Baseline measures for women with mesh complications accessing a pain service (as part of the London Complex Mesh Centre)

Abstract

Introduction

Pelvic mesh was first used for stress urinary incontinence in 1998 following which its usage rapidly expanded to include treatment of pelvic organ prolapse. Numerous complications relating to mesh insertion soon became apparent, culminating in the Independent Medicines and Medical Devices Safety: First Do No Harm Report published by Baroness Cumberlege in 2020. Following this report, the UCLH London Complex Mesh Centre funded by NHS England, was one of a small number of specialist centres set up for mesh-injured women. The Pelvic Pain service of the Pain Management Centre at UCLH provides a service for patients attending the London Complex Mesh Centre. The aim of our study was to distinguish the differing needs of mesh-injured women from those with chronic pelvic pain by comparing patient-reported outcome measures between these two cohorts.

Methods

Distribution of data was calculated using the D’Agostino–Pearson normality test. Mann–Whitney tests were used to ascertain statistical difference between the two cohorts. Ethnicity was compared between groups using Fisher’s exact test. Quantile regression models were used to assess whether differences in medians between groups remained after adjustment for age and ethnicity. Statistical significance was set at p < .05.

Results

Patients with mesh were significantly older than those with chronic pelvic pain and were more likely to be of white ethnicity. After adjustment for age and ethnicity, analysis revealed that bladder interference, sex interference and DAPOS A were significantly higher amongst mesh-injured women, whereas GP and hospital admissions were significantly lower.

Discussion

Our data shows the importance of mesh-injured women having access to pain management services with pathways of care integrated within women’s and mental health services. It is essential that these programmes include support to discuss ways of returning to sexual relationships and have models to address anxiety such as graded exposure and psychological input.

Keywords

Chronic pain pelvic pain pain management postoperative visceral pain

Introduction

Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are highly common conditions with a respective prevalence of up to 50% and 53%.^1,2 These conditions are burdensome at an individual and societal level with an estimated one in five women needing surgery for either SUI or POP by the age of 80.³ Tension-free vaginal mesh tape (TVT) made from the non-absorbable synthetic polymer polypropylene, was first used for SUI in 1998 as an alternative to colposuspension, the gold standard procedure performed at the time. Mesh procedures rapidly superseded colposuspension due to shorter procedure times, reduced costs and being less invasive.⁴ The use of mesh shortly became widespread and by 2001 the mesh transvaginal tape (TVT) was ‘the most performed operation for stress incontinence in the UK’.⁵ Following the use of mesh tape for SUI, mesh sheets were introduced in the treatment of female POP. Between 2008 and 2017, NHS England data has revealed that 100,516 patients had a mesh insertion procedure for SUI, and 27,016 patients had a mesh insertion procedure for POP.

As usage expanded, numerous complications relating to mesh insertion both immediate and delayed became apparent. These included localised complications such as recurrent infection, erosion, chronic pain, voiding dysfunction, fistulae and organ perforation as well as systemic complications such as fibromyalgia and autoimmune conditions are also considered to occur though more research for a causative effect is required.⁶ With exposure of these complications, the Food and Drug Administration (FDA) in the U.S ordered the immediate cessation of mesh being used for POP in 2019. In the UK, the use of mesh for SUI and POP is currently on ‘pause’ until recommendations regarding surgical training, informed consent and a dataset of mesh procedures are agreed.⁷

On the 8^th July 2020, the Independent Medicines and Medical Devices Safety: First Do No Harm Report was published by Baroness Cumberlege. This review was inspired by longstanding patient campaigns alleging harm, focusing on how healthcare systems respond when patients, their families and support groups raise concerns about the safety of treatments.⁸ Pelvic mesh was one of three major issues highlighted in this review, the other two being hormone pregnancy test, primodos, and anti-epileptic medication, sodium valproate. In relation to pelvic mesh, the Cumberlege report reviewed hundreds of testimonials from patients who reported a lack of informed consent for their surgeries. The review panel found that learning and patient safety were compromised by years of medical professionals and regulatory bodies disregarding patient’s debilitating symptoms, displaying dismissive attitudes and a culture of denial.⁹

There is a long history of complex urogynaecological surgery at University College London Hospital (UCLH) with mesh removal surgery and holistic treatments such as pain management and psychological support taking place for the past 15 years. Following the Cumberlege report, the UCLH London Complex Mesh Centre (LCMC) was one of a small number of specialist care centres for mesh-injured women set up with new direct funding from NHS England. The UCLH centre was launched on 1^st July 2021, primarily accepting tertiary referrals from London and the South East of England. As the largest abdominal pelvic pain service in the UK, UCLH has a large sample of chronic pelvic pain data. Patients with pelvic pain tend to have a lower quality of life than those with general chronic pain.¹⁰ Patients report issues with sitting tolerance, difficulty wearing tight clothing and many aspects of daily life including intimate relationships and toileting. The consequence can be the inability to stay active, loss of independence and loss of confidence leading to increasing disability, depression and psychological illness. In those living with pelvic pain, there are higher levels of depression, catastrophising and suicidal ideation (up to 23%).¹¹

The aim of our study was to compare patient-reported outcome measures (PROMs) in mesh-injured women to a comparable group, women with chronic pelvic pain. Such an analysis has enabled us to consider what extra needs mesh-injured patients may require over our non-mesh pelvic pain patients.

Materials and methods

Study design

This was a retrospective comparative study conducted in a single tertiary-care centre. We compared patient-reported outcome measures (PROMs) in mesh-injured women to the same measures in women with non–mesh-related chronic pelvic pain presenting to the UCLH Pain Management Centre in the United Kingdom.

Setting

UCLH is a 665 bed tertiary centre in London, UK. Last year 211 patients were seen in the specialist mesh pathway and 376 in the abdominal pelvic pain pathway.

Participants

We included all female patients over the age of 18 years old who attended the abdominal pelvic pain clinic and the specialist mesh service. We excluded all patients who had incomplete questionnaires from both cohorts. Females with abdominal pathology were excluded from the abdominal pelvic pain data set to leave only chronic pelvic pain patients.

Data collection

Since 2013, PROMs have been collected in patients attending the specialist chronic abdominal pelvic pain service at the UCLH Pain Management Centre. Following the establishment of the UCLH LCMC in July 2021, the same PROMs were collected in mesh-injured women. PROMs were collected in the form of questionnaires which were sent to patients to complete prior to an initial consultation with a specialist nurse and physiotherapist. Data from both cohorts were collected prior to any direct contact with the pain team to ensure there was no effect on the PROM scores from contact. PROMs from the chronic pelvic pain cohort were collected by paper between July 2013 and March 2020 (n = 1256). PROMs for patients with implantable mesh were collected electronically and by paper between August 2021 and November 2022 (n = 156). Questionnaires received by both cohorts were identical aside from the omission of the EQ5D5L in the chronic pelvic pain cohort from 2013 to 2016. All patients signed consent forms permitting their anonymised data to be used for research purposes.

Patient-reported outcome measures

PROMS chosen were Bladder Interference with Life, Bowel Interference with Life, Pain Interference with Sex, EQ5D5L, Health Visual Analogue Scale (VAS), Patient Catastrophising Scale (PCS), Patient Self-Efficacy Questionnaire (PSEQ), Brief Pain Inventory Severity (BPI S), Brief Pain Inventory Interference (BPI I), DAPOS Depression(D), DAPOS Anxiety(A) and DAPOS Positive Outlook Score (PO), Number of Accident and Emergency Visits in 6 months, Number of Hospital Appointments in 6 months and Number of GP Appointments in 3 months. Following multi-disciplinary panel discussions between pain physicians, specialist nurses, psychologists and physiotherapists, outcomes were selected based on prior cross-validation studies and applicability. These were also in-line British Pain Society recommendations.^12–15

Statistical analysis

Analysis was performed by physicians at the UCLH Pain Management Centre. Data were analysed using statistical software GraphPad Prism (Version 9.4.1) and Stata version 17 (Statacorp Texas). The distribution of data was calculated using the D’Agostino–Pearson normality (omnibus K2) test which revealed that all data were non-parametric in distribution. As the data analysed were non-parametric and unpaired; Mann–Whitney tests were used to ascertain statistical difference between the two cohorts. Fisher’s exact test was used to compare ethnicity between groups. Quantile regression models were used to assess whether differences in medians between groups remained after adjustment for age and ethnicity. For A&E admissions, where around 70% of patients had no admissions, we used the 75th percentile rather than the median in the regression models. Statistical significance was set at p < .05 (Tables 1–3).

