Key Takeaways
- The FDA has cautioned surgeons to stop using laparoscopic power morcellators for most women’s uterine surgeries because the devices can spread cancer cells.
- Each year about 50,000 U.S. women have uterine surgery with these devices, which use spinning blades to remove the uterus or its tumors.
- If a patient has undiagnosed cancer, the spinning blades can fling and spread cancer cells throughout the abdominal cavity.
- Non-cancerous fibroids can mask sarcoma, and experts suggest about one in 350 women who have fibroid surgery later discover they have sarcomas.
- The FDA’s November 24 notice didn’t require removing the devices from the market, but several companies, including Johnson & Johnson, voluntarily withdrew theirs.
About 50,000 women annually in the United States undergo uterine surgery via medical devices called “laparoscopic power morcellators.” Now, the Food and Drug Administration warns that the device can spread cancer cells.
Surgeons in the United States have been cautioned by the FDA to stop using laparoscopic power morcellators to perform uterine surgeries on most women. The medical devices, once thought to be a breakthrough in uterine surgical technology, have been linked to the spread of cancer cells.
The power morcellators use spinning blades to remove a woman’s uterus or the tumors inside her uterus. What researchers have found is that some women undergo uterine surgery with undiagnosed cancer. When surgeons use the laparoscopic power morcellator on a patient with cancer, the spinning blades can fling and spread cancer cells throughout the abdominal cavity.
Laparoscopic uterine surgery using the morcellators was a popular choice for women living with fibroid tumors in their uterus. While fibroid tumors are non-cancerous, they can mask the presence of an aggressive type of uterine cancer called sarcoma. Experts suggest that about one out of every 350 women who undergo uterine fibroid surgery discovers later that they have sarcomas.
According to the FDA, “Morcellating a sarcoma may spread cancer and decrease the long-term survival of patients.”
The FDA’s notice released on November 24 does not require the removal of laparoscopic power morcellators from the market, but several companies – Johnson & Johnson being one of them – have voluntarily withdrawn their product.
In addition to its strong caution, the FDA also suggested that power morcellator manufacturers update the warning labels on their product to include the risk of spreading cancer in women with undetected sarcomas.
If you or someone you know has undergone uterine removal or fibroid removal surgery using the laparoscopic power morcellator device which caused the spread of cancer, you may have a claim. We invite you to contact a Portland injury lawyer at Paulson Coletti today to discuss.