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6 Materials, Devices andGadgets forHernia Surgery
51
PPM 7, 30days
®
®
16weeks
) 1, 3, 9,
®
28days
) PPM (Marlex
®
®
) Open ePTFE (DualMesh
®
)
®
)
®
®
21days
)
®
®
Sepramesh
PPM (Parietene
®
)
®
E/X
®
Composix
ePTFE (DualMesh
Parietene Composite
Open Parietex Composite™
®
)
®
E/X
®
®
)
®
4weeks
Open PPM
)
®
4weeks
®
)
®
®
)+AlloDerm
®
(Prolene
Sepramesh
Open ePTFE (DualMesh
®
)
®
)+AlloDerm
®
16weeks
14days
) 1, 3, 9,
®
®
®
Mesh)+Interceed
Open ePTFE (DualMesh
)
®
®
E/X
®
Open PPM (Bard
Mesh)
®
®
E/X
®
Lap Parietex Composite™ 28days
)
®
®
)
®
®
(continued)
30, 90days
) (30days)
®
(90days)
®
Surgisis
Open PPM (Marlex
)
®
®
Parietex™
PPM+Icodextrin Parietex™ PPM+Icodextrin
Sepramesh
Rats 91 PPM Open Sepramesh
[134]
2003 Van‘t Riet etal.
Sepramesh
ePTFE (DualMesh
PPM (Marlex
Rabbits 20 ePTFE (DualMesh
Pigs 21 PPM Lap Sepramesh
[135]
2003 Matthews etal.
2004 Borrazzo etal.
Rats 80 PPM (Parietene
[136]
2004 González etal.
Composix
ePTFE (DualMesh
Parietex Composite™
Sepramesh
Parietene Composite
[137]
PPM
ePTFE (DualMesh
(Prolene
Sepramesh
19 PPM (Prolene
Guinea
pigs
Rats 60 PPM (Surgipro™)
[138]
2004 Butler and Prieto
[139]
2005 Kayaoglu etal.
Vypro II®Parietex Composite™
Sepramesh
Composix
Rabbits 30 ePTFE (DualMesh
[140]
2005 Matthews etal.
2005 Demir etal. [141] Rats 30 PPM (Bard
PPM (Bard
Composix
Mesh)+Interceed
Pigs 8 PPM (Prolene
2005 McGinty etal.
ePTFE (DualMesh
Surgisis
Parietex Composite™
Rats 48 PPM (Marlex
[142]
etal. [143]
2005 Konstantinovic
52
D. L. Sanders et al.
30days
) 2months
®
PPM (Prolene
®
Open Sepramesh
®
)
®
)+Hyalobarrier
®
®
®
)+Tissucol
®
) 28days
®
PPM (Prolene
®
Open PPM+Interceed
®
)
)
®
®
7, 30days
®
®
Sepramesh
Open Sepramesh
®
)
®
®
Parietex Composite™
)
®
®
®
) 16weeks
®
) PPM (Marlex
®
ePTFE (DualMesh
Sequential
lap
)
®
E/X
®
®
)
®
®
)
®
®
®
PPM (Prolene
PPM+Vicryl
Mersilene
®
®
Proceed
Open ePTFE Bard
)
®
®
®
®
®
Lap Parietex Composite™ PPM 28days
) 1, 3months
®
PPM (Marlex
Composix™
Open cPTFE (MotifMESH™)
)
®
)
®
®
Year Author Animal N Meshes Open/Lap Fewer adhesions More adhesions Timescale
2006 Sikkink etal. [144] Rats 60 PPM (Prolene
Table 6.2 (continued)
PPM
(Prolene
ePTFE (DualMesh
gel
Sepramesh
PPM (Prolene
Parietene Composite
Sepramesh
PPM +Interceed
2006 Dilege etal. [145] Rats 30 PPM (Prolene
2006 Burger etal. [146] Rats 200 PPM (Prolene
ePTFE (DualMesh
Timesh®Sepramesh
Parietex Composite™
Ultrapro
Proceed®Tutomesh
Composix
2006 Harrell etal. [147] Rabbits 60 ePTFE (DualMesh
PPM (Marlex
Proceed
PPM+Vicryl®ePTFE Bard
Mersilene
2007 Kiudelis etal. [148] Rabbits 42 PPM (Prolene
Proceed
Parietex Composite™
2007 Jacob etal. [149] Pigs 10 Proceed
PPM
ePTFE (DualMesh
Proceed
Composix™
PPM (Marlex
Rats cPTFE (MotifMESH™)
[93]
