The lawsuit involving the Power Morcellator concerns the increased risk of significantly upstaging undiagnosed cancer during laparoscopic uterine fibroid removal surgeries. Upstaging means a change in the stage of a person's cancer from a lower stage (less extensive) to a higher stage (more extensive).

By upstaging an undiagnosed cancer, a patient’s chances for survival are dramatically decreased. Unfortunately, the manufacturers of these products failed to adequately warn of this risk, resulting in injuries to many women.

increased risk of dying from uterine cancer

The main manufacturer of the power morcellator is Ethicon, a subsidiary of Johnson & Johnson.

 

 

 

 

Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators

As the number of laparoscopic and minimally invasive procedures has increased with the introduction of new surgical technologies and techniques, additional safety information has become available regarding the use of LPMs. Recent discussions within the patient and clinical communities, as well as the peer-reviewed medical literature, have raised awareness of the risk of spreading unsuspected cancerous tissue beyond the uterus when LPMs are used during gynecologic surgeries intended to treat benign fibroids. Numerous case reports and case series have been published that describe the iatrogenic dissemination, implantation, and subsequent growth of unsuspected neoplastic tissue within the peritoneal cavity following laparoscopic morcellation of uterine tissue believed to contain fibroids based on preoperative diagnosis. FDA’s recent analysis of available information suggested that the risk of an occult uterine sarcoma in a woman undergoing surgical intervention for presumed fibroids is substantially higher than had previously been assumed or reported. FDA’sanalysis also suggested that patient outcomes, including survival, may be significantly adversely impacted from this upstaging of disease. To read more, click Guidance for Industry and Food and Drug Administration Staff

FDA warns against using laparoscopic power morcellators to treat uterine fibroids

Today, the U.S. Food and Drug Administration is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids. In an updated safety communication, originally issued in April 2014, the FDA warns against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women. In an Immediately in Effect (IIE) guidance, the FDA is also recommending that manufacturers of laparoscopic power morcellators include in their product labeling specific safety statements in the form of a boxed warning and two contraindications. The IIE guidance allows the FDA to issue its recommendations expeditiously to help address a significant public health issue. To read more, click FDA New Release

Ethicon voluntarily recalled all of its power morcellator products. This recall occurred among great public scrutiny and concern about the risks associated with power morcellators.

As of this time, there have been no large group settlements involving the power morcellators and the potential link to upstaging cancer. Litigation likes this takes many years to resolve, with teams of lawyers spending millions of dollars trying to determine exactly what occurred, and how it could have been prevented. Generally, large groups of settlements do not occur until such time as a few cases are tried before a jury, and the manufacturer is able to more thoroughly understand its financial risk.