New FDA Guidelines Could Help Women with Dense Breasts Detect Cancer Earlier

By Steve Blanchard - March 13, 2023

There are new rules in place that require mammogram providers across the country to notify women about their breast density. Doctors recommend that patients consult with a doctor about their individual risk factors, including breast density, and the possibility that they might benefit from additional screening tests.

The new rule is in relation to new standards released by the Food and Drug Administration this month that could help more women detect breast cancer earlier.

“Dense breasts can make it more difficult for doctors to identify cancers in those mammograms,” said Dr. Bethany Niell, section chief of breast imaging at Moffitt Cancer Center. “I think these regulations have the potential to save lives. They remind all of us to get regular screening mammograms because they save lives.”

The new requirements, finalized March 10 by the FDA, are aimed at standardizing the information given to millions of women following mammograms. Regulators first proposed the changes in 2019 and health care providers will have 18 months to comply with the policy.

“These regulations empower patients to know about their risk factors for cancer,” Niell said. “One of those risks is breast density and as a breast radiologist, I want patients talking to health care providers about risk factors.”

Niell said that those conversations allow all those in the medical field to take better care of patients and to not only help achieve better health outcomes, but to offer the care patients want and expect.

Breast cancer is the most common cancer among women in the U.S., except for skin cancer. About a third of all new female cancers annually are a breast cancer diagnosis. Statistics from the Centers for Disease Control show that about half of women over the age of 40 have dense breasts, which have more tissue compared to fat.

So, what can patients expect from these new FDA guidelines? Niell said change will mostly come in the way in which information is relayed.

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"The language will likely change when the state regulations sunset in 2023 and in 2024, patients will see there’s updated language that will be used across the U.S."

- Dr. Bethany Niell, breast radiologist

“Patients will see changes in the letters they get in the mail following a mammogram,” she said. “Florida is one of 38 states that already has existing legislation to communicate breast density, that went into effect in 2018. Women here already get notified of their breast density. The language will likely change when the state regulations sunset in 2023 and in 2024, patients will see there’s updated language that will be used across the U.S.”

Having that universal language conveying mammogram information will help patients across the country, Niell said.

Dr. Hilary Marston, the FDA’s Chief Medical Officer, said the updated guidelines represent the agency’s broader commitment to support innovation to prevent, detect and treat cancer.

“The impact of the Mammography Quality Standards Act on public health has been significant, including a steep decrease in the number of facilities that do not meet quality standards,” Marston said in a statement. “This means that more women have access to consistent, quality mammography. We remain committed to advancing efforts to improve the health of women and strengthen the fight against breast cancer.” 

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