FDA: Women need breast-density information

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WASHINGTON — The Food and Drug Administration on Wednesday proposed requiring mammogram providers to notify women with dense breasts that the condition can make it harder to interpret mammograms and urging them to they talk to their doctors about whether they should have additional tests to check for cancer.

Dense breasts have relatively high amounts of glandular tissue and fibrous connective tissue and relatively low amounts of fatty breast tissue, according to the National Cancer Institute. Nearly half of women age 40 and older who get mammograms are found to have dense breasts.

Dense breast tissue appears white on a mammogram, as does cancer and some other abnormal changes, so it can make it harder for health care professionals to identify cancer on a screening test. In addition, dense breasts raise a woman's risk of developing breast cancer, the institute says.

More than three dozen states have laws requiring women who have mammograms that the have dense breasts. The new FDA language would establish a minimum standard that would apply nationwide.

The proposal would update regulations issued under the 1992 Mammography Quality Standards Act, which authorized federal oversight of the more than 8,000 mammography facilities in the U.S. Those rules involve the accreditation of the facilities, as well as annual inspections and enforcement of mammography quality rules.

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In announcing the proposal, FDA officials said it would improve medical decision-making because women with dense breasts could confer with their doctors about whether they should get supplemental tests such as ultrasounds of MRIs.

The U.S. Preventive Services Task Force has concluded there isn't sufficient evidence currently to determine whether the benefits of extra testing outweigh the potential harms.

The proposal would modernize the agency's oversight of mammography services "by capitalizing on a number of important advances in mammography, like the increased use of 3-D digital screening tools and the need for more uniform breast density reporting," FDA Commissioner Scott Gottlieb said in a statement.

In addition, the changes would allow the FDA to directly notify patients and their health care providers if a facility did not meet quality standards and a repeat test might be needed, the agency said.

The topic of breast density has generated keen interest on Capitol Hill.

Nancy Cappello, who led the push for legislation to provide women with more information about breast density, died in November 2018 of complications from cancer treatment. She founded the advocacy group Are You Dense? and was considered the founder of a movement to educate women about breast density.


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