A rising number of injuries linked to robotic surgery has been reported to Massachusetts health officials, spurring the state to call for better oversight on training and more disclosure to patients on potential risks.
The state’s Board of Registration in Medicine said in a statement on its website yesterday that it has received “an increasing number” of reports of patient complications related to the surgery in the last two years. While the board doesn’t name any company, the only robot system cleared in the U.S. for soft tissue surgery is made by Sunnyvale, California-based Intuitive Surgical Inc. (ISRG)
“Risks for robot-assisted surgery should be thoroughly explained” to patients with advisories about how much experience a surgeon has in performing a particular robotic procedure, the board said in its statement.
The state board listed three examples of complications that have occurred following robotic surgery. In one case a surgeon inadvertently left rectal tissue in the abdomen after a procedure for ulcerative colitis. In another case a patient undergoing a robotic hysterectomy and ovary removal experienced damage to the bowel and left ureter, requiring multiple corrective treatments.
Robotic operations “carry risks of complications and poor outcomes” like any surgery, the state board said in the advisory. Credentialing doctors “should be based on proven competency and proficiency, rather than completion of a set number of cases.”
Angela Wonson, a spokeswoman for Intuitive Surgical, said the company agrees “with the conclusions in the report” which “does not oppose robotic surgery.”
In robotic surgery, a doctor sits at a video-game style console several feet from the patient and peers into a high- definition display. Foot pedals and hand controls maneuver mechanical arms equipped with surgical tools, guided by a 3-D camera that shows the work as it is done inside a patient.
A burgeoning debate is taking place among doctors and in the courts over the cost, usefulness and safety of Intuitive’s robots.
At least 10 lawsuits have been filed over the last 14 months alleging injuries from robot surgery, and almost all cite Intuitive’s training regimen. On Feb. 28, Bloomberg News reported that U.S. regulators were surveying surgeons about the robots following a rise in adverse event reports that include as many as 70 deaths since 2009.
Intuitive Surgery shares rose 2.7 percent to $495.87 at the close in New York. The stock has fallen 14 percent since Feb. 27, the day before the survey became public.
Some doctors also question the robots' cost-efficiency, pointing to the lack of large, randomized trials showing significant health gains and data in hysterectomies showing robotic surgery doesn’t reduce complications compared with conventional, less-invasive procedures.
A 2011 study found that hospital websites often exaggerate the benefits of robotic surgery. The analysis in the Journal of Healthcare Quality by researchers at Johns Hopkins University School of Medicine in Baltimore found that 86 percent of the websites that mentioned robot surgery claimed superiority, while none described the risks of the robot method. Often the websites used stock images or text provided by the manufacturer, the researchers found.
“Many hospital websites overestimate the benefits and underestimate the risks of robotic surgery, potentially misinforming patients,” the study authors concluded.
The robots and related products generated most of Intuitive’s $2.2 billion revenue in 2012.
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