Table 1.

Baseline characteristics by group.

		Mesh N = 156	Chronic pelvic pain N = 1216	p value
Age, median [IQR]	Years	59 [52–67]	40 [32–53]	<.0001
Ethnicity, N (%)	White	146 (94.8%)	1004 (83.7%)	.005
	Asian	5 (3.3%)	86 (7.2%)
	Black	1 (0.7%)	53 (4.4%)
	Mixed	1 (0.7%)	35 (2.9%)
	Other	1 (0.7%)	22 (1.8%)

Patients with mesh were significantly older than those with chronic pelvic pain (59 years vs 40 years, p < .0001) and were more likely to be of white ethnicity (94.8% vs 83.7%, p = .005).

Table 2.

PROMs by group.

	Median [IQR]		p value (Mann–Whitney U test)
	Mesh N = 156	Chronic pelvic pain N = 1216	p value (Mann–Whitney U test)
Bladder interference	7 [5–9]	4 [1–8]	<.0001
Bowel interference	6 [3–8]	5 [0.3–8]	.003
Sex interference	10 [0–10]	8 [0–8]	<.0001
DAPOS A	8 [5–12]	7 [4–11]	.001
DAPOS D	13 [8–18]	12 [8–17]	.50
DAPOS PO	9 [7–11]	9 [7–11]	.82
EQ5D5L	0.43 [0.10–0.65]	0.39 [0.10–0.64]	.48
Health VAS	45 [30–65]	50 [30–60]	.55
PCS	28 [18.3–41]	30 [20–40]	.56
PSEQ	22 [10–36]	19 [10–30]	.08
BPI S	24 [18–29]	24 [18–29]	.87
BPI I	6.28 [3.81–8.08]	6.11 [4–7.67]	.22
GP appointments in 3 months	0 [0–1.75]	2 [0–4]	<.0001
Hospital appointments	0 [0–2]	2 [1–4]	<.0001
A + E appointments	0 [0–0]	0 [0–1]	.002

Patients with mesh were found to have significantly greater bladder, bowel and sex interference, higher DAPOS A and significantly lower GP, hospital and A & E visits.

Table 3.

Quantile regression models for PROMS data.

	Unadjusted model		Age and ethnicity adjusted
	Coefficient (95% CI)	p value	Coefficient (95% CI)	p value
Bladder interference	−3 (−4.3, 1.7)	<.0001	−3 (−4.2, 1.8)	<.0001
Bowel interference	−1 (−1.9, −0.1)	.04	−1 (−2.5, 0.5)	.20
Sex interference	−2 (−2.9, −1.1)	<.0001	−2 (−3.0, −1.0)	<.0001
DAPOS A	−1 (−2.0, 0.0)	.05	−2 (−3.0, −0.9)	<.0001
DAPOS D	−1 (−3.3, 1.3)	.40	−1.9 (−3.8, 0.04)	.06
DAPOS PO	0 (−0.95, 0.95)	1.00	0 (−0.57, 0.57)	1.00
EQ5D5L	−0.03 (−0.12, 0.06)	.57	−0.01 (−0.12, 0.09)	.81
Health VAS	5 (−4.0, 14.0)	.28	0 (−6.3, 6.3)	1.00
PCS	2 (−1.3, 5.3)	.24	0.2 (−3.4, 3.9)	.90
PSEQ	−3 (−5.9, −0.1)	.05	−1.4 (−4.8, 2.0)	.41
BPI S	0 (−1.9, 1.9)	1.00	0.8 (−1.3, 2.9)	.44
BPI I	−0.11 (−0.66, 0.44)	.69	−0.70 (−1.29, −0.11)	.06
GP appointments in 3 months	2 (1.1, 2.9)	<.0001	2 (1.3, 2.7)	<.0001
Hospital appointments in 6 months	2 (1.5, 2.5)	<.0001	2 (1.6, 2.4)	<.0001
A + E appointments in 6 months^a	1 (0.47, 1.53)	<.001	0.1 (−0.7, 0.9)	.87

^a75^th quantile.

