Acoustic surgery with high frequency ultrasound waves is revolutionizing the treatment of uterine fibroids (non-cancerous masses located in the uterus), which cause painful and chronic symptoms in one in every four U.S. women. Ultrasound treatments have long been used to break up kidney stones, soothe muscular spasms and speed recovery in bodies that have sustained traumatic injury. Now, ultrasound waves can perform surgery without incisions, just like futuristic healers Dr. "Bones" McCoy and Nurse Chapel used to do on the Star Trek TV series.

This new surgical technique involves high-intensity sound waves beaming through skin and also holds great promise for eradicating benign and malignant tumors. FDA approved, acoustic surgery has achieved excellent results on women with uterine fibroids in trials at Boston's Brigham and Women's Hospital.

The fact is, acoustic surgery boasts several practical advantages over conventional surgery: by not breaking skin, infection risk is diminished; there is no blood loss so transfusions are unnecessary; patients experience less pain; recovery time is reduced. There's also a lower complication rate with this surgery. Unlike conventional surgery, where dead tissue has to be removed, acoustic surgery allows the body's own cleansing system to break down and excrete dead cells. As opposed to conventional surgery-- which can be very painful and involve lengthy recovery time-- after acoustic surgery, the patient goes home later that day and doesn't need pain medication.

The tool used in acoustic surgery is the Sonablate 500, devised by scientists at Indiana University in Indianapolis. The Sonablate uses sound waves broadcast through specially designed speakers to destroy diseased or cancerous tissue. The waves, which are at frequencies too high for people to hear, converge inside the body-- an effect similar to using a silver tanning reflector to focus the sun's light on one's body. The waves burn at the focal point in the body. Because the energy level is so high, the tissue gets extremely hot in less than a second, and the cells die instantly. The device also beams low-frequency sound waves to create a 3-D image for doctors, similar to how ultrasound is used to find tumors or detect fetal abnormalities.

Another ultrasonic device worth mentioning is the ExAblate 2000 System. In October 2004, the Food and Drug Administration (FDA) approved this tool that uses magnetic resonance image-guided focused ultrasound to target and destroy uterine fibroids. The device is appropriate for use only on women who have completed child bearing or for those who do not intend to bear children.

FDA expedited review of the device because it offers significant advantages over existing treatments for uterine fibroids.

ExAblate combines two systems--a magnetic resonance imaging (MRI) machine to visualize patient anatomy, map the volume of fibroid tissue to be treated, and monitor the temperature of the uterine tissue after heating, and a focused ultrasound beam that heats and destroys the fibroid tissue using high frequency, high-energy sound waves. This is the first time these two systems have been combined and the first time MR has been used to monitor tissue temperature.

The treatment requires repeated targeting and heating of fibroid tissue while the patient lies inside the MRI machine. The procedure can last as long as three hours.

The new device can be used to treat some--but not all--fibroids. Fibroids close to sensitive organs such as the bowel or bladder and those outside the image area cannot be treated.

Approximately 20 percent to 40 percent of women 35 and older have fibroids. Although many of these women do not experience any symptoms, in others the location and size of fibroids can cause heavy and prolonged menstrual periods, pain in the back, legs or pelvis, pressure on the bladder or bowels, and pain during sexual intercourse.

Women who experience problems from uterine fibroids are currently treated with hormone therapy, myomectomy (removal of the fibroids while leaving the uterus intact), or by hysterectomy (removal of the uterus). ExAblate provides a uterine-sparing alternative for these women that is a non-invasive treatment.

FDA approved the system based on a review of clinical studies of safety and effectiveness conducted by the manufacturer and on the recommendation of a panel of outside experts convened by the agency to review the device.

InSightec, Ltd., of Israel , the manufacturer, studied use of the ExAblate System to treat 109 women with uterine fibroids at seven medical centers around the world. The study compared the results with those of 82 women who had hysterectomies. When the ExAblate-treated women were followed up six months later, the study showed that the new device had successfully reduced fibroid-related problems in 71 percent.

However, 21 percent of the patients needed an alternative surgical treatment for fibroids within a year. This means that while the ExAblate treatment may succeed in reducing the symptoms from the treated fibroids, at a later time, fibroid symptoms may return in some women and require additional treatment either with ExAblate or an alternative treatment. Labeling for the device indicates that no more than two treatments should be performed in a two-week period.

InSightec won the bronze medal in the Wall Street Journal's 2004 Technology Innovation Awards competition for a non-invasive method of treating uterine fibroids, it must be stressed that the ExAblate treatment is never intended for women who desire future pregnancy. The procedure could alter the composition and strength of the uterine tissue, and the effects of the treatment on the ability to become pregnant and carry a fetus to term or on the development of the fetus have yet to be determined.

FDA is requiring InSightec to conduct a three-year post-market study to better assess the long-term safety and effectiveness of the ExAblate System. The study will include additional numbers of African-American women because, as a group, these women have a greater incidence of uterine fibroids, but were under-represented in the original study.

For authoritative information on acoustic surgery for treatment of uterine fibroids, click on http://www.uterine-fibroids.org.