Beruflich Dokumente
Kultur Dokumente
Scientific (Exp)/Research
Experimental Surgery Laboratory, Medical Faculty, Rouen University, UPRES EA 3830 GRHV, 22 Bd. Gambetta-76183
Rouen Cedex 1, France; bCNRS FRE 3101, Polymers, Biopolymers, Surfaces, Rouen National Institute of Applied Sciences,
Mont-Saint-Aignan Cedex, France; cDepartment of Digestive Surgery, Rouen University Hospital, Rouen Cedex, France
KEYWORDS:
Abdominal hernia;
Elasticity;
Linear force;
Polypropylene;
Prosthesis;
Retraction
Abstract
BACKGROUND: Although polypropylene (PP) is the most common biomaterial used for ventral and
inguinal hernia repairs, its mechanical properties remain obscure.
METHODS: Retraction, solidity, and elasticity of 3 large pore-size monofilament PP prostheses, 1
heavy-weight PP (HWPP), a second low-weight PP, and a third coated with atelocollagen were evaluated
in a rabbit incisional hernia model. A small pore-size multifilament PP implant (MPP) also was tested.
RESULTS: Unlike pore size, the weight of the prosthesis was not an influencing factor for retraction.
Atelocollagen coating reduced retraction (P .05). HWPP and MPP were less likely to rupture (P .05).
HWPP had comparatively better elasticity (P .05), whereas MPP supported the greatest elastic force (P
.05). Nevertheless, the amount of shrinkage of MPP (30% of the original size) made this prosthesis unusable.
CONCLUSIONS: In this study, HWPP presented the most advantageous biomechanical compromise
for hernia surgery.
2010 Elsevier Inc. All rights reserved.
0002-9610/$ - see front matter 2010 Elsevier Inc. All rights reserved.
doi:10.1016/j.amjsurg.2009.09.024
F. Sergent et al.
Table 1
407
Commercial name
Filament structure
Knitting meshes
Pore size, mm
Parietene PP (HWPP)
Parietene PPL (LWPP)
Parietex Ugytex (CPP)
Surgipro SPM (MPP)
Monofilament
Monofilament
Monofilament
Multifilament
Not blocked
Not blocked
Not blocked
Blocked
2.0
1.5
1.5
.7
Methods
Four models of PP prostheses were tested as follows: (1)
a large pore size (1 mm) of heavy weight (density, 75
g/m2) monofilament material (Parietene PP; Covidien Company, Trvoux, France), which was termed heavy-weight
PP (HWPP); (2) a large pore size of low weight (density,
75 g/m2) monofilament material (Parietene PPL; Covidien
Company, Trvoux, France), which was referred to as lowweight PP (LWPP); (3) a third model (Parietex Ugytex;
Covidien Company, Trvoux, France), whose characteristics were practically identical to the preceding prosthesis
(LWPP), but that was coated with a hydrophilic and absorbable film composed of type I porcine atelocollagen, polyethylene glycol, and glycerol, which was referred to as
collagen PP (CPP); and (4) a small pore size (1 mm) of
heavy-weight multifilament material (Surgipro SPM; Tyco
Healthcare, Plaisir, France), which was referred to as multifilament PP (MPP). The precise characteristics of the prostheses used in this study, are summarized in Table 1.
The principal types of prostheses in PP currently used in
human abdominal wall reconstructive surgery then subsequently were evaluated.
HWPP and LWPP prosthesis characteristics were exactly
identical except in terms of density. CPP was a LWPP
prosthesis with a collagen coating. MPP was different from
the 3 other prostheses by its multifilament weaving and
its pore size. This method made it possible to perform a
2-by-2 comparison of the prostheses, characteristic by
characteristic.
1.7
1.5
1.5
.3
Weight, g/m2
Amids5 classification
75
38
38
85
1
1
1
3
Figure 1
408
a
c
S
Tension
Prosthesis
b
Tension
Figure 2 Principle of the mechanical study performed on the Instron tensiometer. a: sample length, interjaw distance, 10 mm; b: sample
width, 10 mm; c: sample thickness, variable depending on the type of prosthesis; S: sample section subjected to tensile strength, b c.
surface before implantation, thus was deduced. This corresponded to our definition of the prosthetic retraction.
All the prostheses then were cut again, preserving only
the middle part of the prosthesis, so that their width corresponded to 1 cm. They were maintained in the traction jaws
of an Instron tensiometer (model 5543; Instron SAS, lancourt, France) with the interjaw distance fixed at 1 cm (Fig.
2). Prostheses were subjected to an elongation of 5 mm/min
until rupture. For each prosthesis, we obtained a curve of the
linear force (expressed in N/cm) to which the prosthesis was
subjected per unit of width, depending on its deformation
(expressed in % of the initial length).
Elasticity is the physical capacity of a body to return to
its initial shape after suppression of the deformation. A body
is perfectly elastic if it completely returns to its original
form after suppression of the traction. It is partially elastic
if the deformation produced by the external forces does not
completely disappear when traction is stopped. The relationship between the force applied to the body, in this case
the prosthesis (per section unit), and the deformation shown,
remain constant, as long as the deformation is small and the
elastic limits of the material are not reached. This is
Hookes law: E (F/S)/, with E as the constant indicated
by Youngs modulus or elastic modulus; F as the force
applied to the body; S, its section; and , its deformation.