After adjustment for age and ethnicity, bladder interference, sex interference and DAPOS A remained significantly higher, GP and hospital admissions remained significantly lower, and bowel interference and A & E admissions were no longer significant.

Results

Characteristics of study participants

The study population consisted of 1256 patients in the chronic pelvic pain cohort, collected between July 2013 and March 2020, and 156 patients in the mesh-injured women cohort, collected between August 2021 and November 2022. The chronic pelvic pain cohort had a reduced number of patients (n = 542) when looking at the EQ5D5L, as this PROM was collected from 2017 to 2020. There was a reduced number of patients in the ‘sex interference with life’ PROM (n = 123 for mesh-injured women, n = 1080 for chronic pelvic pain patients) as this question was not applicable to all participants. The mean age of participants in the mesh-injured cohort was 59.6 years, with the mean age of participants in the chronic pelvic pain cohort being 42.7 years (Figure 1).

Discussion

Pelvic mesh was inserted between 1998 and 2018 for prolapse and incontinence.⁴ Significant concerns were raised around safety and potential complications which cumulated in the Cumberlege report and the setting up of a number of specialist centres for those living with the complications of mesh insertion. The Pelvic Pain service of the Pain Management Centre at UCLH provides a service for those patients attending the LCMC. As a part of providing care, we sought to distinguish the differing needs of mesh-injured women from those we care for with chronic pelvic pain due to other causes. This paper looks at statistical difference in PROMs between the two cohorts.

In our data, mesh-injured women were found to be significantly older and had a significantly higher proportion of patients of white ethnicity. All results were adjusted for age and ethnicity to account for baseline characteristics as a potential source of bias. We found that BPI S&I in the mesh-injured cohort were equivalent to the general pelvic pain group. We did not subdivide by type of mesh and as a consequence possible mechanisms include nerve damage from the surgical approach. The focus of this paper is on associated symptoms that we see in the pain clinic and the importance of collaborative work. Delays in diagnosis, the disregard and dismissive approach as commented on in the Baroness Cumberlege report will also potentially contribute to pain mechanisms and the issues we face.

Sexual dysfunction

Verit et al. reported that females with chronic pelvic pain have significantly higher rates of sexual dysfunction (68%) than those without (32%). They also found that 74% of women with chronic pelvic pain suffering from sexual dysfunction had a sexual pain disorder.¹⁰When considering this data against our own, our analysis indicates extremely high levels of pain interference with sex in mesh-injured women in comparison to the chronic pelvic pain cohort (p < .0001).

In our study, the PROM, Pain Interference with Sex, rated on a scale (0–10), was used as a marker of sexual function. It is clear from our data that patients are less able to grade sexual dysfunction, more often scoring it as a 10 (completely interferes). It is postulated that mesh-related complications such as erosion, scar tissue formation, nerve entrapment and mesh contraction may be exacerbated by movement and pressure during sexual intercourse leading to significant dyspareunia.¹¹ These physical complications effect the neurological, vascular and endocrine systems which may also have an impact on sexual function.¹⁶

Sexual arousal is associated with increased sensory perception from the genital area (as well as other body parts) and through the process of central sensitisation which may also contribute to pain associated with sex. This pain, in combination with issues surrounding body image and confidence, become a huge barrier for even considering intimacy and disrupts a key and valued area of life. As a result, many patients report that they have given up on sexual activity. Dyspareunia is associated with a range of negative emotions for both patients and their partners, including fear of sexual activity, loss of sexual intimacy and stress within relationships.

As a retrospective analysis, we were able to determine association but not causality between mesh insertion and pain interference with sex. Verbeek et al. report that up to 83% of women suffering with pelvic floor disorders, the most common being SUI, POP and faecal incontinence, may experience sexual dysfunction. Research should also look at whether significantly higher levels of pain interference with sex in the mesh cohort are solely a product of mesh insertion or if they are also influenced by the underlying disease process.

