ACOG Reaffirms Breast Density Guidance – FDA Proposes New Notification Rule
Learning Objectives and CME/Disclosure Information
This activity is intended for healthcare providers delivering care to women and their families.
After completing this activity, the participant should be better able to:
1. State the ACOG guidance on follow up testing for women with dense breasts 2. Discuss the ACR BI-RADS categories for breast density
Estimated time to complete activity: 0.25 hours
Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project
Disclosure of Conflicts of Interest
Postgraduate Institute for Medicine (PIM) requires faculty, planners, and others in control of educational content to disclose all their financial relationships with ineligible companies. All identified conflicts of interest (COI) are thoroughly vetted and mitigated according to PIM policy. PIM is committed to providing its learners with high quality accredited continuing education activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of an ineligible company.
The PIM planners and others have nothing to disclose. The OBG Project planners and others have nothing to disclose.
Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, and has financial interest in The ObG Project, Inc.
Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.
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ACOG has reaffirmed its committee opinion (2019) regarding additional testing following detection of dense breasts on mammography. While ACOG states unequivocally that healthcare professionals comply with all laws, evidence is lacking as to clinical utility and improved outcomes with additional screening and testing.
Therefore, currently ACOG
…does not recommend routine use of alternative or adjunctive tests to screening mammography in women with dense breasts who are asymptomatic and have no additional risk factors.
The College strongly supports additional research to identify more effective screening methods that will enhance meaningful improvements in cancer outcomes for women with dense breasts and minimize false-positive screening results.
BI-RADS Density Categories (for more on BI-RADS classification, see ‘Related ObG Topics’ Below)
a. Breasts are almost entirely fatty
Mammography considered highly sensitive in this setting (88%)
b. There are scattered areas of fibroglandular density
Still sensitive but decreased from category a (82%)
c. Breasts are heterogeneously dense
Small masses may be obscured
Sensitivity drops to 69%
d. Breasts are extremely dense
Significantly lowers sensitivity of mammography (62%)
There are multiple states that do have laws requiring breast density notification after mammography, while some states do not necessarily require notification, but do require effort be made to inform and educate. The government, in the funding bill (February 2019) directed the FDA to ensure, at a minimum, language in mammography reports that includes
Effect of breast density in masking the presence of breast cancer on a mammogram
The qualitative assessment of the provider who interpreted the mammogram
A reminder to patients that individuals with dense breast tissue should talk with their providers if they have any questions or concerns about their summary
Note: The proposed FDA rule (publication date March 2019) proposes the following
Require reporting to patients and healthcare providers to include an assessment of breast density, in order to provide them with additional information about their mammography and the potential limitations of their mammogram results so they and their healthcare providers can make informed healthcare decisions
FDA is proposing to amend the mammography reporting requirements in § 900.12(c) to require that the written report of the results of the mammographic examination provided to the healthcare provider and the lay summary of the results provided to the patient also include information concerning patient breast density
Dense breast tissue and screening is more common
in younger women
Accuracy of mammography for the detection of
breast cancer is reduced (less sensitive)
In women with heterogeneously and extremely
dense breasts, digital mammography appears to be superior to film with respect
Breast cancer risk
Dense breast tissue (BI-RADS density categories c
and d) is associated with increased breast cancer risk
BI-RADS c breast cancer risk: 1.2 relative risk
compared to average breast density
BI-RADS d breast cancer risk: 2.1 relative risk
compared to average breast density
ACOG considers state mandated breast density
legislation to be ‘problematic’ for the following reasons
Currently, breast density classification remains
somewhat subjective, and not objective and quantifiable
To date, there are not clinical guidelines that
recommend additional screening in the setting of isolated breast density (related
to lack of clinical utility evidence)
While breast density does confer increased risk
for the higher categories, “breast density is not a major cancer risk factor”
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Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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