2007 Voskerician etal.
6 Materials, Devices andGadgets forHernia Surgery
53
3, 7,
14days
) 1year
®
®
Sepramesh
) PPM (Marlex
®
Parietex Composite™
PPM-PU 99
Sequential
®
Proceed
lap
®
Sepramesh
Open ePTFE (DualMesh
)
®
)
®
E/X
®
ePTFE (DualMesh
Composix
PPM (Surgipro™) 28days
E/X PPM 3months
®
®
Open Composix
Lap Sepramesh
E/X
®
Composix
PPM-PU 99
5weeks
PPM
Open PPM+brin glue
E/X
®
®
Sepramesh
Composix
)
®
ePTFE (DualMesh
Plus
)+brin glue
®
ePTFE (DualMesh
Plus
PPM 30days
®
Open Parietene Composite )
)
®
ePTFE (DualMesh Plus
®
®
)
®
)+brin glue
®
ePTFE (DualMesh
PPM+brin glue
ePTFE (DualMesh
Parietene Composite
Plus
90days
Lap No difference No difference 7, 21,
®
PPM (Prolene)
PPM
Lap No difference No difference 3months
®
Light)
®
®
PPM
Open PPM+brin glue PPM
)+SurgiWrap
(TiMesh
30days
)
®
PPM
ePTFE (DualMesh
PPM+Col
Lap PVDF+PPM
)
®
PPM
PPM+Col
ePTFE (DualMesh
) 7, 30days
®
PPM (Prolene
(7days)
®
PPM+NVP/BMA
(30days)
Open Proceed
)
®
®
PPM+NVP/BMA
Proceed
PPM
(continued)
Rabbits 24 PPM (Surgipro™)
2007 Novitsky etal. [46] Rabbits 20 PPM (Marlex
2007 Bellón etal. [150] Rabbits 24 Parietex Composite™
2007 Miwa etal. [53] Rats 20 PPM
2008 Marcondes etal.
Pigs 10 PPM
[151]
[152]
2008 Matin-Cartes etal.
Pigs 6 PPM (TiMesh
[153]
2008 Junge etal. [97] Rats 40 PVDF+PPM (DynaMesh
2008 Conze etal. [98] Rabbits – Co-PVDF
2008 Schug-Pass etal.
Rats 40 PPM+brin glue
etal. [154]
2008 Prieto-Diaz-Chavez
2009 Junge etal. [97] Rats 40 PVDF+PPM
2009 Emans etal. [155] Rats PPM (Prolene
54
D. L. Sanders et al.
120days
®
®
Composix
Open C-Qur™ Proceed
3, 6 ,12,
7, 30days
®
(7days)
C-Qur™ (7days)
No difference (30days)
Lap Parietex Composite
)
®
\0
®
®
®
®
)
®
®
®
PPM+PAF
Open SIS PPM
180days
PPM+ePTFE 21, 90,
PPM+SIS
Open PP—PU 99
30days
90days
Polyester—collagen
composite
Open HPM
Open cPTFE+HPM cPTFE
cPTFE+HFL
18months
)
®
PVDF+PPM
(DynaMesh
®
Lap Parietex Composite
)
®
®
Year Author Animal N Meshes Open/Lap Fewer adhesions More adhesions Timescale
2009 Pierce etal. [156] Rabbits 41 C-Qur™
Table 6.2 (continued)
PPM (Prolite Ultra™)
Composix
Parietex™
Proceed®Sepramesh
ePTFE (DualMesh
Rats PPM (Prolene
2009 Schreinemacheret
PPM (Ultrapro
TiMesh
Parietex Composite
Proceed
al. [157]
