Power morcellators are medical devices used for a number of different gynecological surgical procedures.

Among the procedures are myomectomy (removal of fibroids), hysterectomy (removal of the uterus), oophorectomy (removal of the ovaries) and salpingectomy (removal of fallopian tubes). Since its approval in 1993, the use of laparoscopic morcellation (cutting the tissue into small pieces that can be easily removed via a port incision) to treat uterine fibroids and perform hysterectomies has become increasingly common.

Providing a minimally invasive surgery that reduces infection risk, lessens scarring and speeds up recovery time, the procedures have become increasingly popular over the past 10 years. However, a concern has arisen that laparoscopic power morcellation used in hysterectomies or myomectomies may cause cancer to spread in women. The concern, specifically, is for leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers that may be hidden within the uterus.

Due to that risk, Highmark Inc., a Pennsylvania health insurance company, announced that it will stop covering costs of uterine fibroid removal procedures or laparoscopic hysterectomies that involve the use of a power morcellator. The announcement was made just days after Ethicon, Johnson & Johnson’s power morcellator unit, declared a recall of the medical device “until and unless new technology can make the procedure safer.”

Highmark’s policy statement was made together with the University of Pittsburgh Medical Center, a major hospital network in western Pennsylvania. The medical center declared it was stopping all use of power morcellation for these procedures.

Highmark also owns West Penn Allegheny Health System. Expectations are that by the end of September, power morcellation-aided procedures will cease to be performed throughout most of Pennsylvania as they will also no longer perform the procedure.

Power Morcellators and the Cancer Link

It’s estimated that close to 50,000 women annually have morcellator-assisted laparoscopic hysterectomies. According to the U.S. Food  and Drug Administration (FDA), around one in 350 women undergoing laparoscopic surgery for uterine fibroids may have a uterine sarcoma (cancer in their uterus). If a woman has an unsuspected sarcoma that her doctor is unable to detect prior to surgery, the concern is that use of laparoscopic morcellation can cause that cancer to spread aggressively throughout the body. This can significantly reduce the chances for survival in the long-term.

The FDA took notice of the number of mounting cases and adverse event reports connecting the use of power morcellation in laparoscopic hysterectomies to cancer and issued a warning in April urging doctors to avoid using the medical device. They also called an advisory committee meeting to review the data.

The committee members agreed there was no known way to make morcellation safe in uterine fibroid removal procedures. However, authorities called in to consult were unable to reach agreement on whether power morcellators should be banned. Proponents of the minimal invasion the medical device provides argue in favor of it still being available with significantly stronger warnings about the possible risks.

Lack of Warnings

It is the lack of warnings to the risks that is behind many of the power morcellation lawsuits. Many victims say there were insufficient, or no, warnings about the risk of morcellation spreading uterine cancers like leiomyosarcoma and endometrial stromal during a laparoscopic hysterectomy or fibroid removal. Women, and families on their behalf, state that they could have avoided the spread of cancer if the medical community had been informed about the dangers, as other treatment options are available. There are also questions being raised as to whether the manufacturers made the devices as safe as they could have been.