Complaints surrounding the Da vinci robot surgical process have sparked an FDA investigation; with investigators concerned at the cost of the procedure and its relatively immeasurable benefit to the patient. With the popularity of the surgical procedure increasing dramatically, the FDA looks to decrease complaints, and increase medical training.
The da Vinci surgical robot is designed and marketed as the lease invasive, most effective treatment option available today. It is commonly used for prostatectomies, cardiac valve repair, and gynecologic surgical procedures. Recently, critics have been complaining that there is a steep learning curve for surgeons, with procedures lacking any positive long-term benefits in utilizing the robot when compared to standard human controlled surgery.
Synim Rivers, a spokeswoman for the FDA, noted that the investigation began after a number of complaints were received by patients who underwent procedures performed by the robots.
“Since it is difficult to know why the reports have increased, FDA has elected to talk with surgeons to better understand the factors that may be contributing to the rise in report numbers…We are conducting a survey with a small sample of surgeons who used the da Vinici Surgical System” wrote Rivers, in response to the investigation.
Intuitive Surgical, the producer of the da Vinci robots, has been further criticized for circumventing FDA approval processes and not providing adequate training for surgeons using the equipment.
The da Vinci robotic surgery has completed over 367,000 surgeries in the past year alone, accounting for a 26 percent increase from the previous year, despite the higher costs and relatively little evidence for its efficacy when compared to human operated procedures.