Staying Informed: What You Need to Know About the New FDA Mammogram Guidelines
Women's Health
January 08, 2025
Staying Informed: What You Need to Know About the New FDA Mammogram Guidelines

At Texas Health, we’re dedicated to keeping you informed about important health updates, including a new update regarding mammogram reporting. In March 2023, the U.S. Food and Drug Administration (FDA) set forth regulations that required breast density information to be included in all mammogram reports for patients by the end of September 2024. For many, this update offers a new layer of insight into breast health, giving both patients and providers another valuable tool in early cancer detection and prevention.

We spoke with Teresa McCloud, R.T. (R), manager at Sue A. de Mille Women’s Diagnostic Center in Plano, and Stacy Lee, M.D., a diagnostic radiologist on the medical staff at Texas Health Presbyterian Hospital Plano, to get their insight on what this means, and how these guidelines can impact you.

Understanding Breast Density

You may have heard the term "breast density" before, but what does it really mean? Breast density refers to the proportion of dense tissue in the breast as compared to fatty tissue. Dense breast tissue can make it harder to detect small cancers on mammograms, as the dense tissue appears white — the same color as potential tumors. Lee notes that this can make it more challenging to detect small cancers on a mammogram.

“Dense breast tissue not only makes it harder to spot potential issues by essentially hiding underlying masses, but it also slightly increases your risk of developing breast cancer,” Lee adds. “That's why it's crucial for you to be aware of your breast density.”

What the New FDA Guidelines Mean for You

Under the new FDA guidelines, every mammogram report must include your breast density status, categorizing it as either “dense” or “not dense.” This requirement is significant because it brings clarity and uniformity to reporting practices across the country. In Texas, Henda’s Law has already required this type of notification since 2012, but now the FDA mandate ensures everyone receives clear and detailed breast density information in their reports.

Why Breast Density Matters for Early Detection

According to the Centers for Disease Control and Prevention, about one in eight women will get breast cancer in her life, impacting hundreds of thousands of Americans each year. Mammograms continue to be the best tool for breast cancer screening and detection.

For women with dense breast tissue, early detection becomes more challenging. Fortunately, research shows that adjunct imaging tools, like ultrasound or MRI, can enhance detection.

“Adding an ultrasound to a mammogram can increase the detection of breast cancers by approximately 3-4 cases per 1,000 women, especially among those who have dense breasts,” Lee says.

How to Use This Information in Conversations with Your Doctor

If you find out you have dense breast tissue, both Lee and McCloud recommend having an open discussion with your primary care provider, OB/GYN, or breast radiologist/specialist about your options.

“We recommend patients stay informed about their breast tissue and breast density,” McCloud adds. “Talking with your provider or imaging specialist can help determine if further imaging options are necessary based on your density report.”

Additionally, many facilities now offer risk assessment scores, which take into account your density status and other risk factors.

“Our breast center and most of Texas Health is also working with new software that will start to calculate a patient’s risk assessment score. This report with calculations will start to appear in your patient chart as well as your report to your health care providers,” McCloud explains.

McCloud recommends that if you’re unsure about your breast density or anything on your patient report, you should reach out to your imaging center. They can clarify your density level and what it means for your breast health.

Does Dense Breast Tissue Mean More Screenings?

While not everyone with dense breast tissue will require additional screenings, McCloud adds that many patients do choose to pursue more frequent or varied types of imaging. Some may not have realized they had dense breast tissue before the FDA’s guideline, so this information may prompt a conversation with their provider about their unique screening needs. Checking with your insurance provider about coverage for additional imaging can also help guide your decisions.

Preparing Yourself with the Right Knowledge

The FDA’s new regulation helps put more control into the hands of patients by providing critical information about their breast density status. By knowing more about your own breast tissue, you have the opportunity to make more proactive choices about your breast health. McCloud emphasizes, “Patients can be better equipped with the right knowledge and tools. Early detection is key.”

Takeaways for Your Next Mammogram

When you receive your next mammogram report, take note of your breast density and any recommendations for additional imaging. Remember, this information is a starting point for meaningful conversations with your health care team about your unique breast health needs. Staying informed and taking action on breast density knowledge could play a crucial role in your health journey.

As Teresa McCloud adds, “Knowledge is power. Having more information about your health allows you to make informed decisions with your provider and understand the options available to you. Early detection saves lives!”

To schedule a mammogram at a Texas Health facility, visit TexasHealth.org/BreastCare.

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