8 ms·

Do some surgical implants do more harm than good?

41 points by hhs 7y ago

billfruit 7y ago
"""For much of Western history, however, surgery lay somewhat apart from the practice of medicine. Hippocrates was leery of it, writing, “He who wishes to be a surgeon should go to war”; the crude practices of the battlefield were, as Roy Porter put it in his classic history of medicine, “Blood and Guts” (2002),"the work of hand not head.” This suspicion bred an enduring medical division of labor, in which many healers viewed surgery as inferior. Well into the modern era, surgical procedures were the province of the barber, along with pulling teeth.""" Even now sometimes I wonder is surgery a science? Does it use the scientific method?
- mattkrause 7y ago
  Yes! It's common to run clinical trials comparing different types of implants, different surgical approaches, and even decisions on when/if to do the surgery at all. On the other hand, they are relatively to run and interpret. For a drug trial, you can give everybody a fixed dose of a drug (X mg; Y mg/kg bodyweight) in a fixed way (pill, injection, etc). Surgery is a lot harder to standardize. Along with the patient-to-patient variability, there's also surgeon-to-surgeon variability. Different surgeons might be faster or slower, cut more (and get a better visualization of whatever they're doing) or less (reduced tissue damage). Moreover, the individual surgeons improve with practice and it sometimes takes a lot (e.g., 100-200 knee arthroscopies) to plateau, which makes it tricky to evaluate a totally new method. This is a nice paper discussing some of the issues in more detail: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5415901/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5415901/
- Ididntdothis 7y ago
  I am not sure how much the scientific method applies to medicine in general. Medicine is a very diffuse subject. But I work in medical devices and I know for sure that there isn’t much data available of how well a procedure works. There is no centralized database that tracks outcomes. Most surgeons view a surgery as success if the surgery as such went well. They don’t do much tracking of whether the patient is doing better so there is risk they will keep doing surgeries that don’t really work. The manufacturer gets some information but also not much. There definitely should be a countrywide or even better worldwide database of outcomes.
  - noelsusman 7y ago
    There are many centralized databases in the US that track outcomes (e.g. https://www.sts.org/registries-research-center/sts-national-database https://www.sts.org/registries-research-center/sts-national-...).
    - Ididntdothis 7y ago
      I know for sure that my company doesn’t have great long term data about its own devices in the field and even less about competitors. Once implanted, most patients disappear.
      - noelsusman 7y ago
        The hospitals buying your devices probably do, depending on the device. Our long term data is incomplete because people can switch providers, but we actively monitor long term patient outcomes for a wide range of devices that we use.
        Ididntdothis 7y ago
        But how do you get data from thousands of hospitals? I also assume hospitals don’t exchange much data. The data is just very fragmented.
- billfruit 7y ago
  A quote from George Eliot's Romola, sort of indicative of how a doctor in 1400s Italy viewed surgery with some contempt, maybe it is exaggerated a bit for effect: """" “It is but fitting that a great medicus like you,” said Nello, adjusting the cloth, “should be shaved by the same razor that has shaved the illustrious Antonio Benevieni, the greatest master of the chirurgic art.” “The chirurgic art!” interrupted the doctor, with an air of contemptuous disgust. “Is it your Florentine fashion to put the masters of the science of medicine on a level with men who do carpentry on broken limbs, and sew up wounds like tailors, and carve away excrescences as a butcher trims meat? Via! A manual art, such as any artificer might learn, and which has been practised by simple barbers like yourself—on a level with the noble science of Hippocrates, Galen, and Avicenna, which penetrates into the occult influences of the stars and plants and gems!—a science locked up from the vulgar!” """
glitchc 7y ago
Much of the risk in implants is not tied to concept or design, but rather execution. The final product has been distorted to some degree by market forces (cost/profitability, application domains, viable hosts), and this reflects, I believe, in the majority of harmful use cases that we observe.
lgleason 7y ago
My mother went in for a fusion on her spine and came out with MRSA and died from it. In this case the cure was worse than the disease.
- ebg13 7y ago
  Your situation is tragic and I'm saddened by the loss, but fatal infection is orthogonal to the subject of the article. MRSA infection is a procedural error not caused by the implant itself.
  - kube-system 7y ago
    The article discusses infection risk. Infection risk is an inherent part of the total risk associated with any medical procedure. It is not separable -- you cannot use an implant if it is not implanted.
    - Balanceinfinity 7y ago
      Sadly, horribly, that is now a risk with every major procedure - but at least it's a known risk that the patient can choose to accept when the underlying condition is not life threatening. Devices that don't work properly and haven't been properly reviewed by the FDA are risks the patient can't reasonably evaluate.
      - kube-system 7y ago
        > Sadly, horribly, that is now a risk with every major procedure Infection always has and likely always will be a risk when you open up a human. Evaluating, understanding, and measuring those risks is the only way we can begin to mitigate them. On the bright side, recent medical technology has also brought us a lot of minimally or non-invasive procedures. Those generally have much lower (sometimes almost zero) risks of infection.
