Since 2000, at least 144 deaths and more than 1,000 injuries have been linked to robotic surgeries, according to a new study titled Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data.
What’s the Problem?
According to the study, robotic surgery complications were the result of broken instruments falling into patients’ bodies, electrical sparks causing tissue burns and system errors forcing procedures to take longer than anticipated.
“Despite widespread adoption of robotic systems for minimally invasive surgery, a non-negligible number of technical difficulties and complications are still being experienced during procedures,” the study’s authors wrote. “Adoption of advanced techniques in design and operation of robotic surgical systems may reduce these preventable incidents in the future.”
Robotic Surgery Complications on the Rise
Specifically, the research cites 144 deaths, 1,391 injuries and 8,061 device malfunctions out of more than 1.7 million robotic surgeries performed between Jan. 2000 and Dec. 2013. These figures were taken from reports submitted by hospitals, patients and others submitted to the U.S. Food & Drug Administration (FDA). The authors caution that the true number of adverse events associated with surgical robots could be higher.
Since 2007, the number of injuries and deaths per procedure has remained relatively constant, according to the study. However, because use of surgical robots is increasing “exponentially,” the number of complications linked to the instruments is increasing every year.
When robotic surgery problems do occur, patients are more likely to die if the procedure involves the heart, lungs, head and/or neck rather than gynecological or urological operations. Although it is not clear why this is the case, the researchers suggest the former are more complex surgeries for which surgical robots are less commonly used, so there is less experience and expertise available.
Cost vs. Value
Surgical robots are extremely expensive – typically costing millions of dollars each – but they offer advantages over conventional surgery such as smaller incisions / scars, faster recovery time and less risk of infection. Yet despite these advantages, sales of the devices fell by 2% in 2013 – the most recent year for which figures are available – according to the International Federation of Robotics (IFR).
This has led some medical experts to question whether the cost of robotic surgery is justified by improved outcomes. According to the American College of Obstetrics and Gynecologists (ACOG):
“There is no good data proving that robotic hysterectomy is even as good as – let alone better – than existing, and far less costly, minimally invasive alternatives. Aggressive direct-to-consumer marketing of the latest medical technologies may mislead the public into believing that they are the best choice.”
Injuries Caused by Broken Parts
Although the study cites hundreds of surgical robot complications, in most cases the figures do not clarify whether use of the devices was the direct cause. In fact, only 5 deaths and 436 injuries were specifically linked to technical errors that occurred during robotic surgery.
However, the authors still feel there is reason to be concerned. The study lists:
- 1,166 cases of broken / burned components falling into patients’ bodies, which contributed to at least 119 injuries and 1 death;
- 52 injuries and 2 deaths caused by uncontrolled movements and spontaneous powering on and off of the devices;
- 193 injuries linked to electrical sparks, unintended charring and damages accessory covers, and
- 41 injuries and 1 death attributed to loss of quality video feeds and/or reports system error codes.