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

Inclusion Criteria:

* Female patients 18 to 45 years old with at least one diagnosed breast fibroadenoma
* Diagnosis of fibroadenoma must be based on:

  * clinical examination
  * ultrasound image alone for patients Under 35 years old. For women older than 35 years, a mammogram will be performed in addition to ultrasound. the BI-RADS score of this mammogram must be less than 3. In all cases where an uncertainly exists, the patient will not be included.
  * histological confirmation after core needle biopsy by two independant readers (biopsy must be performed at least two weeks before therapy unless a micro biopsy has been already done less than 3 months before inclusion visit and histopathology slices are available)
* the requirements for the distance from the skin and the following régions of the fibroadenoma are:

  * depth anterior edge \< 19.4mm
  * nodule thickness \> 7.3 mm
  * depth of posterior edge \> 12.5 mm
  * depth to rib cage \> 10mm
* patient's fibroadenoma size is greater to equal to 0.3 cc (measured by ultrasound on the day of the procedure)
* Lesions should be less than 20 mL
* The lesion must be sonographically visible
* Lesions presented during previous surveillance a minimum 20% increase volume AND/OR
* Patient are presenting a pain level \>= 3 as meaured on the VAS during the last 30 days AND/OR
* Patient are presenting a anxiety level \>= 3 as meaured on the VAS during the last 30 days before selection visit
* Fibroadenoma is palpable
* Patient candidate for sugery
* Patient has signed a written informed consent
* Patient with a social security coverage

Exclusion Criteria:

* Patient is pregnant or lactating
* Patient with history of laser or radiotherapy in the targeted breast
* Core biopsy diagnosis suggestive of cytosarcoma phyllodes tumor or other malignancy
* Patient with breast implant in the targeted breast
* Patient with predominantly liquid nodule
* Macro-calcifications in pre-focal HIFU path
* Nipple and or areola in pre-focal HIFU path
* Patient's fibroadenoma not clearly visible on the ultrasound images (in B-mode) at the inclusion visit
* Scars or moles before the focal point of the HIFU
* Patient participating in another clinical trial involving an investigational drug, or device