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 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 Turku, Finland, that is using focused ultrasound to treat uterine fibroids.

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

Zhang P, Xie L, Chen J, Zhan P, Xing HR, Yuan Y. The Impact of HIFU Ablation on the Histopathological Features of Locally Recurrent Fibroids Tissue Post-HIFU Treatment. Ultrasound Med Biol. 2024 Sep;50(9):1381-1386. doi: 10.1016/j.ultrasmedbio.2024.05.014. Epub 2024 Jun 18. PMID: 38897842 

Gu W, Yuan J, Zhou Y, Li Y, Wang Y. Impact of ultrasound-guided high-intensity focused ultrasound for the treatment of uterine fibroids on ovarian reserve and quality of life: a single-center prospective cohort study. BMC Womens Health. 2024 Aug 24;24(1):470. doi: 10.1186/s12905-024-03315-5. PMID: 39182055 

Xue H, Wu S, Xiao K, Ding G, Chen S. Sonographic features of uterine fibroids that predict the ablation rate and efficacy of high-intensity focused ultrasound. Front Oncol. 2024 Aug 16;14:1451626. doi: 10.3389/fonc.2024.1451626. eCollection 2024. PMID: 39220651 

Ng VW, Cheung VY. Ultrasound-Guided High-Intensity Focused Ultrasound of Uterine Fibroids and Adenomyosis: An 11-Year Experience from a Single Center in Hong Kong. J Clin Med. 2024 Aug 14;13(16):4788. doi: 10.3390/jcm13164788. PMID: 39200930 

Wang L, Liu Y, Lin J, Pan Y, Liu Y, Lv F. The Predictive Effect of Quantitative Analysis of Signal Intensity Heterogeneity on T2-Weighted MR Images for High-intensity Focused Ultrasound Treatment of Uterine Fibroids. Acad Radiol. 2024 Jul;31(7):2848-2858. doi: 10.1016/j.acra.2024.04.023. Epub 2024 May 3. PMID: 38704283 

Tang NH, Fang CL, Hu WH, Tian L, Lin C, Hu HQ, Shi QL, Xu F. Response: Age-stratified risk factors of re-intervention for uterine fibroids treated with high-intensity focused ultrasound. Int J Gynaecol Obstet. 2024 Jul;166(1):462-463. doi: 10.1002/ijgo.15584. Epub 2024 May 9. PMID: 38721712 

Vannuccini S, Petraglia F, Carmona F, Calaf J, Chapron C. The modern management of uterine fibroids-related abnormal uterine bleeding. Fertil Steril. 2024 Jul;122(1):20-30. doi: 10.1016/j.fertnstert.2024.04.041. Epub 2024 May 8. PMID: 38723935 

Mo S, Chen C. Commentary on “Age-stratified risk factors of re-intervention for uterine fibroids treated with high-intensity focused ultrasound”. Int J Gynaecol Obstet. 2024 Jul;166(1):461. doi: 10.1002/ijgo.15583. Epub 2024 May 10. PMID: 38726791 

Ponomarchuk E, Tsysar S, Kvashennikova A, Chupova D, Pestova P, Danilova N, Malkov P, Buravkov S, Khokhlova V. Pilot Study on Boiling Histotripsy Treatment of Human Leiomyoma Ex Vivo. Ultrasound Med Biol. 2024 Aug;50(8):1255-1261. doi: 10.1016/j.ultrasmedbio.2024.05.002. Epub 2024 May 17. PMID: 38762389 

Li C, He Z, Lv F, Liao H, Xiao Z. Predicting the Prognosis of HIFU Ablation of Uterine Fibroids Using a Deep Learning-Based 3D Super-Resolution DWI Radiomics Model: A Multicenter Study. Acad Radiol. 2024 Jul 4:S1076-6332(24)00384-2. doi: 10.1016/j.acra.2024.06.027. PMID: 38969576 

Slotman DJ, Bartels LW, Nijholt IM, Huirne JAF, Moonen CTW, Boomsma MF. Development and validation of a deep learning-based method for automatic measurement of uterus, fibroid, and ablated volume in MRI after MR-HIFU treatment of uterine fibroids. Eur J Radiol. 2024 Jul 3;178:111602. doi: 10.1016/j.ejrad.2024.111602. PMID: 38991285 

Han WY, Kim Y, Kim PH, Kim EK. Abdominal Wall Hernias Following High-intensity Focused Ultrasound Therapy: Three Case Reports. Arch Plast Surg. 2024 Jul 18;51(4):363-366. doi: 10.1055/a-2268-6986. eCollection 2024 Jul. PMID: 39034981 

