June 9 — The Obstetrics and Gynecology Devices panel will meet next month to discuss the safety of laparoscopic power morcellators, devices that were recently linked to an increased risk of spreading cancer.
The U.S. Food and Drug Administration (FDA) will review the findings of the panel as part of an ongoing safety review that began in April, when the FDA published a Safety Communication. Within weeks, Johnson & Johnson stopped selling the devices.
According to the advisory committee calendar, the meeting is set for July 10-11 and the agenda includes:
“The committee will discuss the safety of laparoscopic power morcellator devices as it pertains to their potential to disseminate and upstage a confined, but undetected (occult) uterine malignancy during laparoscopic hysterectomy or myomectomy.”
Conclusions of the panel could lead the FDA to re-classify morcellators as Class II or Class III (high-risk) medical devices. The FDA might also change requirements for the appropriate use, premarket testing, labeling, and other risk-management techniques.
The FDA will also consider risk-mitigation techniques like using surgical bags. Currently, some hospitals allow power morcellation so long as bags are used; other hospitals have banned the procedure altogether. The problem with surgical bags is that the ones used in morcellation were never designed for this purpose, they are difficult to use, and only one is FDA-approved for uterine fibroid surgery.
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, 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.
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