Friday, December 15, 2017
News Roundup

Robot hot among surgeons but FDA taking fresh look

CHICAGO — The biggest thing in operating rooms these days is a million-dollar, multi-armed robot named da Vinci, used in nearly 400,000 surgeries nationwide last year — triple the number just four years earlier.

But now the high-tech helper is under scrutiny over reports of problems, including several deaths that may be linked with it, and the high cost of using the robotic system.

Is it time to curb the robot enthusiasm?

Some doctors say yes, concerned that the "wow" factor and heavy marketing are behind the boost in use. They argue that there is not enough robust research showing that robotic surgery is at least as good or better than conventional surgeries.

The da Vinci is used for operations that include removing prostates, gallbladders and wombs, repairing heart valves, shrinking stomachs and transplanting organs. Its use has grown worldwide, but the system is most popular in the United States.

"We are at the tip of the iceberg. What we thought was impossible 10 years ago is now commonplace," said Dr. Michael Stifelman, robotic surgery chief at New York University's Langone Medical Center.

But the Food and Drug Administration is looking into a spike in reported problems. Earlier this year, the FDA began surveying surgeons using the robotic system. The agency conducts such surveys of device use routinely, but FDA spokeswoman Synim Rivers said the reason for it now "is the increase in number of reports received" about da Vinci.

Reports filed since early last year include at least five deaths.

Last year there were 367,000 robot-assisted surgeries versus 114,000 in 2008, according to da Vinci's maker, Intuitive Surgical Inc. of Sunnyvale, Calif.

Complications can occur with any type of surgery, and so far it's unclear if they are more common in robotic operations. That's part of what the FDA is trying to find out.

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