Health Canada has suspended the licences for Biocell breast implants linked to a rare but serious form of cancer.
Following a 2017 safety review on “breast implant-associated anaplastic large cell lymphoma” (BIA-ALCL), licences for Allergan’s Biocell textured breast implants have been suspended because the potential risks associated with them outweigh their benefits, Health Canada said in a release today.
According to the health agency, these are the only macro-textured implants available in Canada.
Health Canada says it has been notified of 26 confirmed Canadian cases of breast-implant-associated anaplastic large cell lymphoma, 22 of which (85%), involve Allergan’s Biocell breast implants.
BIA-ALCL is a “serious but rare type” of non-Hodgkin lymphoma, which is cancer that affects the immune system, that may develop many months or years after a breast implant procedure.
However, it is not a cancer of the breast tissue and usually presents as an accumulation of fluid (known as seroma fluid) between the implant and the surrounding tissue.
According to Health Canda, while its cause is unknown, “possible risk factors and causes for the disease include the high surface area of the implants, genetic factors, and long-term (chronic) inflammation around the implant triggered by factors such as bacteria around the implant.”
Moving forward, no one can sell Allergan’s Biocell breast implants in Canada or import them into the country.
At Health Canada’s request, Allergan has agreed to voluntarily recall unused Biocell devices from the Canadian market. Additionally, Allergan’s other breast implant products are not affected by this decision.
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.
Patients should discuss the risks and benefits of removal with their healthcare professional.