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A Lifesaving Standard: FDA Announces New Breast Density Notification Rule

Statement from the Brem Foundation to Defeat Breast Cancer:

The Brem Foundation to Defeat Breast Cancer welcomed today's announcement from the FDA of a new national requirement for breast density reporting to both patients and referring health providers.  We are still reviewing it in its entirety.  The rule requires all healthcare providers to notify patients if they have dense breasts and notes that those with dense tissue may require imaging tests in addition to a mammogram, which may help find cancers. The rule will allow for all patients who undergo breast cancer screening to have necessary information about breast density for informed decision-making with her provider about potential essential screening options. 

Breast density impacts 40% of women in the U.S. – some two-thirds of premenopausal women have dense breasts, and about a quarter of post menopausal women. Nearly 50% of U.S. women over 40 who are getting mammograms today have dense breast tissue. Breast cancer is more likely to occur in dense tissue, and is also much harder to find without essential screenings, such as breast ultrasounds or MRIs, in combination with an annual mammograms.

This long-awaited FDA rule (an amendment to the Mammography Quality Standards Act - MQSA) is an important step in providing patients actionable information to increase their chances of finding breast cancer early when it is most treatable and outcomes are best. 

Today’s published rule sidesteps the topic of insurance coverage, expressing that it is not within the scope of the authority of the MQSA. Yet the out of pocket costs for screening beyond mammography – sometimes referred to as the “hidden costs” of breast cancer diagnosis - are often prohibitive and a barrier to access. This barrier contributes to the vast disparities in breast cancer mortality rates among people of color in the US.  The Brem Foundation is actively working with legislators to support the passage of The Find It Early Act, which would require both private and government insurers to cover these costs, leveling the playing field for patients to access thorough breast cancer screening that can – and does – save lives.  

As women navigate the complexities of breast health, they deserve every tool available to detect a potential cancer as early as possible; this includes consistent information on established risk factors as well as no-cost screening and diagnostics beyond mammography.

What Is Breast Density? 

Breast density is the term used for describing how much connective tissue there is in breasts, as compared to the amount of fatty tissue. Breast density is important because dense breast tissues can conceal cancer on mammograms and a woman’s risk for breast cancer is 4-6 times more likely if she has dense breasts.

To learn more about breast density, and understand your potential risk factors, read this in-depth blog post: What Are Dense Breasts? What You Need to Know About Dense Breast Tissue. 


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