Question Period Note: SAFETY OF BREAST IMPLANTS

In April 2019, Health Canada completed a safety review of the risk of breast implant associated-anaplastic large cell lymphoma (BIA-ALCL). Health Canada noted a significant increased risk of this type of cancer associated with macro-textured breast implants.

In May 2019, Health Canada informed Allergan of the decision to suspend the medical device licences of Biocell breast implants (the only macro-textured breast implants on the Canadian market). All Biocell products were voluntarily recalled from the market. Since then, other regulators have proposed or taken similar action. In July 2019, Allergan announced a voluntary worldwide recall of Biocell breast implants and tissue expanders.

Health Canada continues to monitor the situation closely and to make information available to Canadians, including through website updates and directly through meetings with patient groups. Health Canada also continues to work with its international regulatory partners on the safety of breast implants.

• What is the Government doing to protect the health and safety of Canadians in regard to monitoring the safety of breast implants?

• The health and safety of Canadians is our top priority.

• Health Canada found that the rate of breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) in Canada is significantly higher in patients with macro-textured breast implants compared to other types of breast implants.

• Health Canada suspended the licences for Allergan’s Biocell breast implants—the only macro-textured implants available in Canada.

• Health Canada continues to monitor these, and all other medical devices. The Department has started a second safety review on systemic symptoms associated with breast implants.

IF PRESSED ON THE SAFETY OF BREAST IMPLANTS…

• Health Canada’s decision to issue medical device licenses for silicone gel-filled breast implants followed a lengthy and thorough scientific review. The decision was informed by a wide range of sources, including medical and scientific publications, and the reports of three independent scientific panels.

• All health products are associated with safety risks. Some risks are known at the time of product licensing, while others may not be known until later.

• We are aware of the incidence of a rare form of cancer (breast implant associated-anaplastic large cell lymphoma, or BIA-ALCL) associated with breast implants and of new information showing an increased risk of this lymphoma in association with macro-textured breast implants.

• It is for this reason that Health Canada took prompt action in reviewing all the available scientific and clinical data.

Anaplastic large cell lymphoma (ALCL) is a very rare cancer. It is a type of non-Hodgkin’s lymphoma. Breast-implant associated anaplastic large cell lymphoma (BIA-ALCL) is a subtype of ALCL. There are currently 26 confirmed Canadian cases of the disease reported to HC. These reported cases are associated with both saline and silicone gel-filled implants, and seen almost exclusively in patients with textured surface implants (as opposed to a smooth surface).

In summer 2017, Health Canada completed a safety assessment of the risk of BIA-ALCL, and issued a risk communication on November 17, 2017. We strengthened the product labelling on the risk of BIA-ALCL and enhanced surveillance of these products.

An updated safety review on BIA-ALCL was finalized in April 2019. Health Canada concluded that macro-textured breast implants are associated with a higher risk of BIA-ALCL than micro-textured or smooth breast implants. A risk communication was issued in May 2019 advising that:
• Health Canada had suspended the medical device licences for Allergan`s Biocell breast implants on May 27, 2019
• The department had requested that breast implant manufacturers strengthen the labelling of remaining licensed breast implants
• The department will work with stakeholders to develop a decision checklist to support informed consent by the patient.

Allergan had agreed to voluntarily recall unused Biocell devices from the Canadian market when Health Canada suspended the medical device licences. Since then, other regulators have taken similar action. In July 2019, Allergan announced a voluntary worldwide recall of Biocell breast implants and tissue expanders.

The conditions applied during the 2006 licensing of silicone gel-filled breast implants included the manufacturers’ commitment to provide Health Canada with annual reporting on large post-approval studies (PAS) of these devices. This commitment is still in effect and Health Canada will continue to receive and analyze this information.

Health Canada also met with Canadian patients representing patient advocacy groups on breast implant safety issues.

Given the concern around the safety of breast implants, Health Canada has started another safety review focusing on systemic symptoms. The results of this second safety review will be available in 2020.

Health Canada continues to provide information on its website regarding medical device license application reviews, including updated Summary Basis of Decision documents for authorized breast implants.

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