Summary Safety Review - Breast Implants - Assessing the Potential Risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma

Review decision

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.


Issued: 2022-04-06

Product

Breast Implants

Potential Safety Issue

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare but serious type of cancer that affects the immune system

Key Messages

  • Health Canada completed safety reviews in 20171 and 20192 on Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare but serious cancer of the immune system linked with breast implants. This updated review was performed as part of Health Canada’s commitment to monitor for newly reported Canadian cases of BIA-ALCL.
  • The updated review found that the estimated risk of BIA-ALCL continues to vary according to surface texture of the breast implant:
    • The macro-textured implants have an estimated risk of 1 in 1,636, which would be considered rare3 . Although no longer available in Canada, macro-textured breast implants remain implanted in some people.
    • The micro-textured implants have an estimated risk of 1 in 17,627, which would be considered very rare3.
    • There are no confirmed cases of BIA-ALCL in individuals in Canada who have a known history of only smooth breast implants.
  • Preventive removal of breast implants is not recommended in the absence of signs or symptoms suggestive of BIA-ALCL since:
    • BIA-ALCL is commonly slow growing and when diagnosed at early stages has an excellent health outcome, particularly when treated with surgery4.
    • 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.
  • People should discuss the risks and benefits of implant removal with their healthcare professional if they have concerns.
  • Health Canada has worked with manufacturers to strengthen the labelling of all breast implants with information regarding the risk of BIA-ALCL by including box warnings of this risk5.
  • Heath Canada will communicate about the risk of BIA-ALCL to the public through a Public Advisory.
  • Health Canada will continue to monitor and publish newly reported Canadian cases of BIA-ALCL on the Public Health Infobase6, and will continue to support informed decision-making for people considering breast implants.

Overview

This safety review on BIA-ALCL is an update to the 20171 and 20192 safety reviews on this topic. The 2019 safety review found an increased risk of BIA-ALCL with the use of macro-textured breast implants. As a result, Health Canada suspended the medical device licences of Biocell macro-textured breast implants, which were the only macro-textured breast implants available in Canada at that time.

Since the publication of the 2019 safety review, there has been an increase in the number of BIA-ALCL cases reported to Health Canada and internationally. New information has also been published in the scientific literature and by international regulatory agencies. The purpose of this update was to consider new information and determine if additional measures are needed to help mitigate the risk of BIA-ALCL. Even though macro-textured breast implants have not been available in Canada since May 2019, they remain implanted in some people.

BIA-ALCL is a serious but rare type of non-Hodgkin lymphoma, a cancer that affects the immune system, that may develop many months or years after a breast implant procedure. It is not a cancer of the breast tissue. BIA-ALCL usually, but not necessarily, presents as an accumulation of fluid between the implant and the surrounding tissue. It can also present as a lump or a mass. The cause of BIA-ALCL is not fully understood.

Use in Canada

  • Breast implants are regulated in Canada as class IV medical devices, the highest risk class of medical devices.
  • Breast implants are licensed for sale in Canada to increase breast size, correct or improve a previous breast implant surgery, correct breast unevenness, or rebuild breast tissue following surgery.
  • Breast implants are made of a smooth or textured (micro- or macro-textured) silicone shell and are typically filled with silicone gel or sterile salt water (saline).
  • There are no macro-textured implants currently available in Canada. However, macro-textured breast implants remain implanted in some people.
  • At the time of this review, there were 3 manufacturers with licences for the sale of breast implants in Canada: Allergan Inc., Mentor (Johnson & Johnson Medical Products, a division of J&J Inc), and Ideal Implant Inc.
    • Of the 16 licences for these 3 manufacturers, 6 are for micro-textured breast implants, and 10 are for smooth breast implants.
  • In March 2022, a fourth manufacturer, Sientra Inc., obtained 2 new licences to sell smooth breast implants in Canada. As such, the risk of BIA-ALCL was not considered for Sientra breast implants as part of this review.

