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 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.
- 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.
Regulatory Approval and Reimbursement
In 2014, 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.
Laughlin-Tommaso S, Barnard EP, AbdElmagied AM, Vaughan LE, Weaver AL, Hesley GK, Woodrum DA, Jacoby VL, Kohi MP, Price TM, Nieves A, Miller MJ, Borah BJ, Moriarty JP, Gorny KR, Leppert PC, Severson AL, Lemens MA, Stewart EA. FIRSTT study: randomized controlled trial of uterine artery embolization vs focusedultrasound surgery. Am J Obstet Gynecol. 2019 Feb;220(2):174.e1-174.e13. doi: 10.1016/j.ajog.2018.10.032. Epub 2018 Oct 26.
Liu X, Xue L, Wang Y, Wang W, Tang J. Vaginal delivery outcomes of pregnancies following ultrasound-guided high-intensity focused ultrasound ablation treatment for uterine fibroids. Int J Hyperthermia. 2018 Oct 25:1-8. doi: 10.1080/02656736.2018.1510548.
Nguyen MD. Single-Phase Focused Ultrasound Surgery for 15-Leiomyoma and Huge Leiomyoma Patients. Gynecol Minim Invasive Ther. 2018 Oct-Dec;7(4):178-180. doi: 10.4103/GMIT.GMIT_52_18. Epub 2018 Sep 26.
Mohr-Sasson A, Machtinger R, Mashiach R, Nir O, Inbar Y, Maliyanker N, Goldenberg M, Rabinovici J. Long-term outcome of MR-guided Focused Ultrasound Treatment and Laparoscopic Myomectomy for Symptomatic Uterine Fibroids. Am J Obstet Gynecol. 2018 Sep 11. pii: S0002-9378(18)30750-6. doi: 10.1016/j.ajog.2018.09.002.
Wang Y, Wang ZB, Xu YH. Efficacy, Efficiency, and Safety of Magnetic Resonance-Guided High-Intensity Focused Ultrasound for Ablation of Uterine Fibroids: Comparison with Ultrasound-Guided Method. Korean J Radiol. 2018 Jul-Aug;19(4):724-732. doi: 10.3348/kjr.2018.19.4.724. Epub 2018 Jun 14.
Liu Y, Zhang WW, He M, Gong C, Xie B, Wen X, Li D, Zhang L. Adverse effect analysis of high-intensity focused ultrasound in the treatment of benign uterine diseases. Int J Hyperthermia. 2018 May 24:1-6. doi: 10.1080/02656736.2018.1473894.
Stewart EA, Lytle BL, Thomas L, Wegienka GR, Jacoby V, Diamond MP, Nicholson WK, Anchan RM, Venable S, Wallace K, Marsh EE, Maxwell GL, Borah BJ, Catherino WH, Myers ER. The Comparing Options for Management: PAtient-centered REsults for Uterine Fibroids(COMPARE-UF) registry: rationale and design. Am J Obstet Gynecol. 2018 Jul;219(1):95.e1-95.e10. doi: 10.1016/j.ajog.2018.05.004. Epub 2018 May 8.
Sandberg EM, Tummers FHMP, Cohen SL, van den Haak L, Dekkers OM, Jansen FW. Reintervention risk and quality of life outcomes after uterine-sparing interventions for fibroids: a systematic review and meta-analysis. Fertil Steril. 2018 Apr;109(4):698-707.e1. doi: 10.1016/j.fertnstert.2017.11.033.
Click here for additional references from PubMed.
Animated treatment video courtesy of Insightec