On May 28, 2019, upon completing a safety review, Health Canada has officially suspended Allergan’s licence to sell its Biocell textured breast implants, finding the products are linked to an increased risk of a rare cancer. At Health Canada’s request, Allergan agreed to voluntarily recall unused Biocell devices from the Canadian market[1].
The decision followed the department’s notice to suspend in April 2019, stating that if Allergan’s response was unsatisfactory, it would suspend Biocell’s medical device license, prohibiting the implants from being sold in Canada.
Implants linked to cancer risk
Allergan filed material with Health Canada last month in an attempt to keep the implants on the market but, in making its decision, the department deemed the evidence “insufficient.” Health Canada found that the rate of BIA-ALCL in Canada to be significantly higher in patients with macro-textured breast implants compared to other implants.
BIA-ALCL is a type of non-Hodgkin lymphoma (a cancer that affects the immune system) that can develop months or years after an implant surgery. Symptoms usually take years to develop and can present more than 10 years following implant surgery.
The risk
It’s been estimated that 700 cases of BIA-ALC, predominantly linked to textured implants, have been found globally. As a result, Europe and Brazil have removed the implants from the market.
Health Canada has been notified of 28 confirmed Canadian cases of BIA-ALCL, of which 24 (86%) involve Allergan’s Biocell breast implant.
Treatment Recommendations
Health Canada has advised that if you have an Allergan Biocell breast implant, that removing your breast implants is not recommended if you do not have any signs or symptoms suggesting BIA-ALCL. Patients should always discuss the risks and benefits of removal with their healthcare professional.
If you are experiencing unusual changes to your breasts, including breast pain, sudden swelling, or a lump, consult a healthcare professional right away.
Canada Allergan lawsuit
Howie Sacks and Henry LLP has partnered with Beyond Law LLP to pursue individual mass tort actions on behalf of women and their families who have suffered injury due to Allergan breast implants.
With decades of experience in personal injury law, Howie Sacks and Henry LLP handles every personal injury claim with professionalism and compassion. Beyond Law LLP is a Toronto-based litigation firm focusing on serious personal injury cases. The firm prides itself on its hands-on and personalized approach.
Contact us
Call us today at 877-771-7006 for a free consultation.
[1] http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/69520a-eng.php
