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RESEARCH SHOWS SURGERY-SPARING TREATMENT FOR UTERINE FIBROIDS SUCCESSFUL; CONSUMER INFORMATION AVAILABLE

ORLANDO, Fla. -- As research from the United States and Canada mounts showing that a new non- surgical procedure to treat uterine fibroids has a more than 85 percent success rate, consumer information about the technique is being made widely available by the Society of Cardiovascular & Interventional Radiology (SCVIR).

The procedure, fibroid embolization, is a minimally invasive, uterine-sparing alternative to hysterectomy. More than 200,000 women in the United States undergo hysterectomy each year to treat benign tumors called uterine fibroids. Performed by interventional radiologists, fibroid embolization involves cutting off blood flow to the fibroid without surgery, causing it to shrink.

"Fibroid embolization is a very promising new procedure for women," said James B. Spies, M.D., chief of interventional radiology and vice chairman of the department of radiology at Georgetown University Medical Center, Washington, who is presenting a study today at the SCVIR's 24th Annual Scientific Meeting. "Although further research is needed, the data coming in allows us to be optimistic that this provides women a non-invasive alternative to hysterectomy."

The Society also announced today the availability of new consumer education information on the procedure:

A free patient brochure, Uterine Fibroids: Their Symptoms and Treatment.

Consumer information on fibroids and treatment options on its Web site: www.scvir.org.

A free service that allows people to locate one of the interventional radiologists who perform fibroid embolization in the United States and Canada. The service can be accessed either through the SCVIR Web site, at www.scvir.org, or by calling toll-free

1-877-35-SCVIR.

A number of insurance companies are paying for fibroid embolization procedures. While embolization to treat uterine fibroids has been performed for about six years, catheter embolization of the uterus is not new. It has been performed successfully by interventional radiologists for 20 years to treat heavy bleeding after childbirth. Research is being conducted on the long-term benefits of the procedure. Georgetown University Study

Dr. Spies' study adds to the literature that has documented fibroid embolization's high success rate. In the Georgetown study, 61 women who underwent fibroid embolization experienced a 29 percent average decrease in the size of the uterus after three months, and a 51 percent average reduction in the size of the fibroid. Heavy menstrual bleeding, a common side effect of uterine fibroids, improved in 89 percent (48/54) of the women with this symptom. Another common symptom, pelvic pain or pressure, improved in 96 percent (44/46) of women with this symptom. Ninety-five percent of patients (58/61) said they were satisfied to some degree, with 82 percent (50/61) of patients moderately to very satisfied with the outcome of treatment.

University of Toronto Study

Eighty percent of the 100 women participating in the multi-center Canadian study had fully recovered from the procedure within two weeks, according to epidemiologist Gaylene Pron, Ph.D., of the University of Toronto Department of Medical Imaging, who coordinated the study. The procedure typically required a hospital stay of one or two days, according to Dr. Pron. This experience compares favorably with recovery times of 4 to 6 weeks for myomectomy and hysterectomy, the surgical alternatives to fibroid embolization. In myomectomy, the fibroids are shaved or cut away from the uterus. In hysterectomy, the entire uterus is removed. Both procedures generally require a 2- to 4-day hospitalization.

"Most of the women in the trial were young -- on average 43 years old," said Dr. Pron. "Most also had their fibroids for several years and, at the time of treatment, usually had large and multiple fibroids. In many cases, they had been told their uterus was as large as a four-month pregnancy or larger." The Fibroid Embolization Procedure

In the fibroid embolization technique, an interventional radiologist makes a small nick in the skin -- less than one-quarter inch -- in the groin, places a catheter in the artery and guides it to the uterus while watching the progress of the procedure via a moving X-ray (fluoroscopy). The interventional radiologist then injects small plastic and/or gelatin sponge particles into the vessels supplying blood to the fibroid to cut off the blood flow, or embolize it. The right and left uterine arteries are generally embolized during the procedure.

A question that has not been resolved in using embolization for fibroids is whether the woman's fertility is affected. Studies of the pregnancy rate after fibroid embolization have not been completed, but some women who have had the procedure have become pregnant.

Some facts about uterine fibroids:

Between 20 percent and 40 percent of women 35 and older have fibroids of significant size. African-American women are at higher risk, with about 50 percent developing fibroids of a significant size.

Fibroid tumors are noncancerous (benign) growths that develop in the muscular wall of the uterus.

The fibroids can range in size from one-quarter inch to larger than a cantaloupe.

Depending on location, size and number of fibroids, symptoms include: heavy, prolonged menstrual periods; pelvic pain or pressure; pain in the back, legs or flank; pain during sexual intercourse; frequent urination; constipation; and bloating.

Fibroids can be diagnosed in a gynecologic pelvic exam, as well as by ultrasound, magnetic resonance (MR) and computed tomography (CT), painless imaging techniques.

Co-authors of a paper on the topic being presented by Dr. Spies are: Anthony R. Scialli, M.D., Reena C. Jha, M.D.; Izumi Imaoka, M.D.; Susan M. Ascher, M.D.; Vivian M. Fraga, M.D.; and Klemens H. Barth, M.D.

Co-authors of a paper on the topic being presented by Dr. Pron are: Andrew A. Common, M.D., Stuart Bell, M.D., Murray Asch, M.D., John Bennett, M.D. and Kenneth W. Sniderman, M.D.

An estimated 5,000 people are attending the Annual Scientific Meeting in Orlando, Fla., of SCVIR, a professional society based in Fairfax, Va., for physicians who specialize in minimally invasive interventional procedures.

An interventional radiologist is a physician who has special training to diagnose and treat illness using miniature tools and imaging guidance. Typically, the interventional radiologist performs procedures through a very small nick in the skin, about the size of a pencil tip. Interventional radiology treatments are generally easier for the patient than surgery because they involve no surgical incisions, less pain and shorter hospital stays.

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Copies of 1999 SCVIR news releases are available online at www.pcipr.com/scvir beginning Monday

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