ObjectiveTo systematically review the value of the fine-needle biopsies in the diagnosis of benign and malignant breast nodules. MethodsA computer based online search was conducted in PubMed, The Cochrane Library (Issue 7, 2016), EMbase, CBM, CNKI, VIP, WanFang Data databases up to August, 2016 to collect the relevant diagnostic studies of the fine-needle biopsies for benign and malignant breast nodules. Two reviewers independently screened literature, extracted data and assessed the methodological quality of included studies. Then, meta-analysis was performed using Stata 12.0 and Meta-Disc 1.4 software.ResultsA total of 22 studies involving 24 496 patients were finally included. The results of meta-analysis showed that the pooled Sen, Spe, +LR, –LR, and DOR were 0.95 (95%CI 0.95 to 0.96), 0.96 (95%CI 0.96 to 0.96), 38.27 (95%CI 23.17 to 63.19), 0.05 (95%CI 0.03 to 0.07), 1 031.11 (95%CI 514.19 to 2 067.68), respectively. The AUC of SROC was 0.99 (95%CI 0.98 to 1.00).ConclusionThe current evidence indicates that the FNAC has high diagnostic value in the differential diagnosis of benign and malignant breast nodules.