Information Update - Health Canada advises Allergan of its intent to suspend its licences for Biocell breast implants as a precautionary measure

OTTAWA, April 4, 2019 /CNW/ - To protect Canadian patients from the rare but serious risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), Health Canada is advising Allergan that the Department intends to suspend its licences for Biocell breast implants as a precautionary measure.

This follows the completion of Health Canada's scientific assessment of macro-textured implants, as part of its larger ongoing safety review of breast implants and BIA-ALCL, which was launched in November 2018. Health Canada initiated the review because of an increase in Canadian and international cases of BIA-ALCL. As of today, Health Canada has been notified of 28 confirmed Canadian cases of BIA-ALCL, of which 24 (86%) involve Allergan's Biocell breast implant.

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. The cause of BIA-ALCL is unknown.

Health Canada continues to monitor and review all available scientific and clinical information regarding the safety of textured breast implants. This includes any new evidence provided by Allergan in the next 15 calendar days. If a satisfactory response is not received by then, it is Health Canada's intention that the Biocell medical device licences will be suspended. This means that the product would no longer be permitted to be sold in Canada.

Health Canada is engaging internationally on this issue, including recent meetings with the French regulator, Agence Nationale de Sécurité du Médicament et des Produits de Santé, and the U.S. Food and Drug Administration.

Health Canada has been in contact with the Agence Nationale de Sécurité du Médicament et des Produits de Santé concerning its decision today to suspend the sale of all macro-textured breast implants and polyurethane-coated breast implants. Allergan's Biocell implants are the only macro-textured devices available in Canada. There are no polyurethane-coated breast implants for sale in Canada.

The entirety of Health Canada's safety review of breast implants and BIA-ALCL will be available by the end of April. Health Canada will not hesitate to take further action, as necessary.

Health Canada takes patient health and safety very seriously. As a result, it has started a second safety review on the systemic symptoms associated with breast implants. The results of this second safety review will be made public in summer 2019.  

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.

What you should do:

If you have breast implants

• Speak with your surgeon or healthcare professional about which type of breast implant you received.
• You can find some helpful information on the risks associated with breast implants, including the risk of BIA-ALCL, by visiting the breast implant section on Canada.ca.
• Conduct regular breast self-exams and see your healthcare professional for periodic follow-up.
• If you experience unusual changes to your breasts, including breast pain, sudden swelling, or a lump, consult a healthcare professional.
• Note that removal of your breast implants, whether or not you have any signs or symptoms suggesting BIA-ALCL, is an option best discussed between you and your healthcare professional.

If you are considering getting breast implants

• If you are considering getting breast implants, you are encouraged to get more information and to discuss the risks and benefits 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 some 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 benefits and risks of their options, including the risk of BIA-ALCL, so that they can make an informed decision.
• Stay informed about the signs and symptoms of BIA-ALCL and the testing 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 adverse events involving health products to Health Canada by calling toll-free at 1-866-234-2345, or by reporting online, by mail or by fax.
• Stay connected with Health Canada and receive the latest advisories and product recalls.

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SOURCE Health Canada

Media Inquiries: Health Canada, [phone], [email protected]; Public Inquiries: [phone], 1-866 225-0709