FDA Approves New Power Morcellation Device

Washington, DCThe US Food and Drug Administration (FDA) has approved a new containment device for use with certain laparoscopic power morcellation devices. The system is designed to isolate uterine tissue that is not believed to be cancerous. The device approval comes amid lawsuits alleging women were put at risk of serious cancer complications caused by laparoscopic uterine surgery using power morcellation.

In a news release issued April 7, 2016, the FDA notes that it has approved the use of the PneumoLiner, designed to effectively contain uterine tissue. Despite the approval, the FDA also said the maker of the PneumoLiner must warn patients and health care professionals that the system has not been proven to reduce the risk of spreading cancer.

According to an analysis, the FDA estimates that one in 350 women who undergo hysterectomy or myomectomy for non-cancerous growths actually has an unsuspected uterine sarcoma. During laparoscopic uterine surgery, power morcellation breaks up the uterine tissue into small pieces so they can be removed through a tiny incision. Women who have an unsuspected uterine sarcoma are put at risk that breaking up the tissue will result in cancerous tissue being spread throughout their abdomen, increasing the risk of death.

Although the PneumoLiner is designed to contain tissue created by breaking up the fibroids, it has not yet been proven to reduce the spread of potentially cancerous tissue. As a result, the FDA is still not recommending laparoscopic uterine surgery using power morcellation for the majority of women who require removal of fibroids.

“This new device does not change our position on the risks associated with power morcellation,” said William Maisel, MD, MPH, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health.

Lawsuits have been filed by women alleging the use of power morcellation during their laparoscopic uterine surgery resulted in the spread of cancerous tissue. As of April 15, 2016, 30 lawsuits were consolidated for pretrial proceedings in MDL 2625. The situation is concerning enough that in 2015, members of Congress asked the US Government Accountability Office to examine how it was possible for power morcellators to stay on the market, despite there being evidence of a risk of spreading undetected cancer.

“This device can take a Stage 1 treatable cancer immediately to a Stage 4 terminal cancer,” the letter reads. “For too many women, this routine procedure ended with a death sentence.”