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Education and Early Detection: Why the FDA now requires women be informed if they have dense breasts

July 17, 2023
by Amanda Steffen

It is estimated nearly half of women have some degree of dense breast tissue, which increases the risk of developing breast cancer. Compounding this risk is the finding that dense breast tissue also can mask small tumors on a mammogram.

Breast ultrasounds and MRIs can substantially increase cancer detection in dense breasts, but women need to be aware if their breast density places them at risk and then consider additional screening in consultation with their health care providers.

Thirty-eight states have already passed breast density notification laws, requiring mammogram imaging centers to inform women if they have dense breasts and the additional screening options available to them. Now, as of this March, the FDA has mandated such notification nationwide. This means that regardless of where a woman lives, she will receive this information following a mammogram.

A 2016 study funded by Women’s Health Research at Yale showed the value of ultrasound screening in detecting breast cancer. It also found the majority of women who knew they had dense breasts believed extra screening was worth doing as it provided the opportunity to consider other useful information, in addition to genetics, family history, and health history, while making health care decisions.

Another consideration many women face is that the cost of breast ultrasound or MRI may not be covered by insurance. Women who cannot afford these costs may delay or skip the extra testing, which can have important consequences. To eliminate the financial barrier to this form of early detection, thirteen states and Washington, D.C. require insurers to cover breast ultrasounds and MRIs.

Importantly, there is an effort to expand this coverage nationwide and to more women. Congresswoman Rosa DeLauro (D-Conn.), who has been an outstanding advocate for women’s health and is an Honorary Member of the WHRY Council, and Congressman Brian Fitzpatrick (R-Penn.) have introduced a bill called the Find it Early Act. If passed into law, this would require insurers to cover additional breast imaging for women with dense breasts or those at increased risk, for example – due to a known genetic risk factor such as a BRCA gene mutation – with no out-of-pocket cost.

Submitted by Amanda Steffen on July 03, 2023