OTTAWA, Feb. 12, 2019 /CNW/ - Health Canada will be updating its safety review of breast implant-associated anaplastic largecell lymphoma (BIA-ALCL) following an increase in reports of Canadian cases. As of January 1, 2019, Health Canada has received reports of 22 confirmed and 22 suspected Canadian cases of BIA-ALCL. In its initial safety review
It is expected that the updated safety review will be completed in spring 2019. Upon completion, Health Canada will take action as required and inform Canadians and healthcare providers.
BIA-ALCL is a serious but rare type of non-Hodgkin lymphoma (a cancer that affects the immune system) that may develop many months or years after 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 consulted with the Canadian Society of Plastic Surgeons and the Canadian Society for Aesthetic Plastic Surgery during its initial review, and is again engaging with these associations during this updated review.
Health Canada is also working with its international counterparts to gather information to inform any regulatory actions, including the European Commission's Scientific Committee on Health, Environmental and Emerging Risks, France's health regulator, Agence Nationale de Sécurité du Médicament et des Produits de Santé and the U.S. Food and Drugs Administration.
We will continue to work closely with our international partners to ensure alignment when appropriate and to exchange data related to the safety of these products.
As part of Health Canada's Action Plan on Medical Devices, announced in December 2018, the Department is taking steps to strengthen the monitoring and promotion of medical device incident reporting. This includes strengthening regulations and taking action to improve the reporting of medical device incidents by industry, healthcare providers and Canadians.
What you should do:
If you have breast implants
If you are considering getting breast implants
Information for healthcare professionals
Report health or safety concerns
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SOURCE Health Canada
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