Overstated Harms of Breast Cancer Screening? A Large Outcomes Analysis of Complications Associated With 9-Gauge Stereotactic Vacuum-Assisted Breast Biopsy

The purpose of this study was to assess the rate, type, and severity of complications related to 9-gauge stereotactic vacuum-assisted breast biopsy (SVAB) and to delineate associated factors that may contribute to a higher rate of complications. This retrospective study included 4776 patients who underwent SVAB between 2003 and 2016. A total of 319 patients with documented postbiopsy complications were identified. Complications were subcategorized as bleeding, pain, lightheadedness, bruising, and other complications, and their severity was classified as minor, moderate, or severe. Hematoma volumes were correlated with biopsy location and complication severity. A group of control subjects who underwent SVAB but had no complications was compared with the group of study patients with regard to age, biopsy location, lesion type, and pathologic findings. Postbiopsy screening adherence was assessed. Statistical analyses were performed using the Fisher exact, Mann-Whitney, Kruskal-Wallis, and Spearman rank correlation tests. Of the 319 patients with complications who were identified (representing 6.7% of the 4776 patients who underwent SVAB), 307 (96.2%) had mild complications, 12 (3.8%) had moderate complications, and no patients had severe complications. The most common complication was bleeding or hematoma (89.3% of patients [285/319]), followed by pain (6.9% [22/319]), lightheadedness (0.9% [3/319]), bruising (0.9% [3/319]), and other complications (1.9% [6/319]). No significant differences were noted between the study group and the control group in terms of age (p = 0.474), biopsy location (p = 0.065), histologic findings (p = 0.056), or lesion type (p = 0.568). Hematoma volume (median, 7.5 cm ) did not correspond to the severity of complications. Larger hematoma volumes were associated with a posterior biopsy location (p = 0.008). The rate of return to annual screening after biopsy was not adversely affected by the presence of biopsy complications. Clinically significant complications associated with SVAB were exceedingly rare (0.3%) in this large study spanning 13 years.