Updates to the mammography regulations were published today by the U.S. Food and Drug Administration. They strengthened the FDA’s oversight and enforcement of facilities, require mammography facilities to inform patients about the density of their breasts, and assist interpreting physicians in better classifying and evaluating mammograms.
“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” said Hilary Marston, M.D., M.P.H., 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.”
One of the most significant revisions to the MQSA standards mandates that clinics inform patients about the density of their breasts. Dense breast tissue, as shown on a mammography, is present in around half of American women over the age of forty. Dense breast tissue might make it more challenging to find tumors during a mammography.
Dense breast tissue has also been linked to an increased risk of breast cancer. The changes that were finally adopted today include precise language that explains how breast density can affect mammography accuracy. They advise people with thick breasts to discuss their personal circumstances, risk factors for breast cancer, and breast density with their doctor.
Around one in eight women may develop breast cancer over their lifetime, which affects hundreds of thousands of Americans every year, according to the Centers for Disease Control and Prevention. The best method for detecting and screening breast cancer is mammography.
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