The Operation that Ruined My Life Panorama


The Operation that Ruined My Life

Similar Content

Browse content similar to The Operation that Ruined My Life. Check below for episodes and series from the same categories and more!

Transcript


LineFromTo

How have simple medical devices left

thousands of women in total agony?

I

0:00:090:00:14

think when you have this amount of

pain, it's horrendous, really

0:00:140:00:20

horrendous.

American manufacturers

have made huge profits but are now

0:00:200:00:26

paying out millions of dollars in

damages.

How can they sleep at night

0:00:260:00:33

knowing that they injure thousands

and thousands of women?

Tonight on

0:00:330:00:40

Panorama - we reveal one of the

world's biggest medical companies

0:00:400:00:44

who failed to fully inform doctors

of the extent of the risks.

If you

0:00:440:00:48

knew there was a problem, you should

have told everybody.

And how

0:00:480:00:54

permanent mesh implants were put

inside women before long-term human

0:00:540:00:59

studies were completed.

They're

experimental test subjects. They put

0:00:590:01:05

money in front of the health and

safety of women.

0:01:050:01:09

Panorama has been in contact with

dozens of women who are in extreme

0:01:220:01:27

pain. They've been recording their

stories.

It's 4. 35am. Once again

0:01:270:01:37

I'm not sleeping.

Can't sit upright.

It's like needles digging into my

0:01:370:01:45

groin.

They're suffering after an

operation they were told was the

0:01:450:01:48

gold standard.

It can feel like

glass, actual like broken glass.

0:01:480:01:54

That's the way I'd describe it.

I'm

sore all the time, tired all the

0:01:540:02:01

time. Can't do anything. It really

has ruined my life.

I've counted

0:02:010:02:14

them many times, every one of the

49.

Each of the 49 steps to get to

0:02:140:02:19

Claire Daisley's flat is a struggle.

Do you want a rest?

I tell myself

0:02:190:02:28

only a few.

Three more.

This is

Claire seven years ago. Like many

0:02:280:02:37

women, child birth left her with a

weakened bladder. So she had an

0:02:370:02:41

operation to fix it. She was told it

was a simple procedure.

20 minutes,

0:02:410:02:49

25 minutes. New woman. Sort you out.

Gold standard. You can get back to

0:02:490:02:58

your normal life.

Just go straight

through to the left.

A small strip

0:02:580:03:03

of plastic known as mesh was fitted

to support a tube from her bladder.

0:03:030:03:07

But it damaged her nerves and caused

constant pain.

I was crying getting

0:03:070:03:13

in the car, out of the car, coming

up the stairs. The pain in my legs

0:03:130:03:19

was just horrendous. There was no

feeling in my pelvic region. It was

0:03:190:03:24

numb.

Can I give you a hand?

Claire

had her mesh taken out two years

0:03:240:03:34

ago, but it has made the damage even

worse.

I don't want to be here any

0:03:340:03:39

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

Because sometimes you don't know if

0:03:390:03:49

you can take the next day... To the

day you've had, how can I go through

0:03:490:03:58

another day?

I've been reporting on

the story of Claire and women like

0:03:580:04:06

her for the past three-and-a-half

years. Their campaign led to the

0:04:060:04:12

Scottish Government calling for a

suspension of mesh products. Vaginal

0:04:120:04:23

mesh implants are used to treat

incontinence or prolapse, when

0:04:230:04:28

organs move out of place in the

pelvis. When they were launched, in

0:04:280:04:33

the late '90s, they were seen as a

great thing, because they promised

0:04:330:04:36

quicker, cheaper surgery. They're

made of plastic and now, they're

0:04:360:04:42

inside millions of women worldwide.

Including tens of thousands in the

0:04:420:04:46

UK. E...

That hook goes into the

patient's right side. That hook goes

0:04:460:04:54

into the left side.

These are the

hooks used to fit mesh, similar to

0:04:540:05:00

the one Claire had.

