The number of adverse incident reports involving Intuitive Surgical Inc.’s robots more than doubled this year, according to U.S. regulators who also released a physician survey showing no consistent training exists for the complex machines.
The Food and Drug Administration received 3,697 adverse reports through Nov. 3, compared with 1,595 in 2012. The surge, though, doesn’t necessarily mean the rate has changed, said William Maisel, with the FDA’s device unit. Rising robot use and recent media reports and recalls may have spurred public attention, he said. The reports, from the company and medical professionals, are largely unverified by the agency.
The FDA survey released yesterday included 11 doctors who have performed from 70 to 600 robot surgeries each. While the unidentified surgeons said the device led to fewer complications and shorter recoveries, they reported incidents in which robot arms collided or missed a mark and said training was an issue.
“All respondents report that learning how to use the da Vinci Surgical System is the biggest challenge because of the device’s complex user-interface,” the FDA said in a report on the survey, which reveals a wide variety of training experiences for doctors in four different specialties.The agency declined to draw conclusions on the device's function because of the small survey size, according to its statement.
The 11 doctors surveyed also reported diverse patient complications, including reversible limb palsy, temporary nerve damage in the fingers, bleeding from perforated bowels and peripheral vision loss.
“While we are pleased with the surveyed surgeons’ very positive observations about the benefits of robotic surgery, this small informal survey cannot serve as the basis for any scientifically valid conclusions,” Angela Wonson, a spokeswoman for Sunnyvale, California-based Intuitive, said in a statement. “Large clinical studies have documented the comparative benefits of robotic surgery.”
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Added training is available for surgeons who request it, Wonson said, “in many forms -- from the manufacturer, from their hospital and from surgical societies.” Referring to comments that some doctors weren’t generally aware of recalls, she said they may not have been using the precise products recalled at a given time.
Intuitive has faced scrutiny this year over the marketing, cost effectiveness and safety of its robots, which cost $1.5 million apiece. In July, the company received an FDA warning letter after an inspection found it hadn’t adequately reported adverse events and device corrections. It also faces about 50 liability lawsuits from patients who allege injuries tied to the robot.
Bloomberg News reported last month that the rising use of robotic surgery has largely been fueled by aggressive marketing tactics by doctors and hospitals that gain a competitive edge from the use of the robots.
This includes widespread advertising that, in some cases, inflated the advantages of the robots by claiming fewer complications without proof and ignored broad-based contradictory studies finding little or no advantage to their use over similar non-invasive surgery.
Since Bloomberg News first reported in February on the existence of the FDA survey, the company’s shares have fallen 32 percent. On Oct. 17, Intuitive reported a decline in third-quarter profit as a result of lower sales. The company gained 2.7 percent to $389.83 at the close yesterday in New York.
In robot-assisted surgery, a physician sits at a video-game-style console several feet from the patient and peers into a high-definition display. Foot pedals and hand controls move mechanical arms equipped with tools, guided by a 3-D camera that shows the work as it is done inside a patient.
The FDA incident reports related to Intuitive’s robotic surgical system include injuries and deaths linked to robotic surgery operations, as well as malfunctions where no injury occurred. The agency first began looking at adverse events associated with the robots in 2011, when there were just 511 reports, said Maisel, the chief scientist for the FDA’s Center for Devices and Radiological Health.
“We identified issues that warranted additional investigation, and that prompted us to go out to the company and inspect them,” Maisel said in a telephone interview. The agency will continue to monitor the reports, he said.
“No one should be concluding simply from the increase in adverse event reports that there is a problem with the device and it should not be used,” Maisel said, adding the agency doesn’t have information suggesting the rate of robotic surgery adverse events is increasing.
Wonson, Intuitive’s spokeswoman, said “while the absolute number of adverse events have increased with the growth of procedures, the total adverse event rates have remained low and in line with historical trends.”
The surgeons surveyed by the FDA suggested doctors need time to learn how to use the foot pedals and perform operations. Two urologists said patient safety was “directly related to the surgeon’s training experience,” according to the FDA report.
All but one of the surgeons surveyed reported having trouble with the robot’s arms, which sometimes had to be repaired or replaced. Only three were aware of recalls related to the device.
Robot operations haven’t been proven in randomized trials to offer significant health benefits compared with standard, less-invasive surgery and multiple studies show they can cost thousands of dollars more. A study released in September of 16,000 women in the journal Obstetrics & Gynecology found that using the system for hysterectomies in woman with benign conditions didn’t reduce complications compared with conventional less-invasive techniques.
In gynecology, the doctors told the FDA the da Vinci system is particularly well suited for hysterectomies for patients with cancer or for uterus-preserving surgery to remove benign growths called fibroids. The urologists surveyed said the system was a good fit for prostate surgery and adrenal gland removal, and less well suited for kidney removal surgery, according to the FDA report.
Intuitive’s robotic surgery system was first cleared by the FDA for use in the U.S. in 2000 after a trial on 233 patients, done at a hospital in Mexico City. The 1998 trial compared robotic surgery in 113 patients with conventional operations for removing the gall bladder or treating heartburn. The study found no advantage for robotics, FDA officials told an advisory panel at an agency hearing in 1999.
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