  - unsrsly 7y ago
    MRSA is known to "hide" from the immune system on indwelling hardware. Often, part of the treatment for MRSA infection is to explant the hardware (source control). So even though MRSA infection is not a "device failure," having a device in place is a major factor in whether the body can clear the infection. Also, it's probably rare, but an implant can directly cause an infection if there's a flaw in the sterilization process the manufacturer uses.
hestipod 7y ago
Surgery ruined my life and will be the cause of it's end. I was scared into having surgery I didn't need and told if I did not I would be crippled by middle age. Multiple opinions got multiple variations on what should be done but I was too young and inexperienced to know better. It stole everything from me and has caused so much physical and mental pain as I tried to survive it and society and people turned their backs on me. Then when I became the very thing I was told to fear in all ways...and there was no way out...I tried to end my life and even THAT was denied me and now its all worse. People love to talk about "worth the risk and cost" etc when they have no TRUE idea what the risk and cost are. People love to justify, explain, defend those who do the damage and love to blame, demean, and ignore those who suffer it. Nice little just world package to feel safe and smart. I wish I had never gone to a doctor and I wish I had known the realities of medical mistake frequency and unneeded surgery instead of the whitewashed nonsense that is sold. Even now...post suicide attempt...the system and people are just proving what I believed was true all along...but being correct doesn't bring me any solace or pain relief. *I understand it's bad form to complain about voting...but when your life is so painful and full of invalidation by family, society, and "professionals" even a person pushing a button to further invalidate you hurts and just reinforces what you believe about ego and selfishness in others. Being "right" or in control is always more important than others to most people. I just cannot fathom the thinking of kicking someone who is down over their experience or a generalized comment. Even if I disagreed with someone I wouldn't do that.
- scythe 7y ago
  > a person pushing a button to further invalidate you hurts The problem with your post is that you have predicated it entirely on your personal experiences, while being unwilling to describe those experiences in detail. You have not told us, for example, what kind of surgery was performed, what the complications were, who "scared" you "into having surgery" (and how), or what the negative effects on your life were, specifically. You are free to choose not to share this information -- nobody can fairly expect you to share such intimate and painful details. I realize that is very difficult. But without specifics, an account of your personal experiences does not contribute very much to the discussion.
vorpalhex 7y ago
The answer to any question of the form "Do some X interventions do more harm than good?" is always "Well yes, but is it a statistically significant amount?" This is a set of anecdotes and editorializing about a very statistical kind of question.
- deleted 7y ago
  [deleted]
hhs 7y ago
> Schneider writes, “It is more likely for Toyota to know about faulty exhaust pipes in a Prius than DePuy [medical device company] to understand how a new hip implant is performing in the United States.” A registry of implants would enable the F.D.A., doctors, and patients to access data on their risks and benefits over time, but the U.S. has no such registry, unlike Canada, Australia, New Zealand, Japan, and several countries in Europe. Schneider emphasizes how these systems provide “valuable information about the longevity of an implant when used in real-world conditions by all surgeons.” A registry prevents surgeons from “cherry-picking” to exclude cases that would sully papers about implants they may have designed, and protects against the gaming of data. > Repeated efforts to implement a registry system in the United States have failed. The implant industry has a powerful lobby in Washington, and the courts and recent legislation have made regulatory oversight more feeble. Wonder about the history of this. Which lobby groups are making it hard to build a registry?
- vkou 7y ago
  Because generally speaking: 1. People care about keeping medical information private. 2. Having people opt into making their medical information public would skew the data. 3. Your doctor can't be arsed to update a global registry every time you go to him for a checkup. In the long run, you have a relationship with your GP, not the surgeon who put the implant in. 4. And yeah, I assume the implant industry would like to have the aegis of the high trust people place in the medical profession, without having to do the hard work of earning that trust.
  - kevin_thibedeau 7y ago
    5. They don't want to generate evidence that can be used in a class action lawsuit. Feigned ignorance is a great defense.
at_a_remove 7y ago
"... if a device was sold before 1976, an updated version can be released without new clinical trials, so long as the manufacturer deems it to be 'substantially equivalent' to the existing device. Thirty years after the 1976 legislation was passed, the F.D.A. had approved more than a thousand high-risk devices, only sixteen per cent of which had gone through rigorous clinical testing before sale." Shades of Boeing here. Interesting.
- ska 7y ago
