By now, the problems stemming from use of the Da Vinci robotic surgical device are well known. We’ve blogged about its adverse outcomes for hysterectomies, prostate cancer, and a host of other disorders.
Now, a study published in the Journal of Healthcare Quality finds that of the approximately 1 million robotic surgeries performed since 2000, only 245 complications — including 71 deaths — were reported to the FDA. That’s a remarkably low number — and a suspect one too.
By law, when a device malfunctions or there’s an adverse event with a device during a surgical procedure, the hospital where it occurred must report it to the manufacturer. That company is required to report the incident to the FDA. The study’s researchers say it’s not always happening.
As reported on HealthLeaders Media, “Injuries and death resulting from the minimally invasive Da Vinci surgical robot … have got to be far more numerous than the 245 cases reported to the U.S. Food and Drug Administration so far, Johns Hopkins University researchers contend.
“The team, led by laparoscopic pancreas surgeon Marty Makary, MD, drew that conclusion because 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.”
Robotic surgery is promoted as a minimally invasive procedure suitable for a range of problems involving body parts as diverse as gallbladders and heart valves. The surgeon directs remote-controlled instruments from a console. In some cases the instruments can work in smaller spaces than human fingers can.
But in addition to adverse outcomes, there have been problems with training on the device, and although robotic surgery is more expensive than more traditional laparoscopic procedures, the outcomes are equivalent.
Still, 11 years after FDA market approval, more than 1,400 units were operating on U.S. patients, and they were in as many as 400 in hospitals around the world.
Makary, an outspoken critic of deficient health care, said that if 6 in 10 of those very severe cases weren’t properly reported, there were probably many more that were less serious that also weren’t reported.
Makary wonders why, more than 10 years after Da Vinci was approved by the FDA, it’s the subject of debate. What took so long? “The data,” he said on HealthLeaders, “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.”
Makary is no Luddite: He supports the development of new technologies for medicine, but to do so without rigorous tracking of their outcomes is an exercise untethered to utility. “[W]e have to evaluate new technology properly,” Makary told HealthLeaders, “so we don’t over-adopt — or under-adopt — important advances that could benefit patients.”
You can’t evaluate safety if the system of collecting data is subjective and covert. There’s a reason the FDA demands accounting and accountability, but as the Hopkins study shows, the demand does not result in universal compliance.
The researchers found that of the reported Da Vinci complications, the procedures most often associated with death were gynecologic (22 of the 71 deaths), urologic (15 deaths) and cardiothoracic (12 deaths). The cause of death most often was excessive bleeding. For adverse outcomes other than death by far the most complications were for hysterectomies-43 out of 100 injuries.