http://www.nytimes.com/2014/11/25/health/fda-issues-caution-on-use-of-uterine-surgery-device-that-can-spread-cancer.html 2014-11-25 02:53:50 F.D.A. Issues Caution on Use of Uterine Surgery Device That Can Spread Cancer The agency warns that the tool ought not be used for most women, but critics complain that anything short of a ban is bad policy. === A power device used during uterine surgery in at least 50,000 women a year in the United States The tools, laparoscopic power morcellators, have been widely used in operations to remove fibroid tumors from the uterus, or to remove the entire uterus. Morcellators cut tissue into pieces that can be pulled out through the tiny incisions made during minimally invasive surgery. The safety concern is that women who undergo these operations sometimes have undiagnosed In one in 350 women having fibroid surgery, biopsies after the operation find previously undetected sarcomas, the F.D.A. estimates. The risk of this cancer increases with age. Morcellating a sarcoma, the agency said, “may spread cancer and decrease the long-term survival of patients.” The devices have been in use since the 1990s. But until recently, when The The first contraindication warns that power morcellators should be avoided in women who have reached The second contraindication says that morcellators should not be used when the tissue to be morcellated is known or suspected to be cancerous. The recommendations do not address a technique that some gynecologists have recommended to make the procedure safer: enclosing the tissue to be morcellated inside a bag, to catch any stray cancer cells. In a telephone news conference on Monday, Dr. William Maisel, deputy director for science and chief scientist at the F.D.A.’s Center for Devices and Radiological Health, said the approach made sense but was no guarantee. And he warned that the bags limited what the surgeon could see and so had risks of their own, and that not all surgeons were skilled at using them. The new warnings are the agency’s first use of a type of directive called “immediately in effect guidance,” which allows it to skip the usual procedure of issuing a draft and allowing time for public comments before the guidance becomes final. The warnings update a “ Although the changes are being described as recommendations and not orders, a spokeswoman for the agency, Jennifer Rodriguez, said in an email: “Our experience is that manufacturers follow F.D.A. guidance. The F.D.A. has asked manufacturers of currently marketed devices to submit their revised labeling to the agency within 120 days after issuance of the guidance.” The recommendations leave a “narrow population of patients” in whom morcellation might still be appropriate, the F.D.A. said, citing younger women as an example. But these women should be warned of the risk that the device can spread cancer, the agency said. The American College of Obstetricians and Gynecologists praised the F.D.A. strategy, saying that some women can benefit from morcellation because it enables them to have minimally invasive surgery, which has a shorter recovery time and fewer complications than procedures that require a larger incision. But an opponent of morcellation, Dr. Hooman Noorchashm (pronounced NOOR-chash), called the new guidance “a massive failure” by the F.D.A., and said the agency had been “captured” by the industry it regulates. His wife, Dr. Amy Reed, an anesthesiologist, had a hysterectomy because of fibroids in October 2013 at Brigham and Women’s Hospital in Boston. She was 40; the couple have six children. A Dr. Reed and Dr. Noorchashm have been conducting a nationwide Several morcellators have already been withdrawn. Near the end of July, the Ethicon unit of Johnson & Johnson, a major manufacturer of power morcellators, Ernie Knewitz, a spokesman for Johnson & Johnson, said in an email on Monday: “Ethicon’s morcellation devices remain withdrawn from the worldwide market, and we’ve not announced plans at this time to initiate a relaunch. We are, however, continuing to monitor the landscape, and are also collaborating with the medical community on efforts to reduce the risks associated with hysterectomy and myomectomy procedures.”