<![CDATA[Breast cancer remains a major health concern, and early detection is essential for improving treatment outcomes. Ultrasonography combined with the Breast Imaging Reporting and Data System (BI-RADS) is widely used to assess breast lesions and estimate their risk of malignancy. This literature review aimed to analyze the accuracy of BI-RADS classification on breast ultrasonography in predicting malignancy based on histopathological examination as the gold standard. A narrative literature review was conducted using articles retrieved from PubMed/NCBI, Google Scholar, ScienceDirect, SpringerLink, the Cochrane Library, and other relevant scientific sources. Articles published within the last five years were selected based on predefined inclusion and exclusion criteria. A total of 20 relevant articles were included and narratively synthesized. The findings showed that BI-RADS ultrasonography generally demonstrated high sensitivity, ranging from 83% to 98.4%, whereas specificity varied from 25.0% to 93.8%. The likelihood of histopathologically confirmed malignancy increased progressively with higher BI-RADS categories. BI-RADS 3 was predominantly associated with benign lesions, BI-RADS 4 showed heterogeneous malignancy risks requiring subdivision into categories 4A, 4B, and 4C, and BI-RADS 5 was strongly associated with malignancy. Variations in diagnostic performance were influenced by the BI-RADS cutoff, lesion characteristics, breast density, operator experience, equipment quality, population characteristics, and study design. In conclusion, BI-RADS ultrasonography is an effective tool for breast lesion risk stratification, particularly because of its high sensitivity. However, it cannot replace histopathological examination, which remains necessary for definitive diagnosis, especially for BI-RADS 4 and 5 lesions.]]>
