Are the purported “safety issues” with the da Vinci robot real?

A long article by Lindsey Tanner of the Associated Press was published yesterday on the NBC News “Vitals” web site. It addresses the FDA investigation of reports of “problems, including several deaths” associated with the use of the da Vinci robot surgical system that we have previously referred to.

Reading between the lines of Tanner’s article (“Robot hot among surgeons but FDA taking a new look“), it appears increasingly clear that we need to distinguish very carefully between any real problems that may be associated with the technology and problems resulting from inadequate training and experience in the use of this technology by surgeons (and perhaps by those responsible for maintenance of the equipment at specific institutions). This comes as no surprise to The “New” Prostate Cancer InfoLink.

There is every indication from Tanner’s article that the manufacturer of the technology (Intuitive Surgical, Inc.) has made significant efforts to report to the U.S. Food & Drug Administration all of the “problems” that have come to their attention. Specifically, last year, Intuitive reported a case of a patient whose colon was allegedly perforated during prostate surgery after just seeing a newspaper article about the case. However, when Intuitive approached the surgeon who carried out this procedure to obtain additional information, the doctor’s office apparently declined to provide this.

At the core of this issue is the fact that manufacturers of drugs and devices are legally required to report to regulators any and all problems that come to their attention and that may be associated with the use of specific products. On the other hand, individual physicians are not  required to do this (although they can do this voluntarily). Clearly many doctors may not report details regarding issues that, in their belief, may place them at risk for any form of legal action.

The “New” Prostate Cancer InfoLink thinks it is important to point out, yet again, that the skill, expertise, and experience of the surgeon in the use of the available equipment is a critical factor in a patient’s outcome after radical prostate cancer surgery. While there are certainly instances of technical malfunction of da Vinci robots during surgery, we are not aware of any case in which such malfunction has actually harmed a patient. (Such cases may have occurred but we are not aware of any.) On the other hand, lack of sufficient training and experience for surgeons in the use of a piece of technology with this level of sophistication comes with all sorts of risks. (Would you let your 18-year -old daughter — let alone your 18-year-old son —  take your manual-shift Porsche 911 out on the freeway without careful supervision after she had just passed her driving test in a Toyota Prius with automatic transmission?)

On a separate note is the question of whether the costs associated with the use of the da Vinci robot and the marketing of robot-assisted surgery by Intuitive Surgical and the hospitals that have acquired this equipment can be justified by any real improvements in outcomes for patients. That is a very different (albeit associated) issue. The use of expensive new technology is not necessarily “better” for patients under all circumstances. We would note only that if pressure exerted by hospital administrators to maximize use of the technology (to drive revenue and profitability) has been a factor in increasing the use of the da Vinci robot by insufficiently trained surgeons, then we do have a real problem, but that is not a problem that can be laid at the door of Intuitive Surgical (although the company may be able to exert greater influence on required levels of training for surgeons prior to their unsupervised use of the equipment).

8 Responses

  1. Sometimes I feel that the technology gets blamed for problems when it’s actually a lack of training issue. I agree that there needs to be an inquiry into whether it is a training issue or an equipment or maintenance issue.

  2. The author of this post sounds like he or she is doing the public relations spin for Intuitive Surgical. As a surgeon who has performed many hundreds of open radical prostatectomies, I gave the da Vinci system a very careful assessment.

    This was driven, in part, by the intense promotional campaign of Intuitive who essentially declared that if you aren’t performing prostatectomies with their system, you won’t be doing prostatectomies at all.

    I decided that it would take me 40 or 50 robotic procedures to approach my proficiency with the open technique. My patients typically go home on post-op day 1 or 2. My continence, potency sparing, and margin status compares with the best urologists I have had the opportunity to observe. I haven’t transfused an open radical case in over a decade or more. And I do the operation under spinal anesthesia in most cases with an operative time of about 1 hour and 45 minutes. I simply will not improve these outcomes by switching to the robotic technique.

    That being said, Intuitive Surgical can be legitimately accused of pushing their technology to doctors, hospital administrators, and patients; I have witnessed this. They have virtually no compelling data regarding superiority of their technology over open prostatectomies with experienced surgeons.

