When surgeons insist on cutting on patients using the million-dollar da Vinci robot system, patients should demand to know why — and to be skeptical to the nth degree whether the device-based operation will be beneficial to them, or if it is yet another way for doctors and hospitals to make medical care exorbitantly expensive and to boost their profits.
NBC News, as part of a global investigation of medical devices and their harms, deserves credit for adding yet more disturbing disclosures with a detailed story about the da Vinci. The report clearly seeks to be balanced and doesn’t deliver as hard-hitting a point of view as The Bleeding Edge, a recent and important HBO documentary on the surgical robot system.
Still, there are plenty of disturbing items that ought to stop lawmakers, regulators, safety advocates, and patients, and force a hard re-thinking about da Vinci:
Dr. Robert Poston, chief of cardiothoracic surgery at SUNY Downstate Medical Center, told NBC he has concerns about how ill-trained many surgeons may be with the device. He said he has performed 1,200 or so da Vinci procedures, before he did his first with two hours of training on it — less time than most of us would expend on planning and preparing a weekend meal for guests. Intuitive, the da Vinci’s maker, says it has a “four-level training program.”
But the company emphasized that it “cannot legally require surgeons to complete it and cannot train surgeons on patients.” The federal Food and Drug Administration also told NBC it lacks authority to oversee device training and education.
NBC found “no national requirements regulating how much training a surgeon must have to operate using the da Vinci.” Instead, hospitals and doctors — who have inherent time concerns and profit-making conflicts — decide this important issue.
Mounting complaints, hidden in bureaucracy
Broadcast journalists found that in the last decade, the FDA has tallied more than 20,000 reports of “adverse events” related to the da Vinci. More than 2,000 of these involved injuries, 274 were deaths, and nearly 17,000 device malfunctions — some minor, others more serious, including robotic arms uncontrollably going in the wrong direction and insulation cracking off and dropping inside patients’ bodies. To be fair, with more than 3,000 of the devices in use since 2000, the number of da Vinci surgeries performed in the United States has “increased by 52 percent since 2013, to nearly 700,000 procedures in 2017.”
There’s also a bureaucratic trap-door that has kept hidden key information about da Vinci harms, NBC found. The FDA, in a practice that safety advocates has ripped the agency for, has allowed the device maker to batch together complaints into a single file. This makes it appear the total number of incidents is far less than reality. NBC said it found a dozen such instances, including one where “Intuitive combined 200 injuries into a single filing.”
Recalls and warnings
Meantime, the da Vinci has been far from problem free, with the company telling the FDA it has issued 175 recalls in the past decade. These have declined over the years. But the defects have been notable. Some were minor adjustments, such as instruction clarifications and software updates. NBC also found that da Vinci had more serious recalls, like as a surgical knife that might not follow cutting instructions, surgical arms that could fail, and others that could move in unexpected fashion.
The FDA itself has warned the maker about da Vinci defects, including cases “in which electricity arcs from the tip of the robotic arm to the patient’s flesh, causing injury,” NBC found. The agency also cautioned the company for “improperly marketing the machine for certain thyroid surgeries.”
The company was sued by shareholders for misleading statements about its difficulties, and in June, this Intuitive settled the class-action case for $42.5 million, emphasizing this “was not an admission of fault.”
Intuitive is spending tens of millions of dollars to promote its product in concerning ways, NBC reported, noting, “Public records show that since 2013, Intuitive has paid over $144 million to doctors and hospitals, for education, research, and travel.”
Although there are worries as to whether surgeons familiarize themselves with da Vinci robots as deeply as they should, the network said, “the company says that the majority of the payments made to doctors were for education, such as paying doctors to train other doctors.”
Still, in July, a medical study found that Intuitive’s cash appeared to “influence” doctors when they researched the robot. The study, NBC said, “found that if there was a financial relationship between the doctors in each study and Intuitive, there was a higher likelihood of studies reporting a benefit of robotic surgery.”
In my practice, I see not only the harms that patients suffer while seeking medical services but also their struggles to access and afford safe, effective, and even excellent medical care, especially when they’re injured by defective and dangerous products, notably medical devices.
Careful medical journals have built a growing body of research finding not only a dearth of evidence to support the booming business of robotic-assisted surgeries but also worries about under-reported harms from the procedures. News stories in big media outlets, besides NBC, and blog posts have reported on risks and damages associated with the higher-cost machine-assisted operations.
With robotic surgical devices, fawning local news stories may hype their burgeoning use in unhelpful fashion. But research has failed to show a clear and overpowering benefit to patients for complex machinery that costs hospitals millions of dollars to install — sums they seek to recover with surgeries that cost individual patients thousands of dollars more. The machines may provide surgeons greater comfort as they operate. But there are questions whether, over time, young surgeons are losing critical skills and experience they need due to the high costs of operating robots.