We're about to un-ring a fire on Mike Papantonio here with Robert Price.
Robert of course does, you've seen him on the show before.
He does complex litigation all over the country, mostly with medical devices.
So I want to talk to it right now.
The story about surgical mesh, this being implanted in the bodies of thousands of people
every day, is not a story that corporate media can tell you, because their advertisers won't
let them tell you this story.
In fact, they can't tell you because their advertisers, the people who make this product,
not only won't tell them, won't allow them to do it, they'll actually dry up advertising
money if they tell stories like this.
So they can't really do an investigative expose about this.
The advertising dollars are just too big.
So with me right now is Attorney Robert Price.
He's handling hernia mesh cases, and he's going to tell us the story that you won't
hear anywhere else.
Robert, first of all, has it, hernia mesh, it's been around forever, we think it's something
that's fairly innocuous they're putting in human bodies all over the country.
Give me your take on how bad this actually is, this hernia mesh story.
It's really bad, Mike, especially in the past 10 years or so, because you're right.
Surgical mesh, and polypropylene, which is a plastic based mesh, has been used for decades
in the surgical community.
But what we're seeing here is that these manufacturers are now making these, I kind of call them
these easy kits for doctors, with these different meshes with these designs.
There are experimental designs that they each use to try to jump ahead of one another in
this market share race.
In other words, somebody comes in with a hernia operation.
Yeah.
It used to be that you had to have a special surgeon that could do that.
Right.
And so the industry says, "Oh no, we're going to make something where any doctor can do
this.
They don't have to have special training.
They don't have to be a special surgeon.
Just give them the kit, and let them go."
Isn't that kind of what this industry is?
Absolutely correct.
If you've got a really skilled surgeon, that surgeon doesn't necessarily need mesh.
Or if that surgeon does need to use mesh, it's a small piece of mesh, or it's a more
complex procedure.
So absolutely.
It's this sort of sales mentality, it's like, "Well, anybody can do this.
Here's this special mesh.
It's easy to use.
It's got this coding, or it's got this ring, or it's got this special feature that makes
it great."
And the special feature is completely bogus, and it's unstudied, and it's causing infections,
and all sorts of massive, massive debilitating injuries.
Okay.
You saw this same thing.
You kind of led the charge on the vaginal mesh.
They were putting this mesh inside women's vaginas, and inside they're trying to hold
up the kidney, and the urinary system.
Explain that case, because this is just an extension of that, isn't it?
Right.
It's the same garbage they were putting in women's bodies.
Absolutely.
First of all, it was nothing different than just pure fishing line, that you could buy
at a fishing store.
Isn't that kind of what this story developed into?
Right.
Absolutely.
So some years back, you've seen the Kugel Mesh litigation.
This was years ago, where lawyers were bringing claims based on this defective ring.
Then years went by, and we did the transvaginal mesh litigation, and we started learning about
the behavior of these manufacturers, who are the same manufacturers essentially, just the
hernia mesh manufacturers.
You see a broad spectrum behavior of using mesh that's not cleared for medical grade
use.
In fact, some of these manufacturers use polypropylene that actually says on the material sheet,
"Do not use this in the human body."
Yeah, there's a material data sheet, and the material data sheet shows how the product
can be used, or how it should be used.
The manufacturers understood because the document said, "Don't use this to put in a human body."
But they did it anyway.
Exactly.
And that's just one component of the story.
The other component of the story is on top of this bad mesh, you have these coatings,
these chemicals.
One company even uses fish oil.
Just all of these things.
An idea here is that they go to surgeons and they say, "Use this mesh laparoscopically.
It's real easy to do.
You can place it right up against the bowel, and this fish oil coating, or this special
chemical coating, is going to help keep it safe from the bowel."
So what's the truth of the matter?
The truth is the coating either causes infections, or it just literally just wicks right away,
and the mesh actually eats into the bowel causing bowel obstructions, massive surgeries.
People even have to live in a colostomy bag because of damages caused by this stuff.
All because of this kind of marketing transcendence that we see.
Cheap mesh, no studies, slap it out to doctors-
Point out the no studies.
How did this get on the market without them actually doing studies on the hernia mesh
itself?
How did it?
It's out there without studies.
That's what's so remarkable.
It's actually out there without studies.
... yeah.
There are two types of studies you see.
So you see the animal studies.
Probably half the animal studies I've read are the animal studies show, "Oh crap, this
stuff is killing these animals.
Put those studies aside."
And then the other studies that they think are favorable, they parse out those studies
and show those to doctors.
No human studies.
The only human studies, if you want to say, are the adverse event reports that we see
after they've been implanted in thousands of people, thanks to our FDA, who doesn't
required studies to be done in the first place, on humans.
I know you're very well familiar with the 510(k) process, right?
Well the 510(k) is where you have a company that says, "We have an item.
We have a mesh that's similar to the one that you want to put in the human body."
And so the FDA says, "Oh sure.
Go ahead and do it.
Have you done any longterm studies to figure out how humans are affected?"
"No, not really, but it's already out there, so we get to do it too."
Isn't that kind of how that works?
Absolutely, it's like you said.
A lot of these products that are on the market are based on meshes 10 years ago.
What's not funny, but what is crazy about this stuff, is that when you have these experimental
designs, the 510(k) application actually looks like this.
It says, "This mesh is just like this mesh, this mesh, this mesh, and this mesh."
Well, say have you ever studied what would happen if you put all these properties together?"
"No, it's just like these meshes."
And again, the FDA says, "Oh yeah.
That sounds like good science."
Here's the truth of the matter.
We don't spend enough time as patients asking doctors A, "Could you do this without the
mesh?
Could you actually perform the surgery without the mesh?"
The doctor's going to say, "Probably not" Okay.
"So get me the guy who can do this without mesh."
That's the first thing.
The second thing we don't ask them is, "How much do you know about the studies that were
done on this product that you want to put in my body."
All the doctor's really confronted with is what we call the detail, or that's the salesperson
comes by their office, has cupcakes for them, says, "Doc, we're so glad you're buying our
product."
They take them out to lunch.
They'll take them on these exorbitant trips, places like Hawaii, and have what they call
a seminar, where they talk about their product.
It's just the biggest scam, and unfortunately, patients are too often too afraid to confront
the doctor, and ask questions about the pill that they're taking, or about what's being
put in their body.
Không có nhận xét nào:
Đăng nhận xét