It looks

medieval.

For manufacturers, for the

0:05:000:05:06

surgeons, we didn't see it that way.

We thought this is the gold

0:05:060:05:09

standard.

Dr Wael Agur used to fit

mesh, but now he's got concerns.

I

0:05:090:05:19

believe that the risks outweigh the

benefits of the vast majority of the

0:05:190:05:24

mesh procedures and mesh devices.

Looking back on this, we jumped on

0:05:240:05:29

the band wagon to do it and realised

later that perhaps that won't a very

0:05:290:05:33

good idea.

Millions of women around

the world have had mesh implants.

0:05:330:05:44

For the vast majority, the treatment

has been a success. But for a small

0:05:440:05:50

minority, the complications have

been devastating. The proportion of

0:05:500:05:58

women affected is hotly contested.

Previous surgical treatments had

0:05:580:06:02

complications too. But the problems

some women have suffered with mesh,

0:06:020:06:07

from a range of manufacturers, are

significantly more serious than

0:06:070:06:11

patients and doctors had expected.

This is the worst thing that's ever

0:06:110:06:18

happened to me. If it weren't for my

kids, I wouldn't be here. I can

0:06:180:06:22

promise you that. The pain, it's

24/7.

I had to retire from my job at

0:06:220:06:34

the age of 40 in 2013, because I was

not able to work. I was in too much

0:06:340:06:42

pain.

But many doctors think mesh is

an important treatment option. In

0:06:420:06:54

total how many operations would you

have done? Linda Cardozo has fitted

0:06:540:06:59

thousands of mesh implants for

incouldn't nebs. She --

0:06:590:07:03

incontinence. She refers to them as

tape. She's a world leading

0:07:030:07:08

urogynaecologist.

I use the mother,

sister, wife test and say, would I

0:07:080:07:12

have it myself. And the answer is,

absolutely no doubt about it. The

0:07:120:07:18

vast majority of very, very -- are

very, very happy with their tapes.

0:07:180:07:23

Mesh for prolapse uses a bigger

piece of plastic and has led to

0:07:230:07:29

higher complication rates than for

incontinence. Its use is being

0:07:290:07:33

reviewed. You might think that any

device that's going to be put into

0:07:330:07:37

your body for the rest of your life

would be subject to rigorous testing

0:07:370:07:41

and regulation and that any side

effects would have been picked up in

0:07:410:07:46

clinical trials and reported prior

to its use. But when mesh came on

0:07:460:07:57

the market, that wasn't the case.

Whilst medicines require clinical

0:07:570:08:02

trials before use, mesh is a device,

so the rules were different. Mesh

0:08:020:08:08

for hernia was already in use, so

with vaginal mesh manufacturers

0:08:080:08:13

could argue their products were

similar. It's a process called

0:08:130:08:18

equivalence.

That is a loophole in

regulation globally that says my

0:08:180:08:23

device is similar to your device,

could I have access to the market?

0:08:230:08:27

It means there was no clinical trial

evidence of particularly saying this

0:08:270:08:33

is safe device that's we can use

long-term.

You're saying you can put

0:08:330:08:37

a permanent device into someone's

body without any clinical trials?

0:08:370:08:40

Yeah, this is the loophole, if you

like, in the system that leads to

0:08:400:08:45

dire consequences.

Effectively, we

have to trust manufacturers to tell

0:08:450:08:50

us whether their own products work.

Would that be normal, though, to

0:08:500:08:58

start a procedure and, you know, a

permanent implantable device before

0:08:580:09:03

the clinical data?

It's true of many

things that we implant. It's true of

0:09:030:09:07

artificial hips. They were implanted

before there was good data. It's

0:09:070:09:11

true of heart valves. They went in

before there were mature data.

0:09:110:09:17

Unfortunately, you have to start

somewhere.

Launching products

0:09:170:09:22

quickly allows patients to access

new treatments faster. But did that

0:09:220:09:27

mean mesh was used in patients

before the risks were fully

0:09:270:09:30

understood?

