In this opinion piece, Kath Sansom, founder of campaign group Sling the Mesh, looks at flaws in the Government’s approach to women harmed by pelvic mesh surgery receiving financial redress. She highlights the unsuccessful case of Sarah*, who attempted to bring a clinical negligence case after suffering multiple complications as a result of pelvic mesh, to demonstrate that the national Redress Agency recommended by the Cumberlege Review is still very necessary.
It’s so important that mesh-injured women are able to access redress for their injuries, many of which are life-changing. Often, financial support is not a bonus but is necessary, as women have had to leave their jobs or reduce their hours to cope, move to accessible housing or sell their home to live with family. Many have also experienced marriage breakdown as a result of mesh complications. One in four women in Sling The Mesh need a stick to help them walk, so need to pay for mobility aids or scooters, and there are also the ongoing costs of travel to doctors and hospital appointments.
Waiting times are up to four years for mesh removal, so many women cash in savings or pensions to pay for private removal which costs thousands. The psychological impact of mesh injuries also takes a toll and with long NHS mental health waiting lists, many turn to the private sector for counselling for post traumatic stress disorder (PTSD) and trauma. Likewise, many women have difficulty accessing NHS Physiotherapy so turn to the private sector for specialised physio to help mobilise internal pelvic scar tissue which can cause ongoing pain after mesh removal.
The concept of redress is about proactively correcting a wrong that has been done to a group or individual. It differs from clinical negligence, which is about identifying and proving that the actions of an individual healthcare professional or service caused specific harm. Redress involves an authority taking responsibility for harm that has been caused under its watch, whereas clinical negligence is an adversarial process with strict legal boundaries.
In 2020, the Independent Medicines and Medical Devices Safety (IMMDS) Review’s report, ‘First Do No Harm’ (Cumberlege Review), called for “a new independent Redress Agency for those harmed by medicines and medical devices” to be created, based on models operating effectively in other countries. This Agency was to offer women harmed by mesh a specific, non-adversarial route to compensation. However, in its official response to the report, the Department for Health and Social Care (DHSC) rejected this recommendation, stating that “while the government is sympathetic to the experiences of those patients who gave evidence to the report, our primary focus is on improving future medicines and medical devices safety.”
The Government's failure to accept the IMMDS recommendations around setting up a Redress Agency means that the clinical negligence system is the only route left to women to pursue financial compensation, and it is a long, onerous process that is often unsuccessful.
Sarah’s story - failures in the clinical negligence route
Sarah* has spent the last two years fighting for redress through a clinical negligence case because of injuries following pelvic mesh surgery. Over the past few years, she has gone through two episodes of mesh erosion, two surgeries and an episode of sepsis. Since the mesh device was implanted, she has also experienced fibromyalgia and arthritis of the sacroiliac joints.
She recently received a letter from the Head of Clinical Negligence at the law firm she was working with, informing her that they would not take her case forward. It was unlikely to be successful as she had her surgery before complications for mesh surgery were fully understood, and prior to 2013 when National Institute for Health and Care and Excellence (NICE) guidelines for urinary stress incontinence were changed. The letter stated:
"The difficulty with your claim is that your TVT/mesh insertion surgery took place quite some time ago in 2007 when this was considered to be the gold standard to treat stress urinary incontinence, because the mesh surgery was quick, relatively simple and did not require a prolonged stay in hospital. It was only later on that the problems with mesh and the risks associated with mesh became fully known.”
"A court would assess your claim based on the state of medical knowledge and expertise that existed at the time you had the mesh surgery in April 2007, with the problems and risks associated with mesh only becoming known at a later stage.
"Consequently, a court will take the view that the consultant advising you at the time of your surgery in 2007 could only advise you based on the state of medical knowledge that existed at that time and cannot be held legally to blame for the treatment and advice that he gave you, if the risks associated with mesh only became apparent afterwards.
"Therefore, unfortunately, further to the above we believe that if your claim proceeded further with the commencement of court proceedings, we would not have a reasonable prospect of success."
It is my view that, given the evidence of harm caused by pelvic mesh, a woman who underwent surgery in 2007 should be equally entitled to redress as a woman who had surgery much later.
I highlighted the issue with Helen Hughes, Chief Executive of Patient Safety Learning, who responded, “When responding to the IMMDS Review, the Government rejected a recommendation to introduce a separate redress scheme for mesh on the basis that patients could take healthcare providers to court for clinical negligence, or manufacturers for product liability. However, as this case sadly illustrates, the legal complexities involved in this means that for many mesh-injured patients this is simply not an option, leaving them with no alternative route to help meet the cost of any additional care and support they may need.”
A national Redress Agency is the only way to offer equitable redress
A Redress Agency specifically aimed at women with pelvic mesh injuries would offer a more equitable, compassionate route to secure compensation. As well as women having a higher chance of success going through a Redress Agency, women would not be forced to face the stress of legal action that often lasts for years while dealing with the pain and limitations they live with as a result of their injuries. At the moment, it does not appear that the political will or financial provision exists to make this a reality.
*name changed for anonymity
Tokenism in patient engagement is unethical—but it is also dangerous. A blog by Kath Sansom
Doctors’ shocking comments reveal institutional misogyny towards women harmed by pelvic mesh - a Patient Safety Learning blog
“There’s no problem with the mesh”: A personal account of the struggle to get vaginal mesh removal surgery
1 First Do No Harm. The report of the Independent Medicines and Medical Devices Safety Review, 8 July 2020
2 Government response to the report of the Independent Medicines and Medical Devices Safety Review, 21 July 2021