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| Ethicon's Morcellex Sigma Tissue Morcellator--Courtesy of Johnson & Johnson |
Months after the FDA recommended against using laparoscopic power morcellator tools for the "majority" of women undergoing certain gynecological procedures, two new studies are adding to a growing body of literature scrutinizing the devices.
As The Wall Street Journal reports, researchers at the University of Michigan's health system found that 1 in 368 women who undergo hysterectomies for uterine fibroids had an undetected sarcoma that could be spread by a morcellator. The study included 2,575 women undergoing surgery for fibroids at a statewide group of hospitals in 2013, and results were published Thursday in the journal Obstetrics & Gynecology.
The numbers echo those identified by the FDA last year, as the agency said that women undergoing minimally invasive procedures with morcellators to remove uterine fibroids carried a 1-in-350 risk of uterine sarcoma. Prior to the advisory, the device was used in an estimated 50,000 U.S. uterine surgeries each year, the WSJ reported.
A separate study published online Thursday by the Journal of the American Medical Association Oncology found that women who have only fibroids removed with a power morcellator have a lower risk of undetected cancers than hysterectomy patients undergoing the procedures. But the study authors also said that women's risk for undetected cancer increases with age and there is continued uncertainty surrounding the device, according to the WSJ story.
The JAMA Oncology study specifically looked at removing fibroids with morcellators in procedures called myomectomies. Myomectomies are often done without laparoscopic morcellators, and the study found that 7.7% of 41,777 myomectomies performed between 2006 and 2012 involved the devices.
But most patients on whom the devices were used were under age 40, and researchers saw an overall 1-in-1,073 rate of undetected uterine cancer--more than 9 times higher than the 1-in-10,000 rate doctors quoted before the morcellation backlash erupted, the WSJ reports. Study authors concluded that while physicians may still want to consider the procedure for younger patients, myomectomy with power morcellators "should be approached with caution" in women over 50.
The study results come on the heels of more backlash against the devices, as the industry and regulators respond to growing criticism of power morcellator products. In July 2014, Johnson & Johnson ($JNJ)--the largest maker of power morcellator tools--pulled its related device from the global market. The company's Ethicon unit had already suspended sales of the products in April after the FDA discouraged physicians from using the tools in surgical procedures.
In November, the FDA recommended against using the devices for most women undergoing a hysterectomy or the removal of uterine fibroids, advising that manufacturers should add boxed warnings and two contraindications on product labels. But the agency has stopped short of banning morcellators altogether, saying the devices' benefits may outweigh the risks in some women.
- read the WSJ story (sub. req.)
- get the JAMA Oncology abstract