Dozens of gynecologists, cancer doctors and women’s health experts are challenging a U.S. Food and Drug Administration warning on a power device used to remove fibroid growths from a woman’s uterus.
The tool — a laparoscopic power morcellator — grinds up fibroid growths during minimally invasive surgery. The group of experts claim that curbing its use may force patients to undergo riskier, more invasive procedures.
The FDA issued a “boxed warning” label on the devices last year. The agency had concluded that in about one out of every 458 cases, the morcellator chews up an undiagnosed cancerous growth and floods the woman’s abdomen with cancer cells.
But a review group of 46 experts says the FDA got its facts wrong. The likelihood that power morcellation would grind up a cancerous growth is actually much lower, they contend.
“The best case scenario would be for the FDA to recalculate the prevalence estimates to make them more accurate, because they did an absolutely horrible job with them,” said Dr. William Parker, director of minimally invasive gynecologic surgery at University of California, Los Angeles Medical Center in Santa Monica.
Parker is the lead author of a new paper published Dec. 8 in the journal Obstetrics & Gynecology that criticizes the FDA’s action. The authors have also issued an open letter to the FDA asking it to change course.
Benign fibroids, also called leiomyomas, can be found in about 75 percent of all women in their lifetime, the article says. These fibroids result in an estimated 210,000 hysterectomies and 50,000 surgical fibroid removals each year in the United States.
Because of the FDA warning, doctors and women have turned from minimally invasive laparoscopic surgery to full-fledged abdominal surgery to remove fibroids, the review authors contend.
Major surgery entails longer hospital stays and drastically increases risk of complication and death. A group of 100,0000 women undergoing laparoscopic surgery to remove uterine fibroids would be expected to experience 20 fewer deaths, 150 fewer dangerous blood clots in their blood vessels and 4,800 fewer wound infections than an equal number of women having abdominal surgery, the report states.
“Doctors are taking the FDA at their word, and patients take the FDA at their word,” Parker said. “So I think the FDA needs to reconsider what they’ve done and do it better.”
The FDA stands by its decision, the agency said in a statement responding to the new paper.
“At this time, the agency’s recommendations have not changed. We continue to believe that inclusion of a boxed warning and contraindications to the use of power morcellation for uterine fibroid removal in the majority of women is both appropriate and necessary,” the statement reads.
“We welcome the continued scientific dialogue concerning the available evidence about benefits and risks associated with power morcellation and will notify the public if our recommendations change,” it concludes.
The review group contends that the FDA’s data is flawed because the agency only included studies that evaluated cases of fibrous growths that turned out to be cancerous. Using those strict guidelines, the FDA found only seven studies upon which to make its analysis, Parker said.
However, an independent analysis that included all uterine growths, cancerous or not, uncovered 133 studies that were relevant, Parker said. That larger study revealed the risk of coming across a cancerous growth was actually one in 1,960, much lower than the FDA’s estimate of one in 458.
Another recently published large study found two cancerous growths among 8,720 women having surgery for fibroids, the report adds.
Dr. Hal Lawrence III, executive vice president and CEO of the American Congress of Obstetricians and Gynecologists, said that the new article is a “well-timed, thoughtful document” that “really sheds some light” on concerns that gynecologists have had since the FDA raised the issue.
“If the FDA called and asked me, I would say let’s step back and re-look at all of this data and make sure you made the right decision,” Lawrence said. “Maybe you want to modify that decision.”
In the paper, Parker and his colleagues argue there are ways to reduce the risk of spreading cancer while using a morcellator.
Certain ultrasound or MRI findings should increase a doctor’s suspicion of cancerous fibroids in a woman’s uterus, they said.
Also, surgeons should take the time to carefully remove all tissue fragments and then thoroughly irrigate the pelvic and abdominal cavities to wash away loose material, the report states.
Such a process should only take 15 to 20 minutes, Parker said.
“It should be done, and it should be done carefully,” he said. “There should essentially be no tissue left behind.”
For more on uterine fibroids, visit Womenshealth.gov.