Why does the United States have Dense Breast “Inform” Laws? What I learned and why it matters

By JoAnn Pushkin

On the same day I detected a lump in my breast and was diagnosed with breast cancer, I learned that the cancer had been obscured on my mammograms an estimated 5 years in a row behind dense tissue. The cancer did not show up on a mammogram the very day it was large enough to feel.  I was never informed that breast density increases the risk of developing breast cancer, never told that breast density can drastically reduce the likelihood that cancer will be detected on a mammogram, and never told that supplemental screening tools were available which might have detected my cancer at an earlier stage. I was shocked to learn that while this information was not shared with me, my breast density was shared by my breast imager with my physician every one of those years. My breast imager knew I had dense breasts, my physician knew I had dense breasts, the only that didn’t know was the one with dense breasts.

JoAnn Pushkin, Executive Director of DenseBreast-info.org

Why does knowing my breast density matter? 

• If you have dense breasts, a “normal” or “benign” mammogram report does not reliably exclude that cancer is growing undetected.
• Although normal, dense breast tissue is a risk factor for developing breast cancer and the denser the breast, the greater the risk.
• Though mammograms pick up some cancers not seen on other screening tests, in dense breasts, cancers can be hidden on mammography and may go undetected until they are larger and more likely to have spread.
• Other screening tests like ultrasound or MRI, in addition to mammography, substantially increase detection of early stage breast cancer in dense breasts

Unaware of this information, I was not alert that a discussion with my health provider about the implications of dense breast tissue was in order. Surely, a patient being sent for any test or screening should understand the goal of doing the test, what its limitations are, and how they may or may not benefit. If I had been informed that my extremely dense breasts meant that there was a 50% chance cancer may be missed by mammography, of course I would have asked about other screening available that would increase those odds.  What I wasn’t informed of about my dense breasts effectively denied me the chance for discussion about additional screening tools and thus opportunity for an earlier stage diagnosis.  

Why breast density is a unique risk factor
It is well established that dense breasts both hide cancers on a mammogram and increase a woman's risk for developing the disease. Yet, while all other common risk factors (e.g. personal/medical history, family history, lifestyle) are ones which a woman can inform her doctor of, breast density is the only one her doctor must inform her of. 
 
Either breast screening is important or it's not. And, if it is, an informed patient and appropriate screening are particularly important for those who are both at greater risk of developing breast cancer and of having that cancer missed by mammography. In order to have these  
“informed” conversations, those facing this “double risk” need to know. A woman cannot participate in discussions about her own breast health surveillance in the absence of enough information to do so.
 
My own story became the inspiration for New York State’s breast density inform law which went into effect in January 2013. It was the first U.S. state to require that women be informed, in clear unambiguous language, if their breast tissue is dense. As of this writing, 34 U.S. states, encompassing over 84% of American women, now require some level of breast density reporting to a patient after her mammogram.

Do all “inform” laws provide the same information?
No. While the majority of states have enacted such laws, the laws vary and the existence of a law in a state does not necessarily mean a patient will be informed if they have dense breasts. There is no consistency from state to state on what the laws require women be told about breast density. In fact, some density inform laws only require a woman be provided general information about breast density without providing her information as to whether she has dense breasts. Click here for an interactive map and learn what is required by state.

What about a national standard for reporting density to all women?
 Because the laws vary from state to state, after work on my own state bill in New York, I initiated efforts on the federal level for a single national standard. A national reporting standard would mean all women in the U.S., no matter where they live, would receive the same level of information about their breast density. This can happen either through federal regulation or federal legislation and efforts have been initiated on both.  On the federal legislative front, the Breast Density and Mammography Reporting Act of 2017 has been introduced in both the Senate (S 2006) and the House (HR 4122). On the federal regulatory level, the Federal Drug Administration anticipates publishing proposed amendments to the Mammography Quality Standards Act (MQSA) regulations. For more information on U.S. federal efforts, click HERE.
 
After enactment of the New York law I began to hear from women and their health care providers with questions about the implications of dense tissue.  To address these questions, I co-founded a medically-sourced website,  DenseBreast-info.org. For comprehensive information on the topic, please visit.
 
© 2018, JoAnn Pushkin
 
JoAnn Pushkin, Executive Director of DenseBreast-info.org, is a patient/advocate, author and speaker. Her initiative and advocacy served as inspiration for New York State's breast density inform law which went into effect in January 2013. On the federal level, Ms. Pushkin led the efforts for both the introduction of the Federal Breast Density and Mammography Reporting Act, as well as the FDA’s Mammography Quality Standards Act regulatory amendment consideration.