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Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are...

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DynaMesh®-HIATUS DynaMesh®-IPST DynaMesh®-IPOM DynaMesh®-CICAT DynaMesh®-ENDOLAP 3D DynaMesh®-ENDOLAP DynaMesh®-LICHTENSTEIN visible MRI Hernias Tailored Implants made of PVDF by FEG Textiltechnik mbH
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Page 1: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

DynaMesh®-HIATUS

DynaMesh®-IPSTDynaMesh®-IPOMDynaMesh®-CICAT

DynaMesh®-ENDOLAP 3D DynaMesh®-ENDOLAP DynaMesh®-LICHTENSTEIN

visibleMRI

Hernias

Tailored Implants made of PVDF

by FEG Textiltechnik mbH

Page 2: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

2

Visceral Surgery

Legal information

© FEG Textiltechnik mbH Aachen, Germany

Design: high standArt, Osnabrück - hsam.de

Photography: Schubert Fotografie, Ladbergen

Computer images: Jean Philipp Ihle, Leipzig; IOVIS GmbH, Aachen

Text: FEG + Peter Karl Müller, Münster

Translation: mpü medpharm medtec biotec translations, Ulm

Printed by: Druckerei Meyer, Osnabrück

Date of publication: 01/03/2019

Some of our products may not be available in your country. Please contact your local distributor for more information.

Page 3: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

3

Tailored Implants made of PVDF

www.dyna-mesh.com

*The polymer PVDFThe starting point for all DynaMesh®products is a PVDF

monofilament – a synthetic yarn made from polyvinylidene

fluoride. Its diameter is between 0.085 and 0.165 mm. PVDF

is an extremely ageing-resistant, thermoplastic fluoroplastic

with suitably adapted elasticity. It is tear-resistant,

biocompatible and produced with extreme precision. PVDF

has been known to be a superior suture material since 1995;

it has been used successfully in textile implants since 2003

[1,5].

It all begins with a threadIn the beginning, there was not just any thread but a filament made of PVDF*: tear-resistant, biocompatible and smooth. PVDF “naturally” supplies many of the properties

characteristic of an ideal implant. However, the thread first has to be warp-knitted into a textile structure. Not just anyhow but tailor-made for the relevant indication. The right stitch makes the difference. Only through the right stitch can we achieve the “inner values” required, such as stability, elasticity and porosity. So the end result is not a “one fits all” implant but a specifically created DynaMesh® high-tech product. A product which enables doctors to perform their duties as effectively as possible – and which gives patients many symptom-free and safe years.

Page 4: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

4

Visceral Surgery

Contents

It all begins with a thread 3 Contents 4

Our promise: you can rely on it 5 Our company: “Made in Germany“ high-tech products 7 Our development: a specific solution for every indication 9

DynaMesh® products: Excellent properties 11 Superior Textile Engineering 13 Optimal integration 15

DynaMesh® visible: a better internal view without risk 17

Implants for inguinal hernias

DynaMesh®-LICHTENSTEIN - Lichtenstein technique 20 DynaMesh®-ENDOLAP - preperitoneal techniques 22 TEP, TAPP

DynaMesh®-ENDOLAP 3D - preperitoneal techniques 24 TEP, TAPP

Implants for abdominal wall hernias

DynaMesh®-IPOM - intraperitoneal 28 Ventral hernia

DynaMesh®-CICAT - extraperitoneal 30 Hernia prophylaxis Ventral hernia

Implants for umbilical hernias

DynaMesh®-IPOM - intraperitoneal 34 DynaMesh®-CICAT - extraperitoneal 35

Implants for parastomal hernias

DynaMesh®-IPST - intraperitoneal 38 Prophylaxis of parastomal hernia

Implantats for hiatus hernias

DynaMesh®-HIATUS 42 Repair of axial and para-oesophageal hernia

Literature 44

Page 5: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

by FEG Textiltechnik mbH

5www.dyna-mesh.com

Our promiseYou can rely on it

What matters to you as a doctor

Textile implants that deliver optimal and efficient patient care. Efficient

and uncomplicated handling during surgery. Surgical results that give

doctor and patient lasting satisfaction.

