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New research confirms that fewer doctors are using laparoscopic morcellation for uterine fibroid removal; a decision that appears to be backed up by another study that shows women may be less likely to survive when the medical device is used during their hysterectomy or myomectomy.
The studies were both published this week in the medical journal Obstetrics & Gynecology, coming nearly two years after concerns emerged about the potential side effects of morcellators, which may cause undiagnosed cancer cells contained within the uterus to be spread throughout the abdomen, rapidly disseminating the sarcoma to an aggressive and deadly stage.
Power morcellators became increasingly popular over the past decade, providing doctors a way of cutting up and removing the uterus or uterine fibroids through a minimally invasive, laparoscopic procedure. While these procedures reduce recovery time and the risk of infections or other complications, morcellators have been largely abandoned within the medical community since it was discovered that they pose an unreasonable risk for women with hidden cancers, which doctors are unable to detect before the procedure.
One of the new studies, “Occult Uterine Sarcoma and Leiomyosarcoma: Incidence of and Survival Associated With Morcellation,” published by researchers from Kaiser Permanente, found that women were more likely to die if they underwent power or nonpowered morcellation.
“The unadjusted 3-year probability of disease-free survival for no morcellation, power and nonpower morcellation was 0.54, 0.19, and 0.51, respectively,” the researchers determined. “Morcellation is associated with decreased early survival of women with occult leiomyosarcomas.”
FDA estimates suggest that about one out of every 350 women undergoing surgery for symptomatic uterine fibroids may actually have undiagnosed and unsuspected sarcoma contained within the uterus, leading the agency to first warn about the morcellation cancer risks in April 2014.
While the agency has allowed laparoscopic morcellators to remain on the market, with much stronger warnings about the potential risks, many hospitals have announced that they will no longer perform hysterectomy or myomectomy procedures with morcellation, indicating that there is no way to justify the risk.
The other study, published on December 6, “Association of the U.S. Food and Drug Administration Morcellation Warning With Rates of Minimally Invasive Hysterectomy and Myomectomy,” found that doctors are following the recommendations of the federal regulatory agency, shying away from all types of minimally invasive hysterectomies and myomectomies as a result.
Researchers looked at six Florida hospital operating rooms and data on patients who underwent a hysterectomy or myomectomy during the eight months before the FDA warning and the eight months after the warning. The study found a 5.8% decrease in minimally invasive hysterectomies, which are generally laparoscopic and often include morcellation. Minimally invasive myomectomy rates decreased by 19%.
“There was a significant decrease in the proportion of minimally invasive hysterectomies and myomectomies performed during the 8 months after the FDA warning statement on the use of power morcellation,” the researchers concluded.
As more families learn about the link between the devices and uterine cancers diagnosed in recent years, a growing number of laparoscopic morcellation lawsuits are being filed against manufacturers of the devices, alleging that they failed to adequately warn women or the medical community about the cancer risks associated with the minimally invasive procedures.
In October, the U.S. Judicial Panel on Multidistrict Litigation established consolidated federal proceedings for all morcellation lawsuits filed against Johnson & Johnson’s Ethicon subsidiary, which was previously the leading manufacturer of the medical devices. All product liability lawusits filed over the spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers following use of an Ethicon morcellator are centralized before U.S. District Judge Kathryn H. Vratil in the District of Kansas, as part of a federal MDL, or multidistrict litigation.