Complications from robotic surgery are widely underreported, a new study published in the Journal for Healthcare Quality by researchers from Johns Hopkins University School of Medicine finds. In an announcement from Johns Hopkins Medicine, the researchers pointed out that a "slapdash" system of reporting complications paints an unclear picture of the safety of robotic surgery.
Of the roughly 1 million robotics surgeries performed since 2000, only 245 complications (including 71 deaths) were reported to the U.S. Food and Drug Administration, according to the study.
"The number reported is very low for any complex technology used over a million times," Martin Makary, an associate professor of surgery at the Johns Hopkins University School of Medicine, said. "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."
For their study, Makary and his colleagues reviewed the FDA adverse events database from Jan. 1, 2000, to Aug. 1, 2012, also searching legal judgments. They also used LexisNexis to scan media, and PACER to scan court records, cross-referencing the cases. They found that eight cases weren't reported to the FDA, while five were never filed at all, and two were only filed after media reports.
The researchers also found that the procedures most commonly associated with death were gynecologic, with hysterectomies resulting in 22 of the 71 deaths.
In March, the American Congress of Obstetricians and Gynecologists said that robotic surgery for hysterectomies should not be a first or even second choice for women undergoing routine procedures, due, in part, to the learning curve associated with the robotic system. That same month, health officials in Massachusetts sent a letter outlining safety concerns about robotic surgery after two damaging incidents involving robots performing hysterectomies.
The FDA currently is surveying hospitals on complications, outcomes and dangers with Intuitive's da Vinci robot.
"We need to be able to give patients answers to their questions about safety and how much risk is associated with the robot," Makary said. "We have all suspected the answer has not been zero. We still don't really know what the true answer is."
To learn more:
- here's the study's abstract
- read the announcement from Johns Hopkins Medicine
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