The Bleeding Edge Page #5

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And, um, of course...

they suggested some procedures.

My doctor said, "We can take care

of that in a simple 45-minute procedure

with this new thing called mesh.

It's a simple, golden standard

outpatient surgery.

It's better than sliced bread.

It's the new thing."

Mesh is a polypropylene resin

that gets extruded into fibers

and then woven and knit into a mesh.

Johnson & Johnson saw that doctors

were starting to take hernia mesh

and cut very little tiny pieces of it

to help support repairs

where they felt they needed a little bit

extra because the woman's tissue was weak.

So they said, "That's a great idea.

Let's sell the hernia mesh

for pelvic floor treatments."

As women get older,

and if they have several children,

things start to bulge or drop.

Patients come to us

and want things to be fixed.

One approach is what's called

a native tissue repair,

which is basically where we suture

things in place using stitches,

suture material.

Or, theoretically, one could use mesh

to augment the repair.

The surgeon makes a cut in the vagina

and then implants the mesh

to hold organs up in place.

It costs about $25 to bring to market

and they sell for about $2,000 a pop.

I was told that it is superior to

the traditional surgery that's required.

Very easy to place.

Very, very few complications.

I wish I could say that doctors

really understood

the regulation of medical devices.

But the fact is that's not what they do.

That's not their area of expertise.

We were surprised to see how little

surgeons knew, in our study,

about the approval process for devices.

Some of the surgeons seemed to think,

"Well, the FDA are taking care of this."

That of course these devices

had been tested in humans.

I came home from my surgery.

I started having a lot of pain,

discomfort.

I couldn't sit, I'd climb steps,

I felt like a 90-year-old woman.

She had a bad fever.

She was throwing up.

We ended up going

to a few emergency rooms.

We'd seen so many doctors.

They didn't know what was going on

with her. They had no clue.

Once you put mesh in,

it is scarred into place,

permanently affixing it to the tissue.

The scar tissue

causes the mesh to shrink up

and as it shrinks, it starts to contract

and pull against the adjacent tissues

that are in contact with the mesh.

The scar tissue creates

a hard and flexible object in the pelvis.

Around the vagina, around the bladder,

around the urethra.

Structures that need to be able tomove

in very subtle ways in order to function.

Now you have this hard object in there,

and there's a cascade of problems.

So eventually, I find this doctor

in Louisville.

And he says,

"You've got a problem with your mesh

and it needs to be removed...

but I can't do it."

I was never trained to take it out.

I've never took it out.

We were just trained on how to put it in.

Once it's scarred in place...

that's it.

Ain't coming out. Not in its entirety.

I've been told

it's like removing rebarout of concrete,

bubblegum out of your hair.

Because of the position

that they're placed,

they're in very delicate areas

where it's almost impossible

to remove the mesh completely

Once the scarring is complete,

the body doesn't want it to be there.

So it keeps scarring and scarring,

keeps pushing and pushing,

and sometimes it tries to push it

out of the body.

So we do a partial mesh removal.

Six to eight weeks of healing.

My husband and I are trying to get back

to our sexual relations.

I've set the stage, actually.

I've got candles going,

I've got my daughter in bed.

You know, I'm gonna feel

like a woman again.

This mesh problem's gone.

Very shortly into our intercourse,

my husband jumps up.

When I penetrated her...

I ended up getting a...

cut.

He grabs himself.

He turns the light on.

And I have cut...

the top of his penis.

I mean, like, what the hell?

You know? What's going on?

And he's like, "Tammy,

you... you've cut me."

She was confused about it.

Just as well as I was.

So I'm thinking in my head,

"Well, the rest of the mesh."

As a woman, you're thinking,

"Am I ever gonna be able to have relations

with my husband again?"

Was he ever

gonna want to stay with me?

At first, as she's going through

her illnesses and everything,

you're not thinking about that.

But then, you know,

we're talking an eight-year period...

of not having relationships

with your mate.

It can be really stressful.

That was taken from us.

I've had a major surgery...

bladder repair...

cervix removal...

reconstruction.

Your surgeries,

that's a grand total of how many?

Oh, Lord.

Eighteen?

Nineteen?

- Byonia?

- Yeah?

What's today's surgery?

I don't know. I've lost count.

Byonia knows more about mesh

than a lot of doctors.

She's been through every surgery.

I want to be a good wife

and I want to be a good mother,

and I still cannot do the things

I want to do with my daughter.

- Slow up.

- Byonia, slow up.

Yeah.

Mommy can't keep up with you.

I have a daughter that says, "I wish."

"Momma, I wish we could ride my bike.

I wish that I could take your pain."

The hardest one to hear is, uh...

"Mommy, is it my fault you had mesh?"

She's smart enough to know...

She's heard women talk.

That she knows it is a lot of it

from childbirth.

That should never be in her heart

or her mind.

That's my guilt.

We take our responsibilities

as a leader in health care very seriously.

We're fortunate to be in an industry

where human health care

is the basis of our business.

And we measure successby improving

the quality of people's lives.

The CEO of Johnson & Johnson

is Alex Gorsky.

Before he was the CEO,

he actually was the head of Ethicon,

the unit in the company

that these products were sold through.

And on his watch, there was a flood

of information coming into the company...

of women suffering

very severe complications.

When did anybody first

make you aware that anybody in the world

had a concern

about the safety of the Prolift?

I don't recall.

Before the pelvic mesh devices

even came to market,

the surgeons who were developing

the prototypes...

were telling Johnson & Johnson,

"This mesh is not safe."

And the director of medical affairs

acknowledged it on the record

when I took his deposition.

You knew significant retraction

could occur?

Yes.

You knew

that a significant retraction

could lead to pain for the patient,

correct?

Yes.

You knew it could lead

to the need

to have subsequent invasive operations

to try to either...

re... remove or revise

that contracted mesh, correct?

Yes, sir.

As you sit here now,

are there any risks or adverse reactions,

adverse events connected to the Prolift

that medical affairs at Ethicon know of

that were not known at the time of launch?

No. There are no new adverse events that

we were unaware of at the time of launch.

What they did

was willfully ignore the risks

they were putting these women to

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