FDA Updates Mammogram Guidelines for Dense Breasts

The U.S. Food and Drug Administration (FDA) is now requiring that healthcare providers notify patients about the density of their breasts during mammogram visits. The new rule will help people with higher breast density — which confers a higher risk of breast cancer — to decide whether to pursue further testing to detect possible tumors.

Mammogram providers will be required to implement the new standards by September 10, 2024, according to the announcement. “These requirements help address changes in mammography technology and mammography processes since the final regulations were published in 1997,” says Jim McKinney, a press officer for the FDA.

The final rule updates mammography reporting requirements to include, among other things, notification of breast density and additional assessment categories, says McKinney. “Other requirements help to ensure that mammography reports have clearer language to help patients and healthcare providers discuss their mammography results,” he says.

The FDA Ruling Will Change the Status Quo for Some — Not All — Patients

Many women are already receiving information about breast density from their healthcare providers because of state-level regulations, says Harriet Borofsky, MD, the medical director of breast imaging at Hackensack Meridian Health Riverview and Bayshore medical centers in New Jersey.

“Dense breast notifications have been legislated in at least 38 states for well over a decade. This is already required by law in the majority of states; we’ve been doing this for years in New Jersey,” says Dr. Borofsky.

The FDA changes will affect those states that don’t already require reporting about breast density, creating accountability across the board, says Alyssa Cubbison, DO, a radiologist who specializes in breast imaging and the detection of breast cancer at the Ohio State University in Columbus.

“Even in states that have been mandating the notification, the language of the notification may change somewhat,” says Dr. Cubbison. The FDA update means that healthcare workers will now have to write up this notification using nonmedical terms that are easy for the average person to understand, she says.

What Does It Mean to Have Dense Breasts?

Dense breasts are very common; about half of women 40 and older have dense breasts, per the Centers for Disease Control and Prevention (CDC). This is significant because higher breast density can hide cancers, which makes reading mammograms more challenging, says Borofsky.

Rather than having mostly fatty tissue, dense breasts have more fibrous and glandular tissue, which looks white on a mammogram. So do possible tumors, according to the agency. It can be hard for a radiologist reviewing a mammogram to distinguish between a tumor and dense breast tissue.

That doesn’t mean that mammograms aren’t worthwhile. Mammograms have helped reduce breast cancer mortality in the United States by close to 40 percent since 1990, according to the American College of Radiology. Studies have shown that mammograms can nearly cut in half the risk of death from breast cancer.

In fact, the only way to tell whether you have dense breasts is via mammogram. The screening is recommended every one or two years for women starting in their forties or fifties, depending on individual preference and risk factors, according to the Susan G. Komen Foundation.

I Have Dense Breasts — Now What?

Women with dense breasts have a higher risk of breast cancer than women with more fatty tissue in their breasts, according to the National Cancer Institute. This risk is separate from the fact that dense breast tissue may hide cancerous tumors on mammograms. The denser your breasts, the higher your risk.

If you get the notification that you have dense breasts, the next step is to ask your provider if you qualify for a supplemental screening such as a breast ultrasound, says Cubbison. “Just by the factor of having dense breasts, without any other risk factors for breast cancer, you are eligible to receive a screening ultrasound,” she says.

What Are Breast Cancer Screenings Beyond Mammograms?

While the mammograms used to screen for breast cancer are typically covered by insurance, insurance may or may not cover additional or supplementary screenings for patients with dense breasts. Each state has its own laws, and so coverage and copays can vary, according to DenseBreast-Info, a nonprofit educational site.

Ask your provider or call your health insurance company if you aren’t sure what kind of coverage you have for additional screenings.

These additional tests are possible if you have dense breasts.

Ultrasounds This tends to be the least expensive supplemental screening. The technologist applies lubricating gel to the breast and moves a handheld probe over the skin with gentle pressure, according to Columbia University Irving Medical Center.

MRI This kind of screening is significantly more expensive than ultrasounds, says Borofsky. Doctors will typically prescribe an MRI only for people with higher density breasts who are in a higher cancer risk category. The test is more sensitive than mammograms or ultrasounds, meaning it can detect even more cancers.

After a dye is delivered via IV into your arm — this makes tissues and blood vessels more visible — you lie facedown on a screening table and the entire table slides into the opening of the MRI machine. The appointment may take up to an hour, according to Mayo Clinic.

Contrast-enhanced mammography (CEDM) This is a mammogram that uses contrast dye that makes it easier to spot new blood vessels that develop when cancers grow. The test can find breast cancers that can’t be seen on regular mammograms, especially in people with dense breasts, according to Memorial Sloan Kettering Cancer Center.

The Costs of Additional Breast Cancer Screenings Can Add Up

Supplemental screenings can be expensive without health insurance or if your insurance won’t cover it. An ultrasound could cost $250 out-of-pocket, and a breast MRI can cost over $1,000, according to the Brem Foundation to Defeat Breast Cancer.

Right now, the only people who will benefit from these dense breast notifications and additional screenings are those who can afford it, says Borofsky

“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,” she says.

Universal Coverage of Supplemental Tests Could Reduce Disparities in Breast Cancer Screenings and Cancer Deaths

Universal coverage of advanced breast imaging would reduce racial and ethnic healthcare disparities and make these extra screenings available to everyone, says Borofsky.

Disparities in access to cancer-detecting technologies already exist. A study published in Radiology in October 2022 that examined more than four million Medicare claims from 2005 to 2020 found that Black women had less access to new mammography technology than white women, even when they underwent mammograms at the same healthcare facility.

Black women are 40 percent more likely to die of breast cancer than white women, even though white and Black women have similar breast cancer rates, according to the Radiological Society of North America (RSNA).

Interested in advocating for coverage in your state? Check out the National Breast Cancer Coalition for ways to make your voice heard.

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