Vaginal mesh implants: Financial compensation

Approximate read time: 10 minutes

On 5 September 2024 the House of Lords is due to consider the following question for short debate: 

Baroness Cumberlege (Conservative) to ask His Majesty’s Government what progress they have made in ensuring that those who have suffered complications following vaginal mesh implants receive financial compensation. 

1. Vaginal mesh implants

Mesh implants have been used to support the repair of weakened or damaged tissue since the 1950s.^[1] The mesh used for these implants can be made from a variety of synthetic or biological materials. The most commonly used synthetic material for creating mesh implants is the plastic polypropylene.^[2]

Vaginal mesh implants (also referred to as pelvic mesh) have mainly been used to treat the following two conditions: 

• Pelvic organ prolapse (POP)—the protrusion of one or more pelvic organs such as the bladder, rectum, uterus, vaginal vault or bowel into the vagina.^[3] 

• Stress urinary incontinence (SUI)—the involuntary leakage of urine when the bladder is under pressure. For example, SUI can happen during exercise, coughing or laughing.^[4]

2. Medical complications

Concerns have been raised over the safety of vaginal mesh implants by individuals who have experienced complications following surgery and by groups representing patients.^[5] In some cases, women who have received implants have experienced serious and life-changing injuries. In 2024, the Patient Safety Commissioner estimated that at least 10,000 women in England have experienced harms resulting from vaginal mesh implants.^[6] The campaign organisation Sling the Mesh has argued this figure could be even higher, however, at around 40,000.^[7] 

Over the last 10 years such concerns have prompted several reviews both in the UK and internationally of the safety of these implants.^[8] For example, between 2014 and 2017, a working group established by the then Department of Health conducted a review, concluding more data needed to be collected in order to assess the number of patients affected.^[9] It also said there needed to be greater awareness amongst medical professionals of the problems faced by patients adversely affected by these implants.^[10] 

In February 2018, the then Secretary of State for Health and Social Care, Jeremy Hunt, commissioned an independent review of medicines and medical devices safety.^[11] This review, chaired by Baroness Cumberlege, considered the safety of medicines and medical devices including surgical mesh, taking evidence from witnesses including women who had experienced complications following vaginal mesh implant surgery.  

The Independent Medicines and Medical Devices Safety Review heard that some women with mesh implants had been suffering several adverse effects including: “severe and chronic pain, infections, reduced mobility, sexual difficulties, autoimmune issues and psychological strain”.^[12] In July 2018, prior to the publication of the review’s final report, it recommended on the basis of the evidence it had heard up to that point that there should be an immediate halt to the use of vaginal mesh implants as a treatment for SUI.^[13] It said this was necessary to protect women from the risk of “life-changing and life-threatening injuries”, arguing it had not seen evidence the benefits of mesh implants for treating SUI outweighed “the severity of human suffering” caused by complications.^[14] This recommendation was accepted by the Department of Health and Social Care and the NHS and government announced a pause on the use of vaginally inserted surgical mesh in July 2018.^[15]  

3. Calls for financial compensation

3.1 Independent Medicines and Medical Devices Safety Review final report (2020)

The final report of the Independent Medicines and Medical Devices Safety Review was published in July 2020. The review said those suffering the adverse effects of medical treatments, including vaginal mesh implants, found the health system to be “disjointed, siloed, unresponsive and defensive”.^[16] It made several recommendations, including the establishment of dedicated redress schemes for those affected by these medical interventions.^[17] It said these schemes should be established to “meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim”.^[18] The report also recommended the establishment of a redress agency to speed up the resolution of claims.^[19] 

The Conservative government published its response to this report in July 2021.^[20] It did not accept the recommendation to establish new redress schemes, including a dedicated scheme for those affected by complications following vaginal mesh implants. Instead, it said its priority was “to make medicines and devices safer”.^[21]  

The government also did not accept the recommendation to establish a redress agency. It said in its response:  

We do not believe that a redress agency would make products safer and support our commitment to patient safety. We also believe it is already possible for government and others to provide redress where this is considered necessary, the government therefore has no plans to establish an independent redress agency.^[22]  

3.2 Patient Safety Commissioner’s report (2024)

The Independent Medicines and Medical Devices Safety Review also recommended that the government should establish a Patient Safety Commissioner who would “champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety”.^[23] This recommendation was accepted by the Conservative government and Dr Henrietta Hughes was appointed as the first Patient Safety Commissioner in England in July 2022.^[24]   

In February 2024, Dr Hughes published ‘The Hughes Report: Options for redress for those harmed by valproate and pelvic mesh’. This report repeated the recommendation made by the Independent Medicines and Medical Devices Safety Review that the government should introduce a dedicated compensation scheme for those affected by vaginal mesh implants.^[25]  

On 7 May 2024 then Parliamentary Under Secretary of State at the Department of Health and Social Care Maria Caulfield wrote to the Patient Safety Commissioner.^[26] In this letter, she acknowledged the government had not yet published a response to her report. However, the minister said the government was considering how a redress scheme might be established. Specifically, she said the government would need to introduce primary legislation, and that the form this legislation would take was dependant on factors including the possible levels of redress offered and the types of harm that might qualify for compensation.   

On 15 May 2024, Ms Caulfield said in Parliament that the government aimed to respond to the Patient Safety Commissioner in full “in the coming weeks”.^[27] However, the Conservative government did not publish a full response to the Hughes Report prior to the dissolution of the 2019–24 parliament for the general election.   

4. Policy of the new Labour government

On 29 July 2024, Lord Kamall (Conservative) tabled a written question asking the government when it intended to publish a response to the Hughes Report and whether it intended to introduce a compensation scheme as recommended by the Patient Safety Commissioner.^[28] Parliamentary Under Secretary at the Department of Health and Social Care Baroness Merron responded on 2 August 2024, stating: “The government is carefully considering the valuable work done by the Hughes Report and will respond in due course”.^[29]  

5. Read more

• House of Commons Library, ‘The Independent Medicines and Medical Devices Safety Review’, 2 February 2022 

• House of Lords Library, ‘Women’s health outcomes: Is there a gender gap?’, 1 July 2021 

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Cover image by Deposit Photos.