Uterine Fibroids

Focused ultrasound treatment for uterine fibroids has been available to women in the U.S. since a treatment system was approved by the Food and Drug Administration (FDA) in 2004.

Clinical KeyFocused ultrasound is a non-invasive way to treat uterine fibroids. Using this treatment method in conjunction with image guidance, the physician directs a focused beam of energy through the patient’s skin, superficial fat layer, and abdominal muscles to heat and destroy the fibroid tissue without damaging nearby tissue or the tissues that the beam passes through on its way to the target.

The treatment is conducted with the patient awake and uses either magnetic resonance (MR) or ultrasound (US) guidance. This enables the physician to target, control, and monitor the treatment in real time.

Potential Benefits of Focused Ultrasound

The potential benefits of using focused ultrasound to treat symptomatic uterine fibroids include:

  • It is a non-invasive treatment with a low risk of complications, a short recovery time and a quick return to work and the activities of normal life (usually the next day).
  • It offers rapid and durable resolution of fibroid symptoms (sometimes within days of treatment).
  • It has a low rate of complications.
  • It preserves the possibility of retaining fertility after fibroid treatment; anecdotal clinical evidence is showing that women are able to conceive after treatment.

Treatment Sites

There are focused ultrasound systems approved to treat uterine fibroids in the United States, Europe, Asia, Latin America and the Middle East. Less widespread approval exists for the use of focused ultrasound to treat adenomyosis, which occurs when the lining of the uterus grows into the wall of the uterus. Search a full list of treatment sites to identify focused ultrasound centers treating fibroids in your region.

Clinical Trials

There are ongoing clinical trials in the U.S. and other regions of the world to study an updated version of the currently approved system and for a new focused ultrasound system for treating fibroids.

There are also ongoing studies that compare focused ultrasound treatment to other fibroid treatment methods.

Some important clinical trials include:

Our database lists clinical trials for fibroids and other conditions. Studies are being planned continuously, so check back frequently for new studies.

Reimbursement

Because it is a relatively new technology, no major U.S. insurance company currently provides consistent coverage and reimbursement for focused ultrasound treatment of fibroids.  However, Blue Cross/Blue Shield, AETNA, and United have all approved cases on an individual basis. In the United Kingdom, Germany, and Russia, individual patients have gained local level approval. In China healthcare insurance partially or fully covers the cost of the treatment. Our patient support organization, Fibroid Relief, has a toolkit to assist women in navigating the health insurance process.

In Israel, Clalit Medical Insurance is covering MRgFUS for symptomatic uterine fibroids.

Patient Support

To increase patient awareness and access to new treatment options for uterine fibroids (including focused ultrasound), the Foundation manages a patient support initiative called Fibroid Relief.

Notable Papers

Mindjuk I, Trumm CG, Herzog P, Stahl R, Matzko M. MRI predictors of clinical success in MR-guided focused ultrasound (MRgFUS) treatments of uterine fibroids: results from a single centre. Eur Radiol. 2014 Dec 16.

Gorny KR, Borah BJ, Brown DL, Woodrum DA, Stewart EA, Hesley GK. Incidence of Additional Treatments in Women Treated with MR-Guided Focused US for Symptomatic Uterine Fibroids: Review of 138 Patients with an Average Follow-up of 2.8 Years. J Vasc Interv Radiol. 2014 Jul 2. pii: S1051-0443(14)00503-X. doi: 10.1016/j.jvir.2014.05.012.

Ellens N, Hynynen K. Simulation study of the effects of near- and far-field heating during focused ultrasound uterine fibroid ablation using an electronically focused phased array: A theoretical analysis of patient safety. Med Phys. 2014 Jul;41(7):072902. doi: 10.1118/1.4883777.

Cain-Nielsen AH, Moriarty JP, Stewart EA, Borah BJ. Cost-effectiveness of uterine-preserving procedures for the treatment of uterine fibroid symptoms in the USA. J Comp Eff Res. 2014 May 30:1-12. 

Kim YS, Bae DS, Park MJ, Viitala A, Keserci B, Rhim H, Lim HK. Techniques to Expand Patient Selection for MRI-Guided High-Intensity Focused Ultrasound Ablation of Uterine Fibroids. AJR Am J Roentgenol. 2014 Feb;202(2):443-51.

Zhao WP, Chen JY, Zhang L, Li Q, Qin J, Peng S, Li KQ, Wang ZB, Chen WZ. Feasibility of ultrasound-guided high intensity focused ultrasound ablating uterine fibroids with hyperintense on T2-weighted MR imaging. Eur J Radiol. 2013 Jan;82(1):e43-9.

Rabinovici J, David M, Fukunishi H, Morita Y, Gostout BS, Stewart EA. Pregnancy outcome after magnetic resonance–guided focused ultrasound surgery (MRgFUS) for conservative treatment of uterine fibroids. Fertil Steril 2010 Jan;93(1):199-209.

Okada A, Morita Y, Fukunishi H, Takeichi K, Murakami T. Non-invasive magnetic resonance-guided focused ultrasound treatment of uterine fibroids in a large Japanese population: impact of the learning curve on patient outcome. Ultrasound Obstet Gynecol 2009 Nov;34(5):579-83.

Stewart EA, Gostout B, Rabinovici J, Kim HS, Regan L, Tempany CM. Sustained relief of leiomyoma symptoms by using focused ultrasound surgery. Obstet Gynecol 2007 Aug;110(2 Pt 1):279-87.

Click here for additional references from PubMed.

Animated treatment video courtesy of Insightec

 

     

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