Study 2 - Covidien

PARIETEX COMPOSITE
10 YEAR ANNIVERSARY 1999-2009
10 YEARS OF CLINICAL EVIDENCE

THE CONCEPT
Polyester mesh takes on the challenge of
hernia repair with material and manufacturing
innovations to optimize healing and comfort
through fast and intimate tissue in-growth. The
new architecture of hernia repair features an
enhanced hydrophilic, multi-filament construct
and optimal porosity. Studies show that
polyester is superior to other materials, such as
polypropylene and ePTFE, in lack of shrinkage,
advanced rate of healing and improved patient
comfort.
Optimized Material - hydrophilic polyester
enhances rapid tissue in-growth rapid and
complete tissue integration is an important
requirement for an optimal hernia repair mesh 1 .
To answer this need, our technology begins with
a material difference — polyester. When this
material is designed with optimum pore size
it enhances fast and intimate tissue ingrowth.
Polyester promotes the attraction, fixation and
survival of young fibroblasts and mesothelial
cells due to its hydrophilic nature. In contrast,
polypropylene and ePTFE tend to repel all
cells and avoid the fixation of all living cells
to the material because of their hydrophobic
characteristic. When a hydrophobic material
like polypropylene, which do not promote the
attraction of cells, is combined with a small-pore,
size a common result is encapsulation of the
mesh with scar tissue.
Optimized Structure – porosity promotes
connective tissue differentiation. To allow fast
and intimate tissue in-growth without any
peripheral fibrous capsule (which can cause
shrinkage, discomfort and chronic pain), a
mesh must also have porosities that are as large
as possible 5 .Pore sizes below 1 mm trigger an
intense inflammatory response. Inflammation
and scar formation lead directly to encapsulation
which in turn leads to contraction.
Parietex technology creates both micropores for
optimized cellular in-growth between the fibers
and large macropores for true connective tissue
differentiation. Parietex’s porosity allows the
right amount of connective tissue in-growth with
no fibrotic encapsulation or degradation.
Preventing Visceral Attachments
Intraperitoneal placement of the mesh represents
a real advance in the ventral hernia repair:
it facilitates laparoscopic treatment of small
incisional hernia repair. The result is a reduction
of operative time that benefits the patient by
decreasing of surgical and anesthetic morbidity.
When placing a mesh intraperitoneally it must
provide a permanent or temporary interface
between normally separated structures.
The requirements for an ideal mesh are:
• To physically separate anatomical structures
during the early healing phase
• To induce a minimized inflammatory response
in order to reduce both encapsulation and
adhesions to the barrier itself
• To restore normal cleavage plans
Parietex Composite (PCO) Mesh is composed
of three-dimensional polyester structure on the
parietal side and an absorbable collagen film on
the visceral side.

PCO Series
(Laparoscopy Surgery)
A proprietary manufacturing
process creates a strong link
between the film and the
threedimensional polyester
structure (picture 1) which
eliminates the risk of
delamination that has been
reported in other meshes.
PCO OS Series
(Open Surgery)
Picture 1.
The continuous, smooth, hydrophilic and
resorbable collagen film is composed of a
mixture of oxidized atelocollagen type I,
polyethylene glycol and glycerol.
The hydrogel film’s physico-chemical properties:
hydrophilicity, elasticity and transparency
make it easy for surgeons to implant the mesh
intraperitoneally. Moreover, the film extends 5
mm over the mesh edges providing additional
protection.
Parietex Composite (PCO) Mesh provides a
temporary barrier and the film’s hydrophilicity
promotes the attraction of mesothelial cells.
After absorption it leaves a neo-peritoneum
composed by mesothelial cells that will prevent
visceral attachments.
Parietex Composite
Hiatal Mesh
Parietex Composite
Parastomal Mesh
Before resorption of the hydrogelic film
Hydrogelic
film
Mesh
superficial
thread
Mesh deep
thread
Abdominal
wall
Transversal section 1 week after implantation
After resorption of the hydrogelic film
Mesh
superficial
thread
Mesh deep
thread
Abdominal
wall
Transversal section 6 weeks after implantation
Neoformed
mesothelial
layer
Continuous
neoperitoneum
Differentiated
tissue in-growth
Intimate
attachment
of the mesh
to the wall

