Breast Fibroadenoma


Outside Approval SquareBreast fibroadenomas are benign (non-cancerous) tumors. They occur in approximately 10% of women over their lifetimes, and they are the most common type of breast lump in younger women, particularly those in their 20s and 30s.

Most fibroadenomas do not increase the risk for breast cancer unless they are complex fibroadenomas, which contain cysts and calcifications. What causes breast fibroadenomas is not known; however, reproductive hormones likely influence their development. Fibroadenomas are more common in women in their reproductive years, they grow larger during pregnancy, and they tend to shrink after menopause. In addition, use of birth control pills has been linked with the risk for fibroadenomas.

Clinical Trials Square

Current Treatment

Although breast fibroadenomas are benign, some women choose to have them surgically removed by lumpectomy. Once the fibroadenoma is removed, it is examined in the laboratory to check for cancer.

Focused Ultrasound Treatment

Focused ultrasound is a potentially non-invasive type of lumpectomy. Guided by ultrasound or magnetic resonance imaging, the physician directs a focused beam of acoustic energy through the skin. This beam heats and destroys the fibroadenoma without damaging nearby structures or tissues.

As a non-invasive form of lumpectomy, focused ultrasound may offer benefits including:

  • shorter recovery time;
  • little to no scarring and minimal risk for breast deformation;
  • fewer complications; and
  • more precise treatment as a result of real-time guidance by magnetic resonance or ultrasound imaging.

Clinical Trials

More than 60 patients have received focused ultrasound treatment for breast fibroadenoma. These procedures have taken place in the research setting and in clinical routine.

After recent success in a feasibility study on fibroadenoma that was led by David R. Brenin, MD, at the University of Virginia, a subsequent study that will look at efficacy and safety has just been initiated. Patients who are interested in this study, should contact UVA Research Coordinator Katie Rea at (434) 243-0315 or mail to

Additional sites will join this study in the coming months. 

For more information on clinical trials for treating breast fibroadenoma with focused ultrasound, click here.

Treatment Sites

Please see a list of possible treatment sites here.

Regulatory Approval and Reimbursement

The Theraclion Echopulse system has received approval in Europe for the treatment of breast fibroadenoma. To the best of our knowledge, this is the only device approved for this indication.

To the best of our knowledge, focused ultrasound treatment for breast fibroadenoma is not reimbursed universally by medical insurers.

Notable Papers

Farrer AI, Almquist S, Dillon CR, Neumayer LA, Parker DL, Christensen DA, Payne A. Phase aberration simulation study of MRgFUS breast treatments. Med Phys. 2016 Mar;43(3):1374. doi: 10.1118/1.4941013.

Peek MC, Ahmed M, Douek M. High-intensity focused ultrasound for the treatment of fibroadenomata (HIFU-F) study. J Ther Ultrasound. 2015 Apr 14;3:6. doi: 10.1186/s40349-015-0027-6. eCollection 2015.

Kovatcheva R, Guglielmina JN, Abehsera M, Boulanger L, Laurent N, Poncelet E. Ultrasound-guided high-intensity focused ultrasound treatment of breast fibroadenoma-a multicenter experience. J Ther Ultrasound. 2015 Jan 22;3(1):1. doi: 10.1186/s40349-014-0022-3. eCollection 2015.

Cavallo Marincola B, Pediconi F, Anzidei M, Miglio E, Di Mare L, Telesca M, Mancini M, D'Amati G, Monti M, Catalano C, Napoli A. High-intensity focused ultrasound in breast pathology: non-invasive treatment of benign and malignant lesions. Expert Rev Med Devices. 2015 Mar;12(2):191-9. doi: 10.1586/17434440.2015.986096. Epub 2014 Nov 24.

Liberman A, Wu Z, Barback CV, Viveros RD, Wang J, Ellies LG, Mattrey RF, Trogler WC, Kummel AC, Blair SL. Hollow iron-silica nanoshells for enhanced high intensity focused ultrasound. J Surg Res. 2014 Aug;190(2):391-8. doi: 10.1016/j.jss.2014.05.009. Epub 2014 May 10.

Jolesz FA, Hynynen K, McDannold N, Tempany C. MR imaging-controlled focused ultrasound ablation: a noninvasive image-guided surgery. Magn Reson Imaging Clin N Am. 2005 Aug;13(3):545-60.

Click here for additional references from PubMed.

Video courtesy of Theraclion