    Inexperienced urologists are promoting the da Vinci as a marketing device. Stories (verified and unverified by me) have circulated among urologists about robotically related deaths, blindness, bowel and ureteral injuries.

    In an era when the actual indications and justifications for radical prostate surgery are under legitimate indictment, isn’t it interesting that an entrepreneurial technology can be launched whereby more prostatectomies are performed by hospitals once they purchase robots?

    Land of the Free, and Home of the …

  3. Great even-handed article! I wish the studies examining the cost of the da Vinci would look at post-operative hospital stays, to see if there is any difference.

  4. Dear Dr. Kelly:

    Let me assure you that I have no interest whatsoever in how you or any other surgeon choose to carry out a radical prostatectomy. I also do not endorse the way that Intuitive Surgical have gone about the marketing of the da Vinci robot (with the full support of many hospitals and some surgeons).

    Conversely, it is not the fault of the robot if it doesn’t work perfectly. As you well know, neither does a scalpel in the hands of even the best surgeon. People are not perfect. Surgery is not perfect. Things go wrong (whether you use a scalpel or a da Vinci robot). My only point is that when people aren’t willing to own up to their human errors, it is easy to blame the tool. And I have been specifically told by many surgeons that they have come under immense pressure from institutional administrators to maximize use of da Vinci robots once these tools have been acquired. That sounds to me as though at least some in the urology community are unwilling or unable to accept the responsibility for saying no to institutional administrators.

  5. You can snipe back and forth at each other all you want. All the patient wants to know is that he is getting the best care possible using the best methodology available. At some point you, as responsible professionals, have to stop throwing incomplete if not altogether misleading and confusing marketing information at potential patients and disguising it as scientific fact.

    I am a lay person and I don’t know squat about da Vinci versus open surgery. But from what I hear recently on the radio and television the marketing people seem to want to convince me to have robotic surgery to fix a hangnail. Somebody had better stand up to the marketers and the administrators and the bean counters and put the welfare of the patients first. And if it isn’t the doctors then I don’t know who will.

  6. Dr. Kelly and Gary make great points. da Vinci has never had to go through the rigors of FDA testing in the first place. And I agree with Dr. Kelly that da Vinci is a great marketing device, almost to a fault, that there are surgeons who seemingly have not been trained well enough on it since the learning curve IS steep, and it is no secret that serious mistakes have been made.

    One surgeon on the national news last night discussed the issue of making critical robotic mistakes and not even knowing it since it can’t be “felt.”

    The self-protecting urology community does not publicize cogent negative data on collateral mistakes for obvious reasons, putting new patients at risk. Everyone knows it’s going on. Too bad “peer review” and ethical accountability is sadly lacking. Will any urologist have the guts to bring this up in next month’s national urology conference? Yeah, right.

  7. Let s/he in healthcare who has not marketed cast the first stone. As a prostate cancer patient I can share that I was told that what was best for me was whatever the person sitting in front of me was good at. So consumers (let’s take charge and stop calling ourselves “patients”) get informed. Personally, I wouldn’t let anyone with less than a 500 case experience near anyone I know. Surgeons take more than 40 cases to learn how to suture. A robot is an incredible tool but a mechanic isn’t even let loose on your car without the right experience. I remember the push-back from doctors about minimally invasive surgery in the early 90s. Many surgeons lined up to fight change. It’s hard with the lives of others in your hands. But outcomes prevailed and the technique flourished worldwide. If there is a travesty in robotics it’s the lack of courage and creativity that restricts its use. That thing can reach where a surgeon’s baby finger can’t fit and we’re stuck on RP. That said, I look forward to broader outcomes studies.

  8. Did anyone see the article “Salesmen in the surgical suite” by Roni Caryn Rabin, published March 25, 2013 in The New York Times? This reports the forthcoming legal action arising from the very sad case of a man who passed on some time after RALP (robot-assisted laparoscopic prostatectomy) using the da Vinci equipment. Of course this is only a media report and the contents have not been tested in court. But if the evidence quoted here is only marginally correct, it certainly points to training problems.

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