Health CanadaGeneral Alert

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

Veröffentlicht: 6. April 2022Rückruf-ID: 64057Kategorie: VerbraucherprodukteLand: Kanada
Canada
Safety AlertHealth CanadaCanadaCanada

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

Recalling Firm: Communications and Public Affairs Branch

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Grund für den Rückruf / Gefahr

New safety information

Produktbeschreibung & Identifikation

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.

Betroffene Produkte

Breast implants

Additional Source Details

FieldValue
N I D64057
U R Lhttps://recalls-rappels.canada.ca/en/alert-recall/updated-safety-review-breast-implants-underscores-continuing-importance-monitoring
IssueNew safety information
TitleUpdated safety review of breast implants underscores the continuing importance of monitoring for cancer; increased risk with highly textured (macro-textured) implants
ProductBreast implants
Archived0
CategoryMedical devices
Last updated2022-04-06
OrganizationCommunications and Public Affairs Branch
What you should doIf 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.

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Check the model number, serial number, and date stamp on the rating label on the back or underside of the product.

2Isolate & Discontinue Use

Immediately discontinue using the product. Unplug electrical items and keep juvenile items out of reach of children.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (Health Canada).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought Updated safety review of breast implants underscores the continuing importance of monitoring for cancer; increased ri...?

Immediately stop using the product and keep it out of reach of children. Disconnect power if electrical, and do not attempt makeshift home repairs.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (Health Canada). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Übersicht

  • Rückrufendes UnternehmenCommunications and Public Affairs Branch
Recall Hazard Severity
Caution (Class III)
Offizielle Behördenwarnung

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🚨 SAFETY ALERT: Communications and Public Affairs Branch - Updated safety review of breast implants underscores the continuing importance of monitoring for cancer; increased risk with highly textured (macro-textured) implants

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