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FDA warns against laparoscopic power morcellation for hysterectomy, myomectomy
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The FDA today released an “immediately in effect” guidance that recommends laparoscopic power morcellators list a boxed warning and two contraindications on the label due to the risk for the device to disseminate unsuspected uterine cancer.
“The FDA’s primary concern is the safety and well-being of patients, and taking these steps will help the agency’s safety recommendations to be implemented as quickly as possible,” William Maisel, MD, MPH, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in a press release. “Updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed.”
William Maisel
The FDA guidance recommends laparoscopic power morcellators warn of the risk to spread cancer during fibroid surgery — and the decreased long-term survival associated with this dissemination — in a boxed warning.
The FDA also recommends the contraindication of laparoscopic power morcellators for women who are peri- or postmenopausal, or women who are candidates for en bloc tissue removal through the vagina or mini-laparotomy incision. A majority of women undergoing fibroid surgery fall into these categories, according to a press release from the FDA.
Power morcellators also should not be used in women with uterine tissue that is known or suspected to be cancerous.
The guidance is an update to an April FDA statement that discouraged the use of laparoscopic power morcellation for most women undergoing hysterectomy or myomectomy for fibroid removal. The FDA released this warning in part due to data that indicated approximately one in 350 women undergoing these procedures have unsuspected uterine sarcoma that can spread by laparoscopic power morcellation to the abdomen and pelvis.
“There is no reliable way to determine if a uterine fibroid is cancerous prior to removal,” Maisel said in an FDA press release issued at the time of the April warning.
The current recommendations follow an FDA-convened Obstetrics and Gynecology Devices Panel in July. The panel also discussed populations for which laparoscopic power morcellation may be warranted, such as in young women who may wish to keep their uterus intact to have children.
Traditional surgical hysterectomy and myomectomy, laparoscopic hysterectomy and myomectomy without morcellation and mini-laparotomy may be alternative surgeries to remove symptomatic uterine fibroids, according to the FDA release.
“The FDA strongly encourages doctors to inform their patients of the risk of spreading unsuspected cancer from the use of these devices in fibroid surgery and discuss the benefits and risks associated with all treatment options,” Maisel said.
Perspective
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Jason D. Wright, MD
The advisory by the FDA provides further guidance addressing the growing concern surrounding the use of the risk of electric power morcellators for gynecologic surgery. The FDA release adds to prior warnings by the agency and provides the most specific guidance to date.The latest recommendations by the FDA specifically outline two contraindications to electric power morcellation. First, the advisory recommends against use of electric power morcellation for women with suspected malignancies. Second, the FDA advisory states that electric power morcellation is contraindicated in peri- and postmenopausal women undergoing surgery for suspected fibroids who are candidates for en bloc resection of the uterus. Additionally, the FDA will update device labeling with a warning that uterine tissue may contain unsuspected cancer.
These recommendations are based on the growing understanding of the potential risk for cancer in women undergoing hysterectomy for presumed benign gynecologic conditions. Importantly, this advisory recognizes the finding that advanced age appears to be the factor most strongly associated with the discovery of an occult malignancy.
For clinicians, these guidelines highlight the potential risk of electric power morcellation, especially in older women. Currently available diagnostic modalities lack precision in the diagnosis of uterine tumors, making preoperative recognition difficult. The advisory likely will impact clinical practice, as many women undergoing hysterectomy for fibroids fall into the age range described by the FDA. Although the FDA guidance recognizes the risk associated with electric power morcellation, further studies are still needed to define women who may benefit from electric power morcellation as opposed to other surgical techniques.
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