Safety Review Findings

  • Health Canada reviewed information from the Canadian incident reporting database, scientific literature, international regulatory agencies and from the manufacturers.
  • As of September 2021, Health Canada has received 64 confirmed Canadian cases of BIA-ALCL, including 3 deaths. The implant texture was known in 51 of the 64 confirmed cases, and all 51 cases involved textured devices.
  • The updated review found that the estimated risk of BIA-ALCL continues to vary according to surface texture of the breast implant:
    • Although no longer available in Canada, the macro-textured implants have an estimated risk of 1 in 1,636, which would be considered rare3.
    • The micro-textured implants have an estimated risk of 1 in 17,627, which would be considered very rare3.
    • There are no confirmed cases of BIA-ALCL in individuals in Canada who have a known history of only smooth breast implants.
  • Reasons for the rise in reports might include:
    • growing awareness of BIA-ALCL among individuals and the health community that has led to increased reporting;
    • the application of consistent diagnostic criteria; and
    • an increase in the actual number of cases, as BIA-ALCL can take months, but usually years, to develop.
  • With this in mind, it is expected that cases of BIA-ALCL cases will increase over time as these devices remain implanted in some Canadians.
  • The increase in reported cases in Canada is consistent with what is being seen in other countries, including the United States7. 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).

Conclusions and actions

  • Conclusions:
    • While the cause of BIA-ALCL is not fully understood, Health Canada's latest safety review found that the risk of BIA-ALCL continues to be higher with macro-textured breast implants compared to breast implants with other surface textures (micro-textured and smooth).
    • While no longer available in Canada, for individuals with macro-textured implants, the estimated risk has approximately doubled since 2019. Given that BIA-ALCL can take months, but usually years, to develop, cases of BIA-ALCL can be expected to increase over time.
    • For the micro-textured and smooth breast implants available in Canada, the estimated risk remains approximately the same as the estimated risk reported in May 2019.
    • Preventive removal of breast implants is not recommended in the absence of signs or symptoms suggestive of BIA-ALCL since:
      • BIA-ALCL is commonly slow growing and when diagnosed at early stages has an excellent health outcome, particularly when treated with surgery4.
      • 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.
    • People should discuss the risks and benefits of implant removal with their healthcare professional if they have concerns.
  • Actions:
    • Health Canada has worked with manufacturers to strengthen the labelling of all breast implants with information regarding the risk of BIA-ALCL by including box warnings of this risk5.
    • Health Canada will communicate about the risk of BIA-ALCL to the public through a Public Advisory.
    • Health Canada will continue to work with stakeholders to support informed decision-making for people considering breast implants. People with breast implants or who are considering them can find more information by visiting the breast implant website on Canada.ca.
    • Health Canada will continue to monitor and publish newly reported Canadian cases of BIA-ALCL on the Public Health Infobase6, including a yearly follow-up with manufacturers of breast implants. Health Canada will take appropriate and timely action if any new health risks are identified.
    • For timely and relevant up-to-date information on breast implants, Canadians can subscribe to receive Health Canada updates on breast implants, including:
      • general information;
      • safety or recall information;
      • risk communications; and
      • updates to the Public Health Infobase and website pages.

Additional information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international medical device incident reports, and what is known about the use of these medical devices both in Canada and internationally.

For additional information about Health Canada's assessment, contact the Medical Devices Directorate.

References

  1. Summary Safety Review - Breast Implants - Assessing the potential risk of cancer (Breast implant associated-anaplastic large cell lymphoma) - Health Canada. Issued: 2017-11-24
  2. Summary Safety Review - Breast Implants - Assessing the potential risk of cancer (Breast implant associated anaplastic large cell lymphoma) - Health Canada. Issued: 2019-05-28
  3. World Health Organization. Quality Safety Efficacy: Definitions
  4. Clemens MW, Jacobsen ED, Horwitz SM. 2019 NCCN Consensus Guidelines on the Diagnosis and Treatment of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Aesthetic Surgery Journal. 2019;39(S1):S3-S13
  5. Breast implants: Health Canada’s role - Health Canada. 2021
  6. Public Health Infobase - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) - Canadian Surveillance 2021 Data
  7. U.S. Food & Drug Administration. Press Announcements: FDA Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant-Associated Lymphoma. 2020

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