Journal of Visceral Surgery (2013) 150, 52—59

Available online at

www.sciencedirect.com

ORIGINAL ARTICLE

A review of available prosthetic material for

abdominal wall repair
M. Poussier , E. Denève , P. Blanc , E. Boulay ,
M. Bertrand , M. Nedelcu , A. Herrero , J.-M. Fabre ,
D. Nocca ∗

Service de chirurgie digestive A, Hôpital Saint-Eloi, CHU de Montpellier, 80, avenue

Augustin-Fliche, 34295 Montpellier cedex 5, France

KEYWORDS Summary Abdominal wall incisional and inguinal hernia repair can call for utilization of
Prosthetic material; implants or prostheses as an alternative to simple suture techniques. The various implants
Abdominal wall can be synthetic, biologic or mixed: their physicochemical properties condition the mechanical
repair; results and the long-term outcome of the repair. The increasing number of available mate-
Hernia rials allows the surgeon to choose between a wide variety depending on the indication, the
site of implantation, the surgical approach and whether the operative field is contaminated
or not. With regard to evidence-based medicine, while several synthetic implants have been
shown to be superior in efficacy to simple suture, other studies are underway to develop the
indications for bioprostheses, in particular in contaminated fields. This review of the litera-
ture 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 Autorité de santé 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 first 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 multifilaments, woven, knitted or glued in the form of a mesh.
Ideally, these implants should be chemically inert, not elicit any inflammatory 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).

1878-7886/$ — see front matter © 2012 Published by Elsevier Masson SAS.

http://dx.doi.org/10.1016/j.jviscsurg.2012.10.002
A review of available prosthetic material for abdominal wall repair
Synthetic implants
Classification and properties
The HAS has classed the abdominal wall implants in three
categories: flat, 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 field) where non-
absorbable prostheses can be used [1]. Absorbable
prostheses (example: Vicryl® ) can be used for emergency
repair, in a contaminated or infected field, to reduce
the risk of evisceration, but with poor long-term results
with regard to hernia recurrence because of the weak-
ness 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 anti-
adhesion 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 film (example: ePTFE or expanded poly-
tetrafluorethylene). 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 fibro-
blasts, 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 inflammatory reaction
is generated by each individual fiber; 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 poly-
mer and the size of the grid. Heavy-weight prostheses
(> 90 g/m2 ) are made by tight braiding with thick,
microporous filaments. Light wieght prostheses are com-
posed of thin filaments and/or large macroporous grids
(> 1 mm), leading to less inflammatory reaction and more
elasticity;
• elasticity: this characteristic varies according to whether
the implant is light-weight (20—35% at a pressure of
16 N/cm2 ) or heavy-weight (4—16% 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 abdomi-
nal containment; conversely, inguinal hernia repair would
benefit from a light-weight, large grid implant where elas-
ticity would increase patient comfort during movements
53
(flexion of the thigh) and decrease inflammation in an
abundantly innervated region;
• size: the size of the prosthesis should be adapted to the
size of the orifice to be covered. In the treatment of
incisional hernia, the overlap should be at least 5 cm in
all dimensions [2]. One must not forget the ‘‘shrinkage’’
effect, which translates as in vivo shortening of the
implant due to tissular reaction.
Classical implants
At the present time, there are three different non-
absorbable implants available that differ by their chemical
composition as well as by their plaiting: polypropylene,
polyester and expanded polytetrafluoroethylene (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 polytetrafluoroethylene (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.
Light-weight and extra light-weight implants
The concept of light-weight material appeared in 1998 with
the commercialization of Vypro® by Ethicon. The basic mate-
rial was reduced by 30% compared with classical implants
while the size of the pores increased (3 to 5 mm vs. < 1 mm
for the classical implants). Large grids were therefore used
to obtain light-weight prostheses.
Later, partially absorbable (50%) implants were obtained
either by adding absorbable filament meshes to polypro-
pylene meshes, or coating the polypropylene filaments
with absorbable polymers. With this type of implant,
the inflammatory reaction is decreased by 70% and heal-
ing takes place around each monofilament, not globally.
The initial partially absorbable light-weight prostheses
were composed of polypropylene + polygalactine 910 (exam-
ple: Vipro® and Viproll® ) or polypropylene + polyglycapone
(example: Ultrapro® ). Polygalactine (Vicryl® ) is absorbed
within 6 weeks and polyglycapone (Monocryl® ) within 12 to
20 weeks. These composite implants are supple, easy to use
because of their form memory and provoke less inflamma-
tion [4].
The other materials used in association with polypropyl-
ene include ␤-D glucan (Glucamesh® ), or poly-L-lactic acid
(PLLA) (example: 4DDome® ), the goal of which is to accel-
erate tissue integration.
Hernia repair with light-weight prostheses have been
noted to decrease the risk of chronic pain [5,6] when the
anterior approach is used, and are associated with better
tolerance when the laparoscopic approach is used [7].
Biface implants
When implants are placed intraperitoneally, as for exam-
ple, 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 Non-absorbable Implant for endoscopic
knitted or woven, coated implant not knitted nor or mini-invasive
or non-coated woven surgery, anatomic,
pre-formed, pre-cut,
with positioning
system, plugs
Price TIPSa Surface ≤ 100 cm2 49.7 D Surface ≤ 100 cm2 182.94 D 102.45 D
100 cm2 < Surface ≤ 61.44 D 100 cm2 <Surface ≤ 365.88 D
250 cm2 250 cm2
Surface > 250 cm2 80.49 D 250 cm2 < Surface ≤ 518.33 D
450 cm2
Surface > 450 cm2 1067.14 D
a All prices are net with tax; TIPS: tarif interministériel des prestations sanitaires (Interministerial tariff for health-related acts).

