Johnson & Johnson’s Ethicon subsidiary has announced that it will stop selling its power morcellators used for uterine fibroid removal surgery. Medical research has shown that use of the devices during minimally invasive laparoscopic hysterectomy and myomectomy procedures may carry a risk of spreading sarcoma cancer.
Johnson & Johnson Ethicon: No Recall
The company, which manufactured and sold uterine fibroid surgery morcellators since 1998, has stopped sales, promotion and distributing the medical devices after an April 17 FDA warning. The FDA warned doctors to avoid the devices because of the risk of spreading preexisting uterine sarcomas.
Many hospitals have announced that they will no longer be performing laparoscopic hysterectomy or fibroid removal surgery with morcellators, Johnson & Johnson has not announced a recall the devices at this time.
Johnson & Johnson morcellator devices included the Gynecare Morcellex, Morcellex Sigma, and Gynecare X-Tract. The company is the world’s largest morcellator manufacturer, with nearly three quarters market share in 2011.
FDA Warning
The FDA has warned that use of the devices carries an unreasonable risk, since an estimated 1 out of every 350 women who undergo a laparoscopic hysterectomy or myomectomy may have unsuspected uterine sarcoma, and there is no reliable way of discovering the uterine sarcoma cancer prior to the fibroid surgery.
What is a Power Morcellator?
Power morcellators cut tissue into smaller pieces, which allow doctors to remove the uterus or fibroid tumors through a port incision during minimally invasive laparoscopic surgery. Women with undiagnosed uterine sarcomas, the morcellators may spread the aggressive cancer throughout the body, greatly reducing the chances for long-term survival.
Lawsuits Over Fibroid Surgery Morcellators
As women learn that cases of stage 4 leiomyosarcoma or other uterine cancers diagnosed following a hysterectomy or myomectomy may have been caused by the use of morcellators, questions are being raised about why adequate warnings were not provided and whether Johnson & Johnson and other manufacturers failed to make the devices as safe as they could have been.
Along with Johnson & Johnson’s Ethicon unit, the equipment for the process is manufacturers by closely-held companies including Karl Storz GmbH & Co., Richard Wolf Medical Instruments Corp., LiNA Medical and Blue Endo.
According to the Wall Street Journal, J&J purchased FemRx and its “Diva” morcellator in 1998. By 2011, they owned a owned a 72% share of the power morcellator market.
Ethicon is facing at least one lawsuit filed by a woman who died of metastatic leiomyosarcoma at the age of 53, one year after undergoing a hysterectomy with a power morcellator.
