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ACS CAN reacts to proposed FDA rule that would require women to get breast-density information along with their mammogram

A proposed rule issued by the U.S. Food and Drug Administration (FDA) on March 27 would modernize mammography quality standards and address breast density reporting to patients and their health care providers.

The following is a statement from Lisa Lacasse, president of the American Cancer Society Cancer Action Network (ACS CAN):

"We are pleased to see the agency issue a proposal that will empower women to make more informed decisions about their health. The proposal issued today related to breast density, which ACS CAN has continually advocated for, will help ensure women get the most accurate information they need following a mammogram.

"While screening mammography is currently considered the most effective way of detecting breast cancer and reducing mortality from the disease, it does have its limitations. This is particularly true for women with dense breast tissue. Dense breast tissue makes it more difficult for doctors to detect cancer from a mammogram because the dense tissue can mask potential masses or tumors. The FDA proposal to standardize reporting of dense breast tissue to patients and providers will allow women to make the best decision for their health in coordination with their doctor.

"We look forward to working with the FDA in the coming months to ensure the finalized rule on mammography empowers women to make more accurate and informed decisions about their health."

About half of women in the U.S. in their 40s and 50s have dense breast tissue. Now, more than three dozen states have laws requiring that women who have mammograms be informed if they have dense breasts, but the language differs widely. Some states mandate that these notifications also include recommendations that women with higher breast density should consider supplemental screening tests, such as ultrasound and MRI. The FDA proposal would establish a minimum standard that would apply nationwide, but states could retain more stringent requirements if they wished.

A recent ACS-funded study by researchers at Yale’s School of Public Health and School of Medicine found that women living in states with laws recommending supplemental screening tests had increased rates of breast ultrasound and cancer detection after the law was implemented. In contrast, the researchers found no changes in clinical practice related to notifications that only included information about breast density.




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