The majority of the hundreds of thousands of robotic surgeries performed in the U.S. each year are done safely. However, as use of the machine increases, so are reports of injuries: The U.S. Food and Drug administration has received more than 200 reports since 2007 of burns, cuts and infections – including 89 deaths – after robotic surgery. Rock Center's Dr. Nancy Snyderman investigates Intuitive Surgical Systems and meets a woman who blames her devastating complication on the robot.
By Ami Schmitz and Melissa Dahl
The newlywed had been grappling with excruciatingly painful periods for as long as she could remember, when her doctor told her one way she could end the agony was a hysterectomy. Michelle Zarick, then 37, didn’t question it when the doctor wanted to use the latest high-tech option that medicine had to offer: a hysterectomy done with the help of a robot.
“She mentioned that doing the robotic-assisted hysterectomy would shorten my recovery time at home,” says Zarick, who had been diagnosed with fibroids, non-cancerous tumors that grow in the uterine walls.
So Zarick agreed – and initially, everything seemed fine. But in the weeks after the 2009 procedure with the machine, called the da Vinci, she suffered a horrifying complication that is still impacting her life.
Across the country, nearly 400,000 robotic-assisted surgeries were performed last year, according to Intuitive Surgical, the company that makes the robots. Use of the machine for performing hysterectomies is on the rise, increasing from .5 in 2007 to 9.5 percent in 2010, according to a study published in a February issue of the Journal of the American Medical Association. Besides gynecological surgeries, the da Vinci can deftly perform procedures like heart surgeries, colorectal surgery, plus treatments for prostate, kidney, lung, throat and bladder cancers, among others.
The majority of the hundreds of thousands of robotic surgeries performed in the U.S. each year are done safely. However, as use of the machine increases, so are reports of injuries: The U.S. Food and Drug administration has received more than 200 reports since 2007 of burns, cuts and infections – including 89 deaths -- after robotic surgery.
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The robotic surgery works like this: The patient is on the operating table while the doctor sits a few feet away at a console, where he or she can manipulate the robotic arms while watching the procedure through a 3-D viewfinder.
Many surgeons say the robot makes it easier to see and navigate to hard-to-reach places; plus, the robot-assisted surgery makes small incisions and causes minimal bleeding, leaving minimal scars and speeding post-surgery recovery time. But critics of the da Vinci worry that the high-tech, futuristic factor is driving the decision to use the robots, despite the fact that research has shown that for a hysterectomy, robotic-assisted surgery doesn’t lower complication rates for patients when compared to other surgical procedures and can cost about $2,000 more.
The first few days after Zarick’s surgery, she felt OK, she told Rock Center’s Dr. Nancy Snyderman, chief medical editor of NBC News. But five weeks after her hysterectomy, in February 2009, the unimaginable happened. There’s no delicate way to put this: Her intestines fell out of her vagina.
“I felt like I had to have a bowel movement, and -- as I was bearing down -- I felt something kind of pop inside me,” says Zarick, who looked down and saw her intestines where they were absolutely not supposed to be. “I knew that the situation that I was in at that moment was dire.”
When a hysterectomy is done, after the uterus and cervix are removed, surgeons suture the vagina at the top, where the cervix used to be. In Zarick’s case, that seal reopened, and her intestines spilled out. It’s rare, both in cases of robotic and non-robotic surgery. But published reports of this happening after robotic surgery are increasing. Researchers aren’t yet sure how often it happens.
At the hospital, surgeons were able to repair the damage, though Zarick was left with a large abdominal scar -- and lasting damage to her physical relationship with her husband of less than a year, Ryan, she told Rock Center. “Afterwards I felt like a monster. I mean, just the way that the scars and my abdomen looked,” she said. Zarick has filed a lawsuit against Intuitive; her case is one of more than a dozen filed in the last two years.
The FDA is looking into the issue to determine whether the growing number of injuries reported is simply because more robotic surgeries are being done, or if they’re being caused by the machine itself or by the surgeons, who, critics argue, may be given inadequate training.
da Vinci robot idles in empty operating room
Catherine Mohr, the director of medical research at Intuitive, described the training process to Rock Center. The company requires surgeons to take online training to learn da Vinci-specific terms – like “remote center” – that wouldn’t be found in traditional operating rooms. Surgeons must also practice the robotic surgery at Intuitive in Sunnyvale, Calif., initially on an inanimate object, learning how to move the arms around and generally familiarizing themselves with the machine. After that, they practice on a cadaver or an animal, making the robotic arms move through surgical steps like dissection and sewing.
