Uterine Fibroids

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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.

Focused ultrasound is a noninvasive 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.

How it Works
Focused ultrasound energy heats and destroys the targeted tissue at the focal point. This process is repeated until the entire selected volume is destroyed.

Advantages

  • It is a noninvasive treatment with a short recovery time and a quick return to work and 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 fertility with published studies reporting that women are able to conceive and have normal pregnancies after treatment.

Get Treated

There is a clinical trial in the Netherlands, which is a 2:1 randomized trial comparing MRI-guided focused ultrasound to other treatments (hysterectomy, myomectomy, or uterine artery ablation). See the website for this trial, called MYCHOICE, for more information. 

There is a clinical trial in Germany, that is a randomized trial comparing MRI-guided focused ultrasound to myomectomy.

There is a clinical trial in France that exploring fibroid elasticity and diffusion to assess how those factors predict success in focused ultrasound ablation of uterine fibroids.

There is a clinical trial in Turku, Finland, that is using focused ultrasound to treat uterine fibroids.

There is a clinical trial in Canada using MRI-guided focused ultrasound to treat uterine leiomyomas. This trial is only open to Canadian citizens.

See a list of treatment sites > 
See a list of clinical trials sites >
See a list of laboratory research sites >

Regulatory Approval and Reimbursement

In 2004, MRI-guided focused ultrasound was approved by US Food and Drug Administration for the treatment of uterine fibroids. Currently, no major U.S. insurance company 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.

Internationally, focused ultrasound is approved in Canada, China, Europe, India, Japan, Korea, the Middle East, Oceania, Russia, South America, and Taiwan. 

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. 

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

Notable Papers

Lin Y, Wu RC, Huang YL, Chen K, Tseng SC, Wang CJ, Chao A, Lai CH, Lin G. Uterine fibroid-like tumors: spectrum of MR imaging findings and their differential diagnosis. Abdom Radiol (NY). 2022 Mar 26. doi: 10.1007/s00261-022-03431-6.

Zheng S, Rong Y, Zhu H, Zhang X, Liu X, Wu Y, Zhao M. Role of magnetic resonance-high intensity focused ultrasound (MR-HIFU) in uterine fibroids management: an updated systematic review and meta-analysis. Wideochir Inne Tech Maloinwazyjne. 2022 Mar;17(1):83-94. doi: 10.5114/wiitm.2021.109760. Epub 2021 Oct 8.

Ferrario L, Garagiola E, Gerardi C, Bellavia G, Colombo S, Ticca C, Rossetti C, Ciboldi M, Meroni M, Vanzulli A, Rampoldi A, Bignardi T, Arrigoni F, Porazzi E, Foglia E. Innovative and conventional “conservative” technologies for the treatment of uterine fibroids in Italy: a multidimensional assessment. Health Econ Rev. 2022 Mar 18;12(1):21. doi: 10.1186/s13561-022-00367-x.

Anneveldt KJ, van ‘t Oever HJ, Verpalen IM, Nijholt IM, Bartels W, Dijkstra JR, van den Hoed RD, van ‘t Veer-Ten Kate M, de Boer E, Veersema S, Huirne JAF, Schutte JM, Boomsma MF. Increased MR-guided high intensity focused ultrasound (MR-HIFU) sonication efficiency of uterine fibroids after carbetocin administration. Eur J Radiol Open. 2022 Mar 21;9:100413. doi: 10.1016/j.ejro.2022.100413. eCollection 2022.

Gong X, Zhang X, Liu D, Yang C, Zhang R, Xiao Z, Chen W, Chen J. Physician Experience in Technical Success of Achieving NPVR 80% of High-Intensity Focused Ultrasound Ablation for Uterine Fibroids: A Multicenter Study. Front Med Technol. 2022 Mar 8;3:790956. doi: 10.3389/fmedt.2021.790956. eCollection 2021.

Gao H, Li T, Fu D, Wei J. Uterine artery embolization, surgery and high intensity focused ultrasound in the treatment of uterine fibroids: a network meta-analysis. Quant Imaging Med Surg. 2021 Sep;11(9):4125-4136. doi: 10.21037/qims-20-1331.

Ji J, Liu J, Chen Y, Liu X, Hao L. Analysis of high intensity focused ultrasound in treatment of uterine fibroids on ovarian function and pregnancy outcome. J Clin Ultrasound. 2022 Feb;50(2):202-208. doi: 10.1002/jcu.23116. Epub 2021 Dec 29.

