Robotic surgery complications may be under-reported

The current system of reporting complications paints an unclear picture of the safety of robotic surgery, according to researchers from the Johns Hopkins University School of Medicine, Baltimore, who suggest that robot-related complications may be under-reported.

Among all reported complications, urologic procedures were the second most commonly associated with mortality since 2000 (15 deaths).

In their report published online in the Journal for Healthcare Quality (Aug. 27, 2013), the researchers found that of the approximately one million robotic surgeries performed since 2000, 245 complications were reported to the FDA. The required reporting of an adverse event or device malfunction by hospitals to manufacturers and from manufacturers to the FDA doesn’t always happen, the researchers say.

“The number reported is very low for any complex technology used over a million times,” said lead author Martin A. Makary, MD, MPH. “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.”

The researchers found several incidents reported in the national news media that were not reported to the FDA until after the stories appeared in the press, even though the incidents took place before the media exposure. Dr. Makary says it’s likely many other incidents go unreported, never to be captured by researchers or the FDA.

For their study, Dr. Makary and colleagues reviewed the FDA adverse events database from Jan. 1, 2000 to Aug. 1, 2012. They also searched legal judgments and adverse events using LexisNexis to scan news media and PACER (Public Access to Court Electronic Records) to scan court records. The cases were then cross-referenced to see if they matched. They found that eight cases were not appropriately reported to the FDA, five of which were never filed and two of which were filed only after a story about them appeared in the press.

In their review of all reported complications, researchers found 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 had the most complications (43% of injuries).

Good information on robotic surgery is not only needed for research, but also to ensure patients are fully informed about potential risks. Right now, according to Dr. Makary, it is too easy for a surgeon to say there are no additional risks related to robotic surgery because the evidence cannot be found.

“Decisions should not be made based on the information in the FDA database,” he said. “We need to be able to give patients answers to their questions about safety and how much risk is associated with the robot. We have all suspected the answer has not been zero. We still don’t really know what the true answer is.”

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