The U.S. Food and Drug Administration has investigated cancer deaths associated with power morcellator devices.

The investigations focused on power morcellator devices used during minimally invasive surgeries performed at various hospitals throughout the U.S.

Brigham & Women’s Hospital, Rochester General Hospital and University of Rochester Medical Center were some of the hospital locations included in the FDA power morcellator investigation.

The inquiries into the power morcellator deaths came as a response to a letter written by Congressman Mike Fitzpatrick to FDA Director George Karavestos in December of last year.

The letter alleged that several hospitals did not report patient complications and deaths that resulted from the use of power morcellator devices.

The FDA responded to Congressman Fitzpatrick on March 29 by letter, stating “In recent months, we have conducted inspections of hospitals highlighted in your latter, including Brigham & Women’s Hospital, Rochester General Hospital, and the University of Rochester Medical Center,” the FDA stated.

Section 803 of Title 21 of the Code of Federal Regulations mandates that manufacturers and hospitals are required to report adverse events such as serious injuries or deaths that occur following the use of a medical device. The reports are to be made directly to the FDA within 10 to 30 days of the event.

The FDA’s response did not outline the details of any criminal investigations being conducted at any of the hospital but only confirmed the hospitals were being investigated.

“In order to protect the integrity of the investigative process, it is FDA’s policy not to confirm or deny the existence of a criminal investigation, Dayle Cristinzio, Acting Associate Commissioner at U.S. Food and Drug Administration, Office of Legislation told Congressman Fitzpatrick in the letter. “FDA appreciates your interest in this issue and we will continue to keep you and your staff apprised of any updates.”

Power Morcellator Controversy

A power morcellator is a medical device used in minimally invasive surgeries in gynecology, specifically for hysterectomy and uterine fibroid removal.

A small incision is made into the patient, and the morcellator is inserted into the surgical opening. The rotating blades on the device cut the tissue into small pieces which can then be removed through the tiny incision.

The controversy over the devices centers on women that may have undiagnosed cancer cells that can potentially be disturbed by the power morcellator.

Once the morcellator disturbs the cancerous cells, they can be quickly disseminated throughout the abdominal cavity, leading to advanced stage uterine cancer. What started as easily treatable fibroids can quickly become a death sentence for women with this condition.

The FDA estimates that about 1 in 350 women have undiagnosed cancer that can potentially be spread by the power morcellator that can cause upstaged uterine cancer. In 2014, the FDA issued a warning about the increased risk of uterine cancer relating to power morcellator use.

Johnson & Johnson, the largest manufacturer of the power morcellator, removed its devices from the market shortly after the FDA warning.

Currently, many hospitals have abandoned the use of power morcellator devices altogether and many insurances no longer cover surgeries that use a power morcellator.

Following the FDA’s warning, updated warnings were called to be included on power morcellator labels, but currently the devices are still available on the market.