From a pain management perspective, specific support around intimacy is important and this appears to be especially true for mesh-injured patients. In the past, our team has reported on persistent pain and sexual relationships and designed a holistic model (ReConnect) to ensure patients are supported with intimacy issues.¹⁷

Anxiety

Research studying mesh-related outcomes has predominantly been quantitative, focusing on the physical complications of mesh, however, more recently, qualitative studies have also addressed themes such as anxiety and mental health. Dunn et al. explored the experiences of 84 women presenting to a urogynaecology clinic for mesh-related complications. The initial dismissal of mesh-related complications by the medical profession was cited as a major trigger for anxiety. This was compounded by decreasing confidence in bodily functions such as voiding, contributing to psychological distress and social isolation. Women indicated hopelessness due to the uncertainty of future surgeries, coupled with the prospect of living with unbearable pain for the rest of their lives. Common themes of spoiled identity, degraded self-esteem and a lost sense of femininity were also identified.^18,19

We used DAPOS A as an assessment tool for anxiety, and our analysis revealed that mesh-injured women were significantly more anxious than other women with chronic pelvic pain (p < .0001). When considering the significant difference in anxiety levels between the two cohorts, the differing timeframes in which data were collected may present a source of bias. It was in March 2020, when the UK announced their first nationwide lockdown due to the COVID-19 pandemic that chronic pelvic pain patient data collection ceased. However, data in the mesh-injured women cohort were collected from August 2021 onwards. The pandemic was shown to negatively affect mental health and well-being through social isolation, unemployment, illness and grief.²⁰ The WHO reported the COVID-19 pandemic triggered a 25% increase in anxiety and depression worldwide.²¹

Whilst we can speculate as to why those living with mesh have a greater tendency towards anxiety than other pelvic pain patients, acknowledging the psychological impact of living with mesh complications is important. Helping patients develop self-management strategies to recognise and cope with the impact are key components of a pelvic pain management programme. For certain issues, the support of mesh-specific psychological support working with non–pain-related mental health will also be essential. Recognising these women have experienced repeated traumatic encounters throughout their health care journey is important when addressing their anxiety. By considering ‘trauma informed care’ as a framework, we can help support mesh-injured women, creating physical and emotional safety to avoid re-traumatising.²²

Bladder and bowel dysfunction

The PROMs, Bladder Interference with Life and Bowel Interference with Life were used to assess continence. It is well established that pelvic pain is frequently associated with bladder dysfunction. In mesh patients, the situation is more complicated because the insertion of the mesh was often for bladder and voiding related issues. Our data clearly demonstrates that bladder dysfunction is an issue for this group of patients. As a consequence, there needs to be a strong link between urology/urogynae services and pain management services for best assessment and care pathways. Bowel issues appear less common, though when present, can be equally distressing. This lower incidence may reflect that the mesh in our cohort of patients was primarily for bladder-related issues.

Healthcare utilisation

Mesh-injured women were found to have had significantly less GP appointments in 3 months (p < .0001) and hospital appointments in 6 months (p < .0001). A plausible rationale for our findings includes mesh-injured women being less likely to seek help for fear of not being listened to after years of having their concerns dismissed and being gaslighted by healthcare professionals.²³ The COVID-19 pandemic may also be responsible for the disparity in healthcare utilisation found between the two cohorts. Moynihan et al. conducted a systematic review of 81 studies across 20 countries, reporting a median reduction of 37% overall in healthcare utilisation when comparing pre-pandemic and pandemic data. There is also the possibility of mesh-injured women simply having a lower burden of disease thus requiring less healthcare utilisation than women with chronic pelvic pain however when reviewing both quantitative and qualitative studies this appears less likely.^24,25 Irrespective of the reason for our findings which may be multi-factorial, it is important to empower these women to obtain the help they need and once again this should be a key component in any pelvic pain management programme.

Conclusion

Our data clearly shows the importance that those living with the complications of mesh have access to pain management service with pathways of care integrated within women’s health services and mental health. These specialised programmes provide a space for women to develop self-management strategies to manage pain as well as gain access to pain medication and other medical interventions. We provide specialised specific group pain management programmes for female abdominal and pelvic pain as part of the multi-disciplinary approach. It is essential that these programmes include support to discuss ways of returning to sexual relationships and have models to address anxiety such as graded exposure and psychological input.

Footnotes

Author contributions

AT performed statistical analysis and wrote the first draft. KP, JC, APB, MT and VT further developed the manuscript. All authors critically appraised and commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iD

Anish Thillainathan

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