For years, women who suffered from uterine fibroids - benign tumors that cause a multitude of disabling symptoms – had but one option: hysterectomy. The American College of Obstetricians and Gynecologists (ACOG; New York) has finally given its stamp of approval for a much less drastic treatment alternative.
A new ACOG practice bulletin approving uterine fibroid embolization (UFE) also opens the door for interventional radiologists to start helping the more than 200,000 women in the U.S. who might otherwise undergo hysterectomies.
"In a city like mine [Washington], we already get referrals from dozens of gynecologists," said James Spies, MD, FSIR, chair and chief of service at Georgetown University Medical Center's (Washington) Radiology and Interventional Radiology section. "But in areas where people have been waiting for a definitive statement, this is the definitive statement. This is an opportunity for women to be better informed and puts gynecologists on notice that they ought to consider this treatment alternative."
UFE, which was developed and is performed by interventional radiologists, blocks tiny blood vessels that feed the fibroids, causing the tumor to die and symptoms to subside. An interventional radiologist uses imaging to guide a thin catheter to the uterine artery to treat the source of the disease internally, avoiding open surgery. The procedure offers less risk, less pain and a shorter recovery time compared to hysterectomies.
Although the procedure has been around for a few years, the ACOG practice bulletin wasn't issued until now because there wasn't enough evidence.
"In the last two to three years, there have been three randomized trials that have increased the evidence," Spies told Medical Device Daily. "It's been several years since they looked at this issue. It's a reasoned, measured assessment of the literature. It's an effective and safe therapy with what appears to be good outcomes."
And although Spies said the formal recommendation from ACOG is to their credit and that it will benefit women, "It's not something some of their members want to hear," he said.
That's because many gynecologists will lose the income related to hysterectomies they will no longer perform. However, Spies pointed out that it would be unfair to characterize the majority of gynecologists as being concerned with the lost revenues.
"The average gynecologist would like to do what's best for their patients," he said. "It initially caused them concern because they didn't have quality data to know if this is the right thing to do. The majority of gynecologists were concerned about whether this is safe and if the fibroids would return. Ultimately, ACOG is doing women a favor with this recommendation."
Uterine fibroids are benign tumors that can cause prolonged, heavy menstrual bleeding that can be severe enough to cause anemia or require blood transfusions. It also causes disabling pelvic pain and pressure, urinary frequency, pain during intercourse and miscarriages. Up to 40% of women age 35 and older have uterine fibroids of a significant size. But they are only treated if they have symptoms.
ACOG lists UFE among Level A treatment options, meaning that the minimally invasive treatment is considered safe and effective based on long- and short-term outcomes data. Level A evidence is the highest grade possible. The ACOG practice bulletin is used by doctors to aid in making decisions about appropriate patient care.
The major player in the UFE space is BioSphere Medical (Rockland, Massachusetts), with a reported 75% share of the market.
BioSphere's Embospheres are microporous beads made of an acrylic copolymer. The beads are delivered via catheter and small incision in the groin into the uterine arteries where they are injected into the blood vessels that feed the fibroids. The beads block the flow of blood nourishing the fibroids – which are essentially benign tumors growing from the wall of the uterus – causing them to shrink.
"We are pleased UFE has obtained this important recognition, and believe it is a significant step in the ongoing development of the market for this minimally invasive, uterus-sparing alternative to hysterectomy," said Richard Faleschini, president/CEO of BioSphere. "We believe the new guidelines in this practice bulletin should result in more gynecologists discussing UFE as a mainstream treatment option with their patients and forging collaborative relationships with interventional radiologists to optimize the quality of care offered to women with fibroids."
Some of the data that encouraged ACOG to issue the practice bulletin comes from studies related to BioSphere's product. More than 5,300 patients have been followed since 1995, including the Fibroid Registry, which was completed in 2005, with 3,000-plus patients enrolled.
In 2005, ACOG first included UFE as a viable treatment option in its patient education brochures. Previously, ACOG had been reticent to support UFE, in part because it competes directly with hysterectomy and myomectomy, two surgical procedures performed by gynecologists.
UFE reimbursement usually is about $2,500. Hospitals also benefit handsomely, as Faleschini said it is "the most favorable fibroid treatment," yielding between $1,100 and $1,600 of profit to the hospital. (MDD, Feb. 28, 2006).