FDA Announces New Mammogram Standards for People With Dense Breasts

Women with dense breast tissue are more likely to develop breast cancer, yet most of us aren’t educated by our doctors about this risk factor. A new regulatory measure from the Food and Drug Administration (FDA) seeks to change that.

The FDA is planning to implement new mammogram standards to support people with dense breasts, according to a letter from Katherine Klimczak, the agency’s acting legislative director. Writing to United States Rep. Rosa DeLauro of Connecticut, Klimczak said the FDA aims to “modernize” its breast cancer screening standards by requiring that healthcare providers “identify whether the patient has one of two categories of density (whether the patient has low or high density breasts) and include a prescribed paragraph on the significance of breast density.”

The agency is “optimistic that the [new regulation] will publish before the end of the 2022 calendar year or early 2023,” Klimczak added.

This is significant because many women aren’t aware that they have dense breasts — or that breast density is a risk factor for developing cancer. Once this update goes into effect, doctors nationwide will be mandated to educate their patients about breast density, empowering people to make more informed decisions about screenings.

Since dense breast tissue can sometimes obscure small tumors on mammograms, people with dense breasts may want to request a different screening procedure, such as a breast ultrasound or MRI. They may also opt for more regular screenings.

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The FDA’s announcement comes on the heels of mounting pressure from Rep. DeLauro, a vocal advocate for breast cancer awareness, and journalist Katie Couric, who recently opened up about her breast cancer diagnosis. In a personal essay published in September, the TODAY show alum noted that she recently learned she has dense breasts.

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