Abstract
BACKGROUND: The aim of our multicenter study was to assess the clinical outcome and safety of ultrasound (US)-guided high-intensity focused ultrasound (HIFU) in patients with breast fibroadenoma (FA). METHODS: From May 2011 to February 2013, 42 women with 51 FA in one or both breasts were selected for treatment with US-guided HIFU. Eight of 51 FA were treated twice. Patients' age ranged from 16 to 52 years (mean 32 years). All patients with FA underwent core needle biopsy with histological confirmation. HIFU treatment was performed as an outpatient procedure under conscious sedation. Exclusion criteria were pregnant or lactating women, microcalcifications within the lesion at mammogram, history of breast cancer, previous laser or radiation therapy, and breast implant in the same breast. All patients signed written informed consent. After the treatment, follow-up US with volume evaluation was performed at 2, 6, and 12 months. RESULTS: The FA mean baseline volume was 3.89 ml (0.34-19.66 ml). At 2-month follow-up, the mean volume reduction was 33.2% ± 19.1% and achieved significance at 6-month (59.2% ± 18.2%, p < 0.001) and 12-month (72.5% ± 16.7%, p < 0.001) follow-up. Related side effects as superficial skin burn with blister-like aspect in three patients and hyperpigmentation over the treated area in one patient were transient and resolved spontaneously. In one patient, asymptomatic subcutaneous induration persisted at the end of the study. CONCLUSIONS: US-guided HIFU treatment is an effective noninvasive method for the treatment of breast FA and well tolerated by the patients. Preliminary results are encouraging and show that HIFU could be an alternative to surgery for breast FA.