Morcellation Risks Highlighted by Woman’s Death from Leiomyosarcoma
A New York woman has died following the spread of aggressive leiomyosarcoma cancer throughout her body during a robotic hysterectomy, highlighting the rapid effects that may be caused by power morcellators used in recent years for uterine fibroid removal.
Brenda Leuzzi and her husband, George, filed a lawsuit earlier this year on May 1, alleging that an Ethicon Gynecare Morcellex power morcellator caused leiomyoscaroma to be spread throughout her peritoneal cavity, rapidly upstaging the cancer.
The complaint (PDF) indicated that Leuzzi she had no cancer diagnosis before she underwent the robotic hysterectomy for uterine fibroid removal in September 2012.
According to a “Suggestion of Death” (PDF) filed this week by the family’s lawyers, the 44 year old Leuzzi died on October 24, surviving just two years after undergoing the minimally invasive uterine fibroid surgery.
Power morcellators have been used during thousands of laparoscopic hysterectomies and myomectomies in recent years, allowing surgeons to cut up the tissue through a small incision in the abdomen. The minimally invasive procedures were promoted as a superior surgical method, reducing the risk of complications associated with a traditional hysterectomy and shortening recovery time.
In recent years, concerns have emerged about the risk that power morcellators may spread leiomyosarcoma or other cancerous tissue that some women may have contained within their uterus before the surgery. Most medical experts now agree that the devices pose an unreasonable danger and indicate that they should no longer be used, since there is no way to determine which women may have unsuspected sarcoma.
Following Leuzzi’s hysterectomy, she was diagnosed with leiomyosarcoma, which is an aggressive form of uterine cancer that has a low survival rate once it is spread. However, the cancer may remain dormant for long periods of time if it is contained within the uterus, resulting in a much higher survival rate if the tumor is surgically removed before it spreads.
Leuzzi’s death highlights the devastating consequences that can result from the use of power morcellators, as she may still be alive today if Ethicon had provided warnings about the cancer risk with uterine fibroid morcellation.
Power Morcellator Cancer Risks
Leuzzi’s lawsuit was filed only a few weeks after the FDA issued a warning in April 2014, indicating that power morcellators should not be used to remove uterine fibroids, due to the risk of doctors unintentionally spreading cancer that may be contained within the uterus.
The FDA estimated that about 1 out of every 350 women who undergo uterine fibroid surgery have unsuspected sarcoma, and there is no reliable way for doctors to identify these women and diagnose the cancer prior to use of a morcellator. Therefore, the regulatory agency urged doctors to avoid use of the devices and has been reviewing whether the devices should be recalled from the market or whether stronger warnings should be placed on power morcellators.
Just a couple months after Leuzzi filed her lawsuit, an Ethicon morcellator recall was issued by the manufacturer, after the company decided to stop making the devices since there does not appear to be a way to make them safer. While Johnson & Johnson’s Ethicon subsidiary controlled more than 70% of the U.S. market for power morcellators, other manufacturers have not followed suit.
In July 2014, an FDA advisory panel met to review the link between power morcellators and cancer, concluding that there is no way to reduce the risk of the devices spreading leiomyosarcoma or other forms of uterine cancer. However, the panel split on whether to recommend that the FDA recall all power morcellators or just require stronger warnings by the manufacturers.
Morcellator Cancer Lawsuits
Leuzzi’s complaint was one of a growing number of hysterectomy morcellation cancer lawsuits filed in recent months, which all involve similar allegations that the manufacturers of these controversial devices knew or should have known about the risks, yet continued to aggressively promote the minimally invasive procedures, potentially sacrificing the small percentage of women with unsuspected sarcoma.
Plaintiffs claim that they never would have agreed to undergo a laparoscopic hysterectomy instead of an traditional treatments for uterine fibroid removal if they knew the procedure may carry a risk of quickly spreading aggressive cancer that may lead to their death.
A number of alternative treatment options are available for women with symptomatic uterine fibroids, 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.
Following her death last week, Leuzzi’s husband will likely file an amended complaint against Ethicon, converting the claim to a wrongful death lawsuit.
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