Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)

Inclusion Criteria: * Female patients 18 years or older with at least one diagnosed breast fibroadenoma. * Diagnosis of fibroadenoma must be based on: * clinical examination, * women ≤ 40 years of age: ultrasound image alone; women \> 40 years of age: ultrasound image and mammogram, * histological confirmation of fibroadenoma of the breast. * Patient's fibroadenoma size as determined by ultrasound imaging: the longest diameter is limited to 25 mm. * Women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to HIFU treatment. * Patient must be able to understand the nature and the extent of the study and the procédures required and be willing and able to complete the screening and study procedures. * Patient must give written informed consent (personally signed and dated) before completing any study-related procedure. Exclusion Criteria: * Patient who is pregnant or breast-feeding. * Patient with history of ipsilateral breast cancer within 5 years prior to study inclusion or radio therapy to the target breast within 5 years prior to study inclusion. * Patient with implant on the treated breast. * Patient with target fibroadenoma pre-treated by cryoablation or interstitial laser therapy within 12 month before recruiting for HIFU. * Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit. * Patient participating in other studies using drugs or medical devices within 3 months prior to study inclusion or during study participation including the follow-up period.