
Do some surgical implants do more harm than good? - hhs
https://www.newyorker.com/magazine/2020/04/20/do-some-surgical-implants-do-more-harm-than-good/
======
apsec112
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-
crensh...](https://www.politifact.com/factchecks/2020/mar/23/dan-crenshaw/did-
fda-regulations-slow-testing-coronavirus/)

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-
pressur...](https://abcnews.go.com/Politics/distillers-lawmakers-pressure-fda-
revise-hand-sanitizer-guidelines/story?id=69918064)

Companies developed at-home coronavirus tests, but the FDA shut them down:

[https://www.statnews.com/2020/03/21/fda-warns-new-home-
coron...](https://www.statnews.com/2020/03/21/fda-warns-new-home-coronavirus-
tests-unauthorized/)

(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-
ox...](https://www.city-journal.org/fda-blocks-apple-watch-blood-oxygen-
feature)

~~~
bosswipe
It is also not prudent to assume that regulators are always scheming, wicked
villains, or power hungry idiots or whatever. For example, in your distillery
link the FDA explains that incidents of kids eating hand sanitizer are up
since the pandemic.

~~~
ahmedtd
That's not a problem that should be solved by poisoning ("denaturing") the
alcohol.

~~~
mattkrause
The article is a little bit confusing on the nature of denaturing.

Alcohol can be denatured by making it literally unsafe to drink (methanol,
gasoline, etc), or by making it really unpalatable (denatonium benzoate,
vinegar, etc), or both. The list of agents and formulae are here:
[https://www.law.cornell.edu/cfr/text/27/part-21](https://www.law.cornell.edu/cfr/text/27/part-21)

Balancing the safety effects of kids eating hand sanitizer vs. the safety
effects of not having enough hand sanitizer is tough, but insisting on a
bitterant doesn't strike me as totally indefensible.

~~~
ahmedtd
Oh, ok. I guess bittering is reasonable.

------
hhs
> 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
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
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
"... 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
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
I must be missing something. That sounds almost exactly like the Boeing
situation to me.

~~~
ska
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.

~~~
kansface
Forgive me, but I also had the same thought as OP and honestly can't tell the
difference between what you are describing and Boeing.

> 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.

Just like the FAA and Boeing until it didn't?

> We know there was an engineering failure followed by a process failure wrt
> 737 max.

My reading of the situation was a process failure, a couple of engineering
screw ups, and possibly user error.

~~~
ska
How are the both of you not included all regulatory oversight in the same
bucket?

Could the FDA process become weaker to the point of a problem, sure. Is there
any evidence that it currently is? I haven't seen any. Is this something they
(the FDA and similar) should keep an eye on, absolutely

Honestly, I don't see how you are drawing the parallel. In what wad do you
think the FDA is making the "same" mistake as the FAA did?

~~~
at_a_remove
Ah, well, the FAA did not make Boeing go through recertification for the new
"version" of the plane. Close enough. Same thing. Did it back then, should be
alright. And so the safety process was not seen through on this new model.

Similarly, the FDA grandfathered in a bunch of devices and because they are
"substantially equivalent," the FDA did not ask for recertification and the
safety process was not gone through for these devices.

~~~
ska
What I am saying is I think that your last paragraph is a misunderstanding of
what the 510(k) and de-novo pathways are, and that they are a safety process,
which was and is followed.

If you argued that the V&V necessary for a 510(k) filing is insufficient, I
would understand where you are coming from, and it could be interesting.

If you argued that a PMA is needed for all medical devices, I would understand
the argument but probably disagree.

Your 'similarly' just isn't that similar, unless I've vastly misunderstood the
FAA/Boeing case.

Again it's clear that the FDA _could_ fall into a state where it's review and
audit processes had the same sort of problems that the FAA exhibited with the
737max. But I don't see evidence at all that this has actually happened.

What do you think the substantively equivalent bar for a 510(k) allows a
company to do?

Regulatory capture is a real risk for any regulatory oversight, but it is not
synonymous with that regulatory oversight.

~~~
kansface
> What I am saying is I think that your last paragraph is a misunderstanding
> of what the 510(k) and de-novo pathways are, and that they are a safety
> process, which was and is followed.

I don't think anyone in this chain has tried to claim that the 510(k) is not a
safety process nor that it is not followed - merely that avoiding more
rigorous testing and review of a new device by tying it to the safety rating
of a previous device sounds exactly like what happened with boeing's 737 max,
and secondly, that existing regulations incentivize bad outcomes whereby
companies make more expensive/dangerous/worse products that get less testing.

> What do you think the substantively equivalent bar for a 510(k) allows a
> company to do?

