OTTAWA, April 4, 2019 /CNW/ - To protect Canadian patients from the rare but serious risk of breast implant-associated anaplasticlarge cell lymphoma (BIA-ALCL), Health Canada is advising Allergan that the Department intends to suspend its licences for Biocell breast implants as a precautionary measure.
This follows the completion of Health Canada's scientific assessment
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.
Health Canada continues to monitor and review all available scientific and clinical information regarding the safety of textured breast implants. This includes any new evidence provided by Allergan in the next 15 calendar days. If a satisfactory response is not received by then, it is Health Canada's intention that the Biocell medical device licences will be suspended. This means that the product would no longer be permitted to be sold in Canada.
Health Canada is engaging internationally on this issue, including recent meetings with the French regulator, Agence Nationale de Sécurité du Médicament et des Produits de Santé, and the U.S. Food and Drug Administration.
Health Canada has been in contact with the Agence Nationale de Sécurité du Médicament et des Produits de Santé concerning its decision today to suspend the sale of all macro-textured breast implants and polyurethane-coated breast implants. Allergan's Biocell implants are the only macro-textured devices available in Canada. There are no polyurethane-coated breast implants for sale in Canada.
The entirety of Health Canada's safety review of breast implants and BIA-ALCL will be available by the end of April. Health Canada will not hesitate to take further action, as necessary.
Health Canada takes patient health and safety very seriously. As a result, it has started a second safety review on the systemic symptoms associated with breast implants. The results of this second safety review will be made public in summer 2019.
The world of medical devices is constantly evolving, and the Government of Canada is working to ensure that regulations and guidance keep pace. 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. In addition, to better support women's health, Health Canada has established a new Scientific Advisory Committee on Health Products for Women.
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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