Lawsuit Raises Questions About Push for Robotic SurgeryMar 26, 2013
A lawsuit set for trial in April raises significant questions about the safety of robotic surgery and the quality of training surgeons receive regarding the use of the equipment.
Josette Taylor brought the suit against Intuitive Surgical Inc., the manufacturer of the da Vinci robot system used in her husband’s 2008 prostate surgery. Fred Taylor suffered injuries and complications, including kidney and lung damage, sepsis and a stroke, that led to his death last year. Documents in the court filing reveal that Taylor’s surgeon had never before used the robotic equipment without supervision, The New York Times reports.
Hospitals are responsible for training and credentialing surgeons for robot systems, but company emails suggest that Intuitive sales representatives often pressed for lower standards, which would increase the number of surgeons using the robots, the Times writes. Sales representatives presented themselves as experts on the system and sometimes were even present in operating rooms, advising surgeons. Company emails also show that Intuitive sales staff were urged to persuade surgeons to choose the da Vinci procedure even when they were planning to use a different method, according to the Times.
Nearly 1,400 U.S. hospitals currently use the da Vinci system, and about half a million robotic procedures were performed worldwide last year, The New York Times says. The U.S. Food and Drug Administration (FDA) allowed the sale of the da Vinci system under a controversial pre-market approval process that allows a manufacturer to bring a device to market without rigorous safety trials by claiming the device is similar to devices already on the market. Under this type of approval, the FDA “cannot require training programs as a condition of clearance,” said FDA spokeswoman Synim Rivers.
Researchers are now studying outcomes, comparing robotic surgery to more conventional minimally invasive methods. A recent study of robotically assisted hysterectomies found no overall difference in complication rates, according to the Times, but the robotic surgeries cost about one-third more.