  It's not really shades of boeing, though I can see how it may look like that from the outside. The problem is that a pre-market assessment (PMA) is a huge and expensive beast, if you require every device/implant/etc. to go through that it will definitely slow things down a lot and make them more expensive... So the pre-market notification and de-novo paths were created to keep rigor in the system without adding years and millions to development costs of everything. For the most part it works fairly reasonably to balance these concerns. There is already a classification system (I, II, III) which captures this and can force your device through a PMA if it is deemed high enough risk. One could argue that class II is being used to much I suppose, but that is a very different issue than pointed at by boeing.
  - ken 7y ago
    I must be missing something. That sounds almost exactly like the Boeing situation to me.
    - ska 7y ago
      It's a rigorous process, that is designed to remove or reduce the need for a different rigorous process. It's been working pretty well for decades. How is that parallel to the Boeing situation? We know there was an engineering failure followed by a process failure wrt 737 max. If we have similar evidence in devices (i.e. the process isn't working, or the developers are cutting corners, or both) that should certainly be addressed. But drawing that line with information such as this article seems a stretch, at best.
Balanceinfinity 7y ago
Makes one wonder - in the absence of thorough regulation, why a third-party evaluator hasn't arisen to provide real risk analysis for patients regarding each device (the good device seal) - and I'm surprised insurance companies aren't more aggressive in ensuring that they aren't making the patients worse 9which would increase their insurance costs).
- Ididntdothis 7y ago
  My theory is that insurance companies don’t try to save money as long as they can pass the cost to the patient or whoever pays the premiums. Otherwise I can’t explain the insanity of the charges hospitals are getting away with.
  - novok 7y ago
    If your limited to a certain percentage of costs as your profits, you have an incentive to increase costs. Hospitals and insurance enter into an unholy pact to increase costs implicitly as a result.
    - Klinky 7y ago
      Doesn't gaming the system to increase profits by increasing costs show malevolent motives which would not be fixed by removing profit restrictions? I mean if you're "evil" with regulations, why should I trust that removing regulations will make you "less evil"? It sounds like a crook asking you to remove the handcuffs.
      - nickff 7y ago
        Removing the profit regulations has less to do with enabling greed (which exists either way) than it does with aligning incentives. The idea is that you want the insurance companies to profit from patients getting timely, cost-effective care, rather than incentivizing them to drive up costs and delays.
        7y ago
apsec112 7y ago
A registry is a plausible idea, but in general, this article seems to assume by default that regulators are always wise and benevolent, and companies are always scheming, wicked villains. This year's coronavirus pandemic has showed that we can't just assume this. Eg., the FDA made it illegal for labs to develop their own coronavirus tests, which let the disease spread: https://www.politifact.com/factchecks/2020/mar/23/dan-crenshaw/did-fda-regulations-slow-testing-coronavirus/ https://www.politifact.com/factchecks/2020/mar/23/dan-crensh... Distilleries have been trying to make hand sanitizer, but the FDA has made this much more difficult by requiring that the alcohol be denatured first: https://abcnews.go.com/Politics/distillers-lawmakers-pressure-fda-revise-hand-sanitizer-guidelines/story?id=69918064 https://abcnews.go.com/Politics/distillers-lawmakers-pressur... Companies developed at-home coronavirus tests, but the FDA shut them down: https://www.statnews.com/2020/03/21/fda-warns-new-home-coronavirus-tests-unauthorized/ https://www.statnews.com/2020/03/21/fda-warns-new-home-coron... (the FDA later approved one by LabCorp - at-home testing does in fact work - but this took almost a month, and AFAICT the original sellers still haven't been approved) The Apple Watch has the ability to test blood oxygenation, which would be incredibly useful now, but it can't because that would be an illegal medical device: https://www.city-journal.org/fda-blocks-apple-watch-blood-oxygen-feature https://www.city-journal.org/fda-blocks-apple-watch-blood-ox...
- pkaye 7y ago
  Why is Fitbit able to get a pulse oximeter in the market while Apple is not?
  - ggreer 7y ago
    It's not clear if Fitbit's pulse oximeter update was ever shipped in the US. I can only find forum posts by disgruntled users who say they don't have it. I asked an acquaintance and he says he doesn't have the functionality despite owning a compatible device. Amusingly, both Fitbit and Apple are part of the FDA's digital health software precertification pilot program[1], which is intended to streamline the approval process. If not for the FDA, both companies could have shipped this 3+ years ago. I'm sure the data would have saved quite a few lives. 1. https://www.fda.gov/medical-devices/digital-health/digital-health-software-precertification-pre-cert-program https://www.fda.gov/medical-devices/digital-health/digital-h...
ken 7y ago
Anyone who's seen TV commercials in the past several years ("Attention surgical mesh patch implant patients!") must be aware that the answer is "no". Likewise for OTC and prescription drugs, cleaning products, garden products, pet foods, etc. Companies do not always have your best interests in mind. Class-action lawsuits are good at showing how bad they can be.
executive 7y ago
https://www.youtube.com/watch?v=x53DnZC1JKE https://www.youtube.com/watch?v=x53DnZC1JKE
zomg 7y ago
One obvious variable that is not mentioned in the article, and is a contributing factor to case outcomes, is surgical technique. I work in the medical device industry and have observed (live, bedside), plenty of laparoscopic surgeries and have seen plenty of good surgeons and also many bad ones. I'm not defending the medical devices (every company I've worked at has had recalls and devices fail, injuring people), but the reality is that the implant is only as good as it is placed.

