Remote-control surgery grows, despite inconclusive evidence
Chubby, pink and anesthetized into unconsciousness and paralysis, 16-week-old Ian Lund was a small bump under blue drapes on an operating table at University of Chicago Medicine. Perched above him was a robot, with arms like a three-legged spider.

One long instrument, containing a camera, had been inserted through the baby's bellybutton. Two others had been slipped into small incisions in his left side, each with tiny operating tools. All three arms were controlled by a surgeon sitting in a boothlike console facing a wall several feet away.

Operating the surgical instruments with joystick-like controls and the camera with his foot, Dr. Mohan Gundeti carefully snipped away a blocked portion of Ian's left ureter, the tube that carries urine from his left kidney to his bladder, and sewed the healthy part back to his kidney.

The operation was a success; Ian would go home the next day. His mother, Denise Lund, burst into tears upon hearing the news.

"Can I tackle-hug you?" she asked, rising to embrace Gundeti.

The robot, known as the da Vinci Surgical System, was built by Intuitive Surgical Inc. The Sunnyvale, Calif., company has sold more than 1,500 robotic systems in the U.S. In Illinois, more than 60 hospitals and medical groups have invested in at least one.

Intuitive Surgical is a medical sensation, transforming surgery in some fields, especially gynecology and urology, in about a decade. More than 250,000 hysterectomies and prostate removal surgeries were done with the da Vinci last year, according to the company. Surgeons are expanding use of the machines to other procedures, from gastric bypasses to thyroid cancer surgeries. Advocates of the devices say they make minimally invasive surgery possible for more patients, helping them recover more quickly and in less pain.

But patients wondering whether they should opt for robot-assisted surgery should be aware that the choice is sometimes more complex than the messages presented by hospitals and the company.

Despite a flood of scientific papers associated with the da Vinci, there is a dearth of randomized, controlled studies showing patients do best if procedures are performed with the da Vinci. Federal oversight of medical devices such as the da Vinci is light. There have been voluntary recalls — more than a dozen since 2005 — involving problems with software and surgical instruments. Lawsuits have helped raise concerns that some surgeons are using the devices before the doctors are adequately trained.

This month, a jury awarded a Chicago man's family $7.5 million after he died following a robot-assisted removal of his spleen in 2007 at the University of Illinois Hospital. Neither the hospital nor Intuitive was named as a defendant in the lawsuit. The family alleged that the man's small intestine was punctured twice during surgery, causing a fatal infection.

The man's surgeon testified it was the first time he had used the robot on a living person, according to court documents.

"The robot is the symbol of the current American health care marketplace — rapid widespread adoption with little to no evidence to support it and increased costs," said Dr. Martin Makary, a surgeon at Johns Hopkins School of Medicine and author of a study of 400 hospital websites that found they were making unsupported claims about robot-assisted surgery.

The technology that eventually gave birth to the da Vinci robot was created in the 1950s by engineers who wanted to develop robotic arms that could be maneuvered from afar to handle hazardous materials or go places people cannot easily go, such as in space or at the bottom of an ocean.

Eventually people wondered whether the technology, which had been expanded and refined, could be used to improve surgery.

Before the da Vinci, minimally invasive surgery was accomplished with hand-held long instruments and a camera introduced through guiding tubes inserted through small incisions. Known as laparoscopic surgery, that approach spared patients a long scar while potentially reducing complications, pain and recovery time.

But laparoscopic surgery proved hard for many surgeons to learn. The instruments had limited movement compared with the human wrist, and the technique was difficult to adapt to more complex procedures.

The engineers behind the da Vinci aimed to solve those problems, said company CEO Gary Guthart, an engineer who has been with the company since 1996. The da Vinci system would let the surgeon sit and move tools designed to mimic the natural motion of the wrist. The tools would move intuitively. Minimally invasive surgery would be easier to learn. A special video camera would offer a three-dimensional image.

Makary said he remembers when he saw a da Vinci system for the first time, at a surgery conference. Surgeons crowded the exhibit booth, vying for a chance to try the robot.

"It was the hottest thing," he said.