A Michigan woman who was diagnosed with stage-4 bone and breast cancer has filed a lawsuit against Karl Storz Inc., the manufacturer of a power morcellator that allegedly spread cancer during her hysterectomy.

The power morcellator lawsuit was filed by Denise W. in the U.S. District Court for the Eastern District of Michigan on Jan. 26. The lawsuit alleges that the power morcellator manufacturing company failed to provide adequate warnings to patients and doctors about the risk of cancer being spread during hysterectomy procedures using the Storz Rotocut G1 morcellator.

A Storz Rotocut G1 power morcellator was used in Denise’s surgery in June 2011, when she had a hysterectomy to treat uterine fibroids. The morcellator was used to slice up tissues in her uterus, making them easier to remove through small incisions in her abdomen.

In July 2014, while she was hospitalized for spinal surgery, doctors found late-stage cancer had metastasized in her body. The power morcellator lawsuit blames the spread of cancer on the morcellator.

Last year, the U.S. Food and Drug Administration (FDA) added a “Black Box” warning that morcellators can spread undiagnosed cancer, greatly worsening a patient’s prognosis. According to the morcellation lawsuit, Denise must now endure extensive medical treatments, including radiation therapy.

“As a result of the use of the Rotocut G1 power morcellator, Plaintiff developed Stage 4 bone and breast cancer, and has had to undergo extensive and intensive therapies for the treatment and management of her advanced-stage cancer,” the power morcellator lawsuit states. “This treatment includes daily hormone medications, regular injections of medications by her physicians and multiple ten-week rounds of radiation therapy.”

Power morcellators are medical devices used during laparoscopic hysterectomy and uterine surgery in order to reduce recovery time and limit the risk of surgical complications. However, serious concerns have emerged recently about the risk of power morcellation causing the spread of undiagnosed cancer cells contained within the uterus.

FDA Warns Against Morcellation

The FDA’s announcement warns against morcellation based on data that suggests risks of spreading undetected cancerous tissue into areas outside of the uterus. According to the FDA, approximately one in 350 women who receive treatment for uterine fibroids have a rare form of cancer known as uterine sarcoma. There is no way to determine if a fibroid is cancerous before removal.

When power morcellation is used to treat women with undetected uterine sarcoma, there is a risk that cancerous tissue might spread. According to the FDA, this can significantly worsen chances of long-term survival.

Power Morcellation Lawsuits

This morcellation cancer lawsuit joins thousands of similar complaints from women throughout the United States in recent years alleging that power morcellator manufacturers, like Karl Storz, failed to furnish sufficient warnings concerning the cancer risks to patients and doctors.

Power morcellators have been used in about 50,000 procedures each year. The FDA issued stronger warnings in December 2014 against the use of the devices after an advisory panel concluded that there was no safe way to use them, but has stopped short of banning them.

Denise is seeking compensation for her pain and suffering, medical and hospital expenses and punitive damages for Karl Storz’s alleged reckless disregard for public safety. The filed complaint indicates a demand for a jury trial for this case.

The Power Morcellation Lawsuit is Case No. 4:15-cv-10352-TGB-APP, in the U.S. District Court Southern for the Eastern District of Michigan.