What is the BI-RADS (Breast Imaging-Reporting and Data System) classification of a hypoechoic breast lesion with a macrolobulated margin, internal vasculature, and documented progression in size?

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BI-RADS Classification

This lesion is BI-RADS 4 (suspicious abnormality warranting biopsy), and given the documented progression in size, it should be classified as BI-RADS 4B or 4C depending on the degree of suspicion. 1

Key Features Supporting BI-RADS 4 Classification

The combination of concerning sonographic features places this lesion firmly in the suspicious category:

  • Hypoechoic appearance with macrolobulated margins are suspicious features that elevate concern beyond benign (BI-RADS 3) 2
  • Internal vascularity adds to the suspicion for malignancy 2
  • Documented progression in size is a critical feature that automatically upgrades any lesion to require tissue diagnosis, as growth indicates biological activity inconsistent with stable benign disease 1

Why This Cannot Be BI-RADS 3

BI-RADS 3 (probably benign) requires:

  • Lesions must be less than 2 cm with low clinical suspicion 1
  • Lesions must remain stable on follow-up imaging 1
  • The malignancy risk must be less than 2% 3

Any lesion that increases in size on follow-up automatically requires tissue sampling and cannot remain in BI-RADS 3. 1

Subcategorization Within BI-RADS 4

The BI-RADS 4 category can be further refined:

  • BI-RADS 4A (low suspicion): 10% malignancy rate 4
  • BI-RADS 4B (intermediate suspicion): 21% malignancy rate 4
  • BI-RADS 4C (moderate concern): 70% malignancy rate 4

Given the macrolobulated margins, internal vascularity, and documented growth, this lesion likely falls into BI-RADS 4B or 4C rather than 4A. 4, 2

Immediate Management Required

Core needle biopsy (preferred) or surgical excision with specimen radiograph is mandatory for all BI-RADS 4 lesions. 1, 3

  • The overall positive predictive value for malignancy in BI-RADS 4 lesions ranges from 34% to 44.9% 5, 6
  • Pathology-imaging concordance must be documented after biopsy 1, 3
  • If pathology and imaging are discordant, repeat imaging and additional tissue sampling or surgical excision is required 1

Critical Pitfall to Avoid

Never observe a lesion that has demonstrated growth, regardless of other benign-appearing features. Progression in size overrides all other considerations and mandates tissue diagnosis. 1

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

A New Practical Decision Rule to Better Differentiate BI-RADS 3 or 4 Breast Masses on Breast Ultrasound.

Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine, 2022

Guideline

BIRADS Classification and Management

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2026

Guideline

BI-RADS 4 Classification and Coding

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2026

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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