41 points by hhs 7y ago

"""For much of Western history, however, surgery lay somewhat apart from the practice of medicine. Hippocrates was leery of it, writing, “He who wishes to be a surgeon should go to war”; the crude practices of the battlefield were, as Roy Porter put it in his classic history of medicine, “Blood and Guts” (2002),"the work of hand not head.” This suspicion bred an enduring medical division of labor, in which many healers viewed surgery as inferior. Well into the modern era, surgical procedures were the province of the barber, along with pulling teeth.""" Even now sometimes I wonder is surgery a science? Does it use the scientific method?

mattkrause 7y ago
Yes! It's common to run clinical trials comparing different types of implants, different surgical approaches, and even decisions on when/if to do the surgery at all. On the other hand, they are relatively to run and interpret. For a drug trial, you can give everybody a fixed dose of a drug (X mg; Y mg/kg bodyweight) in a fixed way (pill, injection, etc). Surgery is a lot harder to standardize. Along with the patient-to-patient variability, there's also surgeon-to-surgeon variability. Different surgeons might be faster or slower, cut more (and get a better visualization of whatever they're doing) or less (reduced tissue damage). Moreover, the individual surgeons improve with practice and it sometimes takes a lot (e.g., 100-200 knee arthroscopies) to plateau, which makes it tricky to evaluate a totally new method. This is a nice paper discussing some of the issues in more detail: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5415901/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5415901/
Ididntdothis 7y ago
I am not sure how much the scientific method applies to medicine in general. Medicine is a very diffuse subject. But I work in medical devices and I know for sure that there isn’t much data available of how well a procedure works. There is no centralized database that tracks outcomes. Most surgeons view a surgery as success if the surgery as such went well. They don’t do much tracking of whether the patient is doing better so there is risk they will keep doing surgeries that don’t really work. The manufacturer gets some information but also not much. There definitely should be a countrywide or even better worldwide database of outcomes.
- noelsusman 7y ago
  There are many centralized databases in the US that track outcomes (e.g. https://www.sts.org/registries-research-center/sts-national-database https://www.sts.org/registries-research-center/sts-national-...).
  - Ididntdothis 7y ago
    I know for sure that my company doesn’t have great long term data about its own devices in the field and even less about competitors. Once implanted, most patients disappear.
    - noelsusman 7y ago
      The hospitals buying your devices probably do, depending on the device. Our long term data is incomplete because people can switch providers, but we actively monitor long term patient outcomes for a wide range of devices that we use.
      - Ididntdothis 7y ago
        But how do you get data from thousands of hospitals? I also assume hospitals don’t exchange much data. The data is just very fragmented.
billfruit 7y ago
A quote from George Eliot's Romola, sort of indicative of how a doctor in 1400s Italy viewed surgery with some contempt, maybe it is exaggerated a bit for effect: """" “It is but fitting that a great medicus like you,” said Nello, adjusting the cloth, “should be shaved by the same razor that has shaved the illustrious Antonio Benevieni, the greatest master of the chirurgic art.” “The chirurgic art!” interrupted the doctor, with an air of contemptuous disgust. “Is it your Florentine fashion to put the masters of the science of medicine on a level with men who do carpentry on broken limbs, and sew up wounds like tailors, and carve away excrescences as a butcher trims meat? Via! A manual art, such as any artificer might learn, and which has been practised by simple barbers like yourself—on a level with the noble science of Hippocrates, Galen, and Avicenna, which penetrates into the occult influences of the stars and plants and gems!—a science locked up from the vulgar!” """

