The risk of cancer that comes from using a morcellator to remove uterine fibroids has spawned a regulatory response as well as a wave of private litigation.

Uterine fibroids are growths that develop from the muscular tissue within the uterus. They’re actually fairly common, and usually they don’t cause symptoms.

But in some cases, uterine fibroids can cause pain, pressure, frequent urination and heavy or prolonged menstrual bleeding.

When symptoms become too severe to tolerate, some women require surgical removal of the fibroids – either through a myomectomy, which removes just the fibroids, or through a hysterectomy, which removes the uterus itself.

These procedures can be done laparoscopically, using smaller incisions that allow the patient to enjoy certain benefits like a lower risk of infection and a shorter recovery time after the surgery.

Laparoscopic surgery like this may use a power morcellator to cut up and remove fibroids or the uterus through the smaller surgical incisions.

The problem arises when the patient has uterine cancer or other nearby cancerous tissue that evades detection prior to surgery.

According to the FDA, an estimated 1 in 350 women undergoing surgery for fibroids has an unsuspected uterine cancer. The agency also says there is no reliable way to detect this type of cancer before beginning surgery.

Using a power morcellator during this surgery creates the risk that cancerous tissue, particularly that from uterine cancer, may be cut up and spread elsewhere in the abdomen and pelvis. This effect can aggravate the existing cancer and significantly worsen the patient’s chances of long-term survival.

FDA Warns About Morcellator Cancer

The FDA has addressed the issue by recommending against the use of a power morcellator for myomectomy or hysterectomy in most patients.

In a Safety Communication issued in April 2014 and updated the next November, the agency said that power morcellators should not be used to remove tissue from patients who are peri- or post-menopausal, or who are candidates for “en bloc” tissue removal.

The agency commented that most women undergoing surgery for fibroids fall within those categories.

In the same communication, the agency also announced a new recommended morcellator boxed warning advising doctors and patients about the possible risk of morcellator cancer.

The FDA itself is being investigated by the U.S. Government Accountability Office regarding the issue to find out why the agency allowed morcellators to remain on the market for twenty years before issuing a warning.

In March 2016, the FDA reported it had been notified of the investigation and that it plans to cooperate fully.

Litigation Over Morcellator Cancer

The risk that morcellator use may spread uterine cancer has led to a new wave of dozens of lawsuits against Johnson & Johnson, which manufactures the devices through its Ethicon unit.

Claims in federal court have been consolidated into a single federal court in Kansas City, Kan. Other claims against J&J have still been pending in state courts.

The company had already suspended sales of its morcellators in April 2014. Then it withdrew them from the market entirely the next July.

As of March 2016, J&J had settled about 70 of an estimated 100 morcellator lawsuits filed against the company. The company’s payouts are expected to be worth several millions of dollars. Dollar amounts of the individual settlements have reportedly ranged from $100,000 to around $1 million.