0:09:300:09:37

To find out, I've travelled to

America, where most mesh comes from.

0:09:390:09:46

Take the exit on the right...

Over

here is the headquarters of one of

0:09:460:09:50

the biggest mesh manufacturers in

the world. Ethicon is part of the

0:09:500:09:58

multibillion dollar company Johnson

and Johnson. Their mesh products are

0:09:580:10:00

commonly used in the UK. One of

Ethicon's corporate videos promoted

0:10:000:10:11

the benefits of their mesh products.

You can enjoy life and do things

0:10:110:10:14

that you always wanted to.

But now

some 60,000 other women in the US

0:10:140:10:20

are suing Johnson and Johnson, after

problems with their mesh implants.

A

0:10:200:10:27

division of Ethicon, a Johnson and

Johnson company.

Adam Slater is the

0:10:270:10:35

lawyer representing 240 of them.

What Johnson and Johnson did is

0:10:350:10:39

terrible. They put money in front of

the health and safety of women. I

0:10:390:10:44

took the deposition of the worldwide

medical affairs director of Johnson

0:10:440:10:48

and Johnson and Ethicon in charge of

these products. He testified under

0:10:480:10:53

oath that they knew the risks from

day one.

All of the different

0:10:530:10:57

adverse events I've asked you about

with regard to the devices, these

0:10:570:11:01

were known from the very beginning,

when the TVT began to be marketed,

0:11:010:11:03

correct?

I agree.

They knew that the

risk profile was horrific.

Ethicon

0:11:030:11:14

said using only one part of his

testimony is selective. And that all

0:11:140:11:20

surgical pelvic floor procedures,

with and without mesh, come with the

0:11:200:11:24

risk of developing these

complications. They said they cared

0:11:240:11:30

deeply about patients who use their

products.

0:11:300:11:38

Panorama has obtained hundreds of

documents from US legal cases. Among

0:11:420:11:50

them, e-mails that appear to show

how doctors lobbied on behalf of

0:11:500:11:56

Ethicon to ensure patients kept

getting mesh implants. Our story

0:11:560:12:06

starts with this man, Dr Don

Ostergard. He's a vocal critic of

0:12:060:12:13

mesh and a decade ago, he argued

doctors should treat mesh surgery as

0:12:130:12:19

experimental.

Since there was no

information as to what the long-term

0:12:190:12:24

effects of the mesh was, patients

were not able to be informed of what

0:12:240:12:30

would happen once that mesh is put

into place.

That became a big

0:12:300:12:37

problem for Ethicon, when a major

doctors association, called ACOG,

0:12:370:12:43

agreed with Dr Ostergard.

ACOG is

the leading professional

0:12:430:12:49

organisation, whose focus for over

50 years has the advancement of

0:12:490:12:52

women's health care...

They issued

advice to their 55,000 members that

0:12:520:12:56

mesh for prolapse should be treated

as exarptal. -- experimental. Why

0:12:560:13:03

would it have mattered to the

manufacturers or to anyone else if

0:13:030:13:08

mesh was described as experimental?

If you're going to tell a patient

0:13:080:13:14

we're going to put some mesh in

yeah, and the mesh itself and the

0:13:140:13:20

procedure is experimental, patients

aren't going to like that.

But six

0:13:200:13:29

months later, ACOG changed its

advice. This helped promote the

0:13:290:13:32

widespread use of mesh. The word

"experimental" was dropped and

0:13:320:13:40

e-mails from inside Ethicon help

explain why. They reveal that

0:13:400:13:51

behind-the-scenes Ethicon was

liaising with doctors about lobbying

0:13:510:13:56

ACOG. Among them Dr Vincent Lucente.

Here he is in a promotional video.

0:13:560:14:02

... Give women their lives back

again...

Ethicon paid him 1. $1.7

0:14:020:14:08

million over ten years to consult

and teach other doctors how to

0:14:080:14:11

implant mesh. But the e-mails show

he did more.

