Got Dense Breasts? Here's What the FDA's New Rule Means for You!

In March 2023, the U.S. Food and Drug Administration (FDA) passed a critical mandate regarding breast density. Under this new rule, mammography centers across the United States must notify women about their breast density after undergoing a mammogram. This mandate went into effect on September 10, 2024, and aims to standardize breast density notifications to help women make informed decisions about their breast health.

Breast density is an important factor in breast cancer risk, but until now, there were inconsistencies in how states communicated this information. Some states had clear laws requiring breast density notification, while others lacked a uniform approach, leaving many women unaware of their dense breast tissue and its implications.

The Susan G. Komen Foundation, a leading breast cancer advocacy group, has been pushing for national legislation to ensure that women are informed about breast density, applauding the FDA’s decision. While this mandate is a significant step forward, much work remains to educate women on what breast density means and how it impacts their health.

“Knowing you have dense breasts is crucial. If a mammogram reveals dense breasts, your doctor should inform you, both in person and in writing. What you do with that information is equally important: you should have a conversation with your doctor about your personal risk factors, which may include family history or other health issues. In some cases, additional imaging may be necessary, Natasha Mmeje, Director of Community Health Outreach at Susan G. Komen®, says.

What is Breast Density, and Why Does it Matter?

Breast density refers to the proportion of dense tissue (glandular and fibrous tissue) to fatty tissue in the breast, as seen on a mammogram.

“It’s important to understand what breast density really is. Breast density is a finding on a mammogram, not something you can feel during a self-exam. Breasts are made up of different types of tissue—lobes, milk ducts, and fat. Women with more dense breast tissue have less fat, which shows up white on a mammogram. Unfortunately, cancers also appear white on a mammogram, so it can be difficult for radiologists to detect cancers in women with dense breasts—some liken it to finding a polar bear in a snowstorm,” Mmeje adds.

Women with dense breasts are four to five times more likely to develop breast cancer than those with less dense breasts. However, having dense breasts does not mean you are destined to develop breast cancer, but it does make it more challenging to spot early tumors through standard mammograms.

Who is Affected by the New FDA Rule?

This new mandate affects all women who undergo mammograms in the United States. Mammography centers are now required to inform patients if they have dense breasts. While this rule ensures that every woman receives the same information, it is especially critical for certain groups who may be at higher risk, including:

Black women: Studies suggest that Black women are more likely to have dense breasts than white women, putting them at higher risk of breast cancer.
Younger women: Dense breast tissue is more common in younger women, a demographic not traditionally seen as high-risk for breast cancer.
Lean women: Research has also shown that women with lower body fat are more likely to have dense breast tissue.

What Black Women Should Know About Breast Density

Black women in the U.S. face distinct challenges when it comes to breast cancer. They are more likely to be diagnosed at a younger age, with more aggressive forms of the disease, and often at later stages. Dense breast tissue can further complicate the ability to detect cancer early.

“We do know that Black women tend to be diagnosed with breast cancer at younger ages, often at later stages, and with more aggressive forms like triple-negative breast cancer. It’s vital that healthcare providers take concerns seriously, especially when young women present with breast-related problems,” Mmeje notes.

Racial disparities in healthcare often mean that Black women are less likely to be believed or receive the necessary diagnostic follow-ups.

“We published a report in 2022 called Closing the Breast Cancer Gap: Saving the Lives of Black Women in America, which found that Black women often face medical bias or racism, leading to delayed diagnoses. Providers need to be proactive — if a young woman presents with a breast problem, they should believe her and take the necessary steps to screen her. Also, the general messaging around breast health tends to focus on women over 40, but we need to start much earlier. Clinical breast exams should begin at age 25, and mammograms for women of average risk should start at 40,” Mmeje adds.

As Black women are more likely to encounter bias and unequal treatment, it’s also vital to advocate strongly for your health.

What Should You Do After Receiving a Dense Breast Notification?

Once informed that you have dense breasts, you may be unsure of what to do next. Mmeje recommends the following:

Insist on a second opinion, especially if you’re experiencing symptoms or have a family history of breast cancer.
Ask specific questions about your breast density, risk factors, and the next steps in screening or diagnosis.
Keep records of conversations with your healthcare providers and any imaging results, so you can refer back to them if needed.
Find a provider who is attentive to your concerns. Sometimes, it’s necessary to switch doctors if you feel your current one isn’t addressing your needs.

Barriers to Accessing Additional Screening

One of the major barriers women face after learning they have dense breasts is the cost of supplemental imaging. While most insurance plans cover standard mammograms, additional screenings like breast MRIs or ultrasounds often come with out-of-pocket expenses.

“If additional imaging is required beyond the screening mammogram, we want to ensure that it’s accessible for everyone. Unfortunately, while health insurance may cover some of this supplemental imaging, many women still face significant out-of-pocket costs, which can be a barrier,” Mmeje says.

This cost can deter many women from getting the follow-up care they need, especially women from marginalized communities, including Black women, who are already more likely to face financial barriers to healthcare.

The Susan G. Komen Foundation and other advocacy groups are working to eliminate these costs through legislation. The Access to Breast Cancer Diagnosis (ABCD) Act, currently under consideration in Congress, seeks to remove patient cost-sharing for medically necessary diagnostic imaging. As of July 2024, 24 states have already implemented laws to reduce or eliminate the costs of supplemental breast imaging, but federal legislation is still needed to ensure broader access.

“We’re always working on policy advocacy. Every few years, we update our legislative agenda based on feedback from communities and advocates to address the issues people face,” Mmeje adds.

Innovations in Breast Cancer Screening for Dense Breasts

While mammography is the gold standard for breast cancer screening, researchers continue to explore innovative technologies to improve detection for women with dense breasts. Some of the advancements being studied include:

Digital breast tomosynthesis (DBT): Also known as 3D mammography, DBT creates a three-dimensional picture of the breast, offering clearer images for women with dense tissue.
Molecular breast imaging (MBI): This technology uses a radioactive tracer to highlight cancerous tissues in dense breasts more effectively than traditional mammograms.
Contrast-enhanced mammography: This technique combines mammograms with an injected dye to help identify cancerous tissues.

As these innovations develop, you should stay informed and discuss your options with healthcare providers to ensure you are receiving the most accurate and effective screenings.

Final Thoughts: Protecting Yourself Against Breast Cancer

If you have dense breasts, early detection is key. The new FDA mandate is a step in the right direction, but knowing what to do with the information is even more important. Rember to take these proactive steps:

Understand your breast density: Don’t just accept the notification—ask your doctor about what it means for your health.
Seek out additional imaging: Advocate for yourself if your doctor doesn’t automatically suggest further screening.
Stay informed: Keep up with new developments in breast cancer screening, especially for dense breast tissue.

By staying informed and advocating for appropriate care, you can take control of your breast health and increase your chances of early detection and successful treatment.