Because of the various morcellation cancer lawsuits filed against numerous medical device manufacturers for alleged personal injuries, the US Food and Drug Administration (FDA) has made several decisions and public safety announcements regarding the use of power morcellator tools during minimally invasive laparoscopic hysterectomy and uterine fibroids procedures.

FDA Power Morcellator Warnings

In November 2014, the FDA required medical device manufacturing companies to include a black box warning, the strongest federal warning possible, to inform consumers, doctors, and hospitals of the risks associated with laparoscopic morcellation.

The agency also noted that most women needing uterine fibroid removal surgery or a hysterectomy should not do so with a power morcellator, as there is a risk that the medical device may spread undiagnosed uterine sarcoma cancer cells.

Furthermore, the FDA also included contraindications on the power morcellator warning labels. These contraindications suggest that laparoscopic power morcellators should not be used in female patients who could have the target uterus tissue removed intact, as well as women in which the uterus tissue that is slated to be morcellated is known to contain cancerous cells.

The FDA’s morcellation cancer contraindications states:

“Based on a quantitative analysis of currently available data, the FDA estimated that approximately one in 350 women who are undergoing hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma. If laparoscopic power morcellation is performed in these women, 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.”

Since the FDA issued this power morcellator black box warning, many doctors and hospitals have made the executive decision to stop using the morcellation technique and medical devices all together.

What Are Power Morcellators?

A power morcellator is a medical device that is inserted into a person’s abdominal or vaginal cavity in order to remove uterine fibroids, benign tumors, and the uterus as a whole. The morcellation device works by employing blades that shred the biological tissue into smaller pieces so that it can be removed via the same small incision in which the device was inserted into the body.

This process was at one point very popular among the gynecological community, as it required less recovery time and resulted in less scarring for patients undergoing hysterectomy and myomectomies. However, this same grinding procedure that makes quick recovery time possible also has the ability to grind up undetected uterine sarcomas, or cancerous cells, thus spreading the cancerous tissue through-out a patient’s body and upstaging a cancer diagnosis from Stage 1 to Stage 3.

Despite the various morcellation cancer studies, power morcellator cancer lawsuits, and numerous adverse event reports, the FDA has not chosen to ban power morcellators.

Currently, there exist 22 morcellation cancer lawsuits filed in 16 federal courts across the country, which similarly allege personal injury, wrongful death, and product liability claims against several power morcellator manufacturing companies. The plaintiffs of these lawsuits have requested to have their power morcellator lawsuits centralized in Kansas federal court before U.S. District Judge Kathyrn H. Vratil.