glitchc 7y ago

Much of the risk in implants is not tied to concept or design, but rather execution. The final product has been distorted to some degree by market forces (cost/profitability, application domains, viable hosts), and this reflects, I believe, in the majority of harmful use cases that we observe.

lgleason 7y ago

My mother went in for a fusion on her spine and came out with MRSA and died from it. In this case the cure was worse than the disease.

ebg13 7y ago
Your situation is tragic and I'm saddened by the loss, but fatal infection is orthogonal to the subject of the article. MRSA infection is a procedural error not caused by the implant itself.
- kube-system 7y ago
  The article discusses infection risk. Infection risk is an inherent part of the total risk associated with any medical procedure. It is not separable -- you cannot use an implant if it is not implanted.
  - Balanceinfinity 7y ago
    Sadly, horribly, that is now a risk with every major procedure - but at least it's a known risk that the patient can choose to accept when the underlying condition is not life threatening. Devices that don't work properly and haven't been properly reviewed by the FDA are risks the patient can't reasonably evaluate.
    - kube-system 7y ago
      > Sadly, horribly, that is now a risk with every major procedure Infection always has and likely always will be a risk when you open up a human. Evaluating, understanding, and measuring those risks is the only way we can begin to mitigate them. On the bright side, recent medical technology has also brought us a lot of minimally or non-invasive procedures. Those generally have much lower (sometimes almost zero) risks of infection.
- unsrsly 7y ago
  MRSA is known to "hide" from the immune system on indwelling hardware. Often, part of the treatment for MRSA infection is to explant the hardware (source control). So even though MRSA infection is not a "device failure," having a device in place is a major factor in whether the body can clear the infection. Also, it's probably rare, but an implant can directly cause an infection if there's a flaw in the sterilization process the manufacturer uses.

hestipod 7y ago

Surgery ruined my life and will be the cause of it's end. I was scared into having surgery I didn't need and told if I did not I would be crippled by middle age. Multiple opinions got multiple variations on what should be done but I was too young and inexperienced to know better. It stole everything from me and has caused so much physical and mental pain as I tried to survive it and society and people turned their backs on me. Then when I became the very thing I was told to fear in all ways...and there was no way out...I tried to end my life and even THAT was denied me and now its all worse. People love to talk about "worth the risk and cost" etc when they have no TRUE idea what the risk and cost are. People love to justify, explain, defend those who do the damage and love to blame, demean, and ignore those who suffer it. Nice little just world package to feel safe and smart. I wish I had never gone to a doctor and I wish I had known the realities of medical mistake frequency and unneeded surgery instead of the whitewashed nonsense that is sold. Even now...post suicide attempt...the system and people are just proving what I believed was true all along...but being correct doesn't bring me any solace or pain relief. *I understand it's bad form to complain about voting...but when your life is so painful and full of invalidation by family, society, and "professionals" even a person pushing a button to further invalidate you hurts and just reinforces what you believe about ego and selfishness in others. Being "right" or in control is always more important than others to most people. I just cannot fathom the thinking of kicking someone who is down over their experience or a generalized comment. Even if I disagreed with someone I wouldn't do that.

