FDA Approves Device that Shrinks Uterine Fibroids Without Surgery

The Food and Drug Administration (FDA) last week added symptomatic uterine fibroids to the list of conditions now approved for treatment using the device Embosphere Microspheres. Manufactured by Massachusetts-based BioSphere Medical, Embosphere Microspheres consisting of spherical particles injected into an artery in the groin obstruct blood flow and thereby shrinks fibroid growths within weeks after treatment. The technique, known as uterine artery embolization (UAE), offers a less invasive alternative to the surgical and more common procedure of hysterectomy (removal of the uterus).

The FDA’s decision comes after promising results from a six-month-long clinical study conducted at seven US medical centers. Of 132 women receiving Embosphere Microspheres, 65 percent showed over 50 percent reduction in bleeding. While data beyond the six months are not available, BioSphere Medical will continue patient monitoring for at least three years.

Thirty to 70 percent of all women especially those in their 30s and 40s and African American women are estimated to have uterine fibroids. Uterine fibroids are non-cancerous growths that can cause often debilitating side effects such as pain and heavy bleeding, as well as pregnancy complications, including miscarriages and infertility. Hysterectomies, considered the “definitive treatment” for uterine fibroids by the National Institutes of Health (NIH), are performed at a rate of about 600,000 per year in the US.

Mifepristone (also known as RU-486 or the “abortion pill”) has also been shown in clinical trials to be an effective method of treating fibroids without the use of surgery. The Feminist Majority Foundation has been leading a campaign to increase clinical trials and research into the potential uses of mifepristone to treat not only fibroids, but also endometriosis, breast cancer, uterine cancer, ovarian cancer, and other serious illnesses. However, anti-abortion extremists are working to limit US women’s access to a potentially lifesaving drug, most recently with a petition this year to the Food and Drug Administration asking for review of FDA’s approval for the drug.

TAKE ACTION Increase Mifepristone Research Funding and Protect Safe Medical Abortion


Associated Press 11/26/02; FDA 11/27/02; HealthScoutNews 11/27/02; BioSphere Medical 11/25/02

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