Robotic Surgery Complications Going Underreported 99
First time accepted submitter neapolitan writes "PBS has a report on the difficulties of tracking the complications arising from surgical robotic systems, particularly the Da Vinci robotic surgery apparatus. The original study (paywall) notes that there is a large lag in filing reports, and some are not reported at all. It is difficult to assess the continued outcomes and safety without accurate reporting data."
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Its called lawsuits, that's why the are not reporting it. Slashdot should post the same article over how many human surgeries that end in complications go unreported those types of surgeries are by far would exceed the lack of proper reporting on robotic complications, which is a huge huge problem of the "health care system/medical industry".
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Its called lawsuits, that's why the are not reporting it. Slashdot should post the same article over how many human surgeries that end in complications go unreported those types of surgeries are by far would exceed the lack of proper reporting on robotic complications, which is a huge huge problem of the "health care system/medical industry".
Let's not try and minimize the complications from just surgeries. We're told half-truths with damn near every drug we try too. We all know that within a group of 100 people trying a new drug, there will be some percentage of that group where death is an acceptable side effect.
Then again, when they're (semi) truthful about a new drug, and spend the last 27 seconds of a commercial rattling off the side effect list, doubt I'm going to be any less worried about taking the new drug, wondering how many billions
Re: IT IS CALLED BUSINESS !! (Score:5, Insightful)
There are lives at stake. The least they should do is give info for accurate statistics.
Re: IT IS CALLED BUSINESS !! (Score:5, Informative)
I write these reports and analyze medical device complaints for a living. There is a legal responsibility to report any death or serious injury involving a medical device to the FDA within 30 days (5 days for very serious malfunctions) of the Become Aware date. That's the date that the reporter became aware there was an incident. This is filed on an Medical Device Report (Form 3500A). Both the users and manufacturers are responsible for reporting with the manufacturer having an obligation to investigate each reportable event and file an investigative conclusion (Follow up) if the investigation is not completed on the first report. The FDA audits medical device manufacturers on a regular basis (yearly, bi-annually, or for cause) and any missed reports found in the manufacturers records are automatic observations (483). A failure to respond to the observations can result in a Warning Letter. Further failure to respond leads to the Justice dept. getting involved and potential device seizure, manufacturing stoppage, and corporate shut down actions (Consent decree). An individual caught hiding info or being untruthful can face permanent black listing from ever working in a medical or medical device manufacturing profession for the rest of their life.
Re:IT IS CALLED BUSINESS !! (Score:4, Interesting)
Are you a troll, or just that stupid?
You *certainly* don't want to live in any kind of society. People who sell things that break, badly, and don't admit it, can, if someone gets hurt enough, wind up in jail for fraud and criminal negligence.
And you... you're probably a libertarian, meaning you have the ethics and morals of a spoiled two-year-old.
mark
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But the free market will fix every problem.
Eventually, one of the heirs of somebody who dies will hire a hitman to kill the CEO of the company who made the device that killed the person.
Way the world works, baby (Score:1)
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investors and medicos on the bleeding edge of a new and they hope lucrative technology are doing to do everything they can to promote it, including silencing problems
There was no indication from the article that non-reporting or under-reporting was for the sake of "silencing problems". Obviously that's something that should be investigated, but don't jump to conclusions. If they are trying to silence it, they're doing a lousy job. There were 245 incidents properly reported, and 8 cases of under or non-reporting. That's 3% of the incidents having been "silenced".
Re:Way the world works, baby (Score:4, Insightful)
There are eight known cases of under or non-reporting as evidenced by PACER and LexisNexis, i.e. cases that led to legal complaints. The number could be a little bit larger, although probably not by much.
I find it interesting that the Da Vinci name is still on the market; it carries a lot of negative connotations from early tests where it was used in fully-automated knee and hip surgery (although I think the current robot is different from the infamous one.) It tended to cause a great deal more damage than it fixed, as while it was perfectly good at fixing bone, there was no consideration whatsoever for soft tissue and, IIRC, it just cut its way in. It sounds like something out of Terminator when you hear it described in detail.
