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FDA Finalizes New Mammography Dense Breast Notification Rule

SUMMARY:

The FDA has updated the mammography regulations and now requires that mammography facilities notify patients about the density of their breasts. The amendments incorporate language that specifies how breast density can influence the accuracy of mammography in addition to recommending a discussion with their healthcare professional. The rule goes into effect September 10, 2024. Currently, the ACOG committee opinion states unequivocally that healthcare professionals comply with all laws, although evidence is lacking as to clinical utility and improved outcomes with additional screening and testing.

Summary of Results to be Provided to Patients (FDA Rule)

Non-Dense Breast

Breast tissue can be either dense or not dense

Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer

Your breast tissue is not dense

Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation

Dense Breast

Breast tissue can be either dense or not dense

Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer

Your breast tissue is dense

In some people with dense tissue, other imaging tests in addition to a mammogram may help find cancers

Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation

ACOG

  • The current ACOG Practice Advisory States

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

BI-RADS Density Categories (for more on BI-RADS classification, see ‘Related ObG Topics’ Below)

  • a. Breasts are almost entirely fatty
    • Prevalence: 10%
    • Mammography considered highly sensitive in this setting (88%)
  • b. There are scattered areas of fibroglandular density
    • Prevalence: 43%
    • Still sensitive but decreased from category a (82%)
  • c. Breasts are heterogeneously dense
  • d. Breasts are extremely dense

KEY POINTS:

  • 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 to efficacy
  • 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
  • The FDA also has required reporting language that should be provided to the referring healthcare professional that falls into 4 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

(D) The breasts are extremely dense, which lowers the sensitivity of mammography

Learn More – Primary Sources:

FDA Updates Mammography Regulations to Require Reporting of Breast Density Information and Enhance Facility Oversight (2023)

ACOG Committee Opinion 625: Management of Women With Dense Breasts Diagnosed by Mammography

ACOG Practice Advisory: The U.S. Food and Drug Administration Requires Notification of Breast Density in Mammography Reports

BI-RADS: Standardizing Breast Imaging and Reporting

WHAT IS IT?

BI-RADS: Breast Imaging Reporting and Data System, was developed by the American College of Radiology (ACR) to standardize mammogram reporting, as well as breast ultrasound and MRI reporting.

The standard mammogram report includes the following

  • Indication and type of mammogram (screening/diagnostic)
  • Statement regarding breast density
  • Description of pertinent findings including size and location, oriented by quadrant and clock position
  • Summary of important findings and BI-RADS category

KEY POINTS:

BI-RADS Classification Standardizes Findings and Recommendations for Further Management

BI-RADS 0 : Incomplete

  • Recall for additional imaging/comparison with prior examinations, or both

BI-RADS 1: Negative  (Essentially 0% chance of malignancy)

  • Routine screening

BI-RADS 2: Benign (Essentially 0% likelihood of malignancy)

  • Routine screening

BI-RADS 3: Probably benign (> 0% but ≤ 2% likelihood of malignancy)

  • 6 month follow-up or continued surveillance

BI-RADS 4: Suspicious (> 2% but < 95% likelihood of malignancy)

  • 4A: Low suspicion for malignancy (> 2% to ≤ 10% likelihood)
  • 4B: Moderate suspicion for malignancy (> 10% to ≤ 50% likelihood)
  • 4C: High suspicion for malignancy (> 50% to < 95% likelihood)
  • Tissue diagnosis needed for all BI-RADS 4  categories

BI-RADS 5: Highly suggestive of malignancy (95% likelihood of malignancy)

  • Tissue diagnosis needed

BI-RADS 6: Known, biopsy proven malignancy

  • Surgical excision when appropriate

Density Categories

  • Category a: Breasts are almost entirely fatty
    • Prevalence: 10% of the population
    • Mammography considered highly sensitive in this setting (88%)
  • Category b: There are scattered areas of fibroglandular density
    • Prevalence: 43% of the population
    • Still sensitive but decreased from category a (82%)
  • Category c: Breasts are heterogeneously dense
  • Category d: Breasts are extremely dense
    • Significantly lowers sensitivity of mammography (62%)
    • Note: Breast cancer risk is 2.1 relative risk compared to average breast density

Learn More – Primary Sources:

ACOG Practice Bulletin No 164. Diagnosis and Management of Benign Breast Disorders 

ACR BI-RADS® Atlas, Breast Imaging Reporting and Data System

ACOG Committee Opinion 625: Management of with Dense Breasts Diagnosed with Mammography