The Operation that Ruined My Life Panorama

How have simple medical devices left

thousands of women in total agony?

I

think when you have this amount of

pain, it's horrendous, really

horrendous.

American manufacturers

have made huge profits but are now

paying out millions of dollars in

damages.

How can they sleep at night

knowing that they injure thousands

and thousands of women?

Tonight on

Panorama - we reveal one of the

world's biggest medical companies

who failed to fully inform doctors

of the extent of the risks.

If you

knew there was a problem, you should

have told everybody.

And how

permanent mesh implants were put

inside women before long-term human

studies were completed.

They're

experimental test subjects. They put

money in front of the health and

safety of women.

Panorama has been in contact with

dozens of women who are in extreme

pain. They've been recording their

stories.

It's 4. 35am. Once again

I'm not sleeping.

Can't sit upright.

It's like needles digging into my

groin.

They're suffering after an

operation they were told was the

gold standard.

It can feel like

glass, actual like broken glass.

That's the way I'd describe it.

I'm

sore all the time, tired all the

time. Can't do anything. It really

has ruined my life.

I've counted

them many times, every one of the

49.

Each of the 49 steps to get to

Claire Daisley's flat is a struggle.

Do you want a rest?

I tell myself

only a few.

Three more.

This is

Claire seven years ago. Like many

women, child birth left her with a

weakened bladder. So she had an

operation to fix it. She was told it

was a simple procedure.

20 minutes,

25 minutes. New woman. Sort you out.

Gold standard. You can get back to

your normal life.

Just go straight

through to the left.

A small strip

of plastic known as mesh was fitted

to support a tube from her bladder.

But it damaged her nerves and caused

constant pain.

I was crying getting

in the car, out of the car, coming

up the stairs. The pain in my legs

was just horrendous. There was no

feeling in my pelvic region. It was

numb.

Can I give you a hand?

Claire

had her mesh taken out two years

ago, but it has made the damage even

worse.

I don't want to be here any

more. That's how far it's taken me.

Because sometimes you don't know if

you can take the next day... To the

day you've had, how can I go through

another day?

I've been reporting on

the story of Claire and women like

her for the past three-and-a-half

years. Their campaign led to the

Scottish Government calling for a

suspension of mesh products. Vaginal

mesh implants are used to treat

incontinence or prolapse, when

organs move out of place in the

pelvis. When they were launched, in

the late '90s, they were seen as a

great thing, because they promised

quicker, cheaper surgery. They're

made of plastic and now, they're

inside millions of women worldwide.

Including tens of thousands in the

UK. E...

That hook goes into the

patient's right side. That hook goes

into the left side.

These are the

hooks used to fit mesh, similar to

the one Claire had.

It looks

medieval.

For manufacturers, for the

surgeons, we didn't see it that way.

We thought this is the gold

standard.

Dr Wael Agur used to fit

mesh, but now he's got concerns.

I

believe that the risks outweigh the

benefits of the vast majority of the

mesh procedures and mesh devices.

Looking back on this, we jumped on

the band wagon to do it and realised

later that perhaps that won't a very

good idea.

Millions of women around

the world have had mesh implants.

For the vast majority, the treatment

has been a success. But for a small

minority, the complications have

been devastating. The proportion of

women affected is hotly contested.

Previous surgical treatments had

complications too. But the problems

some women have suffered with mesh,

from a range of manufacturers, are

significantly more serious than

patients and doctors had expected.

This is the worst thing that's ever

happened to me. If it weren't for my

kids, I wouldn't be here. I can

promise you that. The pain, it's

24/7.

I had to retire from my job at

the age of 40 in 2013, because I was

not able to work. I was in too much

pain.

But many doctors think mesh is

an important treatment option. In

total how many operations would you

have done? Linda Cardozo has fitted

thousands of mesh implants for

incouldn't nebs. She --

incontinence. She refers to them as

tape. She's a world leading

urogynaecologist.

I use the mother,

sister, wife test and say, would I

have it myself. And the answer is,

absolutely no doubt about it. The

vast majority of very, very -- are

very, very happy with their tapes.

