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July 8th 2020

Medical Negligence

Critical review strengthens cases for women seeking clinical negligence damages for life-changing impact of vaginal mesh surgery

Josie Robinson

Josie Robinson

Senior Solicitor, Clinical Negligence

Critical review strengthens cases for women seeking clinical negligence damages for life-changing impact of vaginal mesh surgery

As solicitors representing women who have suffered life-changing injuries after having vaginal mesh surgery we very much welcome the long-awaited findings of an independent review which has concluded that those affected deserve a ‘fulsome apology from the government’.

As solicitors representing women who have suffered life-changing injuries after having vaginal mesh surgery we very much welcome the long-awaited findings of an independent review which has concluded that those affected deserve a ‘fulsome apology from the government’.

Women told the Independent Medicines and Medical Devices Safety Review (IMMDS) team how they have suffered ‘excruciating chronic pain feeling like razors inside their body, damage to organs, the loss of mobility and sex life and depression and suicidal thoughts’

The highly critical review, entitled ‘First Do No Harm’ and led and chaired by Baroness Julia Cumberlege over the past two years, has set out nine major recommendations to bring ‘much-needed help and support to those who have suffered as a result of these interventions’, and to ‘reduce the risk of avoidable harm from medicines and medical devices in the future’.

It comes as the report says the complications that followed surgery ‘reduced so many to a shadow of their former selves, taking a terrible toll on partnerships and family life.

In summarising, Baroness Cumberlege said: “I have conducted many reviews and inquiries over the years, but I have never encountered anything like this; the intensity of suffering experienced by so many families, and the fact that they have endured it for decades. Much of this suffering was entirely avoidable, caused and compounded by failings in the health system itself.

“The first duty of any health system is to do no harm to those in its care; but I am sorry to say that in too many cases our system has failed in its responsibilities.

“We met with people whose worlds have been turned upside down, their whole lives, and often their children’s lives, shaped by the pain, anguish and guilt they feel. It has been a shocking and truly heart-rending experience. We owe it to the victims of these failings, and to thousands of future patients, to do better.”

The review says that in guidance on mesh for stress urinary incontinence published in 2003, it was recommended that only experienced surgeons should operate and an audit of numbers of procedures, outcome measures and adverse events should be kept.

“None of this happened consistently. There were no checks on implementation of the guidance nor enforcement and no consequences for not following it,” the report states.

“Had it been implemented, it is likely that many hundreds, perhaps thousands, of women would have been spared mesh complications.”

Lack of records and knowledge of impact and side effects highlighted

The review team found there was not a proper record of just how many women have been treated for stress urinary incontinence and the repair of pelvic organ prolapse using mesh, nor a system for recording side effects, such as loss of sex life, chronic pain, infection, recurrent urinary incontinence and permanent nerve damage or damage to surrounding organs.

These complications, the report says, have led to relationship and family breakdown, loss of employment, loss of a home or financial hardship.

“We met so many women with limited mobility having to rely on a wheelchair or crutches to move around, unable to sit for periods at a time, unable to play with their children or carry their grandchildren, living daily with the consequences of the operations and procedures they thought would cure them,” the report states.

“The effects of these procedures have caused fractured relationships for some and placed some women and their families in dire financial straits. In short, the system does not know the true long-term complication rate for pelvic mesh procedures.”

Women were not told of risks and doctors ‘ignored’ or ‘dismissed’ problems after surgery

The review also details how women were not always told about the risks of mesh before their procedures and how some who have faced life-changing consequences only had ‘relatively minor’ stress urinary incontinence at the time.

The review team also said they were “appalled” to discover the number of women who were not made aware they were being fitted with mesh.

Many patients subsequently reported that doctors, surgeons or GPs “ignored or dismissed” their concerns, with reactions ranging from ‘it’s all in your head’ to ‘these are women’s issues’ or ‘it’s that time of life’,” the report states.

“For the women concerned this was tantamount to a complete denial of their concerns and being written off by a system that was supposed to care,” it adds.

These are findings in common in with the accounts given by a group of clients represented by Josie Robinson, of Hudgell Solicitors in clinical negligence damages claims.

They are each seeking damages relating to a lack of information provided about the potential health risks related to the procedure, thereby meaning they were unable to truly consent to the surgery they were undergoing.

“In my opinion this report provides strong support for the cases we are running on behalf of woman seeking compensation for clinical negligence relating to the impact vaginal mesh surgery has had on their lives,” Mrs Robinson said.

“It highlights a clear move away from original guidance as to which surgeons should be carrying out this type of surgery, a shocking lack of information on risk provided to patients and a lack of understanding from the medical profession over the side effects which so many have described as having ruined their lives.

“Certainly from the evidence available with regards to the women I am representing there appears to be serious grounds for concern about the lack of information they were each given about the known risks and complications of mesh implants.

“This is information which would, without any doubt, have informed their decision as whether to go ahead. They each say they were given the impression that mesh surgery would be an easy fix for their problems, which has far from proved the case. In fact they have all suffered from long-term complications.

“My clients each paint a poor picture of the consent process, from a lack of information about the type of mesh implant used to the known short and long term complications of mesh implant surgery.

“There was no real understanding about how the mesh actually worked and the difficulty of having it removed, should there be a poor result. The mesh is designed to be permanent and most of my clients were not aware of this. A number of my clients have now been through the difficult and complex surgery of having the mesh removed.”

Recommendations for future learning and improved safety must be implemented

Included in the review recommendations are that the Government ‘immediately issues a fulsome apology on behalf of the healthcare system to the families affected’ and that a ‘Patient Safety Commissioner is appointed’.

It is recommended that this person would be the ‘patients’ port of call, listener and advocate, who holds the system to account, monitors trends, and demands action’, and it is a role Amanda Stevens, of Hudgell Solicitors, would welcome.

She said: “In my previous work with the Civil Justice Council concerning clinical negligence claims I have been involved in discussions  around ways of ensuring better learning and how more transparency can be brought across the health service, all with improving patient safety as the priority.

“It is shocking to learn that there has been no proper record of just how many women have been treated in this way and no record of side effects. Without this there can be no improvement in patient safety and no learning.

“There certainly needs to be a way found to ensure incidents are always reported and collated. It is absolutely key if there is to be improved patient care, no matter what the procedure. This is something a Patient Safety Commissioner could bring and so that is a particularly important change.”

Also recommended in the review findings are that schemes be established to meet the cost of providing additional care and support to those who have experienced avoidable harm and the formation of a Redress Agency for those harmed by medicines and medical devices in future.

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