FDA dense breast rule promotes earlier cancer detection
National notification regulation takes effect next year
Mammography remains the gold-standard imaging tool for early detection of breast cancer but some women might need additional screening. That includes women who have dense breasts.
The FDA is now recommending any facility that offers mammograms must tell women if they have dense breasts that could put the at higher risk for breast cancer. The regulation will begin being enforced next year.
Illinois and Michigan are among 38 states in the country that already require imaging centers to disclose if women have dense breasts but rules vary on how much information they require in the notification. The new federal regulation will mandate that notification in all states and standardize what must be disclosed.
Jessica Guingrich, MD, is radiologist and medical director of OSF HealthCare Center for Breast Health in Peoria. She says for women with dense breasts, it can be more difficult to detect cancer with mammography, which relies on contrast to detect cancer. She says dense tissue, which is white, can mask changes in breasts such as a tumor.
“We’re trying to see white findings (tumors) so the denser tissues means there’s more whiteness in the background and it’s harder to see those white findings,” Dr. Guingrich explained.
Having dense breasts not only makes cancer detection more challenging, it can also increase cancer risk, particularly for the roughly 10% of women over 40 that fall into the category of very dense breasts. Dr. Guingrich says a woman can’t determine her own breast density through self-exams or through a clinical exam. Radiologists use national guidelines based on the amount of fibrous tissue within the breasts.
“The density actually has nothing to do with how they feel on physical exam or the breast size. It actually has to do with that appearance on the mammogram.”
Breast density can change over time so a women who earlier was considered for advanced imaging such as a breast ultrasound or MRI might not qualify another time if the density has changed. But, the goal of the notification is to promote a discussion with medical providers about whether advanced imaging is needed to detect cancer earlier and reduce the need for aggressive treatment.
So what are the best options for women who receive the notification? Dr. Guingrich says that will depend on a woman’s risk factors. She stresses having dense breasts is a minor risk factor compared to other considerations such as family history.
“Like if one has a first-degree relative or a pre-menopausal relative diagnosed with breast cancer or if they have a personal history of breast cancer, those women are at higher risk. If a lady is a gene carrier or if a lady has had chest wall radiation.”
The American Cancer Society says breast cancer is the most common cancer diagnosed among U.S. women and is the second leading cause of death from cancer among women after lung cancer. Insurance coverage for advanced breast imaging varies from state to state and the new FDA recommendations don’t address coverage so it’s best to check with your insurance provider.
Here are the Center for Disease Control and Prevention’s answers to frequently asked questions about dense breasts and implications for additional screening beyond a mammogram.