Vincent Lucente went

0:14:110:14:23

behind-the-scenes and manipulated

ACOG and he got them to remove the

0:14:230:14:26

word "experimental".

Dr Lucente

bragged to Ethicon saying, "This is

0:14:260:14:33

one I am taking the credit for" and

"this is a major victory". One

0:14:330:14:40

senior Ethicon employee was

overjoyed.

The world wide marketing

0:14:400:14:48

director at Ethicon says, and this

is all capital letters, "I am doing

0:14:480:14:53

the happy dance. I love you, man."

And a big happy face. It's all about

0:14:530:15:00

money. That is a marketing director

who knows that the money train is

0:15:000:15:05

going to keep going.

0:15:050:15:12

Dr Lucente told as he made a single

phone call to Acog, because

0:15:120:15:18

"experimental" wasn't accurate. He

said the scope of his work with

0:15:180:15:21

Ethicon never included any lobbying

of professional bodies. Ethicon said

0:15:210:15:25

it is customary to engage with

physicians and researchers. And Acog

0:15:250:15:34

said Dr Vincent Lucente played no

part in the changing of the word.

0:15:340:15:38

They said it was ambiguous and the

word mesh was already being used. --

0:15:380:15:42

and mesh was already being used. I

am on my way to Philadelphia to meet

0:15:420:15:46

a woman who sued Johnson & Johnson

because of the damage caused by her

0:15:460:15:51

mesh implants. So, is this the first

time you have been back?

Yeah. This

0:15:510:15:59

is the first time I've been back to

Philadelphia since 7th September,

0:15:590:16:05

when I won my verdict the first

time...

Ella Ebaugh won $57 million.

0:16:050:16:12

I met her with her family at home

lawyer's office.

This is my softball

0:16:120:16:19

days, when I played on a major

women's softball team called the

0:16:190:16:24

Lakerettes, and we were six time

national champions.

Ten years ago,

0:16:240:16:28

Ella had two mesh is implanted to

treat a weak bladder. One of them

0:16:280:16:34

was Ethicon's latest model, the TVT

Secur.

It felt like I was on fire, I

0:16:340:16:41

had infections all the time, my

groin is numb just sitting here. It

0:16:410:16:47

feels like the best way for me to

describe it is like pins and

0:16:470:16:51

noodles, like when your hand goes to

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

0:16:510:16:54

sitting. So, in bed is where I spend

most of my time.

This is you and

0:16:540:17:04

Jamie?

This was a beautiful day. I

was sad because I couldn't help my

0:17:040:17:12

daughter out with her wedding and

getting things ready, because the

0:17:120:17:16

pain was just too bad.

Ella went

through several surgeries to try to

0:17:160:17:22

remove the mesh from her body.

The

pain that I have, I will have to

0:17:220:17:29

live with for the rest of my life.

There's nothing they can do to help

0:17:290:17:33

me.

They said they can't reverse it?

Plus nothing they can do to fix it.

0:17:330:17:38

I love her no matter what. But it

sort of Rob us of what we expected.

0:17:380:17:48

Sju is still all that and a bag of

chips.

It is tough, the man that I

0:17:480:17:56

love, I can't be intimate with him.

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

0:17:560:18:04

years old. We should be enjoy in our

life together.

Kila Baldwin is Ella

0:18:040:18:13

Ebaugh's lawyer. At the heart of

their case were e-mails from inside

0:18:130:18:22

the company about the TVT Secur.

The

first time I went through these

0:18:220:18:26

e-mails my jaw almost hit the floor,

I thought this is really frightening

0:18:260:18:29

that a company can conduct itself

this way.

These e-mails show that

0:18:290:18:35

Ethicon had done very little testing

on Ella before they planted it. In

0:18:350:18:44

fact they had only tested it on 31

women and in sheep.

