Hysterectomy Morcellator Lawsuits Begin to Mount Over Spread of Cancer
As more women and families learn about the potential link between the spread of uterine cancer and hyesterectomy morcellation, a growing number of product liability lawsuits are being filed against the manufacturers of power morcellators, claiming that consumers and the medical community should have been warned about the risks associated with use of the medical devices during minimally invasive, laparoscopic hysterectomies.
Over the last week of 2014, at least three new complaints were filed in the federal court system, joining about a dozen other hysterectomy morcellator lawsuits filed on behalf of women diagnosed with the spread of leiomyosarcoma, endometrial stromal sarcoma or other cancer following uterine fibroid surgery.
Power morcellators are medical devices that have been increasingly used in recent years during laparoscopic hysterectomy and myomectomy procedures, allowing the surgeon to cut up the uterus or uterine fibroids and remove the tissue through a small incision in the abdomen. The tool facilitates a minimally invasive surgery, which reduces recovery time, minimizes scarring and helps avoid many of the risks associated with traditional surgery.
Although morcellators were rapidly adopted throughout the medical community, concerns have emerged over the past year about the risk that the devices may spread undiagnosed cancer contained within the uterus.
Estimates now suggest that about one out of every 350 women undergoing a laparoscopic hysterectomy with morcellation may have unsuspected sarcoma, which doctors are unable to detect before the surgery.
Since power morcellators may spread this cancerous tissue throughout the abdomen, rapidly upstaging the cancer and reducing the risk of long-term survival, the medical community has largely abandoned the use of power morcellators over the past year.
All of the lawsuits filed against manufacturers of these devices outline similar factual patterns and raise nearly identical allegations, claiming that hysterectomy morcellators are unreasonably dangerous and that information about the risk of uterine cancer being spread was withheld from the medical community.
New Power Morcellator Cancer Lawsuits Filed
Among the lawsuits filed late last month is a complaint (PDF) brought by Romona Yvette Gourdine and her husband, Randolph, which was filed in the U.S. District Court for the District of South Carolina on December 23. The case names morcellator manufacturer Karl Storz as a defendant, claiming that the company failed to warn that the Storz Rotocut GI Morcellator was unsafe for it’s intended purpose.
Gourdine indicates that she underwent a laparoscopic supra-cervical hysterectomy involving the Rotocut morcellator on December 28, 2011, to remove a fibroid and her uterus. It was only after the procedure that she discovered that the fibroid was actually leiomyosarcoma, a deadly and aggressive form of uterine cancer that is much more difficult to treat once it is spread outside the uterus.
“The use of the Storz Morcellator in cutting, shredding, and removing the uterus and fibroid(s) from Ms. Gourdine created the potential for dissemination of cancerous cells throughout her abdominal cavity,” the complaint claims. “This potential dissemination worsened her long-term prognosis for the course of this cancer.”
Another complaint (PDF) filed the same day by Jennifer Sanders and her husband, Randall, raises nearly identical allegations. That morcellator lawsuit was filed in the U.S. District Court for the Eastern District of Pennsylvania against Johnson & Johnson and it’s Ethicon subsidiary.
Sanders underwent a hysterectomy with morcellation to remove uterine fibroids, her left fallopian tube and ovary on December 24, 2012, during which surgeons used an Ethicon Gynecare Tissue Morcellator, which has since been removed from the market after the manufacturer determined that there is no way to make the devices safe.
Following the procedure, Sanders discovered that her fibroid contained carcinoma cancer, which was spread during the morcellator surgery to advanced stage metastatic serous carcinoma, forcing her to undergo severe chemotherapy treatments.
The third complaint (PDF) filed in the U.S. District Court for the Middle District of Tennsessee on December 24, by Timothy Schroeder, whose wife, Cynthia, died on December 31, 2013.
According to allegations raised in the morcellator wrongful death lawsuit, Schroeder’s wife underwent laparoscopic supra-cervical hysterectomy morcellator surgery on January 4, 2008, during which an Ethicon Gynecare Morcellex was used to remove her uterus, fibroids and ovaries.
Following the surgery, Cynthia Schroeder was diagnosed with the spread of leiomyosarcoma cancer throughout her body, which was diagnosed in December 2010. Despite three years of aggressive treatment, she died of the metastatic cancer.
Hysterectomy Morcellation Concerns
Concerns about the risk of hysterectomy morcellators spreading cancer began to gain widespread attention within the medical community in April 2014, when the FDA announced that it was investigating the risk and warned doctors to avoid uterine fibroid morcellation due to the risk of unsuspected sarcoma.
An FDA advisory panel was convened over the summer to evaluate the available data on the controversial devices, which resulted in a determination that there is no way to make power morcellators safer. However, the panel was split on whether to recommend morcellators be recalled or that stronger warnings be placed on the devices.
In a widely criticized move, the FDA announced in November that it will allow hysterectomy morcellators to remain on the market with substantially stronger warnings about the risk of cancer and more limited indications for appropriate use of the devices.
Many hospitals have already announced that they will no longer perform a hysterectomy with morcellation, and many experts agree that the vast number of prior procedures performed involving the device are no longer appropriate.
Plaintiffs in the rapidly growing hysterectomy morcellator litigation allege that the rapid spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers may have been avoided if any number of different alternative treatment options available for women with symptomatic uterine fibroids had been used, including traditional surgical hysterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy and laparoscopic hysterectomy or myomectomy without use of morcellation.
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