Summary Safety Review - Breast Implants - Assessing the potential risk of cancer (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: 2019-05-28

Product

Breast Implants

Potential Safety Issues

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Key Messages

  • Breast implants are medical devices licensed for sale in Canada to increase breast size, correct or improve the results of a previous breast implant surgery, correct breast unevenness, or rebuild breast tissue following surgery. Breast implants marketed in Canada are made of a smooth or textured silicone shell and are filled with silicone gel or sterile salt water (saline).
  • Health Canada completed an update to its 2017 safety review on Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a rare but serious complication linked with breast implants. This updated review was triggered by newly reported Canadian cases, as well as newly published literature and information issued by international regulatory agencies.
  • Although the cause of BIA-ALCL is not fully understood, the available scientific and clinical evidence strongly suggests an increased risk of BIA-ALCL in individuals with highly textured (macro-textured) implants in comparison with those having less textured (micro-textured) or smooth implants. Biocell breast implants made by Allergan are the only macro-textured implants currently available in Canada.
  • Health Canada's updated safety review found an increased risk of BIA-ALCL with the use of macro-textured breast implants. On May 27, 2019, Health Canada notified Allergan of the suspension of the licences for Biocell breast implants.
  • For the remaining authorized breast implants sold in Canada, Health Canada will:
    • work with manufacturers to strengthen the device safety information (Instructions for Use) of all breast implants;
    • work with stakeholders to develop new information tools to support patients' informed decision-making; and
    • continue to actively monitor the safety of these medical devices.

Overview

This safety review on BIA-ALCL is an update to one completed in June 2017, and focused on reviewing all new information and proposing additional ways to further reduce the risk of BIA-ALCL. Since the original safety review, there has been an increase in the number of BIA-ALCL cases reported to Health Canada and internationally. Furthermore, new articles in the medical literature have been published, and new information has been provided by international regulatory agencies on this topic.

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. The first case was described in 19971. It is not a cancer of the breast tissue. BIA-ALCL usually presents as an accumulation of fluid (known as seroma fluid) between the implant and the surrounding tissue, but can also present as a lump/mass. The cause is currently unknown. The rate of BIA-ALCL in Canada varies depending on the type of breast implant, from 1 in 3,565 for Allergan Biocell macro-textured breast implants to 1 in 16,703 for Mentor Siltex micro-textured breast implants. Health Canada has received 26 confirmed Canadian cases of BIA-ALCL, of which 22 (85%) involve Allergan's Biocell macro-textured breast implants. There are no reported Canadian cases of BIA-ALCL associated with smooth breast implants.

Use in Canada

  • Breast implants are regulated in Canada as class IV medical devices, the highest risk class of medical devices.
  • Breast implants are medical devices 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 currently 3 manufacturers with licences for the sale of breast implants in Canada: Allergan Inc., Mentor, and Ideal Implant Inc.

