Tape or Mesh: Take-home messages

April 18, 2018

What can we learn from the NHS review of Surgery for Prolapse and Stress Urinary Incontinence using Tape or Mesh?

Carl Heneghan

NHS Digital published a retrospective review of surgery for prolapse and stress urinary incontinence using tape or mesh, on the 17th of April. The review included women who had surgical procedures for prolapse and stress urinary incontinence using mesh and or tape (tape is a form of mesh) between 2008/09 and 2016/17.

This is a seriously difficult report to understand so here we present a summary of the data and the take-home messages.

But before we start there are several limitations to this report that need to be taken account of. Results do not include procedures before the audit review period or those that occurred in hospitals outside England or in a private setting. Also reporting of the primary diagnosis is not mandatory in Hospital Episode Outpatient data, only 4.9% of attended appointments had a main diagnosis recorded. There is also no General Practice data that reflects the work and morbidity in primary care.

The number of years of follow up decreases in the more recent insertion years. The 2008/09 cohort has the longest follow-up, and therefore we considered the most robust averages with fewer fluctuations. We used this to inform the re-operation rate and outpatient appointment use for nine years of follow-up.   

(If you are using this data for a publication check the figures with the original report)

Take-home messages:

SUI Tape Mesh

After nine years of follow up, 39 (95% CI, 36 to 43) per 1000 women treated with SUI mesh tape required a  reoperation. This number continued to rise in the 10th year of follow-up. It is therefore likely that the cumulative number of re-operations will go on rising (the reoperation rate will likely persist over the life course of a woman with the implant and is currently around 2 to 3 per 1000 per year).

The total cohort of 100,516 women who had an SUI mesh tape procedure done required 993,035 outpatient appointments.  Each hospital outpatient appointment costs the NHS approximately £120 (not accounting for any additional procedures), We, therefore, estimate the cost to the NHS of these appointments to be £119,164,200. [1]

However, this is an underestimate if we wanted to take account of follow-up for all nine years for this cohort of women (in later years women had less follow-up). Table 1.3 shows that 220,618 outpatient appointments were required for the 13,990 women who had an SUI mesh tape procedure done in 2008/09, an average of 15.8 appointments were required per person over the nine years. This results in 1,588,153 appointments over nine years of follow-up for the 100,516 women, who had an SUI tape mesh done, at an estimated cost of £190,578,336 to the NHS.

The average number of appointments required per year for the 2008/09 cohort of women (n=13,990) ranged from 70 per 1000 for pain management clinics to 400 for other (not specified) clinic appointments (see Table 1.2). There was a trend for higher rates in later years for many specialities suggesting complications worsen over time.

Women with the mesh procedure required fewer appointments for colorectal, general surgery, gastroenterology, pain management and urology clinics than women with non-mesh procedures. There was no difference in rates for Gynaecology, Rehabilitation, Physiotherapy and Occupational Therapy or Trauma and Orthopaedics clinics. These comparisons, however, should be treated with caution, the numbers of non-mesh SUI treated women are small, and these are likely to be high-risk cases. Also, it is not clear if the so-called no mesh group received mesh or not. The code used to identify the non-mesh group was M52.1, a suprapubic sling operation. This operation normally includes mesh tape.

Prolapse Mesh

After nine years of follow up 17 (95% CI, (95% CI 13 to 22)  per 1000 treated with mesh for prolapse required reoperation. This rate increased in the 10th year of follow-up (rate 2.6 per 1000 insertions in year 10).

The total cohort of 27,016 women who had a mesh prolapse procedure required 276,957 outpatient appointments. The cost to the NHS is estimated to be £33,234,840. [2]

Table 2.3 shows that 51,933 outpatient appointments were required for the 3,073 women who had a prolapse mesh procedure done in 2008/09, an average of 16.9 per women treated.  Using this number would results in 456,564 outpatient appointments over nine years of follow up for the whole cohort of 27,016 women – estimated cost of £54,787,709 to the NHS.

