Patient Safety News: Power morcellator worsened prognosis for women

Johnson & Johnson has an estimated 100 claims filed against them involving their now discontinued power morcellator. The device had been used to cut up fibroids in the uterus until the United States Food and Drug Administration (FDA) reported that the morcellators spread cancerous tissue to parts of the abdomen and pelvis. The FDA also reported thpharmaceutical at 1 in 350 women are found to harbor a uterine sarcoma that is undetectable prior to the operation.

The Wall Street Journal is reporting that about 70 of the estimated 100 claims have been settled in the past few months with settlements ranging anywhere from $100,000 to $1 million.

Here’s an excerpt from the recent Wall Street Journal article:

The U.S. Government Accountability Office continues to probe why the device was allowed to be on the market for two decades before the FDA warned it can spread uterine cancer, according to a person familiar with the investigation. In a statement Friday, the FDA said it was notified by the GAO and plans to fully cooperate with the review.”

Johnson & Johnson told the Wall Street Journal that the power morcellator, which came off of the market in July of 2014, had “always included cautions in their instructions for use about the potential spread of malignant (or suspected malignant) tissue,” but failed to take the product off of the market for over two decades.

The FDA recommends that manufacturers place the following on the label of the morcellator as of November 2014:

WARNING: Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer, and decrease the long term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.

Power morcellators aren’t exclusively manufactured by Johnson & Johnson. Smith & Nephew, who still markets their morcellator as “Safe, gentle, effective, and efficient,” has kept their product available regardless of the FDA warning. Karl Storz and Lina Medical have also produced the devices that have caused catastrophic injury to women.

Susan Faunce, an attorney at Berman & Simmons who handles cases involving dangerous drugs and medical devices, is working in collaboration with other national law firms to handle legal claims involving women who were diagnosed with cancer after a gynecological surgery involving morcellation.