The pelvic mesh health scandal – new redress scheme for patients proposed

Posted: 06/03/2024

Many women experience stress incontinence following childbirth, which is bladder leakage caused either by impact activities, or simply from coughing or sneezing. One in five feel it negatively affects their lives to the point of considering surgery for vaginal mesh (also known as pelvic mesh) implants. 

Likewise, up to half of women who have had children suffer pelvic organ prolapse, where their bladder, rectum or uterus sags and moves out of place, due to a weakening of, or damage to, the pelvic floor muscles, ligaments and tissue that usually hold these organs in place. Pelvic mesh surgery was also considered an option for these women. 

For many years, pelvic mesh was considered to be the gold standard treatment for stress incontinence and prolapse in women. Some women benefited from vaginal mesh insertion, but unfortunately for many, it resulted in harm as the net-like implant, made of polypropylene, can erode and harden, cutting through tissue and causing serious pain. 

Some women have undergone removal surgery, following medical recommendation, but the mesh is permanent, and was never designed to be removed, being described as like ‘chewing gum’ to try to extract in its entirety. Removal surgery also carried risk of damage to nerves and organs, including the bladder and bowel. 

Tragically, thousands of women experienced life-changing complications as a result, costing them their mobility, independence, careers, and relationships, and leaving them in constant pain. Some women were unable to walk, to work again, or to have sex, and were in significant pain every day. Pelvic mesh became regarded as a health scandal, and data suggests that more than 127,000 mesh implants were undertaken between 2008 and 2017 to treat incontinence and pelvic prolapse. 

Commenting on the situation, one pelvic mesh harmed patient said: “It’s important for someone to take responsibility for what’s happened to thousands of women whose lives have been ruined by this horrible mesh. Someone to say I’m sorry this happened to you, but really mean it … I had this mesh put in my body at the age of 43 and was told it was the best thing since sliced bread. How wrong they were.” 

Accordingly, the circumstances of pelvic mesh surgery formed part of the IMMDS Review (Independent Medicines and Medical Devices Safety Review), chaired by Baroness Cumberlege, which published a report in July 2020, commonly referred to as the ‘First Do No Harm’ report. 

One of the most serious patient safety issues highlighted by the First Do No Harm report was the lack of informed consent as part of the process of preparing a woman for mesh surgery. Many women had not been counselled sufficiently to be able to have given their informed consent to mesh surgery. They should have been given all the information to consider the advantages and disadvantages of the procedure – its benefits but also its risks – and all the other reasonable treatment options they had. 

Baroness Cumberlege reported: “We have been appalled by the numbers of women who have come forward to say they never knew they had mesh inserted, or where they gave consent for ‘tape’ insertion, they did not know they were being implanted with polypropylene mesh or were misinformed as to the extent of longer-term adverse side effects.” 

Then in terms of the removal of mesh, Baroness Cumberlege added: “We subsequently heard from women who underwent mesh removal surgery on the understanding that it would be a full removal. They consented to the operation on the basis of that understanding, only to discover in the weeks, months, and in some cases years that followed, that that was not the case.”

The IMMDS Review concluded that the UK government had a ‘strong ethical responsibility to provide redress’ and that a specific redress scheme should be set up for women who had suffered injury due to mesh, described as ‘avoidable harm’, as part of a wide-ranging ‘Redress Agency’. 

However, to date, no such agency or scheme has been introduced and instead the government has pointed towards harmed women having the ability to bring legal claims for compensation. Unfortunately, the introduction of a claims gateway by NHS Resolution has not obviously assisted women in trying to secure compensation, many of whom found their claims rejected for being out of time. 

In April 2023 the government reported that only 16 claims had been received by NHS Resolution through the gateway process and at that stage, none had resulted in compensation being paid. The claims gateway did not create a simpler, easier route to investigation and/or litigation, and did not change the law on the limitation periods for a claim to be brought within. It was also not an independent assessment of the claims, as NHS Resolution was assessing them itself. 

This led in 2022 to the Minister for Women’s Health, Maria Caulfield, commissioning the Patient Safety Commissioner for England, Dr Henrietta Hughes, to review the issue of redress for women harmed by vaginal mesh. Dr Hughes published her report and recommendations in February 2024 – the 10 key recommendations were:

• the government has a responsibility to create a redress scheme providing financial and non-financial redress for women harmed by pelvic mesh;
• it should work with other government departments, the healthcare system, and local authorities to measurably improve access to, and experience of, public services for harmed women;
• the government should create a two-stage financial redress scheme, comprising an interim scheme and a main scheme;
• the interim scheme should award directly harmed women a fixed sum of £20,000 by way of financial redress and these payments should start during 2025;
• the interim scheme should be followed by a main scheme, offering more bespoke financial support to directly harmed women, based on their individual circumstances, and also to potentially offer redress to those indirectly harmed too; 
• women who received pelvic mesh surgery either under the NHS or in the private sector should be eligible for the two schemes;
• the schemes should be straightforward, accessible and non-adversarial, embedded with a presumption of truth being applied when assessing women’s eligibility and circumstances;
• both schemes should be administered by an independent body commanding the confidence of patients;
• both schemes should signpost harmed women to services which can offer them free emotional support; and
• the government must ensure that the launch of both schemes is accompanied by an awareness raising campaign, and needs to make specific efforts to reach patients from disadvantaged and marginalised groups. 

It is important to remember that the redress scheme recommendations are only recommendations at this stage and have not yet been adopted by the government, nor are they guaranteed to be. It remains to be seen what action is taken and what redress scheme, if any, is put into place.

If enacted, the details of any such scheme would also need to be considered, in terms of eligibility factors, and whether women who have already brought clinical negligence claims are included or excluded from being considered for redress. 

Alison Johnson, partner in the Penningtons Manches Cooper clinical negligence team, comments: “Naturally, many women have approached us for advice, having had pelvic mesh surgery and having heard about the potential redress scheme. Some of these women are only realising now that they may not have been good candidates for mesh surgery, or may not have been consented properly and wouldn’t have decided to go ahead, had they known more about the risks of the surgery and the complications that can arise. Some are women that we have previously represented and settled clinical negligence claims for.

“It is noteworthy that the scheme proposed by Dr Hughes includes potential redress (financial and non-financial) for those indirectly harmed by pelvic mesh; presumably, the families of the directly harmed women, who probably would not be entitled to any clinical negligence compensation typically.”

The clinical negligence team at Penningtons Manches Cooper has a specialist practice dedicated to investigating pelvic mesh claims. If you believe you may have a claim following mesh surgery, please contact us for a free, no obligation discussion with one of our lawyers.

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