Hopkins study says risks of robotic surgery rarely mentioned

Hospitals are pushing robotic surgery even as their websites are filled with unsubstantiated claims and marketing materials provided by the primary manufacturer of the technology, according to new research from Johns Hopkins physicians.

A study published Wednesday in the Journal of Healthcare Quality claims that an estimated 40 percent of larger hospitals in the U.S. publicize the use of robotic surgery, often claiming it is better than traditional surgery.

Hopkins’ own website, as well as sites for the University of Maryland Medical Center and other large hospitals in the state, include information provided by the main manufacturer of robotic surgery equipment.

Dr. Marty Makary, an associate professor of surgery at the Johns Hopkins University School of Medicine and the study’s leader, said the study looked at 400 hospital websites and found that the risks of using robots in surgery were hardly ever mentioned, and the benefits were overestimated and influenced by the company that produces the vast majority of the machines used — Sunnyvale, Calif.-based Intuitive Surgical Inc., maker of the da Vinci line of machines.

Makary said the use of robotic surgery is rising drastically. In an April filing with the Securities and Exchange Commission, Intuitive Surgical reported that in 2010, approximately 278,000 surgical procedures were performed with the da Vinci Surgical System, a 35 percent increase from 2009.

“It’s the newest craze,” Makary said. “Hospitals have been aggressively marketing robotic surgery, and patients have responded.”

“They think it results in a better operation, but the data and the marketing are discordant,” he added.

According to the National Institutes of Health, robotic surgery is, “a technique in which a surgeon performs surgery using a computer that remotely controls very small instruments attached to a robot.”

The study found that many of the websites offering robotic surgery highlighted benefits of using the machines that include less scarring and blood loss in addition to shorter recovery time and less pain. However, the study said such claims are not backed up by the published research to date.

Makary said the Hopkins researchers reviewed 10 studies that looked at robotic surgery, with the largest consisting of 25 patients. That’s not enough to claim that using a robot is any more safe and effective than other minimally invasive surgical techniques such as laparoscopy, he said.

“Studies of that size just don’t justify having a robot in every major hospital in the U.S., and that’s the state of medicine today,” he said.

Christopher Simmonds, senior director of marketing for Intuitive Surgical, said that while the sample sizes have been small, nearly 3,800 studies have been carried out looking at robotic surgery and have been supportive of the technology. He said the company is sponsoring new research that will use larger samples.

Simmonds said the da Vinci line received its first approval 10 years ago and continues to be a safe and affordable option especially when compared to “open” surgical procedures such as open heart surgery or open hysterectomies. He said while the push has been for less invasive procedures, the so-called open options are still employed often when the harder-to-perform open surgery is the better choice.

“Laparoscopic is very hard, and a lot of very good surgeons can’t do it,” he said. “The da Vinci allows these very good open surgeons to operate as a less invasive one.”

Internet feeding the trend

Makary and the other five researchers — four of whom are affiliated with Hopkins — produced the study, which said much of the growth of robotic surgery is being driven by the Internet as web savvy patients research surgical options to find the best alternative. But, he said, instead of being presented with objective risks and benefits, they are being presented in many cases with a sales pitch for the use of robotic surgery, provided by the manufacturer.

“A hospital’s official website is a trusted pillar in the community,” Makary said. “It should be where a patient gets information just as they would from a physician.”

In the study, the researchers called for potential oversight from the federal government of such claims via the U.S. Food and Drug Administration.

Simmonds said the company provides stock images and marketing materials for hospitals if they request it.

“Really, it is their decision [if] they want to use them or not,” he said.

To cut down on the use of such material, the study calls for better self-policing of hospital websites.

Content provided by Intuitive Surgical has even found its way on to some web pages of Johns Hopkins Medicine, which has a self-policing policy banning such material. Stock photographic images of da Vinci machines and written copy from the manufacturer could be seen on the Johns Hopkins Hospital Department of Gynecology & Obstetrics web page describing robotic surgery as well as on Johns Hopkins Medicine member Suburban Hospital’s Cardiac Care and Robotic Surgery web page.

A spokeswoman for Johns Hopkins said the material should not have been posted to the websites and that Hopkins would work to bring the websites into compliance.

Hopkins is not alone in its use of material from Intuitive Surgical. Robotic surgery websites for the University of Maryland Medical Center and LifeBridge Health’s Northwest Hospital also incorporate images and copy from the company.

Financial incentive

The researchers said that hospitals might be driven to push robotic surgery for reasons of prestige, being seen as state-of-the-art and ahead of the curve technologically than other institutions. The hospitals also have a financial incentive to push robotic surgery, the researchers said — it adds an average of $3,200 to the overall cost of the procedure.

“There is a fog about what is better — robotic surgery, laparoscopy or the other minimally invasive approaches,” Makary said. “We need to determine what the best approach is, but not base it on what’s cool. Newer technology doesn’t always mean better.”

The machines are a big business for Intuitive Surgical. The publicly traded company has a $3.8 billion market cap and reported revenue of $278 million for the first three months of 2011, and a net profit of $104.1 million for the quarter compared to $85.3 million in 2010. Shares of Intuitive Surgical closed at $352.78, up $2.86 in Nasdaq trading on Wednesday.

In a filing with the Securities and Exchange Commission, Intuitive Surgical said a da Vinci system sells for between $1 million and $2.3 million. The company makes most of its money, though, from the service contracts on the machines, which typically run from $100,000 to $170,000 per year. Intuitive Surgical had 1,752 systems in place at the end of 2010.