c-Qur™
2009 Costa etal. [158] Rats 55 PPM
PPM+PAF
SIS
Rats 60 PPM
2009 Ansaloni etal.
PPM-PU 99
PPM+SIS
PPM+ePTFE
No mesh (control)
[159]
cPTFE+HPM
Polyester—collagen
composite
HPM
2009 Jin etal. [160] Pigs 9 cPTFE
cPTFE+HPM
cPTFE+HFL
Rats 20 cPTFE
[161]
2010 Voskerician etal.
2010 Zinther etal. [162] Sheep 16 Parietex Composite
PVDF+PPM (DynaMesh
6 Materials, Devices andGadgets forHernia Surgery
55
7days
®
Sepramesh
Open Parietex Composite™
)
®
)
®
E/X
®
ePTFE (STP
PPM (Surgipro™)
Composix
)
®
®
®
Mesh
®
ePTFE (DualMesh
MycroMesh
Parietex Composite™
Vypro II
Vicryl
®
®
Sepramesh
AlloDerm
Permacol™
30days
®
SurgiWrap
®
Lap SurgiWrap
®
®
®
Peri-Guard
Veritas
3, 7,
®
®
®
Prevadh
Open Parietex Composite™ Sepramesh
®
®
Prevadh®Sepralm
14days
Proceed
Open PPM+PLLA 4weeks
®
®
Sepramesh
Proceed
30, 60,
90days
PPM+HA+PLC
Open PPM+Collagen+PLC PPM+PLC
PPM+Sepralm
PPM+HA+PLC
PPM+Collagen+PLC
– Poloxamer—triblock copolymers consisting of central hydrophobic block of polyethylene glycol anked
)
®
)—monolament PPM mesh (Bard
®
by two
– PPM (Marlex
– Polyester composite—polyurethane-covered Dacron mesh (Braun)
(continued)
)—monolament PPM mesh (Ethicon)
®
– PPM (Prolene
Rats 32 SurgiWrap
2010 Gaertneret al. [163] Rats PPM (Marlex
2010 Gruber–Blum etal.
Rabbits 18 Parietex Composite™
[164]
2011 Rodriguez etal.
[165]
2011 Fujino etal. [166] Rabbits – PPM+PLLA
2011 Yao etal. [167] Rats 93 PPM+PLC
)
®
) – Hydrophilic blocks of polyethylene glycol
®
)—nonwoven macroporous
®
—nonwoven ePTFE (Bard
®
polymer (Solvay)
– Composix
E/X—PPM mesh sewn with polypropylene
®
stitching to a thin sheet of ePTFE (Bard
– Composix
– cPTFE (MotifMESH
—auto manufactured mesh woven with PVDF
—decellularized human dermis (LifeCell™) – PGA—polyglycolic acid
®
®
– Co-PVDF
– AlloDerm
coating (atrium)
condensed PTFE (Proxy Biomedical)
