Risk of Undiagnosed Cancer Spread by Morcellation Highlighted in Study
Amid continuing concerns about the risk of unsuspected cancer being spread by power morcellators used during laparoscopic hysterectomies and uterine fibroid removals, new research suggests that one out of every 370 women undergoing the minimally invasive surgery may carry undiagnosed cancer cells that could be quickly upstaged.
The findings of a study published today by the Journal of the American Medical Association (JAMA) appear to reinforce concerns the safety of power morcellators and recent recommendations that the medical devices should not be used during uterine fibroid surgery.
Morcellation involves the use of a medical device to cut up the uterus or uterine fibroids through a small incision in the abdomen, allowing doctors to remove the tissue without the risk of complications associated with an open procedure. However, for women with unsuspected sarcoma contained within the uterus, power mocellators may pose a serious and life-threatening risk.
Researchers from Columbia University looked at data on 232,882 women from a large insurance database known as Perspective. All of the women underwent a minimally invasive hysterectomy between 2006 and 2012, with morcellation used with nearly 16% of the cases, or 36,470 women.
At least 99 cases of uterine cancer were found among the women who underwent morcellation during the hysterectomy, with the prevalence of the undiagnosed sarcoma, leiomyosarcoma (LMS) or other cancers increasing with age.
There is no effective way for doctors to diagnose the cancer prior to the morcellation surgery, and use of the medical device may cause the contained cancer cells to be spread throughout a woman’s body, rapidly upstaging the cancer to a very advanced and life-threatening degree. This can result in substantially shortened life expectancy and lower quality of life.
The findings support estimates recently provided by the FDA in April 2014, when the agency urged doctors to stop using power morcellation for uterine fibroid removal. At that time, the agency estimated that about 1 out of every 352 women who underwent a laparoscopic hysterectomy or myomectomy had unsuspected sarcoma, and one out of every 498 had the far more lethal LMS.
Following a meeting earlier this month of two FDA advisory committees that examined the medical literature and data on cancer risks with morcellation, the agency is expected to make a final regulatory determination about whether a power morcellator recall should be issued or whether stronger warnings should be required for the devices.
Morcellation Cancer Lawsuits Filed By Women
As women and families learn that cases of aggressive uterine cancers diagnosed following a laparoscopic hysterectomy or myomectomy may have been caused by morcellation, questions are being raised about why adequate warnings were not provided and whether manufacturers failed to make the devices as safe as they could have been.
A number of morcellation cancer lawsuits are now being pursued on behalf of individuals who had leiomyosarcoma, endometrial stromal sarcoma or other cancers spread during the procedures.
Plaintiffs allege that as they are currently designed, power morcellators are unreasonably dangerous. In addition, women claim that they may have avoided spreading cancer throughout their body if information about the risk had been provided to the medical community, since a number of alternative treatment options are available for women with symptomatic uterine fibroids, including traditional surgical hyesterectomy 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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