Safety Review Findings

  • As of May 2019, Health Canada received information on 28 confirmed Canadian cases of BIA-ALCL. Since the completion of the safety review, Allergan has confirmed 2 duplicates in the Canadian cases, bringing the total number of confirmed BIA-ALCL cases to 26. One case involved metastatic disease, where cancer spread to other parts of the body. The implant texture was known in 25 of the 26 confirmed cases of BIA-ALCL, and all 25 involved textured devices (22 with Allergan breast implants, 2 with Mentor breast implants and 1 with a Silimed implant that is not licensed in Canada). No deaths have been reported in Canada.
  • Based on Canadian confirmed case data and device sales data provided by the manufacturers, Health Canada estimates that the risk of BIA-ALCL are 1 in 3,565 for Allergan Biocell macro-textured breast implants and 1 in 16,703 for Mentor Siltex micro-textured breast implants.
  • The number of BIA-ALCL cases and estimated disease rate are evolving. A recent study detailed 656 cases of BIA-ALCL worldwide (all implant types), including 17 deaths2. Consistent with what is observed in Canada, the scientific literature has shown an increased risk of BIA-ALCL with Biocell macro-textured breast implants. A study collected information on 81 BIA-ALCL cases in Australia and New-Zealand, and calculated the risk of disease based on sales data as being 1 in 3,345 for Biocell macro-textured breast implants and 1 in 86,029 for Mentor Siltex micro-textured breast implants. This is equal to a 16.52 times higher risk for Biocell devices3.
  • International regulatory agencies have reported additional BIA-ALCL cases since the June 2017 Health Canada safety review. A total of 457 unique BIA-ALCL cases have been reported to the US FDA, including 9 deaths (as of September 30, 2018). In addition, 78 cases were reported in Australia, including 4 deaths (as of May 3, 2019), and 59 confirmed cases in France (as of March 2019).
  • Canadian and international data indicate that the risk of BIA-ALCL is higher with macro-textured breast implants compared to breast implants with other surface textures (micro-textured, smooth).
  • The cause of BIA-ALCL is not fully understood but is likely the result of multiple factors. Proposed risk factors and causes for the disease currently include the high surface area of implants, genetic factors and long-term (chronic) inflammation around implants (peri-implant). The chronic peri-implant inflammation may be triggered by factors such as bacteria around the implant, the implant shell, or breakdown products of the implant shell.
  • A review of the physician and patient device safety information (Instructions for Use) identified areas that require strengthening.
  • Canadian plastic surgeon associations were consulted during the safety review update. They informed Health Canada that they believe the use of macro-textured breast implants has been declining among Canadian plastic surgeons since 2010, in part due the risk of BIA-ALCL, and that most Canadian plastic surgeons are no longer using Biocell macro-textured breast implants. They also noted that textured breast implants may be beneficial in certain cases and that the risk of BIA-ALCL seems to be greater with highly textured implants.

Conclusions and actions

  • Although research to fully assess the causes of, and risk factors for BIA-ALCL is ongoing, Health Canada's updated safety review found that there was 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. Biocell breast implants made by Allergan are the only macro-textured implants currently available in Canada.
  • Consequently, Health Canada notified Allergan of its intent to suspend the medical device licences of Biocell macro-textured breast implants. The manufacturer's response to this notification was assessed, and it was determined that it did not provide sufficient evidence to demonstrate that the benefits of Biocell textured breast implants continued to outweigh the potential risks associated with their use. Therefore, Health Canada proceded to formally suspend the licences held by Allergan for their Biocell textured breast implants.
  • Suspension of the licenses for Allergan Biocell macro-textured breast implants means that they will no longer be marketed in Canada.
  • Preventive removal of breast implants is not recommended in the absence of signs or symptoms suggestive of BIA-ALCL. Patients should discuss the risks and benefits of implant removal with their healthcare professional if they have concerns.
  • Health Canada will work with all breast implant manufacturers to strengthen the Instructions for Use of all breast implants on the risk of BIA-ALCL.
  • Health Canada will also work with stakeholders to develop new information tools to support informed decision-making for individuals considering breast implants. Patients with breast implants or who are considering them can find more information by visiting the breast implant section on Canada.ca.
  • Health Canada will continue to actively monitor for newly reported Canadian cases of BIA-ALCL 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.

Additional information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction 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 Marketed Health Products Directorate.

If manufacturers or industry associations require more information at this time, they are encouraged to contact the Therapeutic Products Directorate (hc.tpdgeneral-generaldpt.sc@canada.ca).

References

  1. Keech JA Jr, Creech BJ. Anaplastic T-cell lymphoma in proximity to a saline-filled breast implant. Plast Reconstr Surg. 1997 Aug;100(2):554-5.
  2. Collett DJ, Rakhorst H, Lennox P, Magnusson M, Cooter R, Deva AK. Current Risk Estimate of Breast Implant-Associated Anaplastic Large Cell Lymphoma in Textured Breast Implants. Plast Reconstr Surg. 2019 Mar;143(3S A Review of Breast Implant-Associated Anaplastic Large Cell Lymphoma):30S-40S.
  3. Magnusson M, Beath K, Cooter R, Locke M, Prince HM, Elder E, Deva AK. SPECIAL UPDATE: The epidemiology of Breast Implant Associated Large Cell Lymphoma in Australia and New Zealand confirms the highest risk for grade 4 surface breast implants.
    Plast Reconstr Surg. 2019 Feb 13. doi: 10.1097/PRS.0000000000005500. [Epub ahead of print]

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