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Re: Way the world works, baby (Score:1)
You are living in lala land!
I am a surgeon. There is NO autonomous robotic system. The surgeon still does all the work. There is NO AUTOMATION.
I have been consulted on numerous intra operative injuries due to the use of the robotic system. Without getting to technicalities of the trade, there is NO advantage in using the robot. Everything can be done in less time with smaller incisions using laparoscopic surgery.
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I am a surgeon. There is NO autonomous robotic system.
You're right, but we'll fix that, just as we're fixing it with aircraft now, and working towards it with cars. Real engineers find it abhorrent to let wetware control anything - it's never given us anything but trouble.
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'Real engineers' says the 'software engineer'.
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Which software engineer? I'm an electrical engineer.
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Then you should know better.
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It's normal (Score:5, Funny)
Those robotic surgeons operate 24 hours a day 7 days a week, they don't have time to write reports.
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But don't worry, automated cars will work better.
The robots aren't automated. They're controlled by a surgeon using a control panel in the room next door.
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And they don't write reports. There is something called a "joke", but that's often missed on Slashdot.
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And even if the driving robots don't work better than the sugary robots, just look for a robotic two-for-one deal and you are almost guaranteed to make it to your destination in one piece.
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Re:It's normal (Score:4, Informative)
Bullshit. I make quite a good living from transcribing operative notes for these very surgeries. From the reports I see, they do make mistakes, but not as many as one would think one would while using robotic equipment.
It's even worse than that! (Score:5, Insightful)
It's even worse than that!
All the primary sources which would let us know about this are behind paywalls, so even when you post them on slashdot, nobody can read the freaking things, so it doesn't matter...
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I wish I could say this stage was unnecessary (Score:5, Interesting)
I was a big fan, but as a student of both philosophy and the history of science I had to ask how he justified performing the procedure *before* (until) he got the complication down to the level of the standard open incision. He was outraged (as were my classmates) and tersely stated that he had gotten consent (not knowing that I'd done a thesis on the inadequacies and inherent ludicracy of getting "informed consent", especially based on information from the surgeon who wishes to do the procedure).
It was a sincere question, one that I felt could not answer to my own satisfaction (his answer didn't help; he'd simply been looking to "the medical advance" and had never been trained in genuine ethics), but despite that, I feel that he had done the right thing, and that tens of millions have greatly benefited since.
Though not all would-be 'medical advances' end so salubriously, the sad fact is, we don't know any better way -- and I'd wager that we'll have workable fusion generators long before we have a better usable method for making medical advances. "First, do no harm" was a simplistic principle suited to the era before Christ when a doctor was as/more likely to do harm as/than good. (Note that the Hippocratic Oath forbids surgery outright)
We are now skilled enough that some of our advances seem "too good to deny to all comers" without full data -- but where are we to get that data, except by trial (and error). We are not yet advanced enough that MOST of our attempts at medical advance are so beneficial, nor are we advanced enough to have a much better alternative to "try it and see".
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Though not all would-be 'medical advances' end so salubriously, the sad fact is, we don't know any better way --
Whats the copay and deductible on a "salubrious" medical advance?
Sign me up for some of that, Webster!
I love the bonus vocabulary that comes with well educated scholars. Its nice to get a $10 word to go with that $20 aspirin.
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Hey ma, lookit! That them there mister don't like big words neither.
Sorry, I didn't mean to sound facetious.
But I did have to refresh my recollection of the word "salubriously" (its not even in my browser's spell checker).
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Sorry, I didn't mean to sound facetious.
I didn't perceive you were being facetious. Rather, you came off as an antiintellectual.
get a better dictionary.
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Using a big word when there is a perfectly good short word is not genuinely intellectual.
