Top Surgeon: Robotic Operations Safe If You Choose the Right Doctor

Tuesday, 09 Apr 2013 05:13 PM

By Nick Tate

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As the FDA investigates a spike in reported problems with robotic surgeries, a leading authority in the field tells Newsmax Health that it’s the choice of doctor – not the technology – that most often leads to complications.

David Samadi, M.D., vice chairman of the Department of Urology and Chief of Robotics and Minimally Invasive Surgery at the Mount Sinai School of Medicine in New York City, says he welcomes the agency’s decision to look into complications during operations involving the da Vinci robotic-surgery system.

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The FDA scrutiny of da Vinci systems, used in nearly 400,000 surgeries nationwide last year, could weed out inexperienced or incompetent surgeons who use the multi-armed devices to help in removing prostates, gallbladders, and wombs, repairing valves, shrinking stomachs, and transplanting organs.

“The FDA should look into this to be sure doctors are doing this properly,” he says, but argues problems aren’t with the technology itself, but with surgeons who aren’t trained to use it properly.

“An experienced surgeon plus the da Vinci is equal to a superb outcome for patients,” says Dr. Samadi, who has performed upwards of 4,000 procedures using the da Vinci systems over the past 12 years. “When you have inexperienced surgeons using the robots, you have complications and other problems and issues.”

Dr. Samadi says the FDA action is “a big deal” that should prompt consumers to take note and to closely evaluate a surgeon before scheduling an operation. A competent surgeon will have had extensive training in using the da Vinci robots, a low complication rate, and at least 300-400 robotic surgeries under his or her belt.
“The problem we have is patients sometimes don’t know what experience the surgeon has using the robots,” he explains. “And just because someone claims they’re a robotic surgeon, it doesn’t mean they are an experienced robotic surgeon.”

Robotic surgeries are a growing trend. The da Vinci systems have been installed in more than 2,000 U.S. hospitals, according to the technology’s maker, Intuitive Surgical Inc. of Sunnyvale, Calif. Last year some 367,000 robot surgeries were performed – three times as many as just five years ago. Many facilities promote robotic surgery in patient brochures and advertising to attract business that helps pay for the high cost of the devices.

The $1.5 million da Vinci system, on the market since 2000, includes a multi-armed robot that surgeons manipulate while sitting at a computer screen. Tiny video cameras allow them to see inside the patient’s bodies. Proponents argue that robotic surgery is more precise, with less bleeding and faster recovery.

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But the FDA said reports of problems, including several deaths that may be linked with it and the high cost of using the robotic system, have prompted regulators to take a closer look. There have been several alarming incidents involving the systems, including a case where a robotic hand wouldn't let go of tissue grasped during surgery and a da Vinci arm hitting a patient in the face as she lay on the operating table.
Dr. Samadi says FDA officials contacted him as part of a survey, asking about credentialing criteria, training, hospital support, and whether there was “pressure from the hospital” to do more robotic surgeries.
“The problem is we have some surgeons using two or three rooms to run the surgeries at the same time … and they go room to room,” he says. “That’s when you have some problems.
“A good driver in a Lamborghini is going to win NASCAR. But someone who’s not a good driver in a Lamborghini … he’s going to flip the car and maybe kill himself.”

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