Study: Intuitive Surgical’s da Vinci Robot System No Better Than Traditional Surgery for Bladder Removal

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Unfavorable-Study-Surgicals-da-Vinci-Robot-SystemAn emerging study found that patients undergoing cystectomy (bladder removal) may not benefit from robotic bladder removal when compared to the traditional, open procedure.

According to Fierce Medical Device, based on insurance claim information, patients experienced similar rates of complication and hospital stays, whether or not they underwent robotic cystectomy or cystectomy by hand. The study included 118 patients from Memorial Sloan Kettering Cancer Center from 2010 and 2013; participants were chosen randomly for either open or robotic surgery. The researchers’ data was peer-reviewed, according to a New England Journal of Medicine (NEJM) spokeswoman writing in an email, The Wall Street Journal wrote.

Intuitive Surgical, which makes the da Vinci robot system, described the study results in an interview with The Journal, as being “grossly misleading,” adding that complications with cystectomies tend to occur during bladder reconstruction, which is only handled as an open surgery, regardless of the manner in which the bladder is removed. The Journal also indicated that robotic cystectomy costs about $16,250, which is approximately 10 percent more expensive than open surgery. The robot systems sell for approximately $2 million each.

Other studies on robotic surgery have revealed unfavorable results. In a prior study, Johns Hopkins researchers concluded that robotic surgery-related complications are considerably underreported, adding to the mounting academic evidence that questions the value and safety of robotic surgery, wrote Fierce Medical Device. The U.S. Food and Drug Administration (FDA) has questioned surgeon training on the surgical robot, as well, and the maker of the da Vinci, Intuitive Surgical recalled more than 1,300 systems in late 2013.

Also, a 2013 study questioned the financial benefit of using the da Vinci for hysterectomy procedures when compared to laparoscopic procedures conducted by hand, wrote The Wall Street Journal. In fact, the da Vinci robot is promoted for use in hysterectomies; however, the American College of Obstetricians and Gynecologists previously announced that, “Robotic surgery is not the only or the best minimally invasive approach to hysterectomy … nor is it the most cost-effective.”

Personal injury lawsuits brought over the da Vinci have alleged significant internal injuries, including burns, tears, and other complications. Lawsuits have also alleged that some procedures have left patients with chronic pain or disability; some have alleged patient deaths have been tied to the robot systems. Lawsuits also blame Intuitive’s long-known aggressive marketing practices, design flaws intrinsic to the da Vinci, and poor physician training.

Last week, Intuitive Surgical announced that its revenues dropped 11.5 percent, with profits down 35 percent, year-over-year, in the second quarter. During the quarter, Intuitive shipped 96 systems. More than half of these, according to Fierce Medical Device, were the upgraded da Vinci Xi system, which received FDA clearance earlier in 2014.