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.
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.
- 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.
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, which is a randomized trial comparing MRI-guided focused ultrasound to myomectomy.
There is a clinical trial in Canada using MRI-guided focused ultrasound to treat uterine leiomyomas. This trial is only open to Canadian citizens.
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.
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Animated treatment video courtesy of Insightec