Robotic Surgery: Growing Sales, but Growing Concerns
When Intuitive Surgical went public 13 years ago at $9, it dazzled Wall Street with its sizzling story of something that would revolutionize medicine: a surgical robot called the da Vinci.
Born in Silicon Valley, the da Vinci was steeped in technology so advanced that it "overcomes many of the shortcomings" of traditional open surgery, notably less blood loss and a faster recovery, Intuitive boasted in its IPO filing.
Since then, da Vinci hospital robot placements and procedures have skyrocketed. Last year alone, installations rose by 21 percent to 2,585 units worldwide at a cost of more than $1.5 million each. And robotic surgical procedures leaped by 25 percent to 450,000.
While one of the downsides of robotic surgery is a lack of tactile feel, surgeons who sit at a console a few feet from the patients raved about its 3-D vision. "The vision compensated for everything," world-renowned prostate specialist Dr. Ash Tewari of New York Presbyterian Hospital said in a recent interview. He performs as many as four of the two-to-three hour procedures a day, four times a week. "If you look at it from a surgical standpoint, every surgeon's dream is to get to see exactly what he or she is doing and get to do it in a field (of vision) which is not pooled with a lot of blood."
Such testimonials have helped propel Intuitive into what Northland Capital analyst Suraj Kalia calls "the 'Apple' of the medtech sector."
Intuitive, which builds and sells the machines, also collects more than $100,000 in service maintenance agreements for each machine and sells the disposable instruments used by the machines for surgical procedures.
With revenue last year topping $2 billion, its stock has climbed well above $500, propelling its current market valuation to more than $20 billion.
In recent years, as the da Vinci's popularity has grown, so have questions and concerns about its safety, training and the aggressiveness of its marketing.
Intuitive executives declined to be interviewed for this story, and a spokeswoman said the company would not comment on issues of safety, training and marketing because they are "within the context of active litigation."
However, at a recent investment conference, Intuitive dismissed safety concerns, telling analysts that given the number of procedures it does, it believes its safety record is "exemplary."
And in a statement to CNBC, Intuitive said: "In any definitive treatment for complex disease, such as surgery of the cancerous prostate, heart, or other major organs there are risks of complications. Robotic surgery has proven benefits in reducing the risk and complications associated with open surgical procedures thereby extending the benefits of minimally invasive surgery to a broader population of patients. Overall, adverse event rates are very low. Da Vinci surgery has been shown to be safer than the open surgery alternatives in numerous independent large scale, peer reviewed studies."
Many surgeons, including critics, agree that in the right hands the da Vinci is generally safe.
However, a CNBC Investigations Inc. review, which included numerous interviews with surgeons, lawyers, ex-employees and patients and an extensive review of internal documents, multiple studies, lawsuits and depositions of current employees, shows:
- A sharp rise in lawsuits and complaints about injuries, complications and even deaths following da Vinci procedures. At least 10 have been filed over the past two years, most of them in 2012; many more complaints, plaintiffs attorneys says, are headed toward mediation.
- Surgeons can use the robot to operate on patients after several steps, including at least an hour of online training, four hours watching two full-length procedures online, seven hours operating on a pig and as few as two surgeries, overseen by a more seasoned robotic surgeon. The number of supervised cases can vary by hospital.
- A high-pressure sales culture driven by quarterly "quotas" on surgical procedures has led sales people to lean on surgeons to do more robotic surgeries, according to interviews with former salespeople and internal emails.
On its website, Intuitive promotes the da Vinci as superior to open surgery, with such benefits as less blood loss, faster recovery and less pain.
In some procedures, such as hysterectomies, robotic surgery is being promoted and used as an alternative to laparoscopic surgery, another so-called "minimally invasive" surgical technique. A recent study published in the Journal of the American Medical Association concluded that "To date, robotically assisted hysterectomy has not been show to be more effective than laparoscopy."
And in prostatectomies, while robotic surgery is likely to result in less blood loss and faster recovery than traditional open surgery, the most feared side-effects of all—incontinence and sexual impotence—"are high after both," according to a study released last year by the Journal of Clinical Oncology.
Just last week, in what amounted to a stinging rebuke of robotic surgery, the president of the American Congress of Gynecologists and Obstetricians said: "Many women today are hearing about the claimed advantages of robotic surgery for hysterectomy, thanks to widespread marketing and advertising. Robotic surgery is not the only or the best minimally invasive approach for hysterectomy. Nor is it the most cost-efficient. It is important to separate the marketing hype from the reality when considering the best surgical approach for hysterectomies."
(Read More: Gynecologists Urge Caution on Robotic Hysterectomies)
The Food and Drug Administration recently asked surgeons to take part in a voluntary survey asking about complications involving the da Vinci. The FDA told CNBC the surveys are a routine part of its surveillance to help evaluate the device and its performance and to help understand the risk/benefit profile for devices like this.