Mesh for prolapse uses a bigger

piece of plastic and has led to

higher complication rates than for

incontinence. Its use is being

reviewed. You might think that any

device that's going to be put into

your body for the rest of your life

would be subject to rigorous testing

and regulation and that any side

effects would have been picked up in

clinical trials and reported prior

to its use. But when mesh came on

the market, that wasn't the case.

Whilst medicines require clinical

trials before use, mesh is a device,

so the rules were different. Mesh

for hernia was already in use, so

with vaginal mesh manufacturers

could argue their products were

similar. It's a process called

equivalence.

That is a loophole in

regulation globally that says my

device is similar to your device,

could I have access to the market?

It means there was no clinical trial

evidence of particularly saying this

is safe device that's we can use

long-term.

You're saying you can put

a permanent device into someone's

body without any clinical trials?

Yeah, this is the loophole, if you

like, in the system that leads to

dire consequences.

Effectively, we

have to trust manufacturers to tell

us whether their own products work.

Would that be normal, though, to

start a procedure and, you know, a

permanent implantable device before

the clinical data?

It's true of many

things that we implant. It's true of

artificial hips. They were implanted

before there was good data. It's

true of heart valves. They went in

before there were mature data.

Unfortunately, you have to start

somewhere.

Launching products

quickly allows patients to access

new treatments faster. But did that

mean mesh was used in patients

before the risks were fully

understood?

To find out, I've travelled to

America, where most mesh comes from.

Take the exit on the right...

Over

here is the headquarters of one of

the biggest mesh manufacturers in

the world. Ethicon is part of the

multibillion dollar company Johnson

and Johnson. Their mesh products are

commonly used in the UK. One of

Ethicon's corporate videos promoted

the benefits of their mesh products.

You can enjoy life and do things

that you always wanted to.

But now

some 60,000 other women in the US

are suing Johnson and Johnson, after

problems with their mesh implants.

A

division of Ethicon, a Johnson and

Johnson company.

Adam Slater is the

lawyer representing 240 of them.

What Johnson and Johnson did is

terrible. They put money in front of

the health and safety of women. I

took the deposition of the worldwide

medical affairs director of Johnson

and Johnson and Ethicon in charge of

these products. He testified under

oath that they knew the risks from

day one.

All of the different

adverse events I've asked you about

with regard to the devices, these

were known from the very beginning,

when the TVT began to be marketed,

correct?

I agree.

They knew that the

risk profile was horrific.

Ethicon

said using only one part of his

testimony is selective. And that all

surgical pelvic floor procedures,

with and without mesh, come with the

risk of developing these

complications. They said they cared

deeply about patients who use their

products.

Panorama has obtained hundreds of

documents from US legal cases. Among

them, e-mails that appear to show

how doctors lobbied on behalf of

Ethicon to ensure patients kept

getting mesh implants. Our story

starts with this man, Dr Don

Ostergard. He's a vocal critic of

mesh and a decade ago, he argued

doctors should treat mesh surgery as

experimental.

Since there was no

information as to what the long-term

effects of the mesh was, patients

were not able to be informed of what

would happen once that mesh is put

into place.

That became a big

problem for Ethicon, when a major

doctors association, called ACOG,

agreed with Dr Ostergard.

ACOG is

the leading professional

organisation, whose focus for over

50 years has the advancement of

women's health care...

They issued

advice to their 55,000 members that

mesh for prolapse should be treated

as exarptal. -- experimental. Why

would it have mattered to the

manufacturers or to anyone else if

mesh was described as experimental?

If you're going to tell a patient

we're going to put some mesh in

yeah, and the mesh itself and the

procedure is experimental, patients

aren't going to like that.

But six

months later, ACOG changed its

advice. This helped promote the

widespread use of mesh. The word

"experimental" was dropped and

e-mails from inside Ethicon help

explain why. They reveal that

behind-the-scenes Ethicon was

liaising with doctors about lobbying

ACOG. Among them Dr Vincent Lucente.

Here he is in a promotional video.

... Give women their lives back

again...

Ethicon paid him 1. $1.7

million over ten years to consult

and teach other doctors how to

implant mesh. But the e-mails show

he did more.

