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FDA Approves Ultrasound Device for the Treatment of Uterine Fibroids

The Food and Drug Administration (FDA) approved a new device that would provide a non-invasive treatment alternative to those suffering from uterine fibroids. The device, a product co-produced by General Electric, is called the ExAblate 2000 System. According to the FDA, the device first uses magnetic resonance imaging to locate fibroids in the uterus, then applies ultrasound waves to destroy the fibroid tissue while the patient lies inside an MRI machine. Treatment can take up to three hours, and it cannot be undertaken on women who plan to become pregnant or whose fibroids are close to sensitive organs. Uterine fibroids are non-cancerous tumors that affect 80 percent of women at some point in their lifetime, according to the National Institutes of Health. Though some women experience no symptoms, many suffer from heavy and prolonged menstrual periods, miscarriage, pain and pressure. Uterine fibroids are one of the leading causes of the more than 600,000 hysterectomies performed each year in the United States. According to the FDA, review of the device was expedited because “it offers significant advantages over existing treatments.” While offering a less invasive option to women when compared to surgery, critics cite that its use is limited for numerous reasons, including its limited availability at only seven locations nationwide and its unknown cost, the Associated Press reports. Critics also say that this high-tech method’s efficacy is limited and that other safer and extremely effective methods for treating fibroids exist but have yet to be FDA-approved. “Mifepristone has been shown to be safe and effective in treating uterine fibroid tumors,” said Dr. Beth Jordan, medical director of the Feminist Majority Foundation. “Unfortunately, because of an unusual FDA policy, the drug is only available for medical abortion and can not be used in an Ôoff-label’ manner to treat uterine fibroid tumors, nor for uterine cancer, ovarian cancer or other indications for which it could be a life-saving treatment. It’s time to bring this drug properly to market because of the vast multiple medical potential it possesses.” Carla Dionne, executive director of the National Uterine Fibroids Foundation, said, “The FDA approved [the ExAblate 2000 System] in a remarkably short period of time … while mifepristone languishes for a decade or so. An inexpensive drug that requires no expensive equipment, no time off from work, no recovery period whatsoever, and we know it works on fibroids with remarkably high efficacy … and yet it sits in the background completely inaccessible to women in this nation.” LEARN MORE about the Feminist Majority Foundation’s Mifepristone Compassionate Use Program DONATE to the Feminist Majority Foundation and support its Campaign for Mifepristone and Women’s Health

Sources:

FDA 10/22/04; Associated Press 10/24/04; Reuters 10/23/04; Kaiser Daily Reproductive Health Report 10/25/04; Feminist Majority Foundation