1 23
Surgical EndoscopyAnd Other Interventional TechniquesOfficial Journal of the Society ofAmerican Gastrointestinal andEndoscopic Surgeons (SAGES) andEuropean Association for EndoscopicSurgery (EAES) ISSN 0930-2794 Surg EndoscDOI 10.1007/s00464-012-2156-0
Use of fibrin sealant (Tisseel/Tissucol) inhernia repair: a systematic review
René H. Fortelny, Alexander H. Petter-Puchner, Karl S. Glaser & Heinz Redl
1 23
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REVIEW
Use of fibrin sealant (Tisseel/Tissucol) in hernia repair:a systematic review
Rene H. Fortelny • Alexander H. Petter-Puchner •
Karl S. Glaser • Heinz Redl
Received: 2 August 2011 / Accepted: 15 December 2011
� Springer Science+Business Media, LLC 2012
Abstract
Background Abdominal wall and inguinal hernia repair
are the most frequently performed surgical procedures in
the United States and Europe. However, traditional meth-
ods of mesh fixation are associated with a number of
problems including substantial risks of recurrence and of
postoperative and chronic pain. The aim of this systematic
review is to summarize the clinical safety and efficacy of
Tisseel/Tissucol fibrin sealant for hernia mesh fixation.
Methods A PubMed title/abstract search was conducted
using the following terms: (fibrin glue OR fibrin sealant
OR Tisseel OR Tissucol) AND hernia repair. The bibli-
ographies of the publications identified in the search were
reviewed for additional references.
Results There were 36 Tisseel/Tissucol studies included
in this review involving 5,993 patients undergoing surgery
for hernia. In open repair of inguinal hernias, Tisseel
compared favorably with traditional methods of mesh fix-
ation, being associated with shorter operative times and
hospital stays and a lower incidence of chronic pain.
Similarly, after laparoscopic/endoscopic inguinal hernia
repair, Tisseel/Tissucol was associated with less use of
postoperative analgesics and less acute and chronic post-
operative pain than tissue-penetrating mesh-fixation meth-
ods. Other end points of concern to surgeons and patients
are the risks of inguinal hernia recurrence and of compli-
cations such as hematoma formation and intraoperative
bleeding. Comparative studies show that Tisseel/Tissucol
does not increase the risk of these outcomes and may, in
fact, decrease the risk compared with tissue-penetrating
fixation methods. When used in the repair of incisional
hernias, Tisseel/Tissucol significantly decreased both
postoperative morbidity and duration of hospital stay.
Conclusions Clinical evidence published to date supports
the use of Tisseel/Tissucol as an option for mesh fixation in
open and laparoscopic/endoscopic repair of inguinal and
incisional hernias. Guidelines of the International Endo-
hernia Society recommend fibrin sealant mesh fixation,
especially in inguinal hernia repair. Nonfixation is reserved
for selected cases.
Keywords Hernia � Repair � Tension-free �Fibrin sealant � Tisseel � Tissucol
Introduction
Abdominal wall hernias are common: more than 1 million
repair procedures are performed in the United States alone
each year [1]. The vast majority of hernias occur in the
inguinal region, and the high incidence of this condition
means that inguinal hernia repair is the most frequently
performed surgical procedure in the United States [1] and
in Europe [2].
Hernia repair may be carried out as a laparoscopic/
endoscopic or an open procedure [1, 3]. Originally con-
ducted as a tissue-based suture repair technique, open
repairs are now more commonly carried out as a tension-
free mesh-based method, such as the time-honored Lich-
tenstein technique [1]. Prosthetic mesh, which is usually
made of polypropylene [4] but may be made of Dacron or
Mersilene [1], has traditionally been secured using sutures,
R. H. Fortelny (&) � K. S. Glaser
Department of General, Visceral and Oncological Surgery,
Wilhelminenspital, Vienna, Austria
e-mail: [email protected]
A. H. Petter-Puchner � H. Redl
Ludwig Boltzmann Institute for Experimental and Clinical
Traumatology, Vienna, Austria
123
Surg Endosc
DOI 10.1007/s00464-012-2156-0
and Other Interventional Techniques
Author's personal copy
staples, or tacks. However, a study in which unfixated
mesh-based repair of inguinal hernias was associated with
less postoperative pain than tack-fixated mesh-based repair
[5] has led to the conclusion that inappropriate placement
of fixation devices may be a cause of the chronic postop-
erative pain that is described by many patients [1].
