Slashdot Mirror
Robotic Surgery Complications Going Underreported
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."
And you do not report your faults if you want to STAY in business !! Do not like it then move to Mexico !! Or Canada !!
Let's be honest here. The company, its 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. We're lucky even this much got out and wonder why the MSM haven't reported it? Because it is filled with egotistical assholes like Schieffer who think his opinion is a substitute for real reporting: http://www.salon.com/2013/06/17/schieffer_on_snowden_this_kid_is_a_jerk_because_dr_king_and_911/
Those robotic surgeons operate 24 hours a day 7 days a week, they don't have time to write reports.
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...
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".
I called this back in July. 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.
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.)
I have to wonder how much of the underreporting is a result of pressure from the device manufacturer. If I recall, there has been a similar scandal surrounding the use of TASERs. A number of coroners have been threatened, (possibly sued), for concluding that a taser was the cause of death for a suspect. ( http://tucsoncitizen.com/morgue2/2004/08/26/198063-head-of-stun-gun-firm-denies-pressuring-coroner/ )
There is a lot of money to be made with the sale of robotic surgery devices, which may lead the manufacturer to exert pressure on operators to not report surgical errors by the machine. Unfortunately, that does a disservice to anyone who may have to go under the knife. It also breeds complacency on the development end when there is no pressure to make improvements.
My wife is currently undergoing robotic surgery, and I came across this story while in the waiting room, with her procedure about to start. Not the best timing.
http://slashdot.org/story/13/10/23/1414248/surgeon-simulator-inside-the-worlds-hardest-game
Before modding the obvious way, please watch *all* of http://www.youtube.com/watch?v=G8Sux0n-kAM
Also FatPhil on SoylentNews, id 863
Robotic surgery is in regular use now?
Did I oversleep by a few decades?
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 and collection agencies, and just drop dead. We're already halfway there.
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. The have systematically insinuated themselves throughout every capital venture in medicine from the student loan for med school to the GE MRI finance package, and everything in between. This is why they will do anything to stop a single payer health care system.
How much longer will it be before we do the math and stop listening to politicians who only serve the lobby? Stop voting for them! All of them. Insist on paying all your medical costs directly for medical treatment. Get the insurance company shareholder profit out of the middle of your medical costs. Each dollar you spend for your good health and well being should go exclusively to the medical practitioners.
Nobody needs insurance - what we need is medical treatment.
We should devote the funds we pay and pay and pay to remain available to those costs alone.
Sorry BlueCross brown nose, but you'll have to get a job at McDonald's.
Has anybody here ever had users who were willing to file and capable of filing proper bug reports or trouble tickets?
I had cancer removed from my left kidney back in 2010. Two and half weeks later I was back to work. Normal surgery would have required almost 6 months to recover. I was lucky that I had the doctor from Duke medical who wrote the book on this type of surgery perform the operation.
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.
Further, there's no indication that this is worse than non-reporting in traditional surgery.
Bullshit; it merely moved the malpractice lawsuits to federal courts, which increased the costs. Seriously, dude, your strawman is worn out; time to burn it.
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.
You're really pumping that message. With federal judges allowing companies to anonymously block federal agencies from publishing reported instances of product's posing "unreasonable risks of injury or death" http://www.washingtondcinjurylawyerblog.com/2012/12/federal_judge_permits_company_1.html, it is reasonable to infer that the number of non-reported cases has been under-reported as a result of pressure from device manufacturers.
And many of those are the "Have you or a loved one been harmed by robotic surgery?"
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 to remove my prostate on a Tuesday, and went to the theater to see, "Indiana Jones and the Crystal Skull" on the following Friday. I could have "pushed" myself back to work after 2 weeks, but waited 3 and felt very good when getting back.
Surgery is dangerous no matter how you do it, so it is not hard to find where something went wrong with or without a machine. While sitting around home recovering, I went to the DaVinci manufacturer's website, and saw stats on how many doctors were trained on the machine by locality. My single state of Virginia had 8,800 doctors trained to do robotic surgery with the machine. And then I looked at Canada, that shining star of gov't-run healthcare, that had 6,800 doctors trained on the machine for the entire country. 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.
I had a divinci hysterectomy in Feb. at a Ft. Wayne hospital. Worse descission I ever made.I have had nothing but problems. Severe bleeding, chronic infection, was told my insides were like wet tissue paper and tearing apart in surgery no.2 to dangerous to finish. Emergency surgery in Sept. for vaginal cuff dehiscence my intestine was coming through. Probably will need more surgery in the future. I was a healthy woman before. I have been through hell because of this!!! Now have to see a colon specialist. I only wish I would have known. I pray anyone who is thinking of this does their research!! Wishing I knew then what I do now. No one told me. I would have been much better off having it the old fashioned way. Ended up being cut open from hip to hip anyway.
DaVincis are like any other machine. They're either a benefit or a hazard. If they're a benefit, it's not my problem.
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).
Not only are you spamming scum, you're no good at it- your post hasn't even got a functioning link in it.
Why don't you get an honest job instead of having everyone hate you?
Business of any and all kinds believe deception of the consumer is part of doing business.
Even when lives hang in the outcome.
Like grocery store 3 for one after we jack the price up 3 times more than the cost.
From the article, they looked at "nearly 12 years, scrubbing through several data bases to find troubled outcomes. Researchers found 245 incidents reported to the FDA, including 71 deaths and 174 nonfatal injuries. But they also found eight cases in which reporting fell short, including five cases in which no FDA report was filed at all."
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.
These comments are mine; I do not speak for my employer.
Lol
In theory, insurance companies compete to provide you the best ratio care quality/cost possible more efficiently than any bloated government bureaucracy possibly could ... But that's theory and it works in an ideal world only!
In practice, like in any other business domain, companies have discovered that it is way more profitable to milk the customer as much as possible while providing as little as possible in return ...
So now, take another look at ISPs in the States, where depending where you live, you have huge prices, monopolies, ridiculous speeds and caps, throttling, and tell me the FREE MARKET (tm) is better than systems in Europe, Australia, Japan or Korea ...
Then again, take another look at the health insurances in the States, where people loose their coverage when they quit their job (you don't like to be a slave but you don't mind your leash?), coverage is so expensive that they do without, companies have ridiculous clauses to avoid to pay (but hey, it is in a contract, so it is ok), and god forbid you have an expensive illness that is not covered in your plan because you are out of luck!
The government systems are not perfect either, but generally better and cheaper, and most of all not optimized to screw you at every chance they get!
Wake up!
The free market is a trademarked ideology, not a naturally occurring phenomenon. Granted, the american voting system is also rigged so the people cannot do a lot about what matters nowadays but remember that governments were created to serve the people not to enslave them!
Well ... In theory anyway ...
If americans got their heads out of their Fox News and united, things that matters could start to change ...