FDA warns against robotic surgery for breast cancer, cervical cancer, & other women's cancers

Originally published at: https://boingboing.net/2019/03/01/breast-cancer-robot.html

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It’d be interesting to know what (if anything) the problem is. In theory it makes no difference whether you’re holding a scalpel in your hand or via a robot, except that perhaps tactile feedback is more important than people thought in determining exactly what tissue to remove. Or maybe surgeons are more aggressive with manual surgery, so that if they miss something there is a higher chance that they will remove it as part of the collateral damage anyway.

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"Error: This Medpod is calibrated for male patients only."

(That scene from Prometheus still annoys me. You can drag a robot doctor halfway across the galaxy but you can’t spare a few megabytes of disk space for a software update?)

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Also, IT WAS EXPLICITLY STATED AS BEING FOR CHARLIZE THERON’S PRIVATE USE

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I just want a cheap 3D dental printer. How hard could that be?

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Planning to drain the tooth fairy for all it’s worth or just bedazzling your dress shirts?

ETA: My ex-wife’s father was a dentist and actually had a 3D dental printer. Not cheap as I recall.

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I thought it might be related to morcellation:

http://surgicalwatch.com/2014/05/fda-issues-cancer-warning-for-laparoscopic-morcellators/

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I’m so tired of the patriarchy oppressing women.

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The bots are not without reports of technical problems(search for vendor “INTUITIVE SURGICAL” here with your preferred date range and severity classification); but I suspect you are right to suspect the emphasis on bring minimally invasive and such in the case of cancer specifically.

If surgeons were medical devices they would probably also have a rather alarming set of incident reports, so failure to be infallible isn’t enough to make the boots presumptively worse than the humans; but the trade-off between avoiding false positives and avoiding false negatives is a fairly fundamental one; and one that can really bite you when the false negatives self replicate uncontrollably.

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Let me guess: all of the development and FDA trial subjects were, as always, strictly male.

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Not just that.

It’s the robot patriarchy, and you know they’re the worst ones.

Update: I have a client whose business is in this field, and he says:

What that actually means is there is a company with a lot of money that’s getting ready to compete against DaVinci. Happens all the time in the healthcare business.

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When I was about 40, I had what could have been an angina attack. It wasn’t, but the point of the story is that I was sent first for a stress test, my doctor being one who takes this kind of thing seriously. The stress consisted of walking on a treadmill, and every 3 minutes it would speed up. After a few minutes of this, the heart monitor went haywire, and everyone got very upset; “Stop! Stop running! Stooooopp!!”. The monitor indicated that I was having a heart attack. I was fine.

The stress test had (maybe still has) a 50% false positive rate in women.

Also;https://www.treehugger.com/culture/male-designed-world-dangerous-and-unfair-women.html
The comments are amusing.

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The studies I’ve seen have pointed out that it is very tough to tease out differences in real-world use of robotic surgery vs. manual surgery because hospitals tend to prioritize the use of the robotic systems for higher-risk cases. In order to find differences in mortality between the two methods, a large randomized trial would be required. It sounds from the FDA bulletin that only small, retrospective trials have shown this trend.

That said, these are off-label procedures for the Da Vinci system. In order to legally market it for these procedures, Intuitive would need to do a large randomized trial to prove non-inferiority of the system for the specific procedure.

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Last time I checked, Intuitive hadn’t come out with a morcellation attachment. (checks) Nope. No morcellators. It’s weird that the article from Surgical Watch jumps right to Da Vinci when talking about morcellators, when none of the instruments for the robot do morcellation or really anything like it. It’s kinda a non sequitur.

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In the cases I read about they were used together for minimally invasive procedures. Not saying one tool does it all, but it sounds like some reported issues are lumping them together and causing people to consider other methods.

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Thanks.

I’ve observed live cases with the Da Vinci. There’s no way anyone should be doing manual surgery in combination with robotic. There’s no room to maneuver in there, limited visibility, and too much opportunity for the instruments to interfere with each other.

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Wish this was more accessible, but it sounds like they have been using two tools:

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My thanks, again!

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At a wild guess they trip out at the higher pulse rates or otherwise poorly calibrated alarms.

Not that it matters. Still inexcusable.

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Because I had the false positive, I had to have two more tests; an ultrasound, and a thallium stress test, which was interesting if nothing else. So two more expensive tests to rule out angina/infarction/damage.

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