What matters to your patients

Textile implants which are virtually undetectable, which provide freedom

of movement without discomfort or restrictions and whose long-term

functioning can be monitored postoperatively, thanks to visible

technology, without further surgical procedures. Long-term solutions

which mean they can live free of pain and discomfort.

What matters to us as the manufacturer

Textile implants made of a raw material which we understand completely:

PVDF. A production that we have under control from start to finish. Our

products are not only tailor-made for the relevant indications or surgical

techniques but also been developed alongside surgeons for new and

improved surgical procedures.

Page 6: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

by FEG Textiltechnik mbH

6

Visceral Surgery

Everything from a single sourceWhether it’s a matter of product development,

manufacture, quality control, dispatch or

advice, we undertake all production steps

ourselves from spinning the filament (yarn) to

final packaging. In this way, we achieve optimal

results at every stage in the process.

Everything under one labelWe, FEG Textiltechnik mbH, have our company head office in

the city of Aachen (North Rhine-Westphalia, Germany).

We are the leading developer of textile implants, which we

manufacture exclusively in Germany. They are distributed

worldwide under the brand name DynaMesh®.

Everything under controlWhen manufacturing our products

we place the utmost importance

on compliance with Medical Device

Directive 93/42/EEC and are certified

according to DIN EN ISO 13485.

Production takes place in clean rooms

certified according to ISO 14644-1 and

graded as class 7 and class C under the

EC GMP Directive.

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by FEG Textiltechnik mbH

7www.dyna-mesh.com

Everything for the doctorOur range includes customised textile implants for modern

hernia and stoma surgery. At the same time, we offer special

mesh implants for hernia repair and prophylaxis. Together with

experienced surgeons we organise seminars and workshops.

The latest information: You can find information about workshops at:

http://dyna-mesh.com

Everything with distinctionIn 2007, our visible technology won an award (“Innovation

competition to promote medical technology” by the Federal

Ministry of Education and Research).

Everything for the futureOur high-performance Research and

Development Department is working on

the next generation of products today.

In association with the world’s leading

research facilities and hospitals, our

engineers work with well-known medical

specialists to shape the future.

Our company“Made in Germany“ high-tech products

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8

Visceral Surgery

Understanding the problemsTo develop an optimal implant we need to ask ourselves a lot of questions.

For example: In which part of the body will it be implanted? What functions does it

have to fulfil? What static and dynamic stresses act on the implant?

Relevant dynamometric measurements, discussions with surgeons

and the expertise of our engineers provide the answers.

Defining functionalityTogether with medical experts our engineers can define the shape, functionality and

profile of properties for the implant. They now know exactly what stabilities, elasticities and

porosities are required, how handling can be improved for the surgeon

and much more.

Restoring functionalityImplants are designed to replace natural bodily functions that have been lost

and in doing so to restore balance to destroyed physiology.

StabilityOptimal

patient safety

Optimalpatientcomfort

Elasticity

Porosity

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9www.dyna-mesh.com

Finding individual solutions - avoiding the wrong pathThere is no such thing as a single textile structure for all indications – no “allrounder” for all cases (no “one fits all”).

As every indication makes different demands of a textile implant, every indication needs its individual solution

(a tailored approach).

Adapting propertiesDynaMesh®products are not woven or conventionally knitted but warp-knitted*.

This technology, unlike any other, makes it possible to make specific varia-

tions in the shape and structure of a textile implant, which means that we can

construct features with different characteristics in different places within the

structure. More accurate adaptation of implants to the relevant indication is

impossible.

*Warp-knitted fabric. Warp-knitted fabrics are a type

of knitted fabric. A warp knitting

machine is used for industrial

production of this kind of fabric

(by stitch formation from thread

systems).

Our developmentA specific solution for every indication

Page 10: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

300%

250%

200%

150%

100%

50%

0%

10

Visceral Surgery

The filament (“yarn”) we spin from the

high-tech polymer PVDF is the first guarantee of the high quality

of DynaMesh®products: a filament with many positive “natural” properties.

The textile structures warp-knitted from this are the second guarantee.

