Risk of Disseminated Cancer After Laparoscopic Hysterectomy Assessed in Report
A new study calls for more specific guidelines for use of power morcellators during laparoscopic hysterectomy surgeries, amid concerns that the devices can spread and disseminate cancer that is hidden in the uterus.
In a report published in the American Journal of Obstetrics & Gynecology (ACOG) on February 5, researchers from the Irvine Medical Center at the University of California indicated that preoperative evaluation before uterine fibroid surgery should be used to determine whether a woman is eligible for a laparoscopic hysterectomy with morcellation.
Power morcellators are medical devices increasingly used in recent years during minimally invasive hysterectomy and myomectomy procedures for uterine fibroids, allowing doctors to cut up the tissue and remove it through a small incision in the abdomen. This is designed to reduce recovery time, minimize scarring and avoid the risk of infections or other complications associated with traditional hysterectomy procedures.
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Power morcellators used during a laparoscopic hysterectomy or uterine fibroid surgery may cause the spread of aggressive cancer.Learn More About this Lawsuit See If You Qualify Now >
This new call for more specific guidelines seems to contradict other reports that have suggested there is no way to make power morcellators safer and reliably evaluate the risk of disseminating cancer during laparoscopic hysterectomy procedures, given an inability to diagnose whether uterine fibroids are cancerous before they are removed.
Researchers looked at data used in a number of studies involving morcellation during a laparoscopic hysterectomy for uterine fibroid removal, and determined that the overall quality of data is low, even in studies that helped the FDA determine that doctors should avoid using power morcellators for uterine fibroid removal in April 2014.
Ultimately, the agency required new black box warnings on all power morcellators to alert doctors and patients of the risk of upstaging undiagnosed uterine sarcoma and leiomyosarcoma. The agency also contraindicated the use of power morcellators for most women.
This latest study from researchers at Irvine Medical Center challenges those conclusions to some degree, and called for new, specific recommendations that would help doctors screen patients more effectively for power morcellation procedures.
“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,” the study’s authors state. “Without reliable data, any recommendation on the safety of power morcellation is premature, given the known benefits of minimally invasive surgery on patient recovery and quality of life.”
During FDA advisory panel meetings this summer, a panel of independent experts convened to evaluate the cancer dissemination risk with laparoscopic hysterectomies concluded that there is no way to make power morcellators safe, given the estimation that about one in 350 women who undergo uterine fibroid removal have undiagnosed uterine cancer. The panel could not decide whether power morcellators should all be recalled or whether they should all include a black box warning, which is what the FDA ultimately decided to do.
“Specific guidelines for the use of power morcellation may be of benefit while awaiting advances in preoperative diagnosis of sarcomas. If preoperative evaluation raises suspicion for malignancy, morcellation clearly should be avoided,” the new study concludes. “Surgeons should review surgical alternatives that include laparotomy, mini-laparotomy, and colpotomy with possible manual morcellation vaginally or within an endoscopic bag.”
In another study published by ACOG in December, researchers from Kaiser Permanente indicated that there were no risk factors which helped determine which women may be at risk of power morcellation cancer, and said no such guidelines are currently reliable.
“There was no association between any of the factors analyzed and uterine sarcoma,” that study determined. “Uterine sarcoma was found in 0.6% of patients who underwent power morcellation but was not found to be significantly associated with any preoperative factors.”
Laparoscopic Hysterectomy Cancer Lawsuits
In recent months, many health experts called for power morcellator recalls to be issued and have recommended that doctors stop performing the minimally invasive, laparoscopic hysterectomy procedures involving morcellation.
The Johnson & Johnson subsidiary Ethicon, which was previously responsible for manufacturing 70% of all power morcellators on the market, announced a that it will no longer manufacture morcellators, indicating that there is currently no way to make the devices safe.
A number of hospital systems, doctors and health insurance companies have turned away from the procedures entirely, deeming power morcellation too risky for women.
As more women and families learn about the link between the spread of cancer and hysterectomy procedures, a growing number of laparoscopic hysterectomy lawsuits over disseminated cancer have been filed against various manufacturers of these devices, alleging that inadequate warnings have ben provided for patients and the medical community for years.
Plaintiffs allege that the rapid spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers may have been avoided if any number of different alternative treatment options available for women with symptomatic uterine fibroids had been used, including traditional surgical hysterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy and laparoscopic hysterectomy or myomectomy without use of morcellation.
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