ORIGINAL ARTICLE

ANZJSurg.com

Is inguinal hernia mesh safe? A prospective study

Bridget Watson ,* Jessica Roberts,† Bruce Dobbs‡ and Ross Roberts‡

*Department of Surgery, Wellington Regional Hospital, Wellington, New Zealand
†Department of Plastic Surgery, Middlemore Hospital, Auckland, New Zealand and
‡Department of Surgery, Christchurch Hospital, Christchurch, New Zealand

Key words Abstract

hernia, inguinal, mesh, post-operative pain.
Correspondence
Dr Bridget Watson, Department of Surgery,
Wellington Regional Hospital, Private Bag 7902,
Wellington 6242, New Zealand. Email: watson.
bridget@gmail.com
B. Watson MBChB, BSc; J. Roberts; B. Dobbs
PhD; R. Roberts MBChB, FRACS.
Accepted for publication 20 September 2019.
doi: 10.1111/ans.15518
Background: Hernia repair surgery using synthetic mesh is the standard of care in modern
surgery. Complications from uro-gynaecological mesh have been reported in the
New Zealand media and there is public concern regarding the use of any mesh for any rea-
son. This study reports long-term outcomes in inguinal hernia surgery in a large cohort of
elective operations using mesh.
Methods: A prospective database of patients having inguinal hernia mesh repairs was
maintained in a private two surgeon practice from 2002 to 2016. Patient demographics,
method of repair, the pre-operative and post-operative pain scores and complications follow-
ing surgery were recorded.
Results: A total of 1711 hernia in 1366 patients were repaired from 2002 to 2016. One
thousand and forty-seven repairs were laparoscopic total extraperitoneal (LTEP), 333 were
open. Post-operative pain scores were significantly lower than pre-operative scores in ingui-
nal hernia repair by any method. Only 22% of patients described no pain pre-operatively
and this rose to 76% post-operatively; conversely 7.9% described severe pain pre-
operatively and this reduced to 1% post-operatively. The recurrence rate for open inguinal
hernia was zero and for LTEP repair was 0.81%.
Conclusion: Inguinal hernia repair using mesh does not appear to produce significant rates
of chronic pain long term. Overall, the complications from open or LTEP inguinal hernia
repair with mesh are low.

uro-gynaecological mesh and subsequently Medsafe8 in New Zealand

Introduction
Hernia repair is one of the most commonly performed operations in
general surgery.1 The use of mesh has been proven to reduce recur-
rence rates of inguinal hernia.2,3 A Cochrane review in 2012 by
Amato et al. concluded that non-mesh repair (Shouldice) of ingui-
nal hernias had a higher recurrence rate of 3.6% when compared to
mesh repair (Lichtenstein technique) rate of 0.6% recurrence at
1 year.3 Recurrence rates with other non-mesh repair techniques
were even higher.3 While some believe that non-mesh repairs avoid
the use of ‘foreign material’ it is important to note that all repairs
require the use of permanent materials – for instance the Shouldice
repair is undertaken using stainless steel wire or polypropylene.4
The adverse outcomes of surgical mesh particularly for col-
posuspension have been widely reported in the surgical literature and
in the media.5 In 2016, uro-gynaecologic mesh was reclassified by
the Food and Drug Administration as a high risk device that demands
a higher level of evaluation of new products.6 In 2017 Therapeutic
Goods Administration7 in Australia withdrew approval for the use of
followed suit in December 2017. In New Zealand this has caused
patients concern about the placement of mesh in any hernia repair.5
Our study prospectively records pre-operative pain scores and com-
pares these to the pain patients report at a year to 15 months post-sur-
gery. Complications of surgery have also been recorded.
With recurrence rates falling, chronic pain following hernia sur-
gery is now the most concerning post-operative complication.9,10
There has been a new focus in defining, assessing and identifying
risk factors relating to developing chronic pain.11 Chronic pain or
inguinodynia lasting longer than 3 months after inguinal hernia sur-
gery is an important problem for many patients.12
Some identified risk factors for post-operative pain include youn-
ger age,12 being female,13 recurrent hernia,14 operative complica-
tions14,15 and high levels of pain in the early post-operative
period.16 Salcedo-Wasick and Thirlby reported a case–control study
of injury versus gradual process inguinal hernia.16 The injury group
showed higher post-operative pain scores, with a mean 33.5 days
versus 12.5 days to return to work.16

