Dense breast

FDA adds breast density information during Women’s History Month

It’s been over 10 years since my request to the Food and Drug Administration (FDA) to consider the requirement that women be informed about their breast density after their mammogram and over 10 years since an FDA advisory committee agreed that women certainly should be.

Today, the FDA has announced a new national requirement for breast density reporting to both patients and their referring health providers, that must be complied with by 9/10/24. This new rule creates a “minimum” reporting standard about dense breasts to U.S. women and their health providers after their mammograms.

Dense breasts, which refers to the tissue composition of a woman’s breasts, are normal and common. But having dense breasts both increases the risk of developing breast cancer and of having that cancer missed on a mammogram (dense tissue shows up as white on a mammogram, unfortunately so does cancer). A potential life-threatening double whammy. In women with densest breasts, a mammogram, even if 3D, will miss about half of cancers present. Half. For women with dense breasts, any additional type of screening after a mammogram, like ultrasound or especially MRI, substantially increases cancer detection over a mammogram alone.

Individual state “dense breast” inform law enactments began in 2009 and there are currently 38 states plus the District of Columbia that have laws requiring women be provided some level of information about breast density after their mammogram. However, the laws are inconsistent and vary widely. Some only provide general information about breast density without telling a woman if she, personally, has dense breasts. All U.S. women should receive clear, unambiguous notification if their breasts are dense - and that having dense breasts increases both her risk of developing breast cancer and of having that cancer missed on her mammogram, and that she should talk to her health provider about supplemental screening. Without this information about her own breasts, a woman cannot effectively participate in her own breast health surveillance. This state-by-state geography-dependent notification has created an inequity of actionable information for women.

My own cancer was missed several years in a row on my mammograms because it was hidden by dense tissue. During that time, my mammograms were reported as “normal.” I finally detected it when a lump was large enough to feel, but by that time it was no longer early stage. Only then did I learn that I had dense breasts and that in dense breasts, a “normal” mammogram does not reliably mean cancer is not present - it means no cancer is seen. My story and advocacy were the inspiration for New York’s density inform law, the first in the nation to specifically tell a woman if her breasts are “dense.” Nearly every state inform law was fought for by a woman with a similar story. Women who dutifully went for annual mammograms that were reported as “normal.” Women who actually had breast cancer that was not seen on the mammogram as it was hidden in dense tissue. Women who, lacking information about the screening and risk implications of their dense tissue, did not know to ask about additional screening after their mammogram that might have detected their cancer at an earlier stage.

Too many patient “density inform” advocates are no longer with us to join me in an exhale of relief that all U.S. women will now be told about their breast density after their mammograms. That their tragedies - of hidden cancers finally found when no longer early stage - may be prevented from wreaking havoc on other families.

So, while we all share a hallelujah! that this has finally come to pass, to quote songwriter Leonard Cohen, for some of us, “it’s a cold and it’s a broken Hallelujah.” But a hallelujah it is.

—JoAnn Pushkin has coauthored educational courses, articles, grants, and speaks on the topic of breast density and inform efforts.