"The robot has a place in surgery," said Dr. Francois Blaudeau, a practicing Alabama gynecologist who also is lead plaintiffs attorney focused on da Vinci-related injuries. Blaudeau, who has been trained on the da Vinci, also cautions that "it is a sophisticated piece of equipment that has its own set of issues." One, he said, is that it can inadvertently cause serious injury.
According to lawsuits, complaints, interviews with alleged victims, plaintiff attorneys and an FDA's database, many of the reported injuries during robotic surgery appear to be burns and other heat-related damage to intestines, ureter, bowels and other organs. Blaudeau and several surgeons interviewed for this story said the injuries can occur beyond the surgeon's range of vision and without the surgeon's knowledge and may only show days after the surgery. This, plaintiff lawyers say, has meant that many of the injuries and complications in the complaints have not been reported to the Food & Drug Administration as a da Vinci issue, resulting in an under-reporting of "adverse events" related to the machine.
Instead patients, unaware of a possible link between robotic surgery and their injuries, have in the past filed malpractice suits against doctors and hospitals, Blauedeau said. Intuitive declined to comment on the specific number of lawsuits and complaints. "Patients and attorneys have a right to make legal claims," a spokeswoman said. "We take any claim seriously, evaluate it on its own merits and trust in the legal system to resolve these matters."
(Read More: What Happens When a Surgical Robot Malfunctions?)
The best official source for medical device "adverse events" is the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. Submissions are voluntary, based only on reported cases and have not necessarily been investigated by the FDA. In fact, the agency cautions that it "is not intended to be used to evaluate" rates of adverse events. And doing so, Intuitive said, would be "factually and contextually inaccurate."
Since 2000, the database shows reports of at least 85 deaths and 245 da Vinci-related injuries. (A complete spreadhseet of 4,600 adverse events, including machine malfunction, filed with the FDA is included in this Intuitive report by Citron Research, which does investment research.)
During the same period, roughly 1.5 million robotic procedures have been performed, suggesting reported problems are statistically insignificant.
But critics like Dr. Marty Makary of Johns Hopkins University Hospital believe the number of injuries and complications are under-reported. A study he co-authored, which is under review by the Journal for Healthcare Quality, cross-referenced the FDA's database with press reports and lawsuits and found eight cases that were either incorrectly or never filed with the FDA.
While that may be a "fraction of procedures that are done," said Makary, the industry has done "a poor job of monitoring the safety profile of certain new technologies, and this is a classic example."
Makary, a pancreatic specialist known for doing complicated procedures—and trained on the robot— prefers straight non-robotic laparoscopy because of its lack "of what we call haptic (tactile) feedback. Because we're working around blood vessels, an inadvertent injury could result in a catastrophic bleed in seconds."
Yet, he added, "we have not even been keeping a national registry of robotic surgery-related complications. And from the ones that we have, we know from our research there is a massive under-reporting."
Blaudeau said after last fall's launch of his website badrobotsurgery.com—and in the wake of several lawsuits he filed—he has received "hundreds" of what he says are "confirmed" complaints involving "ureteral" and other injuries" during da Vinci gynecologic procedures.
And in the three months since advertising robotic injuries for Blaudeau's law firm on television in local markets, "We've probably had over 10,000 calls regarding vascular injuries, bowel, bladder, re-surgical procedures, punctures and tears," said Loni Liss, president of the Legal Communications Group, which conducts advertising campaigns seeking plaintiffs for personal injury lawsuits. "That's a very large response."
Among those who responded was Sonya Melton of Birmingham. Following six weeks in the hospital after what was supposed to be same-day robotic surgery, she said, she was home recovering and watching TV when "I see one of these commercials for attorneys. And they're talking about anyone had any problems with a robotic surgery. I'm like, 'hmmm.' … I start to do a little bit more research. And I was like, 'Well, is that the name of the robot that they used on me? Yeah, it is.'"
In an interview, she said she had become so sick almost immediately after her surgery to remove uterine fibroids that she thought she was going to die. Her condition, she said, puzzled doctors so much that within days they sliced open her stomach open to find out why she was in excruciating pain and had developed a full-fledged pneumonia. What they found, she said, was a perforation in her small intestine.
Shawn Todd, who lives outside of Mobile, Ala., also contacted Blaudeau's firm. She still breaks down and sobs when she tells how doctors, unable to get anesthesia to work, apologized for what they were about to do as they held her down and stuck needles into her kidneys, which had shut down. Turns out, she said they told her, her ureters, which carry urine from the kidneys to the bladder, had somehow been burned.
Intuitive declined to discuss both cases, which are in mediation.
Blaudeau and other surgeons we spoke with say they believe one reason for the injuries is the da Vinci's use of "monopolar" energy for cauterizing and cutting, which can create excessive heat. If there is a failure in insulation on the instruments, they said, it can cause what is known as a "stray current" or arching—when sparks from an instrument leap elsewhere.
Stray currents can occur in regular laparoscopy as well. However, a 2011 study published in the American Journal of Obstetrics & Gynecology said, "robotic instruments have a significantly higher incidence and prevalence of [insulation failure] compared with laparoscopic instruments."
Intuitive said instruments using monopolar energy have been employed in "open and laparoscopic surgery for decades," and the company is "confident that the da Vinci surgical system deploys monopolar energy in a safe and effective way when used as indicated."
The company said it offers instruments that use various types of energy, and "surgeons determine which energy instruments to use."
Training on a Pig
Surgeons, plaintiffs lawyers and at least one lawsuit cite training as a concern. Typically it involves seven hours of training over a weekend, usually operating on a pig.
Then, based on the hospital's criteria, the surgeon is required to conduct two to five surgeries supervised or "proctored" by an experienced robotic surgeon before doing their first unsupervised operation. The more practice, in general, the better, but that also adds to the cost of training.
"Many surgeons are trained the same way, with no differences made as to their prior knowledge or prior ability prior to entering the robotic training," Bladeau said. "It's not reasonable to believe that every surgeon across the country can be adequately trained with one pig lab and two proctored cases."
It was a lack of training, according to one lawsuit filed in Washington state, that ultimately led to the death of Fred Taylor in 2012, roughly four years after undergoing what was supposed to be a routine prostate surgery.
His was the third robotic case for Dr. Scott Bildsten—his first without a supervisor. Instead of taking a few hours, the lawsuit alleges, the surgery lasted around 13 hours and 26 minutes. Two hours later, Taylor was "intubated in an ambulance" after suffering from a torn rectum, losing 15 cups of blood and undergoing "a consequent hypovolemic shock," a lawsuit filed by Taylor's widow claims.
"The weeks and months to come showed the results of the surgery were devastating," it states. Taylor never fully recovered. The lawsuit alleges he died of complications from the surgery.
Meanwhile, Bildsten, according to his deposition in connection with the lawsuit, "gave up robotics forever" one year after he operated on Taylor, saying:
I was under the initial impression you would get a level of comfort within a certain number of cases. And as .... it went along, it seemed it was going to be much longer than that. ... And after speaking with some other urologists in a similar situation, who attempted to use the ....da Vinci robot prostatectomy, a lot of others have decided not to proceed as well. They found the learning curve so steep and lengthy that the level of comfort just took too long and decided to quit. I was one of those.
Neither Bildsten nor his lawyer returned calls seeking comment. Intuitive, in keeping with its policy, declined comment on the lawsuit.
The Marketing Drive
Underlying all of this, according to former salespeople and internal emails, is a company culture steeped in aggressive marketing techniques, that includes high-pressure sales efforts by Intuitive to hospitals and doctors.
"Our extensive field checks highlighted a story where aggressive marketing drives the message and true clinical utility seems secondary in nature," wrote Kalia, the Northland Capital analyst.
Intuitive declined comment on Kalia's report.
His comments are supported by our interviews with former Intuitive salespeople and internal documents, including those filed with the Taylor lawsuit. One common theme is an effort to prod surgeons to "convert" previously scheduled non-robotic surgeries to robotic surgeries to meet quarterly sales quotas.
In one email, Intuitive's clinical sales director bemoaned how the "Mountain West team is forecasting about 285 procedures each week. We need to be at 345 procedures/week to close on our goal."
With two days left in one quarter, another sales leader wrote: "Let's bring it home! Be sure to scrub all schedules, identify cases on Thursday and Friday that can be moved up. ... Turn over every stone possible. I know there are 2 out there."
In another email that day, another sales leader wrote: "Guys, it's time to call in favors for these last 2 cases. ... We need to start calling our surgical champions who know our business first thing tomorrow."
Other emails show sales reps trying to persuade hospitals to lower the amount of supervised surgeries required before surgeons can operate solo.
Marketing the robots to the hospitals, the former salespeople said, was just as aggressive. "We would go to hospitals in a local geography and get docs to pledge they would take business away to other hospitals if their hospital didn't get the robot," said one former regional sales director, repeating something several sales reps said.
With Intuitive, the marketing is to doctors, hospitals and something quite unusual for a surgical device: marketing directly to the consumer.
Hospitals proudly display banners and advertise the arrival of the da Vinci. Northwest Medical Center in Margate, Fla, even put up the da Vinci outdoor billboard with slogans like "The Power Performer" and "da Vinci, same name, same genius."
Some hospitals that have the robot, however, have kept it low key. Massachusetts General, for example, has one robot, has never actively promoted it and has capped the doctors who can use it. "We have had a very conservative, cautious and skeptical approach to the use of it," said anesthesiologist Dr. Peter Dunn, who also oversees the hospital's new surgical technology as head of its perioperative operations.
Dunn said that after five years, Mass General, which prides itself on being on the cutting edge of new medical technologies, has determined the robot has not proven to be the best solution for all patients.
And while the hospital continues to consider new uses for the robot, Dunn said, "more important than the device, is the quality of the surgeon."