Question Period Note: Breast Implants Registry

• What is the Government doing to establish a national breast implant registry?

• The Government of Canada thanks the Standing Committee on Health for its report and recommendations on the creation of a breast implant registry for Canada.
• As initial steps, the Government will engage more broadly with key stakeholders, including provincial and territorial governments, to discuss potential options to implement a breast implant registry and will seek advice from experts on the best way forward to advance work on other recommendations contained in the HESA report.
IF PRESSED ON ESTABLISHING A BREAST IMPLANT REGISTRY

• Health Canada has undertaken a number of actions regarding the safety of breast implants, including the suspension of higher risk breast implants; improved labelling to support informed decision-making; and increased communication to help keep Canadians up to date with safety information on breast implants.
• The Government recognizes the need to identify concrete solutions for the safety concerns related to breast implants and for the development and implementation of a national breast implant registry in Canada and believes that establishing a committee with the required expertise and knowledge is the best next step. The committee will be established in a timely manner to assess options and implementation considerations.
IF PRESSED ON BREAST IMPLANT ILLNESS

• Health Canada is performing a scientific, evidence-based review of breast implant illness, which is a term used to describe a variety of symptoms associated with breast implants. Once finalized, the Department will publish its findings.

The House of Commons Standing Committee on Health (HESA) report on the oversight of breast implants was published on November 30, 2023. The Report, which includes 10 recommendations, states that breast implant recipients are insufficiently protected from adverse outcomes and that significant gaps remain in the oversight of these devices. The Report’s primary recommendation was to establish a national breast implant registry, with Recommendation 2 calling for the Government to establish a committee made up of officials from Health Canada, experts, and patient representatives, and work with PTs to create the implant registry. Recommendations 3-6 address development and implementation considerations. Recommendations 7 to 10 address areas such as data collection, research, and better informing Canadians about the risks associated with breast implants. The Government Response was tabled on April 8, 2024.

The concept of a breast implant registry has been discussed for many years: in the media; previously at HESA; by physician and patient advocates, including people with lived/living experience; and at the Health Canada Scientific Advisory Committee on Health Products for Women. Breast implant registries would typically be used to record the details of individuals who have undergone breast implant surgery, so that they can be traced in the event of safety concerns relating to a specific type of implant.

Several OECD countries have breast implant registries, including the United States, the United Kingdom, Germany, France, Australia, Sweden, and the Netherlands. Currently there is only one known medical device registry in Canada (the Canadian Joint Replacement Registry, or CJRR) managed by the Canadian Institute for Health Information, which collects information on hip and knee replacement surgeries and is used for research purposes to inform clinical practice. The CJRR is not a safety-recall registry.

In collaboration with the Canadian Institutes of Health Research (CIHR), a Best Brains Exchange (BBE) meeting was held on March 7, 2023, with researchers, decision-makers, patient partners, and industry with respect to the implementation of health registries and patient notification. International and domestic stakeholders from across the health care ecosystem also participated in the discussion, which highlighted the complexity of a breast implant registry with participants outlining numerous challenges and complexities. The discussions at the BBE meeting highlighted key operational considerations, such as establishing clear objectives for the registry and which organization would be best placed to manage or implement the registry, as well as considerations about data collection and privacy.

In addition, Health Canada continues to publish information for Canadians and health professionals to support decision making. Health Canada’s website for breast implants is a comprehensive page with clear information about the risks available. A July 2023 update addressed some of the feedback on information communicated about breast implants raised by HESA in spring 2023, and now includes a fact sheet on breast implants to support discussions between people seeking breast implants and their physicians. This is in addition to comprehensive information already available, including: a subscription service to inform interested Canadians about new government publications on breast implants; Health Canada’s safety reviews of implants; information to consider before getting implants; and a link to report problems or adverse effects with implants to Health Canada.

• Breast implant registries are typically used to record the details of individuals who have undergone breast implant surgery, so that they can be traced in the event of safety concerns relating to a specific type of implant.
• On November 30, 2023, the House of Commons Standing Committee on Health (HESA) tabled a report in the House of Commons titled “Strengthening the Oversight of Breast Implants”.
• The Report made 10 recommendations to improve the oversight of breast implants, which primarily focus on the creation of a national breast implant registry.
• The Government assessed HESA’s recommendations and tabled its response on April 8, 2024. As initial steps, the Government will engage more broadly with key stakeholders, including provincial and territorial governments, to discuss potential options to implement a breast implant registry, and will seek advice from experts on the best way forward to advance work on other recommendations contained in the HESA report.