Morcellation means “division,” and in laparoscopic surgery, a morcellator is a surgical instrument used for the removal of large tissue masses. A power morcellator aids in the process of cutting tissue into small pieces that can be removed via an incision.

Since its 1993 approval for gynecologic surgery, a power morcellator is sometimes used during hysterectomy or myomectomy to enable the removal of the uterus or fibroids in pieces. It’s estimated that 50,000 women annually have morcellator laparoscopic hysterectomies.

However, data shows that women who have an undetected uterine sarcoma shouldn’t undergo surgery using a power morcellator for fear of it spreading cancerous tissue throughout the peritoneal cavity. So many concerns were voiced that the U.S. Food & Drug Administration (FDA) posted a safety notice on April 17, urging doctors not to use a power morcellator when performing specified gynecological surgeries.

“If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival,” the report stated. “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, in the safety notice, announced a public meeting would be held to discuss what to do going forward.

A notice was recently posted in the Federal Registry calling a meeting of the FDA’s Obstetrics and Gynecology Devices advisory panel to evaluate how the agency should address the issue. On the table are three questions: “1) the clinical role of laparoscopic power morcellation in the treatment of uterine fibroids, 2) whether surgical techniques and/or use of accessories, such as morcellation/specimen bags, can enhance the safe and effective use of these devices, and 3) whether a ‘boxed warning’ related to the risk of cancer spread should be required for laparoscopic power morcellators.” Also at question is whether or not the medical community should continue using the devices.

What Happens Next

Many hospitals, following the FDA warning, announced they would cease use of power morcellators until the panel comes to consensus on the safest way to use the instruments. Moreover, Ethicon, a division of Johnson & Johnson and the largest power morcellator manufacturer, has stopped sales of the device.

In the meantime, plaintiffs filing morcellation cancer lawsuits allege that the manufacturer’s poor design created unnecessary dangers, and are asking why adequate warnings were not provided to the public. For women with symptomatic fibroids, if sufficient knowledge of risk had been shared with the medical community, they could have chosen an alternative treatment option.

The panel will be meet on July 10 and 11 in Silver Springs, Md.