0:00:09 > 0:00:14How have simple medical devices left thousands of women in total agony?I
0:00:14 > 0:00:20think when you have this amount of pain, it's horrendous, really
0:00:20 > 0:00:26horrendous.American manufacturers have made huge profits but are now
0:00:26 > 0:00:33paying out millions of dollars in damages.How can they sleep at night
0:00:33 > 0:00:40knowing that they injure thousands and thousands of women?Tonight on
0:00:40 > 0:00:44Panorama - we reveal one of the world's biggest medical companies
0:00:44 > 0:00:48who failed to fully inform doctors of the extent of the risks.If you
0:00:48 > 0:00:54knew there was a problem, you should have told everybody.And how
0:00:54 > 0:00:59permanent mesh implants were put inside women before long-term human
0:00:59 > 0:01:05studies were completed.They're experimental test subjects. They put
0:01:05 > 0:01:09money in front of the health and safety of women.
0:01:22 > 0:01:27Panorama has been in contact with dozens of women who are in extreme
0:01:27 > 0:01:37pain. They've been recording their stories.It's 4. 35am. Once again
0:01:37 > 0:01:45I'm not sleeping.Can't sit upright. It's like needles digging into my
0:01:45 > 0:01:48groin.They're suffering after an operation they were told was the
0:01:48 > 0:01:54gold standard.It can feel like glass, actual like broken glass.
0:01:54 > 0:02:01That's the way I'd describe it.I'm sore all the time, tired all the
0:02:01 > 0:02:14time. Can't do anything. It really has ruined my life.I've counted
0:02:14 > 0:02:19them many times, every one of the 49.Each of the 49 steps to get to
0:02:19 > 0:02:28Claire Daisley's flat is a struggle. Do you want a rest?I tell myself
0:02:28 > 0:02:37only a few.Three more.This is Claire seven years ago. Like many
0:02:37 > 0:02:41women, child birth left her with a weakened bladder. So she had an
0:02:41 > 0:02:49operation to fix it. She was told it was a simple procedure.20 minutes,
0:02:49 > 0:02:5825 minutes. New woman. Sort you out. Gold standard. You can get back to
0:02:58 > 0:03:03your normal life.Just go straight through to the left.A small strip
0:03:03 > 0:03:07of plastic known as mesh was fitted to support a tube from her bladder.
0:03:07 > 0:03:13But it damaged her nerves and caused constant pain.I was crying getting
0:03:13 > 0:03:19in the car, out of the car, coming up the stairs. The pain in my legs
0:03:19 > 0:03:24was just horrendous. There was no feeling in my pelvic region. It was
0:03:24 > 0:03:34numb.Can I give you a hand?Claire had her mesh taken out two years
0:03:34 > 0:03:39ago, but it has made the damage even worse.I don't want to be here any
0:03:39 > 0:03:49more. That's how far it's taken me. Because sometimes you don't know if
0:03:49 > 0:03:58you can take the next day... To the day you've had, how can I go through
0:03:58 > 0:04:06another day?I've been reporting on the story of Claire and women like
0:04:06 > 0:04:12her for the past three-and-a-half years. Their campaign led to the
0:04:12 > 0:04:23Scottish Government calling for a suspension of mesh products. Vaginal
0:04:23 > 0:04:28mesh implants are used to treat incontinence or prolapse, when
0:04:28 > 0:04:33organs move out of place in the pelvis. When they were launched, in
0:04:33 > 0:04:36the late '90s, they were seen as a great thing, because they promised
0:04:36 > 0:04:42quicker, cheaper surgery. They're made of plastic and now, they're
0:04:42 > 0:04:46inside millions of women worldwide. Including tens of thousands in the
0:04:46 > 0:04:54UK. E...That hook goes into the patient's right side. That hook goes
0:04:54 > 0:05:00into the left side.These are the hooks used to fit mesh, similar to
0:05:00 > 0:05:06the one Claire had.It looks medieval.For manufacturers, for the
0:05:06 > 0:05:09surgeons, we didn't see it that way. We thought this is the gold
0:05:09 > 0:05:19standard.Dr Wael Agur used to fit mesh, but now he's got concerns.I
0:05:19 > 0:05:24believe that the risks outweigh the benefits of the vast majority of the
0:05:24 > 0:05:29mesh procedures and mesh devices. Looking back on this, we jumped on
0:05:29 > 0:05:33the band wagon to do it and realised later that perhaps that won't a very
0:05:33 > 0:05:44good idea.Millions of women around the world have had mesh implants.
