New FDA Mammogram Rule Requires Facilities to Inform Patients if They Have Dense Breasts

Having dense breasts can make interpreting a mammogram more difficult, as both dense breast tissue and tumors appear white in the imaging. Dense breasts are also linked with a higher cancer risk. The U.S. Food and Drug Administration (FDA) has issued new regulations that, among other things, aim to educate women on these issues.

Last week, the FDA published updates to mammogram regulations issued under the Mammography Quality Standards Act of 1992, which aims to ensure quality screening and promote early detection of breast cancer. It also authorizes FDA oversight over mammography facilities. Among the new updates are requiring facilities to notify patients about their breast density, helping interpreting doctors better categorize and assess mammograms, and strengthening the agency’s oversight and enforcement of these facilities to ensure quality standards are being met.


Dr. Hilary Marston, Chief Medical Officer at the FDA, says, “Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer. Since 1992, the FDA has worked to ensure patients have access to quality mammography. 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. 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.”

Due to the fact that dense breasts can impact the accuracy of mammography, these new regulations require facilities to inform patients of their breast density. It’s also recommended that patients speak with their doctors if they have dense breasts, to discuss risks and their individual situation.


This change will impact many women, as about half of patients over the age of 40 who receive mammograms have dense breasts. The National Cancer Institute says factors impacting breast density include genetics, menopausal hormone therapy, and having a low body mass index. This isn’t something that can be determined during a self-check or during a clinical breast exam, either. It can only be determined via mammogram.

With dense breasts, there is a higher risk of missing cancer during screening and for patients to need follow-up tests. Having dense breasts is also linked with a higher risk of breast cancer, though it is not found to increase cancer mortality.

The FDA says informing patients of the impact of breast density helps ensure a comprehensive breast health strategy. These new changes must be implemented within 18 months.

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