integration characteristics; conversely, the face in contact

with the viscera should resist adhesion formation and
enhance neoperitoneal formation. The non-absorbable pari-
etal face is usually composed of classical material, often
polypropylene; the visceral face can be made of absorbable
or non-absorbable material. Absorbable materials include
oxidized regenerated cellulose (example: Proceed® ), car-
boxymethylcellulose, or a porcin cellulose-based film,
polyethylene glycol and glycerol (example: Composite
Parietex® ) or a bio-absorbable reticulated gel composed of
omega-3 fatty acids (C-QURTM ® ).
Non-absorbable materials include ePTFE (example: Com-
posix L/P® ; Dual Mesh® ), silicone, polyurethane (example:
Intra-Swing Composite® ), or titan. All are inert materials,
hydrophobic, non-adhesiogenic, intended to avoid cellular
penetration.
Other technical improvements
Regular improvements have been made to facilitate the use
of implants. These include:
• preformed or precut implants adapted to different tech-
niques. Examples comprise dome-shaped implants (4D
Dome® ; Ultrapro Plug® , Perfix plug® ) for the plug tech-
niques; different pre-cut prostheses to allow the passage
of the spermatic cord (Lichtenstein technique); meshes
that assume the anatomical contours of the inguinal
region for the pre-peritoneal technique (example: Swing
Mesh 4A® , 3D Max® );
• implants facilitating their fixation: implants furnished
with either an auto-adhesive cover (example: Swing
Contact® , Adhesix® , Progrip® ) or with thermo-inducted
staples (example: Endorollfix® );
• three-dimensional implants theoretically limiting the pos-
sibility of migration (example: UHS® , Ultrapro® , 3D
patch® , PHS® );
• implants adapted to laparoscopic maneuvering, for exam-
ple, pre-rolled to facilitate the passage in the trocar
(example: Endoroll® ), or with pre-inserted cardinal point
sutures (example: Parietex® ).
Table 2 Implant cost: implants for abdominal wall
reconstruction, suspension, or wrapping. Resorbable
without tissues or derivatives of biologic origin.
Nomenclature Absorbable implant
Knitted or woven,
coated or non-coated
Price TIPS Surface ≤ 250 cm2 32.17 Da
Surface > 250 cm2 83.39 Da
a
All prices are net with tax; TIPS: tarif interministériel des
prestations sanitaires (Interministerial tariff for health-related
acts).
Bioprotheses
Nature and physicochemical characteristics of
bioprotheses
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 inte-
gration and cellular colonization of the prosthesis by the host
tissues.
Concept of ‘‘bioactivity’’
Collagen is a hemostatic, biodegradable biomaterial that is
easy to handle and indispensable for cellular ingrowth. It
serves as a scaffold for integration of host tissular regener-
ation via its architectural organization. The rationale is to
guide the healing process and restore the initial host status
so that cellular penetration, neovascularization and fibro-
connective tissue production can form around the implant
[8].