Very high body compatibilityPVDF filaments have excellent biocompatibility and reduce adverse foreign body reactions, such as scar

contractions or pain. In addition, they are finer and smoother than conventional filaments. So PVDF is associated

with substantially lower granuloma formation (scar tissue) compared with conventional polymers [2,3,4].

Reduced bacterial adherenceScientific studies* from Aachen University (RWTH) Hospital

demonstrate that lower quantities of bacteria adhere to textile

implants made from pure PVDF (reduced bacterial adherence).

This is a significant finding for all open techniques because

the risk of infection drops substantially with lower bacterial

adherence.

* Klosterhalfen, B., Pathologisches Institut, Krankenhaus Düren and Klinge, U., Universitätsklinikum Aachen «Vergleich von Bakterienadhärenzen» (2010)

A comparison of 100% PVDF (polyvinylidene fluoride) with 100% PP (polypropylene) and 50% PP + 50% absorbable component. In this study, cultures of

reference strains of relevant bacteria were applied to different meshes. A subsequent fluorescence measurement clearly showed that the smallest

quantity of bacteria had colonised meshes made from pure PVDF.

100 % PVDF

100 % PP (polypropylene)

50 % PP + 50 % absorbable component

Naturaltissue

Foreign body granuloma

=

Scar capsule

+

Inflammatory cell infiltrate

Implant surface

S. aureus S. epidermidis E. coli gentasensitive

A comparison

of different

granuloma thicknesses

cross-sectional view

PVDF

polyvinylidene fluoridemonofilament

PP

polypropylenemonofilament

Page 11: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

11www.dyna-mesh.com

High ageing resistanceIt is not just experience that shows that PVDF

provides lasting success in many surgical

disciplines. A long-term study over seven

years has demonstrated that the condition of

the PVDF surface remains unchanged. Thread

and warp-knitted fabric remain stable and

nothing becomes brittle [2, 52].

A long-term trial (7 years):• PVDF loses only ≈ 10% tensile strength

• PP loses ≈ 50% tensile strength

and stiffens

With the kind permission of:

Laroche G, Marois Y, Schwarz E, Guigoin R, King M W, Pâris E, Douville Y:

Polyvinylidene Fluoride Monofilament Sutures:

Can They Be Used Safely for Long-Term Anastomoses in the Thoracic Aorta?

Artificial Organs 19/11: 1190-1199; ©Blackwell Science, Inc., Boston (12/1995)

DynaMesh® productsExcellent properties

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12

Visceral Surgery

Minimally reactive surfaceIf you want to minimise adverse foreign body reactions and scarring associated with textile implants,

besides using biocompatible material you have to provide the least possible contact area. The following formula applies:

thread surface = bioreactive surface area of the implant. Our implants have a comparatively minimal reactive

surface area, which means that they cause the least possible foreign body reaction and scar tissue formation.

Atraumatic selvedgesDynaMesh®products are not simply cut from a flat piece of mesh. Using our special warp knitting machines we are able to

produce smooth and therefore atraumatic selvedges (no “sawtooth” edges).

These “soft” selvedges make it easy for the surgeon

to place and adjust the implant – without irritating

or even damaging the surrounding tissue. And the

patient receives an implant with selvedges which will

not “pinch” or cause other injury later on.

Comparison conventional closed DynaMesh®- small-pore membrane LICHTENSTEIN mesh implant

Implant/Size

15 x 15 cm 15 x 15 cm 15 x 15 cm

plant surface area 225 cm² 225 cm² 225 cm²

Reactive surface area of the implant (thread surface) 637 cm² 450 cm² 288 cm²

reactive surface area/ implant surface area (factor) 2.83 cm²/cm² 2.00 cm²/cm² 1.28 cm²/cm²

Change in the reactivesurface area compared to + 42 % 0% - 36 %closed membrane

Conventional mesh DynaMesh®-LICHTENSTEIN

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www.dyna-mesh.com 13

Optimal dynamometryTextile implants must reinforce tissue, support muscles and protect organs.

They have to cushion different forces without limiting mobility – including

the extreme stresses associated with coughing, sneezing and laughing.

