One of our past articles on the da Vinci surgical device cited the Chicago Tribune, which quoted Johns Hopkins surgeon and professor Dr. Marty Makary as saying, “The robot is the symbol of the current American health care marketplace–rapid widespread adoption with little to no evidence to support it and increased costs.” The Los Angeles Times reports use of the da Vinci device quadrupled from 2008 — 2011. As mentioned in previous articles, a number of lawsuits have been filed against the da Vinci manufacturer, Intuitive Surgical, but since our last article, Bloomberg has reported that the first verdict in any of these cases is in, and a jury found in favor of Intuitive Surgical.
The New York Times published in an earlier article that the plaintiff was the late Fred Taylor, a 67-year-old Washington resident whose planned five-hour robot-assisted surgery turned into a 13-hour ordeal, complications from which led to incontinence, “kidney and lung damage, sepsis, and a stroke.” He died in 2012, four years after the operation. Dr. Scott Bildsten, the surgeon performing the prostatectomy, despite having performed the same surgery approximately one hundred times manually, had never used the da Vinci unassisted in an actual procedure before Mr. Taylor’s surgery.
Bildsten’s training from Intuitive Surgical included a scant “one day of hands-on training at the company’s facility in California. He also had two practice runs on the equipment with a more experienced surgeon before operating on Mr. Taylor.” He was also not made aware that Taylor’s obesity and previous hernia operation made him unfit as a candidate for robot-assisted surgery.
The Times adds that around 2002, when the number of units sold began to increase, Intuitive scaled back their orientation and training programs, from a “70-item exam for surgeons and three day[s of] hands-on training” to “a 10-question online quiz and reducing the time spent in hands-on training at Intuitive’s facility to one day.”
Taylor’s family sought damages, claiming that Intuitive, with its very limited training requirements, acted negligently. Despite these arguments, the Washington jury came back with a 10-2 verdict. Bloomberg points out that this is the first of (as of May 22) “at least 26 lawsuits” against the company, which is certainly worth bearing in mind. While this is an important development, it is not at all indicative of what will happen in these other cases with different tragic injuries and deaths. As each victim’s story is heard, however, we get more and more evidence that manufacturers of surgical robots need to institute longer testing periods and use components that are less likely to arc and burn patients. Even more importantly, operators of these instruments require longer and more rigorous training periods.
The runaway train of blind acceptance to robotic surgery will hopefully be derailed in a manner that may help protect others from similar harm. CNBC reports the president of the American Congress of Obstetricians and Gynecologists issued a statement saying, “Many women today are hearing about the claimed advantages of robotic surgery for hysterectomy, thanks to widespread marketing and advertising. Robotic surgery is not the only or the best minimally invasive approach for hysterectomy. Nor is it the most cost-efficient. It is important to separate the marketing hype from the reality when considering the best surgical approach for hysterectomies.”
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