Health Canada regulates breast implants as class IV medical devices, the category representing the highest risk. Breast implants are associated with a wide range of adverse effects, including a type of cancer of the immune system known as “breast implant‑associated anaplastic large cell lymphoma.” For decades, the federal government has been called upon to make regulatory changes to enhance the safety of breast implants, yet important gaps remain in the oversight of these devices. Breast implant recipients continue to be insufficiently protected from adverse outcomes. The House of Commons Standing Committee on Health undertook a study to follow up on the improvements put in place as part of Health Canada’s 2018 action plan on medical devices, as well as to assess the feasibility of the creation of a central breast implant registry. The committee heard strong support from plastic surgeons, researchers and patient advocates for the creation of a national breast implant registry. Such a registry would improve the traceability of implants, facilitate recalls and advance research related to breast implants. Other concerns identified during the study include shortcomings in the process for reporting adverse effects to Health Canada, deficiencies in the safety information Health Canada presents to consumers, as well as a lack of research on breast implants. Gender inequity within the health care system was cited as one of the reasons why women’s experiences with breast implants have been historically overlooked.

The federal government should take immediate action to protect the health and safety of those who have received or are considering getting breast implants. In this report, the committee puts forward 10 recommendations on how the Government of Canada can strengthen the oversight of breast implants. Notably, the committee recommends that the federal government establish a national breast implant registry as soon as possible, require private practices to report adverse events, invest in research on breast implants, and make improvements to Health Canada’s website to better inform consumers about the risks of these medical devices.