Robotic surgery safety/marketing concerns in Boston Globe & NY Times stories

The Boston Globe reports that:

Reports of complications from robot-assisted surgery are rising, according to Massachusetts health officials who sent hospitals an “advisory” letter last week alerting them about their safety concerns.

In some cases, it appears that doctors have used the aggressively marketed robots to perform hysterectomies and colorectal operations that were too complex for the technology, or for the surgeons’ skill level in directing the robots’ actions.

…

…the manufacturer and hospitals heavily advertise the technology as reducing complications and speeding recovery.

Brigham and Women’s Hospital last fall allowed shoppers to “test drive” a robot outside Macy’s at the Natick Mall, by sitting at the console and manipulating the arms. Community hospitals have jumped on the bandwagon, too. St. Luke’s Hospital in New Bedford invited the public to get behind the controls of its new robot in January, while others including Beth Israel Deaconess Hospital Milton have erected highway billboards.

The hospitals now say they are reviewing some of their marketing activities.

What is odd is that the Massachusetts officials, according to the Globe, would not provide the data about how many patient injuries during robotic surgery had occurred over the past two years – only that the problem was increasing.

In a piece headlined, “Salesmen in the Surgical Suite,” The New York Times reports on a man who had “robotic surgery, billed as safer, less painful and easier on the body than traditional surgery….for a routine prostatectomy, (expecting) the best medical care new technology had to offer.” Excerpts:

The operation, on Sept. 9, 2008, was supposed to take five hours. But it was marred by a remarkable cascade of complications and dragged on for more than 13 hours, leaving Mr. Taylor, who had been an active 67-year-old retiree, incontinent and with a colostomy bag, and leading to kidney and lung damage, sepsis and a stroke.

Mr. Taylor survived his injuries but died last year. Now, his wife, Josette, is suing Intuitive Surgical Inc., the company that makes the equipment and trained the surgeon to use it. As it turned out, the surgeon, Dr. Scott Bildsten, had never before used the robotic equipment without supervision.

“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.

Addendum on March 28:  See our later post, “More robots, more uses, more questions,” citing more questions about evidence and marketing – this time on robotic knee surgery and on robotic rectal cancer surgery.

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