Costs of parietal reinforcement prostheses Synthesis procedures

Several procedures exist for the synthesis of bioprostheses
The costs of the various prostheses are defined according to (Tutopatch® , SIS® , Tissue Science® process, etc.); these rely
a classification based on their constitution and their proper- on the same basic steps irrespective of the origin of the
ties (Tables 1—3). tissues. In Europe, the Conformité européenne (CE) marking
A review of available prosthetic material for abdominal wall repair
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 Surface ≤ 100 cm2
100 cm2 < Surface ≤ 250 cm2
Surface > 250 cm2
a All prices are net with tax; TIPS: tarif interministériel des prestations sanitaires (Interministerial tariff for health-related acts).
is delivered for implantable medical devices. Products are
divided into four classes (I, IIa, IIb and III) according to their
potential health risks; for each of them, precise modalities
have been established for conformity evaluation.
Biomechanical characteristics
The biomechanical characteristics of prosthetic reinforce-
ment implants are essential to the intrinsic efficacy
of ensuring mechanically reliable tissue reinforcement.
Deeken et al. [9] recently studied several parameters (phys-
ical, thermic, and degradation) in a series of 12 human,
porcine and bovine bioprotheses. All the tested prosthe-
ses 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 non-
reticulated implants.
Reticulation
Reticulation or cross-linking is an old procedure (tan-
ning) 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 dura-
bility and decrease the immunogenicity of xenogenic
implants [10]. Several types of reticulating agents are
used: glutaraldehyde, hexamethylene diisocyanate and 1-
ethyl-3-(3-dimethylaminopropyl) carbodiimide (EDC). These
biological implants were designed with the goal of
reinforcing tissues while gradually degrading over time.
In vivo, reticulation modifies tissue restructuring and cel-
lular infiltration and increases the duration of the implant
before reabsorption [11]. Some authors feel that reticu-
lation limits tissue regeneration because the bioprothesis
behaves like non- or very slowly absorbable synthetic pros-
theses; 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 acti-
vation) and increase the inflammatory response to host
tissues (pro-inflammatory 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
fields (79%) and that their innate tendency to bacterial
55
248.80 Da
292.70 Da
380.51 Da
colonization was elevated [16]. Encapsulation of reticulated
implants, a complication that resembles a graft vs. host
rejection reaction, is due to a combination of host inflam-
matory response, immunogenicity, and to inadequate tissue
restructuration due to insufficient tissue integration [15].
When encapsulation occurs, this may lead to decreased qual-
ity of tissue repair and necessitate implant removal [17].
Classification
At the present time, there is no consensual agreement
regarding classification 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 reconstruc-
tive surgery.
Rationale for bioprosthesis placement
Insertion of synthetic material for tissue reinforcement in an
infected or contaminated field is contra-indicated because
there are major risks of chronic infection, rejection or recur-
rence [18]. Nonetheless, there are indications for the use
of temporary interfaces between infected tissues that are
desirable, if not indispensable, even in the contaminated
field.
In order to respond to this challenging problem, new
implantable medical devices began to be introduced in the
1980s [19]. The rational for these bioprostheses resided
in their progressive biodegradability and their supposedly
weak immunogenicity, while still ensuring high quality tis-
sue regeneration with mechanical characteristics similar
to synthetic prostheses. Among others, Milburn et al. [20]
showed in the rodent experimental model that the acellular
dermal collagen matrix (AlloDerm® ) had better resistance
to Staphylococcus aureus inoculation compared with PTFE
for incisional hernia repair; the bacterial clearance was
19.3% versus 0%. These results were confirmed by Harth
and co-workers [21] who compared the bacterial clearance
of a S. aureus innoculum (104 CFU/ml) injected after pari-
etal repair with prosthetic reinforcement comparing four
bioprotheses (Surgisis® , Permacol® , XenMatrix® , Strattice® )
versus a synthetic polyester implant. Bacterial clearance
was 0% for synthetic material, 58% for Surgisis® , 67% for
Permacol® , 75% for XenMatrix® and 92% for Strattice®
(P = 0.003). This confirms the value of the use of biopros-
theses in infected fields; the ultimate outcome depends on
the type of implant.
The indications for bioprostheses have progressively
increased, even though there have been only a few pre-
clinical and clinical studies with high levels of evidence
56 M. Poussier et al.

