FDA Will Require Mammography Centers to Report Breast Density to Patients

The FDA has updated its mammography regulations, with the key amendment requiring facilities to provide information to patients regarding the density of their breasts.

The amendments, issued under the Mammography Quality Standards Act (MQSA), provide specific language explaining how breast density can influence the accuracy of mammography, and recommend that patients with dense breasts talk to their healthcare providers about breast density, risks for breast cancer, and their individual situations.

About half of women over 40 in the U.S. have dense breast tissue, which can make cancers more difficult to detect on a mammogram. Dense breasts have also been identified as a risk factor for developing breast cancer.

“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,” the FDA wrote in a press release.

In addition to breast density reporting, the FDA announced that the updated regulations will strengthen its oversight and enforcement of mammography facilities, and help 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, the FDA’s chief medical officer, in the press release. “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.”

According to the agency, while nearly all certified mammography facilities meet quality standards, the updated regulations give the FDA the ability, if necessary, to communicate directly with patients and healthcare providers in situations where those quality standards are not being met, and when this information has been inadequately communicated.

This will ensure that information that could affect patient care — such as the need for further evaluation or repeated mammography — is communicated as quickly as possible, the agency said.

In addition, the FDA said the amendments, which are required to be implemented within 18 months, will help “bring the MQSA into the 21st century” by incorporating current science and mammography best practices to improve breast cancer detection into the regulations, and empowering patients with more information as they make decisions regarding their breast health care.