Advisory - Updated safety review of breast implants underscores the continuing importance of monitoring for cancer; increased risk with highly textured (macro-textured) implants

OTTAWA, ON, April 6, 2022 /CNW/ -

Summary
Product: Breast implants
Issue: Health Canada's updated safety review of breast implants and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) found that there continues to be an increased risk of BIA-ALCL with highly textured (macro-textured) implants compared to less textured (micro-textured) or smooth implants.
What to do: People with breast implants should monitor for signs of BIA-ALCL. Those considering breast implants should speak with their healthcare professional about the potential risks associated with these medical devices.

Issue
Health Canada has updated its 2019 and 2017 safety reviews on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare but serious cancer of the immune system that can develop next to a breast implant. This review found that there continues to be an increased risk of BIA-ALCL with the use of highly textured (macro-textured) implants in comparison with those having less textured (micro-textured) or smooth implants.

The 2019 safety review found that the estimated risk of BIA-ALCL in Canada is significantly higher in individuals with macro-textured breast implants compared to micro-textured or smooth implants. As a result, Health Canada suspended the licences for Allergan's Biocell breast implants (the only macro-textured implants available in Canada).

While macro-textured implants have not been available in Canada since 2019, they remain implanted in individuals who received their implants prior to Allergan's suspension.

Updated data from 2019 indicates that that the estimated risk of developing BIA-ALCL with Allergan Biocell macro-textured implants has roughly doubled since Health Canada's 2019 review. For other types of implants (micro-textured and smooth), the risk estimates are relatively the same as in 2019. The following table compares 2019 risk estimates to the updated risk estimates, derived from updated and new confirmed Canadian cases for each type of device:

Implant	2019 risk estimate	Updated risk estimate
Allergan Biocell macro-textured implants	1 in 3,565	1 in 1,636
Mentor Siltex micro-textured breast implants	1 in 16,703	1 in 17,627
Smooth surface implants	0	0

An increase in reported cases in Canada is consistent with trends seen in other countries, including the United States. Canadian and international data continue to indicate that the risk of BIA-ALCL is higher with macro-textured breast implants compared to breast implants with other surface textures (micro-textured and smooth).

While this information is concerning for people who have Allergan Biocell implants, preventive removal of breast implants is not recommended if there are no signs or symptoms suggestive of BIA-ALCL. Individuals who have, or who are considering breast implants, should speak to their healthcare provider about their benefits and risks.

Health Canada will continue to raise awareness of BIA-ALCL to support patient safety. The Department is launching a BIA-ALCL Canadian Surveillance Data Blog, and will continue to monitor and report new Canadian cases of BIA-ALCL. The Department also maintains detailed information on breast implants to support health professionals and people who have, or who are considering implants.

Health Canada will also continue to work with manufacturers to help support patient safety. To date, manufacturers have implemented comprehensive labelling changes, including adding strong warnings about the risk of BIA-ALCL, and patient decision checklists. Health Canada will also conduct yearly follow-ups with manufacturers.

The Department will take appropriate and timely action if any new health risks are identified.

What to do

If you have an Allergan Biocell breast implant or another type of breast implant:

• Removing your breast implants is not recommended if you do not have any signs or symptoms suggesting BIA-ALCL. Discuss the risks and benefits of removal with your healthcare professional, keeping in mind that:
• BIA-ALCL is usually slow-growing and, when diagnosed at early stages, is highly treatable
• There are risks associated with surgery to remove or replace breast implants
• Removal of the breast implants may not eliminate the risk of BIA-ALCL
• Speak with the healthcare provider who did your surgery if you don't know what type of breast implant you have.
• Conduct regular breast self-exams and see your healthcare professional for periodic follow-ups. If you experience unusual changes in your breasts, including breast pain, sudden swelling, or a lump, consult a healthcare professional as soon as possible.
• Find information on the risks associated with breast implants, including the risk of BIA-ALCL, by visiting the breast implant section on Canada.ca, and subscribe to receive email updates from Health Canada on breast implants.

If you are considering getting breast implants:

• Get information about the risks and benefits of breast implants and discuss them with a healthcare professional.
• Find helpful information about breast implants, including what you should ask the surgeon, by visiting the breast implant section on Canada.ca, and subscribe to receive email updates from Health Canada on breast implants.
• Know that breast implants are not lifetime devices. The longer you have breast implants, the greater the chances are that you will develop complications, some of which will require more surgery. Changes to the shape of your breasts may be irreversible.

Information for healthcare professionals

• Provide individuals with information about the risks, including the risk of BIA-ALCL, and benefits associated with their options, so that they can make an informed decision.
• Continue to monitor individuals for symptoms of BIA-ALCL. Stay informed about the signs and symptoms of BIA-ALCL, and the diagnostic guidelines used to recognize and diagnose BIA-ALCL.
• Report incidents of BIA-ALCL and other incidents related to breast implants to Health Canada. Include specific details wherever possible, such as type of implant, symptoms, how BIA-ALCL was discovered, age of patient at implantation, prior implant history, age of patient at discovery, tests conducted to diagnose, staging information, treatment, and clinical outcomes, to help Health Canada better assess the safety issue.
• Stay informed by customizing your MedEffect e-Notice subscription and receive breast implant information.

Report health or safety concerns

• Report complaints involving medical devices to Health Canada.
• Stay connected with Health Canada and receive the latest advisories and product recalls.

SOURCE Health Canada

Media enquiries, Health Canada, [phone], [email protected]; Public enquiries, [phone], 1-866 225-0709, [email protected]