The Bleeding Edge Page #10

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across the country

to participate with us at this conference.

I speak,I think, for the entire industry.

Where we were five years ago at the FDA

compared to where we are today

is night and day.

And I think your leadership

has made a huge difference

and we are really grateful for that.

In 25 years,

we will, I think, be worse off.

All the legislation we're seeing,

again, driven by lobbying from industry,

is moving in the wrong direction

and there's no evidence

that's gonna shift.

I just came out of a briefing

with senior officials at the White House

about the executive order that

President Trump will sign this morning.

We issued an order which says,

for every one new regulation,

two old regulations must be eliminated.

"Regulation is bad. Let's cut regulations.

For every regulation,

we're going to cut umpteen regulations."

That bravado...

may apply to certain fields,

but it can't and shouldn't apply

when you're talking about

putting a device in someone's body.

We're very proud of this one.

I'm gonna leave.

I need to go find a place.

Mom!

You ready?

We are going to go try to find a hotel

that will take us all in

with a reasonable price.

And call it a day, I guess.

Mom, there's a homeless over there.

I know, baby.

You see, girls? It could always be worse.

He probably doesn't have a car or anything

and we do have a car.

Does he know us?

- Does he know us?

- No. Okay.

Hi. How much is it for a two-bed?

- 110 for one night?

- Yeah.

Do you have weekly discounts

or anything like that?

Nothing right now.

Give me a second, okay?

- So it's 110.

- 110 and a private room.

- Are you guys happy?

- Yeah.

Yeah.

Go.

It's really tiny.

So I guess we're home.

For a night.

Familiar faces.

Nice to meet you in person.

Claudia.

Janet.

Yes, Janet, how are you?

Good, how are you?

You're Marilyn, right?

- And you are...?

- April.

Oh, my God!

- Surreal.

- My God, you guys.

I want to thank everybody for coming.

It's just amazing

to finally see all of you.

So let's start off

by maybe just going around,

just say who you are

and where you're from.

My name is Alicia Perry.

I am from Stockton.

I am an implantee,

I'm just going to say it, for ten years.

No longer. And I'm so glad

to see everyone here. Thank you.

I'm Juanita Nunez-Archuleta.

I know it's long.

I'm an admin on the Spanish page

and I am E-free, seven months.

I'm Gaby Avina

and I'm from Martinez, California.

I was one

of the clinical trial participants,

so I had mine implanted in 2000,

and I had mine taken out in 2014.

I don't know if any of you were familiar

with the Ask Gaby website...

that was on Conceptus

and Essure's website.

That was me.

I was a spokesperson.

I failed thousands of women

for seven years.

It's a long time to tell women

that a product is great.

So the guilt that you live with...

and the pain...

and just crazy feelings of responsibility

because of that.

Thank you for being

on this side now

because it's important

that people now see the damage

and more and more doctors

are starting to see it.

Very validating.

We just want to have a discussion

and brainstorm.

What should our new media push be

right now?

I felt good about it

'cause I saw women that came together

to fight for what they believe in.

They're strong, they're smart women,

and they're getting the media to listen.

It was supposed to be safer

and less invasive.

Why are so many people complaining

about a popular birth control device?

Pain, back pain.

It was debilitating. I could barely walk.

I never thought

I would be looking at a hysterectomy...

at 29.

My body is just devastated.

Damaged, they say,

by a birth control device called Essure.

The stories started getting out

in the news and then other news stations

started seeing the other stories and were

like, "Okay, let's do this in our area."

Five heart-wrenching stories

of extreme physical pain.

Six women with severe medical problems.

Thousands of women like Becky

are sharing their experiences on Facebook.

There are now

35,000 members in the group.

We've set up groups in other countries.

We found women in Italy,

willing to take over the page.

We started the Netherlands group.

We had women from France.

They're all branches of us.

So we've got 11 subgroups

that are other countries.

A controversial birth control device

in the US is going off the market

in Europe.

Bayer announced

it is pulling out of the European market

due to a lack of interest.

But a spokesperson says,

"Bayer's decision

does not impact the sale or marketing

of the product in the United States

where there continues to be demand,

despite the recent inaccurate

and biased reporting."

That's bullshit.

The equivalent of the FDA in Europe

asked Bayer to provide more safety data.

And Bayer, at that point, decided

to withdraw it from the market.

It's very frustrating.

Our group has been fighting

in our country for the longest.

Yet we're the ones

with it still on the market.

Bayer has no incentive

to take it off the market here.

Nobody's holding the manufacturer

accountable.

- Bye, honey.

- Bye, honey. Knock 'em dead.

We're not gonna stop

until it's off the market.

The FDA isn't doing anything,

the manufacturer's not doing anything.

We need to push Congress

to force the hand of the FDA.

So this device

is still being inserted in women?

- In the United States...

- In the US?

September 18th, it came

off the market everywhere else.

Look at how far up

the injury and death reports go now.

Because they're not being held liable,

they don't have any incentive

to take these devices off the market.

People are getting harmed and injured,

and nobody's doing anything about it.

We have many, many women

who are ending up with fragments

and massive issues and re-surgeries.

- Women just seem to be expendable.

- Yes.

That's how we're starting to feel.

We're disposable.

The FDA has been very clear that they're

not going to take this off the market.

That this is the manufacturer's

responsibility

I know of no possible reason,

when they are chosen to protect

the health of the people of this country,

that they would choose to go

in the other direction

and protect the manufacturers.

That's gotta be changed.

I wanted to get as much information as

I can with the various personal stories.

I don't know

how many of those that you have.

A lot.

- Thousands.

- Tens of thousands.

Tens of thousands, okay.

This place works

with good people on the inside

trying to maneuver

and push legislation forward.

The way it really works

is the external pressure.

And that's all of you

and you are in great numbers out there.

Welcome to the NFL.

You just cannot get tired.

It is a continuous effort.

We won't stop.

They've already taken away my health.

What else can they take from me?

I have nothing to fear from them.

This has to come to an end.

I don't know how anyone with a conscience

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