Ethics in Medicine

Hazards of Robotic $urgery

Kristen Sparrow • March 26, 2013


woman doctor
Meeting with another Sales Rep? No thanks.

I’m getting quite crabby posting on the “Follow the Money” theme.  Who would have guessed that these expensive robots not only are no better, but can be dangerous?  First, Do No Harm.  I got a bit of snarky satisfaction from the NYTimes title, “Salesmen in the Surgical Suite.”  Click through for the whole thing, I only excerpted a few bits, but it’s the sad story of a surgery gone wrong with an inexperienced robot operator.  Here is a link to a recent article about the lack of benefit for robotic hysterectomy, even though it costs one third more.  ( I was going to blog about it but got weary of haranguing my readers.)
March 25, 2013
Salesmen in the Surgical Suite
When Fred E. Taylor arrived at Harrison Medical Center in Silverdale, Wash., for a routine prostatectomy, he expected the best medical care new technology had to offer: robotic surgery, billed as safer, less painful and easier on the body than traditional surgery..
“We are the old school, where you trust the doctor,” said Mrs. Taylor, who noted that her husband’s life was so limited after the operation that he used to cry about being “trapped in this body.”
It is not the first time patients have claimed they were harmed by Intuitive’s robotic surgical equipment, called the da Vinci Surgical System. But the Taylor case, set for trial in April, is unusual. Internal company e-mails, provided to The New York Times by lawyers for the Taylor estate, offer a glimpse into the aggressive tactics used to market high-tech medical devices and raise questions about the quality of training provided to doctors before they use new equipment on patients.
“Don’t let proctoring or credentialing” — shorthand for supervised surgery and hospital certification — “get in our way,” the e-mail said.
On March 3, 2011, a sales representative wrote in an e-mail to his team that he had met with a gynecologic surgeon in Utah who was trained a year earlier but had stopped doing robotic cases. The surgeon subsequently “agreed to convert the next two to da Vinci.”
In depositions, some Intuitive sales representatives defended their involvement, saying that it was important for surgeons to use the robotic system frequently in order to maintain and improve their skills.
The Food and Drug Administration allowed the sale of the da Vinci system in 2000 under a controversial process called “premarket notification,” often used to bring medical devices to market without the rigorous trials of safety and efficacy typically required of new drugs. ..
The largest study to date of robotic hysterectomies has questioned the use of robot-assisted surgery over more conventional forms of minimally invasive surgery. A study published in February in The Journal of the American Medical Association evaluated outcomes in 264,758 women who had laparoscopic or robotically assisted hysterectomy and found no overall difference in complication rates between the two groups.
But the researchers did find that robotically assisted surgery for hysterectomy costs on average about one-third more than laparoscopic surgery.
Last week, Dr. James T. Breeden, the president of the American Congress of Obstetricians and Gynecologists, publicly urged patients “to separate the marketing hype from the reality” when considering a surgical method for hysterectomy. “Just because it’s newer and higher technology,” he said, “doesn’t mean it’s better.”