Breast implants: Health Canada's role

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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:

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 May 2019, we published a summary safety review of the risks associated with breast implants and breast-implant associated anaplastic large cell lymphoma (BIA-ALCL). We’re continuing to review our incident reports related to BIA-ALCL with the intent of updating the 2019 risk assessment. We expect to complete this risk assessment in early 2022, after which we will let you know the results.

We continue to monitor the safety of breast implants and provide information on our risk assessment activities. For example, we:

We implemented comprehensive labelling changes, similar to those required by the U.S. Food and Drug Administration. Changes include:

We’re also looking at new, innovative ways to keep you informed about the risks of breast implants and BIA-ALCL.

What we don't do

Health Canada doesn't:

Contact us

If you have questions for Health Canada about the licensing of breast implants, please:

If you have questions or concerns about the risks and safety of breast implants, please:

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, please:

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