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Health Canada Breast Implant Safety Review Shows High Risk of BIA-ALCL with Textured Implants

April 20, 2022 By Law Offices of Thomas J. Lamb, P.A.

A recent Health Canada safety advisory comes following an updated safety review of breast implants and the associated risk of BIA-ALCL. According to the April 6, 2022 Health Canada advisory “Advisory – Updated safety review of breast implants underscores the continuing importance of monitoring for cancer; increased risk with highly textured (macro-textured) implants“, the organization found there continues to be a high risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in highly textured implants in comparison to those with smooth implants.

Textured Breast Implants Have Much Higher Risk

This April 2022 Health Canada advisory aimed at evaluating the BIA-ALCL risk level difference between smooth and textured breast implants.

From the April 6, 2022 Health Canada advisory “Advisory – Updated safety review of breast implants underscores the continuing importance of monitoring for cancer; increased risk with highly textured (macro-textured) implants“:

The 2019 safety review found that the estimated risk of BIA-ALCL in Canada is significantly higher in individuals with macro-textured breast implants compared to micro-textured or smooth implants.

Furthermore, in response to these findings Health Canada has suspended Allergan’s Biocell breast implant licenses.

Additionally, the same article reports Canada is not the only country to notice these trends:

An increase in reported cases in Canada is consistent with trends seen in other countries, including the United States. 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).

Recommendations About Next Steps for Women

If you’re wondering where this leaves you in terms of next steps, Health Canada has a few recommendations. The organization is currently recommending implants only be removed if you have spoken with your healthcare provider and there are signs and symptoms of BIA-ALCL. According to the April 2022 Health Canada advisory:

While this information is concerning for people who have Allergan Biocell implants, preventive removal of breast implants is not recommended if there are no signs or symptoms suggestive of BIA-ALCL. Individuals who have, or who are considering breast implants, should speak to their healthcare provider about their benefits and risks.

Health Canada will continue to raise awareness of BIA-ALCL to support patient safety. The Department is launching a BIA-ALCL Canadian Surveillance Data Blog, and will continue to monitor and report new Canadian cases of BIA-ALCL. The Department also maintains detailed information on breast implants to support health professionals and people who have, or who are considering implants.

Health Canada will also continue to work with manufacturers to help support patient safety. To date, manufacturers have implemented comprehensive labelling changes, including adding strong warnings about the risk of BIA-ALCL, and patient decision checklists. Health Canada will also conduct yearly follow-ups with manufacturers.

As always, we will continue to monitor the worldwide issues surrounding Biocell textured breast implants as well as other breast implants and BIA-ALCL. We will provide you with any new or relevant information.

We encourage you to visit our Breast Implants Lymphoma Cancer page on our website for more information. Please submit a free case evaluation if you or someone you know has been diagnosed with BIA-ALCL.

Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.


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Filed Under: Unsafe Medical Devices Tagged With: breast implant cancer, breast implant-associated anaplastic large cell lymphoma, breast implants, breast implants BIA-ALCL, breast implants cancers, breast implants lymphoma cancers, textured breast implants

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