Chen Y, Zhao F, Feng L, Zhou F, Zhou X. Evaluating the Effects of Water Balloons on High-Intensity Focused Ultrasound for Treating Uterine Fibroids. Ultrasound Med Biol. 2024 Feb 14:S0301-5629(24)00027-9. doi: 10.1016/j.ultrasmedbio.2024.01.013. PMID: 38360493  

Cheng Y, Yang L, Wang Y, Kuang L, Pan X, Chen L, Cao X, Xu Y. Development and validation of a radiomics model based on T2-weighted imaging for predicting the efficacy of high intensity focused ultrasound ablation in uterine fibroids. Quant Imaging Med Surg. 2024 Feb 1;14(2):1803-1819. doi: 10.21037/qims-23-916. Epub 2024 Jan 22. PMID: 38415139  

Cui Y, Zhang J, Rao J, Feng M, Yao L, Liao W, Liang C, Huang Y. MR Diffusion-Weighted Imaging in Evaluating Immediate HIFU Treatment Response of Uterine Fibroids. Curr Med Imaging. 2024 Feb 27. doi: 10.2174/0115734056270504231218072151. PMID: 38415459  

Laganà AS, Romano A, Vanhie A, Bafort C, Götte M, Aaltonen LA, Mas A, De Bruyn C, Van den Bosch T, Coosemans A, Guerriero S, Haimovich S, Tanos V, Bongers M, Barra F, Al-Hendy A, Chiantera V, Leone Roberti Maggiore U. Management of Uterine Fibroids and Sarcomas: the Palermo Position Paper. Gynecol Obstet Invest. 2024 Feb 21. doi: 10.1159/000537730. PMID: 38382486  

Li S, Ma WW, Yang MJ, Deng YB, Hu L, Chen JY. Long-term re-intervention after USgHIFU and prediction of NPVR in different ages of patients with uterine fibroids. Int J Hyperthermia. 2024;41(1):2304264. doi: 10.1080/02656736.2024.2304264. Epub 2024 Jan 23. PMID: 38258583  

Yan W, Yuan S, Zhou D, Zhang M, Yang S, Wang W, Wang S. Status and treatment of patients with uterine fibroids in hospitals in central China: a retrospective study from 2018 to 2021. BMJ Open. 2024 Jan 17;14(1):e081736. doi: 10.1136/bmjopen-2023-081736. PMID: 38233053  

Park SA, Lee J, Kim HY. Virtual reality education program for women with uterine tumors treated by high-intensity focused ultrasound. Heliyon. 2023 Dec 16;10(1):e23759. doi: 10.1016/j.heliyon.2023.e23759. eCollection 2024 Jan 15. PMID: 38226233  

Liu Y, Lv F, Liu Y, Zhong Y, Qin Y, Lv F, Xiao Z. Factors influencing magnetic resonance imaging changes associated with pelvic bone injury after high-intensity focused ultrasound ablation of uterine fibroids: a retrospective case-control study. Quant Imaging Med Surg. 2024 Jan 3;14(1):179-193. doi: 10.21037/qims-23-323. Epub 2024 Jan 2. PMID: 38223045  

Dou Y, Zhang L, Liu Y, He M, Wang Y, Wang Z. Long-term outcome and risk factors of reintervention after high intensity focused ultrasound ablation for uterine fibroids: a systematic review and meta-analysis. Int J Hyperthermia. 2024;41(1):2299479. doi: 10.1080/02656736.2023.2299479. Epub 2024 Jan 2. PMID: 38164630  

Chendian T, Guohua H, Wang Z, Fang L, Luo S, Liu X, Shi Q. Factors associated with thermal injury of abdominal skin in focused ultrasound ablation of uterine fibroids. Int J Hyperthermia. 2024;41(1):2295232. doi: 10.1080/02656736.2023.2295232. Epub 2023 Dec 30. PMID: 38159557  

Zhou Y, Zhang J, Li C, Chen J, Lv F, Deng Y, Chen S, Du Y, Li F. Prediction of non-perfusion volume ratio for uterine fibroids treated with ultrasound-guided high-intensity focused ultrasound based on MRI radiomics combined with clinical parameters. Biomed Eng Online. 2023 Dec 13;22(1):123. doi: 10.1186/s12938-023-01182-z. PMID: 38093245  

Capezzuoli T, Aslan B, Vannuccini S, Orlandi G, La Torre F, Sorbi F, Fambrini M, Petraglia F. Recurrence of Uterine Fibroids After Conservative Surgery or Radiological Procedures: a Narrative Review. Reprod Sci. 2023 Dec 18. doi: 10.1007/s43032-023-01418-2. PMID: 38110820  

Click here for additional references from PubMed.

Animated treatment video courtesy of Insightec

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