Daily Independent (Ashland, KY)

Community News Network

November 11, 2013

Robotic surgery deaths, injuries add to call for more training

NEW YORK — A rising number of reports about deaths, injuries and malfunctions linked to the robotic surgery system made by Intuitive Surgical may pressure hospitals to bolster training for doctors using the $1.5 million device.

The 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, 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, Calif.- 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 about 32 percent. On Oct. 17, Intuitive reported a decline in third-quarter profit as a result of lower sales.

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 that "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.

 

1
Text Only
Community News Network
  • Victimized by the 'marriage penalty'

    In a few short months, I'll pass the milestone that every little girl dreams of: the day she swears - before family and God, in sickness and in health, all in the name of love - that she's willing to pay a much higher tax rate.

    April 15, 2014

  • Allergies are the real midlife crisis

    One of the biggest mysteries is why the disease comes and goes, and then comes and goes again. People tend to experience intense allergies between the ages of 5 and 16, then get a couple of decades off before the symptoms return in the 30s, only to diminish around retirement age.

    April 15, 2014

  • treadmill-very-fast.jpg Tax deduction for a gym membership?

    April marks another tax season when millions of Americans will deduct expenses related to home ownership, children and education from their annual tax bill. These deductions exist because of their perceived value to society; they encourage behaviors that keep the wheels of the economy turning. So why shouldn't the tax code be revised to reward preventive health?

    April 15, 2014 1 Photo

  • bomb1 VIDEO: A year after marathon bombing, Boston remains strong

    The City of Boston came together Tuesday to honor those who were injured and lost their lives at the Boston Marathon on the one-year anniversary of the bombing. While the day was sure to be emotional, those affected by last year's race are showing they won't let the tragedy keep them down.

    April 15, 2014 1 Photo

  • Google acquires drone maker Titan Aerospace to spread Internet

    Google is adding drones to its fleets of robots and driverless cars.
    The Internet search company said it acquired Titan Aerospace, the maker of high-altitude, solar-powered satellites that provides customer access to data services around the world. Terms of the deal weren't disclosed.

    April 14, 2014

  • E-Cigarettes target youth with festivals, lawmakers say

    The findings, in a survey released Monday by members of Congress, should prod U.S. regulators to curb the industry, the lawmakers said. While e-cigarettes currently are unregulated, the Food and Drug Administration is working on a plan that would extend its tobacco oversight to the products.

    April 14, 2014

  • Search teams will send unmanned sub to look for missing Malaysian airliner

    Teams searching for a missing Malaysian airliner are planning for the first time to send an unmanned submarine into the depths of the Indian Ocean to look for wreckage, an Australian official leading the multi-nation search said Monday.

    April 14, 2014

  • Why Facebook is getting into the banking game

    Who would want to use Facebook as a bank? That's the question that immediately arises from news that the social network intends to get into the electronic money business.

    April 14, 2014

  • Screen shot 2014-04-11 at 4.49.09 PM.png Train, entertain your pets with these 3 smartphone apps

    While they may not have thumbs to use the phone, pets can benefit from smartphone apps designed specifically for them.

    April 11, 2014 1 Photo

  • Stepping forward: The real Colbert

    Letterman changed the late-night TV game between his run on NBC's "Late Night" and starting the "Late Show" franchise in 1993. And while it's tough to replace a pop-culture icon, Colbert, in terms of pedigree and sense of humor, makes the most sense.

    April 11, 2014