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May 22, 2012  
FIBROIDS1 NEWS: Feature Story

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  • Fibroid Treatment Device Gains FDA Approval

    Fibroid Treatment Device Gains FDA Approval


    November 24, 2004

    By Diana Barnes-Brown for Fibroids1

    A device called ExAblate, used for the treatment of uterine fibroids, won expedited approval from the FDA last month.

    Uterine fibroids, benign tumors that grow in uterine tissue, causing pain, bleeding, bloating, urinary and digestive disturbances, and infertility/miscarriage, are among the most common complaints in women in their late reproductive years.

    Until the past few years, the most common treatment for persistent fibroids was the complete removal of the uterus, or hysterectomy. But hysterectomy was a problematic solution for many: in addition to leaving women unable to bear children, hysterectomy forces menopause and all of the related hormonal problems, causes sexual side effects in many women, and requires a long (and painful) recovery period, with all of the associated risks of a major abdominal surgery. Devices like ExAblate offer patients the advantage of destroying fibroids while preserving the uterus and significantly reducing recovery time and risk factors, because they can treat fibroids in a noninvasive, non-surgical manner.

    ExAblate uses a combination of magnetic resonance imaging (MRI) and ultrasound technology to deliver targeted treatment to fibroids while leaving other uterine tissue and nearby structures intact and virtually undisturbed.

    The device works by using MRI to pinpoint the location of the fibroids and monitor the temperature of fibroid and other nearby tissue. Then, highly focused ultrasound waves are directed at the fibroids and used to destroy fibroid tissue by raising its temperature for a period of up to three hours. All of this can be done without cutting into the body at all, thanks to technology that allows doctors to focus ultrasound waves with precision so that they only affect the desired area of the body.

    The FDA noted that ExAblate treatment might not be right for all women. Fibroid patients whose fibroids are close to the intestines, the bladder, or other organs outside of the uterus should not be considered for this treatment, nor should women who wish to have children, as there is no conclusive evidence that ExAblate can preserve fertility. Also, in recent trials, about one in five women experienced fibroid regrowth after treatment with ExAblate and required further treatment, including surgical removal of the fibroids (myomectomy).

    Other treatments currently available for fibroids include hormone therapy, minimally invasive laparoscopic surgery, which uses small cutting or suction devices and a tiny, telescope-like camera inserted through very small incisions, and uterine fibroid embolization (UFE) which involves the injection of a solution that blocks blood supply to fibroids and causes the them to die.

    Fibroids affect a large number of women all over the world. Some researchers estimate that as many as 70 percent of women will develop fibroids at some point in their lives, though not all of these women develop symptoms that require medical treatment. After menopause, the hormones that cause fibroid growth taper off, which makes fibroids less of a problem for post-menopausal women.

    Last updated: 24-Nov-04

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