Breast lesion excision sample (BLES Biopsy) combining stereotactic biopsy and radiofrequency: Is it a safe and accurate procedure in case of BIRADS 4 and 5 breast lesions?

The aim of this study was to evaluate the accuracy and safety of breast lesion excision system (BLES) procedure with an Intact system device, under stereotactic and ultrasound guidance. Retrospective data review of 32 breast lesions BI-RADS 4 or 5 underwent Intact procedures, from March 2010 to January 2012. Underestimation rates of atypical ductal hyperplasia (ADH) and ductal carcinoma in situ (DCIS) were evaluated; percentage of complete radiologic and histologic removal of the breast lesion were analyzed, as were the complications due to procedure. Complete radiologic excision of the target lesion was achieved in all masses and 58.6% of calcifications. Lesion size was less than 11 mm (mean size 5.6 mm). Underestimation of ADH and DCIS was 0% and 10%, respectively. Low complication rate was noted: only one hematoma. BLES appears an accurate and safe biopsy system for sampling nonpalpable breast lesions, especially in case of microcalcifications clusters categorized as BI-RADS 4 and 5.