CLINICAL RESULTS
An optimal balance of properties backed the largest portfolio of clinical studies.
Study # Adhesion Integration Shrinkage Degradation Pain Infection Elasticity
Balique 1 X X X
Chelala 2 X X X
Burger 3 X X
Jacob 4 X X X
Duffy 5 X X
McGinty 6 X X X
Clavé 7 X
Bracco 8 X
Ramshaw 9 X
Junge 10 X X
Gonzales 11 X
Schreinemacher 12 X X
Köckerling 13 X X
Junge 14 X X X
Rosen 15 X
ADHESION PREVENTION
Study 1.
80 patients were included in this prospective
multicenter clinical trial. The main objective
was to evaluate the antiadhesive properties of
Parietex Composite (PCO) Mesh. Ultrasound
(US) specific examinations of intestinal
movement was initially validated (pre-operative
prediction vs. Preoperative findings) and then
used during the followup.
Results
After 12 months, 86% of the patients were
ultrasonically adhesion free.
• There was 0% occlusion and fistula.
• Late complications were: mesh sepsis (1%),
new defects (4%) and recurrence (2.5%).
• At four years, 56 patients (75.7%) were clinically
evaluated with a mean follow-up of 48±6 months.
• One direct recurrence was noted while six patients
experienced new defect outside the mesh.
No long-term severe complication such as
occlusion or enterocutaneous fistula was observed.
Study 2.
In this retrospective study, the author evaluated
a minimally invasive surgical technique of
moderate to large incisional and ventral hernia
defects using Parietex Composite (PCO)
Mesh. The midterm results for 400 patients are
presented in terms of efficacy and safety.
Results
• On 400 patients, no major complications
were observed, 0 small bowel obstruction,
0 enterocutaneaous fistula and 0 infections.
• A second look study (for other indications) was
performed on 35 patients (8.75%) 3 to 13 months
postoperatively that confirms the global results.
• The majority (23 patients, 65.71%) were adhesion
free.
• Some had loose adhesions of the omentum
(grade 1 of Mueller’s classification; n = 10), and
the remainder had easily cleavable serosal adhesions
(grade 2 of Mueller’s classification; n = 2)
• There were no cases of chronic infection, small
bowel obstruction, fistula, or hernia fistula, and
no conversions occurred in this study.

Study 3
In an experimental rat study, the authors
wanted to evaluate adhesion formation with
different types of currently available composite
meshes. Eight different meshes were placed
intraperitoneally and in direct contact with
abdominal viscera in 200 rats.
The following meshes were tested: polypropylene
(Ethicon's Prolene*), ePTFE (Gore's Dualmesh
®), polypropylene– polyglecaprone composite
(Ethicon's Ultrapro*), titanium–polypropylene
composite (GfE's Timesh®), polypropylene with
carboxymethylcellulose–sodium hyaluronate
coating (Bard* Sepramesh*), polyester with
collagen-polyethylene glycol–glycerol coating
(Parietex Composite), polypropylene–
polydioxanone composite with oxidized cellulose
coating (Ethicon's Proceed), and bovine
pericardium (Tutogen Medical's Tutomesh®).
Adhesion formation, mesh incorporation, tensile
strength, shrinkage, and infection were evaluated
at 7 days and 30 days.
Results
• At 7 days and 30 days, Parietex Composite
resulted in significantly less adhesions (3.9% and
11.2% respectively) than observed with other
meshes except Tutogen Medical's Tutomesh® and
Bard* Sepramesh*
Duamesh
Timesh
Ultrapro
Prolene
Proceed
Sepramesh
PCO
Tutomesh
Study 4.
Adhesion surface at 30 days
0 10 20 30 40 50 60
This prospective, randomized animal study
compared shrinkage, adhesions and tissue
ingrowth between Parietex Composite (PCO)
Mesh, Ethicon's Proceed and uncoated
polypropylene. 3 different 10x15 meshes were
implanted in 10 pigs and then evaluated after
28 days.
• The mean area of adhesions to Parietex
Composite (PCO) Mesh (11%) was significantly
less than for Ethicon's Proceed (48%; p< 0.008)
or PPM (46%;p < 0.008)
%
• Adhesion peel strength was significantly less for
PCO (5.9 N) than for Ethicon's Proceed (12.1 N;
p < 0.02) or PPM (12.9 N; p < 0.02)
60%
50%
40%
30%
20%
10%
0%
Study 5.
In this prospective animal study Parietex
Composite (PCO) Mesh and Bard's Composix®
E/X (Bard) were implanted in female Yorkshire
swine and evaluated in terms of adhesion and
tissue integration. The meshes were analyzed
at 28 days post implantation by a veterinary
pathologist who was blinded to the data.
Results
• At 28 days, PCO induced fewer adhesions than
ePTFE mesh (14.5% vs 53.4%, P=0.007).
• On an adhesion scale (0–5), we had 1.75 for PCO
(P

