A rising number of reports about deaths, injuries and malfunctions linked to the robotic surgery system made by Intuitive Surgical Inc. may pressure hospitals to bolster training for doctors using the $1.5 million device.
The U.S. Food and Drug Administration received 3,697 adverse event reports through Nov. 3, compared with 1,595 through all of 2012, an agency official said in an interview last week. While the FDA said the surge may be tied to added public awareness from more use of the machines or recent media reports and recalls, a survey of surgeons released the same day suggested the complex robot interface was a challenge to master and that physician training was inconsistent.
Standardized training on new medical technologies “is a systemic problem,” said Robert Sweet, a medical training expert at the University of Minnesota, in a telephone interview. The spotlight on robotic surgery may help to focus needed attention on the issue, he said.
“Training for robotics has been the wild, wild west for a long, long time,” Jeff Berkley, chief executive of Mimic Technologies Inc., which makes simulators used for robotic training, said by phone yesterday. With patient lawsuits on the rise, hospitals and doctor organizations are realizing “they have to get their act together and start focusing on training.”
The main problem will be how to pay for and oversee the training of widely scattered physicians, Sweet said.
The doctor survey released by the FDA on Nov. 8 included 11 surgeons who have performed from 70 to 600 robot surgeries each. While the physicians, who weren’t identified, said the robots led to fewer complications and shorter recoveries, they also reported diverse patient problems. These included reversible limb palsy, temporary nerve damage in the fingers, bleeding from perforated bowels and peripheral vision loss.
Adverse incident reports can be sent to the FDA by companies, medical professionals and patients. While they are largely unverified by the agency, they can sometimes serve as a first-alert that U.S. regulators should look more closely at a product.
Angela Wonson, a spokeswoman for Sunnyvale, California- based Intuitive, said that added training is available for surgeons who request it “in many forms — from the manufacturer, from their hospital and from surgical societies.”
While the company was “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,” Wonson said in the Nov. 8 company statement.
Intuitive has faced scrutiny this year over the marketing, cost effectiveness and safety of its robots. 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
“We don’t let inadequately trained people fly airplanes and excuse it by saying that added training is available for pilots who request it,” wrote Erik Gordon, a professor at the Ross School of Business at the University of Michigan in Ann Arbor, in an e-mail.
Bloomberg News reported last month that the rising use of robotic surgery has largely been fueled by aggressive marketing tactics by the company, as well as doctors and hospitals that gain a competitive edge from the use of the robots.
This includes advertising that, in some cases, inflated the robot advantages by claiming fewer complications without proof and ignored broad-based contradictory studies finding little or no advantage to their use over conventional, less- invasive surgeries.
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 in New York on Nov. 8.
The company is also being sued by its insurer for allegedly hiding the number of legal claims it might face when buying product liability insurance.
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 William 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.
–Editors: Reg Gale, Kevin Miller
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