Ethicon, a subdivision of Johnson & Johnson, is the manufacturer of the Gynecare Morcellex, a power morcellator. Power morcellators are surgical instruments that are used in gynecological laparoscopic surgeries such as hysterectomies and myomectomies.
The U.S. Food and Drug Administration first approved the power morcellator in 1991. This approval came through the Center for Devices and Radiological Health under an act called a 501(k). Under the 501(k) a device does not have to go through rigorous safety testing but can be approved by showing that it is “substantially equivalent” to a previously approved device.
In order for a device to be considered substantially equivalent it has to have the same intended use as the original and have the same technological characteristics. The Gynecare Morcellex was approved for sale and use under the 501(k) in 2006 and 2010.
In 2014, the FDA issued a warning to the medical community regarding the use of the power morcellator during gynecological surgeries, indicating that the morcellator could spread undetected malignant cancer cells to other areas of the body. It also gave the morcellator a “black box warning” which reads, “The FDA warns that uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer, and decrease long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.”
South Carolina Lawsuit
The lawsuit, filed on February 3rd, 2015 in the United States District Court for the District of South Carolina Greenville Division under case number 6:15-cv-00516-MGL, alleges that the use of the Gynecare Morcellex caused dissemination of undiagnosed leiomyosarcoma which resulted in the death of a South Carolina woman. Her widower has pursued a lawsuit on her behalf.
On October 2nd, 2012, the deceased plaintiff had a total laparoscopic robotic hysterectomy and cystoscopy performed to remove uterine fibroids. The surgeon used a morcellator to remove three uterine fibroids which were then sent to a pathologist. Despite having had pre-surgical screenings for cancer which returned with no significant findings, the pathologist determined that one of the fibroids contained a form of malignant cancer, leiomyosarcoma.
The lawsuit alleges that the “leiomyosarcoma cancer tissue would have remained encapsulated but for the tissue shredding and dissemination of the Gynecare Morecellex. The device, in cutting and shredding the uterine fibroid, ruptured the capsule containing the cancerous tissue and spread the shredded tissue in the abdominal cavity.” In 2013, the plaintiff was found to have cancer cells consistent with leiomyosarcoma in areas around her vaginal cuff, her ureters, and throughout the omentum. After her diagnosis, she pursued aggressive treatment for her leiomyosarcoma but, unfortunately, passed away on September 25th, 2014, after cancer spread to her hepatic lobe.
This lawsuit is one of many filed since the FDA released their warning. For questions regarding this press release or questions regarding the pending litigation, contact Laurence Banville Esq. at 917-633-4808.