Health Canada has suspended the licences for Biocell breast implants because of an increased cancer risk.
The department says it has completed an update to a safety review, which was launched two years ago, and suspended the licences for Allergan’s Biocell macro-textured breast implants because the potential risks associated with them outweigh their benefits.
It says in a statement that it has been notified of 26 confirmed Canadian cases of breast-implant-associated anaplastic large cell lymphoma, of which 22 involve Allergan’s Biocell breast implants, although no cases have been reported with any smooth surface implants.
It says Allergan has agreed to voluntarily recall unused Biocell devices from the Canadian market.
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Health Canada says breast-implant-associated anaplastic large cell lymphoma is a rare type of non-Hodgkin lymphoma, a cancer that affects the immune system, which may develop many months or years after a breast implant procedure.
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It is not a cancer of the breast tissue and usually presents as an accumulation of fluid between the implant and the surrounding tissue.
Health Canada says its cause is unknown.
The department says if you have an Allergan Biocell breast implant or another type of breast implant, removing them is not recommended if you do not have any symptoms.
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It says patients should discuss the risks and benefits of removal with their health-care professional, and anyone who doesn’t know what type of breast implant they have should speak with the health-care provider who did the surgery.
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