Surgical benefits conveyed by biopsy site marking system using ultrasound localization

Background: With vacuum-assisted biopsy technology all, or most, of a breast lesion may be removed during the initial biopsy; in such cases a metallic marker is often inserted at the site of the biopsy for future localization. The aim of this study was to evaluate the efficacy and impact of the Gel Mark Ultra biopsy site marking system (SenoRx, Aliso Viejo, CA) on the practice of needle localization breast biopsy. Methods: We retrospectively analyzed the experience of 45 general surgeons across the United States in a variety of practice settings using the Gel Mark Ultra clip. Imaging-guided biopsy technique, localization quality, surgeon confidence, and margin status were assessed and compared against the broad data reported in the literature. Results: A total of 432 records of patients who underwent imaging-guided breast biopsy with placement of Gel Mark Ultra clip were reviewed. Of these, 63 (15%) patients required definitive surgical intervention, for which 41 cases were localized with ultrasound and assessed for margin clearance. Clear margins were achieved in 37 (90%) of the 41 cases. These results are statistically superior (P <.01) to positive margins rates reported in the literature. Conclusions: The Gel Mark Ultra biopsy site marking system is a new localization device that provides a safe and effective alternative to traditional localization methods with a significant reduction in the percentage of positive margins, as well as advantages in terms of surgical approach, time, and patient comfort.