What's wrong with 'well' for the original sentence?
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I had to ask how he justified performing the procedure *before* (until) he got the complication down to the level of the standard open incision.
Couldn't something like this be practiced on animals first? If you want to stay in good w/ the ASPCA, become a vet for a while (seriously).
Secondly, are there cases (extreme obesity?) where endoscopic or laproscopic procedures have a particular advantage, such that the possibly greater risks of the new procedure are outweighed by the known risks of a standard procedure for such cases?
Re:I wish I could say this stage was unnecessary (Score:4, Informative)
When I was in medical school (decades ago), we had a lecture by one of the pioneers of endoscopic gall bladder surgery (cut some 1-2cm slits and use long-handled tools and a tiny camera to cut/remove/etc) which I well knew was already preferable to the "open procedure" that slashed the patient open (classic surgical proverb: you can never have too much exposure) so you could have the working space to reach in and do it with your big mitts)
I was a big fan, but as a student of both philosophy and the history of science I had to ask how he justified performing the procedure *before* (until) he got the complication down to the level of the standard open incision. He was outraged (as were my classmates) and tersely stated that he had gotten consent (not knowing that I'd done a thesis on the inadequacies and inherent ludicracy[sic] of getting "informed consent", especially based on information from the surgeon who wishes to do the procedure).
It was a sincere question, one that I felt could not answer to my own satisfaction (his answer didn't help; he'd simply been looking to "the medical advance" and had never been trained in genuine ethics), but despite that, I feel that he had done the right thing, and that tens of millions have greatly benefited since.
I think you answered your own question right there. The benefits of the procedure outweighed the risks. Informed consent, even for risky surgery, is still valid....so long as you properly inform the patient of the risks and benefits of the procedure. The patient gets to make their own decision. I consent patients for emergent (crash) procedures on a frequent basis. They are so sick that they may not survive the operation; however, without one they will certainly die. Most choose to take the risk. (Some decide that enough is enough and wish to be made comfortable, which is a valid option)
Now you can always argue that the patient, not being a physician, will never truly understand the risks, but that's the imperfect world we live in. OTOH, if this physician did not go through all of the risks, then that's another story.
Though not all would-be 'medical advances' end so salubriously, the sad fact is, we don't know any better way -- and I'd wager that we'll have workable fusion generators long before we have a better usable method for making medical advances. "First, do no harm" was a simplistic principle suited to the era before Christ when a doctor was as/more likely to do harm as/than good. (Note that the Hippocratic Oath forbids surgery outright)
We are now skilled enough that some of our advances seem "too good to deny to all comers" without full data -- but where are we to get that data, except by trial (and error). We are not yet advanced enough that MOST of our attempts at medical advance are so beneficial, nor are we advanced enough to have a much better alternative to "try it and see".
Now here's the rub....is robotic surgery any better, or offer benefit above, laparoscopic surgery? I will say with a decent amount of authority, there are very few procedures that have any advantage done robotically (namely those deep in the pelvis) - but note, they can still be done laparoscopicallyor even open. But there are very inherent risks....the robot removes all haptics [wikipedia.org] from the surgeons hands (versus being mildly reduced in laparoscopic procedures). The first exercise you ever do with a robot is rip a piece of suture apart....you never get to feel how much tension is on it - so you "learn" what the limits look like, as opposed to feel like. There are other things inherent to the robot that also make it more difficult such as clutching (think of how you lift your mouse to move it back to the center of the mouse pad when you try to scroll a long distance) and the lack of knowledge of where your instruments are pointing.
To a lot of surgeons out there, robotic surgery is a solution looking for a prob
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Now here's the rub....is robotic surgery any better, or offer benefit above, laparoscopic surgery?
Ultimately it will be since the entire purpose of inserting the robot in the process is to provide finer control and filter out accidental motions that could cause mistakes and complications with traditional, hands-on-the ends-of-sticks laparoscopy.
