FDA's New Mammogram Guidelines Target A Common Risk Factor

More than half of women over 40 have dense breasts, which puts them at a higher risk for breast cancer, according to the Centers for Disease Control and Prevention. Dense breasts can often hide small tumors from a mammogram because it's difficult for medical providers to distinguish them from fibrous and glandular tissue that also shows up white on breast images. Medical oncologist Dr. Harold Burstein told NBC News that looking at images from dense breast tissue is like "looking through frosted glass."

To address this, the U.S. Food & Drug Administration (FDA) updated its mammogram regulations to require mammogram providers to inform patients about their breast density. This would alert patients with dense breasts to talk to their doctors about their specific risks for breast cancer.

Executive Director of DenseBreast-info JoAnn Pushkin says it's been a 10-year fight to require mammogram providers to inform women about the density of their breasts. Although she's pleased about this move, she said it came at a cost. "Too many patient 'density inform' advocates are no longer with us to join me in an exhale of relief that all U.S. women will now be told about their breast density," Pushkin said in a statement on DenseBreast-info's website. "Their tragedies — of hidden cancers finally found when no longer [at an] early stage — may be prevented from wreaking havoc on other families."

According to the FDA, this new mandate strengthens the agency's commitment to ensuring quality mammograms for preventing breast cancer. The amendment is part of the Mammography Quality Standards Act, which was designed to ensure that women receive high-quality mammography services that are accurate and reliable. Mammogram facilities must meet quality standards set forth by the FDA and undergo regular inspections and assessments to ensure compliance with these standards.

This FDA final rule also includes updates that address technological changes in mammography, improve enforcement of quality standards, and clarify the language on the mammogram reports. The rules will become effective September 10, 2024.

The density of a woman's breast changes throughout her lifetime, according to the CDC. Breasts are particularly dense when women are younger, pregnant or breastfeeding, taking hormone replacement therapy, or lower in weight. When a woman's breasts are dense, tests such as a breast ultrasound or MRI can better detect breast cancer than a mammogram.