Results
• After 21 days, adhesion formation was evaluated
and Parietex Composite exhibited the lowest
rate of adhesions with 8.3%, with non significance
difference with other meshes except for
Sepramesh and the untreated mesh.
Untreated Parietene
Control
Sepramesh
Gore-Tex Dual Mesh
Bard Composix E/X
Parietene composite
Parietex composite
Study 12
Adhesion rate in %
0 10 20 30 40 50 60 70 80 90 100
Comparison of adhesion formation between mesh products.
Adhesion rate (%)
This study examined the ability of different
coated and uncoated meshes to attenuate
adhesion formation.
6 meshes were placed intraperitoneally in
rats: Ethicon's Prolene* (polypropylene),
GfE's Timesh® (polypropylene with titanium),
Ethicon's Ultrapro
(polypropylene composites with polyglecaprone),
Ethicon's Proceed (polypropylene mesh coated
with a layer of cellulose) and Parietex Composite
and Atrium's C-QUR (polypropylene mesh
coated with a layer of omega-3 fatty acids).
Adhesions and incorporation were evaluated
macroscopically and microscopically after 7
and 30 days.
%
Results
• Parietex Composite (PCO) and Atrium's
C-QUR showed the lowest score of adhesion
compared to the other meshes with statistical
difference.
• Only Parietex Composite (PCO) showed no
visceral adhesions at 30 days.
Study 13
3 different composite meshes were
laparoscopically implanted in six swine (FEG's
Dynamesh® IPOM, Ethicon's Proceed,
Parietene Composite). Parietene Composite
has the same antiadhesive film than Parietex
Composite.
After 4 months, adhesion incidence and
adhesion coverage were measured.
Results
• Adhesion values were 12.8% for Parietene
Composite, 31.7% for Ethicon's Proceed and
33.2% for Dynamesh IPOM (p = 0.01).
Study 14
4 differents meshes PVDF+PP (FEG's
Dynamesh®), PP+Col (Parietene Composite),
ePTFE (Dual mesh) and PP (a pure
polypropylene mesh serving as control) were
implanted in 40 rats. Parietene Composite
has the same antiadhesive film than Parietex
Composite.
Adhesion rate, tissue integration and shrinkage
were evaluated after 30 days.
Results
• Parietene Composite (PCO) adhesion rate
was (26.8 ± 12.1%) and the PVDF+PP mesh
(34.6 ± 8.2%).

TISSUE INTEGRATION
Study 3
• Parietex Composite (PCO) showed at 7 days
and 30 days the highest tissue incorporation.
• Parietex Composite (PCO) showed the highest
tensile strength (14.2 N)
Tutomesh
Dualmesh
Timesh
Prolene
Proceed
Ultrapro
Sepramesh
PCO
Tensile strengh
0 2 4 6 8 10 12 14 16
Newton
Study 4
• Peak peel strength from the abdominal wall was
significantly higher for PCO (17.2 N) than for
Ethicon's Proceed (10.7 N) or PPM (10 N; p <
0.002)
Study 5
• Good tissue ingrowth and neovascularisation had
been observed in both meshes, although PCO
showed a more complete neoperitoneum.
Study 6
• Peel strength of mesh from the abdominal wall
was greater for PCO (2.8 N/cm, p = 0.001) or
• PPM (2.1 N/cm, p = 0.05) than for ePTFE
(1.3N/cm of mesh width).