Right now it's use is limited by the number of approved procedures and the pack of wolves salivating at the prospect for waves of lawsuits against the manufacturer and operators. This limits the amount of data being produced to evaluate its effectiveness.
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Now here's the rub....is robotic surgery any better, or offer benefit above, laparoscopic surgery?
Ultimately it will be since the entire purpose of inserting the robot in the process is to provide finer control and filter out accidental motions that could cause mistakes and complications with traditional, hands-on-the ends-of-sticks laparoscopy.
You would think that that might be the case. An engineer would think that way...I know I did when I was an engineer.
However, you are wrong. You don't understand how surgery is performed. For starters, this is more biology class than chemistry or physics....this is not a photoelectric cell where light above X wavelength will fail to excite the atom out its orbital to produce a current. This is 2 kg of fertilizer (plus or minus 200 g) will produce more robust flowers then 1 kg will. You are dealing with
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One question though is the cost. It inevitably adds cost to the procedure but has no demonstrated benefit TODAY.With medical costs already out of control, that has to stop. If we need to use it to improve it, let those who will benefit from the sales bear the cost, not the patients who derive no benefit. If anything, the patients should get a discount for their participation in what is effectively a wide beta of the 1.0 version.
iRobot (Score:3)
I called this back in July [slashdot.org]. The lawsuits for the Da Vinci Robot have been going on in my area for at least a year or more. I don't know about you, but I wouldn't want one of those things cutting on me until the Tech is reliable. They started using Da Vinci in the year 2000 and these issues are just now cropping up, so there is a huge backlog to sort through.
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Re:iRobot (Score:4, Informative)
I called this back in July
Your comment was very speculative. Much hospital equipment has malware, so it must be a problem for da Vinci? Or maybe da Vinci's have better computer security. I don't know, but your comment is very speculative.
The lawsuits for the Da Vinci Robot have been going on in my area for at least a year or more.
Intuitive Surgical is a great target for lawsuits because they have deep pockets. Maybe there were one or two was legitimate suits that were won, and now everyone else is piling on, regardless of the merit of their suits. Or maybe they're all valid lawsuits. I don't know - but neither do you.
Da Vinci was great for me, maybe not for others (Score:5, Interesting)
I needed mitral valve repair surgery, and I was a good candidate for robotic surgery: relatively young, good health (other than the valve), not obese (fat gets in the way). Instead of sawing my sternum and spreading my chest open, the surgeon (who has a lot of experience in both robotic and open heart surgery) was able to go in through my right side and leave a 3-inch scar and three puncture wounds. I was in the hospital Tuesday morning, and out Friday afternoon. I'm grateful to have had access to this technology. The benefits of robotic surgery compared to open heart surgery are clear (at least in my case).
But when a hospital has a large fixed cost to acquire technology, it is all too tempting to spread that cost out over a greater number of surgeries. The benefits are not nearly so clear in surgeries that don't require bone-breaking or bone-sawing. If someday I need gall bladder surgery, or if my spouse needs a hysterectomy, I would have a strong preference to avoid robotic surgery unless a skilled surgeon can make a compelling argument that the specifics of our case are a good fit for robotic assistance. (And believe me, I read as much of the medical literature as I could in making the decision: when one of the surgical steps is, basically, "shut down the heart," you want to know as much as you can. Open heart surgery for valve repair is a well-understood, well-practiced technique, but for me the decision to use the robot was about the reduced shock to the body, shorter recovery time, and reduced scarring.)
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I am not a surgeon, but what you described can be done with or without the robot. The part that makes the difference is the keyhole technique, not the robot.
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I have to wonder how much of the underreporting is a result of pressure from the device manufacturer.
There were 245 incidents properly reported, and 8 cases of under or non-reporting. That's 3% of the incidents having been "silenced". Given the amount of money involved, I wouldn't completely rule out your concern. Nevertheless, if that's what they're trying to do, they're doing a lousy job. I'd recommend a Mafia consultant, as the NSA has shown itself to be inept.
