The Food and Drug Administration announced on Wednesday proposed changes to breast-cancer screening standards that would require mammogram providers to tell women whether they have dense breast tissue that can make detection of cancer more difficult.
The proposal marks the biggest change in mammogram standards in two decades. FDA Commissioner Scott Gottlieb said the proposal is aimed at improving the quality of breast-cancer screening.
“Breast cancer is one of the most worrisome health concerns facing women,” Gottlieb said. “We’re proposing new policies to modernize our 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. Today’s proposed rule would help to ensure patients continue to benefit from advances in new tools and robust oversight of this field.”
According to the National Cancer Institute, nearly half of women over 40 have dense breast tissue, which is often hereditary but can increase with exposure to treatments such as postmenopausal hormone replacement therapy. Dense breasts have less fatty tissue and more glandular or connective tissue, both of which can block X-rays that detect cancers and can only be detected through mammograms.
Many U.S. states already have laws that require mammogram providers to inform women when they have dense breasts, although the standards can vary. The FDA’s proposal will set a minimum national standard, which states can make more stringent on their own. Among the FDA’s proposed standards is a letter to patients explaining in lay language about breast density and recommending women with dense breasts talk to their doctors about cancer risk.
Earlier this week, a group of women called on an FDA panel to take more steps to protect consumers from health complications, including cancer, that can result from breast implants, the Washington Post said.