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ORIGINAL ARTICLE
KEYWORDS
Prosthetic material;
Abdominal wall
repair;
Hernia
Summary Abdominal wall incisional and inguinal hernia repair can call for utilization of
implants or prostheses as an alternative to simple suture techniques. The various implants
can be synthetic, biologic or mixed: their physicochemical properties condition the mechanical
results and the long-term outcome of the repair. The increasing number of available materials allows the surgeon to choose between a wide variety depending on the indication, the
site of implantation, the surgical approach and whether the operative eld is contaminated
or not. With regard to evidence-based medicine, while several synthetic implants have been
shown to be superior in efcacy to simple suture, other studies are underway to develop the
indications for bioprostheses, in particular in contaminated elds. This review of the literature summarizes the current knowledge on synthetic and biologic implants (physicochemical
characteristics, forms, indications).
2012 Published by Elsevier Masson SAS.
Introduction
Reinforcing the abdominal wall with an implant during hernia or incisional hernia repair is
accepted by all. The French Health Authority (Haute Autorit de sant or HAS) published
a study in 2008 showing that reinforcement with implant decreased the recurrence rate
(< 1.5%) in comparison to repair without implant [1] (which can be as high as 50% according
to the size of the defect) [2]. More than one million implants are inserted worldwide every
year. Use of prosthetic material for abdominal wall surgery dates back more than one
century. Around 1900, the rst prosthesis used for the treatment of inguinal hernia was
an inoxidable steel metallic mesh, later abandoned because of its rigidity, responsible
for sequellar pain. The modern era started in 1958 with the introduction of polypropylene
implants [3]. At the present time, several new implants are available on the market. These
are made of textile mono- or multilaments, woven, knitted or glued in the form of a mesh.
Ideally, these implants should be chemically inert, not elicit any inammatory reaction,
not be carcinogenetic, not provoke any allergy, be resistant, easily sterilisable, easy to
handle, and inexpensive [2].
Corresponding author.
E-mail address: d-nocca@chu-montpellier.fr (D. Nocca).
Synthetic implants
Classication and properties
The HAS has classed the abdominal wall implants in three
categories: at, 3-D preformed, and biface implants [1].
However, the distinction between the different implants
is greater when their physical properties are taken into
account:
long-term physical behavior: elective hernia repair
(non contaminated or non-infected eld) where nonabsorbable prostheses can be used [1]. Absorbable
prostheses (example: Vicryl ) can be used for emergency
repair, in a contaminated or infected eld, to reduce
the risk of evisceration, but with poor long-term results
with regard to hernia recurrence because of the weakness of the connective tissues generated by the insertion
of the Vicryl mesh. More recently, a new generation of
absorbable synthetic implants (Gore BioA ), composed of
polymers, is under evaluation. Moreover, some implants
associate non-absorbable and absorbable material, in
general to obtain a softer or lighter prosthesis or an antiadhesion effect: these are biological products of vegetal
(Beta D glucane, cellulose), or animal (collagen, omega3)
origin [2];
grid: the implant can be knitted, woven, thermoformed
or present as a lm (example: ePTFE or expanded polytetrauorethylene). The implant is characterized by its
thickness, its density (g/m2 ), its porosity and the diameter
of the grid;
porosity: porosity determines the tissular reaction of
implants. The grid is said to be macroporous when pores
are greater than 75 m, and microporous when the pores
are less than 10 m. The pores must be at least 75 m
to allow penetration of macrophages, ingrowth of broblasts, collagen deposition and neovascularization within
the pores. Implants with large pores create less tissue
reaction and preclude granuloma formation bridging the
interstices. Effectively, an isolated inammatory reaction
is generated by each individual ber; if the implant is
microporous, the granulomas blend together, enveloping
the implant and providing the implant with rigidity;
resistance: the mechanical resistance of implants must
be at least 180 mmHg, that is superior to the maximal
abdominal pressure (which can reach 150 mmHg during
efforts of coughing);
weight: this parameter depends on the type of polymer and the size of the grid. Heavy-weight prostheses
