April 9, 2013

FDA taking closer look at surgeries using robot

Lindsey Tanner / The Associated Press

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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

— A Chicago man who died in 2007 after spleen surgery.

— A New York man whose colon was allegedly perforated during prostate surgery. Da Vinci's maker filed that report after seeing a newspaper article about it and said the doctor's office declined to provide additional information.

— A robotic arm that wouldn't let go of tissue grasped during colorectal surgery on Jan. 14. "We had to do a total system shutdown to get the grasper to open its jaws," said the report filed by the hospital. The report said the patient was not injured.

— A robotic arm hit a patient in the face during a hysterectomy. The company filed that report, and said it is unknown if the patient was injured but that the surgeon decided to switch to an open, more invasive operation instead.

Intuitive Surgical filed all but one of those reports.

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

Intuitive Surgical disputes there's been a true increase in problems and says the rise reflects a change it made last year in the way it reports problems.

The da Vinci system "has an excellent safety record with over 1.5 million surgeries performed globally, and total adverse event rates have remained low and in line with historical trends," said company spokeswoman Angela Wonson.

But an upcoming research paper suggests that problems linked with robotic surgery are underreported. They include cases with "catastrophic complications," said Dr. Martin Makary, a Johns Hopkins surgeon who co-authored the paper.

"The rapid adoption of robotic surgery ... has been done by and large without the proper evaluation," Makary said.

The da Vinci system, on the market since 2000, includes a three- or four-armed robot that surgeons operate with hand controls at a computer system located several feet away from the patient. They see inside the patient's body through a tiny video camera attached to one of the long robot arms. The other arms are tipped with tiny surgical instruments.

Robotic operations are similar to conventional laparoscopy, or "keyhole" surgery, which involves small incisions and camera-tipped instruments controlled by the surgeon's hands, not a robot.

Almost 1,400 U.S. hospitals — nearly 1 out of 4 — have at least one da Vinci system. Each one costs about $1.45 million, plus $100,000 or more a year in service agreements.

The most common robotic operations include prostate removal — about 85 percent of these operations in the U.S. are done with the robot. Da Vinci also is often used for hysterectomies, Wonson said.

Makary says there's no justification for the skyrocketing increase in robotic surgery, which he attributes to aggressive advertising by the manufacturer and hospitals seeking more patients.

He led a study published in 2011 that found 4 in 10 U.S. hospitals promoted robotic surgery on their websites, often using wording provided by the manufacturer. Some of the claims exaggerated the benefits or had misleading, unproven claims, the study said.

Stifelman, the Langone surgeon, said it makes sense for hospitals to promote robotic surgery and other new technology to, but that it doesn't mean that it's the right option for all patients.

"It's going to be the responsibility of the surgeon ... to make sure the patient knows there are lots of options," and to discuss the risks and benefits, he said.

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