SHRINKAGE
Study 2
• Based on the 2 nd look study (35 patients) the
author noted the absence of prosthesis shrinking
and wrinkling in all these cases confirming its
total peritonization on the anterior abdominal
wall.
Study 3
• Parietex Composite (PCO) showed 15.3% at
30 days with no significant difference with other
mesh but Tutogen Medical's Tutomesh® (44.3%)
Study 4
The area of each mesh at the time of insertion
was 150 cm 2 .
• PCO (105.8 cm², 29.5%) had less shrinkage than
Ethicon's Proceed (99.6 cm², 33.6%) but with
no statistically significant difference.
Study 6
The area of each mesh at the time of insertion
was 150 cm 2 .
• ePTFE (94.4 cm 2 , 63% of original area)
• PCO (118.6 cm 2 , 79% of original area, p = 0.001)
• PPM (140.7 cm 2 , 94% of original area, p = 0.002).
Study 13
Parietene Composite and FEG's Dynamesh®
IPOM had a similar value of 14% of shrinkage
while Ethicon's Proceed showed a 25%
reduction in its surface area.
Study 14
• Parietene Composite (PCO) and FEG's
Dynamesh® IPOM had a similar value of 19%
of shrinkage while Dual mesh showed a 52%
reduction in its surface area.

ELASTICITY
Study 10
The study showed that at a strain of 16N new
ideal meshes should show an elasticity of at least
25% in vertical stretching and 15% in horizontal
stretching to achieve almost physiological
properties.
The graphs below show the physiologic elasticity
band and the elasticity of several meshes.
Parietex and Parietene Composite are above
the minimum requirement and don’t impair the
physiological abdominal wall elasticity.
Relative distension (%)
Relative distension (%)
70
60
50
40
30
20
10
Vertical direction
0
0 2 4 6 8 10 12 14 16 18 20 22 24
70
60
50
40
30
20
10
Horizontal direction
0
0 2 4 6 8 10 12 14 16 18 20 22 24
Tensile strengh (N)
3D PET (Parietex ® Composite)
3D PP (Parietene ® Composite)
2D Light weight PP
(Parietex ® Light)
2D Heavy weight PP (Prolene ® )

DEGRADATION
Study 7
The objective of the study was to compare the
state of alteration of different meshes commonly
used in Pelvic Floor Disorder surgery.
Multicentric retrospective and comparative
study of 100 explanted samples of different
meshes: Low Density polypropylene mesh
(LDPPMF), High Density polypropylene
(HDPPMF), Polypropylene Multifilament, Non-
Knotting Non-Woven Polypropylene (NKNW),
Polypropylene-polyglactin acid (Composite),
Polyethylene Terephtalate (PET).
Scanning Electron Microscopy (SEM) analysis
was performed on each explanted meshes.
SEM analysis has shown 39% of impaired
meshes. All Polypropylene meshes 44.5%:
LDPPMF 21%
HDPPMF 47.8%
Multifilament 75%
Composite 87.5%
NKNW 100%
PET 0%
Study 8
SEM analysis was performed on 25 explanted
meshes after primary abdominal wall hernia
repair.
The average period of implant was 32.5 months
(range 2–180)
Results
• 100% of PP meshes (2 to 52 months of
implantation) showed alterations
• 0% of PET meshes (36 to 180 months
of implantation) showed alteration.
PP mesh
PP mesh
PET mesh
Fig. 1 Scanning electron microscopy (SEM)
micrograph (1,000x) of fragment #24
polyethylene terephthalate (PET)
Fig. 2 Scanning electron microscopy (SEM)
micrograph (1,000x) of fragment #20
polyethylene (PP)

Study 9
14 Polypropylene meshes were removed from
patients requiring revision surgery due to
chronic pain, recurrence, infection, adhesions,
or other complications.
PAIN
Study 1
• Pain was reduced to a very low level:
0.2±0.8/10 in the open group and 0.8±1.6/10 in
the laparoscopic group.
• 69% of the patients were totally pain free
(VAS= 0) in the open group and 67% in
the laparoscopic group.
INFECTION
Study 1
• 1 mesh sepsis (1%) occurred at 8 months after
a series of events on the incision, but it was not
related directly to the mesh.
Study 2
• 1 mesh sepsis after day 3 requiring mesh
explantation (0.25%).
• No chronic infection reported.
Study 15
This retrospective human study was designed
to assess postoperative infections, fistulas,
small-bowel obstructions and recurrence rates
using Parietex Composite (PCO) Mesh in a
complex group of patients. 109 patients had
ventral hernias repaired and were tracked for a
year. Forty-two (42%) of the patients were being
treated for a recurrent hernia and twenty-six
(26%) had prior intraperitoneal mesh placement.
Results
• 85% of the explanted meshes showed alterations
of their surface (cracks, fissures, and increased
surface roughness).
• Moreover, nearly all meshes showed a decrease
of the compliance (from 4 to 30 times more force
to fold the mesh than the pristine mesh)
Study 2
• Transient pain was experienced by 10 patients
(2.5%), and resolved over time with analgesic
treatment.
• After 28 months, 97.5% of our patients were
pain free, residual chronic parietal pain was
reported for 10 patients (2.5%)
Results
• In the laparoscopic group, there were no delayed
mesh infections, fistulas or hernia recurrences
during the 14 month follow-up period.
• In the open group, there were no long term
bowel obstructions, fistulas or delayed infections
related to the mesh during the 11 month follow
up period.
• Dr Rosen concluded based on his experience
with a follow up of approximately 1 year,
there does not seem to be an increased risk
of mesh infection, bowel obstructions, or
enterocutaneous fistulas. Polyester mesh seems
to be safe for ventral hernia repair.

