Language selection

Search

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) – Canadian Surveillance 2021 Data

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a cancer of the immune system that can develop next to a breast implant.

Knowledge of BIA-ALCL continues to evolve. For more information on BIA-ALCL, please visit Health Canada’s Breast Implant Risks page.


Understanding the Data Blog

This data is intended to inform Canadians of the number of cases of BIA-ALCL that have been reported to Health Canada. This data cannot be used to determine an individual’s risk of developing BIA-ALCL. Since each person’s health status and personal circumstances are different, concerns regarding BIA-ALCL should be discussed with a health care provider.


Canadian BIA-ALCL Surveillance

  • Given the growing number of cases globally, Canadian BIA-ALCL Surveillance is designed to monitor confirmed and suspected cases of BIA-ALCL within Canada.
  • Cases of BIA-ALCL can be reported directly to Health Canada through the Consumer Medical Device Report Form by individuals and/or their health care providers. Cases are also reported by the breast implant manufacturer and importer, and by hospitals, who have reporting obligations.
  • Therefore, reports are received from manufacturers and importers, health care providers, hospitals, and individuals. These reports are reviewed by Health Canada to identify duplicate reports and to classify cases using the criteria outlined below.
  • Surveillance will remain in place until there is a downward trend in BIA-ALCL cases in Canada following a minimum of nine (9) years of surveillance. Canadian BIA-ALCL Surveillance will continue until at least 2030.
  • The data presented here will be updated annually.

Case Identification

Confirmed Case*

  • Individuals that had or currently have breast implants, AND
  • Confirmation of BIA-ALCL biomarkers, and/or
  • A report from a health care provider indicating a BIA-ALCL diagnosis or treatment

* Pathology results are needed to properly diagnose BIA-ALCL. In recognition of the well established diagnostic criteria, if a case is submitted by a physician indicating a diagnosis of, or treatment for BIA-ALCL, proof of pathology results are not required to be included as a confirmed case.

Suspected Case

  • Individuals that had or currently have breast implants, AND
  • Partial biomarkers for BIA-ALCL, and/or
  • Indication from a health care provider that it is a suspected case of BIA-ALCL

Exclusions

  • Tertiary reports submitted to Health Canada from social media, news articles, journals articles, etc.

2021 Canadian BIA-ALCL Surveillance Estimates

  • Based on the data available, it is estimated that there are currently 64 confirmed and 25 suspected cases of BIA-ALCL in Canada.
  • Health Canada is aware of 3 deaths that can be attributed directly or indirectly to BIA-ALCL.

Figure 1: Yearly distribution of confirmed and suspected BIA-ALCL casesFootnote 1

Figure 1 - Text description
Yearly distribution of confirmed and suspected BIA-ALCL casesFootnote 1
Year Confirmed cases Suspected cases
Before 2014 9 2
2014 2 2
2015 6 1
2016 6 1
2017 9 2
2018 5 3
2019 16 4
2020 10 4
2021 1 6

Figure 2: Surface texture distribution of BIA-ALCL cases (confirmed and suspected cases combined)

Figure 2 - Text description
Surface texture distribution of BIA-ALCL cases (confirmed and suspected cases combined)
Surface texture Number of cases
Macrotextured 64
Microtextured 2
SmoothFootnote 2 1
Unknown 22

Figure 3: BIA-ALCL case presentation with a seromaFootnote 3 (confirmed and suspected cases combined)

Figure 3 - Text description
BIA-ALCL case presentation with a seromaFootnote 3 (confirmed and suspected cases combined)
With a seroma Number of cases
No 23
Yes 44
Unknown 22

Limitations of the data

  • These figures are based on data submitted to the Health Canada before September 30, 2021. New or revised data submitted after this date will be reflected in future updates.
  • Limited health care provider and individual awareness prior to the recall of Allergan’s Biocell breast implants in 2019 may result in underreporting for cases that were diagnosed prior to this date.
  • Some data submitted to Health Canada may be incomplete and/or challenging to audit.
  • Due to multiple data providers, the case numbers presented may contain unidentified duplicates.
  • Underreporting to Health Canada may result in more incidents of BIA-ALCL than reflected in this dataset.

Notes on the data


Date modified: