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Vaginal mesh

What is a vaginal mesh implant?

Meshes used for uro-gynaecological conditions are broadly split into two categories – those which treat stress urinary incontinence (‘SUI’) and those which treat pelvic organ prolapse (‘POP’):

SUI is the symptom of any involuntary leakage of urine on effort or exertion, or on sneezing or coughing. The sign of SUI is the involuntary leakage observed from the urethra seen at the exact time of exertion/effort, or sneezing or coughing. SUI cases are often interchangeably referred to as TVT (Tension-free Vaginal Tape) TVT-O (Tension-free Vaginal Transobturator Tape) and TOT (Transobturator Tape) cases. Mesh can also be described as slings, tapes or ribbons.

Vaginal mesh implants for SUI are generally made from a narrow ‘tape’ of polypropylene mesh which is placed under the urethra like a sling or hammock to keep the urethra in the correct position. They can be implanted in a minimally invasive surgical procedure under local anaesthetic as an out-patient. They are permanent implants that are not intended to be removed. They are placed trans-vaginally (i.e. across or through the vagina) to support the mid-urethra or bladder-neck when the pelvic floor muscles and urethral sphincter are weakened or damaged and unable to stop urine from leaking. There are a variety of tapes available that differ in the surgical insertion technique used. A vaginal mesh tape is inserted through a small (1-2 cm) cut in the vagina, to support the urethra. The surgeon then makes two smaller cuts just above the pubic area (retropubic) or on the inside of both thighs (transobturator) and passes the vaginal mesh implant through.

POP is a protrusion of one or more pelvic organs (bladder, rectum, uterus, vaginal vault, bowel) through the vaginal fascia into the vagina and the downward displacement (‘prolapse’) of the associated vaginal wall from its normal location to or outside the vaginal opening. POP affects a woman’s quality of life by its local physical effects (pressure, bulging, heaviness or discomfort) or its effect on urinary, bowel or sexual function.

Vaginal mesh implants used to treat POP come in various sizes and shapes. They are made of polypropylene and some products may also incorporate a biological/absorbable component, such as a coating. These vaginal mesh implants are placed in the pelvic floor area in a number of different ways to support the vaginal wall and/or other pelvic organs. They are permanent implants that are not intended to be removed. The pore size within the mesh varies depending on the diameter of the polypropylene yarn/filament used and the construction method for the mesh. A larger area of mesh is used for POP repair than that used for treating SUI. The procedure for insertion of the mesh varies depending on the type and extent of prolapse being treated, and is generally performed with the patient under general anaesthesia.

When were they introduced?

Mesh products were first brought to the UK market in the mid-1990s.

In April 2018, NHS Digital released data confirming that:

Between April 2008 and March 2017 – 100,516 patients had a reported tape insertion procedure for SUI. In the first year of that period the total was 13,990, which reduced to 7,425 in 2016/17. In the same ten year period – 1,195 patients had a non-tape procedure for SUI.

Similarly between April 2008 and March 2017 – 27,016 patients had a mesh procedure for POP (in the first year of this period the total was 3,073, reducing to 2,680 in 2016/17). In the same 10 year period – 71,350 had a non-mesh procedure for POP.

What can go wrong?

In most cases, the complications are relatively minor. However, in a small number of cases they can be serious. These include mesh erosion/extrusion (when the mesh pokes through the vaginal wall or cuts through internal tissue), vaginal scarring, fistula formation, painful sex, bladder infection or perforation (piercing), bowel and nerve trauma and pelvic, back and leg pains. Some of these complications may occur years after surgery and can be difficult to treat. Serious complications are rare, given the tens of thousands of women who have had the implants, but can be life-changing for some women.

The Independent Medicines and Medical Devices Safety Review recommended a pause on the use of vaginal mesh for SUI which was accepted by the government and NHS, and implemented in July 2018. The pause was subsequently extended to cover the use of vaginal mesh for POP. The pause remains in place pending the fulfilment of certain patient safety criteria. Whilst the products are not banned, they are only used as a last resort through a high vigilance programme of restricted practice.

The Review “First do no harm”

As a result of concerns raised by mesh-affected women, in April 2018 the then Secretary of State for Health and Social Care, Jeremy Hunt MP, announced a review into the use of vaginal mesh. The review was led by Baroness Julia Cumberlege and the report of the Independent Medicines and Medical Devices Safety (IMMDS) “First Do No Harm” can be read here.

The Government published its response to the IMMDS Review in July 2021.

How do you know if you can make a vaginal mesh claim?

If you have had vaginal mesh surgery as an NHS patient in England and have suffered any of the above symptoms/problems, you may be able to make a claim against the NHS. In addition to side effects, you may be able to claim for implants that were not inserted correctly and/or on the basis that you were given the wrong information or advice.

If your surgery was carried out at a private medical organisation and you or your private medical insurer paid for the procedure, we regret we cannot deal with your claim.

Please see below for details of organisations which can help you find a medical negligence solicitor who can guide you through the process and let you know if you have a valid claim.

