One in 350 women who undergo a hysterectomy or myomectomy procedure using a power morcellator will eventually be diagnosed with uterine sarcoma, according to recent studies.

The threat of spreading cancer tissues through morcellation use has spurred the U.S. Food and Drug Administration to issue a “black box” warning on all power morcellators. An FDA black box warning is the strongest precaution the federal agency will issue before removing the product from the market.

The power morcellator is commonly used during laparoscopic surgery in order to remove uterine fibroids. Morcellation use was once considered a medical breakthrough as patients undergoing a hysterectomy experienced a less invasive procedure as well as a shorter recovery time. However, researchers have since discovered that breaking up undiagnosed cancerous tissues may increase the risk of women developing uterine sarcoma.

Medical experts claim that there is no real way to determine if uterine sarcoma exists prior to the laparoscopic procedure, which places women at an increased risk of developing power morcellator cancer.

By 2014, the FDA issued a strong warning encouraging physicians to “carefully consider available alternative treatment options for the removal of symptomatic uterine fibroids,” due to the possible link between the power morcellator and spreading cancer.

However, some suggest the caution came later than it should have, as power morcellators have been used for years on the estimated 50,000 women who undergo a hysterectomy or myomectomy procedure each year.

Morcellation Cancer Warnings

The FDA warned health care providers to consider the risks of using a power morcellator and seek alternatives but they have also encouraged patients to take some action as well.

The FDA has urged patients to find out whether a physician plans to use a power morcellator during a laparoscopic hysterectomy or myomectomy procedure and seek alternative treatment.

After the federal agency determined power morcellators needed a black box warning, some of the largest health insurance companies in the U.S. decided to change the way the medical tool is classified, making it extremely difficult for patients to obtain insurance coverage. Companies including Cigna, Aetna Inc., UnitedHealth Group Inc. and others are choosing not to cover the power morcellator due to the cancer risks associated with the device.

Power Morcellator Lawsuits

Hundreds of morcellation cancer lawsuits have been filed by plaintiffs who allege that power morcellator manufacturers including Johnson & Johnson misrepresented the medical tool as a reasonably safe device to be used during laparoscopic surgery.

In general, plaintiffs who have filed a power morcellator lawsuit claim that manufacturers ignored years of studies that showed a link between the tool and spreading of cancer and failed to make changes to the device. Some plaintiffs further allege that power morcellator manufacturers knew of the risks of cancer but failed to adequately warn patients.

Several lawsuits have been filed by widowers who claim they lost their spouse due to the spread of uterine sarcoma after a procedure that used a power morcellator.