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 China that is treating adenomyosis in patients with refractory infertility with the goal of enhancing fertility.
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
David M. Letter to the editor: Römer et al. The significance of transcervical ultrasound-guided radiofrequency ablation in the treatment of symptomatic fibroids: results of an expert consensus from German speaking countries? In the Archives of Gynecology and Obstetrics volume 306, pages 1-6 (2022). Arch Gynecol Obstet. 2023 Sep;308(3):1045. doi: 10.1007/s00404-022-06761-4. Epub 2022 Nov 17. PMID: 36394665
Li C, He Z, Lv F, Liu Y, Hu Y, Zhang J, Liu H, Ma S, Xiao Z. An interpretable MRI-based radiomics model predicting the prognosis of high-intensity focused ultrasound ablation of uterine fibroids. Insights Imaging. 2023 Jul 19;14(1):129. doi: 10.1186/s13244-023-01445-2. PMID: 37466728
Liao S, Wang X, Fu N, Huang Y. High-intensity focussed ultrasound and hysteroscopy endo-operative system cold device procedures for treating >4cm diameter FIGO Type 2 uterine myoma and ensuring successful pregnancy. Eur J Contracept Reprod Health Care. 2023 Jun 2:1-4. doi: 10.1080/13625187.2023.2216329. PMID: 37267044
Morris JM, Liang A, Fleckenstein K, Singh B, Segars J. A Systematic Review of Minimally Invasive Approaches to Uterine Fibroid Treatment for Improving Quality of Life and Fibroid-Associated Symptoms. Reprod Sci. 2023 May;30(5):1495-1505. doi: 10.1007/s43032-022-01120-9. Epub 2022 Nov 18. PMID: 36401073
Slotman DJ, Bartels LW, Zijlstra A, Verpalen IM, van Osch JAC, Nijholt IM, Heijman E, van ‘t Veer-Ten Kate M, de Boer E, van den Hoed RD, Froeling M, Boomsma MF. Diffusion-weighted MRI with deep learning for visualizing treatment results of MR-guided HIFU ablation of uterine fibroids. Eur Radiol. 2023 Jun;33(6):4178-4188. doi: 10.1007/s00330-022-09294-1. Epub 2022 Dec 6. PMID: 36472702
Lee S, Stewart EA. New treatment options for nonsurgical management of uterine fibroids. Curr Opin Obstet Gynecol. 2023 May 4. doi: 10.1097/GCO.0000000000000880. PMID: 37144584
Fan C, Qian Y, Li Z, Li B. Ultrasound-guided microwave, radiofrequency, and high intensity focused ultrasound (HIFU) ablation in treating uterine leiomyoma: A systemic review and meta-analysis of retrospective studies. Biotechnol Genet Eng Rev. 2023 Apr 10:1-15. doi: 10.1080/02648725.2023.2199560.
Leonardo-Pinto JP, Maghsoudlou P, Salazar GM, Clark NV, Koch RM, Ajao MO, Einarsson JI, Rassier SLC. Diagnosis of gynecologic malignancy following treatment of presumed benign fibroid disease with Interventional Radiology procedures: a retrospective cohort study. Fertil Steril. 2023 Mar 3:S0015-0282(23)00171-1. doi: 10.1016/j.fertnstert.2023.02.038.
Akhatova A, Aimagambetova G, Bapayeva G, Laganà AS, Chiantera V, Oppelt P, Sarria-Santamera A, Terzic M. Reproductive and Obstetric Outcomes after UAE, HIFU, and TFA of Uterine Fibroids: Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2023 Mar 2;20(5):4480. doi: 10.3390/ijerph20054480.
Qin SZ, Jiang Y, Wang YL, Liu N, Lin ZY, Jia Q, Fang J, Huang XH. Predicting the efficacy of high-intensity focused ultrasound (HIFU) ablation for uterine leiomyomas based on DTI indicators and imaging features. Abdom Radiol (NY). 2023 Mar 13. doi: 10.1007/s00261-023-03865-6.
Zhang M, Yin C, Jiang J, Chen Y, Wang J, Wang Q, Zeng Y, Zhou H. Application value of contrast-enhanced ultrasonography in the treatment of uterine fibroids by high-intensity focused ultrasound ablation: A retrospective study. J Clin Ultrasound. 2023 Jan;51(1):113-120. doi: 10.1002/jcu.23294. Epub 2022 Aug 30.
Qin S, Jiang Y, Wang F, Tang L, Huang X. Development and validation of a combined model based on dual-sequence MRI radiomics for predicting the efficacy of high-intensity focused ultrasound ablation for hysteromyoma. Int J Hyperthermia. 2023;40(1):2149862. doi: 10.1080/02656736.2022.2149862.
Theis M, Tonguc T, Savchenko O, Nowak S, Block W, Recker F, Essler M, Mustea A, Attenberger U, Marinova M, Sprinkart AM. Deep learning enables automated MRI-based estimation of uterine volume also in patients with uterine fibroids undergoing high-intensity focused ultrasound therapy. Insights Imaging. 2023 Jan 5;14(1):1. doi: 10.1186/s13244-022-01342-0.