The Legal Test

In order for a claim to succeed, the party bringing the claim (you, the claimant) must prove, on the balance of probabilities (which means greater than a 50% chance):

  • That there was a breach of duty – that those treating you acted in a way that was contrary to a practice accepted as proper by a responsible body of Gynaecologists/ Urologists/Urogynaecologists at the time. It is not sufficient to prove that another medical professional or even a body of medical professionals would have acted differently – you must prove that no reasonable body of medical professionals operating in the same field would have supported the decisions made in your case. This is sometimes referred to as the ‘Bolam’ test. In the event court proceedings are issued, you are required to have independent expert evidence from an appropriate doctor experienced in the relevant field, supporting your allegations. Your case may concern a failure to obtain informed consent (also sometimes referred to as a ‘Montgomery’ case). You may allege that you were not adequately warned of the material risks of the procedure you underwent and/or that you were not offered reasonable alternative treatments. It is important to note that the test relating to risks requires consideration of which risks were known to the profession at the time of your surgery (i.e. a doctor cannot be held liable for failing to warn of a risk which was not reasonably known to the medical profession at the time your surgery was being discussed).

and

  • That if you had been given additional or different information, you would have chosen to do something different (i.e. opted for a different procedure or conservative treatment, or indeed undertaken no treatment at all and lived with your symptoms). You must be able to satisfy the Court on the balance of probabilities (i.e. more than 50%) that ‘but for’ the Defendant’s breach of duty, you would have opted for a different course. This is known as ‘factual causation’.

and

  • that you suffered an injury (damage) resulting from the breach of duty of care (medical causation). To establish causation, there must be a link between the breach of duty and the injury suffered, and the test for causation is the ‘on balance of probabilities’, which means more than a 50% chance. As above, if court proceedings are issued you will require independent expert evidence detailing your injury, which will include what your condition would have been in any event, and what it is now.

You must be able to satisfy both the breach of duty and causation limbs of the legal test if you are to be successful in recovering damages.

Once the legal test is satisfied, your claim will move to ‘Quantification/Assessment of damages’ – this is sometimes referred to as ‘quantum’. It is split into two categories:

  • General damages (the compensation for your injury; pain, suffering and loss of amenity)
  • Special damages (the losses and expense you have/will incur as a result of your injury)

Expert evidence is usually required to assess your condition and prognosis. You would be required to provide evidence of your losses and expenses (for example through receipts/invoices).

The Claim Process

Ordinarily, all claims against hospitals, GPs, dentists and other healthcare providers are managed by a “pre-action protocol”. The protocol can be read in full here.

The protocol outlines the process for parties to share sufficient information to be able to understand, investigate and respond to a claim without the need for litigation. An overview of the process is outlined here. You may wish to follow that process and if so, a precedent ‘Letter of Claim’ is attached here for you to use. You will note from the protocol that it is necessary to obtain copies of your medical records and forms of authority are attached for your use: GP here and hospital here.

Outlined below is an alternative claims process which you may choose to use. It is entirely up to you which process you select and you may wish to obtain independent legal advice. Whether you submit a Letter of Claim or questionnaire, your claim will be dealt with in the same way and a full investigation will take place and a response will be provided.

Alternative process for vaginal mesh claims:

  1. You will need to complete the questionnaire. We ask that you fill this in and provide as much information as possible. Please remember to sign and date the questionnaire. You will also need to complete the Forms of Authority so that we can gain access to your GP and Hospital records to allow us to investigate your claim.
  2. Please send your completed questionnaire and Forms of Authority to nhsr.mesh@nhs.net. We recommend that for security reasons you put a password on your documents and let us know what that password is in a separate e-mail to the same mailbox. Once we receive all the documents, we will send these to our solicitors who will be tasked to investigate your claim. If we require further information from you, the case manager at NHS Resolution or one of the solicitors will contact you to explain what further information is needed.

Our solicitors will then obtain copies of your medical records and begin their investigations. They will be looking to see if there was a ‘breach of duty’ and will also investigate ‘causation’. This process can take up to 4 to 6 months but they will endeavour to keep you updated on the progress of the investigation and inform you of any unexpected delays.

At the conclusion of their investigations, our solicitors will give us a report and at that stage two things can happen:

  • (i) If the report concludes that the hospital was at fault and that as a result you suffered an injury, our solicitors will be instructed to admit liability which means that you will then be entitled to compensation. In some cases it may be possible to make an offer of compensation to you as soon as we have admitted liability. This will be based on the injury you suffered and whether you have suffered any financial losses as a result of the injury. It may not be possible in all cases to settle your claim immediately as it may be necessary to undertake further investigations to establish the value of your claim. Depending on the value, this further investigation can be lengthy and require further expert evidence.
  • (ii) If the investigations reveal that the hospital was not at fault, the solicitors will inform you of their findings explaining why we do not believe you have a claim.

In either situation, unfortunately we will not be able to release the solicitors’ report to you.

We would like to emphasise that at any point during this process, you have the right to seek independent legal advice. Details of organisations which can help you find a medical negligence solicitor are provided below.

The Citizens Advice Bureau may also be able to assist you.

You may also find the ‘Litigant in Person’ guidance sheet here produced by The Law Society helpful, together with our Frequently Asked Questions note here.

 

 

 

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