Johns Hopkins University researchers say that injuries and deaths resulting from surgeries performed with the da Vinci surgical robot system must be more numerous than the 245 cases thus far reported to the U.S. Food and Drug Administration (FDA).
The research team, led by Dr. Marty Makary, reached this conclusion after they found eight cases of patient harm or death from robot complications in court records or media reports that had not been reported to the FDA or were reported late, according to HealthLeaders Media. If serious complications are going unreported, Makary says, “probably many more of less severe or more routine complications were also not reported.” Makary notes that 245 complications with such a complex technology over a decade, “seems very, very low,” according to HealthLeaders Media.
Makary’s article was published this week in the Journal for Healthcare Quality, and gives the rates for fatal and non-fatal events in various specialties and in numerous types of da Vinci procedures, HealthLeaders Media reports. Of the 245 harmful events reported, there were 71 deaths and 174 other types of harm.
FDA officials, concerned over a spike in adverse-event reports associated with da Vinci surgeries, launched a survey earlier this year to get physicians’ feedback about their experiences with the device, according to HealthLeaders Media. Over 1 million people have had robot-assisted surgeries in the decade since the da Vinci system received FDA approval. Makary questions why data was not collected and analyzed earlier. “[W]e 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.”
Reporting harmful events to the FDA’s Maude (Manufacturer and User Facility Device Experience) database is not mandatory and Makary sees this as a reason why complications go unreported. Many doctors leave it to the manufacturer to do the reporting, according to HealthLeaders Media.