The American Congress of Obstetricians and Gynecologists recommends that each woman who is considering a minimally invasive hysterectomy or myomectomy that involves power morcellation discuss alternative treatment options as well as risks and benefits with their physician.
According to the U.S. Food and Drug Administration, about one of every 350 women undergoing a laparoscopic hysterectomy with power morcellation may have undetected cancer that is spread throughout the pelvis and abdomen during the morcellation process.
What are Morcellators?
Morcellators are medical devices that are used during laparoscopic hysterectomy and myomectomy procedures. They basically allow surgeons to grind up the uterus or uterine fibroids into small pieces so that the tissue may be removed through a small abdominal incision.
But because there is no definitive way to diagnose uterine cancer before using morcellator devices, when the tissue is ground up, the undetected cancer cells can be spread, leading to rapid upstaging of the disease. As this risk has become more apparent, more and more doctors have become wary of using power morcellators.
Morcellators and the FDA
In the past year, the FDA has made various announcements and issued warnings regarding the use of power morcellators, including:
- In April 2014, the FDA began urging doctors to avoid morcellators for laparoscopic hysterectomies or myomectomy
- On November 24, 2014, the FDA announced that it is adding a black box warning, the strongest warning that can be placed on a medical device, to uterine morcellator devices still on the market.
- Also in November 2014, the FDA announced that power morcellators should not be used on women who are near menopause, who are post-menopausal, or who could have tissue removed through the vagina or via a small incision.
A growing number of morcellator lawsuits are being filed filed across the nation, mainly by women who were diagnosed with the spread of leiomyosarcoma, endometrial stromal sarcoma, and other types of cancer following uterine fibroid surgery involving morcellation. Many women allege that they were never warned about the risks of power morcellation.