This might suggest that a technique that involves
unfixated placement of mesh is ideal. However, most sur-
geons feel that some form of fixation is necessary to pre-
vent displacement of the prosthesis and hernia recurrence
[1]. This is supported by preclinical work that showed
significantly more graft motion and lower tensile strength
in unfixated mesh repairs than in those that were fixed in
the preperitoneal space using staples [6]. These findings
leave surgeons with two goals that are difficult to reconcile:
achieve stable mesh fixation and minimize the use of
permanent fixators. These two goals potentially can be
achieved if fibrin sealant is used for mesh fixation in hernia
repair. One such product, Tisseel� (also marketed as
Tissucol�; Baxter Healthcare Corporation, Westlake Vil-
lage, CA, USA), has been widely used in this application.
Tisseel is a two-component fibrin sealant consisting of a
sealer protein solution (human fibrinogen and aprotinin)
and a thrombin solution (human thrombin and calcium
chloride) [7]. Tissucol is indicated in a variety of proce-
dures (refer to country-specific prescribing information) to
improve hemostasis, to seal or glue tissue, and to support
wound healing [8]. The rationale for the use of Tisseel/
Tissucol in hernia repair was established through in vitro
biomechanical and animal studies, beyond the scope of this
review, which demonstrated strong mechanical strength
and repair [6, 9–16], prevention of adhesion formation [17–
19], and improved [6, 18] or similar [13–15] tissue inte-
gration compared to traditional mesh fixation methods. The
purpose of our review is to elucidate the efficacy and safety
of Tisseel/Tissucol, a widely used adhesive in the field.
Methods
This systematic review uses clinical data to summarize the
efficacy and safety of Tisseel/Tissucol in hernia repair.
A PubMed title/abstract search was conducted using the
following terms: (fibrin glue OR fibrin sealant OR Tisseel
OR Tissucol) AND hernia repair.
The full text of each original article was obtained and
reviewed. The bibliographies of the publications were
reviewed for additional references. Studies were consid-
ered for inclusion if they assessed the use of Tisseel/
Tissucol in hernia repair surgery and reported surgical
outcomes. Data abstracted from individual studies, when
available, included type of study, number of patients
evaluated, type of surgical procedure, demographic
characteristics of the patient population, and surgical out-
come measures (e.g., operative times, postoperative pain,
complications, adverse events). Due to the great variance in
the quality of the reviewed studies [e.g., different levels of
evidence (Table 1 [20], Table 2)], a direct comparison
allowing statistic analysis was not feasible.
Results
Efficacy in clinical studies
The clinical studies identified by the search strategy are
summarized in Table 2. The end points used in these
clinical studies include incidence of recurrence, postoper-
ative pain, complication rate, duration of hospitalization,
time to return to work, and quality of life.
Inguinal hernias
Inguinal open surgical technique: comparative studies
In comparative studies of open repair of inguinal hernias,
Tisseel/Tissucol has compared favorably with more tradi-
tional methods of mesh fixation. For example, when
compared with nonabsorbable suture fixation, Tisseel/
Tissucol fixation alone was associated with significantly
shorter operative times [time reduced by 7 min for unilat-
eral hernias (p = 0.002) and by 16 min for bilateral hernias
(p = 0.0008)] and shorter hospital stays [1.8 days (Tisseel/
Tissucol) vs. 2.5 days (nonabsorbable suture); p \ 0.0001],
as well as a significantly lower incidence of chronic pain
Table 1 Levels of evidence according to the Oxford Centre for
Evidence-Based Medicine [20]
Level of
evidence
Description
1A Systematic review of RCTs (with consistent results
from individual studies)
1B RCTs (with narrow CI)
1C All or none studies (e.g., all patients died before
availability of treatment)
2A Systematic review of 2B studies (with consistent
results from individual studies)
2B Individual cohort studies (or RCT of poorer quality),
retrospective cohort studies
2C Outcome studies (analyses of large registries,
population-based data, etc.)
3A Systematic review of case-control studies
3B Case-control studies
4 Case series (i.e., studies without a control group)
5 Expert opinion, animal or lab experiments
RC randomized control trial, CI confidence interval
Surg Endosc
123
Author's personal copy
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Surg Endosc
123
Author's personal copy
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Surg Endosc
123
Author's personal copy
[3.5% (Tisseel/Tissucol) vs. 22.8% (nonabsorbable suture);
p = 0.042] [21]. In this study, the incidence of hematoma
formation was numerically lower in the Tisseel/Tissucol
group, but the difference did not reach statistical signifi-
cance. However, in a randomized trial involving 50
patients who were receiving anticoagulant therapy or who
had a coagulopathy as a consequence of liver disease, the
use of Tisseel/Tissucol significantly reduced the incidence
of postoperative hemorrhagic complications (4% vs. 24%;
p = 0.049) versus controls who did not use Tisseel/
Tissucol [22]. Tisseel/Tissucol fixation was also associated
with less pain than polypropylene suture fixation in a
descriptive study involving patients with bilateral hernias
who acted as their own controls [23].
In a prospective, observational, nonrandomized study
comparing mesh fixation with Tisseel/Tissucol (n = 349)
versus sutures (n = 171), Tisseel/Tissucol again compared
favorably to sutures [24]. In this study, surgical time was
decreased with Tisseel/Tissucol versus sutures (55.6 vs.
51.2 min; p \ 0.001). In the early postoperative phase (from
discharge to 1 month postsurgery), Tisseel/Tissucol was
associated with a higher percentage of patients without
complications (87.4% vs. 76.6%; p = 0.001), lower inci-
dence rates of hematoma (1.7% vs. 8.2%; p = 0.001) and
ecchymosis (8.6% vs. 15.2%; p = 0.001), a lower visual
analog scale (VAS) pain intensity score (2.5 vs. 3.2;
p \ 0.001), and a lower incidence rate of numbness (12.3%
vs. 23.4%; p = 0.003) versus sutures. At 1 month after
surgery, fewer Tisseel/Tissucol-treated patients experienced
pain, numbness, or discomfort (all p \ 0.05), and Tisseel/
Tissucol-treated patients experienced less intense pain
(p = 0.001). At 3 months post surgery, numbness was less
frequent among the Tisseel/Tissucol group (p \ 0.001) [24].
The data from these trials demonstrate substantial ben-
efits of Tisseel/Tissucol fixation over tissue-penetrating
methods of fixation. However, these trials are limited by
their small size [22, 23], restricted inclusion criteria [22],
use of historical controls [21], or lack of randomization
[24]. More reliable data on the relative efficacy of Tisseel/
Tissucol versus suture fixation can be derived from large,
randomized trials. One of these trials, the Tisseel/Tissucol
for Mesh fixation in Lichtenstein hernia repair (TI.ME.LI)
study, was a large (N = 304), prospective, randomized,
blinded trial designed to evaluate the prevalence of post-
operative pain and other complications in patients under-
going primary repair of an inguinal hernia using the
Lichtenstein technique [25]. Publication of the results of
this important study is expected soon. An additional pro-
spective, randomized, blinded trial assessed 156 patients
with 167 inguinal hernias assigned to mesh plug fixation
with sutures (n = 59 hernias), Tisseel/Tissucol (n = 52),
or N-butyl-2-cyanoacrylate (n = 56) performed by a single
surgeon [26]. Tisseel/Tissucol was associated with a lower
rate of morbidity (9.6% vs. 39.0%; p \ 0.001) and a lower
incidence of postoperative pain, local numbness, and
hematoma (all p = 0.01) versus sutures. There were seven
long-term complications in the suture group and none in
the Tisseel/Tissucol group (p = 0.01). There were no sig-
nificant differences between the Tisseel/Tissucol group and
the N-butyl-2-cyanoacrylate group.
Inguinal open surgical technique: noncomparative studies
Noncomparative studies generally provide weaker evi-
dence of efficacy than controlled studies. However, such
studies have allowed surgeons to conclude that Tisseel/
Tissucol, in both the short and long term, is effective as a
means of fixating mesh during open repair of inguinal
hernias [27–30]. For example, when Tisseel/Tissucol was
used instead of sutures in a modification of the Lichtenstein
technique, it was not associated with any complications
during 12 months of follow-up in a series of 80 patients
[27]. Moreover, the surgeons rated Tisseel/Tissucol as easy
to use [mean score of 31 on a VAS (0 = easy and
100 = difficult)] and the technique as personally satisfying
[mean score of 84 on a VAS (0 = little personal satisfac-
tion and 100 = high personal satisfaction)] [27]. In a
prospective longitudinal study of 1,201 patients that
included 526 who underwent open repair of inguinal her-
nia, Tisseel/Tissucol was associated with a low rate of local
complications, low pain scores at 2 days and 1 month, and
a low mean VAS score of 1.6 for ease of use (0 = very
easy and 10 = very difficult) [28]. In a recent study of 233
patients, including 309 consecutive inguinal hernia repairs,
21 (6.8%) postoperative complications were reported [29].
Most complications were minor [e.g., testicular discom-
fort [ 1 month (n = 6), superficial wound infection
(n = 5)] and two major complications (both extraperito-
neal hematoma, 1 requiring surgery) were reported. One
patient reported chronic groin pain lasting longer than
2 months that was resolved at the 6-month follow-up visit.
Inguinal laparoscopic/endoscopic surgical technique:
comparative studies
A reduction in postoperative and chronic pain can also be
expected from Tisseel/Tissucol mesh fixation in laparo-
scopic/endoscopic inguinal hernia repair, e.g., when com-
pared with tissue-penetrating mesh fixation methods.
Tisseel fixation is associated with a significantly lower
need for postoperative analgesics [31], significantly less
pain in the week following surgery [32], and substantially
less pain at both the large (10 mm) trocar site and the
surgical site generally in the month following surgery [33,
34]. In the long term, use of Tisseel/Tissucol as a mesh
fixative has been associated with significantly less chronic
Surg Endosc
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pain than staple fixation in a number of studies [35, 36].
Examples include chronic inguinal pain prevalence of
13.2% (Tisseel/Tissucol) and 20.0% (staples) after a
median follow-up of 1.2 years (a finding that did not reach
statistical significance [31]) and of 4.7% (Tisseel/Tissucol)
and 20.7% (staples) more than 3 months after surgery
(p = 0.002) [35]. However, other analyses have shown that
Tisseel/Tissucol and tissue-penetrating methods of mesh
fixation are associated with similar levels of postoperative
[31] and chronic pain. Significantly shorter postoperative
recovery time was observed in patients who received mesh
fixation by fibrin sealant compared to staples, especially
with respect to the time to return to work [33, 37].
Other end points that are of obvious concern to both
surgeons and patients are the risks of hernia recurrence and
complications such as hematoma formation, intraoperative
bleeding, and incisional hernias. Comparative studies show
that the use of Tisseel/Tissucol does not increase the risk of
these outcomes and may, in fact, be associated with lower
risk than tissue-penetrating methods of fixation. The rates
of hernia recurrence in patients in whom Tisseel/Tissucol
fixed the prosthesis are similar to [33, 37] or numerically
lower (but not significantly) than [35, 36] those of patients
in whom staples or tacks are used. Moreover, a number of
studies have reported that the overall complication rate
associated with the use of Tisseel/Tissucol fixation is lower
than that observed in patients in whom tissue-penetrating
fixation methods have been used. For example, Schwab
et al. [35] observed complication rates of 1.2% (Tisseel/
Tissucol) and 3.5% (staples; p = 0.62), and Olmi et al.
[34] reported a postoperative morbidity rate of 2.2% in
patients whose surgery involved use of Tisseel/Tissucol, a
rate that was significantly lower than that observed in each
of three patient groups in which staple fixation was used
(range = 13.6–14.4%). Some studies have reported that
Tisseel/Tissucol fixation is associated with higher rates of
seroma formation than staple fixation [31, 36], although
this finding has been inconsistent [38]. Moreover, a recent
study that described the use of an angled-tip laparoscopic/
endoscopic spray system for application of Tisseel/Tissucol
reported substantial advantages in fibrin sealant handling,
with no seromas and no recurrences in 27 patients (33
hernias) after 1 year of follow-up [39]. It is likely that the
avoidance of drop formation and local accumulation by
spraying the sealant reduces the incidence of seroma for-
mation. Other advantages of this spray application are cost-
cutting effects in TAPP repair by reducing the required
volume of Tisseel/Tissucol [39]. The use of Tisseel/
Tissucol as a fixative has no consistent effect on operating
time; laparoscopic/endoscopic inguinal hernia studies have
shown that this end point increases [33, 37], decreases [34],
or remains unchanged [31, 38, 40] when compared with
suture or tack fixation.
Inguinal laparoscopic/endoscopic surgical technique:
noncomparative studies
Favorable results achieved in trials comparing Tisseel/
Tissucol fixation of mesh with tissue-penetrating fixation
are supported by the results of noncomparative studies.
Such studies have reported that Tisseel/Tissucol is associ-
ated with a low risk of complications and hernia recurrence
[28, 41–47] and that levels of postoperative and chronic
pain are also generally low [41, 43, 44, 47, 48]. Moreover,
studies that have incorporated use of a VAS to assess pain
have consistently shown that pain decreases markedly after
surgery when Tisseel/Tissucol is used as a mesh fixative
[28, 42, 45].
In addition to reductions in pain, the use of Tisseel/
Tissucol is also associated with improvements in quality of
life. A 52-patient study showed significant improvements
in the physical, emotional, social, and health components
of a validated quality-of-life questionnaire (p \ 0.0001)
[45], and an 11-patient study showed significantly
improved scores for the social function measure and for all
four physical health component measures (Physical Func-
tion, Role Physical, Bodily Pain, and General Health) of
the Short Form (SF)-36 quality-of-life questionnaire [42].
Hospitalization times are typically short after laparo-
scopic/endoscopic hernia repairs in which Tisseel/Tissucol
fixation of mesh has been employed, with patients gener-
ally being discharged within 24 hours of surgery [43, 45,
46]. Moreover, patients generally return to work quickly,
often within 5 days of hernia repair [43, 44]. However,
some studies have reported slightly longer times to return
to work (mean of 7 days [41] and B14 days [47, 48]), and
it should be noted that one large French study (n = 1,201)
reported an average sick leave duration of 25.2 days in
patients who had either laparoscopic/endoscopic or open
hernia repair surgery with Tisseel/Tissucol [28]. It remains
unclear, however, if these findings can be directly related to
Tisseel/Tissucol fixation.
Incisional hernias
A number of studies have investigated the efficacy of
Tisseel/Tissucol as a mesh fixative in patients undergoing
incisional hernia repair. These include a randomized pro-
spective study in which postoperative morbidity after open
repair was 20.0% in patients whose mesh was fixed with
sutures plus Tisseel/Tissucol and 46.6% in patients in
whom Tisseel/Tissucol was not used (p \ 0.01) [49].
Postoperative complications included abscessation/celluli-
tis, hematoma formation, and necessity for blood transfu-
sion, all of which occurred significantly more frequently in
the group that received suture fixation alone. The lower
complication rate in the Tisseel/Tissucol-treated patients
Surg Endosc
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may account for the significantly shorter average hospital
stay in this group [7.1 days (Tisseel/Tissucol) vs. 12.6 days
(suture fixation alone); p \ 0.01].
A recently published prospective, randomized compar-
ative study of laparoscopic/endoscopic umbilical hernia
repair (diameter = 1.5–5 cm) using Tisseel/Tissucol for
mesh fixation versus titanium tacks detected less acute
postoperative pain during rest (p = 0.025) and during
activity (p = 0.014), less discomfort, and a shorter con-
valescence (after median 7 vs. 18 days; p = 0.027) than
tack fixation in a follow-up of 1 month [50]. The 500-unit/
ml thrombin unit was replaced with a 4-unit/ml thrombin
formulation to extend the coagulation time. A uniform
layer of fibrin sealant was applied by a manual application
catheter. Two graspers were used for temporary fixation of
the mesh to the abdominal wall until polymerization of the
fibrin sealant was complete.
The use of Tisseel/Tissucol in incisional hernia repair
has also been reported in a number of noncomparative
studies [51–53]. In one such report, Tisseel/Tissucol was
used in 22 of 116 patients during open incisional hernia
repair to decrease the formation of seromas in patients in
whom extensive skin flaps had been created during surgery
[52]. The surgeons deemed that fibrin sealant, when indi-
cated, was an important factor in the success of their repair
technique. Another surgical team evaluated the use of
Tisseel/Tissucol for the nontraumatic fixation of mesh in
the laparoscopic/endoscopic repair of incisional hernias
and primary abdominal wall defects [54]. The low intra-
and postoperative complication rates and the stable, uni-
form fixation provided by Tisseel/Tissucol led this team to
conclude that this is the preferred technique for repair of
small-to-medium-sized abdominal defects. An additional
case series of 19 patients with incisional hernias (diame-
ter \ 6 cm) undergoing laparoscopic/endoscopic repair
with Tisseel/Tissucol mesh fixation showed that after a
mean follow-up of 20 months, no major postoperative
complications were observed and no intraoperative com-
plications occurred [55, 56]. In these patients, the mean
hospital stay was 1.5 days, and all patients reported very
low postoperative pain when measured with the VAS [55,
56]. A fourth study showed that sutureless open incisional
hernia repair using Tisseel/Tissucol fixation of mesh was
associated with a low incidence of postoperative pain [39
of 40 patients (97.5%) were pain-free at 1 year], a short
hospitalization period (mean = 3 days), and significant
(p \ 0.001) improvement in the physical component of the
SF-12 quality-of-life questionnaire [53].
Safety in clinical studies
The overall complication rate associated with Tisseel/
Tissucol mesh fixation is generally lower than [24, 26, 33–
35] or comparable to [40] that associated with suture, staple,
or tack mesh fixation in both open and laparoscopic/endo-
scopic hernia repair. Seroma may occur more frequently in
Tisseel/Tissucol-treated patients than in controls (e.g.,
17.4% vs. 5.3%; p = 0.009 [31]; 12.1% vs. 9.8% [36]),
although clinical reports have demonstrated that the majority
of these seromas resolve without intervention. Moreover,
recent trial data suggest that use of the new angled-tip Tis-
seel/Tissucol spray applicator may substantially reduce the
risk of seroma formation [39]; the risk may be further
reduced depending on the experience of the surgeon.
Patients who have undergone hernia repair generally
have fairly short hospital stays. Some studies have shown
that the duration of hospitalization is shorter for those
whose repair is accomplished using Tisseel/Tissucol than
in those in whom control methods are used (1.5 vs.
2.3 days, respectively [36]; 1 vs. 1.1–1.2 days (p \ 0.05)
[34]). Other studies show no effect of fixation method on
this end point [26, 31, 35, 40]. Similarly, the time to return
to work after surgery may be reduced (7.9 days (Tisseel/
Tissucol) vs. 9.1 days (staples); p \ 0.001 [37]; 5 days
(Tisseel/Tissucol) vs. 7–9 days (staples); p \ 0.05 [34]) or
similar to [38] that of patients treated using conventional
methods of fixation. As noted in the section describing
efficacy end points above, postoperative pain and chronic
pain are generally reduced by the use of Tisseel/Tissucol
for mesh fixation [21, 24–26, 31–36].
Discussion
This review of the use of Tisseel/Tissucol for mesh fixation
in hernia repair demonstrates that this fibrin sealant prepa-
ration may provide distinct advantages over tissue-pene-
trating mesh fixation methods, including a lower risk of
postoperative complications [24, 26, 33–35] and a trend
toward shorter postoperative recovery times [34, 37].
Moreover, incidence of postoperative and chronic pain—
two of the most common complaints made by hernia surgery
patients—is generally lower in patients whose mesh has been
fixated with Tisseel/Tissucol than in those in whom sutures,
staples, or tacks have been used [21, 24–26, 31–36].
The studies summarized above demonstrate that Tisseel/
Tissucol is usually an effective fixation agent when used in
hernia repair and that Tisseel/Tissucol is strong enough to
be used alone for mesh fixation. However, some problems
with its use have been reported. These include the potential
for mesh slippage at low-adhesive surfaces (e.g., pubic
bone, Cooper ligaments) after repair of large hernias;
therefore, some surgeons prefer clip fixation at these sites
to reduce the risk of hernia recurrence [32].
If the use of fibrin sealant is to be successful, the type of
mesh that is used must be considered. Although synthetic
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meshes (e.g., polypropylene, polyester, expanded polytet-
rafluoroethylene) and biologic meshes derived from
human, porcine, or bovine tissue are available for use in
hernia repair, synthetic meshes are more commonly used
[57, 58]. The most important characteristics for consider-
ation when selecting a mesh are porosity, filament type,
and tensile strength [58]. These factors determine the
weight of the mesh and its biocompatibility and may
influence prosthesis shrinkage, long-term patient comfort,
and the risks of infection and other complications [58].
When fibrin sealant fixation is proposed, other factors must
also be taken into account, including mesh pore size;
however, only a few mesh pore sizes have been evaluated
with fibrin sealant [9, 59].
This systematic review has summarized the clinical
evidence for the safety and efficacy of Tisseel/Tissucol as a
mesh fixative in the repair of inguinal and incisional her-
nias. Although the volume and strength of evidence to
support the use of Tisseel/Tissucol in inguinal hernia repair
is greater than that in incisional hernia repair (for which
there are only two prospective studies), it is evident that
this method of mesh fixation is successful in both proce-
dures, with low rates of recurrence and postoperative pain
[25, 49, 51, 53]. Thus, the current clinical evidence sup-
ports the use of Tisseel/Tissucol as an option for mesh
fixation in hernia repair. According to the guidelines of the
International Endohernia Society, the recommendation
(Grade B) of fibrin sealant mesh fixation should be con-
sidered to minimize the risk of postoperative acute and
chronic pain in laparoscopic/endoscopic inguinal hernia
repair [60]. Additional recommendations (Grade B) of
these guidelines allows the nonfixation of meshes in
selected types of hernias. These include type L1 hernia in
TAPP technique [European Hernia Society (EHS) classi-
fication] and type L1 or L2 and M1 or M2 hernia in TEP
technique (EHS classification). Trials have not been con-
ducted to compare nonfixation with fibrin fixation of the
mesh for either open or laparoscopic/endoscopic repair of
hernias [60].
In small-sized ventral and incisional hernias, intraperi-
toneal onlay mesh plasty fibrin sealant fixation achieved
excellent results with respect to the incidence of acute
postoperative pain and recurrence rate [50, 54, 55]. In
addition to these clinical findings, experimental studies by
Erikson et al. [15], Clark et al. [61], Rieder et al. [62], and
Fortelny et al. [16] verified that fibrin sealant could sig-
nificantly reduce the numbers of perforating fixation
devices for mesh fixation. Thus, a reduction of tissue
trauma and nerve injuries could be achieved. Nevertheless,
recent literature and this systematic review underscore the
need for future randomized controlled trials to more fully
understand the impact of atraumatic mesh fixation by
Tisseel/Tissucol on clinical outcome parameters [32, 63].
In summary, the hypothesis that atraumatic mesh fixa-
tion with Tisseel/Tissucol leads to reproducible clinical
benefits in all kinds of hernia repair is supported by the
growing body of literature. It can be expected that Tisseel/
Tissucol mesh fixation will be routinely used in an exten-
ded spectrum of indications.
Acknowledgment The authors thank Janet Douglas, whose work
was funded by Baxter Inc., for her support in the preparation of this
manuscript.
Disclosures Prof. Redl works as a senior consultant for Baxter. Drs.
Fortelny, Petter-Puchner, and Glaser have no conflict of interest or
financial ties to disclose.
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