Background: This study evaluates the safety, efficacy, and patient acceptance of a vacuum-assisted, hand-held biopsy device (Mammotome) in percutaneous removal of breast masses using ultrasound guidance.Methods: A multicenter, nonrandomized study evaluated 124 women with low-risk palpable lesions. Lesions ≤1.5 cm and those >1.5 cm but ≤3.0 cm were removed using 1-gauge or 8-gauge probes, respectively. Follow-up evaluation was performed at 10 days postbiopsy.Results: The 8-guage probe was used to obtain biopsies from 75 patients, and the 11-gauge was used for 49 patients. Complete removal of the imaged lesion was similar between groups (99% 8-gauge versus 96% 11-gauge). Most complications were mild and anticipated. Most patients (97%) were satisfied with incision appearance, and 98% of patients would recommend the procedure to others.Conclusions: Percutaneous removal of palpable benign breast masses using the Mammotome system is feasible, safe, and yields high patient satisfaction. Long-term efficacy is being evaluated in the ongoing study.