Youngs modulus is the reflection of body elasticity. Any
body, whatever it is, has a certain degree of elasticity.
However, a body with a high Youngs modulus is known as
stiff. In contrast, a body with a low Youngs modulus is
known as supple.
The force of maximum traction, by width unit expressed in
N/cm, to which each prosthesis could be opposed before its
rupture point, its corresponding deformation expressed in percentage of initial length (fixed here at 1 cm), its elasticity
(which corresponded to the Youngs elastic modulus), expressed in megapascals, were calculated (Fig. 3). Based on
prosthesis elastic modulus and the maximum elastic deformation calculations, once known, and according to Hookes law,
it was possible to deduce the maximum traction force value
that should not be exceeded without the risk for the prosthesis
to leave its elastic range and to damage it permanently.
The results were reported by using medians and ranges.
For a given group (day 14, 30, 90, and 180), the 4 types of
prostheses were compared pairwise using the Wilcoxon test,
corrected by the Friedman test. To establish a comparison
between each group, the KruskalWallis test was used,
corrected by the Holm-Bonferroni test. P values less than
.05 were considered statistically significant. The statistical
analyses were performed using SAS software (version 8;
SAS Institute, Cary, NC).
Results
Among the 160 ventral incisional hernia repairs, no defect was observed. Intestinal adherence around prostheses
F. Sergent et al.
was not found. Two prostheses, one in CPP and the other in
MPP, were exposed on the same rabbit in the 90-day group.
Half of the MPP prostheses (5 of 10) were not integrated in
the 14-day group. Twelve abscesses (7.5% of the prostheses) were observed. This included all types of prostheses: 2
for HWPP, 2 for LWPP, 3 for CPP, and 5 for MPP prostheses.
On the 160 implanted prostheses, 115 (72%) retracted,
without any difference between heavy and low weight, collagen coated, monofilament, or multifilament forms. There was
stability over the period (day 14, 30, 90, and 180) in the
number of the retracted prostheses, except for MPP prostheses
ranging from 10% to 80%, for which the maximum retraction
proportion was observed later in the 90- and 180-day groups.
409
Figure 5 Prosthetic solidity and elasticity. Data are expressed as median values (ranges). P 0.05 for 1HWPP versus LWPP, 2HWPP
versus CPP, 3HWPP versus MPP, 4LWPP versus CPP, 5LWPP versus MPP, and 6CPP versus MPP.
410
Comments
All 4 types of tested PP prostheses retracted. For any
given prosthesis, the severity of shrinkage was not predictable. Therefore, this could be a problem when prostheses
are inserted into the abdominal wall. It is possible that the
retraction produced pain. Nevertheless, retraction was not
equal between the different types of PP prostheses. According to Konstantinovic et al,11 in a rat incisional hernia
model, retraction appears maximum at day 14. In our study
at day 14, CPP retracted to a lesser extent compared with the
other monofilament prostheses and also globally compared
with all the prostheses over the sum of all the periods.
To date, published studies have correlated the increase in
prosthesis retraction with prosthesis weight. However, these
comparative studies were not homogeneous with regard to
the structure of the weave of the prosthesis filaments. Klinge
et al12 compared monofilament PP tight meshes of .46-mm
pore size that weighed 95 g/m2 with MPP broad meshes of
2.8-mm pore size, combined with polyglactin 910 that
weighed 55 g/m2. The investigators noted more retraction
with the heavy-weight prostheses but they completely ignored pore size, which was different. Similarly, Scheidbach
et al13 compared 4 different PP meshes of different pore
sizes, of which 1 prosthesis incorporated polyglactin 910.
However, 2 prostheses with different weights, 36 and 16
g/m2, both with pore size greater than 1 mm, had similar
retraction rates of 7% and 5%.
In our study, HWPP and LWPP had the same characteristics, except for weight, which became the only variable.
However, HWPP and LWPP retracted identically. Therefore, our study clearly shows that the weight itself does not
have any impact on the retraction, if pore size and meshes
remain constant.
In our experiment, with nearly equal weight, multifilament prosthesis of .3-mm pore size (MPP) retracted more
than monofilament prosthesis of 1.7-mm pore size (HWPP).
According to Klinge et al,12 who found more retraction for
monofilament prostheses of .46-mm pore size than multi-
filament prostheses of 2.8-mm pore size, it could be deduced that it was not the structure of the prosthesis but
primarily its pore size that influenced its retraction. For
Cobb et al,7 the fibrosis bridges, which are established
between prosthesis filaments and are at the origin of their
retraction, would be facilitated in fact when meshes are
tight.
Other studies have shown that for PP, pore size could
have a role on local inflammatory reaction and fibrosis
generated by prosthesis. In a more recent study, Klinge et
al14 found more macrophages, granulocytes, cell infiltrates,
and fibrous reactions in contact with tight mesh prostheses
than those with broad meshes. Recently, Weyhe et al15 also
confirmed these data and found more fibrosis with tight
mesh prostheses.
