Growing Concerns about Complications from Robotic Prostate Surgery

We’ve shared a good bit on here about treatment and complications for Prostate Cancer. One of the most interesting/frustrating things about medicine today is that so much can change so quickly. There are a lot of different opinions out there and it’s hard to know who’s right and wrong at any given moment. Personally, that makes me crazy.

So, in the interest of fairness, we wanted to share some different perspectives on robotic prostate cancer surgery. A few weeks ago we featured the pro-robot argument from Dr. Charles Chabert of Laparoscopic Urology Australia. Check it out here.

For the anti-robot argument we turn to a recent CNBC News article. Check out the relevant excerpts below.

When Intuitive Surgicalwent 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.

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.

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.

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. 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.

Injury Complaints

“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.

Since 2000, the database shows reports of at least 85 deaths and 245 da Vinci-related injuries. (A complete spreadsheet 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.”

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.”

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.”

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.

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.

Other emails show sales reps trying to persuade hospitals to lower the amount of supervised surgeries required before surgeons can operate solo.

Orange Line

As CNBC notes, not every hospital or surgeon is experiencing the same problems. Some hospitals that have the robot, 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.”

Check out the full article over at CNBC: http://www.cnbc.com/id/100564517

 

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