Electing to undergo da Vinci robotic surgery, which has been heralded as a significant medical advancement in minimally invasive surgery, may not reduce the risk of surgical complications, despite a hefty price tag, according to the findings of new research.
In a letter published in the New England Journal of Medicine on July 24, researchers from the Memorial Sloan Kettering Cancer Center in New York compared the complication rates among patients undergoing bladder cancer surgery involving either the da Vinci robotic treatment or more traditional surgical methods, indicating that they could find no evidence that the use of the robot surgery made the procedure any safer.
The da Vinci Surgical System is a complex robot manufactured by Intuitive Surgical, which is used in a variety of different urologic, gynecologic and other laparoscopic procedures.
It is designed to provide a minimally invasive surgery, where four arms are remotely controlled by a surgeon through the use of hand and foot controls while sitting at a console that provides a virtual reality representation of the patients internal organs.
In the latest study, the researchers randomly assigned 118 patients to either open radical cystectomy or robot-assisted cystectomy to treat bladder cancer. Four of the 60 patients assigned to the da Vinci robotic treatment declined to use the technology, instead electing the more traditional method.
Slightly more patients suffered significant complications with robotic surgery (38 patients or 66%), compared to those who experienced significant complications following open radical cystectomy surgery (32 patients or 62%).
Severe surgical complications occurred in 22% of those who underwent the traditional procueduyre, and 21% who underwent the da Vinci robotic treatment. Researchers found that while patients suffered less blood loss during da Vinci surgery, the open procedure was faster. In both cases, the patients were in the hospital for about eight days.
Researchers said that the findings “argue against a large benefit of robotic techniques,” in their conclusions, stating that “these results highlight the need for randomized trials to inform the benefits and risks of new surgical technologies before widespread implementation.”
da Vinci Robotic Surgery Complications
The study is the latest in a string of concerns regarding the effectiveness and safety of da Vinci robotic surgery, which typically costs much more than traditional treatments and has caused a large number of reports involving serious complications, including internal burns, tears and other injuries.
The da Vinci robot can cost a hospital or medical facility up to $2 million, and many critics have raised concerns about the high-pressure sales tactics used by Intuitive Surgical to make hospitals feel as though they need the device to stay competitive, especially in rural or small hospitals where the volume of robotic treatments is likely to be lower. As a result, many hospitals have aggressively promoted robotic surgery over traditional procedures, which could be driven by a desire to recoup their costs, as opposed to a proven patient benefit.
Intuitive Surgical has faced a number of da Vinci robotic surgery lawsuits brought on behalf of patients who suffered complications following procedures, which were allegedly caused problems with the design of the system and lack of proper instructions provided for surgeons.
According to allegations raised in many of the complaints, Intuitive Surgical sold the surgical system without ensuring proper training and instructions for surgeons, and without providing adequate warnings for consumers about the risk burns, tears and other potential da Vinci surgery complications.
Last summer, Intuitive Surgical scaled back sales expectations for the da Vinci robot amid shrinking hospital budgets, several da Vinci recalls impacting different components and concerns over aggressive sales techniques.
In January 2013, a report by the investment research firm Citron Research highlighted a number of potential issues with the da Vinci robot and Intuitive Surgical’s response to those problems. Citron identified more than 4,600 adverse event reports submitted to federal health regulators involving the da Vinci robot, highlighting what the analysts described as a disturbing trend with the manufacturer making “clearly unfathomable” assertions that the complications had nothing to do with the da Vinci robot.
Growth in da Vinci procedures may have also been impacted by continuing concerns over whether the costs associated with robotic surgery are justified. In February 2013, a study published in the Journal of the American Medical Association (JAMA) found that da Vinci hysterectomies increase costs by more than $2,000, while providing virtually the same complication rate as laparoscopic surgery.