A paper published online first by the Journal of Healthcare Quality, “Underreporting of Robotic Surgery Complications,” raises questions about how accurate a safety picture is publicly available.
The paper is authored by Dr. Marty Makary of Johns Hopkins and two colleagues. Makary is a frequent critic of the proliferation of robotic surgery systems.
I found only a handful of news stories about the paper. The best was by HealthLeaders Media, which reported:
“…he and his research team were able to find eight cases of patient harm or death from robot complications in public court records or media reports.
But no report was made to the FDA’s Maude (Manufacturer and User Facility Device Experience) database for five of those cases and for the other three, the report was improperly filed or filed late, after the adverse event was reported by a major newspaper.
“If 60% of those very severe cases were not reported to the FDA, probably many more of less severe or more routine complications were also not reported,” Makary says. …
Makary asks rhetorically, “Why are we having the debate about robotic surgery now, (more than a decade) after it was FDA-approved, when there have been over one million people who have had robotic surgery. The data could have been captured and analyzed in the first few years and we could have had the discussion about which procedures robotic surgery provides benefit for, and for which procedures there is no difference, and for which procedures are there added risks and costs that make it unwise.”
“We would do a much better job informing our own community and patients about the risks and options if we had this information.”
I recently read Makary’s book, “Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Health Care.”
In the book, he writes:
“I set out to review all 409 research studies on the robot in the medical literature. In my opinion, none showed any convincing clinical benefit over conventional laparoscopic surgery, except for a few studies the robot company had paid for. … I am convinced that future generations of the robots will yield a superior result for patients for a limited set of procedures. However, looking back over the past “decade of the robot,” I wonder how the craze made us spend so many billions of dollars when it resulted in patient outcomes no better than standard minimally invasive surgery.”
It’s an interesting book by someone who, as a third-year medical student, quit medical school in disillusionment. He wrote, “Modern medicine seemed as dangerous and dishonest as it was miraculous and scrupulous.”
Of course, he came back to medicine and is now a surgeon at Johns Hopkins Hospital and an associate professor of health policy at the Hopkins School of Public Health.
Here’s a promotional video for the book:
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