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NHS High Vigilance Warning on Mesh Implants

By - Sweet Cures Founder and Owner

The use of surgical mesh for internal repairs such as hernias goes back to the 50s but by the 90s it was being put forward for use transvaginally.

Between 2006 and 2016, approx. 100,000 women in the UK who were suffering from incontinence or organ prolapse, were treated by using an alternative to the previous lengthy Burch colposuspension (the latter was often colloquially referred to as hitch and stitch - which used a piece of muscle from the stomach wall to make a supporting sling - a lengthy procedure with a potential for complications), so replacing it with something better was welcomed.

This new procedure that involved using a polypropylene (plastic) surgical material called a mesh was consequently welcomed as an alternative. It made sense because inserting the mesh implant took 20 minutes compared to the three hours plus needed for the traditional method, and it was clearly less invasive.

The meshes’ function was the same, and that was to address weakness in the pelvic cavity that can arise mostly post childbirth when a pelvic organ – (bladder, rectum or uterus) drops from its normal position and pelvic floor muscles, ligaments and tissue that hold the organs in place are weak and “sag” creating a prolapse. Other causes of prolapse include prior pelvic surgery, menopause, and just getting older.

The mesh was net-like, and its function as a “sling” or “hammock” was to give permanent support to weakened organs by being implanted into surrounding tissue and literally holding the organs in place.

It was hoped that women were being helped but the BBC in 18 April 2017 reported that [ 1 ] :

“More than 800 UK women are taking legal action against the NHS and the makers of vaginal mesh implants. Some women have been left in permanent pain, unable to walk, work or have sex. One called the implants "barbaric. The pain in my legs and feet was so intense, along with burning pains in my vagina – like being cut with a cheese wire – that I knew something was terribly wrong…”
Kate Langley

Some reported problems include:

  • Organ damage due to the mesh eroding into the bladder, urethra or other organs.
  • Interstitial cystitis
  • Fistulas forming (abnormal communication between organs, such as the bladder and vagina).
  • Chronic symptoms.
  • Mesh injuring nerves, causing pain.
  • Mesh shrinking, leading to pain and vaginal scarring.
  • Incontinence, even without coughing or straining.
  • Severe urgency
  • Pain during sex after mesh surgery
  • Partner having pain and feeling the mesh
  • Frequent UTI’s
  • Becoming wheel chair bound
  • Bladders, vagina walls etc. cut into
  • Extremely sensitive internal tissues often ending sex lives

In fact, the potential for this operation to adversely affect patients’ health in various ways, for example, chronic leg pain, constant urinary infections leading eventually to a need to self-catheterise gradually emerged as more and more patients reported problems. Some reported intense inflammation in intimate parts of the body tissues preventing sexual intimacy and even worse, the sharp mesh could pierce the vaginal wall, urethra and/ or cut into the bladder.

"My husband began complaining that making love to me was like sleeping with a cheese grater. His penis would be cut when we had intercourse. The pain and embarrassment made me anxious, sick and depressed."
Name Withheld

Problems with mesh either emerge quickly, or begin years after implantation. This happens because the material is not inert and as a foreign object in the body, it can shrink, twist, affect healthy tissue, and provide a breeding ground for pathogenic bacteria, and simply break down with unknown and unforeseen consequences. Until 2017, government guidelines had stated the surgery was safe and effective. However, an investigation by the Guardian, supported by NHS data, foundthat one in 15 women given a mesh implant later required surgery to have it removed, with some suffering life-altering complications.

It would seem that the MHRA and the NHS may have underestimated the problem and with big pharma reportedly insisting the procedure was totally safe, many patients felt that they were fobbed off and no connection made with their implant.

Kate Langley says:

“Some women with the implant feel they are “going mad” after being told there is “nothing wrong”, despite years of painful symptoms, they say. Unlike other devices such as hip or breast implants, mesh embeds into the tissue and is designed to be a permanent implant. Removing it is like trying to get chewing gum out of matted hair. It is not mandatory for surgeons to report problems to any database and there is no national register, so in truth nobody knows the true scale of this. All I can see as a patient campaigner is women experiencing chronic pain while in many cases surgeons deny the problem has anything to do with their operation. Some go back and forth for up to 10 years before their problems are properly recognised and addressed.” [ 1 ]

Because of Kate’s work amongst, others attitudes have changed:

“I call this the new thalidomide scandal because thalidomide changed drug regulation overnight, and I hope this case will do the same with device regulation. “Mesh implants were introduced two decades ago without clinical trial evidence looking at the long-term effects, and that there should be much tougher regulations on devices such as the implant.” Carl Heneghan, professor of evidence-based medicine at the University of Oxford. [ 1 ]

In the US, vaginal mesh has been seen as high-risk for nearly 10 years, and some studies have suggested that subsequent pain and perforation can affect up to 75% of women.” Telegraph Radhika Sanghani 23 Oct 2017

The government has accepted the use of vaginal mesh implants to treat complications after childbirth should be stopped immediately to prevent further risk of “life-changing and life-threatening injuries” to women. It would effectively suspend the use of vaginal mesh implants in NHS hospitals, which would represent a major victory for campaigners. It follows an independent inquiry, ordered in February by the health secretary, Jeremy Hunt, which concluded the surgery must be stopped until steps have been taken to mitigate the risks to patients. [ 2 ]
Hannah Devlin, Guardian.

The Government has pledged to review tens of thousands of cases where women have been given harmful vaginal mesh implants. In a major win for campaigners, the Department of Health and Social Care has committed to look at every case back to 2005 to determine the true extent of serious complications that can leave women in agony. Independent Jan 2018

“I have been appalled at the seriousness and scale of the tragic stories we have heard from women and their families. We have heard from many women who are suffering terribly. Their bravery and dignity in speaking out is deeply moving, and their sadness, anger, pain and frustration at what has happened to them and others has been compelling. We had to act now.”
Julia Cumberlege, Chair of the review.

In December, a NICE document states that "randomised controlled trial data showed no added benefit of using mesh compared with native tissue repair".

Nice guidelines recommended that mesh should no longer be used to treat prolapse but so far they have not come to a final conclusion on mesh implants but they have issued a High vigilance warning to clinicians:

High vigilance restrictions on use of vaginal mesh [ 3 ]

On 10 July 2018, NHS Improvement and NHS England wrote to all acute trusts advising of the immediate implementation of a high vigilance restriction period regarding vaginal mesh.

For the majority of patients, mesh surgery should not be performed during this period of high vigilance restriction.

For some patients, mesh procedures may be the only viable treatment option. This includes cases where clinicians judge there is clinical urgency to carry out the procedure and no suitable alternative exists, and/or where delay would risk harm to the patient. However, this treatment should only be used in carefully selected patients who understand the risks and have given fully informed consent.

References:

[1] RCOG Patient Safety Mesh Implants - RCOG.org.uk

[2] Government halts vaginal mesh surgery in NHS hospitals - The Guardian

[3] Vaginal mesh implants: Hundreds sue NHS over 'barbaric' treatment - BBC News

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