Vincent Lucente went

behind-the-scenes and manipulated

ACOG and he got them to remove the

word "experimental".

Dr Lucente

bragged to Ethicon saying, "This is

one I am taking the credit for" and

"this is a major victory". One

senior Ethicon employee was

overjoyed.

The world wide marketing

director at Ethicon says, and this

is all capital letters, "I am doing

the happy dance. I love you, man."

And a big happy face. It's all about

money. That is a marketing director

who knows that the money train is

going to keep going.

Dr Lucente told as he made a single

phone call to Acog, because

"experimental" wasn't accurate. He

said the scope of his work with

Ethicon never included any lobbying

of professional bodies. Ethicon said

it is customary to engage with

physicians and researchers. And Acog

said Dr Vincent Lucente played no

part in the changing of the word.

They said it was ambiguous and the

word mesh was already being used. --

and mesh was already being used. I

am on my way to Philadelphia to meet

a woman who sued Johnson & Johnson

because of the damage caused by her

mesh implants. So, is this the first

time you have been back?

Yeah. This

is the first time I've been back to

Philadelphia since 7th September,

when I won my verdict the first

time...

Ella Ebaugh won $57 million.

I met her with her family at home

lawyer's office.

This is my softball

days, when I played on a major

women's softball team called the

Lakerettes, and we were six time

national champions.

Ten years ago,

Ella had two mesh is implanted to

treat a weak bladder. One of them

was Ethicon's latest model, the TVT

Secur.

It felt like I was on fire, I

had infections all the time, my

groin is numb just sitting here. It

feels like the best way for me to

describe it is like pins and

noodles, like when your hand goes to

sleep. That's how I feel when I'm

sitting. So, in bed is where I spend

most of my time.

This is you and

Jamie?

This was a beautiful day. I

was sad because I couldn't help my

daughter out with her wedding and

getting things ready, because the

pain was just too bad.

Ella went

through several surgeries to try to

remove the mesh from her body.

The

pain that I have, I will have to

live with for the rest of my life.

There's nothing they can do to help

me.

They said they can't reverse it?

Plus nothing they can do to fix it.

I love her no matter what. But it

sort of Rob us of what we expected.

Sju is still all that and a bag of

chips.

It is tough, the man that I

love, I can't be intimate with him.

I am a wife, I'm a mother, I am 51

years old. We should be enjoy in our

life together.

Kila Baldwin is Ella

Ebaugh's lawyer. At the heart of

their case were e-mails from inside

the company about the TVT Secur.

The

first time I went through these

e-mails my jaw almost hit the floor,

I thought this is really frightening

that a company can conduct itself

this way.

These e-mails show that

Ethicon had done very little testing

on Ella before they planted it. In

fact they had only tested it on 31

women and in sheep.

They had data

from sheep and 31 women and then

they decided, let's go ahead and

launch it anyway. That is certainly

not a clinical trial Lunsford they

are experimenting on test subjects.

This has not been tested in a

long-term study for safety.

Ethicon

said it consistently evaluated its

products in clinical settings for

and after launch, and worked with

surgeons to develop them. They

empathised with women who

experienced complications, but said

the vast majority see an

improvement. Women like Ella are

experiencing permanent side-effects.

On a daily basis, these are the

medicines I now have to take. These

are all my painkillers, this is one

to help protect my stomach from the

painkillers. And these are the two

that I used to take...

I think one

of the things that is missing at the

minute is the understanding of the

severity of these complications.

My

life feels like it's over. I

struggle every day to just try to

have some kind of a life.

Panorama has seen evidence that

inside Ethicon, a doctor had

concerns almost a decade ago about

what the company was telling

surgeons. There is an e-mail here

from 2008 which shows the companies

own associate medical director. She

writes to bosses saying they should

amend the instructions for use,

known as the IFUs, what doctors used

to explain to patients what some of

the risks or complications of an

operation might be. Whilst the

instructions refer to painful

side-effects, they suggested they

were transitory, or not permanent.

But in 2009, she says... From what I

see they are not transitory at all.

They were not updated at the time -

and that matters.