– C-Qur™—PPM with an omega-3 fatty acid bioabsorbable
56
D. L. Sanders et al.
)
®
(Bard
®
)—two-component (PPM+PVDF) monolament mesh (DynaMesh)
®
– PPM (ProLite Ultra™)—PPM (atrium)
)
®
)—auto manufactured mesh woven out of
®
ePTFE suture thread CV-4 (Gore
Year Author Animal N Meshes Open/Lap Fewer adhesions More adhesions Timescale
– ePTFE (CV-4
Table 6.2 (continued)
– PPM+PLC—PPM with a polylactide-co-caprolactone coating
– PPM+PAF—PPM with a coating of polylactic acid lm
)
®
)—two-layered ePTFE mesh with one
®
)—Gore-Tex Soft Tissue Patch, ePTFE with
®
smooth surface and one corduroy surface (Gore
– ePTFE (DualMesh
– ePTFE (STP
– PPM+HA+PLC—PPM with a hyaluronic acid and polylactide-co-caprolactone coatings
) – PPM+PLLA—PPM with poly--lactic acid lm
®
)
®
—uoropassivated polyester (SulzerVacutek
®
—absorbable gelatin lm (Pharmacia and
®
two laminar microporous surfaces (Gore
– Fluorosoft
– Gellm
—PPM mesh coated on one side with a Sepralm
®
—bioabsorbable translucent membrane composed of carboxymethylcellulose and hyaluronic
®
—biological anti-adhesive barrier (Sofradim)
—PPM, polydioxanone composite with oxidized cellulose coating (Ethicon)
®
®
polyurethane lm
– PPM+Collagen+PLC—PPM/collagen composite with a polylactide-co-caprolactone coating
Gel—sterile transparent and highly viscous
®
Upjohn)
gel obtained by condensation of hyaluronic acid (Fidia
Advanced Biopolymers SRL)
– Hyalobarrier
– HFL—human fascia lata – PPM+NVP/BMA—PPM with N-vinyl pyrrolidone and n-butyl methacrylate coating
– PPM (Surgipro™)—monolament PPM mesh (Covidien™)
) – Proceed
®
—lyophilized Dura mater (Braun
®
polymer solution (Baxter)
– HPM—human peritoneal membrane – PPM-PU 99—auto designed prosthesis composed of reticular PPM mesh and a non-absorbable
– Icodextrin—iso-osmolar biodegradable, 1,4-linked glucose
– Interceed—oxidized regenerated cellulose (Ethicon) – Prevadh
– Lyodura
acid (Genzyme)
– Silastic—polydimethylsiloxone prosthesis (Dow Corning)
– Sepramesh
) – Sepralm
®
—PPM mesh bonded on one side to
®
—ePTFE (Gore
®
polyester mesh (Covidien™)
a collagen-oxidized lm (Sofradim)
– Parietex Composite™—collagen-oxidized lm treated
– Mersilene—polyester mesh (Ethicon) – PVDF+PPM (DynaMesh
– Parietene Composite
– MycroMesh
—bioresorbable adhesion barrier lm (Mast)
®
—derived from porcine small intestine submucosa (Cook)
—PPM with titanium coating (PFM Medical)
®
®
– SIS—porcine small intestine submucosa mesh
– SurgiWrap
—patch made from bovine pericardium
®
(Covidien™)
– Permacol™—porcine dermal collagen implant
– Peri-Guard
– TiMesh
)
®
(Synovis
hydrophobic block of polyethylene glycol anked by two
hydrophilic blocks of polyethylene glycol
– Poloxamer—triblock copolymers consisting of central
– PGA—polyglycolic acid – Surgisis
6 Materials, Devices andGadgets forHernia Surgery
57
—acellular collagen matrix from bovine pericardium (RTI Biologics)
®
—brin glue (Baxter)
®
– Tissucol
– Polyester composite—polyurethane-covered Dacron mesh
—partially absorbable composite PPM/poliglecaprone-25 monolament mesh (Ethicon)
®
—acellular bovine pericardium (collagen not cross-linked) (Synovis)
®
– Veritas
) – Tutomesh
®
)—monolament PPM mesh (Bard
®
(Braun)
– PPM (Marlex
– PGA—polyglycolic acid – Ultrapro
– Poloxamer—triblock copolymers consisting of central
®
(Mesh)—Polyglactin 910 (Ethicon)
®
– Vicryl
hydrophobic block of polyethylene glycol anked by two
hydrophilic blocks of polyethylene glycol
—PPM/polyglactin 910 composite mesh (Ethicon)
– Vypro II
58
Fig. 6.8 TiMesh
®
whilst coughing or jumping [135]. Therefore, meshes used in hernia repair need to tolerate pres­sure up to at least 180 mmHg before bursting (ten­sile strength up to 32 N). Moreover, it is important that the strength of meshes is tested in a biaxial fash­ion. Virtually all meshes tested invitro are able to withstand this pressure, even the lightweight meshes (e.g. Vypro burst pressure = 360 mmHg [136]). Exceptions are ‘ultra-lightweight’ meshes, such a TiMesh® extralight (16g/m2) (Fig.6.8), which has a tensile strength of only 12N [137]; however, in a clinical trial assessing its performance in groin her­nia repair, it performed favourably [137].
