Summary Safety Review - Breast Implants - Assessing the Potential Risk of Breast Implant Illness Representative Symptoms and Diseases

Breast implants

Breast implant illness (BII) representative symptoms and diseases, including fatigue, problems with memory or concentration ("brain fog"), joint pain or stiffness, and autoimmune diseases

• Health Canada’s review of the available information found that BII representative symptoms and diseases have been reported in individuals with all types of breast implants, regardless of implant size, shape, fill (silicone or saline), or surface texture (smooth, micro- or macro-textured). The extent to which these BII representative symptoms and diseases may be related to breast implants is currently unclear.

• Health Canada completed a safety review on BII representative symptoms and diseases in people with breast implants. This review was performed as part of Health Canada’s continued commitment to monitor potential risks associated with breast implants.

• Preventative removal of breast implants is not recommended in the absence of signs or symptoms suggestive of BII representative symptoms or diseases since there are risks associated with surgery to remove breast implants.

  • However, some people with BII representative symptoms or diseases have reported an improvement of their symptoms with the removal of their breast implants.

• To support informed decision-making, information on BII representative symptoms and diseases has been published on the breast implant website.

• Health Canada will continue to monitor the potential risk of BII representative symptoms and diseases in people with breast implants and will take appropriate and timely action if any changes to the health risk are identified.

Health Canada completed a safety review on BII representative symptoms and diseases in people with breast implants. This review was performed as part of Health Canada’s continued commitment to monitor potential risks associated with breast implants.

• Breast implants are regulated in Canada as class IV medical devices, the highest risk class of medical devices.

• Breast implants are 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 no macro-textured breast implants currently available for sale in Canada. However, macro-textured implants remain implanted in some people.

• At the time of the review, there were 4 manufacturers with licences for the sale of breast implants in Canada: Allergan Inc., Mentor (Johnson & Johnson Medical Products, a division of J&J Inc), Ideal Implant Inc., and Sientra Inc.

• Health Canada reviewed information from the Canadian incident reporting database, scientific literature and international regulatory agencies, as well as labelling provided by the manufacturers.

• Breast implant illness is not currently a medical diagnosis and there are no specific diagnostic tests or recognized criteria to define it. As a result, a broad list of terms was developed based on public information from other trusted regulators, insight that had been shared by people with lived and living experience, and records from meetings of the Scientific Advisory Committee on Health Products for Women (SAC-HPW).

• As of June 2022, Health Canada had received 530 reports of BII representative symptoms and/or diseases in people with breast implants.

  • All surface textures and fill types were represented in the reports. Smooth and silicone were the greatest texture and fill represented, which is consistent with Canadian sales distribution.

  • The reports described the presence of 1 or more symptom or disease. Many reports were missing information, such as implant model, patient characteristics, and time from device implantation to the onset of the symptom(s) and/or disease(s). Most reports did not include a supporting diagnosis by a healthcare professional.

  • Based on the information available in the reports, it was not possible for Health Canada to determine whether breast implants were the cause of the symptom(s) and/or disease(s).

• Health Canada’s review of the recent scientific literature identified a lack of high-quality evidence to support a potential biological mechanism to explain the variety of BII representative symptoms and diseases in people with breast implants.

• Important limitations exist in the information that was reviewed, including potential bias and a lack of controls for potential confounders (other factors that may have contributed to the occurrence of BII representative symptoms and diseases). There is also limited information available related to the mechanisms by which exposure to breast implants could cause the various symptoms or diseases.

• The United States Food and Drug Administration published an updated report regarding systemic symptoms in women with breast implants in December 2023. Some results differ from those found during Health Canada’s analysis of Canadian reports. These differences may have been due, in part, to the use of different search terms to identify reports of BII representative symptoms and diseases.

• The labelling for all breast implants sold in Canada includes a decision-making checklist, including information on BII representative symptoms and diseases, for people who are considering breast implants.

• Health Canada’s review of the available information found that BII representative symptoms and diseases have been reported in individuals with all types of breast implants, regardless of implant size, shape, fill or surface texture. The extent to which these BII representative symptoms and diseases may be related to breast implants is currently unclear.

• Preventative removal of breast implants is not recommended in the absence of signs or symptoms suggestive of BII representative symptoms and/or diseases since there are risks associated with surgery to remove breast implants.

  • However, some people with BII representative symptoms and/or diseases have reported an improvement of their symptoms with the removal of their breast implants.

• Individuals should discuss the risks and benefits of implant removal with their healthcare professional if they have concerns.

• To support informed decision-making, information on BII representative symptoms and diseases has been published on the breast implant website.

• Health Canada will continue to monitor the potential risk of BII representative symptoms and diseases in individuals with breast implants and will take appropriate and timely action if any changes to the health risk are identified.

• For timely and relevant up-to-date information on breast implants, Canadians can subscribe to receive Health Canada updates, including:

  • general information;

  • safety or recall information;

  • risk communications; and

  • updates to the Public Health Infobase and website pages.

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international medical device 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 Medical Devices Directorate.

1. Health Canada. Available from: Breast implants: Overview. https://www.canada.ca/en/health-canada/services/drugs-medical-devices/breast-implants.html