The Food and Drug Administration is proposing a rule for breast cancer screening that requires physicians to get more information about women's dense breast problems.
"Mammograms of dense breasts … can be difficult to interpret, as the dense tissue may mask signs of breast cancer and the sensitivity of breast cancer may decrease the picture," the FDA said. "Dense breasts have also been identified as a risk factor for the development of breast cancer."
The FDA suggests a specific language to explain how density can affect outcomes, and to encourage women to talk with their doctor about how this is related to cancer risk and their individual situation. The agency also wants to tighten the regulation of mammography facilities, including the ability to inform patients that the tests did not meet FDA quality standards. The rule is open to public comment for the next 90 days.
When asked if the agency expects providers to push back, Dr. Jeff Shuren of the FDA: "We need to see what feedback we receive."
"We certainly make additional and stricter demands on these facilities," Shuren said in a call to reporters. "We believe this is important to protect public health and to serve the patient best."
Currently, 37 states are calling for women with dense breasts to provide some kind of notification, according to advocacy group DenseBreast-Info. In one implementation, the language of the FDA would set the national standard, although states could impose stricter requirements, said Shuren, director of the agency of the Center for Equipment and Radiological Health.
He outlined the specific language that women with dense breasts would receive: "Mammography is the best screening test to look for breast cancer, but it does not find all breast cancers." Some patients have a high chest tissue density, more glandular than Breast Fat This makes it harder to find breast cancer in a mammogram Your breast tissue density is high: Some patients with high breast density may need other imaging tests in addition to mammograms Follow the recommendations in this letter and talk to your doctor on the high breast density and their relation to breast cancer risk your individual situation. "