July 8, 2014 — An advisory panel to the U.S. Food and Drug Administration (FDA) will meet on Thursday and Friday this week to discuss ways to mitigate the cancer risks of laparoscopic power morcellators.
The FDA published an Executive Summary (PDF) of the meeting materials earlier this week.
Goals of the panel include:
- Discuss the benefits and risks of morcellators in the use of uterine fibroids
- Consider whether tools like surgical bags can improve safety
- Decide whether specific labeling related to the risk of cancer should be required for the devices.
Since December 2013, the FDA has received 17 adverse event reports involving uterine cancer. The earliest report was submitted in 2006. The most common type of cancer was leiomyosarcoma (LMS), a life-threatening and aggressive type of cancer. About 43% of the victims were women under the age of 50.
The FDA has already recommended against the use of morcellators for the treatment of uterine fibroids, which are painful growths on the uterus that can cause bleeding. About 1 in 350 women who has a hysterectomy to treat fibroids actually has undiagnosed uterine cancer. When morcellators grind up the fibroid, they can leave behind malignant cells that spread cancer throughout a woman’s abdomen.
The panel will consider adding a “Black Box” warning label about the risk of cancer. They may also re-classify the devices as “high-risk,” which would make it harder for manufacturers to bring new devices to market without conducting rigorous safety studies.
Do I have a Morcellator Lawsuit?
The Schmidt Firm, PLLC is currently accepting laparoscopic power morcellator induced injury cases in all 50 states. If you or somebody you know has been injured by uterine cancer after a hysterectomy, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.