A surgical tool commonly used for the surgical removal of the uterus (hysterectomy) and for the resection of uterine fibroids (myomectomy) is under review by the United States Food and Drug Administration (FDA). The tool, known as the laparoscopic power morcellator (LPM), is used for the division and removal in small pieces (‘morcellation’) of large masses of tissue such as the uterus or fibroids in the uterus. It is minimally invasive, requiring only two small incisions; one through which the laparoscopic camera is inserted to visualize the surgical field, and the second through which the tool can cut and extract pieces of target tissue.

As far as surgical procedures go, minimally invasive techniques are favoured due to their benefit to the patient – they result in lower blood loss, less postoperative pain due to smaller incisions and quicker recovery times. The LPM, however, was found to be linked to the awakening of a form of cancer known as uterine sarcomas, present in 1 out of 350 women who undergo hysterectomies or myomectomies.

The two-day review by the FDA’s Obstetrics and Gynecology Devices Advisory Committee resulted in an array of precautionary measures serving as an indictment of the LPM. The advisory panel mandated the requirement of informed consent from both the patient and the surgeon, outlining the risks of unsuspected malignancies in women treated with LPM. 

“There is no reliable way to determine if a uterine fibroid is cancerous prior to removal,” said William Maisel, chief scientist at the FDA’s Center for Devices and Radiological Health. “Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals,” he added. 

The FDA panelists supported the addition of ‘black box’ labels to LPMs, and also suggested identifying characteristics of patients or fibroids, physical exam findings and other common features to help distinguish patients who may have uterine sarcomas before LPM treatment. They also recommended finding strategies to mitigate risks during treatment.

Strong backlash from patients and physicians alike has prompted further discussion into the possible banning of the device. Ethicon by Johnson & Johnson, an LPM manufacturer, has halted the production of LPMs for the time-being until further word is heard from the FDA as to the banning of the device from the market.