A spike in lawsuits over a surgical robot
The following was written by KOSU’s Quinton Chandler
One of the latest developments in surgical technology is named for an innovative genius considered to be ahead of his time. The da Vinci robot manufactured by Intuitive Surgical has fast become a favorite alternative to open surgery around the nation and that includes major Oklahoma hospitals. With the robot, there’s generally less blood loss, scarring and shorter hospital stays for patients. But on the flip side…the surgical robot is costing its maker in courtrooms…
Robotic surgery? Are we really to that point where robots are replacing humans in the operating room? Well the answer’s no. The word robot is really a bit of a misnomer. We’re not talking about metal doctors operating under their own power. These machines are remotely controlled by actual surgeons.
“I use it all the time. It’s how I do virtually 100% of my prostate surgery, about 50% of my kidney surgery, a fair amount of my bladder surgery.”
Doctors using the da Vinci sit a few feet away from the patient behind a control system and a high resolution monitor that gives them a cleaner look inside. The machine can be used in a wide range of operations. Prostate surgery, cardiac, thoracic, hysterectomies…Dr. Matt Cooperberg says this robot brings a lot to his table.
“For me one of the biggest advantages is because its laparoscopic…”
-That’s when surgeons make smaller incisions into the patient.
“There’s much much less bleeding. So you’re able to see critical structures more clearly and consistently preserve nerves during prostatectomy, preserve urinary function and that sort of thing.”
Mercy, Integris, OU Medical, Deaconess, and Stillwater Medical are all Oklahoma hospitals that use the da Vinci. Most of them declined to comment but Integris Health and Stillwater Medical did tell me no one’s complained about their da Vincis.
But, who would choose to have surgery via robot?
“I think my initial thought is I’d pick a surgeon.”
“What do you think would you take a surgeon or would you take a robot?”
“Uh I still think I’d take a surgeon because there are so many anomalies in surgery.”
These two friends were on the same page but believe it or not, they were the minority.
“Probably less chance of infection.”
“I just think they’ve advanced that area so much there’s a lot of perfection in it.”
“Change my answer I want the robot that is so cool. Just so I can say that I had it!”
Da Vinci is FDA approved and Intuitive Surgical says their creation has been used in more than 1.5 million surgeries. But, since 1999 the FDA has collected reports of 85 da Vinci related deaths and about 180 injuries including damaged organs and arteries, bowel injuries, burns. Out of 1 million doesn’t sound too bad.
But, this year, in just 4 months there’s already 6 times the number of injuries from all of 2011 and twice that of 2012. Now, the FDA is asking doctors what’s causing the increase.
“I don’t know of any case where they found the robot to malfunction. It’s more of the operator not being familiar with how it functions.”
“The main allegations in the lawsuit against Da Vinci have been that the manufacturer didn’t provide adequate training and warning to the surgeons.”
Da Vinci robots have caught the attention of in and out of state law firms looking to represent injured Oklahomans in a building case against Intuitive Surgical. Gregg Luther is an attorney who specializes in medical device litigation. He says it’s the manufacturers’ responsibility to make sure doctors have all the information and training they need to keep patients safe. But, the company isn’t the only responsible party.
“The question you have to answer is did the doctor make himself familiar with the device or did the hospital check into the doctor’s ability to use the device safely before they’re granted privileges.”
To train on the da Vinci surgeons usually watch hours of video and go through practice surgery before they operate supervised by an experienced da Vinci surgeon. According to Dr. Cooperberg:
“It’s really quite easy to learn how to use the robot.”
“As far as how much training it is it really depends on what your experience is. People who have done a lot of laparoscopic surgery are going to get used to the robot a lot faster than someone who has only done open surgery.”
But, Gregg says any medical device comes with a learning curve, which simply means the more a doctor uses it the better he gets.
“When I say a steep learning curve it means if you saw it on a graph it would be kind of steep and then plateau off. There’s a lot to learn.”
Some studies suggest it could take hundreds of surgeries before a doctor reaches the peak of da Vinci’s curve. If that’s true is the robot worth the risk?
“There’s no way to tell right now whether the da Vinci will prove to be an advancement in medical technology or whether it proves to be too dangerous and falls by the wayside.”
One research group may have captured the situation perfectly with a recent study, “Angel with Broken Wings, or the Devil in Disguise?”