Archived Summary Safety Review - Breast Implants - Assessing the potential risk of cancer (Breast implant associated-anaplastic large cell lymphoma)

November 24, 2017

Product

Breast implants

Potential Safety Issue

Breast implant associated-anaplastic large cell lymphoma (BIA-ALCL)

Key Messages

• Breast implants are medical devices licensed for sale in Canada, used to increase breast size, replace a previous implant, correct breast unevenness, or rebuild breast tissue following surgery. Breast implants are made of a smooth or textured silicone shell and are usually filled with silicone gel or sterile salt water.
• Health Canada has completed a safety review on the potential risk of BIA-ALCL, following an increase in the number of cases reported internationally. The review analysed the available information on the Canadian rate of BIA-ALCL. The review also looked at the literature on BIA-ALCL to better understand the characteristics of this condition.
• Health Canada's safety review found that the Canadian rate of BIA-ALCL is low. Nearly all of the cases were associated with implants that have a textured surface, similar to what was found in other countries.
• Health Canada will:
  • issue an Information Update and a Healthcare Professionals Risk Communication to increase public awareness of BIA-ALCL and to give physicians more information on BIA-ALCL.
  • update the labeling of breast implants to better inform healthcare professionals about the risk of BIA-ALCL.
  • monitor yearly all Canadian cases of BIA-ALCL.

Overview

Health Canada has completed a safety review on the potential risk of BIA-ALCL, following an increase in the number of cases reported internationally. The review analysed the available information on the Canadian rate of BIA-ACL (the number of confirmed cases of BIA-ALCL reported in relation to the number of implants sold in Canada over the past 10 years). The review also looked at the literature on BIA-ALCL to better understand the characteristics of this condition.

As defined by the World Health Organisation (WHO), BIA-ALCL is a rare type of non-Hodgkin lymphoma. Non-Hodgkin lymphoma is a cancer that originates from lymphatic cells, which are part of the immune system (the system that fights infections). It is not a cancer of the breast tissue. It is usually in the form of a seroma (a clear fluid which develops in a place where tissue has been removed, for example after a surgery) between the implant itself and the surrounding tissue.

Use in Canada

• Breast implants are medical devices licensed for sale in Canada and used to increase breast size, replace a previous implant, correct breast unevenness, or rebuild breast tissues following surgery. Breast implants are made of a smooth or textured silicone shell and are typically filled with silicone gel or sterile salt water.
• Of all breast implants sold in Canada over the past 10 years, approximately 25% were textured implants.
• There are currently 3 manufacturers with authorized licences of breast implants for sale in Canada: Allergan Inc., Mentor and Ideal Implant Inc. (c/o Clarion Medical Technologies).

Safety Review Findings

• At the time of the review, Health Canada had received 5 confirmed Canadian cases of BIA-ALCL for the last 10 years. Out of these 5 cases, 4 involved textured implants; the type of implant in the remaining case was not specified.
• The Canadian rate of BIA-ALCL is 0.0013% or 1 case per 77,190 implants sold over the past 10 years. The Canadian rate per textured implant was estimated at 0.0041% or 1 case per 24,177 textured implants. However, Health Canada acknowledges that some cases may not have been reported to the manufacturers or to Health Canada during this time period. The cases of BIA-ALCL have been reported with both saline-filled and silicone gel-filled implants.
• Internationally, 359 BIA-ALCL cases have been reported to the United States Food and Drug Administration (FDA), including 9 deaths. In addition, 56 cases were reported in Australia, including 3 deaths, and 37 confirmed cases in France.
• While the cause of BIA-ALCL is not clear, research is looking at possible explanations or risk factors such as surface texture, scar tissue that can form around breast implants (severe capsular contracture), trauma to the breast, chronic inflammation, and contamination.
• Physician and patient brochures currently available in Canada for breast implants are not all consistent. Most contain information about BIA-ALCL. However, some of them could provide more up-to-date information.
• Canadian plastic surgeons associations were consulted throughout the review process and they have recommended that physicians, including family practitioners, oncologists and general surgeons, be better informed to identify BIA-ALCL.

Conclusions and Actions

• Health Canada's safety review determined that the rate of BIA-ALCL in Canada is low. Nearly all of the cases were associated with implants that have a textured surface, similar to what was found in other countries.
• Health Canada will issue an Information Update and a Healthcare Professionals Risk Communication to increase public awareness of BIA-ALCL and to give physicians more information on BIA-ALCL.
• Health Canada will also work with the manufacturers to update the labeling of breast implants to better inform healthcare professionals of the risk of BIA-ALCL.
• Health Canada will actively monitor all reported Canadian cases of BIA-ALCL through a yearly follow-up with the manufacturers of breast implants. Health Canada will take appropriate and timely action if and when new health risks are identified.
• Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of these health products.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse event reports and what is known about BIA-ALCL both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.