News Release 

Dense breast notifications are having little impact

FDA should address potential unintended consequences of the notifications before implementing them

Boston University School of Medicine

(Boston)--Dense Breast Notifications (DBNs) are having little impact.

DBNs are a written notification to a woman after a mammogram that her breasts are dense. The goal is to motivate her speak with her doctor about her personal risk and possibly obtain supplemental screening for breast cancer. DBNs are mandated legislatively in more than 35 states and the Food Drug Administration (FDA) is developing standardized language for a federal/nationwide notification.

Prior findings from researchers at Boston University School of Medicine (BUSM) showed many states' DBNs are written at a higher literacy level than women residing in that state, which suggests that women may not be able to understand the notifications. Now those same researchers have conducted one of the first national surveys to ask women about their reactions to these notifications and to understand their knowledge, awareness and plans about breast density while examining whether these findings vary among women of varying race/ethnicity groups.

Overall, they found few differences in responses between women residing in states that require DBNs versus those who do not. There were no differences in awareness that women with dense breasts have a slightly increased risk of breast cancer, and no differences in the proportion of women who had discussed breast density with their doctor. "This suggests that DBNs are not achieving their desired effects, which is contrary to their goal," explained corresponding author Nancy Kressin, PhD, professor of medicine at BUSM. They also found white women with higher incomes had more knowledge when it came to breast density while black women experienced greater anxiety and confusion. "This is particularly concerning given black women's greater mortality from breast cancer."

The researchers hope that the FDA will consider these findings as they develop language for federal notifications regarding breast density, in order to ensure that the wording of the federal notification is clear and understandable to all women and that it leads to the desired outcomes and that unintended harms do not occur.

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These findings appear online in the Journal of General Internal Medicine.

Funding for this study was provided by a pilot grant from the Boston University Clinical and Translational Science institute (1UL1TR001430). Dr. Kressin was supported in part by a Senior VA Health Services Research Career Scientist award from the Department of Veterans Affairs, Health Services Research & Development Service (RCS 02-066-1). Dr. Gunn receives support from the National Cancer Institute (1K07CA221899-01A1).

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