Robotic-assisted surgery is growing rapidly, despite a lack of good data from clinical trials showing its results are any better than those of traditional surgery.
As Chicago Tribune reporter Trine Tsouderos points out in an article last weekend, more than 1,500 units of the da Vinci Surgical System, a robot marketed by Intuitive Surgical Inc, have been sold to hospitals and medical clinics across the country — at up to $2 million each (plus a yearly maintenance contract that can run as high as $180,000).
Some of those buyers are here in Minnesota. A quick web search turned up several Minnesota hospitals proudly promoting the da Vinci robot on their websites.
Doctors are divided
But are robotic-assisted procedures worth the added cost? And, perhaps more to the point, are they safe?
Doctors are divided about the benefits and risks of the procedure. Here’s Tsouderos’ summary of the controversy:
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.
Studies are less than reassuring
Few randomized, controlled clinical trials (the gold standard of studies) have been done on the da Vinci system because, as one supporter of the technology told Tsouderos, it’s hard to recruit patients for such studies. No one wants to leave decisions about their surgery up to “what amounts to a coin toss.”
But that leaves us with studies that are less than reassuring. “Even the data on one of the most popular robot-assisted surgeries, the radical prostatectomy, are mixed,” writes Tsouderos. “The surgery is a difficult one, requiring the surgeon to remove the cancerous prostate without damaging nerves that control a man’s continence and sexual function. Give the nerves too wide a berth, and cancer may be left behind. Get too aggressive, and the nerves may be damaged, risking impotence or incontinence.”
A steep learning curve
One of the clear take-home messages from Tsouderos’ article is that if you’re going to undergo robotic surgery, make sure your surgeon has done the procedure many, many times before.
“Studies have shown that surgeons learning to operate using the da Vinci face a steep learning cure,” she writes. “Accustomed to being guided by the feel of tissue, surgeons must learn to be guided by their eyes, as the robot offers no sense of touch. They must develop hand-eye coordination without seeing their hands.”
One surgeon told Tsouderos that it wasn’t until after his 500th robot-assisted surgery that the procedure “clicked” for him and he felt he could handle the most complex cases.
“Until then, everything was with learning,” he said.
You can read Tsouderos’ article on the Chicago Tribune website.