Stillwater News Press

Our World

November 12, 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 | Photo Reprints
Our World
  • 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

  • Teens trading naked selfies for mugshots

    Will teenagers ever learn? You think yours will. Maybe so. But it's likely that was also the hope of the parents of children who were so shamed by nude photos of themselves that went south - how else can they go - that they killed themselves.

    April 12, 2014

  • Boston doctors can now prescribe you a bike

    The City of Boston this week is rolling out a new program that's whimsically known as "Prescribe-a-Bike." Part medicine, part welfare, the initiative allows doctors at Boston Medical Center to write "prescriptions" for low-income patients to get yearlong memberships to Hubway, the city's bike-share system, for only $5.

    April 12, 2014

  • Is a paleo vegetarian diet possible?

    Research shows most people can follow a regimented eating plan for a short time. That's not the challenge. The challenge is finding a healthful eating plan you can follow day after day and achieve your long-term health goals. At this point, it doesn't appear that the paleo eating plan meets these objectives for most people.

    April 11, 2014

  • Granddaughter_BH.jpg Duke’s granddaughter visits Enid

    Actor John Wayne left a legacy his granddaughter, Anita Swift, works along with other family members to preserve.

    April 11, 2014 1 Photo

  • VIDEO: CBS taps Colbert as Letterman’s Late Show successor

    Bloomberg’s Jon Erlichman reports that CBS has announced Stephen Colbert as its choice to replace the retiring David Letterman as host of “The Late Show” on Bloomberg Television’s “Lunch Money.”

     

    April 11, 2014

  • Screen Shot 2014-04-09 at 4.02.29 PM.png VIDEO: Nebraska prom mishap goes viral

    A group of 22 high school students from Pierce, Neb., all decked out in prom finery, took an unplanned dip in a four-foot-deep pond when the bridge they were posing on for pictures gave way. Photos from the incident have gone viral on social media.

    April 11, 2014 1 Photo

  • pix_internet_security_01.jpg 'Heartbleed' flaw leads security experts to urge password changes

    Security experts are urging consumers to change their Web passwords after the recent disclosure of a vulnerability touching wide swaths of the Internet, even as Google, Facebook and large banks said they weren't affected.

    April 10, 2014 1 Photo

  • Don't blame voters for low turnout

    Suppose nobody votes this year. On Nov. 4 the doors to the polling places are thrown open, and there isn't anyone in line. No absentee ballots are filed. No one litigates, charging either fraud or discrimination, because there weren't any voters.
    It won't happen. But if it did, pundits and activists would surely blame public apathy for such a catastrophe. I'd name a different culprit: the major parties, their candidates and their acolytes in the news media.

    April 8, 2014

  • Screen Shot 2014-04-08 at 10.43.57 AM.png VIDEO: Amazing dance moves at NCAA title game

    Eye-catching action wasn't confined to the court at AT&T Stadium Monday night during the NCAA Championship game between UConn and Kentucky. This pair -- apparently a father and son -- delighted the crowd during a timeout with some synchronized dance moves.

    April 8, 2014 1 Photo

Buy & Share Photos
NewsPress e-Edition
NewsPress Specials
AP Video
Raw: Ferry Sinks Off South Korean Coast Town, Victims Remember Texas Blast Freeze Leaves Florida Panhandle With Dead Trees At Boston Marathon, a Chance to Finally Finish Are School Dress Codes Too Strict? Raw: Fatal Ferry Boat Accident Suspicious Bags Found Near Marathon Finish Line Boston Marks the 1st Anniversary of Bombing NYPD Ends Muslim Surveillance Program 8-year-old Boy Gets His Wish: Fly Like Iron Man Sex Offenders Arrested in Slayings of CA Women India's Transgenders Celebrate Historic Ruling Tributes Mark Boston Bombing Anniversary Raw: Kan. Shooting Suspect Faces Judge
Stocks
NDN Video
Baby Sloths Squeak for Their Cuddle Partners in Adorable Video Miley Cyrus Hospitalized After Severe Reaction To Medicine Raw: Ferry Sinks Off South Korean Coast Toddler climbs into vending machine 8-year-old Boy Gets His Wish: Fly Like Iron Man Much-Anticipated 'Gone Girl' Trailer Finally Debuts! (VIDEO) Dog and Toddler Wear Matching Outfits in Adorable Photo Series VP Biden: "World witnesses ordinary citizens doing extraordinary things" It's Official! Michael Strahan Joins "GMA" Blood Moon Time-lapse Actress Lake Bell Goes Topless The Five Weirdest Local Taxes in America Applicants Vying for 'World's Toughest Job' Get Heartwarming Surprise Awkward: Crist catches Lt. Gov. insulting him on camera NASA Showcases Lunar Eclipse US Airways Tweets Graphic Photo of Nude Woman Behind the scenes of the Marathon anniversary photo shoot American Airlines Responds After Girl Tweets Alleged Terror Threat 'Joke' Charlie White's "Dancing" Mistake Olympic Great & Baltimore Native Michael Phelps Ends Retirement; Eyes Rio
Must Read