In April 2014, the FDA issued a safety communication warning healthcare providers and the public to be cautious when undergoing uterine fibroid of hysterectomy laparoscopic procedures. To minimize scarring, surgeons use a tool called a “morcellator” to cut up large tissues into smaller ones for removal through a small tube. Recent studies, however, have discovered that in some rare cases, the morcellator can spread tiny cancerous tissues around the body, seeding new and more dangerous tumors.
The danger was brought to light again recently when a New York woman died following a robotic hysterectomy, in which a power morcellator was used.
Plaintiff Dies Before Case is Settled
Brenda Leuzzi and her husband, George, filed a morcellation lawsuit on May 1, 2014, in the Western district of New York. According to their complaint, Brenda wet through a robot-assisted hysterectomy with uterine morcellation in September 2012 at the Strong Memorial Hospital of the University of Rochester Medical Center. Prior to the surgery, she had no signs, symptoms, or evidence of cancer.
After the surgery, however, Brenda was diagnosed with leiomyosarcoma, a very rare and aggressive cancer of the connecting tissues in the body, often in the uterus. She began aggressive treatment and therapy at that time.
Unfortunately, just two years later on October 29, 2014, the plaintiffs filed a suggestion of death, noting that Brenda had passed away on October 24, before the case went to trial. She was only 44 years old.
Morcellator Manufacturers Provided Inadequate Warnings
Though power morcellators have made it possible for thousands of women to have hysterectomies, uterine removal, and other gynecological procedures performed with minimally invasive laparoscopy, they have also resulted in diagnoses of aggressive, late-stage cancers for some women who were never made aware of the risks.
“Many women choose to undergo laparoscopic hysterectomy or myomectomy,” the FDA states in their safety communication, “because these procedures are associated with benefits such as shorter post-operative recovery time and a reduced risk of infection” compared to standard abdominal procedures.
Yet up until recently, women were not warned of the cancer danger. Prior to these types of surgeries, it is currently impossible to tell whether the tissues involved are free of cancer. Tumors can exist on fibroids or in other areas of the uterus in a localized manner that creates low risk, but once these tissues are morcellated, they can migrate to other areas of the body, becoming very dangerous.
Brenda and other women injured by the procedures note in their cases that the manufacturers of the surgical tools apparently failed to provide adequate warnings about the risks to both doctors and patients, leaving women totally in the dark about the rare but serious possibilities of a dangerous cancer diagnosis.
Panel Recommends More Severe Warnings
According to the most recent FDA analysis, about one in 350 women undergoing these procedures will have an unsuspected type of uterine cancer that can spread if morcellation is used. In July 2014, an FDA advisory committee discussed the concerns surrounding the procedure and supported greater restrictions and more severe warnings, but so far the administration has not recommended an outright ban of the power morcellation tool.
Exclusively focused on representing plaintiffs, especially in mass tort litigation, Eric Chaffin prides himself on providing unsurpassed professional legal services in pursuit of the specific goals of his clients and their families. Both his work and his cases have been featured in the national press, including on ABC’s Good Morning America.