Issue Health Canada has updated its 2019 and 2017 safety reviews on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare but serious cancer of the immune system that can develop next to a breast implant. This review found that there continues to be an increased risk of BIA-ALCL with the use of highly textured (macro-textured) implants in comparison with those having less textured (micro-textured) or smooth implants. The 2019 safety review found that the estimated risk of BIA-ALCL in Canada is significantly higher in individuals with macro-textured breast implants compared to micro-textured or smooth implants. As a result, Health Canada suspended the licences for Allergan's Biocell breast implants (the only macro-textured implants available in Canada). While macro-textured implants have not been available in Canada since 2019, they remain implanted in individuals who received their implants prior to Allergan's suspension. Updated data from 2019 indicates that that the estimated risk of developing BIA-ALCL with Allergan Biocell macro-textured implants has roughly doubled since Health Canada's 2019 review. For other types of implants (micro-textured and smooth), the risk estimates are relatively the same as in 2019. The following table compares 2019 risk estimates to the updated risk estimates, derived from updated and new confirmed Canadian cases for each type of device: Implant 2019 risk estimate Updated risk estimate Allergan Biocell macro-textured implants 1 in 3,565 1 in 1,636 Mentor Siltex micro-textured breast implants 1 in 16,703 1 in 17,627 Smooth surface implants 0 0 An increase in reported cases in Canada is consistent with trends seen in other countries, including the United States. Canadian and international data continue to indicate that the risk of BIA-ALCL is higher with macro-textured breast implants compared to breast implants with other surface textures (micro-textured and smooth). While this information is concerning for people who have Allergan Biocell implants, preventive removal of breast implants is not recommended if there are no signs or symptoms suggestive of BIA-ALCL. Individuals who have, or who are considering breast implants, should speak to their healthcare provider about their benefits and risks. Health Canada will continue to raise awareness of BIA-ALCL to support patient safety. The Department is launching a BIA-ALCL Canadian Surveillance Data Blog, and will continue to monitor and report new Canadian cases of BIA-ALCL. The Department also maintains detailed information on breast implants to support health professionals and people who have, or who are considering implants. Health Canada will also continue to work with manufacturers to help support patient safety. To date, manufacturers have implemented comprehensive labelling changes, including adding strong warnings about the risk of BIA-ALCL, and patient decision checklists. Health Canada will also conduct yearly follow-ups with manufacturers. The Department will take appropriate and timely action if any new health risks are identified.

Updated safety review of breast implants underscores the continuing importance of monitoring for cancer; increased risk with highly textured (macro-textured) implants

Updated safety review of breast implants underscores the continuing importance of monitoring for cancer; increased risk with highly textured (macro-textured) implants

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