Though it sounds like the opening scene of a science fiction movie, robots are increasingly taking over America’s operating rooms. Figures show that nearly 400,000 procedures were performed by robots in 2012, a number that represents an astounding increase from the 114,000 procedures performed by robots in 2008. Recently published research out of Johns Hopkins University is calling into question the safety of the trend, noting that the number of surgical complications is vastly underreported.
According to the latest study, at least 247 serious injuries and deaths have been reported to the FDA involving robotic surgeries, a figure the researchers note is merely the tip of the iceberg. Researchers did some digging of their own and uncovered several cases where injury reports were submitted to the FDA years after the injuries actually occurred. In other cases, doctors identified cases where robotic surgery fatalities were never reported to the FDA at all. The study’s authors say they have only just begun digging into reports of robotic surgical complications and that there may be many other unreported incidents out there. This is a big worry for those in the medical community who point out that hospitals and doctors rely on the accuracy of FDA reports when deciding whether to purchase and when to employ robotic surgical systems.
Unrelated to the recent Johns Hopkins study, the FDA has announced that it will launch an investigation into a series of more than 500 complaints about the da Vinci surgical robot (made by Intuitive Surgical) the agency received in 2012 alone. These medical malpractice claims include five reports of death. In once case, a woman died during a hysterectomy after the robot clipped a blood vessel. In another case, a man died after the da Vinci robot perforated his colon, leading to an infection. One report revealed how a patient who was having hysterectomy surgery was slapped in the face by the robot, causing the doctor to finish the procedure manually. In another case, a robot grasped onto a patient’s tissue during a colon surgery and would not let go, essentially freezing with a man’s colon in hand. The machine had to be rebooted before it would release the man's organ, likely leading a marked increase in SkyNet nightmares for all involved.
The FDA first approved robotic surgery back in 2000 and since then the numbers of procedures performed by the machines has exploded. Hysterectomies and prostate removal operations are frequently being done with robots, with hospitals and surgeons claiming the robotic surgeons are able to decrease healing time and generally perform surgeries with greater ease. The problem, as many have begun to realize, is that though hospitals frequently tout the machines as superior to human hands, there is little if any evidence to support this claim. In fact, a recent study that appeared in the Journal of the American Medical Association (JAMA) found that robotic surgeries were no better than laparoscopic surgeries in terms of complication rates during and after hysterectomy surgeries.
While the supposed benefits are dubious, costs are significantly greater, with robotic surgeries costing several thousands dollars more than those procedures performed by human surgeons. Though none of this proves that robotic surgery systems should never be used, the reports do raise serious red flags about the dangers posed by the devices. We can only hope that the FDA does its job and rigorously investigates the use of the da Vinci system to ensure the safety of future patients.