© 2019 Royal Australasian College of Surgeons ANZ J Surg (2019)

2 Watson et al.

Persistent or chronic pain has been found in patients following a Results

number of surgeries including mastectomy where no material is
There were 1680 hernia repaired in 1366 patients from March 2002
implanted.17 The mechanisms that cause chronic pain following
to June 2016 who responded to the post-operative questionnaire. The
inguinal hernia repair are not fully understood. However, the
mean age was 57.6 years (range 14.5–98.9). Hernia were repaired in
hypothesized cause is injury or irritation of the three nerves that
1570 men and 110 women. The pre-operative pain score had been
enter the operative field.9 Pain severity appears to reduce over
completed by 532 of the 1366 patients within the study (31% of the
time.9
cohort) as this was only collected from 2013 onwards. The response
European Hernia Society guidelines report that mesh compared
rate in an audited 5-year period to the postoperative questionnaire
with non-mesh in inguinal hernia repairs has been related to lower
was 80%. Inguinal hernia repair by any method had a significantly
postoperative pain in two meta-analyses.2,3 The fixation technique
lower pain scores post-op, P-value = 0.0000, relative risk no pain
and mesh weight may influence pain postoperatively18–20 but some
post-op 10.61 (95% CI 8.42–13.37).
studies found no difference.15,21
Compared to the preoperative pain scores all the approaches had
There are proposed methods to prevent development of chronic
significantly improved pain levels (χ 2 P-value = 0.0002). For
pain such as neurectomy or operative approach to hernia
patients who had LTEP repair the χ 2 P-value = 0.0014 and for open
repair.9,15,22 Chronic pain rates following inguinal hernia repair are
hernia repairs the P-value = 0.0009, see Table 1. Patients who had
reported to range from 5% to 53%.11,23 Methods of assessing both
surgery converted from LTEP to open surgery appeared to have
pain levels postoperatively and the impact on the patient’s quality
more post-operative pain, but these were small numbers. Eighteen
of life are being developed but there is heterogeneity in the current
of 1329 hernias were converted from LTEP to open (1.3%). There
tools.13,23,24
was a significant trend to reduced post-operative pain scores with
increasing age (χ 2 P-value = 0.001), see Table 2. There was no sig-
Methods nificant difference by gender in overall pre-operative pain scores.
Post-operative pain scores were significantly lower in men and
This was a prospective observational study of outcomes following
women post-op, χ 2 P-value for men = 0.038 and women = 0.0027.
mesh repair of inguinal hernia. Two consultant surgeon’s patients
Severe pain was reported in a higher percentage of women (14.7%
treated from March 2002 to June 2016 were studied before and after
pre-operative + 2.7% post-operative) than men (7.4% pre-
hernia repair. Patients completed a standardized questionnaire record-
operative + 0.9% post-operative) but this was not statistically
ing their current level of pain (none, mild, moderate or severe). Post-
significant.
operative pain scores (from 2002) and pre-operative (from 2013)
Comparing the funding source for surgery (either by the ACC –
were analyzed using χ 2 test to detect changes in pain scores. Patients
traumatic hernia or non-ACC – spontaneous hernia) showed there
were routinely seen at 1 week post-operatively by their surgeon.
was a significant difference in the pre-operative pain scores by her-
Twelve months post-operatively, the same pain score questionnaire
nia funding (Table 3). Both the ACC and non-ACC pain scores
was posted to each patient along with question about any complica-
were significantly improved post-operatively. The post-operative
tions following their surgery as free text reply space. Examples were
scores comparing ACC to non-ACC hernia were not significantly
included to prompt patients ‘e.g. wound problems, seroma, bleeding,
different following LTEP χ 2 P-value = 0.063.
infection’. If they did not respond within 3 months a further ques-
Complications were analyzed from LTEP and open repair.
tionnaire was sent at 15 months post-operatively.
These were collated from prospective surgeon notes from ongo-
The database of patients and outcomes was prospectively
ing treatment and retrospective patient recall at 12–15 months
maintained by the clinic nurse in the practice. Data collected
post-operatively. For open repair 76 complications were recorded
included patient demographics, type of hernia (direct/indirect), uni-
(Table 4). The majority (74) of complications were Clavien-
lateral/bilateral, spontaneous or post-traumatic hernia, recurrent or
Dindo classification grade 1–2, for example oral antibiotics treat-
primary hernia repair, approach (LTEP/open) and mesh and fixation
ment of infection, aspiration of seroma or haematoma in the
product used. The data were analyzed using Statview and Excel
programs. The pain score analyses were grouped by approach
(open/LTEP), cause of hernia (Accidental Compensation Corpora-
tion (ACC) funded – that is traumatic versus non-ACC that is spon- Table 1 One year post-operative pain scores by repair approach
taneous), age and gender. Complication data were recorded from Pain post- Laparoscopic total Open (%) Converted
the surgical assessment or ongoing treatment and the patient report operatively extraperitoneal (%)
in the questionnaire at 12–15 months post-op. (LTEP) (%)
The operative approach was a modified Lichtenstein technique for None 1033 (77.7) 243 (69.2) 11 (61)
open inguinal hernia repair using polypropylene (Ultrapro; Ethicon, Mild 214 (16.1) 73 (20.8) 2 (11)
Somerville, NJ, USA) mesh secured with Prolene (Ethicon) sutures. Moderate 73 (5.5) 27 (7.7) 4 (22)
Severe 9 (0.7) 8 (2.3) 1 (5.6)
The three nerves were protected if identified but not explicitly Total 1329 333 18
searched for. Laparoscopic mesh inguinal hernia repair was under-
Change in pre-operative to post-operative pain scores by LTEP method
taken using a totally extraperitoneal approach using Parietex showed χ 2 P-value +0.0001, open 0.0014 and converted 0.009. Conversion
(Medtronic, Minneapolis, MN, USA) mesh and ProTack (Medtronic) rate from LTEP to open was 1.3% of hernia and appeared to have a higher
rate of severe pain but numbers were small.
or AbsorbaTack (Medtronic) securing devices.

