and Drug Administration
Breast implant Photo from the US Food
Results of a safety review suggest there is a low incidence of breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) in Canada.
Health Canada undertook the review because of an increase in reporting of BIA-ALCL internationally.
The review showed that 5 confirmed cases of BIA-ALCL have been reported by Canadian manufacturers in the last 10 years.
This is equal to 1 case of BIA-ALCL per 77,190 implants sold, or 0.0013%.
However, Health Canada acknowledges that some cases may not have been reported to the manufacturers or Health Canada.
Available data suggest that BIA-ALCL is more frequently reported with textured surface implants than smooth surface implants. Textured surface implants account for a quarter of all breast implants sold in Canada.
Four of the 5 reported Canadian cases of BIA-ALCL involved textured implants. The surface type was not reported in the remaining case.
The rate of occurrence of BIA‑ALCL per textured implant sold in Canada is 1 case per 24,177 or 0.0041%.
As a result of its safety review, Health Canada is working with manufacturers to update the safety information on the product labeling for all breast implants.
The agency is also communicating this safety information to Canadians through the Recalls and Safety Alerts database on the Healthy Canadians website.
Health Canada continues to monitor the safety profile of breast implants through its post-market surveillance program.
The agency will also monitor cases of BIA-ALCL through an annual follow-up with manufacturers of breast implants.
Health Canada is recommending that healthcare professionals learn about the signs, symptoms, and testing steps to recognize and diagnose BIA‑ALCL.
In addition, healthcare professionals in Canada should report incidents of BIA-ALCL to Health Canada. These reports should include specific details, such as symptoms, how BIA-ALCL was discovered, the age of the patient at implantation, prior implant history, the age of the patient at discovery, tests conducted to diagnose BIA-ALCL, staging information, the course of therapy, and clinical outcomes.
Reports can be made by calling Health Canada at 1-866-234-2345. Alternatively, visit Health Canada’s webpage on Adverse Reaction Reporting for information on how to report online, by mail, or by fax.