Otonkoski S, Sainio T, Mattila S, Blanco Sequieros R, Perheentupa A, Komar G, Joronen K. Magnetic resonance guided high intensity focused ultrasound for uterine fibroids and adenomyosis has no effect on ovarian reserve. Int J Hyperthermia. 2023;40(1):2154575. doi: 10.1080/02656736.2022.2154575.
Li F, Chen J, Yin L, Zeng D, Wang L, Tao H, Wu X, Wei F, Xu F, Shi Q, Lin Z, Wang Z. HIFU as an alternative modality for patients with uterine fibroids who require fertility-sparing treatment. Int J Hyperthermia. 2023;40(1):2155077. doi: 10.1080/02656736.2022.2155077.
Zhang Q, Chen Y, Lai M, Li Y, Li Q, Fu C, Yao Z, Zhang J. Magnetic Resonance Imaging-guided Focused Ultrasound Surgery in a Swine Adenomyosis Model. Acad Radiol. 2023 Jan 7:S1076-6332(22)00639-0. doi: 10.1016/j.acra.2022.11.034.
Zhu H, Ma Q, Dong G, Yang L, Li Y, Song S, Mu Y. Clinical evaluation of high-intensity focused ultrasound ablation combined with mifepristone and levonorgestrel-releasing intrauterine system to treat symptomatic adenomyosis. Int J Hyperthermia. 2023;40(1):2161641. doi: 10.1080/02656736.2022.2161641.
Chen WC, Hsu CC, Huang HJ, Cheng WJ, Chang TC, Chou HH. Letrozole as premedication of high intensity focused ultrasound treatment of uterine fibroids: A retrospective observation study. Front Med (Lausanne). 2022 Dec 6;9:1069654. doi: 10.3389/fmed.2022.1069654. eCollection 2022.
He X, Liao S. Clinical significance of bladder training in preoperative localization of high-intensity focused ultrasound ablation of uterine fibroids. Ginekol Pol. 2022 Dec 8. doi: 10.5603/GP.a2022.0142.
Tonguc T, Recker F, Ganslmeier J, Strunk HM, Pieper CC, Ramig O, Welz S, Egger EK, Mutschler N, Warwas L, Essler M, Mustea A, Conrad R, Marinova M. Improvement of fibroid-associated symptoms and quality of life after US-guided high-intensity focused ultrasound (HIFU) of uterine fibroids. Sci Rep. 2022 Dec 7;12(1):21155. doi: 10.1038/s41598-022-24994-w.
Slotman DJ, Bartels LW, Zijlstra A, Verpalen IM, van Osch JAC, Nijholt IM, Heijman E, van ‘t Veer-Ten Kate M, de Boer E, van den Hoed RD, Froeling M, Boomsma MF. Diffusion-weighted MRI with deep learning for visualizing treatment results of MR-guided HIFU ablation of uterine fibroids. Eur Radiol. 2022 Dec 6. doi: 10.1007/s00330-022-09294-1.
Li Q. The evaluation through contrast-enhanced ultrasonography for high-intensity focused ultrasound ablation treatment of uterine fibroids. J Clin Ultrasound. 2022 Dec 5. doi: 10.1002/jcu.23303.
Liu D, Zhang X, Gong X, Yang C, Zhang R, Chen W, Chen J. Learning Curve of USgHIFU Ablation for Uterine Fibroids: A Multi-Center Prospective Study. J Ultrasound Med. 2022 Dec;41(12):3051-3059. doi: 10.1002/jum.16056. Epub 2022 Jul 8.
Zhou Y, Zhang J, Chen J, Yang C, Gong C, Li C, Li F. Prediction using T2-weighted magnetic resonance imaging-based radiomics of residual uterine myoma regrowth after high-intensity focused ultrasound ablation. Ultrasound Obstet Gynecol. 2022 Nov;60(5):681-692. doi: 10.1002/uog.26053.
Morris JM, Liang A, Fleckenstein K, Singh B, Segars J. A Systematic Review of Minimally Invasive Approaches to Uterine Fibroid Treatment for Improving Quality of Life and Fibroid-Associated Symptoms. Reprod Sci. 2022 Nov 18. doi: 10.1007/s43032-022-01120-9.
Li Y, Hua C. Is High Intensity Focused Ultrasound Superior to Uterine Artery Embolization in Cesarean Scar Pregnancy and Subsequent Pregnancy Outcomes? A meta-analysis of the Chinese Population. J Minim Invasive Gynecol. 2022 Nov 25:S1553-4650(22)01009-3. doi: 10.1016/j.jmig.2022.11.015.
Zhang J, Go VA, Blanck JF, Singh B. A Systematic Review of Minimally Invasive Treatments for Uterine Fibroid-Related Bleeding. Reprod Sci. 2022 Oct;29(10):2786-2809. doi: 10.1007/s43032-021-00722-z. Epub 2021 Sep 3.
Liao L, Xu YH, Bai J, Zhan P, Zhou J, Li MX, Zhang Y. MRI parameters for predicting the effect of ultrasound-guided high-intensity focused ultrasound in the ablation of uterine fibroids. Clin Radiol. 2022 Oct 11:S0009-9260(22)00644-4. doi: 10.1016/j.crad.2022.09.112.
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Animated treatment video courtesy of Insightec