What is needed therefore is an optimal interaction between predefined

stability and elasticity. We achieve the optimal balance between these

two properties.

High tear propagation resistance Conventional textile implants have a weak point:

once torn or cut a zipper effect frequently

occurs – the mesh continues to tear (mesh

rupture). This does not happen with

DynaMesh® products. The multiple meshing

technique used in our warp-knitted structures

does not allow this unwanted effect to occur in

the first place. Tear propagation resistance is

one of the basic properties common to all our

implants.

A study of explanted abdominal walls (source: Aachen University Hospital)

DynaMesh® Conventional mesh

The behaviour of abdominal walls with different mesh implants under stress

with mesh that is too elastic

healthy abdominal wall with no meshwith optimised DynaMesh®

with mesh that is too stiff

Pressure

Abdominal wall explant

DynaMesh® productsSuperior Textile Engineering

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14

Visceral Surgery

14

Effective porosityDuring incorporation the filaments are enclosed by an internal and external granuloma.

When filament distance is too small there is a risk that the whole of the intervening space will be

filled with scar tissue (closed pores). The scar plates that develop in this way cause patients great

discomfort. Sufficiently large pores can prevent this.

Textile porosity refers to the permeable component of a mesh before the body has reacted to the implant.

Exte

rnal

gran

ulom

a

(colla

gen-

rich

conn

ectiv

e

tissu

e cap

sule

= sc

ar)

Inte

rnal

gran

ulom

a

(cell-

rich

with g

iant

fore

ign

body

cells

)

Monof

ilam

ent

Thre

ad d

istan

ce <

1.0

mm

Pore

s clo

sed

by sc

ar ti

ssue

(“brid

ging

”)

Page 15: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

15www.dyna-mesh.com

*Effective porosity refers to the permeable component of a mesh after the body has reacted to the implant.

Rule of thumb: A “pore” less than 1 mm in diameter is closed by the body with scar tissue = 0% effective porosity

How is this prevented? PP implants must have a pore diameter of at least 1 mm

in all directions - under loading as well (!) (because of the lower granuloma thickness,

just 0.6 mm is sufficient in the case of PVDF) – for the pores to remain open.

Only in this way can local autochthonous tissue form through a pore [6,8].

DynaMesh® warp-knitted fabrics provide this prerequisite because of their optimal pore

geometry and the high effective porosity* (up to 69 %) achieved through this geometry .

Pore

s fille

d with

loca

l aut

ocht

hono

us

tissu

e

Thre

ad d

istan

ce >

1.0

mm

,

so th

e por

e rem

ains i

ntac

t

DynaMesh® productsOptimal integration

Page 16: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

16

Visceral Surgery

The problem with monitoringIn many indications, the correct positioning of the implant must be checked after

a certain time. But a “look inside” involves risks. Conventional mesh implants

are invisible in diagnostic radiology. Patients sometimes have to undergo a

second-look operation.

A simple alternativeThe unique DynaMesh® visible provides cutting edge technology,

which is extremely safe and effective. To put it simply: we mix

the PVDF filament with ferromagnetic micropigments using an

inhouse procedure. This guarantees optimal incorporation of the

pigments. Long-term tests demonstrate that the micropigments

are integrated into the PVDF polymer – you could say hermetically

sealed.

A clear internal viewDynaMesh® visible implants can be made visible using magnetic

resonance imaging (MRI) [7] both in standard sequences and in high-

resolution, three-dimensional images or even films. As such, radiologists

can reliably and accurately determine the position and condition of the

implant. Additionally, if required, they can observe how the implant behaves

in motion.

Effective healingBecause it is so easy and safe to take a „look inside”, DynaMesh® visible opens up new

perspectives. Risk-free monitoring of how healing is progressing, optimal monitoring in clinical

studies or more rapid development of pioneering implants – together with world-renowned clinical

partners.

Moreover, DynaMesh® visible is the world’s first technology to visualise textile implants. It was

given an award by the German Federal Ministry of Education and Research (BMBF 01EZ 0849).

