Despite legislative mandates in 35 states, dense breast notifications (DBNs) have yet to make any impact on a woman’s understanding of cancer risks associated with dense breast tissue, according to a new study.

Researchers at Boston University School of Medicine found no difference among women in the understanding that dense breast tissue signifies a slightly increased risk of developing breast cancer. They also found it made no difference in the proportion of women who have discussed breast density with their physicians.

"This suggests that DBNs are not achieving their desired effects, which is contrary to their goal," said corresponding author Dr. Nancy Kressin, professor of medicine at BUSM, in a statement.

Dense breast tissue masks the presence of tumors during mammogram scans and raises a woman's risk of developing breast cancer in her lifetime. As a result, doctors recommend that women with dense breast tissue consult their primary care physicians about supplemental testing, such as breast ultrasound or breast MR. Some, however, are hesitant to relay breast density status and the risks that come with it to patients out of fear of increasing their anxiety. Not all state laws mandate that physicians notify their patients, and those that do vary in the depth of information they are required to relay.

The timing of the study, however, comes as the FDA works to develop standardized language for a federal, nationwide notification, a decision that was passed into law earlier this year. Information in that notification will include:

• The effect of breast density in masking the presence of breast cancer on a mammogram
• The qualitative assessment of [breast density by] the provider who interprets the mammogram
• A reminder to patients that individuals with dense breast tissue should talk with their providers if they have any questions or concerns about their summary.

Prior findings out of BUSM have shown that many states with DBNs write them up at a literacy level higher than that of the women who might receive them. The authors of the current study also found that white women with higher incomes were more knowledgeable than black women, who experienced greater anxiety and confusion from the notifications, according to the study.

"This is particularly concerning, given black women's greater mortality from breast cancer," said Kressin, who hopes that the research will influence the FDA to ensure wording within federal notifications regarding breast density is clear and understandable to all women, so that desired outcomes can be reached without patients suffering unintentional harm.

JoAnn Pushkin, executive director of nonprofit educational group DenseBreast-info.org, says that in her anecdotal experience, "inform" laws do increase awareness but not necessarily understanding “as to what the notification means in terms of next steps or what follow-up conversations may be beneficial to have with a health provider,” and asserts that a single national reporting standard is necessary to address this issue.

She adds, however, that the study’s findings should be read with caution, noting a number of limitations, such as the fact that it does not account for DBNs varying widely in depth and breadth regarding the level of information provided.

“Some state laws (CT, TX, NJ, MD, MO and LA) do not tell the woman if she, herself, has dense breasts, and instead supply only general information about breast density. Thus, women in these states, who do live in a state with an ‘inform’ law, are not notified that they actually have dense breasts,” she said. “Another variation is that while some state inform laws mention the possible benefit of supplemental screening, others do not. The study did not distinguish between "inform" laws that do versus don't tell women if they actually have dense breasts, or laws that do versus don't mention supplemental screening as a topic to discuss with a health provider. To understand the effect of personal notification, an analysis of state inform laws which do contain personal density notification and mention of supplemental screening compared to states with no DBN would have been helpful.”

Funding was provided through a pilot grant from the Boston University Clinical and Translational Science Institute. Kressin also received support through a Senior VA Health Services Research Career Scientist award from the Department of Veterans Affairs, Health Services Research and Development Service. Another author, Dr. Christine M. Gunn, was supported by the National Cancer Institute.

The findings were published online in the Journal of General Internal Medicine.