Woman Dies From Leiomyosarcoma Following Morcellation Procedure
November 17, 2014—Recently, a 44-year-old New York woman who had undergone morcellation died as a result of cancer that spread allegedly due to the power morcellation technique. Her death occurred as more and more medical experts were speaking out against morcellators, claiming the device does more harm than good.
Brenda Leuzzi developed an aggressive leiomyosarcoma cancer following a hysterectomy that included morcellation. Leuzzi and her husband, George, filed a lawsuit May 1, 2014, against Johnson & Johnson’s Ethicon Gynecare Morcellex regarding the power morcellator. The lawsuit is expected to be amended to include a wrongful death charge.
Prior to Leuzzi’s September 2012 procedure, she had not been diagnosed with cancer. Experts familiar with the problems regarding power morcellators believe it is possible that the cancer was present at the time of the procedure but spread rapidly in response to the use of the power morcellator.
Morcellation for uterine fibroids is considered noninvasive, but many are questioning the risk associated with the procedure. Leuzzi lived just 2 years after her surgery.
Dangers of Power Morcellators
Power morcellators have been utilized in thousands of laparoscopic hysterectomies and myomectomies in recent years. The device uses spinning blades to dice up the tissue and make it easily removable through a small port during surgery. It should be noted that nobody is alleging morcellation causes cancer, but because there is no way to definitely know before surgery whether a fibroid cancerous, the cutting can create the spread of cells, causing an immediate upstaging of a previously undetected cancer.
Manufacturers of morcellators promoted the procedure as a superior surgical method that reduces the risks and complications associated with traditional hysterectomies. Morcellation is also supposed to reduce recovery time.
Leuzzi was diagnosed with leiomyosarcoma shortly after her hysterectomy. Leiomyosarcoma is an aggressive form of uterine cancer that can remain dormant when contained in the uterus. However, the survival rate is very low if it spreads. Many, including Leuzzi’s husband, believe she would be alive today if she had understood the risks associated with morcellation—something they believe was not possible because Ethicon failed to disclose the information it had regarding its machine.
Though there are still supporters of the device, most medical experts now agree that morcellators pose an unreasonable danger. Efforts are underway to stop their use in hysterectomy procedures because it is difficult to know for sure if an unsuspected sarcoma is present.
Several alternative treatment options are available for women suffering from uterine fibroids, including traditional hysterectomies performed vaginally or abdominally. Women can also discuss with their doctors the benefits of catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy, and laparoscopic hysterectomy or myomectomy without morcellation.
Lawsuits Against Manufacturers of Morcellators
The FDA issued a warning on morcellators in April 2014, just a few weeks prior to the filing of Leuzzi’s lawsuit. It is estimated that about one in every 350 women undergoing uterine fibroid surgery have undiagnosed cancer. As of July 2014, the FDA had not officially recalled the devices but continued to urge doctors to avoid their use because it is difficult to determine whether a woman is cancer-free prior to the procedure.
Two months after Leuzzi filed her suit against the company, Ethicon issued its own recall and stopped making the devices. Ethicon was responsible for more than 70% of the morcellator market in the United States.
Leuzzi’s suit was one of a growing number of suits against morcellator manufacturers. All involve similar allegations—that the manufacturers failed to warn doctors and patients despite awareness of the risks involved with the use of the device. Affected women and their families claim they would not have agreed to the procedure had they understood the risks.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.