(> 90 g/m2 ) are made by tight braiding with thick,
microporous laments. Light wieght prostheses are composed of thin laments and/or large macroporous grids
(> 1 mm), leading to less inammatory reaction and more
elasticity;
elasticity: this characteristic varies according to whether
the implant is light-weight (2035% at a pressure of
16 N/cm2 ) or heavy-weight (416% at a pressure of
16 N/cm2 ). Elastic implants are characterized by a certain
degree of freedom on mobile parts of the abdominal wall
(example: the groin) while rigid, non-elastic, implants
reduce abdominal distension. As an example, a rigid,
nearly non-distortable implant might be preferred to
repair a recurrent linea alba hernia in a patient with
chronic bronchitis, because what is needed is abdominal containment; conversely, inguinal hernia repair would
benet from a light-weight, large grid implant where elasticity would increase patient comfort during movements
53
Classical implants
At the present time, there are three different nonabsorbable implants available that differ by their chemical
composition as well as by their plaiting: polypropylene,
polyester and expanded polytetrauoroethylene (nylon
meshes have been abandoned because they degrade in the
long-term):
polypropylene: hydrophobic, inert, rigid, highly resistant,
this basic material is used in most woven prostheses
(example: Prolene , Marlex );
polyethylene terephtalate polyester (Dacron): elastic,
hydrophilic, woven. These meshes are supple, easy to
use, and exist also as large grid, highly porous woven
material (example: Mersutures );
expanded polytetrauoroethylene (ePTFE) (example:
Dual Mesh ). This material is rigid, hydrophobic and its
absence of integration by the organism decreases the risk
of adherence, but this material is rarely indicated for
parietal repair.
Biface implants
When implants are placed intraperitoneally, as for example, during laparoscopic incisional hernia repair, the face
in contact with the abdominal wall should have good
54
M. Poussier et al.
Table 1 Cost of implant: implants for abdominal wall reconstruction, suspension, or wrapping. Non-absorbable without
tissues or derivatives of biologic origin.
Nomenclature
Non-absorbable implant
knitted or woven, coated
or non-coated
Non-absorbable
implant not knitted nor
woven
Price TIPSa
102.45 D
49.7 D
61.44 D
80.49 D
182.94 D
365.88 D
518.33 D
1067.14 D
All prices are net with tax; TIPS: tarif interministriel des prestations sanitaires (Interministerial tariff for health-related acts).
Absorbable implant
Knitted or woven,
coated or non-coated
Price TIPS
32.17 Da
83.39 Da
All prices are net with tax; TIPS: tarif interministriel des
prestations sanitaires (Interministerial tariff for health-related
acts).
Bioprotheses
Nature and physicochemical characteristics of
bioprotheses
Synthesis procedures
Origin of bioprotheses
The bioprostheses used in abdominal wall surgery derive
from animal (xenogenic) or human (allogenic) tissues. They
are constituted by type I, III or IV collagen matrixes as well
as sterile acellular elastin produced by decellularization,
sterilization and viral inactivation, in order to enhance integration and cellular colonization of the prosthesis by the host
tissues.
Concept of bioactivity
55
Table 3 Cost of implant: implants for abdominal wall reconstruction, suspension, or wrapping. Non-absorbable or
absorbable containing derivatives of animal origin.
Nomenclature
Implant
Knitted or woven,
coated or non-coated
Price TIPS
248.80 Da
292.70 Da
380.51 Da
All prices are net with tax; TIPS: tarif interministriel des prestations sanitaires (Interministerial tariff for health-related acts).
Biomechanical characteristics
The biomechanical characteristics of prosthetic reinforcement implants are essential to the intrinsic efcacy
of ensuring mechanically reliable tissue reinforcement.
Deeken et al. [9] recently studied several parameters (physical, thermic, and degradation) in a series of 12 human,
porcine and bovine bioprotheses. All the tested prostheses supported a tension of greater than 20 N applied to
the attachment sutures; half of them tore when tension
exceeded 20 N. Resistance to rupture varied from 66.2 N/cm
for Permacol to 199.1 N/cm for X-Thick AlloDerm . All the
prostheses except Surgiguard , Strattice and CollaMend
manifested signs of wear after application of 10 to 30%
of a mean stress of 16 N/cm. The reticulated CollaMend
and Permacol implants have shown better resistance to
high temperatures and enzymatic degradation of collagen
(by collagenase and metalloproteinases) than the nonreticulated implants.