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it is reasonable to infer that the number of non-reported cases has been under-reported as a result of pressure from device manufacturers
No, not with a 3% under or non-reporting rate. Absent specific reasons to be skeptical, it's only reasonable to suggest it might be a problem, and that it warrants investigation. However some posters here are playing armchair cynic and jumping to conclusions - that's my only point. And no, I don't own any stock in Intuitive Surgical.
As for the ruling you cited, it's absurd. However, it applies to the CPSC, which only handles consumer products. It doesn't apply to the FDA (or at least not yet).
Damn you, Slashdot (Score:1)
ObDupe! (Score:2)
Before modding the obvious way, please watch *all* of http://www.youtube.com/watch?v=G8Sux0n-kAM
They don't want to void the warranty..... (Score:2)
If there is ever any concern about how medicine is administered, just ask their lawyers. They will call the insurance company who will prepare the Hospital Administrator to testify on behalf of a robot, prior to the deposition. This might be why that new medical procedure is so expensive, even though robots don't need malpractice insurance or an early tee time. Maybe we can eventually eliminate all medical personnel and just give all of our health care dollars directly to insurance company shareholders an
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Perhaps we could afford our medicine if we just paid for medicine without the added cost of the insurance and finance and legal lobby that have infiltrated our every transactional need.
Texas implemented tort "reform" for malpractice and it did nothing to control medical costs. Overhead and bureaucracy is another matter - it's well documented that our costs are several times higher than for countries with civilized and efficient systems, and it show in our costs. We're also the only developed country that relies on for-profit insurance companies for basic medical insurance. When Switzerland instituted universal health care about 20 years ago (about the last developed country to do so, asid
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it merely moved the malpractice lawsuits to federal courts
That's your strawman. The cited costs of malpractice suits includes both state and federal cases. With some people it's so entrenched in their minds that "tort reform" is a an important way to reduce costs, that they refuse to accept the reality that it's not. "Including legal fees, insurance costs, and payouts, the cost of all US malpractice suits comes to less than one-half of 1 percent of health-care spending." [wikipedia.org]
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That's because tort reform was a JOKE.
In what jurisdiction was it a joke? How was it a joke? What should have been done?
I am a surgeon and I can say that the amount of a potential lawsuit is not the incentive to cover my ass. It's the act of being sued.
Why?
Especially when the legal system is rigged against the docs.
How so?
And my profession is ability to practice is at stake.
Really? There seem to be plenty of surgeons, and doctors in general, for an endangered profession. If you think there is a real shortage, consider pushing for an increase in the arbitrarily restricted number of residency slots.
P.S. I think most people would be willing to accept serious changes in the way malpractice is handled if doctors were more willing to police their own. Revoke the licenses of the truly incompe
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We're also the only developed country that relies on for-profit insurance companies for basic medical insurance.
The Netherlands aren't a developed country now? News to me.
We definitely have mandatory health insurance [government.nl] over here. You get to pick your insurance company, but you have to pick one. The companies have to provide certain minimum coverage and can't discriminate based on age or health (but they get compensated by the government for having to take on riskier clients).
The system seems to work quite well AFAICT.
Surprise? (Score:5, Insightful)
It was great for me. (Score:2)
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What about the training surgeons? (Score:4, Interesting)
What kind of training do surgeons undergo for using the da Vinci? That could be a big factor.
Da Vinci aside, what kind of training do surgeons undergo for regular laproscopic surgery? I would think/hope that people coming out of their residencies learned it from the get go, but what about surgeons who've been practicing for 10 or 20 years? I understand that regular laproscopic can be tough, if for no other reasons than that the tools operate backwards, and visibility can be an issue (those are some of the things the da Vinci is supposed to fix). Wish I could find the link, but it was reported that laproscopic worked better than traditional open, but only if the surgeon had good training and lots of experience.
