FDA to require breast-density notifications from mammography facilities
The U.S. Food and Drug Administration on Thursday updated mammography regulations to require that facilities notify women about of the density of their breasts.
Changes also will “strengthen the FDA’s oversight and enforcement” of imaging providers while making it easier for radiologists to categorize and assess mammograms, the administration said March 9. Officials touted a “steep decrease” in the number of breast imaging facilities that do not meet quality standards since the landmark law was passed in 1992.
“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” Hilary Marston, MD, chief medical officer of the FDA, said in a statement.
About half of women over age 40 in the U.S. have dense breast tissue, the FDA noted, adding that the trait can both increase cancer risk and make cancer detection more difficult. Thursday’s update provides specific language to help patients understand how density may influence the accuracy of a mammogram. Plus it recommends that affected patients talk with providers about density and the risks it may pose.
In other updates, the FDA is “enhancing” its enforcement capabilities over breast imaging facilities. This will include bolstering the administration’s ability to communicate directly with consumers and providers “where a facility did not meet quality standards and is not adequately communicating with patients about its deficiencies.”
“This is intended to help ensure important information that could affect decisions about patient care, such as the potential need for further evaluation or a repeat mammogram, is communicated as completely as possible,” the FDA said in its notice.
Additionally, the modifications will “modernize” mammography regulations by incorporating current science and imaging best practices. This, the FDA noted, will help improve cancer detection and empower patients to take agency over their breast health.
The final rule is slated to be published in the Federal Register on Friday, March 10, and implemented “within 18 months.” Advocates applauded the announcement on Thursday. JoAnn Pushkin said it’s been 10 years since she asked the FDA to consider adding this requirement and even longer since an advisory committee urged the administration to do so.
“Too many patient ‘density inform’ advocates are no longer with us to join me in an exhale of relief that all U.S. women will now be told about their breast density after their mammograms,” Pushkin, who is executive director of DenseBreast-info.org, said in a statement. “That their tragedies—of hidden cancers finally found when no longer early stage—may be prevented from wreaking havoc on other families. So, while we all share a hallelujah! that this has finally come to pass, to quote songwriter Leonard Cohen, for some of us, ‘it’s a cold and it’s a broken Hallelujah.’ But a hallelujah it is.”
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.