Oct. 25, 2004 -- A new device that uses sound waves to destroy uterine fibroids may offer an alternative to surgery for some women who suffer from the bleeding and painful condition.
The FDA approved the new device, known as the ExAblate 2000, for the treatment of uterine fibroids in women after an expedited review process because it offers significant advantages over existing treatments for uterine fibroids.
About 20%-40% of women over 35 develop uterine fibroids. Much of the time these noncancerous growths in the uterus do not cause symptoms or require treatment. But in some cases, the size and location of growths can cause heavy menstrual periods; pain in the back, legs, or pelvis; pressure on the bowels or bladder; and miscarriage.
Treatments for uterine fibroids include hormone therapy, surgical removal of the growths while leaving the uterus intact, or a hysterectomy (removal of the uterus). However, many women seek alternatives to these therapies because they want to have children or do not wish to have their uterus removed despite having completed childbearing.
Researchers say the ExAblate 2000 system offers a noninvasive alternative to surgery that leaves the uterus intact.
However, the device is not intended for use by women who wish to become pregnant. Researchers say the procedure may alter the composition and strength of the uterine tissue, and the effects of treatment on the ability to become pregnant and carry a baby to term have not been determined.
New Treatment for Uterine Fibroids
In approving the ExAblate 2000, the FDA reviewed clinical studies of the device's safety and effectiveness conducted by the manufacturer, InSightec Ltd.
The treatment combines two systems for treatment of uterine fibroids. First, magnetic resonance imaging (MRI) creates a map of the area to be treated and monitors the temperature of the uterine tissue. Then, a focused ultrasound beam heats and destroys the fibroid tissue using high frequency sound waves.
The treatment requires repeated targeting and heating of all fibroid tissue while the patient lies inside an MRI machine, which may take up to three hours.
In a study conducted by the manufacturer, researchers used the ExAblate system to treat 109 women with uterine fibroids at seven medical centers around the world and compared the results with those of 82 women who had hysterectomies.
After six months of follow-up, the study showed the ExAblate device had successfully reduced uterine fibroid-related problems for 71% of the women. But 21% of the women required additional surgery for uterine fibroids within a year.
The FDA says that means that the ExAblate system may successfully reduce symptoms of uterine fibroids but those symptoms may return at a later time in some women and may require additional treatment. Officials say no more than two ultrasound treatments should be performed within a two-week period.
The FDA is also requiring the manufacturer to conduct a three-year post-market study to better determine the effects of the ExAblate system in African-American women, who have a greater incidence of uterine fibroids and were underrepresented in the study.