Reticulation
Reticulation or cross-linking is an old procedure (tanning) long used in the leather industry to render skins
more resistant to degradation The goal of bioprosthetic
reticulation is double: to reduce collagen degradation
by the host collagenases, and to increase the durability and decrease the immunogenicity of xenogenic
implants [10]. Several types of reticulating agents are
used: glutaraldehyde, hexamethylene diisocyanate and 1ethyl-3-(3-dimethylaminopropyl) carbodiimide (EDC). These
biological implants were designed with the goal of
reinforcing tissues while gradually degrading over time.
In vivo, reticulation modies tissue restructuring and cellular inltration and increases the duration of the implant
before reabsorption [11]. Some authors feel that reticulation limits tissue regeneration because the bioprothesis
behaves like non- or very slowly absorbable synthetic prostheses; this may potentially result in a reduced robustness of
repaired tissues in the long term [12]. Moreover, reticulated
implants may be very immunogenic (macro/monophage activation) and increase the inammatory response to host
tissues (pro-inammatory cytokines) [13,14]. Clinically, a
recent retrospective study, from the database of the Food
and Drug Administration (FDA) [15] found that there was a
75% complication rate associated with the use of reticulated
bioprostheses, especially when they were used in infected
elds (79%) and that their innate tendency to bacterial
Classication
At the present time, there is no consensual agreement
regarding classication of bioprostheses. Nonetheless, these
implants can be classed according to their tissue origin,
the process of synthesis (reticulation), and their indications.
Although less than exhaustive,Table 4 lists the bioprostheses
in use throughout the world for abdominal and reconstructive surgery.
56
M. Poussier et al.
Table 4
Indications
Mean follow-up
(months)
Yes
Multiple
10
RO
Chavarriaga
et al. [17]
18
No
Incisional
hernia
7.8
Permacol
RC
Cobb et al.
[24]
55
No
Incisional
hernia
Strattice
PO
Shaikh et al.
[26]
Hsu et al. [25]
20
No
18
28
Yes
12
Commercial name of
prosthesis
Study
type
Authors
AlloDerm
RO
CollaMend
Number of
cases
PO
Itani et al.
[30]
85
Yes
Incisional
hernia
Incisional
hernia
Hernia
Surgisis
PR
Ansaloni et al.
[33]
35
No
Hernia
36
Veritas
PO
Franklin et al.
[32]
Helton et al.
[34]
Ueno et al.
[35]
Limpert et al.
[36]
116
Yes
Multiple
52
53
Yes
14
20
Yes
Incisional
hernia
Multiple
22
Yes
Incisional
hernia
22
Pohamac et al. 16
[39]
Yes
Incisional
hernia
16
RO
RO
RO
RO
XenMatrix
RO
AlloDerm
CollaMend
Permacol
Strattice
Surgisis
Veritas
XenMatrix
16
15
Complications
Global (%) Recurrent
hernia (%)
Seroma
(%)
Infection Dehiscence
(%)
(%)
Fistula
(%)
Removal of
prosthesis
(%)
86.7
17.1
31
40
8.8
11.6
38.9
44.4
22.2
22.2
6.6
3.3
1.8
40
21
67
15
10.7
15
10
14.3
22
10
3.5
23
5
3.5
15
2.5
0
0
33
17.1
2.9
50
50
23
7
17
30
19
9.4
11
10
3.8
40
3.8
21
32
36
21
6.2
RO: retrospective observational; RC: retrospective controlled; PO: prospective observational; PR: prospective randomized.
AlloDerm
The bioprosthesis AlloDerm , a non-reticulated sterile acellular collagen matrix derived from human dermis, is the
57
AlloMaxTM
Veritas
TM
TM
The bioprosthesis AlloMax (formerly Neoform ) is a nonreticulated sterile acellular collagen matrix derived from
human dermis used for post-mastectomy reconstruction.