They had data

0:18:440:18:49

from sheep and 31 women and then

they decided, let's go ahead and

0:18:490:18:53

launch it anyway. That is certainly

not a clinical trial Lunsford they

0:18:530:18:59

are experimenting on test subjects.

This has not been tested in a

0:18:590:19:02

long-term study for safety.

Ethicon

said it consistently evaluated its

0:19:020:19:07

products in clinical settings for

and after launch, and worked with

0:19:070:19:12

surgeons to develop them. They

empathised with women who

0:19:120:19:17

experienced complications, but said

the vast majority see an

0:19:170:19:21

improvement. Women like Ella are

experiencing permanent side-effects.

0:19:210:19:30

On a daily basis, these are the

medicines I now have to take. These

0:19:300:19:35

are all my painkillers, this is one

to help protect my stomach from the

0:19:350:19:41

painkillers. And these are the two

that I used to take...

I think one

0:19:410:19:45

of the things that is missing at the

minute is the understanding of the

0:19:450:19:50

severity of these complications.

My

life feels like it's over. I

0:19:500:20:00

struggle every day to just try to

have some kind of a life.

0:20:000:20:07

Panorama has seen evidence that

inside Ethicon, a doctor had

0:20:120:20:19

concerns almost a decade ago about

what the company was telling

0:20:190:20:21

surgeons. There is an e-mail here

from 2008 which shows the companies

0:20:210:20:29

own associate medical director. She

writes to bosses saying they should

0:20:290:20:33

amend the instructions for use,

known as the IFUs, what doctors used

0:20:330:20:39

to explain to patients what some of

the risks or complications of an

0:20:390:20:43

operation might be. Whilst the

instructions refer to painful

0:20:430:20:49

side-effects, they suggested they

were transitory, or not permanent.

0:20:490:20:53

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

see they are not transitory at all.

0:20:530:20:59

They were not updated at the time -

and that matters.

We would expect

0:20:590:21:05

all the company hands of information

about the adverse events to be

0:21:050:21:08

present in the manufacturer's

instructions for use, because this

0:21:080:21:12

is what I would rely on in

identifying all available risks so

0:21:120:21:17

that I can explain these two by

patients.

Ethicon said that the IFUs

0:21:170:21:23

were evaluated by a specialist and

that the wording was appropriate for

0:21:230:21:28

the intended users, trained

surgeons. They said it was

0:21:280:21:33

appropriate for professional

educational materials. It can take

0:21:330:21:36

years for the worst effects of mesh

to appear.

This problem has started

0:21:360:21:41

to come into light in the last few

years. We did not realise the extent

0:21:410:21:47

of this problem five, six years ago.

Years after it is fitted, mesh can

0:21:470:21:57

cut into nearby organs.

So, this

must be the ninth or tenth trip to

0:21:570:22:09

the toilet tonight between 12 and

six. Which is what mesh has done to

0:22:090:22:17

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

Helen Flinders had two mesh implants

0:22:170:22:29

fitted for incontinence in 2011.

They were not made by Ethicon but I

0:22:290:22:36

different mesh manufacturer.

I was

told that this is gold, A-star

0:22:360:22:44

surgery. For a couple of years I was

OK, I was fine. And this is what

0:22:440:22:49

happens, that often women have it

fitted and they're fine for the

0:22:490:22:52

first few years.

Three years after

her operation, her symptoms got

0:22:520:22:55

worse. The mesh into the tube from

her bladder. It is called an

0:22:550:23:03

erosion.

I do get like a burning

pain where the tapes sit. I can feel

0:23:030:23:09

exactly where the tapes are sitting,

a really hot, fiery feeling inside.

0:23:090:23:16

Now, she's about to have an

operation to try to remove her mesh.

0:23:160:23:21

So, I've heard four operations in

the last two and a half years. To

0:23:210:23:28

fix the erosions and to try and

relieve the discomfort that I'm

0:23:280:23:35

experiencing.

0:23:350:23:39

Julie Satari had a mesh fitted for

incontinence ten years ago.

