
Patients shocked, burned by spinal cord stimulators touted to treat pain - tareqak
https://apnews.com/86ba45b0a4ad443fad1214622d13e6cb
======
scribu
There’s a broader story about poor regulation in the medical implant industry
as a whole. [1]

Unlike drugs, implants don’t need to go through clinical trials in most cases.

Furthermore, there is no central registry for aggregating problems that
patients experience with particular devices.

[1] [https://www.theguardian.com/society/2018/nov/25/revealed-
fau...](https://www.theguardian.com/society/2018/nov/25/revealed-faulty-
medical-implants-harm-patients-around-world)

Edit: Summarized main problems from The Guardian article.

~~~
flarets
"Unlike drugs, implants don’t need to go through clinical trials in most
cases."

The artical says "surgical innovations" which probably means instruments and
procedures. Also "some implants" are exempt from showing efficacy in clinical
trials under HDE for cases in which the patient would have died anyway (e.g.
pacemakers).

All medical devices of Class 2 and 3 must go through clinical trials to prove
safety and efficacy as part of the FDA IDE. Spinal implants would certainly be
Class 3.

Edit: clarification

~~~
tjoff
> _Also "some implants" are exempt from showing efficacy in clinical trials
> under HDE for cases in which the patient would have died anyway (e.g.
> pacemakers)._

How about if the implant kills the patient?

There was a local story today about a pacemaker where the electrode had failed
and he was defibrilated 47 times during 3 hours before the battery ran out.

~~~
flarets
It depends if the implant does more good than if it wasn't implanted. All
regulated devices require post market monitoring by the company and reporting
to the FDA. If the data shows harm is being done to patients the FDA can issue
a recall.

~~~
tjoff
That seems like a very slow process. Another story today that implants has
caused 83 000 deaths.

I assume/hope they have saved much more lives than that but regardless the
types of failures seems to indicate that a lot more could be demanded of these
products.

[http://www.tellerreport.com/news/\---83-000-deaths-in-
unsafe-...](http://www.tellerreport.com/news/---83-000-deaths-in-unsafe-
medical-devices-in-10-years--.SkeMIhDd0Q.html)

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slr555
I observed a total knee replacement surgery where the surgeons were not using
their preferred system due to the fact that the patient already had one knee
replacement and the doctors felt the same system should be used on both sides.
The representative from the implant company was in the OR for a couple of good
reasons. The first was that every system uses different jigs and guides to aid
in the resection of the bone and placement of the appliance, the
representative helped the doctors understand how to use the system. The second
reason was that the surgeons needed to have access to a range of component
sizes to make sure they could place a correctly sized implant. Using the same
system on both knees also helped ensure that the geometry of both knees would
be consistent.

At the time I was pretty stunned that the rep was talking the docs through the
operation but the procedure was successful and I learned that when new devices
are introduced it is very often the company that trains surgeons in its use.

~~~
lostlogin
In my experience of this sort of situation, the reps are there to yell ‘stop’
when the orthopod tries to smack something fragile with a hammer. Each sub
speciality has its traits and orthopaedics is no exception.

------
freedomben
> _Companies and doctors aggressively push them as a safe antidote to the
> deadly opioid crisis in the U.S. and as a treatment for an aging population
> in need of chronic pain relief._

> _Although there are roughly 4,000 types of medical devices in the FDA’s
> data, just six of them accounted for a quarter of device injury reports
> since 2008. (Francois Duckett /AP) But the stimulators — devices that use
> electrical currents to block pain signals before they reach the brain — are
> more dangerous than many patients know, an Associated Press investigation
> found. They account for the third-highest number of medical device injury
> reports to the U.S. Food and Drug Administration, with more than 80,000
> incidents flagged since 2008._

This is shocking (pun not intended). I understand the desire and rush to get
us off of opioids, but I think this is a horrific reminder that we still need
to approach things cautiously and not get swept up in excitement and the
promise of a "panacea"

~~~
mikestew
_the promise of a "panacea"_

Especially considering that the “panacea” of OxyContin’s “impossible to abuse”
marketing is kinda what got us into this mess in the first place.

------
eleitl
Such a device has been life-changing for my elderly father, who is in constant
pain. No malfunctions so far -- don't know the exact product, this is Germany.

------
8bitsrule
From the 1930s to the 1950s, 'fluoroscopes' used strong x-rays to let
customers and employees of many shoe stores consider shoe 'fit'. _Each second_
they were turned-on exposed customers -adults and children- to _a year 's
worth_ of natural exposure. And employees?

New medical technologies should be avoided during the de-bugging stages.
Guinea pigs are underpaid.

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newname2018
If this device works in a certain percentage of users, what is the problem?
Pain sufferers have further options i.e. opiates As one who's been in this
exact situation it seems very good that there is a partially workable option.
If it causes other issues they can fall back to the other ( opiate )
treatments

~~~
ggggtez
Basic ethics? Seriously, think through the implications of allowing companies
to sell medical treatment that don't mention the risks.

~~~
walshemj
I would assume that in the US as with the UK with any implanted device/surgery
the doctor/surgeon goes through the risks.

I have done this several times in the UK - oh and one of the most serious ones
was 1/5000 chance of death :-)

