A New York woman has sued Ethicon Endo Surgery Inc., accusing them of failing to adequately warn doctors and patients that its laparoscopic uterine morcellation devices may spread occult cancer during fibroid removal.
Affecting about 20 percent of women, fibroids are not of major concern. They are typically non-cancerous tumors that grow in the uterus. If they cause no symptoms, they are usually left alone. Medications sometimes can shrink them or ease discomfort. When drugs do not work, surgery may be necessary to remove them. Although there are many different surgical options, one of the most popular is called “open power morcellation,” in which the surgeon can remove the fibroid (or even the entire uterus) through a small incision, using a laparoscope. Some reports have indicated that in some cases, this procedure could lead to serious cancers or even premature death.
The May 1st complaint, filed in the Western District of New York, says Ethicon failed to properly design the devices in order to prevent the potential spread of malignancy.
According to the complaint, Brenda Leuzzi had a robot-assisted hysterectomy surgery with uterine morcellation in September 2012 at The Strong Memorial Hospital of the University of Rochester Medical Center. Her physician used Ethicon’s laparoscopic power morcellator, which divides tissue into smaller pieces or fragments.
The lawsuit contends that prior to the surgery, there was no evidence of disseminated and/or metastatic cancer; but following the procedure, Leuzzi was informed that she had cancer. Since then, she has been undergoing aggressive treatment and therapy, the complaint states.
“Each and every defendant failed to warn about the possibility of dissemination of an occult uterine leiomyosarcoma throughout the peritoneal cavity,” Leuzzi contends. “Defendants were each aware of the risks, complications, and/or adverse events associated with their products used for uterine morcellation.”
In an April 17th warning, the U.S. Food and Drug Administration (FDA) said that when used for hysterectomy or myomectomy for women with uterine fibroids, laparoscopic power morcellators could sometimes disperse occult cancerous tissues beyond the uterus. The agency is discouraging the use of these devices for hysterectomies and myomectomies. As a result of the FDA warning, Ethicon suspended worldwide sales of its laparoscopic power morcellators, which include the Gynecare Morcellex Tissue Morcellator, the Morcellex Sigma Tissue Morcellator System, and the Gynecare X-Tract Tissue Morcellator.
The scientific journal JAMA recently published an article expressing concern about the procedure. The problem is that though most fibroids are non-cancerous, a few are malignant. Cutting up malignant tissues into small pieces increases the risk that some of those pieces will migrate to other areas of the body, where they will seed new cancers.
This is just what happened to Dr. Amy J. Reed, who developed a rare, aggressive uterine cancer after going through morcellation. She has started a campaign to stop the use of the procedure, “A review of the literature reveals that 1 in 415 women who go for fibroid surgery actually has sarcoma (cancer),” she writes. “This means that every day 2-5 women in the U.S. – and more around the world will have a deadly cancer spread because of morcellation.”
The JAMA notes that the process “may disperse fragments of undetected malignant tumors throughout the abdominal cavity and upstage otherwise contained cancers.” They go on to state that since it is difficult to detect the presence of these cancerous tumors before the surgery, the procedure may, in fact, “be too risky under any circumstance.”
Leuzzie says that Ethicon should have designed its morcellator to deploy an intra-peritoneal bag in order to prevent the potential spread of cancer. Additionally, the company misrepresented that its morcellation products were safe and concealed information regarding the significant risks of serious injury and/or death associated with their devices.
The lawsuit lists claims of negligence, strict products liability, breach of express and implied warranties and fraudulent misrepresentation and omission. Leuzzi’s husband, George asserted a claim of loss of services.
If you or a loved one underwent laparoscopic morcellation surgery and were diagnosed with a new cancer, you may be entitled to compensation for your pain and suffering. For more information, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).