I was

0:23:460:23:57

very happy, everything was very

comfortable. I was back at work

0:23:570:24:01

within two weeks. I thought it was a

success.

She then suffered a

0:24:010:24:08

prolapse and had a second mesh put

in. At this point she became more

0:24:080:24:12

unwell.

Sometimes I'm in pain,

particularly at night, it can be

0:24:120:24:17

quite aggressive.

She visited 11

consultants to try to fix the

0:24:170:24:22

problem.

Frustrated is how I feel

most of the time. Frustrated, it

0:24:220:24:28

makes me angry. I get quite

emotional sometimes.

She's been

0:24:280:24:35

chatting with Helen on the phone for

months. Now, they're both at a

0:24:350:24:41

private hospital, where they're

having their mesh removed.

How real

0:24:410:24:52

does this feel now?

Really real.

How

are you feeling?

A little bit

0:24:520:24:57

nervous about it but I know I'm in

good hands.

Figures compiled for

0:24:570:25:05

panorama show that since 2006, there

have been more than 6000 procedures

0:25:050:25:11

for mesh removal or partial removal

on the NHS. Because mesh is designed

0:25:110:25:17

to work its way into surrounding

tissue, it is hard to remove it

0:25:170:25:20

completely. Sohier El-Neil and her

team have done hundreds of surgical

0:25:200:25:26

removal is.

We're going to go ahead

with this surgery today? Briefly

0:25:260:25:37

again, risk of bleeding, infection,

trauma to the bladder, the urethra

0:25:370:25:44

and surrounding tissues and vessels

- any questions?

No, I'm ready!

What

0:25:440:25:52

was happening was that increasingly

people saw this as a Kwik-Fit is and

0:25:520:25:56

therefore many people were advised

to go ahead and have some form of

0:25:560:25:59

insertion of mesh. It was felt that

patients were going to get the best

0:25:590:26:05

deal, the Hospital, the NHS,

everybody was getting a good deal.

0:26:050:26:08

At actually, at the end of the day,

those in whom it worked, great. But

0:26:080:26:13

those in whom it didn't did not get

a great deal.

It is now clear that

0:26:130:26:21

some women weren't told the full

extent of the risks. The rules for

0:26:210:26:27

devices like mesh are set to change

in a few years. But in the meantime,

0:26:270:26:31

more than 1000 women from England

and Scotland are now involved in the

0:26:310:26:35

collection. About half of them are

suing the NHS.

I think it is a

0:26:350:26:42

disaster. Everybody who has had a

device now needs to be in a

0:26:420:26:47

registry, we need to follow it up

and we need to say, what is the true

0:26:470:26:52

rate of benefit and harm?

Many

doctors say mesh can have real

0:26:520:26:58

benefits for the majority of women.

You cannot operate without

0:26:580:27:01

complications occurring in a small

minority of cases. You are never

0:27:010:27:06

aware of complications that may

occur many years later. And that

0:27:060:27:08

doesn't just occur with these tapes

and meshes.

So, where does that

0:27:080:27:14

leave all the women who have mesh

inside them?

There is no need to be

0:27:140:27:19

an chess. The vast majority of women

will not have problems with these

0:27:190:27:26

vaginal implants, but be vigilant,

because problems can develop years

0:27:260:27:30

later.

Helen's mesh was removed. It

is early days but she's feeling

0:27:300:27:39

hopeful.

So, I'm 16 days post-op and

I feel great, to be honest. I can go

0:27:390:27:48

four or five hours without needing

to urinate. So, I'm not looking for

0:27:480:27:53

a toilet everywhere I go now.

But

for other women, the damage caused

0:27:530:28:01

by a small piece of plastic cannot

be undone.

It was 20-25 minutes to

0:28:010:28:08

destroy your life. That's all it

took. And I'm never going to get it

0:28:080:28:13

back.

0:28:130:28:18

Download Subtitles

SRT

ASS