On the heels of an FDA advisory panel raising concerns about a surgical device commonly used in hysterectomies and to remove fibroids, a new JAMA study provides an estimate of how many women might have undetected cancer that the device could unintentionally spread.
Background on the procedure
Laparoscopic power morcellation was developed as an alternative to invasive surgery for women with symptomatic uterine fibroids, which are responsible for about 40% of the 500,000 hysterectomies performed each year in the United States. It uses a power device to grind uterine tissue so it can be removed through a tiny incision and is used in about 50,000 procedures annually in the United States.
The technique has come under fire for its potential to spread a type of cancer—known as a uterine sarcoma—within the body.
In April, FDA issued a safety communication notice discouraging the use of the procedure.
After FDA warning, groups defend use of morcellation
Earlier this month, an FDA advisory panel said that there are no proven ways to use morcellation for hysterectomies and fibroid removal without risking the spread of malignant cancers to other parts of the body. FDA takes its panelists' recommendations into account when making regulatory decisions, but it has not announced a timeline for making a determination about the use of morcellation.
FDA considers banning common surgery procedure
For the study, researchers used a large insurance database to identify 232,882 women across 500 U.S. hospitals who between 2006 and 2012 underwent minimally invasive hysterectomies using various techniques. Of that total, 36,470 women underwent power morcellation, and researchers found that 99- or one in 368 cases—had uterine cancer that was undetected until after the procedure.
Previous estimates had put the rate of undetected cancer lower, ranging from one in 500 to one in 10,000 cases, the New York Times reports. A recent FDA analysis put the estimate lower, saying one in 352 women undergoing a hysterectomy or fibroid removal has sarcomas, which are aggressive and hard-to-detect cancers.
The study also found that 32% of the women with previously undetected uterine cancer were under age 50. According to the Washington Post, some physicians have argued that it is safe to use morcellation for younger women.
The study did not assess the long-term outcomes for women who underwent morcellation.
Recommendations and reaction
Study lead author Jason Wright, director of Columbia University College of Physicians and Surgeons' gynecologic oncology division, said the study "is an answer to some of those criticisms and might mitigate the concerns of those who disagree with the FDA figures."
He added that while he was unsure if "morcellation should be banned ... the data [are] important to allow people to make decisions." Wright and his colleagues recommended in the study that physicians inform patients of the risks of using power morcellation prior to surgery.
Meanwhile, American Congress of Obstetricians and Gynecologists spokesperson Kate Conners said, "ACOG continues to recognize that power morcellation can be a treatment option for certain women" (Hogan, Washington Post, 7/22; Belluck, New York Times, 7/22).
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Daily roundup: July 29, 2014