Question Period Note: Safety of Breast Implants

What is the Government doing to protect the health and safety of Canadians in regard to monitoring the safety of breast implants?

Breast implants undergo a rigorous scientific review by Health Canada before they are licensed for sale in Canada.
All health products are associated with both benefits and risks.
Health Canada continues to monitor the safety of all medical devices once licensed, including breast implants, as scientific and medical information is continuously emerging.
The monitoring of breast implants has supported decisive actions, including the suspension of higher risk breast implants, improved labelling to support informed decision-making by patients and healthcare professionals, and communication of these actions.
IF PRESSED ON A BREAST IMPLANT REGISTRY …
Discussions regarding the creation of a registry include important privacy considerations and involve health authorities and organisations, including provincial and territorial governments, all of whom have roles to play.
Health Canada is playing a key role in engaging with stakeholders to facilitate exploring potential options.
HESA is currently studying the feasibility of a breast implant registry. Health Canada had the opportunity to appear before the committee to share the government’s perspective. We will assess the committee’s recommendations once the report is available and provide a response in a timely manner

The Standing Committee on Health (HESA) is studying the feasibility of establishing a central breast implant traceability registry. Health Canada participated as a witness on April 25, 2023. Additional meetings were held on May 9 and 11, 2023.
All breast implants in Canada undergo a scientific review for safety and effectiveness before Health Canada issues an authorization. Once licensed, Health Canada monitors breast implants and takes actions if required. Health Canada has completed numerous post-market safety reviews of breast implants and taken a number of actions, including:
o Suspending the medical device authorization for a breast implant associated with the risk of developing a rare form of cancer; and,
o Implementing comprehensive labelling changes, including a boxed warning and patient decision checklists.
Health Canada continues to actively monitor for new or increasing risks associated with breast implants. In addition, Health Canada continues to publish information for Canadians and health professionals to support decision making.
Health Canada does not provide medical advice, regulate medical decisions by doctors, or maintain a database linking individuals with the specific types of implants they have.
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.
While registries are often used to support research, it is not a common mechanism to monitor the safety of medical devices. Currently there is only one known medical device registry in Canada managed by the Canadian Institute for Health Information and used for research purposes to inform clinical practice.
Health Canada was one of several federal partners who participated in a Best Brains Exchange (BBE) meeting that examined the development of a registry. International and domestic stakeholders from across the healthcare ecosystem also participated in the discussion which highlighted the complexity of a breast implant registry with participants outlining numerous challenges and complexities.

Breast implants have benefits and risks and undergo the highest level of review before they are licensed.
Health Canada continues to actively monitor breast implants after they are licensed.
Health Canada has undertaken a number of actions for breast implants, including suspending the licence for breast implants posing a higher risk of developing a rare form of cancer and working with manufacturers to implement comprehensive labelling changes to support informed decision-making.
Physicians are responsible for discussing the benefits and potential risks with patients before procedures.