The natural elasticity of the abdominal wall at 32 N is about 38%. More compliant lightweight meshes have been shown to have an elasticity of about 20–35% at 16 N [136]. Less compliant heavyweight meshes have only half this elasticity (4–16% at 16N) and therefore may restrict abdom­inal movement and distension in some patients.
6.2.5 Classication ofMeshes
Classication systems are vital in improving the possibility of comparing different studies and their associated results and would enable us to structure evidence-based therapeutic guidelines regarding the use of certain meshes in different clinical scenarios.
The best-documented mesh classication sys­tem was created by Amid in 1997 [138] based on mesh porosity (Table6.3).
In 2012, a German research group, in conjunc­tion with mesh manufacturers, devised an alter­native classication system taking into account developments in the prosthetics industry [139].
D. L. Sanders et al.
Table 6.3 Amid mesh classication system [178]
Type Description Type I Macroporous Type II Microporous Type III Macroporous or microporous components Type IV Biomaterials with submicronic pores/sheets
Table 6.4 The German group mesh classication system
[179]
Class Description Class ILarge pore meshes (textile
porosity of >60% or an effective porosity of >0%)
Class IISmall pore meshes (textile
porosity of <60% and without any effective porosity)
Class
Meshes with special features To prevent III Class IVMeshes with lms Meshes without
Class V3D meshes
Class VIBiological Non-cross-linked
Subgroups/ features
Monolament Multilament Mixed structure or polymer Monolament Multilament Mixed structure or polymer
infection
porosity Submicronic pore size Secondarily excised pores
Cross-linked Special features
This classication system differentiates ‘major’ differences (objectied through randomized con­trolled trials) and ‘minor’ differences (not signi­cantly different in randomized controlled trials) between available meshes (Table6.4).
The classication is intended to be used for analysis of the data from the registry of hernia repairs, as well as implant failures to detect major mesh material-related problems. These classication systems provide useful compara­tive groups for research purposes; however, none of the current classication systems give a con­cise hernia-specic overview of which mesh/ group of meshes is best for a particular scenario.
Coda and his working colleagues have pro­posed a classication system based on dening the weight [140]:
6 Materials, Devices andGadgets forHernia Surgery
59
1. Ultralight ≤35 g/m
2. Light C 35–70 g/m
3. Standard C 70–140 g/m
4. Heavy C ≥140 g/m
2
2
2
2
This classication involves grouping of sim­ple, composite or combined meshes, which is based on biomaterial composition: simple (pros­thetics made of one pure biomaterial), composite (prosthetics made of two or more different lay­ers), combined (prosthetics made of two materi­als knitted or woven together) and biologic.
6.2.6 Commercially Available
Meshes
Some of the commercially available meshes are shown in Tables 6.5, 6.6 and 6.7. Whilst this is a comprehensive list, it is by no means exhaustive and since writing this more meshes will likely be available on the market. For clarity, they are divided into (a) synthetic non-composite meshes, (b) composite meshes and (c) biological meshes. The list is not exhaustive but rather includes the most commonly used meshes in each category. In addition to the meshes listed, many manufactur­ers produce plugs/hernia systems made of the same material as the at meshes for hernia-spe­cic repairs.
6.2.6.1 Low-Cost Mesh
Although the use of alloplastic mesh is a com­monplace in more economically developed coun­tries, in developing countries the cost of mesh often prohibits its use. In situations, where com­mercial material is not available or not afford­able, large-pore high-density polyethylene mosquito net has been used as an alternative [141148]. It has been found to have a similar microscopic structure to the commercially avail­able large-pore meshes (Fig.6.9) and has compa­rable bursting forces [149]. In two clinical trials assessing the use of mosquito net compared to a commercial hernia mesh, there was no signicant difference in the clinical short-term outcome or in the surgeons’ comfort in handling the two dif­ferent materials [141, 143]. The price of the
locally bought polyethylene mesh was US$0.0043 as compared to US$108 for the commercial mesh [143]. Some surgeons initially raised concern over the use of nylon mosquito net and the risk of infection and recurrence [53, 150]; however, recent data shows no difference in complication rate or recurrence rate when compared with com­mercial mesh [151, 152].
