In a statement released Thursday afternoon, the federal agency says it wants to “protect Canadian patients against the rare but serious risk of anaplastic large cell lymphoma associated with breast implants (LAGC-AIM).”
The manufacturer of Biocell prostheses, Allergan Canada, has been informed by the Ministry of Health that its sales licenses are suspended “as a precautionary measure,” it says.
The company has 15 days to convince the federal government of the safety of its products, otherwise Ottawa intends to completely ban commercialization.
Health Canada says it has made this decision following a “scientific evaluation of macro-textured implants … as part of its broader and ongoing review of the safety of breast implants”.
This review was launched in November due to reports of an increase in LAGC-AIM-type cases at home and abroad. The health agency says it has identified 28 cases in Canada, 24 of which are linked to Biocell implants manufactured by Allergan.
According to Health Canada, LAGC-AIM is a serious form of non-Hodgkin’s lymphoma that can develop months or years after implant placement. It is not a form of breast cancer. It manifests itself as an accumulation of fluid between the implant and the surrounding tissues.
In its press release, the ministry mentions having discussed the issue with its French counterparts, the National Agency for the Safety of Medicines and Health Products, and the Americans, the “Food and Drug Administration”.
The Biocell implant model would be the only “macro-textured” product available in Canada.
Recommendations to patients
Women who have had breast implant surgery should contact their surgeon to confirm the type of product they have received.
Information is available on the Breast Implants page of the canada.ca website.
It is recommended to conduct a breast self-examination regularly and to consult your doctor for periodic follow-up.
In case of pain, sudden swelling or breast mass, women are advised to consult their doctor.