Shun Wong FW, Li TK. Noninvasive High-intensity Focused Ultrasound Surgeries for Fibroids and Adenomyosis during COVID-19 Pandemic in Hong Kong: A Gynecologist’s Viewpoint. Gynecol Minim Invasive Ther. 2021 Nov 5;10(4):272-273. doi: 10.4103/GMIT.GMIT_18_21. eCollection 2021 Oct-Dec.

Wu MH, Zhang Y, Chen D, Zhou N, Li H, Peng L, Huang MS, Kuo TC. Pretreatment bowel manipulation during ultrasound-guided high-intensity focused ultrasound therapy for posterior wall uterine masses. Taiwan J Obstet Gynecol. 2021 Nov;60(6):1078-1083. doi: 10.1016/j.tjog.2021.09.020.

Wong WSF, Lee MHM, Wong PH. A Journey from Learning a Noninvasive High-intensity Focused Ultrasound Surgical Treatment for Gynecological Diseases to Providing High-intensity Focused Ultrasound Services in Hong Kong. Gynecol Minim Invasive Ther. 2021 Apr 30;10(2):71-74. doi: 10.4103/GMIT.GMIT_23_21. eCollection 2021 Apr-Jun.

Huang Y, Zhou S, Wang J, Pang Z. Efficacy and safety of magnetic resonance-guided focused ultrasound surgery (MRgFUS) ablation in the management of abnormal uterine bleeding due to uterine leiomyoma or adenomyosis. Am J Transl Res. 2022 Jan 15;14(1):656-663. eCollection 2022.

Torres-de la Roche LA, Rafiq S, Devassy R, Verhoeven HC, Becker S, De Wilde RL. Should Ultrasound-Guided High Frequency Focused Ultrasound Be Considered as an Alternative Non-Surgical Treatment of Uterine Fibroids in Non-Asiatic Countries? An Opinion Paper. J Clin Med. 2022 Feb 5;11(3):839. doi: 10.3390/jcm11030839.

Rizzo G, Mappa I, Manna C, Patrizi L. High intensity focused ultrasound for uterine myomas ablation: Is the treatment of choice for women seeking pregnancy? J Clin Ultrasound. 2022 Feb;50(2):209-210. doi: 10.1002/jcu.23115.

Krzyzanowski J, Wozniak S, Szkodziak P, Krzyzanowski A, Wojciech W, Paszkowski T. Minimally invasive treatment options for uterine fibroids – state-of-the art 2021. Ginekol Pol. 2022 Feb 2. doi: 10.5603/GP.a2021.0202.

Yang MJ, Yu RQ, Chen JY, Wang ZB. Comparison of Dose and Effectiveness of a Single-Session Ultrasound-Guided High-Intensity Focused Ultrasound Ablation of Uterine Fibroids With Different Sizes. Front Oncol. 2021 Dec 21;11:725193. doi: 10.3389/fonc.2021.725193. eCollection 2021.

Hyvärinen M, Huang Y, David E, Hynynen K. Comparison of computer simulations and clinical treatment results of magnetic resonance guided focused ultrasound surgery (MRgFUS) of uterine fibroids. Med Phys. 2021 Oct 3. doi: 10.1002/mp.15263.

Zheng Y, Chen L, Liu M, Wu J, Yu R, Lv F. Prediction of Clinical Outcome for High-Intensity Focused Ultrasound Ablation of Uterine Leiomyomas Using Multiparametric MRI Radiomics-Based Machine Leaning Model. Front Oncol. 2021 Sep 10;11:618604. doi: 10.3389/fonc.2021.618604. eCollection 2021.

Sainio T, Saunavaara J, Komar G, Otonkoski S, Joronen K, Viitala A, Perheentupa A, Blanco Sequeiros R. Feasibility of T2 relaxation time in predicting the technical outcome of MR-guided high-intensity focused ultrasound treatment of uterine fibroids. Int J Hyperthermia. 2021;38(1):1384-1393. doi: 10.1080/02656736.2021.1976850.

