by Dudley S. Danoff, MD, FACS
Laparoscopic, robot-assisted surgery has grown dramatically, increasing more than 400 percent in the United States between 2007 and 2011. About 1,400 da Vinci systems, which cost $1.5 million to $2.5 million each, have been purchased by hospitals, according to the manufacturer of the da Vinci unit.
A recent article in the New York Times pointed out that the Food and Drug Administration (FDA) is not notified of many complications resulting from robot-assisted surgeries. By law, medical device manufacturers and 
hospitals are required to report every device-related death and serious injury to a database maintained by the FDA within 30 days of learning about an incident. But a new study has found that there have been many lapses in reporting problems with robotic surgical equipment.
The da Vinci robotic system (manufactured by Intuitive Surgical Inc., Sunnyvale, California) has been on the market for about 10 years. More than one million procedures have been performed with it. Between January 2000 and August 2012, thousands of mishaps were reported to the FDA. In most cases, the patient was not harmed, but among the reports were 174 injuries and 71 deaths related to da Vinci surgery, according to a study published in the Journal for Healthcare Quality. Nearly one-third of the deaths that were reported to the FDA database occurred during gynecologic procedures, and 43 percent of the injuries were associated with hysterectomies. The incidence of patient injuries and deaths associated with robotic surgeries for the treatment of prostate cancer was rare.
The overall criticism of the use of the da Vinci device is that “the expansion has occurred without proper evaluation and monitoring of the benefits,” said Dr. Martin A. Makary, an associate professor of surgery at Johns Hopkins. He was referring to the use of the da Vinci device across the board, in all surgeries.
By comparison, in a study published in the journal Urology, researchers at Stanford University clearly demonstrated that minimally invasive laparoscopic radical prostatectomy resulted in significantly reduced complications, fewer blood transfusions, shorter hospital stays, and decreased mortality versus standard open prostatectomy. This was no small study. It identified 5,319 radical prostatectomies: 4,036 minimally invasive surgeries (laparoscopic and robot assisted) and 1,283 open procedures.
“When evaluating minimally invasive surgery techniques, particularly robotic-assisted surgery, which is now the standard of care in the United States for prostatectomies, it is important to use the surgery it is replacing as a comparator,” said Myriam Curet, MD, chief medical advisor at Intuitive Surgical. “The introduction of laparoscopic urologic surgery and subsequent development of robotic techniques have dramatically increased the use of minimally invasive radical prostate surgery. This examination of the most robust, independent surgical database clearly demonstrates that a minimally invasive radical prostatectomy can be safely performed with low complication rates, particularly when compared to alternative procedures.” She did not comment on gynecologic procedures.
Prior to the introduction of robotic-assisted surgery, 95 percent of prostate surgeries were performed open, through a midline abdominal incision. Today, more than 85 percent of the prostate surgeries performed in the United States are performed robotically through small keyhole incisions. The pertinent medical literature indicates that most of the complications utilizing the da Vinci robotic system occur in gynecologic surgery. It is also interesting to note that the overall incidence of complications has dramatically decreased as more surgeons gain operative experience using the da Vinci robot.
The da Vinci system is a surgical platform that enables doctors to perform complex surgery using a minimally invasive approach. It is designed to scale, filter, and seamlessly translate the surgeon’s hand movements into more precise movements with the EndoWrist, an instrument modeled after the human wrist that offers a greater range of motion than a human hand. The net result is an intuitive interface with improved surgical capabilities. By providing surgeons with superior visualization, enhanced dexterity, greater precision, and ergonomic comfort, the da Vinci surgical system makes it possible for skilled surgeons to perform more minimally invasive procedures involving complex dissection or reconstruction.
Although all surgery presents risk, based on my 40 years of performing radical prostatectomies—first by the open technique and now utilizing the laparoscopic robot-assisted da Vinci device—I can testify that the new technique is a quantum leap forward in the technology of prostate cancer surgery. I firmly believe that as the experience of surgeons utilizing the device increases, and as the device evolves, the advantages will become even more magnified. At the end of the day, in the surgical treatment for prostate cancer, robotic surgery wins hands down.