scythe 7y ago
> a person pushing a button to further invalidate you hurts The problem with your post is that you have predicated it entirely on your personal experiences, while being unwilling to describe those experiences in detail. You have not told us, for example, what kind of surgery was performed, what the complications were, who "scared" you "into having surgery" (and how), or what the negative effects on your life were, specifically. You are free to choose not to share this information -- nobody can fairly expect you to share such intimate and painful details. I realize that is very difficult. But without specifics, an account of your personal experiences does not contribute very much to the discussion.

vorpalhex 7y ago

The answer to any question of the form "Do some X interventions do more harm than good?" is always "Well yes, but is it a statistically significant amount?" This is a set of anecdotes and editorializing about a very statistical kind of question.

deleted 7y ago
[deleted]

hhs 7y ago

> Schneider writes, “It is more likely for Toyota to know about faulty exhaust pipes in a Prius than DePuy [medical device company] to understand how a new hip implant is performing in the United States.” A registry of implants would enable the F.D.A., doctors, and patients to access data on their risks and benefits over time, but the U.S. has no such registry, unlike Canada, Australia, New Zealand, Japan, and several countries in Europe. Schneider emphasizes how these systems provide “valuable information about the longevity of an implant when used in real-world conditions by all surgeons.” A registry prevents surgeons from “cherry-picking” to exclude cases that would sully papers about implants they may have designed, and protects against the gaming of data. > Repeated efforts to implement a registry system in the United States have failed. The implant industry has a powerful lobby in Washington, and the courts and recent legislation have made regulatory oversight more feeble. Wonder about the history of this. Which lobby groups are making it hard to build a registry?

vkou 7y ago
Because generally speaking: 1. People care about keeping medical information private. 2. Having people opt into making their medical information public would skew the data. 3. Your doctor can't be arsed to update a global registry every time you go to him for a checkup. In the long run, you have a relationship with your GP, not the surgeon who put the implant in. 4. And yeah, I assume the implant industry would like to have the aegis of the high trust people place in the medical profession, without having to do the hard work of earning that trust.
- kevin_thibedeau 7y ago
  5. They don't want to generate evidence that can be used in a class action lawsuit. Feigned ignorance is a great defense.

at_a_remove 7y ago

"... if a device was sold before 1976, an updated version can be released without new clinical trials, so long as the manufacturer deems it to be 'substantially equivalent' to the existing device. Thirty years after the 1976 legislation was passed, the F.D.A. had approved more than a thousand high-risk devices, only sixteen per cent of which had gone through rigorous clinical testing before sale." Shades of Boeing here. Interesting.

ska 7y ago
It's not really shades of boeing, though I can see how it may look like that from the outside. The problem is that a pre-market assessment (PMA) is a huge and expensive beast, if you require every device/implant/etc. to go through that it will definitely slow things down a lot and make them more expensive... So the pre-market notification and de-novo paths were created to keep rigor in the system without adding years and millions to development costs of everything. For the most part it works fairly reasonably to balance these concerns. There is already a classification system (I, II, III) which captures this and can force your device through a PMA if it is deemed high enough risk. One could argue that class II is being used to much I suppose, but that is a very different issue than pointed at by boeing.
- ken 7y ago
  I must be missing something. That sounds almost exactly like the Boeing situation to me.
  - ska 7y ago
    It's a rigorous process, that is designed to remove or reduce the need for a different rigorous process. It's been working pretty well for decades. How is that parallel to the Boeing situation? We know there was an engineering failure followed by a process failure wrt 737 max. If we have similar evidence in devices (i.e. the process isn't working, or the developers are cutting corners, or both) that should certainly be addressed. But drawing that line with information such as this article seems a stretch, at best.

Balanceinfinity 7y ago

Makes one wonder - in the absence of thorough regulation, why a third-party evaluator hasn't arisen to provide real risk analysis for patients regarding each device (the good device seal) - and I'm surprised insurance companies aren't more aggressive in ensuring that they aren't making the patients worse 9which would increase their insurance costs).

