I do not watch Last Week Tonight because it is HBO’s hyper-biased version of the Daily Show, hosted by former Daily Show jagoff, John Oliver.

I was alerted to the segment that ran on Sunday night and when I watched it, it nearly gave me a fucking stroke.

Understand this was my life for almost a decade.

I earned my masters and doctorate in projects related to orthopedic implant design and manufacture.  My graduate advisor and mentor had previously been the chief metallurgist of the medical device company Zimmer in Warsaw, Indiana.

I went to work for a consulting company to do medical device failure analysis and actually worked on the DePuy Synthese ASR case.

I was patent pending on two medical devices until I ran out of money to continue the application.

My dad’s law firm specialized in regulatory compliance and I did 510(k) reviews for his firm.

And with all the technical knowledge and authority that I have, what John Oliver says is fear-inducing, panicky horseshit that will help nobody and destroy the medical device industry around the world.

First of all, I found the original article he quoted on the 80,000 deaths figure.

Medical devices for pain, other conditions have caused more than 80,000 deaths since 2008

The media partners found that, across all types of medical devices, more than 1.7 million injuries and nearly 83,000 deaths were reported to the FDA over the last decade.

That sounds bad, but here is the caveat that John Oliver didn’t point out.

Although there are roughly 4,000 types of medical devices in the FDA’’ data, just six of them accounted for roughly a quarter of device injury reports since 2008. Spinal cord stimulators — which are implanted in 50,000-60,000 people a year — are the third-most reported device for injuries.

Oh, well gee.  So most of the 4,000 FDA cleared devices are perfectly good, only a tiny percent have real issues.

The way this data was presented was that at any moment your insulin pump or pacemaker could fail and it’s all because the implant manufacturers are a bunch of lazy, greedy bastards.

The article this was pulled from was a tearjerker about people who suffered from spinal cord stimulator for pain blocking.

I am familiar with this kind of device.  It is intended for pain management in severe cases that do not respond to any other treatment.

I am not victim blaming here, but the patient who received these devices, or at least those these devices are intended for, are already incapacitated by chronic pain or are doped into incapacitation on opiates.  So we are already dealing with less than optimal patient conditions in a patient.

This gets even more complicated.  I published a paper on medical device failure for fracture fixation devices.  I have been an expert in medical device failure in spinal fusions.

Quite frequently device failure is blamed on the device and not the patient.  Here’s something you are not often told, there is no fixation plate that is strong enough to hold you together forever.  None.  They are not designed to be permanently load bearing.  Your bone needs to heal.  If your bones do not heal, the fracture plate and screws will fail in fatigue.  You have about 30 days.

Spinal fusion rods are the same.  If your vertebrae do not fuse in 60 days, your rods will fail.  There is not enough room in your body to make a rod thick enough and strong enough to be permanently load bearing.

The primary cause of hip implant failure is loosening on the proximal end of the femur due to bone resorption from a poor fit.  If this happens, blame the surgeon or osteoporosis.

Restenosis is the re-narrowing of an artery after the implant of a stent.  It is also considered a device failure.  It can happen to just about any patient.  Inflammation of the artery wall can stimulate more plaque build-up, there are some drug-eluting stents that can hold the inflammation at bay for a while but once all the drug is gone, it can happen.

I could do this all day, go through what are listed at device failures that are not the result of a defect in the design or manufacture of the device.

Medical device design is ridiculously difficult.  It’s worse than aerospace.  You can only operate within a narrow margin of safety.  You can’t just make a part thicker or bigger to reduce stress because it still needs to fit inside of a person.  You are dimension constrained by being able to fit into the bone or under the skin or in a vein or artery.

Your material selection is limited by what does not cause a negative reaction in the body.  Pretty much you are limited to polyethylene, Teflon, titanium, cobalt-chrome (Satellite), and some austenitic stainless steels, but the industry is trying to get away from that because of issues with nickel.  There are some very special alloys that are used in very limits applications like zirconium or platinum for electrodes but not in bulk devices.

So the suggestion that all of the deaths and injuries of device failure is directly the result of devices being bad is just flat fucking wrong.

But onto the bulk of John Oliver’s bullshit.

The Pre-market Notification of Approval or 510(k) is not a loophole.

