US FDA Updates Mammography Regulations With Breast Density Notification Requirement

The US Food and Drug Administration published updates to the mammography regulations requiring mammography facilities to notify patients about the density of their breasts. The update also strengthens the FDA’s oversight and enforcement of facilities and helps interpreting physicians better categorize and assess mammograms.

“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” said Hilary Marston, MD, MPH, FDA’s Chief Medical Officer. “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.”

The final rule amends regulations issued under the Mammography Quality Standards Act (MQSA) of 1992, a law passed to ensure quality mammography, which is very important for early breast cancer detection. The MQSA authorizes FDA oversight over mammography facilities, including their accreditation, certification, annual inspections and enforcement of standards to help ensure mammography facilities provide quality care.

One of the key updates to regulations under the MQSA requires facilities to provide information to patients regarding the density of their breasts. Approximately half of women over the age of 40 in the U.S. have dense breast tissue, a description of its appearance on a mammogram. Dense breast tissue can make cancers more difficult to detect on a mammogram. Additionally, dense breasts have been identified as a risk factor for developing breast cancer. The amendments finalized today provide specific language explaining how breast density can influence the accuracy of mammography. They recommend patients with dense breasts talk to their health care provider about breast density, risks for breast cancer and their individual situation.

Helping to promote patient access to information about the impact that breast density and other factors can have on the risk for developing breast cancer is an important part of a comprehensive breast health strategy. 

JoAnn Pushkin, executive director of DenseBreast-info, Inc., issued the following statement: “It’s been over 10 years since my request to the Food and Drug Administration (FDA) to consider the requirement that women be informed about their breast density after their mammogram and over 10 years since an FDA advisory committee agreed that women certainly should be.

“Too many patient “density inform” advocates are no longer with us to join me in an exhale of relief that all US women will now be told about their breast density after their mammograms. That their tragedies - of hidden cancers finally found when no longer early stage - may be prevented from wreaking havoc on other families.”

Pushkin’s own cancer was missed several years in a row on her mammogram because it was hidden by dense tissue. Her story and advocacy inspired the first density inform law in the country in New York state. Since then, 38 states and the District of Columbia have passed similar laws that require some level of notification regarding breast density after a mammogram.