FDA’s Update to Mammography Regulations will Reduce Breast Cancer Mortality

March 10, 2023

ATLANTA —March 10, 2023 — On behalf of the nearly 300,000 women who will be diagnosed with breast cancer this year, the American Cancer Society (ACS) and American Cancer Society Cancer Action Network (ACS CAN) commend the Food and Drug Administration (FDA) for taking steps to modernize the Mammography Quality Standards Act (MQSA) which will help reduce breast cancer mortality. The final rule will improve screening by addressing newer technologies, better enforcement of facility accreditation and quality standards, and enhance the reports that are provided to women and their physicians.

The following is a statement from Dr. Karen Knudsen, CEO of the American Cancer Society and ACS CAN. 

“We are particularly pleased with the inclusion of notification to patients and physicians about breast density. Dense breast tissue can make cancers more difficult to detect and are a known risk factor for breast cancer.”

“In addition, we applaud the inclusion of required timeframes for mammography reports to be sent to healthcare providers, since delays in communication of screening results can lead to delays in diagnosis and result in worse outcomes.”

“Despite these advances, we maintain concern that the FDA did not include provisions to address the variability in the quality of mammography interpretation and encourage the FDA to take action on this issue immediately.”

Today’s final rule will benefit all women but can help reduce the large disparity in breast cancer mortality between Black and White women. While Black and White women get screened for breast cancer at similar rates, Black women are more likely to experience lower quality screening, contributing to the ongoing disparity.

Why is breast density important?

  • Women who have dense breast tissue have a 1.5 to 2-fold higher risk of breast cancer compared to those with average density.
  • It is unclear at this time why dense breast tissue is linked to breast cancer risk. It may be that dense breast tissue has more cells that can develop into abnormal cells.
  • Dense breast tissue also makes it harder for radiologists to see cancer on mammograms. Dense (fibrous and glandular) breast tissue looks white on a mammogram, as do breast cancers, and dense breast tissue can partially or entirely obscure signs of cancer. While women with extremely dense breast tissue often require specialized screening strategies to detect cancer, even a small amount of density may require alternative imaging to ensure a woman can be confident she has had a complete screening examination. Therefore, it is important women are told if they have mammographically dense breasts.  

More information on breast density can be found here.



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