Ididntdothis 7y ago
My theory is that insurance companies don’t try to save money as long as they can pass the cost to the patient or whoever pays the premiums. Otherwise I can’t explain the insanity of the charges hospitals are getting away with.
- novok 7y ago
  If your limited to a certain percentage of costs as your profits, you have an incentive to increase costs. Hospitals and insurance enter into an unholy pact to increase costs implicitly as a result.
  - Klinky 7y ago
    Doesn't gaming the system to increase profits by increasing costs show malevolent motives which would not be fixed by removing profit restrictions? I mean if you're "evil" with regulations, why should I trust that removing regulations will make you "less evil"? It sounds like a crook asking you to remove the handcuffs.
    - nickff 7y ago
      Removing the profit regulations has less to do with enabling greed (which exists either way) than it does with aligning incentives. The idea is that you want the insurance companies to profit from patients getting timely, cost-effective care, rather than incentivizing them to drive up costs and delays.
      - 7y ago

apsec112 7y ago

A registry is a plausible idea, but in general, this article seems to assume by default that regulators are always wise and benevolent, and companies are always scheming, wicked villains. This year's coronavirus pandemic has showed that we can't just assume this. Eg., the FDA made it illegal for labs to develop their own coronavirus tests, which let the disease spread: https://www.politifact.com/factchecks/2020/mar/23/dan-crenshaw/did-fda-regulations-slow-testing-coronavirus/ https://www.politifact.com/factchecks/2020/mar/23/dan-crensh... Distilleries have been trying to make hand sanitizer, but the FDA has made this much more difficult by requiring that the alcohol be denatured first: https://abcnews.go.com/Politics/distillers-lawmakers-pressure-fda-revise-hand-sanitizer-guidelines/story?id=69918064 https://abcnews.go.com/Politics/distillers-lawmakers-pressur... Companies developed at-home coronavirus tests, but the FDA shut them down: https://www.statnews.com/2020/03/21/fda-warns-new-home-coronavirus-tests-unauthorized/ https://www.statnews.com/2020/03/21/fda-warns-new-home-coron... (the FDA later approved one by LabCorp - at-home testing does in fact work - but this took almost a month, and AFAICT the original sellers still haven't been approved) The Apple Watch has the ability to test blood oxygenation, which would be incredibly useful now, but it can't because that would be an illegal medical device: https://www.city-journal.org/fda-blocks-apple-watch-blood-oxygen-feature https://www.city-journal.org/fda-blocks-apple-watch-blood-ox...

pkaye 7y ago
Why is Fitbit able to get a pulse oximeter in the market while Apple is not?
- ggreer 7y ago
  It's not clear if Fitbit's pulse oximeter update was ever shipped in the US. I can only find forum posts by disgruntled users who say they don't have it. I asked an acquaintance and he says he doesn't have the functionality despite owning a compatible device. Amusingly, both Fitbit and Apple are part of the FDA's digital health software precertification pilot program[1], which is intended to streamline the approval process. If not for the FDA, both companies could have shipped this 3+ years ago. I'm sure the data would have saved quite a few lives. 1. https://www.fda.gov/medical-devices/digital-health/digital-health-software-precertification-pre-cert-program https://www.fda.gov/medical-devices/digital-health/digital-h...

ken 7y ago

Anyone who's seen TV commercials in the past several years ("Attention surgical mesh patch implant patients!") must be aware that the answer is "no". Likewise for OTC and prescription drugs, cleaning products, garden products, pet foods, etc. Companies do not always have your best interests in mind. Class-action lawsuits are good at showing how bad they can be.

executive 7y ago

https://www.youtube.com/watch?v=x53DnZC1JKE https://www.youtube.com/watch?v=x53DnZC1JKE

zomg 7y ago

One obvious variable that is not mentioned in the article, and is a contributing factor to case outcomes, is surgical technique. I work in the medical device industry and have observed (live, bedside), plenty of laparoscopic surgeries and have seen plenty of good surgeons and also many bad ones. I'm not defending the medical devices (every company I've worked at has had recalls and devices fail, injuring people), but the reality is that the implant is only as good as it is placed.