6.3 Techniques ofMesh Fixation
6.3.1 Introduction
The assessment of success rate of surgical repair depends on multiple factors that can be broadly classied into two categories: patient-based out­come measures and surgical outcome measures. The patient-based outcome measures include wound complications, recurrence, length of hospital stay, chronic pain and quality of life. Surgical outcome measures include ease of mate­rial handling and its implantation, in addition to the operative time. These two categories are fur­ther inuenced by a number of factors including patient’s demographics and comorbidities, the hernia itself (type, size and complexity), surgical technique, the mesh and the method of xation used in the repair.
The purpose of mesh xation is to prevent migration that can potentially lead to hernia recur­rence. Different xation methods have been described including sutures, tacking, stapling devices, brin sealant, glues and self-xing meshes; however, this xation process can be time consum­ing and costly. Furthermore, signicant complica­tions have been attributed to the method of xation, presumably due to insufcient xation or nerve and tissue damage [153]. Complications reported include mesh migration and recurrence [154158], meshoma [159], tack hernias [160], chronic pain [153, 161165] and infection [166, 167].
The desirable characteristics of a xation device (or non-xation technique) are the same as those factors considered previously in relation to meshes, namely, biocompatibility, prevention of recurrence, handling, socioeconomics, infec­tion risk and longevity.
60
D. L. Sanders et al.
(continued)
(Bard)
®
(Bard)
®
P1 (Cousin)
®
(Ethicon)
®
Prolene
Biomesh
Bard Mesh
Preshaped Atrium™ Mesh (Atrium)
pore
(Bard)
®
Mesh (Meadox)
®
Surgipro™ Monolament (Covidien™)
Trelex
3DMax
Preshaped Bard Soft Mesh
Lightweight/large
(Braun)
®
, Optilene Elastic
®
Mesh (Braun)
®
P8 (Cousin)
/Optilene LP
®
®
Optilene
Biomesh
ProLite™ Mesh/ProLite Ultra™ Mesh (Atrium)
Premilene
pore
Titanium coating
Light/
®
(SulzerVacutek)
(Ethicon)
®
ExtraLight/TiMesh
Strong (PFM Medical)
®
®
Surgipro™ Open Weave (Covidien™)
3DMax™ Light Mesh (Bard)
TiMesh
TiMesh
®
Mersilene
Fluorosoft
Coated C-Qur™ Mesh (Atrium) Omega-3 fatty acid coating
Parietex™ (2D, 3D, lightweight monolament) (Covidien™)
Preshaped Parietex™ (various preshaped and folding meshes) (Covidien™)
Sutureless ParietexProGrip™ (Covidien™)
microporous surface and one macroporous
surface
surface and one corduroy surface
) Two-layered ePTFE mesh with one smooth
®
(Gore
®
Dulex™ Mesh Two-layered ePTFE mesh with one
®
DualMesh
regularly spaced macropores
) Two laminar microporous surfaces
®
)
(Gore
®
®
®
Gore Soft Tissue Patch
®
) Silver carbonate and chlorhexidine diacetate
®
) Microporous node and bril structure with
(Gore
MycroMesh
Plus (Gore
®
Plus (Gore
®
MycroMesh
Antimicrobial coating DualMesh
PPM Monolament Heavyweight/small
Non-
absorbable
Non-composite meshes Special characteristics Mesh and manufacturer
Table 6.5 Commonly used commercially available meshes (synthetic non-composite)
Multilament Surgipro™ (Covidien™)
Polyester
mesh
ePTFE mesh Bard