0:05:44 > 0:05:50For the vast majority, the treatment has been a success. But for a small
0:05:50 > 0:05:58minority, the complications have been devastating. The proportion of
0:05:58 > 0:06:02women affected is hotly contested. Previous surgical treatments had
0:06:02 > 0:06:07complications too. But the problems some women have suffered with mesh,
0:06:07 > 0:06:11from a range of manufacturers, are significantly more serious than
0:06:11 > 0:06:18patients and doctors had expected. This is the worst thing that's ever
0:06:18 > 0:06:22happened to me. If it weren't for my kids, I wouldn't be here. I can
0:06:22 > 0:06:34promise you that. The pain, it's 24/7.I had to retire from my job at
0:06:34 > 0:06:42the age of 40 in 2013, because I was not able to work. I was in too much
0:06:42 > 0:06:54pain.But many doctors think mesh is an important treatment option. In
0:06:54 > 0:06:59total how many operations would you have done? Linda Cardozo has fitted
0:06:59 > 0:07:03thousands of mesh implants for incouldn't nebs. She --
0:07:03 > 0:07:08incontinence. She refers to them as tape. She's a world leading
0:07:08 > 0:07:12urogynaecologist.I use the mother, sister, wife test and say, would I
0:07:12 > 0:07:18have it myself. And the answer is, absolutely no doubt about it. The
0:07:18 > 0:07:23vast majority of very, very -- are very, very happy with their tapes.
0:07:23 > 0:07:29Mesh for prolapse uses a bigger piece of plastic and has led to
0:07:29 > 0:07:33higher complication rates than for incontinence. Its use is being
0:07:33 > 0:07:37reviewed. You might think that any device that's going to be put into
0:07:37 > 0:07:41your body for the rest of your life would be subject to rigorous testing
0:07:41 > 0:07:46and regulation and that any side effects would have been picked up in
0:07:46 > 0:07:57clinical trials and reported prior to its use. But when mesh came on
0:07:57 > 0:08:02the market, that wasn't the case. Whilst medicines require clinical
0:08:02 > 0:08:08trials before use, mesh is a device, so the rules were different. Mesh
0:08:08 > 0:08:13for hernia was already in use, so with vaginal mesh manufacturers
0:08:13 > 0:08:18could argue their products were similar. It's a process called
0:08:18 > 0:08:23equivalence.That is a loophole in regulation globally that says my
0:08:23 > 0:08:27device is similar to your device, could I have access to the market?
0:08:27 > 0:08:33It means there was no clinical trial evidence of particularly saying this
0:08:33 > 0:08:37is safe device that's we can use long-term.You're saying you can put
0:08:37 > 0:08:40a permanent device into someone's body without any clinical trials?
0:08:40 > 0:08:45Yeah, this is the loophole, if you like, in the system that leads to
0:08:45 > 0:08:50dire consequences.Effectively, we have to trust manufacturers to tell
0:08:50 > 0:08:58us whether their own products work. Would that be normal, though, to
0:08:58 > 0:09:03start a procedure and, you know, a permanent implantable device before
0:09:03 > 0:09:07the clinical data?It's true of many things that we implant. It's true of
0:09:07 > 0:09:11artificial hips. They were implanted before there was good data. It's
0:09:11 > 0:09:17true of heart valves. They went in before there were mature data.
0:09:17 > 0:09:22Unfortunately, you have to start somewhere.Launching products
0:09:22 > 0:09:27quickly allows patients to access new treatments faster. But did that
0:09:27 > 0:09:30mean mesh was used in patients before the risks were fully
0:09:30 > 0:09:37understood?
0:09:39 > 0:09:46To find out, I've travelled to America, where most mesh comes from.
