US agency warns against morcellation in hysterectomies and myomectomies.

The US Food and Drug Administration (FDA) issued a safety communication on 17 April urging doctors not to use laparoscopic power morcellation for hysterectomies or removal of uterine fibroids over concerns that the technique may spread uterine sarcomas beyond the uterus. These procedures use a device with rapidly spinning blades to cut the uterine tissue into fragments so that it can be removed through a small incision. The term comes from the French morceler, to break into pieces. However, according to a new FDA analysis, about 1 in 350 women having a hysterectomy or myomectomy for fibroids has an undetected uterine sarcoma. In these cases, the agencywarns, there is a risk the device’s rapidly spinning blades will disperse tumor tissue within the pelvis and abdomen, disseminating the disease and greatly reducing the woman’s chances of survival. “For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids,” the FDA safety communication says. When uterine cancer is suspected or known, the procedure should not be used at all, the FDA said. Controversy over the technique gained national attention in the US last year when Amy J Reed, a 41 year old anesthesiologist at Boston’s Israel Deaconess Medical Center, and her husband, Hooman Noorchashm, a cardiothoracic surgeon at Brigham and Women’s Hospital, launched a campaign against the procedure. Reed, a mother of six, was diagnosed with stage 4 leiomyosarcoma after having uterine morcellation. Their campaign has prompted several US medical centers to re-evaluate use of the technique. Powermorcellation can be used during any kind of hysterectomy or myomectomy but is usually performed as part of laparoscopic or robotic assisted surgical procedures, which have the advantages of less pain, fewer infections, and quicker recovery. In its statement, the FDA said that in cases in which laparoscopic power morcellation is considered the best therapeutic option, physicians should inform patients of the risk that their fibroids may contain unsuspected cancerous tissues that may be spread by the procedure. The FDA also noted that “some clinicians and medical institutions now advocate using a specimen ‘bag’ during morcellation in an attempt to contain the uterine tissue and minimize the risk of spread in the abdomen and pelvis.” The FDAhas instructed themanufacturers of powermorcellators to review their current product labeling to make sure it includes accurate risk information for patients and providers. It will convene a public meeting of its obstetrics and gynecology medical device advisory committee to discuss the clinical role of laparoscopic power morcellation in the treatment of uterine fibroids; whether surgical procedures, such as the use of specimen bags to capture tissue fragments, improve safety; and whether a “boxed warning” of the risk of cancer spread is required for laparoscopic power morcellators.