What Are the New FDA Guidelines on Mammograms?

The FDA’s updated regulations, effective September 2024, emphasize the limitations of mammography for women with dense breasts. The new rules require that all mammogram reports inform patients about their breast density and the associated risks. The FDA now requires that mammography reports for referring healthcare providers include one of four categories:

  • “Almost entirely fatty”
  • “Scattered areas of fibroglandular density”
  • “Heterogeneously dense, which may obscure small masses”
  • “Extremely dense, which lowers the sensitivity of mammography”

For patients, this information is presented in a lay summary. If your breasts are classified as “dense”, the summary will state that dense tissue makes it harder to detect cancer via mammogram and may raise your cancer risk​ [2].

What Does This Mean for You?

If you receive a report stating that your breast tissue is dense, this means mammograms alone may not provide a clear view of your breast health. Dense breast tissue can hide cancer on mammograms, reducing detection accuracy. About 40% of women over 40 have dense breasts, significantly lowering mammographic sensitivity to around 30-35% in the most extreme cases​ [1,2]. In these cases, supplemental imaging options like ultrasound, MRI, or thermography may help provide a fuller picture.

Why Does Dense Breast Tissue Matter?

Breast density plays a critical role in cancer detection because dense breasts have more fibrous and glandular tissue and less fat. This dense tissue appears white on mammograms, as does cancer, which makes it harder to detect abnormalities [3]. 

Women with heterogeneously or extremely dense breasts are more likely to have cancers missed on mammograms [1]. This update from the FDA aligns with what we’ve been advocating in our practice for years: mammograms have limitations—especially for women with dense breasts​.

How Common Are Dense Breasts?

Dense breast tissue is more common in younger women, though many retain density as they age. About 40% of women over 40 have dense breasts [1]. This density can increase during breastfeeding, as glandular tissue is stimulated [3]. Additionally, for women on bioidentical hormone replacement therapy (BHRT), hormone correction often restores breast density to levels seen in younger years, making mammograms less effective.

How Does This FDA Guideline Align With Our Screening Philosophy?

At our practice, we’ve long recognized the limitations of mammography, particularly for women with dense breasts. By offering thermography screening alongside traditional imaging and biomarker testing, we aim to provide a holistic screening that addresses the shortcomings of mammography alone.

Thermography is a non-invasive, radiation-free imaging tool that detects heat patterns and blood flow changes in the breast tissue. These physiological changes can indicate inflammation or abnormal cell growth long before structural abnormalities are detectable by mammogram.

Thermogram showing vascular abnormalities. Follow-up biopsy found a 1” carcinoma in the left breast.
Thermogram showing vascular abnormalities. Follow-up biopsy found a 1” carcinoma in the left breast.

How Does Our Clinic Take Screening Further with Biomarker Testing?

To enhance breast health screening, we combine thermography with a tumor marker trio: AFP (Alpha-fetoprotein), CA 15-3 (Cancer Antigen 15-3), and CEA (Carcinoembryonic Antigen). These markers are measured in the blood and offer a comprehensive view of your breast health. AFP aids in early detection, CA 15-3 boasts a 96.43% specificity, and CEA provides valuable insights into the curative effect and prognosis of breast cancer. This panel has a sensitivity of 83.46% and an accuracy of 80.25% in detecting breast cancer, as shown in a recent study from Frontiers in Oncology [4]. Together, these biomarkers offer a fuller, more accurate assessment, making it an essential addition to your breast cancer screening regimen.

What Should You Do if You Have Dense Breast Tissue?

If your mammogram shows that you have dense breasts, it’s important to discuss your screening options with your healthcare provider. These may include Abbreviated Breast MRI, Ultrasound, and Thermography imaging.

At our clinic, we offer Thermography as a supplemental imaging tool that can help detect early signs of cancer in dense breast tissue. Additionally, our tumor marker trio enhances your screening, giving you a clearer understanding of your breast health.

Throughout October, in recognition of Breast Cancer Awareness Month, we are offering $30 off upper-body thermography scans. This is an excellent opportunity to explore thermography as a complementary tool for your breast health, especially for women with dense breast tissue or those on BHRT. Whether you are at increased risk due to dense breasts, hormone therapy, or family history, our integrated screening methods offer you a more comprehensive and proactive understanding of your breast health.

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References:

  1. Berg, W. A., Seitzman, R. L., & Pushkin, J. (2023). Implementing the National Dense Breast Reporting Standard, Expanding Supplemental Screening Using Current Guidelines, and the Proposed Find It Early Act. Journal of Breast Imaging, 5(6), 712–723. https://academic.oup.com/jbi/article/5/6/712/7123687 
  2. U.S. Food and Drug Administration (2024). Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide. Retrieved from https://densebreast-info.org/legislative-information/fda-national-dense-breast-reporting/
  3. Mount Sinai Health System (2023). What Are Dense Breasts and Can They Increase My Risk of Cancer? Retrieved from https://health.mountsinai.org/blog/what-are-dense-breasts-and-can-they-increase-my-risk-of-cancer/
  4. Luo, J., Xiao, J., Yang, Y., Chen, G., Hu, D., & Zeng, J. (2023). Strategies for five tumour markers in the screening and diagnosis of female breast cancer. Frontiers in Oncology, 12, 1055855. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9899879/ 
Picture of Lilly Young

Lilly Young

Lilly Young, raised in the realm of health and wellness by her mother, Dr. Lari Young, blends her passion for writing and medical research to offer insightful contributions to the MyHealth1st blog.