Panorama set to lift the lid on the vaginal mesh implant scandal

PUBLISHED: 00:01 11 December 2017 | UPDATED: 16:27 11 December 2017

BBC Panorama expose the regulatory failings of vaginal mesh implants on Monday December 11 at 7.30pm.

BBC Panorama expose the regulatory failings of vaginal mesh implants on Monday December 11 at 7.30pm.

Archant

A vaginal mesh implant was trialled on just 31 women and a few sheep before it was launched in hospitals across Britain, Panorama is set to reveal.

The documentary will lift the lid on what is called the biggest global health crisis since Thalidomide.

BBC Panorama investigation reveals global medical companies failed to fully inform doctors of the extent of risks posed by its vaginal mesh implants.

The investigation comes amid growing anger among campaigners that today surgeons are still not warning women about mesh risks.

In UK hospitals surgeons insist they do not use “the mesh in the media” to fix incontinence but are using a “tape” - yet this tape is made of plastic mesh.

For women worried about prolapse they tell them they use a different mesh.

They believe they can do that because they insert it through the tummy and not the vagina to get round guidelines, due out any day soon, banning the use of transvaginal prolapse mesh.

Campaigners say this breaks ethics rules.

Panorama will reveal that Ethicon, a subsidiary of multi billion dollar Johnson and Johnson, failed to update doctors with risks for its leading transvaginal meshes.

NHS figures given to BBC Panorama show there have been more than 6,000 procedures for removals or partial removals of vaginal mesh in England and Wales in the last decade.

Sling The Mesh says that figure is much lower than the true picture as it does not take into account hundreds of women who get snips of mesh tapes that have poked their way through vaginal walls.

These procedures are carried out in outpatient departments who do not have to send their figures to NHS HQ.

Also it does not show the number of women having mesh removal in private hospitals.

Pelvic mesh implants have been surgically fitted into millions of women globally since the late 1990s to help cure incontinence or pelvic organ prolapse.

Campaigners say nobody has a clue of the true number suffering as surgeons deny mesh causes their health problems and less than 40 per cent record problems.

Another issue is industry influence on surgeons like Linda Cardozo , who appears on Panorama saying mesh is an effective treatment option for the vast majority.

Dr Cardozo has written scores of studies on mesh use, including one that insists women have a healthy sex after pelvic mesh surgery.

Sling The Mesh, which has 4,800 members, says at least 2/3 of women in its Facebook support group lose their sex life.

Dr Cardozo is a consultant to four medical industry giants and to a UK based company that promotes innovation - medical speak for testing new products in humans.

She also gets research grants from another medical giant.

BBC Panorama says it has discovered Ethicon launched a mesh implant called the TVT Secur in 2006 after testing it in just 31 women for five weeks, and in sheep.

It was intended to be the company’s safest and most effective pelvic floor mesh product but was withdrawn in 2012.

Professor Carl Heneghan warned some surgeons are now insisting prolapse mesh operation risks are higher than incontinence mesh.

But he said: “Surgeons are using the same evidence with the same quality issues that underpinned mesh in prolapse to say everything is alright with incontinence mesh.

“It is the same issues; lack of Equivalence, trials done by manufacturers, lack of long term evidence and the losses to follow up which are high.”

The company told Panorama: “While we empathise with those who have experienced complications, the vast majority of women with pelvic mesh see an improvement in their day to day lives.”

Dr Cardozo, from the Royal College of Obstetricians and Gynaecologists, said: “You cannot operate without complications occurring in a small minority of cases. You are never aware of complications that may occur years later and that doesn’t just occur with these tapes and meshes.”

Ethicon says pelvic mesh has helped improve the quality of life for millions of women with serious, debilitating conditions.

The MHRA, the UK medical devices regulator, told Panorama it recognises some women develop serious complications, and many women gain benefit from these surgical procedures.

Professor Carl Heneghan warned some surgeons are now insisting prolapse mesh operation risks are higher than incontinence mesh.

But he said: “Surgeons are using the same evidence with the same quality issues that underpinned mesh in prolapse to say everything is alright with incontinence mesh.

“It is the same issues; lack of Equivalence, trials done by manufacturers, lack of long term evidence and the losses to follow up which are high.”

Sling The Mesh says part of the controversy is that women are treated with a total lack of respect from surgeons who deny mesh is an issue.

Some of the worst things surgeons have said to women presenting with mesh problems include:

• Do you think all this research is good for your mental well being?

• One surgeon told a campaigner ‘you have a beautiful vagina.’

• One surgeon said “we will try and make your quality of life comfortable.” The woman never heard from him again.

• A woman was told she was obese and if she lost weight her symptoms would go.

• One surgeon said the woman was born with the problem. The fact that pain started instantly after operation was purely coincidence.

• A woman told her surgeon she was in terrible pain when she moved her legs. He replied, don’t move them then.

• When the sharp edges of the mesh cut a woman’s partner during sex the surgeon told her, it can’t be the mesh you must have something else sharp in there.

• One surgeon said “You’ve been reading too much Daily Mail and the Internet.”

• A consultant said: “I can assure you the tape is fine, I have done thousands of these operations. It’s media hype.”

• After collapsing with a massive bleed and vomiting blood one surgeon said: “Do you get anxious around doctors?”

• One woman told a male surgeon of her chronic groin, leg and pelvic pain. He suggested gymnastics, saying practising the splits would do her good.

• One woman was told it’s just one of those things. You’re just going to have to live with the pain.

• After telling her GP she hadn’t been intimate with her partner for six years as it was too painful, the surgeon printed out an online brochure for a device to make her “feel tight and wanted again.”

• One surgeon said: “It’s not like it’s life threatening is it.”

• A consultant said: “I think this woman is obsessed with her vagina and should hurry back to work”.

• A neurologist said a campaigner had to push through the pain and retrain her brain.

• BBC Panorama: The Operation That Ruined My Life. BBC One, 7.30pm, Monday 11th December.

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