Calif. Researchers Suggest Pre-Op Evals for Power Morcellator Patients
A group of California researchers are urging doctors to conduct preoperative evaluations on fibroid removal patients to assess whether they should undergo power morcellator surgery.
This determination was included in a report published February 5th in the American Journal of Obstetrics & Gynecology that stresses, most significantly, the lack of quality data used to determine dangers associated with the surgery tool. Research for this study was led by a team at the University of California’s Irvine Medical Center, and is the latest to look at the association between power morcellators and the risk for uterine sarcoma and other cancers in women. Specific recommendations for these types of procedures would help doctors screen patients more effectively, the study’s authors said.
Uterine Sarcoma Risk Remains Largely Undocumented, Researchers Say
“There are limited data on the prevalence of sarcoma in morcellated specimens and even fewer cases and studies on the incidence of disseminated disease in patients who underwent minimally invasive surgical techniques with the use of power morcellation,” according to Irvine Medical Center researchers.
The lack of information involving uterine morcellation dangers is also present in studies that led U.S. health regulators last year to urge doctors against using the devices. In its original alert on April 20, 2014, the U.S. Food and Drug Administration (FDA) estimated that 1 in every 350 women having fibroids removed may have cancer cells that may only be diagnosed after surgery. These individuals could be at an increased risk for the disease spreading via a power morcellor if one was used in their surgery.
In the wake of these findings, Johnson & Johnson’s Ethicon unit halted sales of its power morcellators before removing them from the market in July. This was just a few weeks after a panel of FDA advisers met to discuss the issue, but came up empty on the decision of whether to ultimately ban their use.
In November, the federal agency announced its decision to require all power morcellator manufacturers to add black box warnings to their products that noted their possible association with the spread of serious uterine cancers.
Consider a Power Morcellator Lawsuit
Over the past year, women have begun to come forward in filing power morcellator lawsuits that accuse manufacturers of failing to warn about risks associated with the devices. Call our Firm for more information about filing a case of your own at (877) 779-1414.