From hysterectomies to heart procedures, robots are becoming popular assistants in the operating room. In 2011, in the U.S. alone, there were more than 300,000 robot-assisted procedures, up from zero in 2000 when the FDA approved the technology. Doctors direct the robots, which allow for more precise and less invasive operations.
But there are mistakes made during these procedures—and worse, the risks of complications are probably a lot bigger than even the medical world realizes, according to a recent study from researchers at Johns Hopkins University.
Through the manufacturer of the Da Vinci surgical robots, hospitals are required to tell the FDA when a "device-related" mistake occurs. These mistakes are entered in a public database. Since 2000, 1 million surgeries have been performed. There have been only 245 reports.
"It seems astonishingly low to have only 245 complications for any complex, high-tech device over a decade," says Martin Makary, an associate professor of surgery and health policy at the school. Without knowing the true hazards, he says, neither doctors nor patients can evaluate whether the benefits outweigh the risks and justify a hospital buying the expensive equipment.
So Makary and his team conducted an investigation to back up their suspicion.
Using comprehensive databases like LexisNexis, they searched news media reports and lawsuits that discuss complications from surgeries using the Da Vinci systems. Reporters, it turns out, have been paying close attention to the rise of these operations for the last few years.
From 22 incidents in media reports and 48 lawsuits, the team identified eight cases that were either never reported to the FDA or reported only after the media got wind of them. For example: In August 2009, a man died after a urology surgery assisted by a robot. In May 2010, the Wall Street Journal cited his death as an example of the risks of robot-assisted surgeries. And finally in June 2010, a full 292 days after the surgery, the hospital filed a required report of the episode to the FDA.
The fact that just eight cases out of this small sample—only cases serious enough to turn up mentions in news articles or court documents—looked suspicious, suggests to Makery that there are many other unreported cases the public never finds out. In one anonymous survey, more than 55% of surgeons reported that they experienced "irrecoverable operative malfunction" while using the Da Vinci system.
There are surgeries where a robot is clearly superior to current methods, but that's not the case for every surgery. The technology is certainly evolving—one problem that leads to screw-ups is that doctors lack their sense of touch when using a robot, but now the ability incorporate better "haptic feedback" in the robot is improving.
The authors of the study, published in the Journal of Healthcare Quality, are calling for a standardized national registry for the procedure, with independent accountability measures. "We introduce new technology, but we don’t evaluate it properly. In the case of robotic surgery, we have over a million procedures done ... how are the patients doing? We don’t really have a good idea. Most of the studies that we have are limited to individual case studies or single-institution experiences," Makery says. "One of the big problems in health care—in medicine—is that we don’t learn from our performance."