PURPOSE: To evaluate patient acceptance of stereotactic or ultrasonographically (US) guided directional vacuum-assisted 11-gauge needle biopsy of breast lesions and short- and long-term changes at, mammography and US resulting from the procedure. MATERIALS AND METHODS: For 91,benign lesions that had been sampled at either stereotactic or US-guided directional vacuum-assisted breast biopsy performed with 11-gauge needles, clinical, mammographic, and US changes were evaluated 1,week after biopsy; 6-month follow-up findings Were available for 74 lesions. The subjective. outcome of the procedure and patient satisfaction were assessed on the basis of a patient-completed questionnaire that incorporated a multistage scoring system. Statistical analysis of scores for condition for both biopsy methods was performed with the chi(2) test. RESULTS: Adverse events occurred during the procedure in four patients'. Clinically visible hematomas were observed at 1-week follow-up in 79% of patients. Densities were observed on mammograms in 46% of patients 1 week after biopsy; hematomas with a maximum diameter of 2 cm were seen on sonograms in 74%. Six months after biopsy; mammography revealed discrete architectural changes in one case. No. abnormalities were found at 6-month follow-up,US. Fifteen patients had various complaints during the procedure; six reported feeling constrained during the first few days after biopsy, and one patient was not satisfied With the cosmetic result. No patient reported a retrospective preference for surgical biopsy instead of directional vacuum-assisted biopsy. Analysis of scores for the stereotactic and US-guided methods revealed a significant difference (P < .001) in favor of the stereotactic method for condition during biopsy, While scores for condition in the first days after biopsy were more equally distributed between the two methods (P = .386). CONCLUSION: Directional vacuum-assisted 11-gauge needle biopsy of the breast is well accepted by patients and rarely produces changes that may alter the mammographic or, sonographic appearance of the breast at 6-month follow-up. ((C)) RSNA, 2003.