There is growing concern that laparoscopic power morcellation used in uterine fibroid surgical procedures may cause aggressive cancers to spread in women.
It’s estimated that 50,000 women annually have morcellator laparoscopic hysterectomies. However, a new study from researchers at Columbia University says that close to 27 women out of every 10,000 undergoing a myomectomy (uterine fibroid removal), has undiagnosed cancer that can spread during the procedure, causing a dangerous situation.
The Columbia University team submitted a research letter discussing their findings in the Sept. 24 issue of the Journal of the American Medical Association (JAMA). In it they discussed how they used the Premier Perspective database (which helps doctors and nurses track patient care during hospitalization at over 500 hospitals) to look at women who underwent minimally invasive hysterectomies between 2006 and 2012.
Of the 232,882 women who underwent the procedure during those years, 15.7 percent (36,470) of them used morcellation. Within that group, 99 cases of uterine cancer were identified.
This research backs up recent concerns about the link between morcellation and the spread of cancer. It shows that on average about one woman out of every 370 who used morcellation were later discovered to have uterine sarcoma.
The researchers also found higher rates of cancer as the women aged, with the prevalence for uterine malignancies highest for women 65 and older.
Uterine Threat and Power Morcellation
A surgical instrument used for the removal of large tissue masses, a power morcellator aids in the process of cutting tissue into small pieces that can be removed via an incision.
Since its 1993 approval for gynecologic surgery, power morcellation is often used during hysterectomies or myomectomies to enable the removal of the uterus or fibroids through a port incision. This is generally a safer procedure, with limited scarring and a faster recovery time. It’s estimated that 50,000 women annually have morcellator-assisted laparoscopic hysterectomies.
However, available U.S. Food and Drug Administration (FDA) data shows that 1 in 350 women have uterine sarcoma, a type of uterine cancer. The issue is that there is no reliable method for forecasting whether a woman with uterine fibroids has a uterine sarcoma. Use of power morcellation may cause this cancer and its tissue to spread throughout the body.
Morcellation Warnings
Since there is no reliable way for doctors to detect which women may have unsuspected sarcoma, the FDA issued warnings urging doctors to stop using power morcellators due to the cancer risks in April 2013.
Following the FDA warning, many hospitals announced they would stop using power morcellators while an FDA advisory committee came to consensus on the safest way to use the instruments. They discontinued use of the morcellators after the committee determined that there is no way to ensure safety of power morcellator use.
Moreover, Ethicon, a division of Johnson & Johnson and the largest power morcellator manufacturer, with 70 percent of the market, has stopped sales of the device. Additionally, some regional health insurance carriers are no longer covering the risky procedure.
Interestingly enough, doctors nationwide are still using power morcellators months after the FDA warning.
The Wall Street Journal reported that some doctors believe the “risks of unknown cancer have been overblown and the government shouldn’t interfere with patient treatment.”
In the meantime, plaintiffs who were injured by morcellation procedures say that the manufacturer’s poor design created unnecessary dangers, and are asking why adequate warnings were not provided to the public.
For women with symptomatic fibroids, if the manufacturers had shared the knowledge of risk with the medical community, patients could have chosen an alternative treatment option.
In general, morcellator cancer lawsuits are filed individually by each plaintiff and are not class actions.
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If you or a loved one were diagnosed with cancer in the uterus, pelvis or abdomen within two years of undergoing surgery for a myomectomy (removal of fibroids), hysterectomy (removal of the uterus), oophorectomy (removal of the ovaries), or salpingectomy (removal of fallopian tubes), you may have a legal claim. See if you qualify by filling out the short form below.
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