OTTAWA, Nov. 24, 2017 /CNW/ - Health Canada's recent safety review of breast implant-associated anaplastic large cell lymphoma(BIA-ALCL) found that the rate of cases reported to the Department is low.
BIA-ALCL is a rare type of non-Hodgkin lymphoma (a cancer that affects the immune system) that may develop many months or years following a breast implant procedure.
Health Canada undertook the safety review because of an increase in reporting of BIA-ALCL internationally.
Five confirmed Canadian 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 during this time period.
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 five reported Canadian cases of BIA-ALCL involved textured surface 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 labelling for all breast implants. Health Canada is also communicating this important 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, to help ensure that the benefits of these products continue to outweigh the risks. Health Canada will also monitor cases of BIA-ALCL through an annual follow-up with manufacturers of breast implants. If new safety information is identified, Health Canada will take action as required.
What consumers should do
If you have breast implants
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SOURCE Health Canada
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