Power morcellators are electronic devices that are used to remove tissue during hysterectomies and other gynecological surgeries. These devices have been tied to the spread of a rare, but aggressive, uterine cancer called leiomyosarcoma.
Leiomyosarcoma is a cancer of smooth muscle cells that can occur in the uterus, stomach and intestines, walls of all blood vessels, and skin. Leiomyosarcoma can also develop in uterine fibroids. While this cancer is very rare, there is no reliable test to diagnose potential malignancy in fibroids before a woman undergoes morcellation. If the cancer is present during morcellation, the leiomyosarcoma cells can be spread throughout the body, quickly changing a Stage 1 cancer into Stage 4.
It is estimated that a power morcellation hysterectomy makes up 80,000 of the 600,000 hysterectomies performed annually in the U.S., most for the treatment of fibroids which are usually benign. The power morcellator is used during laparoscopic surgeries to grind down the fibroids, so that smaller pieces of tissue can be removed through small incisions. On rare occasions, cancer cells from undiagnosed leiomyosarcoma can hide within these fibroids.
The FDA conducted a quantitative analysis of available data and estimated that about 1 in 350 women who undergo a hysterectomy or myomectomy for fibroids are later found to have unsuspected uterine sarcoma. The FDA has stated that if power morcellation is performed in these women, the procedure could “significantly worsen the patient’s likelihood of long-term survival.”
In April 2014, the United States Food and Drug Administration (FDA) issued a safety communication warning against using power morcellators in surgeries to remove the uterus or fibroids for the vast majority of women undergoing these procedures.
By November 2014, the FDA took their warnings a step further by recommending that manufacturers include a black box warning about the risk for morcellators to spread cancer. A black box warning is the strongest warning a medical device or drug can receive before it is recalled from the market.
Although safer alternatives for uterine fibroid treatment are available, manufacturers of morcellators withheld important information from the medical community, which may have caused thousands of women to suffer advanced cancer, greatly reducing the their length of life and overall quality of health.
If you or a loved one underwent a surgical procedure using a power morcellator and suffered cancer, you may be entitled to pursue a claim against the manufacturers for damages. For a free and confidential case evaluation, please call our office toll-free at (888) 747-5342 or complete our online contact form and we will promptly respond to your inquiry.