© 2019 Royal Australasian College of Surgeons

Pain following hernia repair 3

Table 2 Postoperative pain scores following inguinal hernia repair by age

Post-operative pain (%) <40 years old 40–49 years old 50–59 years old 60–69 years old 70–79 years old >80 years old

None 69.1 68.2 74 79 82.1 89

Mild 21.3 22.4 18.2 14.2 14.4 9.6
Moderate 8.5 7.9 6.6 5.5 3.5 1.1
Severe 1.1 1.4 1.2 1.3 0 0

The 10-year age groups for post-operative pain showed a χ 2 P-value = 0.016.

Table 3 Accident Compensation Corporation (ACC) funded and non-ACC inguinal hernia repair pain scores

Pain All pre- All post- All pre-operative All post-operative Post-operative Post-operative
operative ACC (%) operative ACC (%) non-ACC (%) non-ACC (%) ACC LTEP (%) non-ACC LTEP (%)

None 17 (11.4) 380 (73.1) 105 (27.4) 896 (77.2) 323 (74.8) 710 (79.2)
Mild 38 (25.5) 92 (17.7) 133 (34.7) 195 (16.8) 72 (16.6) 142 (15.8)
Moderate 75 (50.3) 41 (7.9) 122 (31.9) 59 (5.1) 32 (7.4) 41 (4.6)
Severe 19 (12.8) 7 (1.3) 23 (6) 10 (0.9) 5 (1.2) 4 (0.4)
Total hernia 149 520 383 1160 432 897

Pre-operative ACC pain scores compared to pre-operative non-ACC hernia pain scores χ 2 P-value of +0.0017. Pre-operative ACC pain scores compared to
post-operative ACC pain scores χ 2 P-value of <0.0001. Post-operative ACC pain scores compared to post-operative non-ACC pain scores had χ 2 P-value 0.28. In
LTEP ACC to non-ACC post-operative pain scores χ 2 P-value = 0.063.

