A lawsuit against the manufacturer of a controversial surgical tool used to perform hysterectomies and remove uterine fibroids has been settled for an undisclosed amount. The lawsuit, filed against medical device maker Lina Medical ApS, was expected to be the first power morcellator claim to reach trial.
The lawsuit was filed by Scott Burkhart, whose wife Donna died in 2013 nearly a year after undergoing power morcellation to remove her uterus. She learned after surgery that she had a rare type of uterine cancer, or uterine sarcoma, known as leiomyosarcoma.
Power morcellators are surgical tools fitted with a long, tube-like blade that minces entire uteruses or uterine fibroids inside the uterine cavity and removes the tissue through a small incision in the abdomen. The procedures have been preferred over open surgeries by some medical professionals because power morcellation is less invasive, leaves less scar tissue, and offers shorter recovery time.
However, doctors found that power morcellation could spread cancerous tissue throughout the abdominal cavity, seeding new cancer growth, spreading the deadly cancer and making it more difficult to treat. There are also no reliable ways to diagnose uterine sarcoma before tissue is removed. So, women who undergo the procedure are essentially playing Russian roulette.
A campaign was waged by victims of power morcellation and their survivors to ban power morcellation. The Food and Drug Administration (FDA) launched an investigation and, late last year, placed a black box warning on the devices and advised that the procedure not be used on “most women” due to the risk of cancer spread.
Burkhart’s lawsuit, which was filed in March 2014, was expected to reach trial later this year. At least another 21 lawsuits targeting power morcellator manufacturers and their failure to warn of risks have been filed and more are expected as news of dangerous power morcellator injuries come to light.