This is the same bullshit we see when it comes to Lefties talking about guns or some right guy not paying enough in taxes where “everything I don’t like is a loophole.”

It’s a system set up by the FDA that allows medical device manufacturers to piggyback on prior approved devices to get products to market faster and cheaper.  To do that, a 510(k) device needs to show “substantial equivalence” not “substantial similarity” (that fuck-nut couldn’t get that right either) to existing items.

What does this mean for practical purposes?

That allows companies to make iterative design changes and improvements without having to spend five years and a billion dollars doing clinical trials.

The benefit is that it allows smaller companies and startups to come in and innovate without the need for capital and time that a clinical trial requires.  A lot of medical device design starts this way.  Especially in orthopedics, where some surgeon has an idea from 20 years of practice and works with an engineer to make a device, get the 510(k) and then sell out to a major biotech company.  I’ve known more than a few guys like this.

(If you are an orthopedic surgeon with an idea, I’m here to help, just email me)

Without the 510(k) process, every design change would be bank-breakingly difficult to bring to market and would be unreasonably expensive if it made it there at all.  Eliminating “the 510(k) loophole” would pretty much kill medical device R&D.

John Oliver can be a smarmy little fuck about DePuy wanting to make money off this device and the party that they threw, but I know guys at DePuy and I will say the same thing about them that I say about the people I know in the gun industry.  They are good engineers who do a job they are passionate about.  They want to help people.  The idea that they are just a bunch of unethical monsters who don’t care that people get hurt for the bottom line is ugly and wrong.

One of the reasons I stopped watching John Oliver or Adam Ruins Everything isn’t just because Adam Conover looks like he gels his hair with jizz, but because I am sick and fucking tired of the conspiratorial nature of these shows, i.e.:

Never trust the company out to make a buck.  They are always lying and cheating.  But me the intrepid journalist with a message to push and who makes money from views is honest and only looking out for your best interests.  Also that bureaucrats are our friends who only exist to make the world safer from those evil corporations.  

What I can tell you about the DePuy ASR case is that there may have been some design aspects that probably should have gone through more clinical trials, but there was also an issue with surgeons not putting them in correctly that severely exacerbated the problems with the design.

Furthermore, the ASR was designed to replace a worse problem.

Surgeons were putting artificial hips into younger and younger patients.  Some guy with a hip twinge at 62 would get a hip so he could play 18 holes of golf.  This was far beyond the design constraints of older metal or UHMWPE hips.  The ceramic on ceramic hips had a fatal flaw that they were not as shock resistant and the ceramic acetabular cup could shatter.

Cobalt-chrome on cobalt-chrome was hard, wear resistant, and shock resistant.  It was supposed to outlast the plastic cups with a range of motion that younger patients wanted.  Unfortunately, there were problems.

This is a far cry from the way that John Oliver portrayed the ASR release.

The end of the segment was the worst fucking thing I’ve ever seen.

“The FDA companies is up medical device manufacturers’ asses.”

Yes, they lobby to keep regulations at bay.  They do so because there are fuck-holes like John Oliver who would regulate the industry out of existence.  The 510(k) system exists to ease innovation, which more and more only comes out of the United States because the rest of the world has regulated their medical device industries out of the R&D market.

“Manufacturers are getting rich.  Doctors are getting rich.”

So the fuck what?  Good products are being created.  Patients are getting the devices they need.  Quality of life is being improved.

HBO is getting rich bullshitting you.  That is actually worse.

“And patients are getting their insides turned into oil and cheese.”

This is a rare mistake.  The vast majority of devices don’t have issues and a lot of problems are the result of compound causes, not just a bad device.

We already hear too many complaints about the cost of drugs.  Much of that comes from the same source, the almost unbearable cost of regulatory compliance.  Now these shit-for-brains want to cripple the medical device market with the same regulatory costs.

I cannot fathom the thought process that goes on in their heads?  Do they understand what the outcome is for what they want?

“Well, no new medical devices have been released in years.  A few medical device companies have gone out of business.  Patents are having to use the same older, less effective designs that have been around for decades.  But at least nobody was hurt by a new device that went through the 510(k) ‘loophole’ and doctors stopped becoming millionaires from R&D.”

John Oliver is fear mongering about things he doesn’t understand with a grotesque bias.  He is little more than HBO’s Wesley Mouch.