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Indications forPure Tissue Repairs
A.Koch, R.Bendavid, J.Morrisson, C.Hill,
K.Petersen, andV.Iakovlev
21
21.1 Broad Aperçu
oftheScientic Literature
“I tore myself away from the safe comfort of certainties through my love for truth—and truth
rewarded me”. Simone de Beauvoir.
As a disciple of Jean-Paul Sartre, Simone de
Beauvoir in her existentialist philosophy sends
her own powerful message in her autobiography
“All Said and Done” [1]. She stood as a frail beacon of truth and integrity. Would that our surgeon-scientists emulate her!
John Ioannidis, professor of Medicine and of
Health Research and Policy at Stanford
University, stated that: “There is increasing concern that in modern research, false ndings are
the majority or even the vast majority of published research claims” [2]!
No less emphatic in his criticism, Barbour
who is aware and attuned to a similar drumbeat
declares that: “Journals may increasingly become
close to works of ction, telling stories dictated
by lobbyists, rather than Works of Science” [3].
G.R. Steen, to limit these disquieting ethical
references, buttresses our concerns by raising
doubts about the integrity of modern authors. He
authenticates a sobering if somber thought …
that: “In 2010, it was revealed that the United
States leads the world in retracted Journal articles
A. Koch · R. Bendavid (*) · J. Morrisson · C. Hill
K. Petersen · V. Iakovlev
Tel Aviv University, Tel Aviv, Israel
and its scientists were cited as the most prone to
engage in deliberate fraud” [4]. In short, readers
beware!
21.2 Statistical Relevance
The commonest statements or implications nowadays in all submissions and publications which
feature groin hernias are the following: “… mesh
has reduced the incidence of recurrence in hernia
surgery” and “mesh repairs are the Gold
Standard” [5, 6]!
Another notion which seems to permeate the
extant references on hernias is that polypropylene
mesh has been used since the mid-1950s when
introduced by Francis Usher, suggesting that polypropylene has been used for the last 60years with
satisfactory results, free from any signicant complications. Nothing is further from the truth [7].
In fact frequent use of polypropylene meshes
did not spread until the early 1990s when the rst
gadget was introduced [8], after which the attitude seemed to be that if mesh is good in complicated cases then it must be good for all cases,
hence the panoply of ready-made gadgets such as
plugs, PHS, precut patches, and countless varieties of mesh.
Another document from the website of
HerniaSurge [herniasurge.com] sponsored by
Bard, Ethicon, and Medtronic attempts to disseminate a “guideline” on adult hernias, recommending
that all groin hernias in all adults be done with
© Springer International Publishing AG, part of Springer Nature 2018
G. Campanelli (ed.), The Art of Hernia Surgery, https://doi.org/10.1007/978-3-319-72626-7_21
199
200
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A. Koch et al.
mesh, while all women must be done with mesh
laparoscopically, a conclusion which is far and
away not in keeping with the experience of the
average general surgeon, nor do they agree with
the reports and statistics from the Shouldice
Hospital (presented herein) which agree most
closely with the recommendations of Herniamed,
the data base of the German Hernia Society. Both
data base, Shouldice and Herniamed, have nearly
400,000 patients each. HerniaSurge by the EHS
on the other hand has no data base but relies on
looking for “level 1” evidence within randomized
controlled trials and meta-analyses in publications
deemed worthy of consideration. RCTs are not
without criticisms as they should be planned by a
methodologist beforehand, not after as one seeks
in meta-analysis. On the other hand, a data base
allows a more accurate propensity score matching
and random registry trials in assessing outcomes.
21.3 Pure Tissue Repairs
The era of successful hernia repairs began with
Bassini in 1887 [9]. Since then, there have been
numerous imitations and modications. Alfred
Iason in his colossal historical review had already
reported 46 inguinal and 80 femoral variations of
the two Bassini operations “Bassini devised two
operations one for inguinal, the other for femoral
hernias” [10]! Of all the repairs, not one divided
the posterior inguinal wall as Bassini described
except for the Shouldice repair. The McVay
repair, which appeared in 1948, does gain access
to the pre-peritoneal space, while individual
modications do not and, instead, do the procedure blindly which represents a dire risk for any
aberrant obturator artery should one be present.
In this failure to divide the posterior wall lies the
failure of all the modications of Bassini which
had always been poorly taught. The Shouldice
repair respected all the tenets of Bassini and
added a signicant improvement in the muscular
reconstruction of the internal ring by wrapping
the lateral stump of the cremasteric around the
spermatic cord at the internal ring; a second muscular layer to protect, reinforce, and secure the
primary “triple layer” of Bassini is added; a continuous suture to seal evenly the suture line is a
further improvement. Signicantly, the pre-peritoneal space is always entered to verify the presence or absence of femoral and prevesical hernias.
Figure21.1 illustrates the secret of the success in
pure tissue repair: access to the pre-peritoneal
Fig. 21.1 The
pre-peritoneal space,
once entered, offers the
possibility of all mesh
and non-mesh repairs,
for all groin hernias.
Copyright: Shouldice
Hospital
21 Indications forPure Tissue Repairs
201
space. A step which takes 15–20min under local
anaesthesia, following which, any conceivable
repair, with or without mesh, becomes feasible.
21.4 Indications forPure Tissue
Repair
In 2013, the Shouldice Hospital carried out 6665
hernia operations. Men accounted for 89.45%
and women for 10.55% of the patient population.
The majority of abdominal wall hernias are in the
groin, 5657 out of 6665 (84.8%).
Twenty years ago, the Shouldice repair for
groin hernia was considered the gold standard
against which new mesh repairs were measured.
The industry, abetted by many surgeons
swayed by the concept of tension-free repair, has
been successful in convincing the surgical world
that mesh is better and that pure tissue repairs
ought to be abandoned. The Shouldice surgeons
were not convinced. Yet, as any physiatrist will
know, lack of tension will lead to atrophy of the
skeletal muscle and alter the physiology of the
groin muscles. With mesh coverage, the posterior
wall becomes a permanent brosed plate. As a
result of aggressive sponsoring by the industry,
few publications have appeared in defense of pure
tissue repairs. However, two landmark, epiphanic
papers have appeared in December 2015 and
March 2016 which have subdued this broad,
industrial, marketing maneuver of mesh for all
and which have further conrmed the stance of
the defenders of pure tissue repairs, namely:
David Urbach’s paper reviewing 235,000 hernia
operations [11] and Lange and Meyer’s insightful
dissertation which highlighted the incidence and
severity of the new chronic post-herniorrhaphy
pain syndrome linked to mesh [12].
The paper by David Urbach detailed 235,192
patients, the world’s largest single study ever
undertaken through the data base of the Ontario
government, the sole payer of healthcare in
Ontario, Canada. The population of Ontario is
13.6million. The period surveyed was a 14-year
span from 1993 to 2007, thus providing an 8–24year postop follow-up. All patients were between
18 and 90years of age. All patients had a primary
groin hernia. The Shouldice Hospital performed
65,127 operations (27.7% of all operations in
Ontario). All other hospitals in Ontario managed
170,065 patients (72.3%).
An advantage of a government data base is
that patients who may have a recurrence but consult a different surgeon would be recorded and
the recurrence assigned to the former surgeon!
The recurrence rates in Ontario hospitals were
5.21% (95% condence interval [CI] 4.94–
5.49%) in the lowest-volume general hospitals
and 4.79% (95% CI 4.54–5.04%) in highest-volume general hospitals.
In contrast, the Shouldice Hospital had a
1.15% (95% CI 1.05–1.25%) recurrence rate [11].
The David Urbach study did not approach the
Shouldice Hospital for participation nor to obtain
statistics on the types of hernias involved. Nor
did the Urbach team know whether we used mesh
or how often.
We identied within our data base the 65,127
Shouldice Hospital patients covered by the
Urbach study. Our numbers were larger, more
exactly 70,519 patients which included out-ofprovince and out-of-country patients. Our results
were as follows:
Considering men alone, mesh use was seen in
1.16%, men and women combined 1.36%, and
women alone 5.45%. Women present a different
clinical picture and they are dealt with separately
in the next section.
The results of the Shouldice Hospital recommend, except in cases of femoral hernias in men
and women, that all hernias be attempted with a
pure tissue repair rst, reserving mesh for recurrences, if the recurrence is not an indirect hernia
which was overlooked or missed!
Polypropylene meshes were introduced at
Shouldice Hospital in 1986, and by 1992, we had
published a set of statistics which reected the
need for mesh and constituted what would be
eventually called a “tailored approach” [13]. The
recommendations in the hands of the surgeons of
the Shouldice Hospital have not changed signicantly to reect the drive of the medical devices
industry to universalize mesh surgery! Table21.2
stands as a witness to that constancy! The only
difference being that femoral hernias are treated
202
A. Koch et al.
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more aggressively with mesh, but this still represents a small segment of the hernia population.
Compare Tables 21.1 and 21.2.
Because of the reliable results of the Shouldice
repair over the years, the low recurrence rate, and
the volume of surgery of each surgeon (600–1000
per year), we classied hernias as small, medium,
and large. We are adopting the simple EHS classication and will, in the near future, review any
correlation between size and recurrence within
the already low incidence of recurrences
(Table21.3).
Table 21.1 Results of the Shouldice repair by well-
known authors in the 1990s all with corresponding
follow-ups
Author# Cases% Follow-up
Shearburn
[56]
Volpe [
Wantz
58]
[
Myers
[
59]
Devlin
60]
[
Flament
[
61]
Wantz
62]
[
Shouldice
[
63]
Moran
64]
[
Berliner
[65]
550 100 13 0.2
57] 415 50 3 0.2
2087 – 5 0.3
953 100 18 0.7
350 – 6 0.8
134 – 6 0.9
3454 – 1–20 1.0
2748 – 35 1.46
121 – 6 2.0
591 – 2–5 2.7
Years
follow-up
Recurrence
(%)
21.5 Indications forPure Tissue
Repairs inWomen
We have reviewed a 5-year period of surgery on
female patients for the years 2008–2012, both
years inclusive. There were 894 patients who
responded out of 1430 patients, amounting to a
62.5% response rate.
This table can be examined and interpreted in
light of anyone’s curiosity. Salient features are
that indirect inguinal hernias amount to 65% of
all hernias in women and can be much higher in
some series and will seldom if ever require mesh,
especially when the absence of a femoral hernia
is established. The unfortunate 11 recurrences
within the indirect hernia group, when traced,
revealed that they were done by novice surgeons!
A seasoned surgeon would rarely miss an indirect
inguinal hernia. This is an area where our recommendations are totally at variance with the EHS’
guidelines and more in line with Herniamed, the
large and explicitly informative data base of the
German Hernia Society.
Direct hernias can also result in higher recurrence rate (9.4%) as do pure femoral hernias
Table 21.3 Incidence of use of mesh in various hernias
in 1992, compared to a more recent Table21.2 from 2016
Ventral hernia 154/729 2.00 (%)
Groin hernias 98/7085 1.30
Direct hernia 26/2890 0.90
Indirect hernia 4/4028 0.10
Femoral hernia 48/144 33.30
Inguinofemoral hernias 20/23 87
Table 21.2 Incidence of various hernias and mesh use at Shouldice Hospital in males (M) and females (F)
Sex Op type Mesh No mesh Grand total Mesh use (%)
F Femoral 130 257 387 33.59
Inguinal direct 22 289 311 7.07
Inguinal indirect 20 2587 2607 0.77
Inguinofemoral 9 5 14 64.29
F Total 181 3138 3319 5.45
M Femoral 215 146 361 59.56
Inguinal direct 355 24,868 25,223 1.41
Inguinal indirect 161 41,405 41,566 0.39
Inguinofemoral 46 4 50 92.00
M Total 777 66,423 67,200 1.16
Grand total 958 69,561 70,519 1.36
21 Indications forPure Tissue Repairs
Table 21.4 Summary of all hernias in 894 female patients
Research
survey results Totals
Pure Femoral 151 16.9% 84 8 9.5 67 2 2.9 10
Direct 55 6.2% 53 5 9.4 2 0 5
Indirect 578 64.7% 578 11 1.9 0 0 11
Direct &
Indirect
Direct &
Femoral
Indirect &
Femoral
Direct &
Indirect &
Femoral
InguinoFemoral
Other 25 2.8% 24 1 0
Apparent
incidence cf
recurrence
% of all
hernias
37 4.1% 37 2 5.4 0 0 2
8 0.9% 5 3 60 3 0 3
35 3.9% 24 1 4.3 11 1 9.1* 2
4 0.45% 3 3 33.3 1 1 100* 2
1 0.1% 0 1 0
894 808 31 86 4
Pure
tissue
Pure tissue
recurrences
% of
recurrence Mesh
3.80% 4.70%
Mesh
recurrences
% of
recurrence
203
Total
recurrences
(9.5%) when mesh is not resorted to. The combination of a direct and a femoral hernia would
appear, though numbers are too low (0.9%) for
accurate prediction, to be an absolute indication
for the use of mesh in the repair.
It would appear by extrapolation that if 20
more cases (for femoral, direct, or combination
thereof) had been performed, the total recurrence
rate would be 1.2%.
Even if one were to blindly use mesh for all
femoral, direct inguinal hernias, and combinations thereof, this use would cover a third of
female patients rather than the 100% suggested
by the EHS International guidelines (Table21.4).
21.6 Indications forPure Tissue
Repairs asAssessed at Arm’s
Length fromOutside
Shouldice Hospital:
AComparative Statistical
Study—The Contribution
ofHerniamed
The international guidelines and recommendations by the EHS-HerniaSurge Group (www.her-
niasurge.com) [14] call for a detailed and serious
critical analysis. They have strongly recommended the use of mesh-based hernia repairs in
every adult patient! HerniaSurge has concluded
that large numbers of patients and consistent
results convey a seal of approval to the available
ndings so that they may be translated as a sign
of usability and reliability in current practice. Is
there really evidence to support such strong recommendations as we dissect the scientic and
ethical aspects of these designated publication?
A publication in Annals of Surgery pointed out
that industry funding of surgical trials leads to
exaggerated positive reporting of outcomes [15].
The Cochrane review by Amato underlined that
the quality of the included studies assessed
according to the Jadad scale was low [16]. Are
the results truly valid to give such a weighty recommendation? The Shouldice technique which
was the standard procedure for many years, with
good results, should still remain the benchmark
by which every new technique is gauged.
The Jadad scale (out of three) or the expanded
version (out of ve) assigns a category to a study
depending on its rating. Four and ve points only
are deemed consistent with good quality. Only
the study by Miedema has four points and no difference existed between the Shouldice and mesh
204
A. Koch et al.
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repairs. There is also a lack of reports on funding.
Conict of interests should be included in the
evaluation of all available data.
In hernia surgery in particular, it was found
that not all COI are properly declared or recorded
[17] (Comparison of Conicts of Interest among
Published Hernia Researchers Self-Reported
with the Centers for Medicare and Medicaid
Services Open Payments Database. Oscar A
Olavarria, MD, Julie L Holihan, MD, Deepa
Cherla, MD, Cristina A Perez, MD, Lillian S
Kao, MD, MS, FACS, Tien C Ko, MD, FACS,
Mike K Liang, MD, FACS published in JACS,
Volume 224, No 5, May 2017. pp: 800–804).
The authors concluded that a COI can inuence the validity of the design, conduct, and
results of a study. Finally poorly designed studies
Table 21.5 Shows the studies which were included into the decision tree
Number
of
Year First author Groups
1998 McGilliguddy Lichtenstein vs.
2000 Leibl etal. TAPP vs.
2001 Tschudi etal. TAPP vs.
2002 Nordin etal. Lichtenstein vs.
2004 Miedema
etal.
2004 Köninger
etal.
2005 Arvidsson
etal.
2007 Butters etal. TAPP–
2007 Berndsen
etal.
2007 Van Veen
etal.
2008 Pokorny etal. TEP/TAPP/
There were about 3000 patients included in the randomized trials. Long-term follow-up (36months) of RCTs comparing Shouldice with different mesh techniques—analysis of the EHS guidelines [66]
Shouldice
Shouldice
Shouldice
Shouldice
Lichtenstein vs.
Shouldice
TAPP–
Lichtenstein vs.
Shouldice
TAPP vs.
Shouldice
Lichtenstein vs.
Shouldice
TAPP vs.
Shouldice
Lichtenstein vs.
Shouldice
Lichtenstein vs.
Shouldice
patients
708 60 476 (67%) 0.5 vs. 2.1 1.1 vs.
102 70 Probably 91 (89.2%) 2.1 vs. 4.7 0 vs. 0
127 60 107 (84%) 3.0 vs. 8.2 1.5 vs.
297 36 284 (96%) 0.7 vs. 4.7 5.6 vs.
101 85 50 (50%) 7.7 vs. 4.9 37.9 vs.
280 52 231 (83%) – 24.2 vs.
1.068 61 920 (86%) 6.6 vs. 6.7 –
280 52 231 (83%) 1.3 vs. 8.1 –
1.068 60 867 (81%) – 8.5 vs.
182 128 80 (44%) 1.4 vs. 12.5 –
272 36 249 (92%) 3.3 vs. 4.7 5.4 vs.
without disclosure of potential conicts of interests could not and should not form the basis for a
“strong recommendation” to use any particular
technique in every case.
The evaluation of these studies with respect to
their statistical power reveals an additional and
interesting fact that most of the studies do not
have the statistical power to discriminate between
evidence and happenstance! So the differences
were not evident (Tables 21.5, 21.6 and 21.7).
With this background, we did a multivariable
analysis of 50,153 primary inguinal hernias with
a complete 1-year follow-up in the German
Database Herniamed. For recurrences, individual
risk factors such as hernia localization (direct)
and BMI were more signicant than the technique of repair. The technique and the size of the
Follow-up
duration
(months,
mean)
Follow-up number
(percentage with
physical
examination)
Recurrence
(%)
Chronic
pain (%)
0.3
14.8
4.2
7.1
37.8
11.4
6.3
21 Indications forPure Tissue Repairs
205
Table 21.6 Jadad evaluation of relevant references
Author Year
Barth 1998 105 Not
Danielsson 1999 200 Not
Hetzer 1999 385 Not
Miedema 2004 146 Not
Zieren 1998 160 Not
Nordin 2002 300 Not
McGillicuddy 1998 672 Not
Butters 2007 186 Not
Table 21.7 Power analysis for the sample size needed so
that the differences can be considered signicant and
evident
1998 McGilliguddy 838 1817
2000 Leibl 191 –
2001 Tschudi 330 71
2002 Nordin 273 3856
2004 Miedema 1239 33
2004 Köninger – 195
2005 Arvidsson 976,466 –
2007 Butters etal. 162 –
2007 Berndsen etal. – 1733
2007 Van Veen etal. 88 –
2008 Poorny etal. 3195 10,881
Sample
size Funding Jadad
1
reported
2
reported
1
reported
4
reported
3
reported
3
reported
1
reported
3
reported
Sample size per group
Recurrence Chr. Pain
hernia were also factors inuencing the risk of
chronic pain (small hernias, young patients, and
mesh repairs being signicant) (Table21.8).
There is a signicant place for the Shouldice
repair in a tailored concept for inguinal hernia
repairs. In the available literature, there is no evidence to exclude the technique from a daily
application [18].
21.7 Chronic Post-Herniorrhaphy
Pain Syndrome: TheNewest
Indication forPure
Tissue Repair
A patient who develops groin pain any time after
mesh inguinal hernia surgery is most likely having pain caused by the mesh. Mesh elicits chronic
inammation to some degree in 100% of patients
[1]. This leads to chronic pain in 11–20% of
patients [12], while in 2–4% of patients, the pain
leads to “functional and socioeconomic disability” [19]. The hernia recurrence rate after mesh
inguinal hernia surgery is 1.1–5.1% [11].
A recurrence can cause pain but without an
obvious bulge to support the diagnosis; mesh
pain should remain at the top of the differential in
a patient with pain after hernia surgery with no
other clear cause for such pain.
Mesh pain can start in the recovery room or
decades after the implant surgery with no prior
hint of the pain to come [20]. Waiting can further
complicate the patient’s condition because it hardens the chronic pain state through a phenomenon
Table 21.8 Independent risk factors for outcomes and their correlations with p-values
Target p-valueType/surgery Hernia type ASA Age/elderly BMI Risk factors EHS class
Intraop complication * * * <0.001
Postop complication *** *** *** *** ** ** ** <0.001
Reoperation * *** *** * * <0.001
Recurrence * *** *** <0.001
Pain at rest *** *** *** *** <0.001
Pain on effort *** *** ** *** *** * <0.001
Requiring treatment *** ** *** *** * <0.001
From Herniamed
206
Three months
A. Koch et al.
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called central pain sensitization [21]. As we
acquire experience with this new clinical syndrome, we may learn to recognize clinical features which would lead us to remove an offending
mesh much sooner, perhaps even before the
3–6 months suggested by most authors to wait
before diagnosing the chronic nature of the pain
or perhaps still even consider explantation of an
offending mesh before the pain becomes established centrally making any treatment nearly
futile! (Tables 21.9 and 21.10).
Mesh pain affects patients of all ages. Although
mesh is not typically used on prepubescent
patients, it is being used on older children. Mesh
pain in an adolescent is particularly devastating.
Ages of patients at the time of mesh removal
ranged from 15 to 73 with a mean age of 45.
Conventional therapy for mesh pain does not
help all patients and rarely is a permanent solution.
Patients who nd some relief with medications
Table 21.9 Distribution in onset of pain
Delay in onset of pain Cases (%)
Immediately 51 50
One week 7 7
Two weeks 5 5
One month 3 3
Two months 6 6
Three months 5 5
Six months 6 6
One year 7 7
Three years 2 2
Five years 2 2
Six years 1 1
Eight years 3 3
Ten years 4 4
102
frequently do not tolerate the side effects and may
run the risk of addiction as pain becomes severe
and relief is nowhere in sight. It is not necessary
to try other treatments prior to mesh removal,
when one is convinced of the etiology of the pain.
Imaging studies are usually unremarkable in
mesh pain cases but may be useful for ruling out
other causes of groin pain such as hip joint disease or renal calculi. But these most often can be
ruled out clinically.
Mesh pain typically is centered where the mesh
is but frequently involves the testicle and may radiate down the thigh and leg and around to the back.
Patients may experience pain to touch, known as
allodynia. They may have widening of their pain
eld and experience pain on the contralateral side
due to central pain sensitization. Patient’s mesh
pain is typically aggravated by activity. Some
patients experience dysejaculation [7].
Mesh pain is classied as nociceptive versus
neuropathic. Neuropathic may be central neuropathic or peripheral neuropathic. Most patients
with mesh pain have mixed nociceptive and neuropathic pain.
The claim that peripheral neuropathic pain
may be effectively treated with retroperitoneal
neurolysis is yet to be conrmed on long-term
follow-up [22].
Pain may be assessed by a physician using the
visual analog pain score or asking about what
important activities the pain interferes with. A
patient who cannot work, cannot exercise, avoids
sex, cannot stand, and cannot drive a car is suffering a lot of pain. On the VAS score, seven and
greater is a lot of pain.
95%
48%
41%
Immediately
One week
Two weeks
Table 21.10 Linear
graph of onset of pain
over 20years
DELAY OF MESH PAIN ONSET
36%
34%
28%
23%
One month
Two months
Six months
18%
One year
11%
9%
Three years
Five years
7%
Six years
7%
4%
Eight years
Ten years
21 Indications forPure Tissue Repairs
207
A patient who has typical mesh pain, with no
other likely cause and whose pain is signicant,
is a good candidate for mesh removal. The
results are likely to be positive when relying on
these indications. In a series of 140 patients
from a single surgeon’s follow-up (KP), the
results with an average follow up of 2.5years
were the pain was cured in 27% of patients and
the pain was much better with a little residual
pain but not enough to affect quality of life or
interfere with activities in 43% of patients. That
is a 70% chance of a very positive result. Two
percent of patients said their pain was worse;
5% said their pain was a little better, enough
that they were glad they had their mesh
removed. So overall there is a 93% chance of a
positive result. The average pain score in these
patients’ preop was 8.5/10. The average VAS
score postop mesh removal was 2.5 (Tables
21.11 and 21.12).
Table 21.11 Follow-up at 2.5years
Pain improvement with
mesh removal Cases (%)
Cured 29 27
Much better 45 42
A little better 24 22
No change 5 5
A little worse 0
Much worse 2 2
107
Table 21.12 Associated symptoms in patients with
severe post-herniorrhaphy inguinodynia
Symptom or problem Affected Affected (%)
Fatigue 50 56
Tender scar 42 47
Insomnia 36 40
Constipation 30 34
Irritable bowel 26 29
Achy joints 24 27
Difculty passing urine 23 26
Neuropathy 22 25
Headache 21 24
Pruritus 19 21
Indigestion 17 19
Memory loss 16 18
Weight loss 15 17
21.8 Understanding
thePathology ofMesh-Body
Interactions
andIts Importance
inUnderstanding
andRetaining Pure
Tissue Repairs
On a histological level, mesh-body interactions
can be separated into three categories: nonspecic processes associated with the presence of
any foreign body, the specic processes seen
with porous meshes as large compartmentalized
objects, and changes in the mesh material itself:
21.8.1 Foreign Object
Despite progress in other elds of medicine,
implantable devices still act as foreign objects.
They do not become an integral part of the tissues. They cannot be remodeled or adapted by
the tissues as would normally occur with native
tissues. There are several phenomena generally
shared by all implantable devices:
Initial body response following implantation.
During the rst hours and days after implantation, the space surrounding an implant becomes
lled with blood and acute inammatory cells.
Then, the blood clot and the damaged tissues
become invaded by capillaries signifying the rst
step in the repair (healing) process—the formation of granulation tissue (Fig.21.2) [23].
Foreign body type inammation. The initial
inammatory response to surgical trauma is
gradually replaced by a foreign body-type (granulomatous) inammation. This type of inammation is composed mainly of macrophages
recruited to degrade the foreign object. The
degree of inammation is generally greater in
degradable materials shedding particles than in
nondegradable materials [24]. As the inammation is nonspecic, it damages the surrounding
tissues and stimulates brosis. When pronounced,
it also plays a role in the mechanisms of pain [25,
26]. In hernia mesh implants, a higher degree of
inammation was observed in meshes removed
due to pain [27]. In our experience, in cases of
208
Tissue repair
Repair of innervation
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A. Koch et al.
Foreign body inflammation
Implant encapsulation
Normal tissue
Implant
ImplantationHealing
Granulation tissue
filling surgical pocket
Normal tissue
Implant Implant
(re- and neo-innervation)
Small distal branches
severed at surgery
Implant
Re-innervation
Visible
larger nerve
Fibrous (scar)
capsule
Foreign body type
inflammation
Fig. 21.2 Healing and tissue reaction associated with
implantation of a foreign object. Spaces around the object
are initially lled with granulation tissue. As healing progresses, the granulation tissue matures into a scar while
disrupted nerve branches reinnervate their target tissues.
The object, if it cannot be resorbed by the macrophages of
mesh-related pain, there is a trend for the foreign
body-type inammation to stay at high levels
over the years, while meshes sampled during
revisions for hernia recurrence without pain tend
to show lower levels of the inammation.
Nevertheless, in all cases the inammation persists indenitely [28].
Fibrous (scar) encapsulation. The granulation
tissue laid down initially matures into scar tissue
within weeks after implantation. It needs to be
remembered that human soft tissues cannot
regenerate and are repaired by a nonspecic pro-
foreign body-type inammation, becomes surrounded
indenitely by the foreign body-type inammation and a
brous capsule. The inammation continues attempting to
degrade the object while the capsule isolates it from the
normal tissues
cess of lling the defects by collagen or scar tissue. The terms “scar” and “brosis” are used
interchangeably, but “brosis” is usually used for
repair of internal organs damaged by a chronic
inammation (cirrhosis, pulmonary brosis,
etc.), while “scar” is more appropriate for wound
repair [23]. Encapsulation of a foreign object is a
defense mechanism by the body for objects
which cannot be resorbed by the inammatory
cells (Fig.21.2).
Bacterial adhesion. Any surface of a foreign
body can shelter bacteria. The degree of bacterial
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