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OTTAWA – Health Canada says it will suspend licences for Biocell breast implants unless the company that makes them provides new evidence about their safety.
The Health Department says it conducted a scientific assessment of macro-textured implants as part of its larger ongoing safety review of breast implants and a rare associated cancer, which was launched in November 2018.
It says breast implant-associated anaplastic large cell lymphoma is a 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, and rather usually presents as an accumulation of fluid between the implant and the surrounding tissue, and its cause is unknown.
Allergan, the company that manufactures the implants, did not immediately respond to a request for comment.
Health Canada says it continues to monitor and review all available scientific and clinical information regarding the safety of textured breast implants, including any new evidence provided by Allergan in the next 15 days.
The department says if a satisfactory response is not received by then, it will suspend licences for the Biocell implants, which means the products would no longer be allowed to be sold in Canada.
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