The average number of outpatient appointments required per year ranged from approximately 70 per 1000 women for pain management to 410 for trauma and orthopaedics appointments. There is a trend for higher rates in later years for some specialities suggesting complications get worse over time.

Women with the mesh procedure for prolapse were significantly more likely to be seen in all types of outpatient clinics compared to those with non-mesh procedures. As an example, they were 56% more likely to be seen in gynaecology outpatients clinics (see 2.4).

Conclusion 

The costs to the NHS are considerable, despite the fact that the costs we have outlined underestimate the true costs to the NHS. Approximately 127,500 women were operated on over a nine-year period, and in the following nine years these women required about 1.35 million outpatient appointments that cost the NHS a minimum of £245 million.

The actual costs, however, to women are not revealed by this report. There is no primary care data (the resource use will be considerable, as every referral will generate pre and post-primary care activity); there is no information on the quality of life and no information on long-term morbidity. The report does, however, tell us that the long-term complications persist and likely worsen over time.

Carl Heneghan is Professor of EBM at the University of Oxford, Director of CEBM and Editor in Chief of BMJ EBM

Download the Appendix with the summary tables

 

  1. SUI (tape) mesh procedure 2008/09 to 2016/17

1.1 procedures

  • 100,516 patients had a reported tape insertion procedure for SUI.
  • In 2016/17 there were 7,245 patients who had an insertion a reduction of 48% from  2008/09 when 13,990 patients were recorded.

1.2 Treatment of Stress Urinary Incontinence (SUI) insertion activity By Year

Time Rates per 1000 Comments
 

Within 30 days

1.2 to 1.7 per 1000 patients
30 days to 1 year 7.3 to 10.2 per 1000 patients 2008/09 10.2

20015/16 7.3

9 years 39 (95% CI 36 to 43)  per 1000 over 9 years follow up* for those with insertion in 08/09 548/13,990 patients have had removal (see figure 4 page 16) and table 3

*Numbers are 567/13990: 41 (95% CI 37 to 44) per 1000  including the 19 procedures counted in 2017-18 (see excel sheet table 4)

Retrospective Review of Surgery for Vaginal Prolapse and Stress Urinary Incontinence using Tape or Mesh April 2008 to March 2017 – Data Tables [224.02KB]

Figure 4: Count of patients with insertion in the treatment of SUI indicating removal  30 days after the insertion date, by insertion procedure year and by year removal procedure activity (2008/09 to 2016/17)

(The number of removal years available decreases in the more recent insertion years, which accounts for the decrease in the slope)

1.3 Outpatient attendance: Appendix D Table A (page 36 of the NHS Digital published review)

Table 1.3.  The rate of outpatient attendances with mesh (tape)  Insertions for SUI done in the 2008/09 cohort   (n=13,990)

Treatment speciality Average nos of appts required every year per 1000 women with SUI insertion done in 2008-09 Total number of appts DONE over the 9 year period for 13,990 women (rate per person)
See Excel sheet 5B:
Colorectal, General Surgery

And Gastroenterology

230 28,496 (2.0)
Gynaecology 340 43,040 (3.1)
Pain management 70 – the trend for it to be higher in later years (90 per year) 8906 (0.64)
Rehabilitation, Physiotherapy and

Occupational Therapy

230 years (320 per year) 28,407 (2.0)
Trauma and Orthopaedics

 

380 – the trend for it to be higher in later years (440 per year) 47,426 (3.4)
Urology 110 14,473 (1.0)
Other 400  trend for it to be higher in later years (530 per year) 49,870 (3.6)
All 220,618 (15.8)

Outpatient attendances relating to Gynaecology and Urology the  1st appointment is excluded, when it occurred within 3 months of the insertion procedure, to allow for the routine post-operative appointment

1.4 Outpatient appointments comparison between the mesh and non-mesh group for women with SUI procedures done in 2008/09

(see table 5b and 5d in the excel sheet)

