A New York couple has filed a morcellator lawsuit in federal court, accusing the Johnson & Johnson subsidiary Ethicon of negligence and other allegations over a device known as a power morcellator used in gynecologic surgeries.

Plaintiffs Brenda and George Leuzzi say Mrs. Leuzzi’s stage 4 uterine cancer was a direct result of the morcellation surgery, which shreds uterine tissue so it can be removed through laparoscopic incisions, according to the morcellation cancer lawsuit. 

Temple University Hospital physician Dr. Enrique Hernandez told CBS News that morcellation — which in April was the subject of an FDA safety notice — can spread undetected uterine cancer throughout the abdomen.

“If you cut the tumor in pieces inside of the abdomen, there is the potential of spread of the cancer throughout the abdomen, so that makes the stage of cancer more advanced,” Hernandez said.

Mrs. Leuzzi had a robot-assisted hysterectomy with uterine morcellation in September 2012 at University of Rochester Medical Center. She opted for the procedure after severe bleeding episodes were caused by uterine fibroids, according to her morcellation cancer lawsuit.

She received the grim diagnosis after the surgery.

“Nobody wants to hear, you’ve got 12 months left to live, or less,” Brenda Leuzzi told CBS News.

Her husband maintains that “they took a tumor that was at a low stage and morcellated it, and now she’s at a high stage.”

The morcellation cancer lawsuit accuses Ethicon of knowing of the morcellator’s risks but failing to warn patients and their doctors about them.

One in 350 women who undergo a robotic hysterectomy or myomectomy (the removal of uterine fibroids) are diagnosed with uterine sarcoma. There are some 50,000 women annually who undergo hysterectomy morcellation surgery.

Uterine fibroids are noncancerous growths of the uterus that often appear during childbearing years. They are not associated with an increased risk of uterine cancer and almost never develop into cancer, according to the Mayo Clinic.

“Fibroids range in size from seedlings, undetectable by the human eye, to bulky masses that can distort and enlarge the uterus. They can be single or multiple, in extreme cases expanding the uterus so much that it reaches the rib cage. As many as 3 out of 4 women have uterine fibroids sometime during their lives, but most are unaware of them because they often cause no symptoms,” the Mayo Clinic explains.

The growths can cause pain and heavy bleeding as well as bladder and bowel dysfunction and are a leading cause of hysterectomies in the United States.

Earlier this year the FDA issued the safety advisory after analyzing data that showed morcellation surgery may cause the spread of unsuspected cancerous tissue outside the uterus. A decision from the FDA is pending regarding whether the morcellation surgery will be banned.

In July, Mrs. Leuzzi was one of several people to testify before an FDA panel of doctors about her experience. The personal trainer and mother of a toddler told the FDA she was “terrified” of cancer. She had numerous pre-op tests to check for the disease and doctors assured her she didn’t have it.