0:09:46 > 0:09:50Take the exit on the right...Over here is the headquarters of one of
0:09:50 > 0:09:58the biggest mesh manufacturers in the world. Ethicon is part of the
0:09:58 > 0:10:00multibillion dollar company Johnson and Johnson. Their mesh products are
0:10:00 > 0:10:11commonly used in the UK. One of Ethicon's corporate videos promoted
0:10:11 > 0:10:14the benefits of their mesh products. You can enjoy life and do things
0:10:14 > 0:10:20that you always wanted to.But now some 60,000 other women in the US
0:10:20 > 0:10:27are suing Johnson and Johnson, after problems with their mesh implants.A
0:10:27 > 0:10:35division of Ethicon, a Johnson and Johnson company.Adam Slater is the
0:10:35 > 0:10:39lawyer representing 240 of them. What Johnson and Johnson did is
0:10:39 > 0:10:44terrible. They put money in front of the health and safety of women. I
0:10:44 > 0:10:48took the deposition of the worldwide medical affairs director of Johnson
0:10:48 > 0:10:53and Johnson and Ethicon in charge of these products. He testified under
0:10:53 > 0:10:57oath that they knew the risks from day one.All of the different
0:10:57 > 0:11:01adverse events I've asked you about with regard to the devices, these
0:11:01 > 0:11:03were known from the very beginning, when the TVT began to be marketed,
0:11:03 > 0:11:14correct?I agree.They knew that the risk profile was horrific.Ethicon
0:11:14 > 0:11:20said using only one part of his testimony is selective. And that all
0:11:20 > 0:11:24surgical pelvic floor procedures, with and without mesh, come with the
0:11:24 > 0:11:30risk of developing these complications. They said they cared
0:11:30 > 0:11:38deeply about patients who use their products.
0:11:42 > 0:11:50Panorama has obtained hundreds of documents from US legal cases. Among
0:11:50 > 0:11:56them, e-mails that appear to show how doctors lobbied on behalf of
0:11:56 > 0:12:06Ethicon to ensure patients kept getting mesh implants. Our story
0:12:06 > 0:12:13starts with this man, Dr Don Ostergard. He's a vocal critic of
0:12:13 > 0:12:19mesh and a decade ago, he argued doctors should treat mesh surgery as
0:12:19 > 0:12:24experimental.Since there was no information as to what the long-term
0:12:24 > 0:12:30effects of the mesh was, patients were not able to be informed of what
0:12:30 > 0:12:37would happen once that mesh is put into place.That became a big
0:12:37 > 0:12:43problem for Ethicon, when a major doctors association, called ACOG,
0:12:43 > 0:12:49agreed with Dr Ostergard.ACOG is the leading professional
0:12:49 > 0:12:52organisation, whose focus for over 50 years has the advancement of
0:12:52 > 0:12:56women's health care...They issued advice to their 55,000 members that
0:12:56 > 0:13:03mesh for prolapse should be treated as exarptal. -- experimental. Why
0:13:03 > 0:13:08would it have mattered to the manufacturers or to anyone else if
0:13:08 > 0:13:14mesh was described as experimental? If you're going to tell a patient
0:13:14 > 0:13:20we're going to put some mesh in yeah, and the mesh itself and the
0:13:20 > 0:13:29procedure is experimental, patients aren't going to like that.But six
0:13:29 > 0:13:32months later, ACOG changed its advice. This helped promote the
0:13:32 > 0:13:40widespread use of mesh. The word "experimental" was dropped and
0:13:40 > 0:13:51e-mails from inside Ethicon help explain why. They reveal that
0:13:51 > 0:13:56behind-the-scenes Ethicon was liaising with doctors about lobbying
0:13:56 > 0:14:02ACOG. Among them Dr Vincent Lucente. Here he is in a promotional video.
