What are the next steps after receiving a Breast Imaging-Reporting and Data System (BI-RADS) score ranging from 0 to 6 for breast imaging?

BI-RADS Breast Imaging Classification: Management Algorithm

Direct Management Recommendations by Category

The management of breast imaging findings is determined by the BI-RADS category assigned, with each category having specific evidence-based next steps that directly impact cancer detection and survival. 1

BI-RADS 0: Incomplete Assessment

• Obtain additional imaging immediately before assigning a final category 1
• This requires supplemental views, ultrasound, or comparison with prior mammograms 1
• This is not considered a diagnostic test requiring follow-up tracking, but rather part of the multi-step screening process 2

BI-RADS 1 & 2: Negative or Benign Findings

• Resume routine annual screening mammography 2, 1
• No additional follow-up or intervention is needed 1
• Category 1 indicates completely normal breasts with no abnormalities 1
• Category 2 indicates definitively benign findings such as calcified fibroadenomas, oil cysts, or lipomas 1

BI-RADS 3: Probably Benign (Malignancy Risk <2%)

Perform unilateral diagnostic mammogram at 6 months, then bilateral mammography every 6-12 months for 1-2 years total before returning to routine screening. 2, 1, 3

Standard Surveillance Protocol:

• Initial follow-up at 6 months with unilateral diagnostic mammogram 3
• Subsequent bilateral mammography at 12 months for women ≥40 years 3
• Continue every 6-12 months until completing 1-2 years of surveillance 2, 3
• If stable or resolved, return to routine screening 2, 3
• If any changes occur (size increase or characteristic changes), proceed immediately to biopsy 2

Critical Exception - When to Biopsy Instead of Surveillance:

Immediate biopsy is appropriate rather than surveillance for: 2, 3

• Strong family history of breast cancer or genetic predisposition (BRCA mutations) 2, 3
• Patients awaiting organ transplant 3
• Known synchronous cancers 3
• Patients attempting pregnancy 3
• Uncertain return visit compliance or follow-up concerns 2, 3
• Extreme patient anxiety significantly impacting quality of life 2, 3
• Patient strongly desires biopsy 2

BI-RADS 4 & 5: Suspicious or Highly Suggestive of Malignancy

Perform tissue diagnosis immediately using core needle biopsy (preferred method) or needle localization excisional biopsy with specimen radiograph. 2, 1

Biopsy Protocol Requirements:

• Core needle biopsy is preferred over fine needle aspiration or open biopsy 2
• Core needle biopsy has >97% sensitivity and 92-99% specificity 2
• Pathology-imaging concordance is mandatory - the pathology result must match the imaging suspicion level 2, 1

Critical Pitfall - Discordant Results:

When pathology and imaging findings are discordant: 2, 1

• Repeat breast imaging and/or obtain additional tissue sampling 2, 1
• Surgical excision is required if pathology and imaging remain discordant 2
• Example: Benign pathology from a spiculated BI-RADS 5 mass is clearly discordant and unacceptable 2

Concordant Benign Results:

• Follow-up with mammography every 6-12 months for 1-2 years before returning to routine screening 2

BI-RADS 6: Known Biopsy-Proven Malignancy

Manage according to breast cancer treatment guidelines - this category is used for lesions already confirmed malignant by biopsy but before definitive treatment begins. 2, 1

Key Clinical Considerations

Assessment Category Assignment:

• The final BI-RADS category reflects the most suspicious finding when multiple abnormalities are present 1
• When both mammography and ultrasound are performed, the BI-RADS category represents cumulative findings from both modalities 1
• Categories may change based on subsequent imaging 1

Quality Metrics for Timely Follow-up:

• BI-RADS categories 4 and 5 require tissue diagnosis to prevent delays in cancer treatment that could impact mortality 2
• The time between positive screening and biopsy is a critical quality metric based on expert consensus 2