The connection between power morcellator use and uterine cancer continues, as the family of a Missouri woman adds another lawsuit to the ever-growing pile filed against Ethicon, a Johnson & Johnson subsidiary.

The morcellation wrongful death lawsuit, filed Dec. 3, 2014, alleges that the use of Ethicon’s Gynecare power morcellator in a robotic hysterectomy in December 2012 caused the spread of leiomyosarcoma in Carol C.M., ultimately causing her death.

The problem in many of these cases is that there is no real way for doctors to know if there are sarcoma cells in the fibroids set for removal. In robot-assisted hysterectomies and uterine fibroid removal, power morcellators are often used in laparoscopic procedures. The use enables a small incision and quicker recovery time; however, if there is undiagnosed uterine cancer, the morcellator, as it grinds up the uterus or uterine fibroids, can cause the cancer to be spread throughout the peritoneal cavity. This can take the cancer from an early stage to a deadly one.

Carol C.M. “underwent aggressive treatment and therapy following her cancer diagnosis until she succumbed to the disease and died as a result of malignant leimyosarcoma on Aug. 22, 2014,” the morcellator cancer lawsuit states.

Merrill’s life partner, Terry S., filed the lawsuit against Ethicon, saying that Ethicon knew or should have known about the uterine cancer risks associated with their power morcellators, and that Ethicon “owed a duty to warn of the hazards and dangers associated with the use of its products for patients such as Decedent herein, so as to avoid harm.”

Terry and Merrill’s sister, Doris S., as joint plaintiffs, are suing Ethicon for negligence, products liability, breach of express and implied warranty, fraudulent misrepresentation and omission, and negligent misrepresentation.

The power morcellator cancer lawsuit is Terry S. and Doris S. v. Ethicon Inc., et al., filed in the U.S. District Court of Missouri, Western District.

What is Morcellation?

Used for a number of different gynecological surgical procedures, power morcellation cuts the tissue into small pieces that can be easily removed through a small incision. Since its approval in 1993, laparoscopic morcellation has been used to perform hysterectomies (removal of the uterus), myomectomies (removal of fibroids), oophorectomy (removal of the ovaries) and salpingectomy (removal of fallopian tubes).

A concern has arisen that morcellation can cause cancerous tissue to spread in women, specifically leiomyosarcoma or other uterine cancers that may be hidden in the uterus that doctors can’t detect. Current FDA estimates are that that about 1 in 350 women undergoing laparoscopic uterine fibroid removal may have unsuspected sarcoma cells in the fibroids.

Morcellator Danger

In April 2014, with no sure way for doctors to detect uterine cancer pre-procedure, the FDA urged doctors to avoid using the devices for laparoscopic hysterectomy or myomectomy procedures.

Based on a variety of reasons, none more compelling than concerns about the risk of uterine fibroid morcellators spreading cancer, Ethicon announced this past summer that they were quitting the morcellation business. This was on the tail of a huge power morcellator recall.

The FDA and a growing number of U.S. Senators hope all other morcellator manufacturers with products still on the market follow suit and remove their products as well. As of November 24, for those uterine morcellators that remain available, the FDA added a black box warning, which is the strongest warning that can be place on a medical device.

The black box warning is welcome, as it is the lack of warnings of power morcellator risks that is behind many of the morcellation lawsuits in court today. Many victims say there were insufficient or no warnings about the risk of spreading uterine cancers like leiomyosarcoma and endometrial stromal during uterine fibroid removal or laparoscopic hysterectomy, and had they and the medical community had been informed about the dangers, they could have chosen one of the many other treatment options available.