0:14:02 > 0:14:08... Give women their lives back again...Ethicon paid him 1. $1.7
0:14:08 > 0:14:11million over ten years to consult and teach other doctors how to
0:14:11 > 0:14:23implant mesh. But the e-mails show he did more.Vincent Lucente went
0:14:23 > 0:14:26behind-the-scenes and manipulated ACOG and he got them to remove the
0:14:26 > 0:14:33word "experimental".Dr Lucente bragged to Ethicon saying, "This is
0:14:33 > 0:14:40one I am taking the credit for" and "this is a major victory". One
0:14:40 > 0:14:48senior Ethicon employee was overjoyed.The world wide marketing
0:14:48 > 0:14:53director at Ethicon says, and this is all capital letters, "I am doing
0:14:53 > 0:15:00the happy dance. I love you, man." And a big happy face. It's all about
0:15:00 > 0:15:05money. That is a marketing director who knows that the money train is
0:15:05 > 0:15:12going to keep going.
0:15:12 > 0:15:18Dr Lucente told as he made a single phone call to Acog, because
0:15:18 > 0:15:21"experimental" wasn't accurate. He said the scope of his work with
0:15:21 > 0:15:25Ethicon never included any lobbying of professional bodies. Ethicon said
0:15:25 > 0:15:34it is customary to engage with physicians and researchers. And Acog
0:15:34 > 0:15:38said Dr Vincent Lucente played no part in the changing of the word.
0:15:38 > 0:15:42They said it was ambiguous and the word mesh was already being used. --
0:15:42 > 0:15:46and mesh was already being used. I am on my way to Philadelphia to meet
0:15:46 > 0:15:51a woman who sued Johnson & Johnson because of the damage caused by her
0:15:51 > 0:15:59mesh implants. So, is this the first time you have been back?Yeah. This
0:15:59 > 0:16:05is the first time I've been back to Philadelphia since 7th September,
0:16:05 > 0:16:12when I won my verdict the first time...Ella Ebaugh won $57 million.
0:16:12 > 0:16:19I met her with her family at home lawyer's office.This is my softball
0:16:19 > 0:16:24days, when I played on a major women's softball team called the
0:16:24 > 0:16:28Lakerettes, and we were six time national champions.Ten years ago,
0:16:28 > 0:16:34Ella had two mesh is implanted to treat a weak bladder. One of them
0:16:34 > 0:16:41was Ethicon's latest model, the TVT Secur.It felt like I was on fire, I
0:16:41 > 0:16:47had infections all the time, my groin is numb just sitting here. It
0:16:47 > 0:16:51feels like the best way for me to describe it is like pins and
0:16:51 > 0:16:54noodles, like when your hand goes to sleep. That's how I feel when I'm
0:16:54 > 0:17:04sitting. So, in bed is where I spend most of my time.This is you and
0:17:04 > 0:17:12Jamie?This was a beautiful day. I was sad because I couldn't help my
0:17:12 > 0:17:16daughter out with her wedding and getting things ready, because the
0:17:16 > 0:17:22pain was just too bad.Ella went through several surgeries to try to
0:17:22 > 0:17:29remove the mesh from her body.The pain that I have, I will have to
0:17:29 > 0:17:33live with for the rest of my life. There's nothing they can do to help
0:17:33 > 0:17:38me.They said they can't reverse it? Plus nothing they can do to fix it.
0:17:38 > 0:17:48I love her no matter what. But it sort of Rob us of what we expected.
0:17:48 > 0:17:56Sju is still all that and a bag of chips.It is tough, the man that I
0:17:56 > 0:18:04love, I can't be intimate with him. I am a wife, I'm a mother, I am 51
0:18:04 > 0:18:13years old. We should be enjoy in our life together.Kila Baldwin is Ella
0:18:13 > 0:18:22Ebaugh's lawyer. At the heart of their case were e-mails from inside
0:18:22 > 0:18:26the company about the TVT Secur.The first time I went through these
0:18:26 > 0:18:29e-mails my jaw almost hit the floor, I thought this is really frightening
0:18:29 > 0:18:35that a company can conduct itself this way.These e-mails show that
0:18:35 > 0:18:44Ethicon had done very little testing on Ella before they planted it. In
0:18:44 > 0:18:49fact they had only tested it on 31 women and in sheep.They had data
0:18:49 > 0:18:53from sheep and 31 women and then they decided, let's go ahead and
0:18:53 > 0:18:59launch it anyway. That is certainly not a clinical trial Lunsford they
0:18:59 > 0:19:02are experimenting on test subjects. This has not been tested in a
0:19:02 > 0:19:07long-term study for safety.Ethicon said it consistently evaluated its
0:19:07 > 0:19:12products in clinical settings for and after launch, and worked with
0:19:12 > 0:19:17surgeons to develop them. They empathised with women who
0:19:17 > 0:19:21experienced complications, but said the vast majority see an
0:19:21 > 0:19:30improvement. Women like Ella are experiencing permanent side-effects.
