Blog: Unsafe Medical Devices

FDA: No Reported Adverse Events Involving Morcellation Cancer Upstaging for 8 Years

Feb 15, 2016

Federal law requires the reporting of adverse events, but for eight years the U.S. Food and Drug Administration (FDA) did not receive reports of cases involving power morcellation and the spread of cancer. Between December 2013 and November 2014, however, the FDA received about two dozen reports discussing cancer and upstaging or dissemination – but all of them pertained to morcellation procedures women had undergone prior to December 2013. Power morcellators use spinning blades to break up...

Responses to Use of Power Morcellators by the FDA, FBI, GOA and Market

Feb 3, 2016

The first reference to power morcellators spurring the ongoing controversy was in December 2013 when the Wall Street Journal profiled Dr. Amy Reed, an anesthesiologist at Beth Israel Deaconess Medical Center in Boston. Dr. Reed underwent a routine morcellation laparoscopic hysterectomy at Brigham & Women’s Hospital to remove uterine fibroids and discovered – after the surgery – that the mass her surgeons had assumed was benign was in fact leiomyosarcoma. Dr. Reed, who now lives in...

Medical Journal Highlights Current Power Morcellator Debate

Jan 27, 2016

This January issue of Obstetrics & Gynecology features two articles diametrically opposed in their messages as to the true risk of power morcellation. In this month’s issue, a group of 48 top gynecological surgeons, headed by William Parker of UCLA, and a few women’s health advocates, including Carla Dionne of the National Uterine Fibroid Foundation (NUFF.org), published a letter directed to the FDA in defense of the use of power morcellation and challenging the FDA on...

What Is a Power Morcellator?

Jan 20, 2016

Power morcellators are made by multiple manufacturers, and provide a less-invasive option in gynecological surgeries. They are shaped much like a drill, and can be inserted into a woman’s lower abdomen through a tiny incision. Once inside, during hysterectomies or myomectomies, they work by rapidly spinning blades which shred, grab and/or and chop up organs and tissue for removal through small incisions. The tool has been used with increasing frequency for laparoscopic gynecological surgeries in...

Power Morcellator Surgery Victims Have Their First Day in Court as Consolidated Cases

Nov 18, 2015

At 1:00 p.m. CST today, women and their families who suffered injuries as a result of a power morcellator will have their first day in federal court as a consolidated litigation in front of the Honorable Kathryn H. Vratil in the United States District Court for the District of Kansas. On October 15, 2015, the United States Judicial Panel on Multidistrict Litigation (JPML) entered an order transferring all power morcellator cases against defendant Ethicon to the...

Power Morcellators – the Risk of Spreading Uterine Cancer and Fibroids Exposed

Nov 13, 2015

One in 352 Women Women undergoing a routine laparoscopic hysterectomy or myomectomy (fibroid removal surgery) with a power morcellator are at risk of spreading cancerous and infected uterine tissue throughout their bodies, reported the U.S. Food and Drug Administration (FDA) in April 2014. According to the analysis of scientific literature, the prevalence of unsuspected uterine sarcoma – a type of cancer – in women undergoing these routine surgeries was one in 352. Meaning: One in 352 women...