Ciccarone F, Biscione A, Lorusso D, Zannoni GF, Cina A, Ferrandina G, Scambia G, Testa AC. Uterine leiomyosarcoma diagnosis 5 years after high-intensity focused ultrasound treatment under magnetic resonance guidance for fibroid. Ultrasound Obstet Gynecol. 2021 Sep 16. doi: 10.1002/uog.24775.

Liu Y, Wu X, Wu A, Gong C, Wang Z, Zhang L. Ultrasound-guided high intensity focused ultrasound ablation for uterine fibroids: long-term outcomes and factors affecting local recurrence. Int J Hyperthermia. 2021;38(1):1341-1348. doi: 10.1080/02656736.2021.1973585.

Zheng Y, Chen L, Liu M, Wu J, Yu R, Lv F. Nonenhanced MRI-based radiomics model for preoperative prediction of nonperfused volume ratio for high-intensity focused ultrasound ablation of uterine leiomyomas. Int J Hyperthermia. 2021;38(1):1349-1358. doi: 10.1080/02656736.2021.1972170.

Rodríguez J, Isern J, Pons N, Carmona A, Vallejo E, Cassadó J, De Marcos JA, Paraira M, Giménez N, Pessarrodona A. Pregnancy outcomes after ultrasound-guided high-intensity focused ultrasound (USgHIFU) for conservative treatment of uterine fibroids: experience of a single institution. Int J Hyperthermia. 2021 Sep;38(2):9-17. doi: 10.1080/02656736.2021.1908633.

Wang Q, Wu X, Zhu X, Wang J, Xu F, Lin Z, Gong C, He M, Zhang L. MRI features and clinical outcomes of unexpected uterine sarcomas in patients who underwent high-intensity focused ultrasound ablation for presumed uterine fibroids. Int J Hyperthermia. 2021 Sep;38(2):39-45. doi: 10.1080/02656736.2021.1921288.

Xu F, Deng L, Zhang L, Hu H, Shi Q. The comparison of myomectomy, UAE and MRgFUS in the treatment of uterine fibroids: a meta analysis. Int J Hyperthermia. 2021 Sep;38(2):24-29. doi: 10.1080/02656736.2021.1933216.

Marinova M, Ghaei S, Recker F, Tonguc T, Kaverina O, Savchenko O, Kravchenko D, Thudium M, Pieper CC, Egger EK, Mustea A, Attenberger U, Conrad R, Hadizadeh DR, Strunk H. Efficacy of ultrasound-guided high-intensity focused ultrasound (USgHIFU) for uterine fibroids: an observational single-center study. H.Int J Hyperthermia. 2021 Sep;38(2):30-38. doi: 10.1080/02656736.2021.1939444.

Xu F, Deng L, Zhang L, Hu H, Shi Q. The comparison of myomectomy, UAE and MRgFUS in the treatment of uterine fibroids: a meta analysis. Int J Hyperthermia. 2021 Sep;38(2):24-29. doi: 10.1080/02656736.2021.1933216.

Laughlin-Tommaso SK, Gorny KR, Hesley GK, Vaughan LE, Woodrum DA, Lemens MA, Stewart EA. Uterine and Fibroid Imaging Analysis from the FIRSTT Study. J Womens Health (Larchmt). 2021 Jul 8. doi: 10.1089/jwh.2020.8892. Online ahead of print.

Wang CJ, Lin G, Huang YT, Weng CH, Wu KY, Su YY, Lin YS, Mak KS. A feasibility analysis of the ArcBlate MR-guided high-intensity focused ultrasound system for the ablation of uterine fibroids. Abdom Radiol (NY). 2021 Jul 9. doi: 10.1007/s00261-021-03203-8.

Yang MJ, Yu RQ, Chen WZ, Chen JY, Wang ZB. A Prediction of NPVR 80% of Ultrasound-Guided High-Intensity Focused Ultrasound Ablation for Uterine Fibroids. Front Surg. 2021 Jun 4;8:663128. doi: 10.3389/fsurg.2021.663128. eCollection 2021.

Zhou Y, Ji X, Niu J, Sun T, Qian Z, Li Y, Yuan J, Fan Q, Huang Q, Bai J, Wang Y. Ultrasound-Guided High-Intensity Focused Ultrasound for Devascularization of Uterine Fibroid: A Feasibility Study. Ultrasound Med Biol. 2021 Jun 16:S0301-5629(21)00242-8. doi: 10.1016/j.ultrasmedbio.2021.05.012.