We would expect

all the company hands of information

about the adverse events to be

present in the manufacturer's

instructions for use, because this

is what I would rely on in

identifying all available risks so

that I can explain these two by

patients.

Ethicon said that the IFUs

were evaluated by a specialist and

that the wording was appropriate for

the intended users, trained

surgeons. They said it was

appropriate for professional

educational materials. It can take

years for the worst effects of mesh

to appear.

This problem has started

to come into light in the last few

years. We did not realise the extent

of this problem five, six years ago.

Years after it is fitted, mesh can

cut into nearby organs.

So, this

must be the ninth or tenth trip to

the toilet tonight between 12 and

six. Which is what mesh has done to

me. So, I've hardly had any sleep.

Helen Flinders had two mesh implants

fitted for incontinence in 2011.

They were not made by Ethicon but I

different mesh manufacturer.

I was

told that this is gold, A-star

surgery. For a couple of years I was

OK, I was fine. And this is what

happens, that often women have it

fitted and they're fine for the

first few years.

Three years after

her operation, her symptoms got

worse. The mesh into the tube from

her bladder. It is called an

erosion.

I do get like a burning

pain where the tapes sit. I can feel

exactly where the tapes are sitting,

a really hot, fiery feeling inside.

Now, she's about to have an

operation to try to remove her mesh.

So, I've heard four operations in

the last two and a half years. To

fix the erosions and to try and

relieve the discomfort that I'm

experiencing.

Julie Satari had a mesh fitted for

incontinence ten years ago.

I was

very happy, everything was very

comfortable. I was back at work

within two weeks. I thought it was a

success.

She then suffered a

prolapse and had a second mesh put

in. At this point she became more

unwell.

Sometimes I'm in pain,

particularly at night, it can be

quite aggressive.

She visited 11

consultants to try to fix the

problem.

Frustrated is how I feel

most of the time. Frustrated, it

makes me angry. I get quite

emotional sometimes.

She's been

chatting with Helen on the phone for

months. Now, they're both at a

private hospital, where they're

having their mesh removed.

How real

does this feel now?

Really real.

How

are you feeling?

A little bit

nervous about it but I know I'm in

good hands.

Figures compiled for

panorama show that since 2006, there

have been more than 6000 procedures

for mesh removal or partial removal

on the NHS. Because mesh is designed

to work its way into surrounding

tissue, it is hard to remove it

completely. Sohier El-Neil and her

team have done hundreds of surgical

removal is.

We're going to go ahead

with this surgery today? Briefly

again, risk of bleeding, infection,

trauma to the bladder, the urethra

and surrounding tissues and vessels

- any questions?

No, I'm ready!

What

was happening was that increasingly

people saw this as a Kwik-Fit is and

therefore many people were advised

to go ahead and have some form of

insertion of mesh. It was felt that

patients were going to get the best

deal, the Hospital, the NHS,

everybody was getting a good deal.

At actually, at the end of the day,

those in whom it worked, great. But

those in whom it didn't did not get

a great deal.

It is now clear that

some women weren't told the full

extent of the risks. The rules for

devices like mesh are set to change

in a few years. But in the meantime,

more than 1000 women from England

and Scotland are now involved in the

collection. About half of them are

suing the NHS.

I think it is a

disaster. Everybody who has had a

device now needs to be in a

registry, we need to follow it up

and we need to say, what is the true

rate of benefit and harm?

Many

doctors say mesh can have real

benefits for the majority of women.

You cannot operate without

complications occurring in a small

minority of cases. You are never

aware of complications that may

occur many years later. And that

doesn't just occur with these tapes

and meshes.

So, where does that

leave all the women who have mesh

inside them?

There is no need to be

an chess. The vast majority of women

will not have problems with these

vaginal implants, but be vigilant,

because problems can develop years

later.

Helen's mesh was removed. It

is early days but she's feeling

hopeful.

So, I'm 16 days post-op and

I feel great, to be honest. I can go

four or five hours without needing

to urinate. So, I'm not looking for

a toilet everywhere I go now.

But

for other women, the damage caused

by a small piece of plastic cannot

be undone.

It was 20-25 minutes to

destroy your life. That's all it

took. And I'm never going to get it

back.