The Bleeding Edge Page #6

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without telling them.

And actually, not just not telling them,

but telling them

how safe this was going to be

and how wonderful

this was going to be,

knowing they didn't have

a basis to say that.

People who go to work

in medical device companies,

they're scientists

who actually want to do the right thing.

But if the science or the medicine

isn't jiving with the marketing,

the marketing is always gonna win out,

always.

So it is December 10th, Sunday.

Um, two days before my lumbar puncture

spinal tap.

My daughter, Rayne, is going to drive me

and stay with me there the whole day.

I think they said they do the procedure

around 7:
00 a.m.

So, yeah.

Yay, spinal tap.

Coming up soon.Oneida.

Have you ever had

any surgeries done?

- Lots.

- What have you had?

I had a medical device called Essure,

- the new female sterilization.

- Oh, yeah.

Those expelled and got migrated

in my uterus.

I had surgery to remove those,

then I had to have a tubal ligation.

- Um...

- So I guess you're not pregnant.

No, because then, later,

I had to have a hysterectomy

because of the fragments

from the devices that broke.

Get out of town!

Then I had two more surgeries

as I wasn't healing from the hysterectomy.

So they had to repair the vaginal cuff

twice.

- Holy crap!

- Yeah.

Sorry, that's like...

I've had three joint surgeries because...

Essure removal

is the bane of my existence.

We've seen the manufacturer

change the removal protocol,

contradicting themselves

and going back and forth on what's okay

and what's not okay.

Because of that,

a lot of doctors are winging it.

And, unfortunately, breaking them,

pulling them,

cutting them, stretching them.

'Cause If you pull them

or stretch them at all,

it'll fragment and leave pieces behind.

This is what happened to me.

The device ended up breaking

and leaving me with fragments everywhere,

which then set off

my immune system.

Which then set off

a connective tissue disorder

that started deteriorating my joints.

Bayer has admitted that it causes

an autoimmune response

in a small percentage of women.

Um, however,

we don't think it's a small percentage.

Women have all these problems

that seem to have nothing to do

with their pelvic area.

So we started

the Autoimmune After Essure group.

What's just as crazy as that,

we see a really high rate of women

that are becoming pregnant

after being implanted with Essure.

So we've started

a Parents of E-babies group.

We're seeing patterns of health problems

with these babies.

We have seen the device puncture

the amniotic sac and cause preterm labor.

We've seen a lot of loss.

I've seen women have to bury

premature babies.

This is devastation.

Life devastation.

There's nobody paying attention.

We are keeping those records

because nobody else is.

We assume the FDA

has the data that they need

to crack down on manufacturers

that have bad devices

or to recall a product,

and they don't have that.

- They don't?

- They don't have that.

There is a system

for reporting complications...

but there's tremendous underreporting,

because it's a voluntary system.

The FDA has said, "If there's a problem,

just come back to us and let us know."

Well, that reporting system

relies on self-reporting.

There are huge problems

with self-reporting complications.

If a physician observes an adverse event,

they do not have to report it.

The only...

bodies that are required to report

adverse events are the companies.

And the industry is not interested

in having problems with devices

become apparent.

It's estimated

that only three to four percent

of all adverse events...

get reported to the FDA.

A study found

that the worse the outcome was,

the less likely it was

that they would report it to FDA.

So we don't know

about the adverse effects of a new implant

until months or years

after it's on the market.

By then, that may have been put into

hundreds or thousands of people.

Yes. That one.

Here's some examples

of doctors putting in multiple coils.

There's three coils here on this side

and one on this side.

This one is way, way out

of the fallopian tube.

Here's one with six devices.

The doctors are told by the Bayer reps

that come in, who aren't doctors...

Reps come into these rooms

to sell these devices,

and they stand there

and watch you get implanted,

and, if it misfires

and it just gets shot off into the uterus,

they just tell the doctor

to load up another one and try again.

So we're seeing women with five, six,

sometimes eight devices, inside of them,

when you're only supposed

to have one per tube.

Every year,

there's an annual ACOG convention.

And ACOG is

the largest gynecological organization

in the United States,

so there will be thousands

of ob-gyn doctors

at this ACOG convention.

There are so many doctors

that still believe

there are no problems with this device.

Looking at the photos

I think changes their minds.

- There's Holly.

- Hi! How's it going?

I'm Janet, one of the main admins.

Nice to meet you.

- I'm Eva.

- Nice to meet you, Eva.

Oh, there's Angie.

Hi!

Oh, what's up?

Nice shirt.

Yeah, you like it?

I love it. Love it.

Bayer has no data!

Do you have malpractice?

Bayer has no data!

Do you have malpractice?

Bayer has no data!

Do you have malpractice?

Bayer has no data!

Do you have malpractice?

Make sure you tell Bayer

we're out here.

- We're not going.

- Are you giving warning?

What was the biggest problem with them?

- Where do we begin? Chronic inflammation.

- Which part?

Uteruses that are swollen,

two and three times the size.

It's been in the market for...

It's been

in the market 15 years.

Oh, really?

Like I said, I'm putting them in

less than I used to.

- But for some...

- You should never put them in.

You have two doctors here

who've been around long enough to know

that there are complications that occur

all the time,

- in all of medicine and surgery.

- Absolutely.

And it's unfortunate.

I'm sorry you had to go through that.

Are you aware

of all the side effects of Essure?

No, if you do a good job,

you don't have any problem.

- Even if they do a good job...

- No, no.

All those women...

See that sign?

All those names are all hysterectomies

and surgeries and salpingectomies.

It doesn't matter where they're implanted.

They move.

- No, no, they don't.

- They... We have proof.

What happens if there is a complication?

Well, then it goes in the category

of people who have complications.

You remove it, and that's it.

How do you remove it?

You remove it by hysteroscopy.

You put it...

You... you pull it out?

You put an instrument inside,

and you pull it out. You pull.

You cannot do that.

It breaks.

You... you...

You are not a doctor.

You are working...

You are talking like nonsense.

I have 33,000 women

in this group...

No, no, no.

...with over 9,000 surgeries.

I can tell you that we've had fragments

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