Tamara Burns  |  September 29, 2016

Category: Legal News

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morcellation-cancer-lawsuitThe use of electric power morcellator devices for assisting in gynecological surgeries is on the decline following the FDA’s warning to stop using the medical device due to the increased risk of spreading latent cancer cells.

In 2013, the FDA recommended against the use of electric power morcellator devices when performing noninvasive hysterectomy surgeries and fibroid removal on women.

The FDA said that one in 350 women is at risk for having unknown uterine cancer cells spread throughout their body as a result of the procedure.

Initially, the FDA warned doctors of the potential safety risk, and a few months later they issued a full recommendation that electric power morcellator devices not be used.

The latest study out of Columbia University reports that electric power morcellator device use dropped by 80% since the FDA’s warning was issued three years ago.

What is an Electric Power Morcellator?

An electric power morcellator is a device used to assist surgeons during minimally invasive gynecological surgeries related to uterine fibroid removal, a procedure known as myomectomy, and for removal of the uterus, or hysterectomies.

In a minimally invasive surgery, also known as laparoscopic surgery, small incisions are made in the woman’s body and the electric power morcellator device is inserted.

The device consists of rotating blades which break up the tissue in the body.

After the tissue is broken down into small pieces, it can be vacuumed out of the body through the small incision.

Because surgery is minimally invasive, women have much shorter recovery time and less pain associated with the procedure.

Electric Power Morcellator Devices and Uterine Cancer

Because women can have latent, undetected cancer cells present in their body without causing symptoms, it was not initially known that power morcellator devices could contribute to an increased risk of uterine cancer.

Caught early, these uterine sarcoma cells are typically easily treated with a small procedure having a good success rate.

However, when these same cells are disturbed by the rotating action of the electric power morcellator blades, the cells can be dispersed throughout the abdominal cavity, causing the once-local cancer to spread.

Following laparoscopic hysterectomy or myomectomy surgeries, some affected women were diagnosed with a later stage invasive uterine cancer.

Columbia University Research

Researchers at the Columbia University College of Medicine conducted a study that looked at 117,653 women in a medical database called Perspective, which keeps data on approximately 500 hospitals throughout the United States.

Of these patients, approximately 15% of hospitalized patients had minimally invasive hysterectomy is performed.

Prior to the FDA’s initial morcellator warning in 2013, approximately 13.5% of patients undergoing hysterectomy had surgeries assisted with an electric power morcellator device.

By the beginning of 2015, only about 2.8% of patients undergoing hysterectomy had an electric power morcellator used during their surgery.

“The FDA warnings might result in a lower prevalence of cancer among women who underwent morcellation due to greater scrutiny on patient selection,” the researchers stated. “However, the high rate of abnormal pathology after the warnings highlights the difficulty in the preoperative detection of uterine pathology. Continued caution is needed to limit the inadvertent morcellation of uterine pathology.”

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