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Robot Surgery Damaging Patients Rises With Marketing
Porter Adventist Hospital in Denver announced last year that Warren Kortz, a general surgeon on the medical staff, was the first in the Rocky Mountain region to use a technique known as robotic surgery to remove gall bladders through one incision in the belly button.
The operation, performed while the doctor sits at a video-game-like console, was "taking advantage of another breakthrough in robotic surgery" and is "easier on the patient," the hospital said in a press release.
"It's Star Wars stuff," Kortz was quoted as saying in another article put out by the hospital touting another operation, robot-assisted parathyroid surgery, in 2010. "My prediction is it will eventually replace everything else."
What the hospital and�Kortz�didn't reveal was the risk. Even as Kortz promoted robotic surgery, 10 patients he treated suffered injuries or complications between 2008 and 2011, according to an April complaint by the Colorado Medical Board. Five had arteries punctured or torn. Objects were temporarily left inside two, and others had nerve damage. One died and another needed cardiopulmonary resuscitation. The complaint charges Kortz with 14 counts of unprofessional conduct, including sometimes not advising patients on alternatives to the robot.
Robotic surgeries are on the rise, fueled by aggressive marketing by doctors, hospitals and�Intuitive Surgical Inc. (ISRG), which manufactures the $1.5 million robot. Advertising on hospital and doctor websites, YouTube videos, billboards, and on radio and television has hyped the advantages of robotic surgeries, often claimed fewer complications without proof, and ignored contradictory studies finding no advantage in some cases.
Robot operations haven't been proven in randomized trials to offer significant health benefits compared to standard, less-invasive surgery and multiple studies show they can cost thousands of dollars more.
U.S. hospitals used robot-assisted surgery in more than 350,000 operations last year, a 60 percent jump since 2010. Robotic surgery is used to perform hysterectomies, gall bladder removals, prostate cancer treatment, heart valve operations, and many other soft tissue operations. And half of general surgeons plan to add robotic systems within two years in response to general demand, according to a JPMorgan Chase & Co. survey reported Oct. 3.
"If there was a�Nobel Prize�for marketing, it would go to Intuitive Surgical," said John Mulhall, an urologist at�Memorial Sloan-Kettering Cancer Center�in�New York, which performs prostate cancer surgery with and without the robot.
The rise of Intuitive's robot surgery also shows flaws in how the U.S.�Food and Drug Administration�regulates the marketing of medical devices, which includes everything from radiation therapy machines to implanted devices such as artificial hips and cardiac defibrillators to drug infusion pumps to surgical instruments and surgical robots.
The FDA has just two full-time employees dedicated to evaluating medical device ads, including those involving robotic surgery, compared with a full�office�of more than 60 people watching over prescription drug promotion.
The complexity of medical devices makes safety and efficacy claims hard to evaluate, creating an environment ripe for misleading advertising, including by hospitals, said�Robert Steinbuch, a professor of law at the�University of Arkansas�at�Little Rock. "Hospital advertising is essentially a free-for-all," he said.
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