Uterine fibroids are one of the most common gynecological disorders, with nearly 70% of white women and more than 80% of black women affected by age 50. Most fibroids are asymptomatic, and most women do not undergo treatment. However, about one quarter of those affected have symptoms that are severe enough to require treatment.
Fibroids can lead to infertility, and symptoms include heavy or prolonged menstrual bleeding, menstrual pain or cramping, passing blood clots, bloating, bowel or bladder dysfunction, and fatigue. Fibroids are the leading cause of hysterectomy in the United States, accounting for 30-40% of all hysterectomies, for a total of 150,000-200,000 performed annually.
In addition to hysterectomy, other fibroid procedures include myomectomy, the surgical removal of fibroids from the uterus, and uterine artery embolization, which involves injecting small particles in the arteries to block the blood supply to the fibroid. These procedures all involve varying levels of invasiveness and recovery time.
About Focused Ultrasound
Focused ultrasound is a non-surgical outpatient procedure that can preserve the uterus and relieve fibroid symptoms while enabling women to return to normal activity in only one or two days.
More than 10,000 patients with symptomatic uterine fibroids have been treated around the world with the combination of magnetic resonance imaging (MRI) and focused high intensity ultrasound waves. High intensity sound waves are focused on individual fibroids much like a magnifying glass focuses on the sun’s rays – the focal point is hot enough to cause cell death while sparing surrounding tissue. Magnetic resonance imaging gives the physician a three-dimensional view of the uterus and of any fibroids. It also provides real-time feedback on the temperature and tissue changes that occur as each fibroid is treated. Risks of focused ultrasound treatment are generally low with a small risk of transient leg pain.
InSightec and Philips currently market MR-guided focused ultrasound systems. The FDA approved InSightec’s ExAblate focused ultrasound system in October 2004. The Philips Sonalleve MR-HIFU system has had European CE marking since 2010. The company is currently recruiting for the SOFIA clinical trial designed for FDA clearance. In addition to the US, the following regions have one or more MR-guided focused ultrasound devices approved to treat symptomatic uterine fibroids: Europe, Korea, Japan, China, India, Israel, Mexico, Russia and Australia, and others.