Robotic surgery has been under investigation from various corners of late. Like dominoes tumbling, first there was the U.S. Food and Drug Administration (FDA)’s investigation into its safety, then the American Congress of Obstetricians and Gynecologists (ACOG) releasing a statement questioning its effectiveness.
As well, health officials from some states are also shining a light on robotic-assisted surgery, among them: Massachusetts, which is calling for better training for doctors, as well as better disclosure regarding potential risks, and the New Hampshire Board of Medicine, which also has joined the chorus of critics.
Specifically the FDA is looking into a “spike in reported problems during robotic surgeries,” according to a story by the Associated Press (AP).
The article related that earlier this year, the FDA began to survey surgeons who use robotic systems during surgery. Such surveys are routine, but FDA spokeswoman Synim Rivers told the AP that there is an "increase in [the] number of reports received" about the da Vinci, which is the brand name of the surgical system manufactured by Intuitive Intelligence.
The da Vinci systems are in fact the only surgical robotic devices cleared for use in soft-tissue surgery. (Other robotic devices have been approved for use in neurosurgery and orthopedics, among other things.)
“Reports filed since early last year include at least five deaths,” the AP reported.
Rivers told the AP that she had no way to quantify the increase in reports – which likely springs from the fact that the filing of these reports is basically left up to the hospitals and device makers, who can have a varying rate of interest in reporting problems to the FDA.
As the AP report noted, the increase in problems with robotic-assisted surgery could also reflect wider use of the systems. Last year there were 367,000 robot surgeries, compared with 114,000 in 2008, according to Intuitive Surgical.
AP ran a search for robotic surgical systems in an FDA database of reported medical device-related problems from Jan. 1, 2012, and found some 500 reports, many of which came from Intuitive Intelligence.
According to the AP, as for injuries that were reported this year, consider the following (Intuitive Surgical filed all but one of those reports):
· A woman died during a 2012 hysterectomy when the surgeon-controlled robot accidentally nicked a blood vessel.
· A Chicago man died in 2007 after spleen surgery.
· A New York man’s colon was allegedly perforated during prostate surgery.
· A robotic arm wouldn't let go of tissue grasped during colorectal surgery on Jan. 14. ("We had to do a total system shutdown to get the grasper to open its jaws," said the report filed by the hospital, AP noted, adding that the report said the patient was not injured.)
· A robotic arm hit a patient in the face during a hysterectomy; it is unknown if the patient was injured.
The da Vinci system, approved by the FDA and sold on the market since 2000, includes a three- and four-armed model, which surgeons operate with hand controls at a computer system located several feet away from the patient. They see inside the patient's body through a tiny video camera attached to one of the long robot arms. The other arms clutch the tiny surgical instruments that are required.
According to AP, robotic operations are similar to conventional laparoscopy, or "keyhole" surgery, which involves small incisions and camera-tipped instruments controlled by the surgeon's hands, not a robot.
Almost 1,400 U.S. hospitals — nearly one out of four — have at least one da Vinci system, each of which cost between $1.5 million and $2 million on average, plus annual service agreements.
The most common robotic operations include prostate removal — about 85 percent of these operations in the U.S. are done with the robot, according to the AP report. The da Vinci also is often used for hysterectomies as well.
The cost, usefulness and safety of Intuitive’s da Vinci robots are all part of the debate taking place among doctors, hospitals and Intuitive Intelligence salespeople, as well as in the court room. But training remains a major issue.
So far, nearly all the lawsuits filed in the past 14 months alleging injuries from robotic surgery allude to the training regimen for doctors who use the da Vinci. As AP noted, these lawsuits include a malpractice case that ended last year with a $7.5 million jury award for the family of Juan Fernandez, a Chicago man who died in 2007 after robotic spleen surgery. The lawsuit claimed Fernandez's surgeons accidentally punctured part of his intestines, leading to a fatal infection.
Marketing is one likely reason why use of surgical robots is on the rise, AP added. Hospitals often use their websites to exaggerate the benefits of robotic surgery, according to a 2011 study in the Journal of Healthcare Quality.
That study found that 86 percent of the websites that mentioned robot surgery focused on the superiority of these procedures – with not a single one describing any of the risks associated with use of the robotic method.
Often the websites were taken – both text and images – directly from the marketing materials supplied by the manufacturer, the researchers said.