In our study, CPP prostheses had the weakest retraction.
Similar to LWPP prostheses, their performance should be
equivalent. Also, the atelocollagen and polyethylene glycol glycerol coating, which is proposed to reduce severe
visceral adherences in abdominal wall or vaginal surgeries,
by favoring a fast and small inflammatory tissue integration,16,17 could be a factor that interferes in the retraction.
Retraction appeared quickly for the 3 tested monofilament prostheses. It did not apparently worsen thereafter,
confirming other studies.11 The delayed integration of the
MPP prosthesis subsequently resulted in a late retraction.
Reduced pore size, certainly by the means of inflammatory
reaction,13 delayed the prosthetic integration. In Amids5
classification of biomaterials, a pore size cut-off value of 75
m to define the capacity of prosthesis tissue integration
must be completed. Tissue integration of a prosthesis whose
pore size exceeds just 75 m is definitely not identical to a
prosthesis whose pore size is greater than 1 mm.
Clinical evidence reported by many investigators seems
to indicate that for a similar material, reduction in its content
decreases its complications. Therefore, the current trend
increasingly is to use low-weight prosthetic materials.18
This evolution must be opposed to the forces to which the
prostheses will be subjected, and which in fact remain
constant. These forces correspond to those of intra-abdominal pressure.
For most investigators, in a human adult population of
normal weight, the maximum physiologic linear force that can
be exerted on the abdominal enclosure is classically 16
N/cm.11,19 For some investigators, it could even reach 27
N/cm.20
In our experimental study, once implanted, all the heavy
prostheses (HWPP and MPP) were able to oppose maximum
linear forces of 16 N/cm and even of 27 N/cm. Nevertheless,
it was not possible for the light prostheses (LWPP and CPP).
This means that light prostheses, approximately 40 g/m2, could
be insufficient in terms of solidity to manage hernia durably. In
fact, in the field of prosthetic hernia repair, O= Dwyer et al8
confirmed these data by recording failure rates of 5.6% for
light PP prostheses of 32 g/m2 versus .4% for heavy PP
prostheses of 85 g/m2 (P .05) at 12 months.
F. Sergent et al.
Except for the MPP late group (day 180), there was no
benefit in solidity after tissue integration of the prostheses.
Indirectly, our study on nonabsorbable prostheses confirms
that only synthetic meshing of the prosthesis renders solidity to the prosthesis and not the tissue that will colonize it,
which is unable to reproduce the biomechanical characteristics of native tissues. Recent data in the urogynecological
literature agree with this concept.21,22
Prosthesis deformation and elasticity specifically were
studied in stress urinary incontinence with suburethral
slings.23 For abdominal wall surgery, ideally the repaired
abdomen should be able to change its shape while breathing.
Theoretically, all the 3 monofilament prostheses, and especially HWPP, were satisfactory. Nevertheless, deformation
of a prosthesis is interesting only if it remains elastic. Once
the forces involving the prosthesis are removed, the prosthesis must return to its initial dimensions. In practice,
beyond 5 to 10 N/cm, these 3 prostheses became irreversibly deformed. Thus, the prostheses were unable to remain
within their respective elastic range with the maximum
abdominal pressure forces to which they could be subjected
(16 27 N/cm). Paradoxically, MPP, which was supposedly
the most stiff biomaterial, was in fact the most appropriate
to remain within the elastic range.
We agree that there were many time points measured,
and the results were not always statistically significant at
each time point, but it was an experimental study with only
40 rabbit models. However, prosthetic solidity and elasticity
remained constant.
Although MPP showed the most interesting biomechanical characteristics (force of maximum traction, deformation,
and maximum elastic force), considerable amount of shrinkage of this prosthesis made it unusable. After MPP, HWPP
was undeniably the best prosthesis for the force at the
rupture. Of the 3 remaining prostheses, HWPP was the only
one able to support the intra-abdominal pressure, and therefore met the requirements of durable hernia repair.
Conclusions
Based on our current knowledge regarding available
prosthetic materials, PP remains the biomaterial of reference in abdominal hernia surgery. Nevertheless, the results
of our experimental study concerning rabbits suggest that all
PP materials are not equivalent.
Retraction was influenced by pore size meshes and appeared rapidly after prosthesis integration. In fact, prosthesis weight did not have any impact on retraction. Atelocollagen coating decreased retraction.
With regard to rupture prosthesis, the synthetic meshing
of the prosthesis alone gives solidity to the prosthesis and
not the tissue that will colonize it. Therefore, low-weight
prostheses could be insufficient in solidity to manage hernias durably.
With regard to elasticity, heavy-weight MPP prostheses
were the most appropriate to remain within the elastic range.
411
Acknowledgments
The authors thank Richard Medeiros, Rouen University
Hospital Medical Editor, for editing the manuscript. The
authors also are grateful for the gift of PP prostheses from
Covidien Company (Trvoux, France).
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