Health Canada safety review finds low incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) reported in Canada
- Starting date:
- November 24, 2017
- Type of communication:
- Information Update
- Medical Device
- Source of recall:
- Health Canada
- Identification number:
November 24, 2017
For immediate release
OTTAWA – 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. It is not a cancer of the breast tissue. BIA-ALCL usually presents as an accumulation of fluid (known as seroma fluid) between the implant and the surrounding tissue. The cause of BIA-ALCL is unknown. BIA-ALCL occurs with both saline-filled and silicone gel-filled breast implants.
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 you should do
If you have breast implants
- Conduct regular breast self-exams and see your surgeon for periodic follow-up.
- If you experience unusual changes to your breasts, including breast pain, sudden swelling, or a lump, consult a healthcare professional who can send you for subsequent testing if necessary.
- Removal of breast implants is not recommended if you do not have any signs or symptoms suggestive of BIA-ALCL.
If you are considering a breast implant
- If you are considering a breast implant, you are encouraged to get more information and to consult with a healthcare professional about the risks and benefits associated with breast implants.
- You can also find such information by visiting the breast implant section of the Health Canada website and consulting with your healthcare professional for more information.
Information for healthcare professionals
- Learn more about the signs, symptoms and testing steps to recognize and diagnose BIA‑ALCL.
- Report incidents of BIA-ALCL to Health Canada. Include specific details, such as symptoms, how BIA-ALCL was discovered, age of patient at implantation, prior implant history, age of patient at discovery, tests conducted to diagnose, staging information, course of therapy and clinical outcomes.
Report health or safety concerns
To report a side effect to a health product to Health Canada:
- Call toll-free at 1-866-234-2345.
- Visit Health Canada’s webpage on Adverse Reaction Reporting for information on how to report online, by mail or by fax.