“Player Piano” Robotic Surgeries Put Women’s Lives At Risk

[Update, March 14, 2013: A little more than a week after my post went up, the President of the American Congress of Obstetricians and Gynecologists (ACOG) issued a statement noting "the outcome of any surgery is directly associated with the surgeon’s skill," and urging patients "to separate the marketing hype from the reality when considering the best surgical approach for hysterectomies."]

 

In Kurt Vonnegut’s novel Player Piano, machines have replaced humans in most jobs, but only humans can be barbers and surgeons, given the complexity of the movements required. As Vonnegut noted, barbers “[u]sed to be sort of doctors, bleeding people and setting their bones and all, and then the doctors got sore and took over all that stuff and left the barbers haircutting and shaving. Very interesting history.” Interesting indeed: for more on the history connection between barbers and surgeons, see “From Haircuts to Hangnails – The Barber-Surgeon.”

 

I had Player Piano on my mind as a result of two articles published last week relating to robotically assisted hysterectomies. The efficacy and safety of robotic assisted surgeries, particularly hysterectomies, is an issue of growing importance. The Da Vinci Surgical robotic surgery system is advertised as having “the potential for significantly less pain, a shorter hospital stay, faster return to normal daily activities,” but it is become increasingly clear that the system has no additional benefits beyond typical laparoscopic surgery, while imposing additional costs and risks.

 

First, the Journal of the American Medical Association published “Robotically Assisted vs Laparoscopic Hysterectomy Among Women With Benign Gynecologic Disease,” a study that found “Between 2007 and 2010, the use of robotically assisted hysterectomy for benign gynecologic disorders increased substantially. Robotically assisted and laparoscopic hysterectomy had similar morbidity profiles, but the use of robotic technology resulted in substantially more costs.” For a while now, surgeons have questioned the value of these machines (one example here, another here), given the absence of any proof that they’re better while costing more than double the price of a typical laparoscopic hysterectomy, and this study confirms the absence of any additional benefit. As the accompanying JAMA editorial argued, “Consumer advertising of expensive devices should be subjected to the same scrutiny as that of new and expensive medications.”

 

Second, Bloomberg News reported that the Food and Drug Administration was surveying surgeons to see if the $1.5 million “Da Vinci” surgical robot manufactured by Intuitive Surgical, Inc., was safe. Bloomberg framed the issue as, “[t]he answers may sway debate on whether robotic surgeries promoted as being less invasive are worth the extra cost,” which is partly true, but we need to clarify what we’re talking about: robotically-assisted hysterectomies. There are plenty of other fascinating robotic surgeries that are being studied and practiced, but each different type of surgery should be analyzed separately.

 

I can tell you the answer quite frankly: no, robotic hysterectomies are not worth the extra cost, and they are likely more risky than laparoscopic surgeries done without them. 

 

Robotic surgery sounds futuristic, like a doctor pushing the button and the robot doing all the work (as Player Piano envisioned almost all jobs), but, in reality, most robotically-assisted surgeries — including the Da Vinci hysterectomies — don’t work that way. The doctor is still making every movement themselves, but they’re doing it by controlling the robot, rather than directly making contact with the surgical instrument. It’s analogous to the difference between using the power steering in your car versus grabbing the handlebar on a bicycle: you’re in control either way, but in the former situation you’re controlling a computer which is then making the movement. Thus, the supposed primary benefit is quite simple: while laparoscopic surgery makes it harder for the surgeon to maneuver and see during the operation, robots can be more dexterous than humans, and so, a properly designed and operated robot can perform surgeries with smaller incisions and more gentle handling of tissues.

 

It sounds like a win-win, but the truth is a lot more complicated. Let’s start with an obvious but important point: a machine is only as good as its operator. The JAMA study noted only a slight increase in intraoperative complications, like bladder and vascular injuries, but (a) it relied entirely on the Perspective Database, which is good but not comprehensive and (b) it didn’t attempt to tease out the differences among physicians performing the procedures — which can be quite substantial. For example, a urologist who did a fellowship in female pelvic medicine and reconstructive surgery has several years more surgical training than a typical gynecologist.

 

It’s no secret that gynecologists don’t receive adequate surgical training:

 

The quality of surgical training in obstetrics and gynecology residency programs has suffered in the past 2 decades. Indeed, 63% of experienced gynecologic oncologists on the faculty of North American residency training programs reported a decrease in the surgical skills of residents compared to those trained 5 years ago. Similarly, in a European study, only 30% of residents and 78% of obstetrician and gynecological surgeons were satisfied with their training.

 

Shockingly, gynecology is the only surgical specialty which doesn’t require at least a year of general surgery. Take a look at some of the requirements for other surgical specialties:

 

  • Colon and Rectal Surgery: General surgery training plus one additional year completing a colon and rectal surgery residency
  • Oral and Maxillofacial Surgery: A four-year graduate degree in dentistry plus a minimum of four years in a general surgery training program
  • Pediatric Surgery: General surgery training plus two years of full time education in an approved pediatric surgery fellowship program
  • Urology: Two years of general surgery training plus a minimum of three years, but usually four years, in urology

 

Notice that most surgical specialties requiring all of the same training as general surgery. Then there’s the training required of gynecologists:

 

  • Obstetrics and Gynecology: Four years: Three years entirely in obstetrics and gynecology, plus one elective year

 

In general, gynecologists don’t spend that whole year training in general surgery, they spend a mere four weeks learning and training in the principles of surgery. That’s like spending four weeks at a painting camp and expecting you can paint your own version of the Mona Lisa. Surgery isn’t a compilation of techniques; it’s an art, one that takes years to master.

 

We see the terrible consequences of inadequately trained gynecologists all the time in our transvaginal mesh cases. The gynecologist goes to a seminar about some sort of bladder sling kit, watches a procedure or two, then comes out thinking they can start operating on women with complicated medical conditions — yet they don’t understand the technique, don’t know how to deal with problems that arise, and don’t even know how to diagnose surgical complications.

 

Put simply, gynecologists are lured by medical device companies into thinking they, too, can perform real surgery despite lacking the years of training surgeons have. A typical Da Vinci robotically-assisted hysterectomy thus begins with a physician — a gynecologist with, at best, a couple weeks on a surgery rotation — who isn’t trained in the principles of surgery. That’s likely why, as Citron Research discovered, a review of the FDA’s MAUDE database shows “The most common reasons for patient injuries [arising from the Da Vinci] are perforations (organ punctures), lacerations (cuts) and tears.” The gynecologists don’t know what they’re doing, and adding a deceptively reassuring machine to the process makes it worse. It’s like we took a step back a century or two, when hysterectomy patients often died of haemorrhage and peritonitis.

 

Then there are two problems with the machine itself. When using the Da Vinci, the surgeon is forced to use a monopolar cautery, a/k/a a “Bovie.” The “Bovie” is an electric scalpel that uses a high-frequency electric current to cut tissue by heating it. There’s nothing inherently wrong with it — it’s one of the great surgical innovations — but it poses a number of risks, most notably the propensity to burn tissue and create “surgical smoke.” Thus, it’s also no surprise that Citron found “the second-most prominent pattern [of injury during a Da Vinci surgery] is electrocautery: burns from electrical discharge.” Given gynecologists lack of experience and training, they’d likely do better with a safer device, like a Harmonic scalpel. Perhaps more worrying, there have been reports of patients being injured when the insulation on the Da Vinci failed, and the electrical current spread from the Bovie scalpel itself and injured the patient.

 

Now, this is a legal blog, not a medical blog, so you can surely see where this post is headed, and, indeed, as of March 2013 more than a dozen lawsuits have been filed against Intuitive Surgical, most of them involving injuries during hysterectomies, many of them burns arising from the monopolar cautery. Even more worrying, the FDA’s MAUDE database of self-reported adverse events includes literally thousands of complaints of injuries, and 55 reported deaths. Consider this adverse event report involving a surgery last October:

 

It was reported 2 days post a successful da vinci si myomectomy procedure, the patient expired. … [T]he surgeon who performed the surgical procedure reported to [a consumer representative] that a tenaculum forceps instrument being used during the surgical procedure was not moving as it should. … [T]he intuitive surgical csr was notified by the surgeon that the patient was re-admitted to the hospital … due to a perforated bowel and the patient expired… .

 

As we know from other medical device litigations, the MAUDE reports are often just the tip of the iceberg. Thus, we might be seeing the growth of a brand new healthcare danger for women — one that wastes millions in healthcare dollars while doing nothing but putting women at risk.

 

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  • Fnord

    It sounds like the issue is more with the physician than with the device (though the device may well be a waste of money). There are some potential issues with the insulation failing, as you say, which is a device problem. But the more pervasive problem is doctors with insufficient surgical training screwing up surgeries.

    • http://www.litigationandtrial.com/ Max Kennerly

      Indeed, in the big picture, the quality of the gynecological surgery is the bigger problem, but Intuitive Surgical makes it much worse by lulling doctors into a false sense of security with their inadequate “training.”

      Take a look at the response to defendant’s motion for summary judgment in the Taylor case out in Washington: http://www.citronresearch.com/wp-content/uploads/2013/02/Taylor-vs-Intuitive-Surgical-Suit.pdf

  • KAA

    I am one of the unlucky ones that had an injury caused during my da vinci assisted hysterectomy. Also unlucky in the fact that it was not discovered and ultimately repaired until almost two weeks later. Due to a thermal injury to my ureter and the delay in diagnosis, I had to be cut open, have my bladder reconstructed and ureter reimplanted back into the bladder. This happened a year ago and I’m still not completely healed…and certainly not emotionally healed. I’d never recommend a da vinci assisted hysterectomy to anyone. Or, if they do choose that, make sure their surgeon has done this surgery hundreds, if not thousands of times!