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‘I feel like the unwilling victim of a cruel experiment that has gone horribly wrong’ - concerns over women’s hospital operation

PUBLISHED: 06:30 05 June 2015 | UPDATED: 08:57 05 June 2015

Kath Sansom has launched a campaign against a gynaecology operation in which a TVT sling is used. Picture: HELEN DRAKE

Kath Sansom has launched a campaign against a gynaecology operation in which a TVT sling is used. Picture: HELEN DRAKE

Archant

Calls have been made for a controversial operation carried out on women to be suspended amid concerns about potentially painful and debilitating after effects.

June Smith of March joins the Sling The Mesh campaign June Smith of March joins the Sling The Mesh campaign

The operation uses a device known as a TVT mesh sling to cure incontinence or pelvic organ prolapse, a problem that can often be caused by natural childbirth, especially if women have had big babies.

However, there have long been concerns about complications caused by the procedure and in Scotland last year health minister Alex Neil called for their use to be suspended pending an inquiry.

Now a campaign called Sling The Mesh, has been set up nationally calling for the procedure to be suspended in the rest of the United Kingdom.

One of the campaign members is Kath Sansom, an Archant journalist from March, in Cambridgeshire, who said: “I feel like the unwilling victim of a cruel experiment that has gone horribly wrong.

“My legs and pelvic area feel like they are full of cut glass. I have burning and shooting pains. Going up a few stairs makes my legs ache terribly. I also have unexplained rashes and a burning face sensation.”

She also called on health experts to fully outline all of the risks to patients, claiming she was led to believe it would be simple and harmless.

June Smith, also from March, who had a TVT operation in May 2012, said: “I want to get this operation stopped. I do not want any other women to go through the nightmare that I have gone through and still going through.”

The tension-free vaginal tape (TVT) procedure sees a synthetic polypropylene mesh implanted under the bladder like a hammock to treat incontinence by supporting the internal organs

But it has caused so many health problems in Australia some of the products were de-registered, while in the USA and Canada around 100,000 lawsuits have been filed from women who have suffered permanent disabilities.

A spokesman for the Medicines & Healthcare products Regulatory Agency (MHRA) said: “The MHRA continues to sympathise greatly with women who have suffered complications after surgery for lifestyle changing incontinence and organ prolapse. We will continue to monitor their safety and performance and we continue to encourage women to report any adverse incidents to us via the Yellow Card Scheme yellowcard.mhra.gov.uk”

To find out more about the campaign, visit Kath’s blog at slingthemesh.wordpress.com.

If you have undergone the operation and want to tell your story, contact Kath on 01354 652621 or email kath.sansom@archant.co.uk

CASE STUDY - KATH SANSOM

I’m having corrective surgery at the John Radcliffe Hospital in Oxford with Natalia Price, one of only two surgeons in the UK who can successfully remove TVT mesh, in September.

Luckily I am able to sit at a desk and type but there have been days where I have had to creep into the kitchen for a weepy moment where I’m in so much pain I don’t quite know what to do with myself.

I was first offered the TVT operation in 2007. It sounded like a dream solution to an embarrassing bladder problem brought on by a 9lb 11oz second baby.

At that point, however, I backed out and didn’t think any more of it until this year when I decided enough was enough and if the operation was that simple as suggested then why not go for it.

I had the TVT mesh operation as a day case in March 2015 but from the outset I knew something was wrong.

I had terrible leg and groin pains, shooting and burning pains inside and I ached doing the simplest tasks.

At first I put it down to settling in pains but after three weeks when it still hadn’t got better – recovery is supposed to be 1-2 weeks - I began to worry.

I had scratching pains inside me and felt like I was being cut with cheese wire. I am super strong and fit as I high board dive, box, mountain bike and swim, so I couldn’t understand why this recovery was taking so long. That was when I Googled TVT gone wrong.

My chin dropped. Up came a list of forums and support groups full of women suffering across the world.

I read a story about a Peterborough woman in a wheelchair because of the operation, another from 2011 about a woman with terrible crippling pains. A Channel 4 Dispatches programme about medical devices not fit for purpose and the fact the procedure was suspended in Scotland in June 2014. And so the list went on.

I sat and cried. I couldn’t believe what I was reading. I then found a blog from a woman in Oxford who was one of the first to have her TVT removed by Natalia Price in Oxford in 2011. I emailed and she replied straight away with advice.

Thanks to her I set the wheels in motion of getting an urgent GP referral to Ms Price.

My GP has been amazing – thanks to him this mesh mess is going to get sorted and I have light at the end of the tunnel.

What our hospitals say

A spokesman for the Norfolk and Norwich University Hospital said: “We offer the retropubic midurethral sling called the Stress Incontinence sling and in 2014 we carried out 57 operations.

“Sometimes patients need short-term complications like difficulty in emptying the bladder and may require an in–out catheter in the ward, or going home overnight with a catheter in place to return in 7-10 days for it to be removed. All complications are recorded in The British Society of Urogynae (BSUG) database.

“All patients are seen in the pre-op clinic usually five to seven days prior to their scheduled operation and counselled in detail about the procedure. The following complications are discussed in details and documented in the notes. They are provided with a detailed information leaflet.

“When we drafted our leaflet there were a lot of stories in the media about this procedure and we wanted to make sure our patients were well informed before they had their operations.

“The urogynae team wanted to give all women the opportunity to consider all possible impacts operations such as this can have, no matter how rare they are.

“We continue to offer this procedure which has significantly improved the lives of many women. Nationally the Medicines & Healthcare Products Agency has no evidence that the devices themselves have inherent problems that would necessitate consideration of product removal from the market.”

King’s Lynn’s Queen Elizabeth Hospital carried out the procedure six times in 2014, none of which led to complications.

Dr Bev Watson, medical director, said: “Patients are warned of the full risks of the tape, such as erosion, pain and discomfort, during the consent process ahead of any operation.

“Patients are also provided with a number of relief methods to try before opting for TVT, such as physiotherapy and pelvic floor exercises. They may be asked to reduce their weight also. If they do not respond to these treatments they are then offered the operation.

“The trust is participating in a national trial to compare standard tapes with mini tapes and is aware of the review being undertaken by the manufacturers.

“The trust continues to work with the British Society of Urogynaecology and will continue to offer this treatment under their guidance whilst ensuring patients fully understand risks ahead of a TVT mesh operations.”

A spokesman for West Suffolk Hospital said it had conducted 10 operations in 2014, with no complications, adding: “We were the last hospital in the UK to start offering TVT mesh operations to treat incontinence when we introduced the procedure four years ago following the publication of NICE guidance. We also offer alternatives, which are fully discussed with our patients before a joint decision is made on their treatment. We do not offer mesh surgery for prolapse, which is where the majority of complications have occurred. We follow guidance from the British Association of Urologists, the British Society of Urogynaecology and NICE in continuing to offer the procedure. The rates of cure from this type of surgery is high.”

The James Paget University Hospital carried out 60 TVT procedures in 2014, but was not able to confirm how many used the mesh. A spokeswoman said it was ‘satisfied’ they should continue to offer it, adding: “All of our patients are fully briefed about the risks and benefits of the procedure ahead of their operation.”

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