What You Need to Know About the FDA’s New Mammogram Rule

Over 40 percent of women have dense breasts, yet it’s only recently that practitioners were required to inform patients about the potential risks of this common breast tissue type. With the FDA’s new mammogram rule taking effect this fall, here’s what you need to know.

What New Mammogram Rule?

The FDA updated standard mammogram quality regulations in the spring of 2023 to require practitioners to inform patients of their breast density. That rule went into effect this fall, meaning your next mammogram will include a breast density assessment and more information on your risk factors and potential next steps.

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The goal is to simplify the information and eliminate overly medical language so that breast density is easily understood. Your doctor will also be required to explain the four categories of breast density and where you fall. They go as follows:

• A: Almost entirely fatty. The breasts are almost entirely made up of fatty tissue. There is very little dense breast tissue.
• B: Scattered areas of fibroglandular density. The breasts are mostly made up of fatty tissue, but there are some scattered areas of dense breast tissue.
• C: Heterogeneously dense. Most of the breast tissue is dense, but there are some areas of fatty tissue.
• D: Extremely dense. Nearly all of the breast tissue is dense breast tissue. There is very little fatty tissue.

What Are Dense Breasts?

You can’t actually know if you have dense breasts without a mammogram. “Breast density does not correlate to any finding on a physical exam, such as breast size or firmness,” says New York OB/GYN Angela Wilson, MD. On a mammogram or X-ray image of the breasts, dense tissue appears white and fat tissue looks black. “The more opaque or white tissue, the more dense the breasts appear on the mammogram,” Dr. Wilson adds.

Dense breast tissue may mask early signs of cancer and make it more challenging to spot abnormalities in standard mammograms. Additionally, cancers are more likely to form in glandular and fibrous tissue than in fatty tissue. That means women with dense breasts have an increased risk of developing breast cancers.

Breast Density Is Now a Part of Your Mammogram

While many states already had rules similar to the newly adopted FDA regulation, this new mammogram rule will standardize the process. Women will be provided a breakdown of breast density and how it impacts mammogram imaging. Your practitioner will also discuss your breast density with you.

The FDA released the specific language to help explain the next steps for those with dense breasts. “Breast tissue can be either dense or not dense,” states the new FDA guidance. “Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. 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.”

To better self-advocate and understand your risks, make sure your healthcare provider is following the FDA’s updated mammography guidelines. After all, they’re now required to.