Honestly, I have _literally_ no idea, and have been trying to tease that
information out of you. Specifically, how does that bar differ from the one
that Boeing had to clear with the 737 Max took which took 5 years and a few
billion dollars (I don't know how much of that was for compliance, but we can
guess its at least 10s of millions).

This is literally the first article I found when I searched google:

[https://www.medicaldesignandoutsourcing.com/boeings-737-max-...](https://www.medicaldesignandoutsourcing.com/boeings-737-max-
crisis-why-the-medical-device-industry-should-care)

~~~
ska
> and have been trying to tease that information out of you

I really didn't get that from your comments. I will try.

1st off I'm no expert in aerospace regulation or anything like it so perfectly
happy to be wrong, but my assumption is this: The 737max issue arose because
of a combination of two things. 1 the engineering standards at Boeing have
been eroded (so they cut corners) and 2) the FAA has been subject to
regulatory capture to the degree that they did not catch this (or did
not/could not act effectively when they did). If I'm wrong here please advise.

Now I suspect there are a lot of differences in how broadly these things are
applied so I will try and draw as close a parallel as I can. Imagine you and I
have a med dev company and we are building a new version of a device X, call
it X2, and we are using a self-predicated 510(k) to do it. When we file that
we still have a full system V&V. We have a hazard analysis that can included
everything for X, but must focus on any functional differences between X and
X2, We run all our system trace & testing, produce he documentation, and file
it with the FDA panel. Now if the panel don't like anything in the V&V (or the
rest of the filing) they can ask use to support it better, and that includes
the previously covered aspects. If they think the predicate is too much of a
stretch they can kick it back. If we can't make them comfortable they can push
it to refile with new methods or a to a full PMA (i.e. clinical trials) and
force us to go the whole route (along with anyone else doing the same thing,
they can't just target our company). We absolutely can propose pretty much
anything to address the variations in our machine, but they don't have to
accept any of them.

So I can see how we might pressure our engineers to cut corners, and we can
see how we might paper it over to file. But I can't see the mechanism where
the FDA fails to do it's part (or for that matter, how a clinical trial would
have caught everything that might be missed that way).

Make sense?

Again, I'm not saying the FDA couldn't have such a problem, all regulatory
bodies can. I just don't see evidence that it _does_ have this problem. And
the narrative that the creation of a 510(k) path was due to regulatory capture
seems pretty weak, for what it's worth.

------
vorpalhex
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.

------
Balanceinfinity
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
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
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
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
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.

~~~
Ididntdothis
If you remove the profit regulations insurances will keep doing exactly what
they are doing now while making more profit. The won’t pass savings to the
patient unless forced to do so. Health care is just a very bad area to apply
regular economics. As far as I know most countries have some kind of price
control including the US with Medicare.

~~~
nickff
You are proposing a cost spiral due to greed; why doesn't this happen in every
industry which provides 'essentials' but has no profit-limiting regulations?

Examples would be grocery stores, clothing, transportation, etc. You can say
'this one is different' about every single industry, but why does that
difference matter?

~~~
Ididntdothis
Because in all these industries pricing is relatively clear, customers have
some level of understanding of the product and they can choose between
competitors. In US health care you have zero pricing information, the employer
chooses insurance based on their needs, not the patient’s, and people are not
in a position to judge the quality of procedures so they do what the doctor
tells them. It’s not a functioning market and probably can’t be.

~~~
nickff
Employer-provided healthcare is a result of tax policy, so it is tough to
blame that on insurance companies.

The average person understands much more about healthcare products than they
do about transportation products. Your car is made up of >20k components, and
extremely intricately designed. Understanding the factors that go into a
reliable car requires a fairly advanced understanding of thermodynamics,
metallurgy, fracture mechanics, electronics, software engineering, statistics,
and manufacturing. Most healthcare is comparatively primitive.

If you're worried about the quality of procedures (as I am), it's a
doctor/hospital issue, not an insurance issue. Doctors have very effectively
avoided oversight, and they often cause huge problems for their patients. The
leading cause of death in hospitals in medical error.

~~~
Ididntdothis
“Employer-provided healthcare is a result of tax policy, so it is tough to
blame that on insurance companies.“

Agreed. However, they make a very good living off this and will fight to keep
things that way.

When you buy a car, you know all competitors, their prices, there is ton of
information about maintenance, durability and all other factors that may cost
you money. In healthcare you get none of this.

