April 9, 2013

FDA taking closer look at surgeries using robot

Lindsey Tanner / The Associated Press

(Continued from page 2)

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In this photo from video provided by Intuitive Surgical Inc. of Sunnyvale, Calif., maker of the da Vinci robotic system, doctors are seen using the device to perform a surgery. Surgeons say the advantages of the system include allowing them to operate sitting down, using small robotic hands with no tremor. But critics say a big increase in robot operations nationwide is due to heavy marketing and hype.

AP

His hospital expects to do more than 1,200 robotic surgeries this year, versus just 175 in 2008.

For a few select procedures that require operating in small, hard-to-reach areas, robotic surgery may offer advantages over conventional methods, Makary said. Those procedures include head and neck cancer surgery and rectal surgery.

Some surgeons say the robotic method also has advantages for weight-loss surgery on extremely obese patients, whose girth can make hands-on surgery challenging.

"At the console, the operation can be performed effectively and precisely, translating to superior quality," said Dr. Subhashini Ayloo, a surgeon at the University of Illinois Hospital & Health Sciences System in Chicago.

Ayloo, who uses the da Vinci robot, last year began a study on the effectiveness of doing robotic obesity surgery in patients who need a kidney transplant. Some hospitals won't do transplants on obese patients with kidney failure because it can be risky. In the study, robotic stomach-shrinking surgery and kidney transplants are done simultaneously. Patients who get both will be compared with a control group getting only robotic kidney transplants.

"We don't know the results, but so far it's looking good," Ayloo said.

Aidee Diaz of Chicago was the first patient and was taken aback when told the dual operation would be done robotically.

"At first you would get scared. Everybody says, 'A robot?' But in the long run that robot does a lot of miracles," said Diaz, 36.

She has had no complications since her operation last July, has lost 100 pounds and says her new kidney is working well.

Lawsuits in cases that didn't turn out so well often cite inadequate surgeon training with the robot. These include a malpractice case that ended last year with a $7.5 million jury award for the family of Juan Fernandez, a Chicago man who died in 2007 after robotic spleen surgery. The lawsuit claimed Fernandez's surgeons accidentally punctured part of his intestines, leading to a fatal infection.

The surgeons argued that Fernandez had a health condition that caused the intestinal damage, but it was the first robot operation for one of the doctors and using the device was overkill for an ordinarily straightforward surgery, said Fernandez's attorney, Ted McNabola.

McNabola said an expert witness told him it was like "using an 18-wheeler to go the market to get a quart of milk."

Company spokesman Geoff Curtis said Intuitive Surgical has physician-educators and other trainers who teach surgeons how to use the robot. But they don't train them how to do specific procedures robotically, he said, and that it's up to hospitals and surgeons to decide "if and when a surgeon is ready to perform robotic cases."

A 2010 New England Journal of Medicine essay by a doctor and a health policy analyst said surgeons must do at least 150 procedures to become adept at using the robotic system. But there is no expert consensus on how much training is needed.

New Jersey banker Alexis Grattan did a lot of online research before her gallbladder was removed last month at Hackensack University Medical Center. She said the surgeon's many years of experience with robotic operations was an important factor. She also had heard that the surgeon was among the first to do the robotic operation with just one small incision in the belly button, instead of four cuts in conventional keyhole surgery.

"I'm 33, and for the rest of my life I'm going to be looking at those scars," she said.

The operation went smoothly. Grattan was back at work a week later.

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