Researchers from Johns Hopkins Medicine have published a study in the Journal of Healthcare Quality suggesting complications arising from robot-assisted surgeries are underreported to the Food and Drug Administration.
Between 2007 and 2011, the number of robot-assisted procedures performed increased by more than 400 percent in the U.S. By 2011, there were 1,400 surgical robots installed in U.S. hospitals, up from 800 in 2007.
The Johns Hopkins team found that of the more than one million robotic surgeries performed since 2000, just 245 complications -- including 71 deaths -- were reported to the FDA.
"The number reported is very low for any complex technology used over a million times," said Martin Makary, an associate professor of surgery at the Johns Hopkins University School of Medicine.
"Doctors and patients can't properly evaluate safety when we have a haphazard system of collecting data that is not independent and not transparent. There may be some complications specific to the use of this device, but we can only learn about them if we accurately track outcomes."
Researchers found several cases that were not reported to the FDA until they received attention in national news media, even though the surgeries took place long before media exposure.
Among cases reported to the FDA, the procedures most commonly associated with death were gynecologic (22 of the 71 deaths), urologic (15 deaths) and cardiothoracic (12 deaths). The cause of death was most often excessive bleeding.
In cases where patients survived, hysterectomy by far had the most complications with 43 percent of injuries.
Adverse events are only reported to the FDA when they are a direct result of the device, but even surgeon error during a robot-assisted surgery should be reported as device-related, Makary said.
A previous study found that nearly 57 percent of surgeons anonymously surveyed reported irrecoverable operative malfunction while using a robotic system and had to switch to laparoscopic or open surgery as a result.
Makary argues that some preventable surgeon errors are more common with robotic surgery, and so should be tracked as device-related to contribute to both device safety and surgeon education.
Until then, Makary says doctors may still tell patients there are no added risks to robotic surgery, because there is no evidence from the FDA.
"Decisions should not be made based on the information in the FDA database," Makary said. "We need to be able to give patients answers to their questions about safety and how much risk is associated with the robot."