Robotic surgery has gained much praise in recent years, and some criticism.
The critics acknowledge the technology's promise but argue that doesn’t always make it the right choice.
One big concern is cost. Robot-assisted surgery is typically more expensive than other minimally invasive procedures. However, insurance companies reimburse hospitals at the same rate as a traditional procedure, forcing hospitals to bear the difference.
The other key concern is around training standards. Despite the learning curve involved, there are no national or state requirements on how much training surgeons must have on robotic systems before they use them for procedures.
A leading voice on the cost criticisms has been the American College of Obstetricians and Gynecologists.
In 2013, its then-president Dr. James T. Breeden called robotic surgery “the most expensive” approach to hysterectomy — removal of the uterus — with additional cost averaging $2,000 for the procedure. He described it as “not the only or the best minimally-invasive” option, citing the learning curve surgeons have to navigate to use the technology effectively as part of his reasoning.
Breeden acknowledged the advantages offered by robotics in complex surgeries, but said use of other minimally invasive procedures for standard hysterectomies could also yield lower pain and recovery times. More importantly, he said, those other procedures could provide "dramatic savings to our health care system.”
Dr. Sharee Livingston of OBGYN of Lancaster thinks that perspective is short-sighted.
Right now, she agrees that data may not justify the extra cost of robotic procedures compared to older minimally invasive approaches. “Let's look at the data 15 years from now. I think it's going to be dramatically different.”
Livingston considers robotic surgery a superior tool and said using it only for complex procedures doesn’t make sense.
“I've chosen the robot,” she said. “I'd rather do everybody the same way so that proficiency is there. That way when I do run into complex anatomy, I’m really comfortable with the technology.”
As for the additional cost, Dr. George Olt of Lancaster General Health said hospitals are bearing it because they believe it will ultimately pay off in the form of better patient satisfaction and surgical outcomes.
Cost comparisons differ depending on the surgery. A 2010 study published in the New England Journal of Medicine looked at 20 types of procedures and found that robotic surgery pushed the price up about $3,200 on average.
Robotic surgery has been widely scrutinized, according to Christopher Schabowsky, with more than 8,000 peer-reviewed studies on it so far and about a hundred more coming in each month.
Schabowsky works for ECRI Institute, a nonprofit organization based near Philadelphia that describes its mission as giving unbiased guidance on medical procedures, devices, drugs, and processes to improve patient care.
Despite the wealth of research, he said, there’s still no evidence ECRI considers conclusive on whether robotic surgery is better than traditional minimally invasive procedures — or whether the additional cost is justified.
For now, ECRI counsels hospitals to deploy robotic surgeries judiciously, to avoid unnecessarily driving up costs.
Competitors to da Vinci — currently the only FDA-approved robotic system in wide use — are expected to hit the market in the next couple of years and could drive down costs, Schabowsky noted.
Safety concerns have centered on the equipment itself and surgeons' training.
In 2014, the company set aside $67 million to settle lawsuits; it attributed them largely to a mechanical problem with the system that the FDA flagged in 2013 and declared resolved the following year. As of this July, the company faced 101 lawsuits from plaintiffs alleging injury or death as a result of a da Vinci system-assisted surgery, according to a regulatory filing.
A recent study found 144 deaths related to robotic surgery between 2000 and 2013. These were in the context of 1.74 million robotic procedures in the U.S. between 2007 and 2013, and the researchers noted that some deaths were attributed to inherent risks or complications during surgery.
Patient harm was more frequent in more complicated surgeries, researchers said, noting that both system design and surgical team expertise play a role and that “despite a relatively high number of [adverse incident] reports, the vast majority of procedures were successful and did not involve any problems.”
Overall, Schabowsky said, ECRI’s analysis shows that robotic surgery is safe if all involved staff members are trained well. Critics say that is big if.
“It’s up to each and every health care facility that has a robotics program to develop their own procedure-specific training,” he said. Intuitive Surgical, which makes da Vinci systems, has also faced criticism for aggressive marketing to hospitals.
A 2013 ECRI survey that polled about 200 hospitals found that a third of them had robotic surgery programs, but not standardized training and credentialing procedures.
ECRI is now working with hospitals to fill that gap, Schabowsky encourages patients considering robotic surgery to ask about training and experience received by those performing the procedure.
Dr. Carlos Roberts, who directs WellSpan Health’s robotic surgery program, said its da Vinci training guidelines call for a series of labs to get the surgeons used to the system and how to use it, practice on animals, then a minimum of five proctored surgeries overseen by a surgeon experienced in the technology.
LG Health has a similar training regimen that requires at least three proctored surgeries, Olt said. There’s also a simulation that can train and rate a surgeon’s proficiency with the system. And changes in the health care industry mean hospitals have growing financial incentives to ensure improved surgical outcomes.
“We are proctored for 20 to 25 cases,” said Dr. Sameera Syed of OBGYN of Lancaster.
She noted that training is a bigger concern for surgeons who are already practicing than it is for upcoming ones: Newcomers are increasingly coming out of residency with experience performing at least one kind of surgery on da Vinci.
Overall, Schabowsky said, he thinks robotic surgery has a bright future, “but you just need to be cautious.”