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New rule set by the FDA goes into effect

Mammogram providers must notify patients and referring physicians about breast density.

Last year, the U.S. Food and Drug Administration (FDA) published updates to the mammography regulations that included requiring mammography facilities to notify patients about the density of their breasts. Beginning Sept. 10, 2024, mammography facilities must provide all patients receiving a mammogram with one of two Federal breast density notification statements (either “not dense” or “dense”). Additionally, the mammogram report sent to referring providers must include an assessment of the patient’s breast density. 

The ACS and ACS CAN released a joint statement last year commending the FDA for taking steps to modernize the Mammography Quality Standards Act (MQSA) which will help reduce breast cancer mortality. 

Breast density is important for two main reasons:

  • Women who have dense breast tissue have a higher risk of breast cancer compared to women with less dense breast tissue. It’s 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. Breast masses and cancers can also look white, so the dense tissue can make it harder to see them. In contrast, fatty tissue looks almost black on a mammogram, so it’s easier to see a tumor that looks white if most of the breast is fat tissue.

Patient access to information about the impact that breast density and other factors can have on the risk for developing breast cancer is an important part of a comprehensive breast health strategy. 

ACS has extensive information on breast density on cancer.org and plans to produce an educational video that will be out in time for the rule to go into effect. A flyer is also available on Brand Central.



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