By Gary Walker
The use of robots in the operating suite is no longer the stuff of science fiction or films.
Robotic technology has been employed for more than a decade and hospitals have engaged in intense public relations campaigns, advertising its accuracy and other advantages to traditional surgery to promote the innovative surgical machinery.
But recent headlines have forced the U.S. Food and Drug Administration to take a look at a company that manufactures equipment for robot-assisted surgery and the use of robotics as a surgical tool in general.
The federal agency has received over 200 reports of incidents since 2007. These include cuts, burns and infections that have occurred during robot-assisted surgery. In investigating these claims, much of the government’s focus has been on the equipment used in the operations.
But a local doctor who has been performing surgeries using robotic technology for a decade strongly believes that a distinct lack of training on the part of surgeons using the machines is the greater concern and that this dearth of experience is what can lead to the aforementioned complications, some often crippling or life-altering.
Dr. S. Adam Ramin is a urologic surgeon at Saint John’s Health Center in Santa Monica and one of the first surgeons in the United States to perform robot-assisted surgery. He believes with this operating technology, it largely depends on the skill and experience of the carpenter and not as much on the tools.
“In my experiences, almost all problems associated with robotic surgery are due to a lack of surgical training with the robot,” Ramin told The Argonaut. “We see major complications with surgeons who are not properly trained to use this technology.”
Dr. Daniel Marcus, a general surgeon at Marina Del Rey Hospital near Marina del Rey is in complete agreement with Ramin.
“The issue is not so much the technology but the person on the other end of the technology,” added Marcus. “There has not been one case where the robot has been implicated in (surgical complications).”
On Sept. 8, 2008 in Silverdale, Wash., a routine prostatectomy for 67-year-old Fred Taylor went horribly wrong during a robot-assisted operation that left him with a colostomy bag and he was rendered incontinent. Taylor passed away last year but the New York Times reported in March that his wife Jossete decided to bring a legal action against Intuitive Surgical Inc., a Sunnyvale, Calif. company that specializes in robotic surgical systems.
A prostatectomy is the partial or complete removal of the prostate gland.
In the Taylor case, the surgeon, Dr. Scott Bildsten, reportedly had never used the robotic equipment without supervision.
Nearly 400,000 robotic-assisted surgeries were performed last year, according to the California-based company, which manufactures da Vinci surgical robots. The machines cost approximately $1.5 million.
As of 2009, Intuitive had installed 1,242 systems worldwide.
In an inspection report sent May 30 obtained by The Argonaut, the FDA notified Intuitive about four instances where they faulted the company for failing to report a correction or removal conducted to reduce a risk to health posed by a device, for illnesses and injuries that were not reported and not adequately establishing procedures for design changes.
The federal agency reported that Intuitive sent a letter to da Vinci clients Oct. 10, 2011 with “suggestions and recommendations for the proper use of instruments with tip covers and the correct generators that should be used with monopolar instruments.”
Three days later, Intuitive sent another letter to da Vinci clients to let them know that the surgical systems were not cleared to perform thyroidectomy indications.
Representatives of Intuitive did not return calls for comment at Argonaut press time. But Medscape Medical News reported that Geoff Curtis, a spokesman for Intuitive, said in an email that the FDA had reclassified these various field actions from nonreportable to reportable. “We take our regulatory obligations seriously,” Curtis wrote.
Onder, Shelton, O’Leary & Peterson, a St. Louis-based personal injury law firm, is representing families and individuals who say they have been injured by the da Vinci robotic equipment. Michael Kruse, the lead attorney on the da Vinci cases, could not be reached for comment.
Robotic technology is now employed frequently in gynecological operations as well as prostate surgeries, heart and colorectal surgeries and treatments for the bladder, prostate and kidney.
“Now, almost all residency programs provide robot training,” Ramin noted.
Surgeons operate the da Vinci robot remotely using a variety of controls and joysticks.
Ramin, who has testified as an expert witness in trials involving robot-assisted surgeries, including in the Taylor case, thinks 20 proctored or supervised surgeries with the da Vinci machine would give doctors the training they need to use robots properly in the surgical suite. “That would allow a surgeon to avoid any major complications,” he said.
The standards for how much training is required seem to vary from hospital to hospital, where the credentialing baselines are set.
“The protocols at most hospitals are not as stringent as they are at (Saint John’s),” Ramin said. “Hospitals tend to only look for proof of training in robot-assisted surgeries and an evaluation by another doctor.”
According to some hospitals and surgeons – including Marcus and Ramin – robotic technology offers doctors the advantages of high definition, three-dimensional images.
Marcus said in robot-assisted operations, the infection rate for patients tends to be lower than in those without the technology.
Ken Alpern, a Mar Vista dermatologist, does not use robots in his practice. But he agrees with Ramin and Marcus that a successful operation is more often than not dependent upon the carpenter and not the tool.
“As with a scalpel, when a surgery goes wrong – robotic or otherwise – it’s the equipment operator, and not the equipment, that’s almost always to blame,” Alpern asserted.
Marcus said the new technology can allow for additional improvements in the surgical suite.
“Robot-assisted surgery has the potential to be even safer, more precise and more refined,” he said.
Ramin said the way that hospitals have advertised robot technology has unintentionally contributed to downplaying the skill of the surgeon and placed more emphasis on the robot.
“The use of robot-assisted surgery has almost become romanticized. It has been marketed in such a way that it reduces the abilities of the surgeon,” he said. “But the robot is only a tool.”
Ramin said patients should inquire about the doctor’s history with robotic equipment prior to undergoing surgery.
“How many of these specific surgeries has the surgeon performed in the past, how long have they been using robotic technology, how many surgeries has the surgeon done within the last few months and their success and complication rates are good questions to ask,” the surgeon recommended.
Marcus said there are many advantages to using robotics in surgery but one stands out to him among the others. “One thing that is very clear is that there is a distinct advantage to robotic technology because we can see things much more clearly,” the doctor asserted.
While complications and even severe injuries have transpired with robot-assisted technology, Ramin is convinced that better training will minimize them and make patients feel more confident about the device’s use in the surgical suite.
“In the proper hands (robotic technology) gives us a tremendous advantage but it can be very dangerous in the wrong hands,” the surgeon concluded.
“If you are a pilot and you only have experience in propeller planes and then you are asked to fly an F-15 Eagle (a U.S. Air Force fighter airplane) without any training, there would probably be complications.”