FDA Advisors Remain Divided on Power Morcellator Ban after July Meeting
A U.S. Food and Drug Administration (FDA) panel of experts could not come to a unanimous decision Friday on whether to ban laparoscopic fibroid removals using a power morcellator, the Boston Globe reports.
A meeting with the FDA’s Obstetrics & Gynecology Devices Panel took place on July 10th and 11th, where its members were divided on the costs vs. benefits of power morcellators in fibroid removal surgeries. Some said the surgical tool should be banned, while others said its use offered benefit to certain women.
According to the Globe report on July 11th, advisors did agree that doctors could not rule out a chance of the devices spreading uterine cancer, and that women having fibroids removed with a power morcellator should be made aware of this risk prior to the procedure. They should also be required to sign a document acknowledging that they were informed, the article states.
In an interview after the Panel meeting, member Dr. Michael Neuman of the Michigan Technological University Center said further review of power morcellators was necessary to adequately address its risks.
“I think there was consensus in that we have so many questions and incomplete answers,” he said.
Spread of Cancer after Morcellation Often Results in Worse Prognosis, FDA Warns
The meeting followed a FDA public health warning on April 17th, 2014 that discouraged doctors from using the device in minimally-invasive hysterectomy and fibroid removal surgeries. Among other things, the public was warned of power morcellators’ potential to spread uterine sarcoma and other cancers, which may be present in 1 in every 350 women undergoing these procedures. Patients whose cancer spread after use of the device were given a worse prognosis 25 to 65 percent of the time, the FDA estimated in the alert, which also announced its intention to delve into the issue further.
According to the Globe, approximately 50,000 women in the U.S. were undergoing power morcellator surgery until recently, as a means of more easily extracting uterine tissue in minimally-invasive fibroid removals.
Many of these individuals and their families have since come together in efforts to ban uterine morcellation. According to an update on July 14th, a Change.org petition to end use of the devices has now garnered over 12,300 signatures.
Considering a Power Morcellator Lawsuit? Contact Us Today.
If you or a loved one were diagnosed with uterine cancer following a minimally-invasive hysterectomy that included a power morcellator, you may be eligible to file a claim over the device. Call the lawyers at Bernstein Liebhard LLP today at (877) 779-1414.