AlloMaxTM can be indicated for complex inguinal or incisional hernia repair in patients where synthetic prostheses
are contraindicated or inappropriate.
Xenogenic bioprostheses
Xenogenic prostheses can be of porcine (dermis or intestinal
mucosa) or bovine (pericardium) origin, reticulated or not.
There are more than 20 commercial products available, but
in France, only six products have received the CE marking
and been studied in clinical trials, albeit with a low level of
evidence (Table 4).
CollaMend
This bioprosthesis is composed of reticulated porcine dermis and has been evaluated in three clinical studies, two of
which were retrospective [17,23].
Permacol
This bioprosthesis, originating from reticulated porcine dermis, was evaluated in 110 references, of which 37 were
clinical studies: two retrospective studies can be considered
of value [24,25] while the level of evidence was low in four
prospective studies [2629].
Strattice
This bioprosthesis, originating from non-reticulated porcine
dermis, has been evaluated in 19 references including four
preclinical studies (one being a retrospective case report
and one, a review of the literature, six clinical cases in all)
and four ongoing clinical studies one of which is a multicenter study for ventral hernia: the RICH study (for use
in infected elds) [30]. A prospective multicenter tripleblinded randomized controlled study comparing the use of
Strattice vs. a synthetic prosthesis for primary inguinal hernia in 170 male patients with an average follow-up of 2 years
is underway and should provide interesting data concerning
the behavior of these bioprostheses [31].
Surgisis or Biodesign
This bioprothesis, composed of non-reticulated porcine
intestinal mucosa, was the object of 800 published articles (all domains) of which 614 were preclinical studies and
211 clinical (case reports, retrospective series); only one
was a long-term (5 years) prospective study [32] concerning laparoscopic hernia repair in contaminated elds while
three retrospective studies were deemed of value [3335].
Tutomesh or Tutopatch
This non-reticulated bovine pericardial bioprosthesis was
studied in more than 90 publications (all domains) including
eight preclinical studies and the rst multicenter prospective randomized trial Protocole Tutomesh comparing the
efcacy of this bioprosthesis in contaminated or infected
elds vs. traditional suture techniques; this will be published
Protexa
This bioprosthesis, originating from porcine dermis, has
been commercialized in France since 2012. A multicenter
study is underway in Italy.
Cost/effectiveness
There are practically no cost-effectiveness studies available for these bioprotheses. In 2008, Blatnik et al.
[37] estimated that the average cost for parietal reconstruction in an infected eld with AlloDerm was
5330 dollars per patient (4100 euros) not including hospital costs, with a hernia recurrence rate of 80%. By
comparison, the average costs are 53 euros/patient for synthetic Prolene prostheses (Ethicon), 79 euros/patient for
Vicryl (Ethicon), and 237 euros/patient for the composite
Parietex (Sofadim/Bard) prosthesis.
Conclusion
The surgeon has to choose the correct implant according to
its properties and the clinical picture. In any case, the procedure should never be adapted to the product available,
which implies that the surgeon should have a wide range of
products at his or her disposal. The important parameters
to take into account include: the size and site of the defect
58
to cover, the rigidity of the implant, the potential contamination of the operative eld, the need or desire for cellular
ingrowth, and the surgical approach; the cost-efcacy ratio
based on similar services should not be ignored. Synthetic
implants have been widely studied and their efcacy proven
for individual indications. Bioprostheses should have their
place in the therapeutic armamentarium of abdominal and
reconstructive surgery, in particular, in complex situations
where the parietal reinforcement has to be made in potentially contaminated or infected elds. The results of the
rst multicenter prospective randomized study in France
comparing the efcacy of Tutomesh versus simple suture
repair for the treatment of inguinal or incisional hernia in
potentially contaminated or infected eld are awaited.
M. Poussier et al.
[15]
[16]
[17]
[18]
[19]
[20]
Disclosure of interest
The authors declare that they have no conicts of interest
concerning this article.
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