On March 9, 2023, the U.S. Food and Drug Administration (FDA) released a final rule updating mammography regulations issued under the Mammography Quality Standards Act of 1992 and the Federal Food, Drug, and Cosmetic Act 2 . In addition to other updates, the new FDA rule requires breast density reporting be included in both 1) the mammography reports provided to clinicians and 2) the lay language summaries provided to patients. The written report provided to clinicians will include an overall assessment of breast density classified into one of the following categories: A) “The breasts are almost entirely fatty”; B) “There are scattered areas of fibroglandular density”; C) “The breasts are heterogeneously dense, which may obscure small masses”; and D) “The breasts are extremely dense, which lowers the sensitivity of mammography.” For the patient notification, the FDA has collapsed the four BI-RADS categories of breast density into two: either “dense” or “not dense.” The patient report will include an FDA-developed prescribed paragraph on the significance of breast density. The full rule can be accessed online at https://www.federalregister.gov/documents/2023/03/10/2023-04550/mammography-quality-standards-act.
Based on the lack of data demonstrating a clear benefit, the American College of Obstetricians and Gynecologists (ACOG) currently does not recommend the routine use of alternative or adjunctive tests to screening mammography in individuals with dense breasts who are asymptomatic and have no additional risk factors 1 . More research is needed to identify more effective screening methods that will enhance meaningful improvements in cancer outcomes for those with dense breasts and minimize false-positive screening results.
Updated ACOG Recommendation
While ACOG does not recommend routine use of alternative or adjunctive tests to screening mammography in individuals with dense breasts who are asymptomatic and have no additional risk factors, ACOG recommends that clinicians comply with the new FDA rule and any state laws and federal rules that require disclosure of a patient’s breast density as recorded in a mammogram report.
ACOG’s clinical guidance is routinely reviewed for accuracy and potential updates. Any new guidance will be published online and in Obstetrics & Gynecology. Please contact [email protected] with any questions.
The American College of Obstetricians and Gynecologists recognizes and supports the gender diversity of all patients who seek obstetric and gynecologic care. In original portions of this document, authors seek to use gender-inclusive language or gender-neutral language. When describing research findings, this document uses gender terminology reported by investigators. To review ACOG’s policy on inclusive language, see https://www.acog.org/clinical-information/policy-and-position-statements/statements-of-policy/2022/inclusive-language.
A Practice Advisory is a brief, focused statement issued to communicate a change in ACOG guidance or information on an emergent clinical issue (eg, clinical study, scientific report, draft regulation). A Practice Advisory constitutes ACOG clinical guidance and is issued only online for Fellows but may also be used by patients and the media. Practice Advisories are reviewed periodically for reaffirmation, revision, withdrawal, or incorporation into other ACOG guidelines. This information is designed as an educational resource to aid clinicians in providing obstetric and gynecologic care, and use of this information is voluntary. This information should not be considered as inclusive of all proper treatments or methods of care or as a statement of the standard of care. It is not intended to substitute for the independent professional judgment of the treating clinician. Variations in practice may be warranted when, in the reasonable judgment of the treating clinician, such course of action is indicated by the condition of the patient, limitations of available resources, or advances in knowledge or technology. The American College of Obstetricians and Gynecologists reviews its publications regularly; however, its publications may not reflect the most recent evidence. Any updates to this document can be found on www.acog.org/clinical.
on acog.org/clinical.
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The American College of Obstetricians and Gynecologists (ACOG) is the nation’s leading group of physicians providing evidence-based obstetric and gynecologic care. As a private, voluntary, nonprofit membership organization of more than 60,000 members, ACOG strongly advocates for equitable, exceptional, and respectful care for all women and people in need of obstetric and gynecologic care; maintains the highest standards of clinical practice and continuing education of its members; promotes patient education; and increases awareness among its members and the public of the changing issues facing patients and their families and communities. www.acog.org
