Overview: The da Vinci surgical robot, manufactured by Intuitive Surgical Inc. has raised a number of safety concerns amidst litigation, injury reports, and evidence suggesting that the company aggressively marketed the system with little concern for patient safety, the New York Times reported. Josette Taylor, whose husband suffered a number of severe complications after undergoing surgery with the da Vinci, states that the procedure was performed by a surgeon who had never operated the surgical robot without supervision.
- Emails from Intuitive employees suggest that hospitals were pushed to use the da Vinci without surgeons being adequately trained
- A lawsuit filed by Josette Taylor alleges that her late husband suffered complications such as incontinence, kidney damage, lung damage, sepsis and stroke after undergoing surgery with the da Vinci
- ACOG and the Massachusetts Board of Registration in Medicine have recently highlighted the risks of robot surgery, especially since there is a high learning curve; ACOG in particular warned consumers to not be swayed by aggressive marketing
Product: da Vinci surgical robot
Manufacturer: Intuitive Surgical Inc.
Side Effects & Complications
- Cut Bile Duct
- Damaged blood vessels
- Organ damage
Aggressive Marketing at the Cost of Patient Safety
Josette Taylor says that her late husband, Fred E. Taylor, went for a routine prostatectomy with the da Vinci in September 2008. Despite promises of innovative technology that was supposed to be less painful, Mr. Taylor suffered a substantial amount of complications, including incontinence, kidney and lung damage, sepsis and stroke. Dr. Scott Bildsten, who performed the operation, had never operated with the da Vinci without supervision before Taylor’s surgery, the New York Times reported. Mrs. Taylor is now suing Intuitive. Taylor’s case is one that had brought to light a substantial amount of evidence showing that Intuitive aggressively marketed da Vinci at the cost of patient safety. Among other things, a May 2011 email from a regional sales manager told salespeople to not “let proctoring or credentialing get in our way,” Another internal email pushed hospitals to lower surgeon credentials for operating the da Vinci, stating that five unsupervised operations was “on the high side.” Evidence also suggests that company employees were present in the operating room, had access to operating room schedules, and pushed surgeons to use da Vinci even if they had planned to use another method.
da Vinci Safety Concerns
Deceptive marketing and oversight have of great concern with regards to the da Vinci surgical robot. The NYT points out that when the device was approved in 2000, the Intuitive had claimed that surgeons would need to under a 70-item exam and 3 days of hands-on experience as part of their training. By 2002, those requirements had been reduced to a 10-item exam and 1 day of hands-on training. This is of particular concern because, as pointed out by the American Congress of Obstetricians and Gynecologists, there is a high learning curve for surgeons looking to become proficient in robot-assisted surgery. ACOG, along with the Massachusetts Board of Registration in Medicine, have recently warned about the risk of complications with the da Vinci in light of growing injury reports.