I am not trying to single out one factor in health care. Insurers, providers,
pharmaceuticals and the various middlemen are all guilty of making an
excellent living off this insanely stupid system on the back of patients who
suffer from it health wise and financially. Where it gets evil is the fact
they lobby for keeping things that way by spreading a lot of misinformation.

~~~
nickff
The ones making the real money in healthcare are the doctors and nurses, who
have been very successful in restricting competition. Doctors and nurses in
the USA (and to a lesser extent Canada) make far more money than they do
almost anywhere else in the world (in either absolute or relative terms).
Doctors have also been successful in preventing/avoiding tracking their
results; some are much worse than others, but it is very tough to find out how
good/bad they are.

Hospitals and clinics in some states have been very successful in reducing
competition, to the extent that you often need permission from your
competitors to open a new one. Hospitals have also avoided much scrutiny by
avoiding cost-accounting, which is a very interesting tactic.

Pharmaceuticals and insurance companies are the bogey-men of the industry, but
they're not as profitable as most imagine, and their high overheads are
largely due to regulatory burden.

~~~
Ididntdothis
You are making the mistake of singling out one participant. In the US health
system all players are making “the real money”. The only exception is the
patient.

------
zomg
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.

------
billfruit
"""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?

~~~
Ididntdothis
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
There are many centralized databases in the US that track outcomes (e.g.
[https://www.sts.org/registries-research-center/sts-
national-...](https://www.sts.org/registries-research-center/sts-national-
database)).

~~~
Ididntdothis
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
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
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.

------
ken
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.

------
glitchc
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.

------
executive
[https://www.youtube.com/watch?v=x53DnZC1JKE](https://www.youtube.com/watch?v=x53DnZC1JKE)

------
lgleason
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
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
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
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
> 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.

------
hestipod
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
> 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.

~~~
hestipod
"The problem" is always the victim...never the people doing the victimization.
This just reinforces that I said and believe. People don't see others as
living, feeling humans. They are means to an end and if they don't "contribute
to the discussion" in the way they want then they are invalidated. It's one
thing to leave people be, it's another to actively push down irl or with
voting. It's saying "you don't matter and what you say and do
annoys/bothers/irritates me and I need to demonstrate that". I cannot
understand such a selfish mindset. But it's my mistake for continuing to
believe people are going to be different. Every psychologist etc I have seen
has said that most people never grow past the ego driven, narcissistic child
phase of emotional maturity, no matter how "intelligent" or "successful" they
appear they just cannot have empathy or care about others as emotional beings
like them.

If I laid out details...which I have done many times...those details would be
ignored, picked apart, invalidated, twisted...and nothing good happens.
Occasionally a good soul reaches out and offers support of some sort...but
only once in my life has that ever been actionable and beyond "I understand
and that sucks". I know it offends people...and I don't even care
anymore...but most people are in it entirely for themselves as I have said.
Everything they do and say is for their own emotional and physical need and
even their seemingly good actions toward others is self serving. My mistake
was believing the few mentors and good examples of loving human beings I have
been fortunate to know were not unicorns and were just people I had to get out
in the world and find. But unicorns they were/are. I learned after my suicide
attempt how even when things are at their worst people will still punch down,
betray, lie, abuse, cheat, and step on you for their own needs. They prevent
people from opting out of life because that scares and angers them...but they
refuse to do whats needed to allow those people in need to survive. They just
keep you in a nice smoldering fire because that's best for them. But since I
AM a feeling human being I cannot just accept it and suffer the fire...I get
upset and lash out and speak out...and it just stokes the flames and I regret
it. Cannot win...can only hurt.

~~~
scythe
>"The problem" is always the victim...never the people doing the
victimization.

You are _not_ being victimized. Your post was downvoted. It is not a big deal.
Nothing bad happened to you here today.

>if they don't "contribute to the discussion" in the way they want then they
are invalidated.

It is a community norm to downvote posts that do not contribute to the
discussion. I like that norm. It's one of the reasons I choose to post here.
If you don't like that rule, there may be other discussion boards more suited
to you.

>If I laid out details...which I have done many times...those details would be
ignored, picked apart, invalidated, twisted...and nothing good happens.

If you choose to assume, before you post anything, that you cannot expect the
people here to be reasonable, then there is no reason to post here at all. Why
would you expect people to believe you when you give no information, given
that you do not expect them to believe you if you do give the information?

Nobody can do anything for you if _you won 't let them_.

~~~
hestipod
You cannot even see what you are doing and are proving my point perfectly. You
invalidate and minimize what I say. You turn it into something lesser to
dismiss. You excuse the things I say bother me. You say it's MY fault there is
no help because I am not LETTING that help happen...which is ironically
classic and well studied victim blaming.

I am done. I am not going to continue to go back and forth. No matter what I
say or do there is reason to interrogate, invalidate, blame. Nothing is every
enough for anyone and every answer leads to more questions and more
positioning to dismiss. I know you don't agree...don't "believe"...it doesn't
matter. For you this is an opportunity to win a debate or show you are smarter
or better. That's what people do. My only mistake is beating my head against
that same wall of human ego because I am in pain and want to make noise to
relieve it.