0:19:30 > 0:19:35On a daily basis, these are the medicines I now have to take. These
0:19:35 > 0:19:41are all my painkillers, this is one to help protect my stomach from the
0:19:41 > 0:19:45painkillers. And these are the two that I used to take...I think one
0:19:45 > 0:19:50of the things that is missing at the minute is the understanding of the
0:19:50 > 0:20:00severity of these complications.My life feels like it's over. I
0:20:00 > 0:20:07struggle every day to just try to have some kind of a life.
0:20:12 > 0:20:19Panorama has seen evidence that inside Ethicon, a doctor had
0:20:19 > 0:20:21concerns almost a decade ago about what the company was telling
0:20:21 > 0:20:29surgeons. There is an e-mail here from 2008 which shows the companies
0:20:29 > 0:20:33own associate medical director. She writes to bosses saying they should
0:20:33 > 0:20:39amend the instructions for use, known as the IFUs, what doctors used
0:20:39 > 0:20:43to explain to patients what some of the risks or complications of an
0:20:43 > 0:20:49operation might be. Whilst the instructions refer to painful
0:20:49 > 0:20:53side-effects, they suggested they were transitory, or not permanent.
0:20:53 > 0:20:59But in 2009, she says... From what I see they are not transitory at all.
0:20:59 > 0:21:05They were not updated at the time - and that matters.We would expect
0:21:05 > 0:21:08all the company hands of information about the adverse events to be
0:21:08 > 0:21:12present in the manufacturer's instructions for use, because this
0:21:12 > 0:21:17is what I would rely on in identifying all available risks so
0:21:17 > 0:21:23that I can explain these two by patients.Ethicon said that the IFUs
0:21:23 > 0:21:28were evaluated by a specialist and that the wording was appropriate for
0:21:28 > 0:21:33the intended users, trained surgeons. They said it was
0:21:33 > 0:21:36appropriate for professional educational materials. It can take
0:21:36 > 0:21:41years for the worst effects of mesh to appear.This problem has started
0:21:41 > 0:21:47to come into light in the last few years. We did not realise the extent
0:21:47 > 0:21:57of this problem five, six years ago. Years after it is fitted, mesh can
0:21:57 > 0:22:09cut into nearby organs.So, this must be the ninth or tenth trip to
0:22:09 > 0:22:17the toilet tonight between 12 and six. Which is what mesh has done to
0:22:17 > 0:22:29me. So, I've hardly had any sleep. Helen Flinders had two mesh implants
0:22:29 > 0:22:36fitted for incontinence in 2011. They were not made by Ethicon but I
0:22:36 > 0:22:44different mesh manufacturer.I was told that this is gold, A-star
0:22:44 > 0:22:49surgery. For a couple of years I was OK, I was fine. And this is what
0:22:49 > 0:22:52happens, that often women have it fitted and they're fine for the
0:22:52 > 0:22:55first few years.Three years after her operation, her symptoms got
0:22:55 > 0:23:03worse. The mesh into the tube from her bladder. It is called an
0:23:03 > 0:23:09erosion.I do get like a burning pain where the tapes sit. I can feel
0:23:09 > 0:23:16exactly where the tapes are sitting, a really hot, fiery feeling inside.
0:23:16 > 0:23:21Now, she's about to have an operation to try to remove her mesh.
0:23:21 > 0:23:28So, I've heard four operations in the last two and a half years. To
0:23:28 > 0:23:35fix the erosions and to try and relieve the discomfort that I'm
0:23:35 > 0:23:39experiencing.