Table 4 Complications from open and LTEP inguinal hernia repair patient pain scores despite a perception that mesh placement is a
Number of hernia Percentage (%) common cause of significant postoperative pain.5 Incidents of
severe postoperative pain were detected in this cohort. The rates of
Open complications
severe chronic pain were lower than found in some other published
Haematoma 32 9.6
Seroma 17 5.1 series, Callesen found severe pain in 8% of patients at 1 year.25
Infection 12 3.6 However, similar to others,26 at 5 years Eklund et al. found 1.9%
Wound problem 15 4.5
in laparoscopic and 3.5% in open repairs.1 Notably, Bright et al.
Recurrence 0 0
Return to theatre 2 0.5 based on referral and outcomes in a chronic pain clinic,27 showed
Total hernia 333 similar results at 1 year. This may be due to a longer follow-up
LTEP complications
period in our study than some other publications.10,27
Haematoma 106 7.9
Seroma 45 3.3 This study used a simple questionnaire for the patient’s assessment
Infection 20 1.5 of their pain at 12–15 months post-operatively. This format is less
Wound problem 20 1.5
detailed than some pain questionnaires8 but the response rate of 80%
Recurrence 13 1
Return to theatre 2 0.2 suggests that a simple questionnaire captures more patients. Unlike
Total hernia 1337 hernia recurrence, post-operative pain scores tend to improve over
time.1,10,27 In keeping with other studies investigating post-operative
pain,9 we found that pain scores after 1 year were higher amongst
office in some cases. Two patients returned to theatre, one for younger patients and those undergoing open hernia repair. Traumatic
removal of infected mesh and one for evacuation of a hernia patients (ACC funded) had more pain pre-operatively but both
haematoma. No patients had recurrent hernia during the period of groups had significant improvement in post-operative pain scores.
the study. A potential weakness of this study is that the pre-operative pain
In the LTEP repair group there were 204 complications scores have been recorded in only 31% of the cohort. As this is an
recorded (Table 4). Eleven recurrent hernia developed in this ongoing prospective study, this proportion will rise over time. The
group (0.81%). Most of the complications were Clavien-Dindo close follow-up and management of early complications may also
grade 1–2. Two patients returned to theatre, one had an infected be outside of the limited resources of a public hospital.
mesh removed, the second had an operation elsewhere and the Some of the strengths of this study include the large size of the
details not captured. cohort, consistency of the surgical technique with postoperative
management focused on early detection and treatment of complica-
tions. Another strength is the prospectively captured pain scores
Discussion
which informs us that most patients with discomfort after surgery
Chronic or persistent pain following inguinal hernia mesh repair is also experienced pain before surgery. Many other studies rely on
one of the most concerning complications for patients and sur- patient recall of their preoperative pain. This is vulnerable to bias.
geons. This study confirms that surgery significantly improves Having dual methods (patient and surgeon) of collecting post-

© 2019 Royal Australasian College of Surgeons

4 Watson et al.
operative complications may also be more accurate in collecting
complications.
Conclusion
This prospective observational study supports the current evi-
dence28 that mesh hernia repair is not associated with an unaccept-
able level of severe chronic pain. Complication rates were low both
for open and laparoscopic surgery and in most instances not related
to the mesh itself. We have shown that pain scores generally
improve after 1 year following inguinal hernia repair. This study of
a New Zealand population confirms the safety and efficacy of mesh
use in hernia surgery.
Acknowledgements
We are grateful to Ms Debbie Osborn, RN and Ms Alexandra Gor-
don, FRACS for their assistance in preparing the data for this study
and reviewing the document.
Conflicts of interest
None declared.
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© 2019 Royal Australasian College of Surgeons