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The findings of a new study indicate that fewer women underwent laparoscopic hysterectomies utilizing power morcellation after federal regulators warned that the practice may result in the spread of aggressive uterine cancers that doctors are unable to diagnose before the procedure.
Power morcellators are medical devices that have been widely used during hysterectomy and myomectomy procedures in recent years, allowing surgeons to cut up and remove uterine fibroids or the entire uterus through a minimally invasive incision in the abdomen. However, concerns have emerged over the past 18 months due to the risk many women undergoing the procedure have unsuspected sarcoma.
In a study published this week in the American Journal of Obstetrics and Gynecology, researchers with the Division of Women’s Health in University of Michigan’s Department of Obstetrics and Gynecology looked at the rate of procedures involving power morcellation before and after an April 2014 warning by the FDA, which urged doctors not to use power morcellators to remove symptomatic uterine fibroids.
Estimates suggest that about one out of every 350 women who undergo a laparoscopic hysterectomy or myomectomy for uterine fibroids may have unsuspected sarcoma, where undiagnosed cancer cells are hidden within the uterus. For these women, morcellators may spread the cancerous tissue throughout the body, rapidly disseminate the cancer to an aggressive and often fatal stage.
On April 17, 2014, the FDA issued a safety communication, indicating that laparoscopic power morcellation may spread cancerous tissue within the abdomen and pelvis, rapidly disseminating the cancer and decreasing a woman’s likelihood for long-term survival.
This latest study looked at the rate of such operations before and after the FDA warning. Researchers collected data on patients undergoing hysterectomy for benign indications in the Michigan Surgical Quality Collaborative, from January 1, through December 31, 2014. They found a 4.1% drop in the rate of surgeries involving power morcellation in the eight months after the FDA power morcellation cancer warning.
Researchers also found a slight uptick in the rate of major complications, from 2.2% to 2.8%, but determined that the “rate of all major surgical complications or hospital reoperations did not change significantly after the date of the FDA communication.”
In the summer of 2014, 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.
Power Morcellator Lawsuits
A number of families throughout the United States are now pursuing power morcellator lawsuits against manufacturers of the devices after women were diagnosed with the rapid spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers following use of the medical device.
The complaints allege that power morcellators are unreasonably dangerous and that the manufacturers should have provided warnings about the potential risks associated with the device, so that women and the medical community could have decided whether the benefits provided by the minimally invasive laparoscopic procedure justify the potential risk.
While the FDA has allowed laparoscopic morcellators to remain on the market, much stronger warnings are now provided about the potential cancer risks and many hospitals have announced that they will no longer perform hysterectomy or myomectomy procedures with morcellation, indicating that there is no way to justify the risk.