Treatment speciality outpatients numbers Total nos of appts  in  13990 women with SUI  mesh insertion done in 2008-09 (%) Total nos of appts  in 141 women with SUI non-mesh procedure  done in 2008-09 (%) Odds ratio for comparison number > 1 indicates a worse outcome for mesh group  (95% CI and p-value)
Colorectal, General Surgery

And Gastroenterology

28,496 (204%) 480 (340%) 0.60 (0.50 to 0.73, p <0.0001)
Gynaecology 43,040 (308%) 476 (338%) 0.91 (0.75 to 1.10, p =0.34) NS
Pain Management 8906 (64%) 225 (160%) 0.40 (032 to 0.49, p <0.0001)
Rehabilitation, Physiotherapy and

Occupational Therapy

28,407 (203%) 264 (187%) 1.08 (0.88 to 1.33, p =0.77) NS
Trauma and Orthopaedics

 

47,426 (339%) 493 (350%) 0.97 (0.80 to 1.17, p =0.74) NS
Urology 14,473 (104%) 598 (424%) 0.24 (0.20 to 0.29, p <0.0001)
Other 49,870 (357%) 576 (409%) 0.87 (0.73 to 1.05, p=0.15) NS
Total 220,618 (1577%) 3112 (2207%) 0.72 (0.60 to 0.85, p =0.0001)

 

  1. Prolapse mesh procedure 2008/09 to 2016/17

2.1 procedures

  • 27,016 patients had a reported mesh insertion procedure for prolapse.
  • In 2016/17 there were 2,680 patients who had mesh prolapse procedure, a reduction of 13% 2008/09 when 3,073 patients were done.

2.2 Treatment of Prolapse insertion activity By Year

Within 30 days 3 reported readmissions
30 days to 1 year 1.8 to 3.9 patients per 1000 2008/09 3.9

20015/16 1.8

> 1 year 0.7 to 1.3 patients per 1000
9 years 17 (95% CI 13 to 22)  per 1000 over 9 years follow* up for those with insertion in 08/09 53/3,073 patients have had removal (see figure 9 page 24) and table 8

*Numbers are 61/3,073: 20 (95% CI 16 to 26) per 1000 including the 8 (rate 2.6 per 1000 insertions in year 10) additional removal procedures counted in 2017-18 (see excel sheet table 4)

  • Trauma and Orthopaedics outpatient attendances in the year after the procedure in 2009/10 were 380 outpatient attendances for every 1000 patients. By 2016/17 this had increased to 460 attendances for every 1000 patients.

2.3 Outpatient attendances with PROLAPSE: Appendix D Table C (page 36 of the NHS Digital published review)

Table 2.3.  The rate of outpatient attendances with mesh (tape)  Insertions for prolapse  done in the 2008/09 cohort   (n =3,73)

Treatment speciality Average nos of appts required every year per 1000 women with prolapse  insertion done in 2008-09 Excel sheet 5a: Total nos of appts over the 9 year period done for 3,073 women (rate per person)
Colorectal, General Surgery

And Gastroenterology

270  7,569 (2.5)
Gynaecology 410 11,340 (3.7)
Pain management 70 1,867 (0.61)
Rehabilitation, Physiotherapy and

Occupational Therapy

240 – the trend for it to be higher in later years (280 per year)

 

6,645 (2.2)
Trauma and Orthopaedics

 

410  trend for it to be higher in later years (460 per year) 11,336 (3.7)
Urology 80 2,189 (0.71)
Other 400 trend for it to be higher in later years (500 per year) 10.987 (3.6)
All 51933 (16.9)


See Appendix D: Outpatient attendance Table C (page 38 of the NHS Digital published review)

Outpatient attendances relating to Gynaecology and Urology 1st appointment is excluded, when it occurred within 3 months of the insertion procedure, to allow for the routine post-operative appointment

