Updated safety review of breast implants underscores the continuing importance of monitoring for cancer; increased risk with highly textured (macro-textured) implants
What the notice records
| Product | Breast implants |
|---|---|
| Issue | New safety information |
| What you should 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 treatableThere are risks associated with surgery to remove or replace breast implantsRemoval of the breast implants may not eliminate the risk of BIA-ALCLSpeak 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 professionalsProvide 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 concernsReport complaints involving medical devices to Health Canada.Stay connected with Health Canada and receive the latest advisories and product recalls. |
| Category | Medical devices |
| Publishing body | Communications and Public Affairs Branch |
| Class | Class not stated |
| Last updated | 2022-04-06 |
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