Complications linked to the introduction of the da Vinci surgical robot highlight the need for better approaches to new surgical technology, to ensure they are safe and effective, according to a new study.
Researchers from the University of California, San Diego, took a look at the use of the da Vinci robot in minimally invasive radical prostatectomy (MIRP) surgeries, and found that patients may have been unnecessarily exposed to an increased risk of medical errors and complications due to the unknown risks linked with the robot. Their findings were published on July 2 in the medical journal JAMA Surgery.
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 surgical 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.
The researchers conducted a cohort study involving 401,325 patients who underwent MIRP with the da Vinci robot between January 1, 2003 and December 31, 2009. They found that patient safety risks doubled when the da Vinci was used, as opposed to patients undergoing traditional open radical prostatectomy in most hospitals. In teaching hospitals, the risks to patients almost tripled.
“During its initial national diffusion, MIRP was associated with diminished perioperative patient safety,” the researchers determined. “To promote safety and protect patients, the processes by which surgical innovations disseminate into clinical practice require refinement.”
Drs Mohamad E. Allaf and Alan W. Partin from Johns Hopkins University’s Department of Urology wrote an accompanying editorial, indicating that such a system is needed, but would be difficult to put into place.
“Designing a new adoption system that ensures quality of care is a laudable but formidable task,” they wrote. “Such a system must remove industry influence on surgeons and hospitals and allow procedures to stand on their own and be objectively tested before widespread use.”
Da Vinci Robot Surgical Complications
Industry influence has been a significant concern surrounding the introduction of the da Vinci robot, with many critics suggesting that the manufacturer, Intuitive Surgical, used high-pressure tactics to get hospitals to buy the expensive robot.
Many hospitals felt the need to buy a da Vinci to stay competitive, then surgeons were pressured to use the surgical robot to help recoup money spent on the device, potentially resulting in complications due to a lack of adequate training.
Intuitive Surgical faces a number of da Vinci robotic surgery lawsuits brought on behalf of patients who indicate that they suffered complications following procedures, which were allegedly caused problems with the design of the system and instructions provided for surgeons.
According to allegations raised in 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 injuries that may occur during da Vinci surgery.
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.