Tyco Healthcare Pty Ltd
166 Epping Road,
Lane Cove NSW 2066
Australia
(t) 1800 252 467
References
1. Balique J.G. et al. Intraperitoneal treatment
of incisional and umbilical hernias using an
innovative composite mesh: 4 years results
of a prospective multicenter clinical trial.
Hernia 2005. 9: 68–74
2. Chelala E et al. The suturing concept for
laparoscopic mesh fixation in ventral and
incisional hernia repair: a mid term analysis
of 400 cases. Surgical Endoscopy, 2006
3. Burger J.W.A et al. Evaluation of new prosthetic
meshes for ventral hernia repair. Surgical
Endoscopy, 2006. 20: 1320–1325
4. B.P. Jacob et al. Tissue ingrowth and bowel
adhesion formation in an animal comparative
study: polypropylene versus Proceed versus
Parietex Composite. Surgical Endoscopy
2007, 21: 629–633
5. Duffy AJ et al. Comparison of two composite
meshes using two fixation devices in a porcine
laparoscopic ventral hernia repair. Hernia
2004;8 : 358-364
6. McGinty J.J et al. A comparative study of
adhesion formation and abdominal wall
ingrowth after laparoscopic ventral hernia
repair in a porcine model using multiple types
of mesh. Surg Endosc (2005) 19: 786–790
7. Clave´ A, et al. Study of the Alterations of
100 Meshes Excised for Complications after
Stress Urinary Incontinence or Pelvic Organ
Prolapses Surgery. Journal of Minimally Invasive
Gynecology 15 (2008) S1eS159
8. P. Bracco et al. Comparison of polypropylene and
polyethylene terephthalate (Dacron) meshes for
abdominal wall hernia repair: A chemical and
morphological study. Hernia (2005) 9: 51–55
Tyco Healthcare Ltd
Ground Floor, 15B Vestey Drive,
Mount Wellington, Auckland
New Zealand
(t) 0508 489 264
9. C.R. Costello, S.L. Bachman, B.J. Ramshaw, S.A.
Grant. Materials Characterization of Explanted
Polypropylene Hernia Meshes. Journal of
Biomedical Materials Research Part B: Applied
Biomaterials. 2007
10. Junge K.et al.: Elasticity of the abdominal wall and
impact for reparation of incisional repairs using
mesh implants. Hernia 2001
11. Gonzales et al. Resistance to adhesion formation:
A comparative study of treated and untreated
mesh products placed in the abdominal cavity.
Hernia (2004) 8: 213–219
12. M. H. F. Schreinemacher et al. Degradation of
mesh coatings and intraperitoneal adhesion
formation in an experimental model. British
Journal of Surgery 2009; 96: 305–313
13. Christine Schug-Pass, Florian Sommerer, Andrea
Tannapfel, Hans Lippert, Ferdinand Köckerling.
The use of composite meshes in laparoscopic
repair of abdominal wall hernias: are there
differences in biocompatibily? Surg Endosc, 2008
14. Karsten Junge et al. Adhesion formation of a
polyvinylidenfluoride/polypropylene mesh for
intra-abdominal placement in a rodent animal
model. Surg Endosc 2008
15. Michael J Rosen. Polyester-based mesh for ventral
hernia repair: is it safe? The American Journal of
Surgery (2009) 197, 353-359.
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