Nonsurgical Fibroid Treatment Deemed Safe

July 13, 2005 -- Complications are rare among fibroid patients treated with a relatively new nonsurgical procedure known as uterine embolization.

This remains true even in centers that perform only a few of them, researchers say.

Early findings from the largest study ever of a fibroid treatment suggest that embolization compares favorably in terms of short-term outcome with surgical interventions such as hysterectomy and fibroid removal.

Uterine artery embolization was introduced in the United States in 1997 and is one of the first nonsurgical treatments for fibroids.

The procedure involves introducing small pellets into the arteries that feed fibroids to choke off their blood supply. Without blood the benign tumors die. Most fibroids shrink dramatically within six weeks, but relief from symptoms usually occurs much earlier.

Approximately 3,000 women who had the embolization procedure at 70 centers throughout the country have been enrolled in a national registry. The women will be followed for at least three years in an effort to better understand long-term results with the treatment.

The first published data from the registry showed that less than 1% of women experienced major complications immediately after having the embolization procedure and just 4.8% developed major complications within 30 days.

Patient characteristics were not a predictor of whether complications would occur, nor did the setting (teaching hospital vs. nonteaching hospital) in which the procedure was performed.

"We found that there was really no significant difference in terms of complications between sites, whether they did 10 of the procedures or hundreds of them," radiologist and study co-author James B. Spies, MD, tells WebMD. "That should reassure everyone that this procedure can be done safely in all kinds of settings."

Between 150,000 and 200,000 hysterectomies are performed in the United States each year to treat heavy menstrual bleeding and pelvic pain caused by uterine fibroids. Another established treatment option for those who want to preserve their fertility is surgical fibroid removal, known as myomectomy.

Embolizations are performed by interventional radiologists like Spies, who specialize in targeted, image-guided treatments. Many ob-gyns have been reluctant to recommend the procedure to their fibroid patients as an alternative to surgical treatments, but this is beginning to change, says Spies.

In an opinion released in January 2004, the American College of Obstetricians and Gynecologists (ACOG) acknowledged that nonsurgical embolization "appears to provide good short-term relief" for women who are appropriate candidates for the procedure.

And the findings from the registry study were published in the July issue of the journal Obstetrics and Gynecology.

But ACOG spokesman Bryan Cowan, MD, tells WebMD that the long-term effectiveness of the procedure has yet to be established.

"We now know that about 25% of women who have myomectomies return for repeat procedures within five years, and that usually means hysterectomy," says Cowan, who is professor and chairman of the University of Mississippi Medical Center department of gynecology.

"We are only just now beginning to get five-year data on a very limited number of (uterine embolization) patients."

Cowan says uterine embolization appears to be a good option for women who aren't concerned about preserving fertility looking for a minimally invasive treatment for symptoms associated with fibroids.

But all agree that the jury is still out on whether it is appropriate for those who want the option of having children. Although pregnancies have occurred in women who have had the embolization procedure, ACOG considers it inadvisable in women wishing to retain their fertility. They state that pregnancy outcomes remain understudied.

"The good news is that we do know that patients can become pregnant after embolization, and it is certainly not anywhere near as final as having a hysterectomy," Spies says. "But the role of embolization in the treatment of women who want to preserve their fertility is not yet known."

Spies is confident that long-term data provided by the registry will answer lingering questions about embolization.

"ACOG is rightly concerned about long-term outcomes, and by following these women we will be able to address these concerns in a few years."

SOURCES: Myers, E.R. Obstetrics and Gynecology, July 2005; vol 106: pp 44-59. James B. Spies, MD, interventional radiologist, Georgetown University Medical Center, Washington. Bryon Cowan, MD, professor and chairman, department of gynecology, University of Mississippi Medical Center, Jackson, Miss. ACOG Opinion on Uterine Artery Embolization for the Treatment of Fibroids, Jan. 30, 2004.