure.
• Stay informed about the signs and symptoms of BIA-ALCL and the testing tools used to recognize and diagnose BIA-ALCL.
• Report incidents of BIA-ALCL to Health Canada. Include specific details, such as type of implant, symptoms, how BIA-ALCL was discovered, age of patient at implantation, prior implant history, age of patient at discovery, tests conducted to diagnose, staging information, course of therapy and clinical outcomes.

Report health or safety concerns

• Report complaints involving medical devices to Health Canada.
• Stay connected with Health Canada and receive the latest advisories and product recalls.

The world of medical devices is constantly evolving, and the Government of Canada is working to ensure that regulations and guidance keep pace. As part of Health Canada’s Action Plan on Medical Devices, announced in December 2018, the Department is taking steps to strengthen the monitoring and promotion of medical device incident reporting. In addition, to better support women’s health, Health Canada has established a new Scientific Advisory Committee on Health Products for Women.

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