Population-based studies of health risks associated with breast implants (BRISK)

Around 4% of middle-aged women have breast implants, the large majority for cosmetic reasons.

There are rising concerns for adverse health effects of breast implants, yet comprehensive research efforts are needed to determine if the indicated health risks are preexisting or caused by the procedure itself.

Therefore, the aim of the BRISK study is to leverage unique Swedish population-based data to determine risks of mental disorders, autoimmune disease, chronic fatigue, and other medical conditions among women with cosmetic breast implants.

In this three-year project, we will identify 29 011 women with cosmetic breast implants through the Breast Implant Quality Register (operated 2014-22) and ongoing mammography studies (identified 2008-21), as well as ~5 000 women undergoing permanent removal of breast implants (1997-2022).

By record linkage to the population-based Patient, Primary Care- and Prescription Registers, we will compare the rates of the studied health risks of women with breast implants to that of their full sisters and an age- and region matched cohort of women. We will assess pre-surgery rates of these conditions and take them into account when assessing post-surgery rates.

Solid evidence on major health outcomes of breast implant surgery is currently lacking, leaving women considering this surgery option largely uninformed on long-term health effects. The BRISK study will provide valuable evidence for this patient group and health care policy worldwide.