After a warning from the U.S. Food & Drug Administration (FDA) about the risk of developing cancer from power morcellators during uterine fibroid removal, it is expected that the use of da Vinci Surgical Robots during these operations will decrease. Robotic hysterectomies are one of the most common uses for the da Vinci Robot, where the device assists in surgery to remove the uterus. Our lawyers are now investigating potential lawsuits for women who were injured after undergoing surgery with a laparoscopic power morcellator.
Morcellator Lawsuit Update 5/20/14: A California woman has filed a product liability lawsuit against the company that manufactures the Wolf Power Morcellator, alleging that use of the device during a laparoscopic supracervical hysterectomy caused leiomyosarcoma cancer to spread throughout her body.
What is the Da Vinci Robot?
Manufactured by Intuitive Surgical, the da Vinci Robot is a complex medical device designed for use in urologic, gynecologic and other laparoscopic surgeries. The robot provides a minimally invasive approach, where up to 4 arms are remotely controlled by a surgeon sitting at a console that provides a virtual reality view of the patient’s internal organs. Hysterectomies are one of the most common uses for the da Vinci Robot, where it assists in removing the uterus. Although the da Vinci Surgical System itself does not have a power morcellator, robotic hysterectomies are often performed together with morcellation using hand-held tools.
Amid Cancer Risks, Intuitive Predicts Slow Growth for Surgical Robot
In May 2014, Intuitive Surgical slashed predictions for da Vinci robot surgery growth from 9-12% down to 2-8%. A company spokesperson indicated that the FDA’s recent warnings over the potential cancer risk from morcellation-assisted robotic hysterectomies was partially responsible for the slowdown.
“The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “There is no reliable way to determine if a uterine fibroid is cancerous prior to removal. Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals.”
According to the FDA, about one in 350 women who undergo uterine fibroid surgery have unsuspected sarcoma, which doctors are unable to diagnose before the procedure. For these women, morcellation of uterine fibroids may cause cancerous cells to spread throughout the body, greatly decreasing the patient’s survival rate.