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Sorry I don't data -- would you like an anecdote instead?
Da Vinci provides quite a bit of training. I had the chance for a company tour, and got to use a Da Vinci for about 20 minutes. They had an 8 inch diamater field of cones and other shapes made from gel set up on a table near the operation position, and an assortment of tiny rubber bands and such. It was a basic familiarization task -- can you put a tiny rubber band on a cone? And it was set up so that I could come out of the hood and glance down a
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They should have setup a miniaturized version of the old "Operation" kids game.
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That's a cute idea. But actually, I think you'd pretty quickly get good at that. Putting a tiny rubber band on a tiny cone of gelatin is much harder than playing Operation.
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if you want to learn a new procedure or simply update your skills, there are dozens of programs to do exactly that
That's good. Are surgeons required to take such a program to perform laproscopic surgery.
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Actual credentialing (read permission to perform robotic surgeries) is performed by the facility/hospital where the surgeon works. Most hospitals have a requirement that a surgeon perform a certain number of proctored cases with the robotic system before being allowed to operate independently.
About every 3rd commercial on CNN: 1-800-BAD-DRUG (Score:1)
Why These Reports Now? (Score:2)
I'll tell you. Its the gov't propagating them. Why? Because DaVinci machines are expensive, and the gov't means to take over all healthcare eventually. But does it want to be paying for surgery with a DaVinci machine, or would it rather have you suffer a longer recovery over many weeks from having your gut cut open and a surgeon's hands probing deep into it to find and remove your cancerous prostate gland? That's a lot cheaper, so the gov't doesn't care about your recovery time.
I had DaVinci surgery
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Gov't's don't care about your additional weeks of laying in bed recovering, they only care about how cheap it is for them.
And insurance companies are different?
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Well, _I_ got DaVinci surgery via Blue Cross, so I guess the answer is yes.
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Obviously one anecdote settles the entire issue. BTW, how would you have fared if you didn't have insurance? In the US it's common, but is never a problem for Canadians.
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Forgot to add: if your beef is Obamacare, your argument is nonsense because you get insurance from a company, not the government. There are also a number of other countries with universal healthcare, such as Germany, the Netherlands and Switzerland, that provide it via insurance companies.
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You have to realize that you don't have a "contract" with the gov't like you do with the insurance company. The insurance company you can sue if they don't do what they're supposed to. With the gov't providing the healthcare, you're essentially in a veterinary medicine situation, with you as the animal and the gov't as the owner, deciding what care you get, when you get it, and how comfortable it is going to be. I call that slavery, myself, whether I technically have to work or not. I will oppose ever
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You have to realize that you don't have a "contract" with the gov't like you do with the insurance company. The insurance company you can sue if they don't do what they're supposed to.
With an actual contract on your side, how could you possibly loose? That's iron clad protection in our system of justice.
Ignore the fact that you may never have actually signed a contract if, like most people, you get it through your employer, and that your employer doesn't give a damn, and that even if you signed a contract it's extremely unlikely you understood it all (your perusal vs, an army of lawyers working for the insurance company), and that all health insurance contracts are full of loopholes for
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A *SIGNED* document? I guess you can't go wrong with a signed document...........AUUUUUUUUUUUUUGH! WHUMP!
With thanks to Shulz.
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Actually, they DO care in places (like Canada) that might have to pay out additional benefits if you can't maintain your income.
You may be confused about robot vs laparoscopic/keyhole vs open. The first one uses the robot. The second uses very similar techniques but no robot. The third is open (the one that requires the extended recovery). Many surgeons say that there is no advantage to using the robot. So in Canada (where they are more evidence based), they likely just use manual laparoscopic with similar
245 incidents reported, 8 fell short, in 12 years (Score:1)
I have no doubt that the reporting isn't perfect, but those numbers don't suggest a massive problem. Let's put things in perspective.