J&J Settling Lawsuits over Cancer Linked to HysterectomyJun 21, 2016
Power morcellators, devices that are used in gynecologic procedures, have been at the center of litigation after they were shown to spread hidden cancerous tissue. Johnson & Johnson is reportedly settling up to 90 percent of its morcellator lawsuits. J&J's Ethicon unit pulled the device from the market in 2014, after the link between morcellators and cancer became public.
In October 2015, a multidistrict litigation (MDL) was created to consolidate J&J morcellator lawsuits. The MDL is centralized before U.S. District Judge Kathryn H. Vratil in the District of Kansas.
Morcellators cut up tissue so it can be more easily removed through small incisions during laparoscopic procedures. They are used in hysterectomy and myomectomy to treat uterine fibroids. In 2014, the FDA warned against the use of morcellators in most women undergoing these procedures. The problem is that sometimes, what appears to be a fibroid is actually cancer. In its 2014 safety alert, the FDA estimated that 1 in 350 women undergoing hysterectomy or myomectomy for fibroid treatment may have an unsuspected uterine sarcoma, a form of uterine cancer that includes leiomyosarcoma. The agency pointed out that this cancer is not detected prior to surgery, stating "At this time, there is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma."
"Because of this risk and the availability of alternative surgical options for most women, the FDA is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids." the FDA stated.