Tsai MC, Chang LT, Tam KW. Comparison of High-Intensity Focused Ultrasound and Conventional Surgery for Patients with Uterine Fibroids: A Systematic Review and Meta-Analysis. J Minim Invasive Gynecol. 2021 Jun 11:S1553-4650(21)00281-8. doi: 10.1016/j.jmig.2021.06.002.

Anneveldt KJ, van ‘t Oever HJ, Nijholt IM, Dijkstra JR, Hehenkamp WJ, Veersema S, Huirne JAF, Schutte JM, Boomsma MF. Systematic review of reproductive outcomes after High Intensity Focused Ultrasound treatment of uterine fibroids. Eur J Radiol. 2021 May 27;141:109801. doi: 10.1016/j.ejrad.2021.109801.

Karacharova IY, Kozarenko TM, Flaksemberg MA, Kornatska AG, Kondratiuk VK, Nikitina IM. Interdisciplinary Interaction in Maintaining the Reproductive Health in Women with Uterine Leyomyoma. Wiad Lek. 2021;74(5):1152-1157.

Łoziński T, Ciebiera M, Łuczyńska E, Filipowska J, Czekierdowski A. Magnetic Resonance-Guided High-Intensity Focused Ultrasound Ablation of Uterine Fibroids-Efficiency Assessment with the Use of Dynamic Contrast-Enhanced Magnetic Resonance Imaging and the Potential Role of the Administration of Uterotonic Drugs. Diagnostics (Basel). 2021 Apr 16;11(4):715. doi: 10.3390/diagnostics11040715.

Lozinski T, Filipowska J, Pyka M, Baczkowska M, Ciebiera M. Magnetic resonance-guided high-intensity ultrasound (MR-HIFU) in the treatment of symptomatic uterine fibroids – five-year experience. Ginekol Pol. 2021 Apr 30. doi: 10.5603/GP.a2021.0098.

Łoziński T, Ludwin A, Filipowska J, Zgliczyńska M, Węgrzyn P, Kluz T, Ciebiera M. Oxytocin and Misoprostol With Diclofenac in the Preparation for Magnetic Resonance-Guided High-Intensity Ultrasound Treatment of Symptomatic Uterine Fibroids: A Prospective Cohort Study. Ultrasound Med Biol. 2021 Jun;47(6):1573-1585. doi: 10.1016/j.ultrasmedbio.2021.02.018. Epub 2021 Mar 28.

Gong C, Lin Z, Lv F, Zhang L, Wang Z. Magnetic resonance imaging parameters in predicting the ablative efficiency of high-intensity focused ultrasound for uterine fibroids. Int J Hyperthermia. 2021;38(1):523-531. doi: 10.1080/02656736.2021.1904152.

Liao P, Jiang J, Zeng YH, Chen Y, Yong M, Qu DC, Zhou HG. Comparison of outcomes of hysteroscopic myomectomy of type 2 submucous fibroids greater than 4 cm in diameter via pretreatment with HIFU or GnRH-a. Int J Hyperthermia. 2021;38(1):183-188. doi: 10.1080/02656736.2021.1874546.

Ierardi AM, Carnevale A, Pellegrino F, Stefano GD, Bonelli C, Renzulli M, Giganti M, Carrafiello G. Uterine Myomas: Extravascular Treatment. Semin Ultrasound CT MR. 2021 Feb;42(1):56-74. doi: 10.1053/j.sult.2020.08.004. Epub 2020 Aug 29.

Napoli A, Alfieri G, Andrani F, Scipione R, Manganaro L, Pecorini F, Catalano C. Uterine Myomas: Focused Ultrasound Surgery. Semin Ultrasound CT MR. 2021 Feb;42(1):25-36. doi: 10.1053/j.sult.2020.08.001. Epub 2020 Aug 21.

Sainio T, Saunavaara J, Komar G, Mattila S, Otonkoski S, Joronen K, Perheentupa A, Blanco Sequeiros R. Feasibility of apparent diffusion coefficient in predicting the technical outcome of MR-guided high-intensity focused ultrasound treatment of uterine fibroids – a comparison with the Funaki classification. Int J Hyperthermia. 2021;38(1):85-94. doi: 10.1080/02656736.2021.1874545.

Click here for additional references from PubMed.

Animated treatment video courtesy of Insightec

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