The controversy over morcellation of fibroid tissue has led to the establishment of a multidistrict litigation in a federal court in Kansas.

A power morcellator is a surgical tool used to cut tissue inside the body into smaller pieces. Use of a power morcellator allows surgeons to remove large masses of tissue through the smaller incisions used in laparoscopic surgery.

Since morcellators became available in the mid-1990s and for several years after that, morcellation found widespread application in gynecological procedures like hysterectomy (removal of the uterus) and myomectomy (removal of particular sections of uterine tissue).

Both those procedures can be used to remove uterine fibroids.

That in turn allows women undergoing fibroid surgery to take advantage of the practical benefits of laparoscopic surgery over traditional open abdominal techniques.

Laparoscopic surgery tends to involve less bleeding, less risk of infection, and shorter recovery time.

But there’s a problem with power morcellation in gynecological surgery that has recently stirred enormous controversy: it creates a risk of spreading pre-existing cancerous tissue that goes undetected prior to surgery.

Some women – about 1 in 350 by the FDA’s estimate – who undergo morcellation of fibroid tissue already have a type of cancer called a uterine sarcoma that goes undetected before the surgery.

Cancers like these can escape pre-surgical detection because there is no reliable way to test for them. They are sometimes confirmed afterwards upon examination of the tissue removed during surgery.

Power morcellators may inadvertently cut up this tissue and spread it throughout the abdomen. Once it has spread, it can take root in its new location and begin to thrive, quickly upstaging the patient’s cancer and threatening their odds of survival.

FDA Advises Against Morcellation of Fibroid Tissue

The FDA addressed this risk in communications issued in April and November 2014. The agency now recommends that doctors and patients avoid morcellation of fibroid tissue in most women who would otherwise be candidates for laparoscopic fibroid surgery.

Manufacturers are now required to include a warning on the product information for their power morcellators, alerting doctors and patients to the risk of spreading cancer. The agency stopped short of taking the devices off the market, however.

But even though the agency did not issue a mandatory recall, Johnson & Johnson soon suspended sales of power morcellators made by Ethicon, J&J’s surgical equipment manufacturing unit.

The company followed up the next summer with a voluntary recall of three different Ethicon morcellators. J&J had previously been a leader in power morcellator sales.

Morcellator Litigation Centralized in Kansas

Some women who developed advanced cancer after morcellation of fibroid tissue have taken to the court system to seek compensation for the damage.

In October 2015, a few dozen of the first federal morcellator lawsuits were transferred to the U.S. District Court for the District of Kansas to be overseen by a single judge as a multidistrict litigation, or MDL. Future morcellator cancer lawsuits filed in the federal court system will also be transferred to Kansas and consolidated into the MDL.

Generally, plaintiffs in these morcellator lawsuits allege the devices are inherently defective and dangerous and that their manufacturers failed to issue a proper warning about the risk of cancer. Plaintiffs say they never would have elected to have morcellation surgery if they had been fully informed of the risks.