Information Update - Health Canada suspends Allergan's licences for its Biocell breast implants after safety review concludes an increased risk of cancer

Canada NewsWire

OTTAWA, May 28, 2019

OTTAWA, May 28, 2019 /CNW/ - Health Canada has completed an update to a 2017 safety review on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and has found that the rate of BIA-ALCL in Canada is significantly higher in patients with macro-textured breast implants compared to other implants. As a result, because the potential risks associated with the implants outweigh their benefits, including the rare but serious risk of BIA-ALCL, Health Canada has suspended the licences for Allergan's Biocell breast implants (the only macro-textured implants available in Canada).

This means that no one can sell Allergan's Biocell breast implants in Canada or import them into the country (Set out in the chart below). At Health Canada's request, Allergan has agreed to voluntarily recall unused Biocell devices from the Canadian market. Allergan's other breast implant products are not affected by this decision.

 

Licence number

Licence name

3112

NATRELLE SALINE-FILLED BREAST IMPLANTS (TEXTURED)

72262

NATRELLE 410 TRUFORM SILICONE - FILLED BREAST IMPLANTS

72263

NATRELLE SILICONE - FILLED BREAST IMPLANTS - BIOCELL ROUND

87277

NATRELLE INSPIRA TRUFORM 1 (RESPONSIVE) BREAST IMPLANT (TEXTURED SHELL)

87279

NATRELLE INSPIRA TRUFORM 2 (SOFT TOUCH) BREAST IMPLANT (TEXTURED SHELL)

 

The license suspensions follow Health Canada's announcement on April 4, 2019, that it intended to suspend Allergan's Biocell licences unless the company could provide evidence within two weeks to support that the benefits of the use of the devices outweighed the risks.

Health Canada received a response from Allergan on April 17, 2019, which departmental experts reviewed. It was determined that the information provided by the manufacturer was insufficient to support the ongoing licensing of the devices. The department concluded that the potential risks associated with the devices outweigh the potential benefits.

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 presents as an accumulation of fluid (known as seroma fluid) between the implant and the surrounding tissue. While the cause is unknown, possible risk factors and causes for the disease include the high surface area of the implants, genetic factors, and long-term (chronic) inflammation around the implant triggered by factors such as bacteria around the implant.

Health Canada has been notified of 26 confirmed Canadian cases of BIA-ALCL, of which 22 (85%) involve Allergan's Biocell breast implants. Based on Canadian confirmed case data and devices sales data provided by the manufacturers, Health Canada estimates that the risks 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. No cases of BIA-ALCL have been reported in Canada with any smooth surface implants.

Health Canada takes patient health and safety very seriously. As a result of the safety review findings, the Department will also:

If you have an Allergan Biocell breast implant or another type of breast implant:

If you are considering getting breast implants:

Information for healthcare professionals

Report health or safety concerns

The world of medical devices is constantly evolving, and the Government of Canada is working to ensure that regulations and guidance keep pace. As part of Health Canada's Action Plan on Medical Devices, announced in December 2018, the Department is taking steps to strengthen the monitoring and promotion of medical device incident reporting. In addition, to better support women's health, Health Canada has established a new Scientific Advisory Committee on Health Products for Women.

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SOURCE Health Canada

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