0:23:46 > 0:23:57Julie Satari had a mesh fitted for incontinence ten years ago.I was
0:23:57 > 0:24:01very happy, everything was very comfortable. I was back at work
0:24:01 > 0:24:08within two weeks. I thought it was a success.She then suffered a
0:24:08 > 0:24:12prolapse and had a second mesh put in. At this point she became more
0:24:12 > 0:24:17unwell.Sometimes I'm in pain, particularly at night, it can be
0:24:17 > 0:24:22quite aggressive.She visited 11 consultants to try to fix the
0:24:22 > 0:24:28problem.Frustrated is how I feel most of the time. Frustrated, it
0:24:28 > 0:24:35makes me angry. I get quite emotional sometimes.She's been
0:24:35 > 0:24:41chatting with Helen on the phone for months. Now, they're both at a
0:24:41 > 0:24:52private hospital, where they're having their mesh removed.How real
0:24:52 > 0:24:57does this feel now?Really real.How are you feeling?A little bit
0:24:57 > 0:25:05nervous about it but I know I'm in good hands.Figures compiled for
0:25:05 > 0:25:11panorama show that since 2006, there have been more than 6000 procedures
0:25:11 > 0:25:17for mesh removal or partial removal on the NHS. Because mesh is designed
0:25:17 > 0:25:20to work its way into surrounding tissue, it is hard to remove it
0:25:20 > 0:25:26completely. Sohier El-Neil and her team have done hundreds of surgical
0:25:26 > 0:25:37removal is.We're going to go ahead with this surgery today? Briefly
0:25:37 > 0:25:44again, risk of bleeding, infection, trauma to the bladder, the urethra
0:25:44 > 0:25:52and surrounding tissues and vessels - any questions?No, I'm ready!What
0:25:52 > 0:25:56was happening was that increasingly people saw this as a Kwik-Fit is and
0:25:56 > 0:25:59therefore many people were advised to go ahead and have some form of
0:25:59 > 0:26:05insertion of mesh. It was felt that patients were going to get the best
0:26:05 > 0:26:08deal, the Hospital, the NHS, everybody was getting a good deal.
0:26:08 > 0:26:13At actually, at the end of the day, those in whom it worked, great. But
0:26:13 > 0:26:21those in whom it didn't did not get a great deal.It is now clear that
0:26:21 > 0:26:27some women weren't told the full extent of the risks. The rules for
0:26:27 > 0:26:31devices like mesh are set to change in a few years. But in the meantime,
0:26:31 > 0:26:35more than 1000 women from England and Scotland are now involved in the
0:26:35 > 0:26:42collection. About half of them are suing the NHS.I think it is a
0:26:42 > 0:26:47disaster. Everybody who has had a device now needs to be in a
0:26:47 > 0:26:52registry, we need to follow it up and we need to say, what is the true
0:26:52 > 0:26:58rate of benefit and harm?Many doctors say mesh can have real
0:26:58 > 0:27:01benefits for the majority of women. You cannot operate without
0:27:01 > 0:27:06complications occurring in a small minority of cases. You are never
0:27:06 > 0:27:08aware of complications that may occur many years later. And that
0:27:08 > 0:27:14doesn't just occur with these tapes and meshes.So, where does that
0:27:14 > 0:27:19leave all the women who have mesh inside them?There is no need to be
0:27:19 > 0:27:26an chess. The vast majority of women will not have problems with these
0:27:26 > 0:27:30vaginal implants, but be vigilant, because problems can develop years
0:27:30 > 0:27:39later.Helen's mesh was removed. It is early days but she's feeling
0:27:39 > 0:27:48hopeful.So, I'm 16 days post-op and I feel great, to be honest. I can go
0:27:48 > 0:27:53four or five hours without needing to urinate. So, I'm not looking for
0:27:53 > 0:28:01a toilet everywhere I go now.But for other women, the damage caused
0:28:01 > 0:28:08by a small piece of plastic cannot be undone.It was 20-25 minutes to
0:28:08 > 0:28:13destroy your life. That's all it took. And I'm never going to get it
0:28:13 > 0:28:18back.