Breast implants: Health Canada's role
On this page
What we do
Health Canada regulates all medical devices for sale in Canada. All makes and models of breast implants sold in Canada must have a medical device licence issued by Health Canada.
After breast implants are licensed, we monitor them for their safety, effectiveness and quality. As part of our post-market surveillance activities, we:
- conduct inspections to ensure a company is complying with the medical device regulations
- monitor breast implants through recalls, problem and incident reports from consumers, manufacturers, health care providers and other sources
We follow up on all reports related to medical device problems and take appropriate action as required. This can range from requesting a label change, to controlling distribution, to recalling the device, to suspending the manufacturer's licence.
Keeping you up-to-date on our risk assessment activities
In April 2022, we published an updated summary safety review of the risks associated with breast implants and breast-implant associated anaplastic large cell lymphoma (BIA-ALCL). To help keep people in Canada up to date with safety information on breast implants, we:
- created a BIA-ALCL Canadian surveillance data blog
- launched an opt-in subscription service to receive timely updates on our breast implant updates
We continue to monitor the safety of breast implants and provide information on our risk assessment activities. For example, we:
- keep people in Canada up-to-date through this webpage and our recall updates
- communicate frequently with international regulators and stakeholders in Canada, including patients with lived and living experience, through the Scientific Advisory Committee on Health Products for Women
We implemented comprehensive labelling changes, similar to those required by the U.S. Food and Drug Administration.
Changes include:
- box warnings of the risk of BIA-ALCL
- patient decision checklists
- information on materials used in the breast implant
- device cards to help trace a device (card is completed and submitted to the manufacturer)
What we don't do
We don't:
- cover the fees for surgery
- provinces and territories determine the reimbursement of medical costs to hospitals, doctors and patients
- you can contact your provincial or territorial ministry of health or your personal health care insurance company
- provide medical or legal advice
- for medical options, speak with your health care provider
- for legal options, speak with a lawyer
- maintain a database linking individual patients with the specific types of implants they have
- regulate medical decisions by doctors (this responsibility falls to the respective medical colleges and regulatory bodies)
Contact us
If you have questions about the licensing of breast implants, contact us by:
- email at meddevices-instrumentsmed@hc-sc.gc.ca
- phone: 613-957-7285
- teletypewriter: 1-800-465-7735 (Service Canada)
If you have questions or concerns about the risks and safety of breast implants:
If you have questions or concerns about an inspection of a company or a recall or wish to report a problem or an incident related to a medical device:
- call toll-free at 1-800-267-9675
- fill out the report a medical device problem form
Learn more: