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6 Materials, Devices andGadgets forHernia Surgery
)
®
61
(Proxy Biomedical)
®
(Solvay)
Mesh (Gore
®
®
Mesh (Braun)
®
(Ethicon)
®
(Syneture)
®
Omyra
cPTFE mesh MotifMESH
PTFE Monolament macroporous INFINIT
Polyglycolic acid Dexon
PVDF mesh Co-PVDF
Mesh (Braun)
®
Sal
Absorbable Polyglactin 910 Vicryl
62
D. L. Sanders et al.
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Table 6.6 Commonly used commercially available meshes (composite meshes)
Composite meshes Aim Additional component Mesh and manufacturer
®
PPM composites Improved physiological
function
Poliglecaprone 25 Ultrapro Polyglactin 910 Vypro
(Ethicon)
®
/Vypro II® (Ethicon)— Vypro = 69% PPM, 31% Vicryl; Vypro II= 50% PPM, 50%Vicryl
Improved physiological function/reduced
Poliglecaprone 25 + polydioxanone
Physiomesh
®
(Ethicon)
adhesions Reduced adhesions Collagen-oxidized lm Parietene Composite
(Sofradim)
ePTFE
®
Bard
Composix® L/P (Bard)
®
Composix® E/X mesh
Bard (Bard)
®
(Hernimesh®)
®
T1 (Cousin)
®
(Ethicon)
Hydrogel (polyvinylpyrrolidone + polyethylene glycol)
Oxidized regenerated cellulose +
Relimesh Intramesh Adhesix (Cousin)—sutureless Proceed
polydioxanone PVDF DynaMesh Sepralm
®
Sepramesh
®
(DynaMesh)
®
(Bard) (carboxymethylcellulose and hyaluronic acid)
Polyester mesh composites
Reduced adhesions Collagen-oxidized lm Parietex Composite™/Parietex
Optimized Composite™ (Covidien™)
Dimethylsiloxane Biomesh
®
A2 (Cousin)—macroporous Intramesh
®
W3 (Cousin)—microporous
®
Others Long-term absorbability
(up to 60weeks)
First bre = glycolide, lactide and trimethylene carbonate
Tigr
Matrix (Novus
Scientic) Second bre = lactide and trimethylene carbonate
Encourages type 1 collagen
Polyglycolic acid + trimethylene carbonate
Reduced adhesions Bovine gastric submucosa +
®
Bio-A
(Gore®)
Ovitex, Ovitex 1S, Ovitex 2S polypropylene or polyglycolic acid
Prevents ingrowth on the visceral side
PTFE + polyglycolic acid/ trimethylene carbonate Porcine small intestinal mucosa +
Synecor
Zenapro polypropylene
®
6.3.2 Fixation Methods
ables that exist are related to the suture material used, the suture technique (interrupted vs. con-
6.3.2.1 Suture Fixation
Since the introduction of plastic hernia meshes in the 1950s, sutures have been the most commonly
tinuous), the bite size, the bite placement (in rela­tion to the edge of the mesh and abdominal wall) and the distance between sutures.
used method for mesh xation in open hernia sur­gery. As a result, suture xation is often used as the control in studies assessing other xation methods [156–158, 168–190]. The suture vari-
Suture Material
Suture material adds to the prosthetic load in her­nia surgery, and this may have an impact on the
ab
6 Materials, Devices andGadgets forHernia Surgery
Table 6.7 Commonly used commercially available meshes (biological meshes)
Biological meshes Mesh and manufacturer Porcine small intestinal submucosa Non-cross-linked Surgisis
Cross-linked Fortagen
Human acellular dermis Non-cross-linked AlloDerm
®
(Cook)
®
(Organogenesis)
®
(LifeCell)
AlloMax (Bard)
®
Flex HD
Xenogenic acellular dermis Non-cross-linked Strattice
Veritas SurgiMend Tutomesh
(Ethicon)
®
(LifeCell)
®
(Synovis)
®
(TEI Biosciences)
®
(RTI Bilogics) XenMatrix (Brennen) Peri-Guard
®
(Synovis)
Cross-linked Permacol™ (Covidien™)
®
CollaMend
(Bard)
63
c d
Fig. 6.9 Low-power electron microscopy demonstrating
the ultrastructure of polyethylene mosquito net compared to the commercial meshes analysed (JEOL scanning elec-
tron microscope 925 original magnication). (a) Polyethylene mosquito net, (b) ProleneÒ, (c) BardÒ mesh, (d) VyproÒ, (e) UltraProÒ, (f) Parietex [189]
64
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e f
Fig. 6.9 (continued)
D. L. Sanders et al.
rate of mesh infection as well as surgical site infection, which is an important factor contribut­ing to hernia recurrence in addition to morbidity and the costs.
It has been recommended (level of evidence, 2C) to use monolament non-absorbable or long­term absorbable sutures in mesh xation. In 2011 a Swedish retrospective review of 82,015 patients concluded that the risk of hernia recurrence fol­lowing Lichtenstein open inguinal hernia repair is more than double when short-term absorbable sutures were used in mesh xation compared to non-absorbable and long-term absorbable sutures (RR 2.23, 95% CI 1.67–2.99, p<0.01) [191]. This review was supported by an animal model study comparing polypropylene and polyglactin 910 sutures. At 8weeks, mesh xation was found to be signicantly greater with polypropylene sutures compared to polyglactin 910 sutures [156].
On the other hand, in 2002 a single surgeon qRCT performed by Paajanen comparing poly­propylene and Dexon™ (Syneture) sutures in mesh xation in 162 inguinal hernia repairs con­cluded that there is no difference in terms of recurrence, pain or infection with a mean follow­up of 2years [183].
In assessment of bacterial adherence to suture material, invitro studies have concluded
that there is a signicantly high rate of bacterial adherence to the suture material when absorb­able braided sutures are used for mesh xation [166, 192]. In order to overcome this problem, sutures have been treated with antibacterial coating. In vitro and animal model settings have shown that sutures treated with triclosan appear to reduce bacterial adhesion and viabil­ity [167, 186].
The choice of suture material does not appear to affect chronic pain, adhesion formation or operative time [156, 183, 191, 193]. There is no evidence to support a particular gauge of suture material over another or one suture needle in preference to another.
In comparison with other xation techniques, several studies have concluded that suture xa­tion results in stronger mesh xation strength compared to tacks or glue [155, 170, 188, 193,
194]. However the clinical signicance of this is
unclear since the majority of studies comparing suture xation with tacks, brin sealant or glue show no difference in recurrence rates between the groups [168, 172, 173, 180–182]. In a rat model, Karatepe etal. found that in a contami­nated surgical eld, infection rates were higher when the mesh was xed with suture material compared to glue [178].
6 Materials, Devices andGadgets forHernia Surgery
65
Suture Technique
The technique used for xing the mesh with sutures depends on the type of the hernia and the mesh position. It is recommended (level of evi­dence: 5) to avoid bridging the hernia defect with mesh in open hernia surgery. In vitro biomechan­ical inguinal hernia models have concluded that a closed hernia defect requires signicantly greater bursting pressure compared to a bridged defect [158]. In the assessment of continuous vs. inter­rupted sutures used in mesh xation, Sekmen et al. have concluded that mesh contraction is lower in the continuous group in rat model [185].
In laparo-endoscopic surgery for inguinal and incisional hernias, it was found that most studies were assessing the use of transabdominal suture technique in mesh xation with no studies assess­ing xation using laparo-endoscopic suturing technique [156, 177, 179, 188, 194–197].
When performing suture xation, it is widely agreed that transfascial sutures are the gold stan­dard technique. This said, a systematic review of 6,016 patients undergoing laparo-endoscopic repair of incisional hernias concluded that there is a signicantly higher rate of surgical site infec­tion in suture xation [198]. They found no sig­nicant difference in recurrence or chronic pain between the two groups.
van’t Riet et al. concluded that the optimal distance between transabdominal sutures for x­ation of mesh in laparo-endoscopic ventral hernia repair was 1.8cm. The study assessed the strength of mesh xation using a porcine model without considering the size of the defect and the type of the mesh used in the repair [188]; however, there is enough data to support these ndings.
6.3.2.2 Glue Fixation
Surgical glue was originally used during the Vietnam War for traumatic wound closure. Its use in hernia surgery was rst described by Farouk etal. in 1996 [199]. It is a synthetic cya­noacrylate-based compound that works by con­tact-induced exothermic hydroxylation of the monomer to form a stable polymer. In order to assess the use of glue in mesh xation, several studies have been conducted. Using an animal
model, glue was found to be inferior to sutures, tacks [194] or staples [170] in terms of xation strength. However these ndings were opposed by other studies that found no difference between glue and sutures [172, 200]. In the assessment of hernia recurrence following open inguinal hernia repair, there are comparable recurrence rates with glue xation compared to other xation methods (level of evidence: 1B). Several studies have concluded that there is no difference between glue xation compared to either suture or brin sealant xation [168, 172, 173, 176,
182, 201, 202]. In the assessment of acute and
chronic postoperative pain, there are lower rates of chronic pain with glue xation compared to suture xation in open inguinal hernia repair (level of evidence, 2B). A RCT has concluded that postoperative pain scores and analgesia requirements were lower in the glue group com­pared to suture group on the rst postoperative day [182]. Also, the incidence of chronic pain was less in the glue group (0% vs. 3.39%) [176,
202]. In contrast, another RCT reported no dif-
ference in acute or chronic pain between glue and suture xation (20.1% vs. 15.5%, P=0.318) [168, 173, 201]. In comparison with suture xa­tion in open inguinal hernia repair, the glue xa­tion showed no difference in terms of wound infection rates (3.3% vs. 1.3%, P=0.448) [173,
201]. However, using an animal model, it was
found that there are lower bacterial adherence rates with glue xation compared to suture xa­tion following hernia repair in the presence of infection [178]. In the assessment of operative time, Bar etal. reported a shorter operative time with glue compared to sutures [168], yet Nowobilski reported no difference in terms of cost or length of hospital stay [182]. This nding was supported by Pagane etal. [201]; however, there is insufcient evidence to support these ndings.
6.3.2.3 Fibrin Sealant Fixation
Fibrin sealants are biological glues that work by reproducing the nal steps of the coagulation cascade. They involve simultaneous application of concentrated human brinogen and lyophi-
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D. L. Sanders et al.
lized factor XIII that is reconstituted with apro­tinin (antibrinolytic agent) and thrombin that is reconstituted with calcium chloride or distilled water [203]. Its use in hernia surgery was rst described by Chevrel etal. in 1997 [204].
For assessment of mesh xation strength, brin sealant was found to be comparable with mechanical xation techniques (level of evi­dence, 5) [205]. In vitro biomechanical models, open and laparo-endoscopic, have suggested that the combination of brin sealants with sutures generates a signicantly higher mesh xation strength, with bursting pressure of 196mmHg, when compared to the use of sutures alone (burst­ing pressure 188mmHg) [157, 206]. This is not true for brin sealant alone, with animal models of open and laparo-endoscopic repair nding no difference between brin sealant and other mechanical xation techniques including sutures, staples and tacks [184, 207–210]. Level 1B evi­dence suggests that recurrence rates with brin sealant xation are comparable with mechanical xation devices in laparo-endoscopic TAPP [211] and TEP [212] and open inguinal hernia repair [206, 213–216]. Expectedly, brin sealant has higher xation strength at 12days postopera­tively when compared to non-xation technique [207, 217].
Level 5 evidence suggested that thrombin con­centration of 4IU/ml is preferable to 500IU/ml and has higher xation strength [218].
In the assessment of postoperative incidence of chronic pain in open and laparo-endoscopic (TEP and TAPP) inguinal hernia repair, level 1B evidence shows that brin sealant results in lower postoperative chronic pain rates up to 1 year compared to mechanical xation including sta­ples, tacks and sutures [169, 174, 202, 206, 211,
212, 216, 219]. The TIMELI trial compared
brin sealant to suture xation in a randomized control trial of 319 patients undergoing open inguinal hernia repair (Lichtenstein method). At 1year postoperatively, they found a signicantly lower rate of patients with one or more disabling complication (chronic pain, numbness or groin discomfort) in the brin sealant group compared to the suture group (8.1% vs. 14.8%, p=0.0344), with a lower analgesic requirement (65.2% vs.
79.7%, p = 0.0009) [220]. Conversely a case series reported no difference between brin seal­ant xation and staples in terms of chronic post­operative pain following TAPP repair of inguinal hernia [213].
The ability of patients to return early to work following TAPP repair of inguinal hernia was found to be faster amongst those who underwent brin sealant mesh xation compared to the sta­ple or anchor mesh xation (5days vs. 7–9days) [216] or suture xation [169]. Conversely, in TEP repair of inguinal hernia, there was no difference in return to daily activity or length of hospital stay between the brin sealant and staple xation [212].
There is insufcient and conicting evidence in the literature with regard to the postoperative wound complications, namely, seroma formation and wound infection. Some studies reported deceased incidence of seroma formation follow­ing open incisional hernia and TAPP repair of inguinal hernia with brin sealant xation com­pared to mechanical xation methods [214, 221]. However, these ndings were conicting with other studies which revealed no difference in seroma formation between these xation meth­ods [204]. In terms of wound infection, it was found that the use of brin sealant might result in reduction in the rate of postoperative infection [204, 222]; however, opposing studies concluded that there was no change in the rate of postoperative infection regardless of the xation techniques [174, 219, 223]. There is a lack of consistent evidence with regard to operative time, reduced hospital stay and cost effectiveness with brin sealant xation compared to other xation methods [211–213, 224].
6.3.2.4 Staple Fixation
Titanium surgical staples are uncommonly used for mesh xation in laparo-endoscopic surgery as well as open hernia repair [181, 213, 225–236]. One of the criticisms of the use of staplers in hernia surgery is the cost compared to sutures [237]. The literature search has revealed conict­ing evidence in this subject.
For assessment of the strength of mesh xa­tion in inguinal hernia repair, level 5 evidence
6 Materials, Devices andGadgets forHernia Surgery
67
suggested that mesh xation strength with sta­ples is higher than no xation of mesh [207, 223] and is comparable to sutures [170] and brin sealant [184].
In regard to the incidence of hernia recurrence following open and laparo-endoscopic (TEP and TAPP) inguinal hernia repair, level 1B evidence has suggested that staple xation has comparable recurrence rates compared with other xation techniques including sutures and brin sealant [180, 181, 187, 211–214, 219, 238–241].
The incidence of postoperative chronic pain was comparable following open inguinal hernia repair using staple xation compared to suture xation (level 2B) [180, 181, 213] and with no xation [238–241]. However in comparison with brin sealant, surgical staples mesh xation was found to result in higher rates of chronic postop­erative pain following open and TEP repair of inguinal hernia (level of evidence, 1B) [206, 211,
212, 219].
Level 1B evidence suggested that there is no difference in postoperative infection rates with staple xation compared to sutures or brin seal­ant in open or laparo-endoscopic (TEP and TAPP) inguinal hernia repair [180, 181, 187, 213,
219].
Regarding seroma formation, there is a con­icting evidence in the literature with lower seroma rates in the staple xation compared to brin sealant in TEP repair of inguinal hernia repairs [212], however with higher incidence in TAPP [214].
6.3.2.5 Tacks andAnchor Fixation
Tacks are spiral-shaped pins that are made of either a non-absorbable titanium or an absorbable material such as polyester (e.g. AbsorbaTack™ Covidien™). The tacks are shaped like a ship’s anchor with two forks rather than a spiral shape. They are made of nitinol, which is a composite of nickel and titanium. The use of surgical tacks has been widely adopted in laparo-endoscopic ingui­nal and incisional hernia repair where suturing is often technically challenging and time consum­ing. They can either be positioned in a single row of tacks around the outer border of the mesh, sometimes combined with sutures, or more com-
monly in ‘double crown’ fashion as an inner and outer row.
Literature has revealed that the tack xation technique has comparable results to other xa­tion methods in terms of xation strength and the recurrence rates in TAPP and TEP repair of inguinal hernia as well as laparo-endoscopic repair of incisional hernias [154, 156, 193, 195,
216, 242–247]. In laparo-endoscopic incisional
hernia repair, there is some concern regarding adhesions, especially with intraperitoneal place­ment of mesh and the tacks as it comes in contact with the viscera. There is no difference in the lit­erature in terms of adhesion formation between non-absorbable and absorbable tacks (level of evidence, 5) [156]. Similarly, there is no clear difference in adhesion formation between tacks, sutures, staples and brin sealant [177, 179].
In terms of postoperative pain, there is con­icting evidence in the literature between tack xation and no mesh xation in TEP repair of inguinal hernia [164, 246–248]. Compared with brin sealant xation, tack xation was found to result in higher pain rates in TAPP inguinal hernia repair [216]. Similarly higher pain rates were found when compared with sutures in laparo­endoscopic incisional hernia repair [195, 196].
Level 2B of evidence has found no difference in wound infection rates with tack xation com­pared to brin sealant or anchors in laparo-endo­scopic (TAPP) inguinal hernia repair [216]. Similarly, there is no difference in wound infec­tion rates when compared to no xation of mesh in TEP inguinal hernia repair (level of evidence,
3) [249]. There is insufcient evidence with regard to handling of tacks compared to other xation device, and in laparo-endoscopic inci­sional hernia repair, there is no difference in operative time with tack xation compared to transabdominal sutures [246, 249] (level of evi­dence, 2B).
6.3.2.6 No Fixation
The idea of hernia repairs without mesh xation approach has emerged to overcome possible complications associated with mechanical xa­tion methods. This method takes advantage of mesh rigidity when placed in a closed anatomical
68
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D. L. Sanders et al.
space that will eventually be secured by mesh ingrowth, especially the case in TEP inguinal hernia repair and open sublay incisional hernia repair. The recommendation from the International Endohernia Society, along with the published European guidelines in July 2011 on TEP and TAPP inguinal hernia repair, was that all but the largest hernia defects (risk of mesh dislo­cation or folding leading to inadequate overlap with tissues and hernia recurrence) could be repaired without mesh xation [250].
Level 1A evidence has suggested that in terms of recurrence rates, there is no difference when comparing no xation to mechanical xation in laparo-endoscopic (TEP) inguinal hernia repair [246, 247, 251, 252]. Similar results were found in a meta-analysis of eight RCTs, showing no signicant difference in recurrence, chronic pain or length of stay for all laparoscopic inguinal her­nia repairs [253]. It is not unexpected that non­xation of the mesh approach in TEP inguinal hernia repair was found to signicantly reduce the operative time and the cost (level 1A evi­dence) [251, 252].
6.3.2.7 Self-Fixing Mesh
The self-xing meshes are characterized by a stronger xation compared to the no-xation approach and with reduced prosthetic load com­pared to the mechanical xation methods.
There are currently two self-xing meshes on the commercial market. Adhesix® (Cousin Biotech) is a lightweight polypropylene mesh that has one-side coated with a hydrogel synthetic glue. ProGrip™ (Covidien™) is a lightweight polyester mesh that has polylactic acid absorbable hooks on one side of the mesh, acting like ‘Velcro’ to hold the mesh in place.
Evidence (level 4) has suggested that self-x­ing meshes have a recurrence rate comparable with suture xation in open inguinal hernia repair [254–256]. In an inguinal hernia animal model, it was reported that the ingrowth was better with a self-xing mesh (Adhesix®) compared with suture xation [171]. There is limited evidence on their efcacy in laparo-endoscopic repairs; however, two case series demonstrate promising results [257, 258].
Lower rates of chronic postoperative pain were noted following open inguinal hernia repair using ProGrip™ self-xing mesh [259] or Adhesix® mesh [256] compared to suture xa­tion. The operative time in open inguinal hernia repair was reported to be shorter with self-xing meshes compared to suture xation (23 mins (15–32) vs. 31min (21–40) P=0.01) [171, 259].
In summary a moderate quality systematic review of 12 RCTs found no signicant difference in recurrence rates or infections rates between all xation methods, and although chronic pain rates were found to be different (sutures 14.7%, glue
7.6%, brin sealant 3.7%, self-xing 18.2%), this was non-signicant in 9 out of 12 RCTs [260].
Conclusion
There are several hundred different products
on the market that can be used in the repair of
different types of hernias; however, the ‘ideal’
prosthetic product has yet to be found. We are,
as yet, unable to predict the most suitable type
of mesh for each hernia and patient type. In
addition, it should be remembered that the
type of mesh and the xation technique are
only two factors amongst a list of important
variables that inuence the outcomes in hernia
surgery.
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