The Bleeding Edge Page #4

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this innovative product."

It's all very glossy.

It's a slick machine.

We've doubled life expectancy

in 150 years.

And that's happened because of innovation.

Just because you have a new technology

doesn't mean it's innovation.

And, I think, too often I hear people say,

"Oh, you're gonna stifle innovation."

They're not talking

about stifling innovation.

They're talking about stifling, um,

putting untested devices on the market.

That's not innovative.

Before Essure,

the only times I was in the hospital

was because I was pregnant.

For the past three years

that I had the Essure,

I've visited the hospital a lot

because of pain.

I was working

and passed out 'cause of the pain,

and I woke up

and I drove myself to the hospital.

I'm more scared because,

if they have to admit me,

I have to find someone

to take care of my kids.

Especially because it's a school night.

So I don't want them to miss school.

Are you Ana Fuentes?

After Essure,

my bleeding wouldn't stop.

It came to the point that I had to start

wearing baby diapers.

I couldn't even function

as a wife to my husband,

and eventually, he ran away.

One of the doctors that I had,

he mentioned that most Latinas

have menstrual problems.

So they thought it was...

because I was Latina

that I would bleed a lot.

But I'm like,

"I've been Latina since I was born

and I became a...

And my mom saw me grow up

and I never bleeded this much.

So this doesn't have to do

with me being Latina."

I've had a headache since 2011.

Normally, the headache's about a four.

And then at night, it starts spiking up.

Seven, eight, nine.

Sometimes ten.

So this is my traction unit.

It stretches my cervical spine,

'cause the inflammation

gives me insane headaches.

Before I had Essure put in,

I was really strong and really healthy.

We went hiking, we went camping.

I could do all the normal things

that moms do.

It's hard for me

not to be doing those things.

I did a little research.

I didn't see too many people online

talking about Essure.

And I said, "I have to warn my friends

and my family members,

and I need to tell them

to stay away from this."

So I started this little Facebook group

called Essure Problems,

and I added all my girlfriends.

I didn't really know

much about Facebook groups,

but then slowly people that I didn't know

started commenting and saying,

"Oh, my God,

this is what I'm going through."

Just stories just started coming in.

People just found me.

It just started snowballing.

I remember hitting 65 people

and going, "Wow, there's 65 people

that are having this problem."

Every day, we had new people

joining the group.

Women were telling their stories.

The day that I was implanted,

I left the hospital

and I was in pain.

They told me to take some Ibuprofen

and it'll get better.

Now I'm going to the OB this week to have

a full hysterectomy at 31 years old.

Slowly, the progression of women

joining and having similar stories,

um, we became a support group

for each other.

And then we started finding information

about how the device was approved.

We found out that Essure

went through something

called the pre-market approval process,

or PMA.

Pre-market approval

is the most stringent pathway

to get a device approved.

But even that process is not that strict.

It's less rigorous

than the process for drugs.

Most drugs had to have

two clinical trials,

and they have to have large

numbers of patients.

With devices, it's only one study.

Those studies are often small.

Sometimes it's 100 people.

I've seen studies with 50 people.

So the approval process

for the riskiest devices is not good.

One of the members of the group

found the transcript

for the 2002 approval meeting

where the FDA approved Essure.

I noticed at the bottom of the transcript

that the entire meeting

had been videotaped

by this video company,

and their phone number was there

so I thought, "I should call them

and see if I can get a copy of that."

And so I did, and they found it,

and they said it was going to be

several hundred dollars.

I put a post on the page.

I'm like, "I think we need this."

And within 15 minutes,we raised $900

on the page, and I ordered those DVDs.

All right.

Let's go ahead and get started.

They approved this device

on such a small number of women

that were followed

for such a short amount of time.

The lead investigator

for the clinical trials

who presented the evidence

to the FDA

on the safety and efficacy of this device,

he owned stock in this company.

I have received compensation

which now represents

a financial interest in the company.

There was a paid spokesperson

that had Essure implanted herself.

Gabriella Avina.

They hired her to come and speak.

It brought about a peace

to my life and to my relationship

that I cannot express to you.

And it was just mind-blowing

because they didn't have a lot of data

for the questions

the panel members were asking.

What would happen if you touched

the electrode to the coils?

How much

uterine cavity will be compromised?

The panel was not supplied with

a summary about compatibility testing.

What about the tubal perforation issue?

I don't know what happens to people

with metal sensitivity

when you implant metals in them.

They still approved it,

even with these open-ended questions.

The device clearly met the criteria

of safety and effectiveness

that are required for approval.

At the end of the meeting,

one of the panel members asked,

"What are we gonna do

if we're seeing problems in ten years?"

Private investigators would find

each of us, bring us back here,

and ask us why we approved this.

How could they joke about this?

Like, they're joking about... us.

You know, here we are, ten years later,

and all these problems...

And... and, you know,

they approved it on... on a joke.

If this is our FDA process

of medical device approval,

then we have a big problem

in this country,

because this is just one device.

I'm from Nicholasville, Kentucky.

Kind of a... Anywhere, USA.

It's a small town.

Great schools.

Great people, wonderful church.

I was in nursing.

I did pediatrics, uh, children.

And I just loved working with the people.

My husband is a machinist

at General Electric.

He works on the machines.

They're bigger than a house.

He's my rock.

Well, we met... Um...

I was young and we were out partying.

So, um, she was with a group of friends

and I was kind of out on my own...

um, looking for trouble, I should say.

Ah... I found it!

We've got a daughter

that's got a beautiful spirit.

Very loving, very compassionate.

Uh, make a great doctor one day,

if she chose to.

I delivered my daughter at 41

and I was working at the hospital,

and when I would go to assist my patients

by transporting them from the bed,

I would leak some.

She started having some problem

with holding her urine.

She went to the doctor to see about it.

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