During September this year, a landmark U.S. Food and Drug Administration (FDA) regulation went into effect, requiring healthcare providers to notify patients about the density of their breasts after mammogram visits.
This new rule addresses a critical gap in patient education, enabling individuals to make more informed decisions about their health and the need for further testing.
Understanding Breast Density and Its Risks
Dense breasts are not uncommon. According to the Centers for Disease Control and Prevention (CDC), approximately half of women aged 40 and older have dense breast tissue.
However, dense breasts present two key challenges. First, they increase the risk of developing breast cancer. Second, dense tissue makes it harder to detect cancerous tumors on mammograms because both appear white on the imaging.
The new FDA regulation ensures that women receive the information they need to discuss breast density with their healthcare providers and consider additional imaging tests if necessary.
As Jim McKinney, an FDA press officer, explains, the rule also modernizes mammography reporting to reflect advancements in technology since the last regulations were issued in 1997.
“The final rule updates mammography reporting requirements to include, among other things, notification of breast density and ‘patient lay summaries’ to ensure that mammography reports have clearer language to help patients and healthcare providers discuss their mammography results,” says McKinney.
What Patients Will See in Their Reports
Under the new rule, every patient will receive specific, standardized information regarding breast density as part of their mammography report. The general message reads:
“Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer.”
Depending on the results, women will receive one of two additional statements:
- For non-dense breasts: Your breast tissue is not dense. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.
- For dense breasts: Your breast tissue is dense. In some people with dense tissue, other imaging tests in addition to a mammogram may help find cancers. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.
A Nationwide Standard for Breast Density Notifications
Although dense breast notifications have been mandated in at least 38 states for over a decade, the FDA’s ruling ensures uniformity across the United States.
“This is already required by law in the majority of states; we’ve been doing this for years in New Jersey,” says Dr. Harriet Borofsky, the medical director of breast imaging at Hackensack Meridian Health Riverview and Bayshore Medical Centers.
However, the new rule doesn’t just extend notifications to states without prior legislation. It also standardizes the language used, requiring healthcare providers to use non-technical terms that are accessible to the average person.
Alyssa Cubbison, DO, a breast imaging specialist at Ohio State University, notes that this update fosters greater clarity in doctor-patient communication.
What Does It Mean to Have Dense Breasts?
Dense breasts are characterized by more fibrous and glandular tissue than fatty tissue. This density complicates mammogram readings, as tumors and dense tissue both appear white on imaging.
Despite these challenges, mammograms remain essential in reducing breast cancer mortality. Since 1990, mammography has cut breast cancer deaths in the United States by nearly 40%, according to the American College of Radiology. For women in their forties and fifties, the Susan G. Komen Foundation recommends mammograms every one to two years based on individual risk factors.
What to Do If You Have Dense Breasts
Women with dense breast tissue face an elevated risk of breast cancer, independent of the imaging challenges dense tissue presents. The higher the density, the greater the risk.
If you receive a notification indicating dense breasts, the next step is to discuss supplemental screenings with your healthcare provider.
“Just by the factor of having dense breasts, without any other risk factors for breast cancer, you are eligible to receive a screening ultrasound,” says Dr. Cubbison.
Exploring Supplemental Screening Options
While mammograms are the gold standard for breast cancer detection, additional screenings can provide a clearer picture for women with dense breasts. These include:
- Ultrasounds
Ultrasounds are a cost-effective supplemental option. Using sound waves, this test can detect abnormalities not visible on mammograms. The procedure is simple: a technologist applies a gel to the breast and moves a handheld probe across the skin.
- MRI (Magnetic Resonance Imaging)
An MRI is more sensitive than both mammograms and ultrasounds, making it ideal for detecting smaller cancers. However, it is also more expensive and typically reserved for women with high-density breasts and additional risk factors. During the test, patients receive a dye injection and lie face down on a table that slides into the MRI machine.
- Contrast-Enhanced Mammography (CEDM)
CEDM combines traditional mammograms with a contrast dye to highlight new blood vessels that may indicate cancer. This test is particularly useful for detecting cancers in dense breast tissue.
Financial Barriers to Additional Screenings
Although these additional screenings can be invaluable, they are not universally covered by insurance. Costs vary widely, with ultrasounds averaging $250 out-of-pocket and MRIs exceeding $1,000, says Brem Foundation to Defeat Breast Cancer.
“That will be the case until there is universal coverage of these screenings for qualified patients, which will require insurance companies to cover it without deductibles and other charges,” says Dr. Borofsky.
Addressing Healthcare Disparities
Universal coverage for advanced breast imaging could help address existing healthcare disparities. Currently, racial and ethnic disparities limit access to cancer-detecting technologies.
A 2022 study in Radiology revealed that Black women undergoing mammograms had less access to advanced technology than white women, even when visiting the same healthcare facilities.
Black women are also 40% more likely to die from breast cancer than white women, despite similar cancer rates, according to the Radiological Society of North America (RSNA). Expanding access to supplemental screenings could significantly reduce these disparities and save lives.
Advocacy for Change
For patients and advocates looking to push for better coverage, organizations like the National Breast Cancer Coalition offer resources to help make your voice heard. Ensuring equitable access to supplemental screenings is a critical step toward improving breast cancer outcomes for all women.
The FDA’s new rule represents a vital shift in empowering women with knowledge about their breast health. With increased awareness and equitable access to advanced imaging, more lives can be saved in the fight against breast cancer.
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