Table 4 Summary of the principal studies of interest concerning the placement of bioprostheses.
Commercial name of Study Authors Number of Contaminated Indications Mean follow-up
prosthesis type cases or infected (months)
operative field
AlloDerm® RO Diaz et al. [38] 240 Yes Multiple 10
®
CollaMend RO Chavarriaga 18 No Incisional 7.8
et al. [17] hernia
Permacol® RC Cobb et al. 55 No Incisional —
[24] hernia
Strattice® PO Shaikh et al. 20 No Incisional 18
[26] hernia
RO Hsu et al. [25] 28 Yes Incisional 16
hernia
PO Itani et al. 85 Yes Hernia 12
[30]
Surgisis® PR Ansaloni et al. 35 No Hernia 36
[33]
Veritas® PO Franklin et al. 116 Yes Multiple 52
[32]
RO Helton et al. 53 Yes Incisional 14
[34] hernia
RO Ueno et al. 20 Yes Multiple 15
[35]
RO Limpert et al. 22 Yes Incisional 22
[36] hernia
XenMatrix® RO Pohamac et al. 16 Yes Incisional 16
[39] hernia

Commercial name of prosthesis Complications

Global (%) Recurrent Seroma Infection Dehiscence Fistula Removal of
hernia (%) (%) (%) (%) (%) prosthesis
(%)
AlloDerm® 86.7 17.1 31 40 8.8 11.6 —
®
CollaMend 38.9 44.4 — 22.2 — — 22.2
®
Permacol — 6.6 — 3.3 — — 1.8
®
Strattice 40 15 10 10 5 — —
21 10.7 14.3 3.5 3.5 — 0
67 15 22 23 15 2.5 0
Surgisis® 33 0 17.1 2.9 — — —
®
Veritas — 7 9.4 — — — —
50 17 11 — 21 — 32
50 30 10 40 — — —
23 19 3.8 3.8 — — —
XenMatrix® 36 7 21 7 7 — 6.2
RO: retrospective observational; RC: retrospective controlled; PO: prospective observational; PR: prospective randomized.

to evaluate their efficacy compared with four times as
many publications about implantation of these prostheses
in uncontaminated fields [22].
Evidence-based medicine and bioprostheses
Allogenic bioprotheses
Allogenic protheses are produced using the dermis or fascia
lata of cadaver donors (Table 4). Commercialization of these
bioprostheses is not allowed in France. Nonetheless, they
are widely used in the United States where they recently
obtained the authorization from the FDA in spite of the lack
of reference studies.
AlloDerm®
The bioprosthesis AlloDerm® , a non-reticulated sterile acel-
lular collagen matrix derived from human dermis, is the
A review of available prosthetic material for abdominal wall repair
most widely studied product (547 references) and has been
implanted in more than one million procedures.
AlloMaxTM
TM TM
The bioprosthesis AlloMax (formerly Neoform ) is a non-
reticulated sterile acellular collagen matrix derived from
human dermis used for post-mastectomy reconstruction.
AlloMaxTM can be indicated for complex inguinal or inci-
sional hernia repair in patients where synthetic prostheses
are contraindicated or inappropriate.
Flex HD® Acellular Hydrated Dermis
The bioposthesis Flex HD® Acellular Hydrated Dermis is
a non-reticulated sterile acellular collagen matrix derived
from human dermis provided by a donor bank (Musculoskele-
tal Transplant Foundation); it is used for post-mastectomy
reconstruction or repair of complex hernia or incisional her-
nia.
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 der-
mis and has been evaluated in three clinical studies, two of
which were retrospective [17,23].
Permacol®
This bioprosthesis, originating from reticulated porcine der-
mis, 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 [26—29].
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 multi-
center study for ventral hernia: the ‘‘RICH’’ study (for use
in infected fields) [30]. A prospective multicenter triple-
blinded randomized controlled study comparing the use of
Strattice® vs. a synthetic prosthesis for primary inguinal her-
nia 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 arti-
cles (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] concern-
ing laparoscopic hernia repair in contaminated fields while
three retrospective studies were deemed of value [33—35].
Tutomesh® or Tutopatch®
This non-reticulated bovine pericardial bioprosthesis was
studied in more than 90 publications (all domains) including
eight preclinical studies and the first multicenter prospec-
tive randomized trial ‘‘Protocole Tutomesh® ’’ comparing the
efficacy of this bioprosthesis in contaminated or infected
fields vs. traditional suture techniques; this will be published
57
soon (Nocca et al. presented the results in the EHS congress
Ghent 2011).
Veritas®
This non-reticulated bovine pericardial bioprosthesis was
studied in 20 publications (all domains) including four pre-
clinical and 14 clinical studies [36].
Protexa®
This bioprosthesis, originating from porcine dermis, has
been commercialized in France since 2012. A multicenter
study is underway in Italy.
Comparative studies between prostheses
After initial feasibility and efficacy studies, several bio-
prostheses have been compared among themselves. In
their retrospective study, Shah et al. [23] compared the
use of five different bioprostheses (AlloDerm® , Permacol® ,
CollaMend® , Surgisis® and Strattice® ) for complex abdom-
inal incisional hernia repair in 58 patients. They found an
overall complication rate of 72.4% including 19% infections,
8.6% seromas and 5.2% abscesses. Reticulated biopros-
theses (Permacol® , CollaMend® ) had higher infection and
removal rates but lower recurrence rates compared with
non-reticulated bioprostheses. Hiles et al. [22] found a 6.7%
recurrence rate for Surgisis® versus 13.6% for AlloDerm® at
16 months in clean environment repair.
Cost/effectiveness
There are practically no cost-effectiveness studies avail-
able for these bioprotheses. In 2008, Blatnik et al.
[37] estimated that the average cost for parietal recon-
struction in an infected field with AlloDerm® was
5330 dollars per patient (4100 euros) not including hos-
pital costs, with a hernia recurrence rate of 80%. By
comparison, the average costs are 53 euros/patient for syn-
thetic Prolene® prostheses (Ethicon), 79 euros/patient for
Vicryl® (Ethicon), and 237 euros/patient for the composite
Parietex® (Sofadim/Bard) prosthesis.
Safety — Informed consent
As is the case for implantable medical devices, bioprosthe-
ses respond to the health criteria relative to their utilization
according to the country in which they are commercial-
ized (premarket approval [PMA] and 510k of the FDA, EC
marking in Europe). These requirements are supposed to
guaranty the safety of the product for the patient, in partic-
ular viral infectious, prion and cancerogenic risks. Despite
all these precautions, results of preclinical studies with
regard to harm are rare and not clear. Along the same lines,
and according the French law of March 4, 2002, patients
must receive complete information concerning the use of
bioprostheses, especially as concerns the tissue origin of
the product, both for ethical reasons and to respect each
patient’s personal convictions.
Conclusion
The surgeon has to choose the correct implant according to
its properties and the clinical picture. In any case, the pro-
cedure 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 contami-
nation of the operative field, the need or desire for cellular
ingrowth, and the surgical approach; the cost-efficacy ratio
based on similar services should not be ignored. Synthetic
implants have been widely studied and their efficacy 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 poten-
tially contaminated or infected fields. The results of the
first multicenter prospective randomized study in France
comparing the efficacy of Tutomesh® versus simple suture
repair for the treatment of inguinal or incisional hernia in
potentially contaminated or infected field are awaited.
Disclosure of interest
The authors declare that they have no conflicts of interest
concerning this article.
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