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 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 Canadians up to date with safety information on breast implants, we have:

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:

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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