Agency overstated odds of power morcellator spreading cancer, review group says
WEDNESDAY, Dec. 9, 2015 (HealthDay News) — Dozens of gynecologists, oncologists, and women’s health experts are challenging a U.S. Food and Drug Administration warning on power morcellator use for the removal of uterine fibroids.
The professional group claims 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 might inadvertently spread undiagnosed cancer cells within the peritoneal cavity. But a review group of 46 experts says the likelihood that power morcellation would spread a cancerous growth is actually much lower.
“The best case scenario would be for the FDA to recalculate the prevalence estimates to make them more accurate,” William Parker, M.D., director of minimally invasive gynecologic surgery at University of California, Los Angeles, Medical Center in Santa Monica, told HealthDay. Parker is the lead author of a new paper published online Dec. 7 in Obstetrics & Gynecology that criticizes the FDA’s action. The authors have also issued an open letter to the FDA asking it to change course.
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