So they’re taught all the steps – everything that, when put together, makes up a surgery like a hysterectomy. But, in Intuitive’s training environment, a surgeon would not do a practice hysterectomy, something that worries critics of the da Vinci who fear doctors aren’t thoroughly trained on the device before using it with actual patients.
“What you're not taught is how to actually do that hysterectomy, because that is something that is part of the surgical training,” Mohr told Rock Center. She later adds, “If you know how to do all of those surgical subtasks, putting them in the correct order on a hysterectomy is something that you would know how to do, as a surgeon.”
After the practice surgery on the cadaver or animal, Intuitive gives the surgeon a certificate of training completion. “The hospital then has to make the decision of whether they are going to grant them operating privileges, and what additional supervision, observed cases, or other things that they need to do before they're allowed to operate solo,” Mohr told Rock Center.
In other words: Should surgeons do three supervised surgeries with the da Vinci before going it alone? Or 30, or 300? It’s up to the credentialing committee at the hospital, Mohr says, something some critics of the da Vinci take issue with.
Patient on table during da Vinci robotic surgery
“So the real question is … is it still safe? In the hands of a good surgeon, yes,” Dr. Marty Makary, a surgeon at Johns Hopkins in Baltimore, told Rock Center. “In the hands of someone who may not have the advanced skill sets, it could be a real danger. “
Additionally, Makary points out that while the da Vinci certainly brings a certain “wow” factor, it hasn’t been proven to be any better at reducing complications for patients than existing surgical techniques.
“We’ve got great, state-of-the-art, minimally invasive techniques that have worked for years, sometimes decades, that are now being replaced with more expensive robotic technology, without a benefit to the patients,” Makary said.
For example, surgeons can remove the uterus through the vagina, a procedure that may sound off putting, but is actually minimally invasive and speeds up the patient’s recovery time. (Zarick told Rock Center her doctor briefly discussed this option with her, but were much more “excitable” about the da Vinci.) And according to the JAMA study, the robotic surgery did not reduce complication rates for hysterectomy patients when compared to existing techniques – that report found that robotic surgery did not reduce complications for hysterectomy cases. But it did add about $2,189 to the cost of each surgery.
In a statement issued to Rock Center, Dr, Myriam J. Curet, chief medical advisor, Intuitive Surgical said: “Over the past decade, more than 1.5 million da Vinci surgeries have been performed in major clinical centers around the world. A study of nearly 20,000 patients from the nationwide inpatient sample (Trinh QD et al, European Urology 2012) demonstrated that patients undergoing a da Vinci prostatectomy are less likely to receive a blood transfusion, to experience complications (both intraoperative and postoperative) and to experience a prolonged hospital stay. A 2011 meta-analysis published in the Journal of Minimally Invasive Gynecology found that ‘compared with traditional laparoscopic hysterectomy, robotic-assisted laparoscopic hysterectomy was associated with shorter length of stay and fewer postoperative complications and conversions to laparotomy’ (open incision).”
“As with any surgery, da Vinci Surgery is not without risk, Curet continued in the statement. “The da Vinci Surgical System is an advanced tool and should not be a substitute for the training, experience and surgical judgment of the surgeon with respect to how a particular surgery should be performed.”
In March, the American Congress of Obstetricians and Gynecologists released a statement on robotic surgery for hysterectomies, cautioning surgeons of the importance of separating “the marketing hype from the reality when considering the best surgical approach for hysterectomies.”
As Makary told Rock Center, “The robot is a technical tour-de-force, but I think patients need to know that for some procedures, there’s no benefit.”
Intuitive Surgical has posted average annual sales growth of 41% in the last decade, as CNBC reported and a robot can cost a hospital as much as $1.5 million – meaning pressure builds for doctors to use them for as many surgeries as possible in order for the hospital to make up for that cost.
“It can take quite a long time, especially if you’re a smaller hospital that doesn’t do as many procedures,” says journalist Herb Greenberg, who’s extensively reported on the da Vinci for CNBC. “Again, that’s what’s remarkable when we look at the story. This was sold originally to major medical centers, major clinics, and now it’s filtering down to community hospitals.”
In Zarick’s case, Intuitive has denied all allegations that her complications were caused by the da Vinci.
Mohr declined to comment on Zarick’s lawsuit.
For years, Zarick says she’s carried the weight of her story and the impact it’s had on her physical relationship with her husband, Ryan. Somehow, her horrific injury and all that followed felt like something she brought on herself, by choosing a new type of procedure she says, even though she knows that’s not a rational thought. But with her husband’s support – and therapy – she’s beginning to realize all of this was not her fault.