More worry for Intuitive as MA questions robotic surgery

Massachusetts' Board of Registration in Medicine is taking a hard look at surgical robots like Intuitive's da Vinci.--Courtesy of Intuitive Surgical

Add Massachusetts to the list of entities taking a closer look at the effect of robotic surgery of late, as the state's Board of Registration in Medicine has highlighted a rise in complications from the popular procedure, putting more scrutiny on market leader Intuitive Surgical ($ISRG).

In a report issued this month, the board cites three cases in which patients needed post-operative procedures to correct problems with initial robotic surgery, concluding that, after the sweeping rise in the use of devices like Intuitive's da Vinci, it is of the utmost importance that physicians more adequately explain the risks inherent in robotic surgery and that surgeons are well-trained to use the devices.

The board does not recommend against robotic surgery en masse, but it does warn surgeons to seriously consider a patient's risk factors and a procedure's complexity before deciding to go with da Vinci. Of course, that can be difficult in the absence of well-vetted data, the board points out.

"While there are numerous single-institution, procedure-specific studies describing robotic-surgical outcomes, large-scale, high-quality, prospective studies of the risks and benefits of robotic surgery as compared to laparoscopic and open procedures have not been carried out," the board writes.

And Intuitive doesn't entirely disagree with the board's conclusion, saying that da Vinci is not a catch-all solution and that surgeons should be properly trained to operate the device.

"We agree that patients need factual information about all of their treatment options, and the evidence supports that robotic surgery has dramatically decreased the number of open hysterectomies in the U.S.," the company said in a statement. "Where patients can receive a safe and effective surgery from a skilled laparoscopic or vaginal surgeon, those cases continue to be performed by traditional minimally invasive methods."

But the Massachusetts board's concerns come at a time when all eyes are on da Vinci.

James Breeden, president of the American College of Obstetricians and Gynecologists, made a similar point last week, saying the lack of definitive studies that prove robotic surgery's worth make it little more than an expensive option for patients. And the FDA has taken to surveying surgeons about whether the rise in adverse event reports are outweighed by the benefits of robotic surgery.

- read the board's report (PDF)