The Food and Drug Administration is warning against the use of laparoscopic power morcellator devices to treat uterine fibroids, while obstetricians and gynecologists insist that some women should still have access to the products.
Morcellators use a fast-spinning blade to cut up tissue for removal through small incisions. The FDA has found that the devices can spread a form of cancer called sarcomas, which can resemble fibroids.
About 1 in 350 women undergoing fibroid surgery have an unsuspected sarcoma found in later testing. The federal agency estimates the devices are used in roughly 50,000 hysterectomies annually.
The FDA is calling on morcellator makers to immediately update their product labels to include a boxed warning and alert women that uterine tissue could harbor hidden cancers that morcellators could spread.
They must also list contraindications that note morcellators shouldn't be used to remove uterine tissue in women who have gone through or are transitioning into menopause. The devices also shouldn't be used in women who could have their uterus removed intact through their vagina or through a mini-laparotomy.
The decision follows an advisory panel meeting of outside experts that took place in July to discuss the risks and benefits associated with the device.
The medical community had a mixed response to the announcement. “We continue to believe that power morcellation has a role in gynecologic surgery,” Dr. Hal Lawrence, CEO of the American College of Obstetricians and Gynecologists, said in a statement. “Power morcellation can make it possible for some women to undergo less-invasive laparoscopic hysterectomy or myomectomy, sparing them the longer recovery time and higher mortality rates associated with a total abdominal procedure.”
The FDA isn't discouraging use of the device for all women. It still may be the best option for some younger women who want to maintain their fertility or women not yet menopausal who wish to keep their uterus after being informed of the risks, the agency says.
Johnson & Johnson, which was the largest morcellator manufacturer, ceased making and marketing the devices in April, when the FDA first raised concerns about the device. Other companies that sell laparoscopic morcellators in the U.S. are Karl Storz & Co., Richard Wolf Medical Instruments Corp., Lina Medical, Trokamed and Gyrus.
The FDA's actions fall short of those requested by New York's Democratic senators, Charles Schumer and Kirsten Gillibrand, who wanted the agency to pull them from the market until regulators have further studied the technology's potential to spread cancer during uterine surgery.
Follow Virgil Dickson on Twitter: @MHvdickson
