According to a report filed with the U.S. Securities and Exchange Commission, the manufacturer of a robotic surgery system is listed as a defendant in approximately 30 different product liability lawsuits. Intuitive Surgical is the company and its product is the da Vinci robotic surgical system. Adoption rates for this system have been climbing in recent years and because of this, many groups are becoming suspect of the device. Surgical errors have allegedly caused injuries to patients, including accidental electrical burns and several adverse events. Many were associated with two types of procedures: hysterectomies and prostatectomies.
The surgical system was first approved by the U.S. Food and Drug Administration in 2000. In 2011, about 292,000 surgeries involved the da Vinci system. Last year, that number jumped to 367,000 procedures with about 2,000 da Vinci systems installed across the country in places like Chicago. Analysts determined that about 80 percent of the procedures that are performed with the robotic system are either urologic or gynecologic, thus the prevalence of hysterectomies and prostatectomies. Both of these procedures are often considered delicate by the patients that undergo them and this could be the reason that so many people are concerned about the use of robotics here.
Even though the system may have been billed as efficient and helpful, some groups of physicians are making sure that members understand that it is not the only route for certain procedures. The American College of Obstetricians and Gynecologists is one group that made such an announcement after a study revealed similar rates of complication between robotic and laparoscopic hysterectomies. The only major difference was that the robotic surgery cost nearly $2,200 more. Other research has indicated that some adverse events regarding the da Vinci system have gone unreported. At least one study has discovered a handful of events that were never reported to the FDA between 2000 and 2012. This suggests that the figures regarding adverse events regarding the robotic system are lower than they are in reality.
Source: Medscape, “Complications of Robotic Surgery Underreported, Study says” Robert Lowes, Sep. 05, 2013