In many subsequent years average outpatient attendance was higher (e.g., 790 per 1000 for gynaecology outpatient attendance in 2016-17 for the 2015/16 insertion group

2.4 Outpatient appointments comparison between the mesh and non-mesh group for women with prolapse procedures done in 2008/09 n =3,073

(see  table 5a and 5c in the excel sheet)

Treatment speciality outpatients numbers Total nos of appts  in 3,073 women with prolapse  mesh insertion done in 2008-09 (%) Total nos of appts  in 8,338 women with prolapse non-mesh insertion done in 2008-09 (%) Odds ratio f r comparison number > 1 indicates a worse outcome for mesh group  (95% CI and p-value)
Colorectal, General Surgery

And Gastroenterology

7,569      (246%) 16,320 (196%) 1.26 (1.20 to 1.32,  P<0.0001)
Gynaecology 11,340   (369%) 19,660   (236%) 1.56 (1.49 to 1.64 P<0.0001)
Pain management 1,867      (61%) 3,622      (43%) 1.40 (1.20 to 1.50, P<0.0001)
Rehabilitation, Physiotherapy and

Occupational Therapy

6,645      (216%) 14,896   (179%)

 

1.21 (1.15 to 1.27, P<0.0001)
Trauma and Orthopaedics

 

11,336   (369%) 25,001   (300%) 1.23 (1.17 to 1.29, p<0.0001)
Urology 2,189      (71%)  4,463     (54%) 1.33 (1.24 to 1.42, p<0.0001)
Other 10,987   (358%) 25,722   (309%) 1.16 (1.11 to 1.12, p <0.0001)
total 51,933 (1690%) 114,461 (1373%) 1.23 (1.18 to 1.29, P<0.0001)


Limitations 

  • Unable to determine from the recording of any procedure whether this has been the first such procedure for a patient or is the latest in a series of procedures
  • Rates of attendances for outpatient visits for the same Treatment Function Codes are also reported for similar age and gender in the wider general population for the year 2016/17
  • Reporting of the primary diagnosis is not mandatory in the HES outpatient’s dataset, the numbers of records with valid entries in these fields remain low in 2016/17 only 4.9% of attended appointments had a main diagnosis recorded
  • A patient assigned different procedure codes within the same hospital episode will appear only once, and is assigned their grouping according to the following hierarchy: mesh procedure for prolapse > tape procedure for SUI > non-mesh procedure for prolapse > non-tape procedure for SUI. However, the analysis may not identify when a single patient has multiple eligible index procedure codes between different hospital episodes. As such, a patient assigned different procedure codes in different episodes may appear as multiple different data points in the analysis.

Carl Heneghan is Professor of EBM at the University of Oxford, Director of CEBM and Editor in Chief of BMJ EBM

Competing interests

Carl has received expenses and fees for his media work including BBC Inside Health. He holds grant funding from the NIHR, the NIHR School of Primary Care Research, The Wellcome Trust and the WHO. He has also received income from the publication of a series of toolkit books published by Blackwells. CEBM jointly runs the EvidenceLive Conference with the BMJ and the Overdiagnosis Conference with some international partners which are based on a  non-profit model. He is a  member of the All Parliamentary group on Mesh. I’ve written reports for lawyer groups but not taken any money for this activity

[1] Guardian Patients missing their appointments cost the NHS £1bn last year

https://www.theguardian.com/society/2018/jan/02/patients-missing-their-appointments-cost-the-nhs-1bn-last-year

[2] Guardian Patients missing their appointments cost the NHS £1bn last year

https://www.theguardian.com/society/2018/jan/02/patients-missing-their-appointments-cost-the-nhs-1bn-last-year

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CEBM Centre Manager Responsible for maintaining the Centre's ability to respond to new initiatives. Facilitating the development and dissemination of research to improve clinical practice and patient care. Elevating the position of all EBM and EBHC learning related activities globally. Follow CEBM on twitter @CebmOxford and facebook cebm.oxford

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