Health Canada will be updating its safety review of breast implants
- Starting date:
- February 12, 2019
- Type of communication:
- Information Update
- Medical Device
- Source of recall:
- Health Canada
- Important Safety Information
- General Public
- Identification number:
- What you should do
- What industry professionals should do
- Report health or safety concerns
- Media enquiries
- Public enquiries
OTTAWA - Health Canada will be updating its safety review of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) following an increase in reports of Canadian cases. As of January 1, 2019, Health Canada has received reports of 22 confirmed and 22 suspected Canadian cases of BIA-ALCL. In its initial safety review in 2017, Health Canada found that the rate of BIA-ALCL cases was low, with 5 confirmed Canadian cases of BIA-ALCL reported by Canadian manufacturers in the last 10 years. Increased awareness by healthcare professionals and the public about BIA-ALCL is believed to be the largest contributing factor to the increased reporting of cases of BIA-ALCL to Health Canada.
It is expected that the updated safety review will be completed in spring 2019. Upon completion, Health Canada will take action as required and inform Canadians and healthcare providers.
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. BIA-ALCL occurs with both saline-filled and silicone gel-filled breast implants.
Health Canada consulted with the Canadian Society of Plastic Surgeons and the Canadian Society for Aesthetic Plastic Surgery during its initial review, and is again engaging with these associations during this updated review.
Health Canada is also working with its international counterparts to gather information to inform any regulatory actions, including the European Commission's Scientific Committee on Health, Environmental and Emerging Risks, France's health regulator, Agence Nationale de Sécurité du Médicament et des Produits de Santé and the U.S. Food and Drugs Administration.
We will continue to work closely with our international partners to ensure alignment when appropriate and to exchange data related to the safety of these products.
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. This includes strengthening regulations and taking action to improve the reporting of medical device incidents by industry, healthcare providers and Canadians.
What you should do
If you have breast implants
- Conduct regular breast self-exams and see your healthcare professional for periodic follow-up.
- Consult a healthcare professional if you experience unusual changes to your breasts, including breast pain, sudden swelling, or a lump.
- Note that removal of your breast implants, even if you do not 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.
- You can find information by visiting the breast implant section on Canada.ca.
What industry professionals should do
- Stay informed about the signs, symptoms and testing 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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