The FDA’s new rules on reporting breast density to women getting mammograms went into effect on September 10. The implementation has been expected for some time, but this week’s rollout generated a wave of positive press coverage that highlights the importance both of breast density awareness and of breast screening.
The FDA in March 2023 said it would implement a national standard requiring providers to inform women of their breast density, which can obscure lesions on conventional X-ray mammography.
- Breast density is also a risk factor for cancer, and patient advocacy groups had been pressuring the FDA to set a standard to replace what has become a patchwork of state-by-state notification rules.
The FDA’s rules have been incorporated into the Mammography Quality Standards Act, and require that …
- Mammography reports include a plain-language patient summary with “an overall assessment of breast density.”
- The summary must include specific language that defines breast density, explains its ramifications for detection and cancer risk, and suggests the need for additional imaging tests.
A novel aspect of the new rules is that they were mostly driven by patients – women like JoAnn Pushkin and the late Nancy Cappello who as patients discovered first-hand the shortcomings of X-ray-based mammography for women with dense breast tissue.
What’s next? Density-awareness proponents are now turning their attention to reimbursement, which for supplemental imaging is inconsistent across the U.S.
- A fix for the problem – the Find It Early Act – is working its way through Congress, and women’s health advocates lobbied on Capitol Hill this week to try to push the legislation through before the end of the current Congressional session.
The new reporting landscape also creates opportunities for better software tools to detect and manage breast density and better predict risk in patients with dense breast tissue.
- Clinicians already realize that women with dense breasts not only need different screening modalities like MRI and ultrasound, but that they might also require more frequent screening due to their heightened cancer risk.
The Takeaway
The FDA’s new breast density rules matter for a variety of reasons, from showing the power of patients to change their imaging experience to outlining a future in which risk plays a more prominent role in breast screening. While more work remains to be done, this is a good time to savor the triumph.