The development was sponsored by the

German Federal Ministry

of Education and Research

(BMBF 01EZ 0849)

Gained an award

in the innovation competition run by the

Page 17: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

17www.dyna-mesh.com

During MRI scans, in imaging terms the part of the body being analysed is scanned step by step and

deconstructed into many “wafer-thin optical slices”. At the end, these “slices” are reconstructed to form

3-dimensional images or motion sequences (remodelling).

The position of the DynaMesh® visible implant can be visualised and monitored in detail.

The 3D internal view supplies useful information.

3-dimensional remodelling

DynaMesh® visible A better internal view without risk

Page 18: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

18

Visceral Surgery

Contents

Implants for inguinal hernias

DynaMesh®-LICHTENSTEIN - Lichtenstein technique 20

DynaMesh®-ENDOLAP - preperitoneal techniques 22 TEP, TAPP

DynaMesh®-ENDOLAP 3D - preperitoneal techniques 24 TEP, TAPP

Implants for abdominal wall hernias

DynaMesh®-IPOM - intraperitoneal 28 Ventral hernia

DynaMesh®-CICAT - extraperitoneal 30

Hernia prophylaxis

Ventral hernia

Implants for umbilical hernias

DynaMesh®-IPOM - intraperitoneal 34

DynaMesh®-CICAT - extraperitoneal 35

Implants for parastomal hernias

DynaMesh®-IPST - intraperitoneal 38 Prophylaxis of parastomal hernia

Implantats for hiatus hernias

DynaMesh®-HIATUS 42 Repair of axial and para-oesophageal hernia

Literature 44

Page 19: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

DynaMesh®-LICHTENSTEIN

DynaMesh®-ENDOLAP

DynaMesh®-ENDOLAP 3D

19

Tailored Implants made of PVDF

Implants for

inguinal hernias

Page 20: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

20

Tailored Implants made of PVDF

DynaMesh®-LICHTENSTEIN

Visceral Surgery

For the repair of inguinal hernias using the Lichtenstein technique

Inguinal hernias

Use and properties

Field

of a

pplic

atio

n

inguinalhernias

Prod

uct

LICHTENSTEIN

Surg

ical a

ppro

ach

Surg

ical t

echn

ique

open Lichtenstein

Mesh

posit

ion

extraperitoneal(subfascial)

Fixat

ion

suture /bonding

Optim

al ha

ndlin

g

Optim

al pa

tient

safe

ty

p.8

Optim

al pa

tient

com

fort

p.8

Green

line m

arke

r

Atraum

atic

selve

dges

visib

le te

chno

logy

p.16

Applies to all product sizesOnly applies to selected product sizes

Can be used in the left and right groin.

For special sizes and other package sizes please see the attached sheet.

DynaMesh®-LICHTENSTEIN Size: 6 cm x 11 cm PV110611F3 Unit = 3 EA / BX

PV110611F10 Unit = 10 EA / BX

Size: 7.5 cm x 15 cm PV110715F1 Unit = 1 EA / BX

PV110715F3 Unit = 3 EA / BX

PV110715F10 Unit = 10 EA / BX

DynaMesh®-LICHTENSTEIN visible Size: 7.5 cm x 15 cm PV170715F1 Unit = 1 EA / BX

Allow for sufficient overlap when selecting mesh size.

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21

Fewer erosions The atraumatic smooth selvedges

in the slit reduce erosion formation

on the spermatic cord [16].They

decrease postoperative pain and

enable the patient to resume normal

activity sooner.

Less effortDynaMesh®-LICHTENSTEIN

is designed for safe and time-

saving surgical handling. The

elastic safety zone in the mesh,

incorporated by using a special

warp-knitting technique, makes it

easier for the surgeon to achieve

fold-free positioning of the

implant.

Less riskThe newly constructed slit design

makes for perfect tunnel modulation

with optimal pressure distribution.

This prevents spermatic cord

stenosis and possible postoperative

complications.

In addition, the high tear

propagation resistance at the

end-point of the slit prevents mesh

ruptures from occurring.

For example: inguinal hernia, on the left

visib

le te

chno

logy

Technical data

Polym

er (m

onof

ilam

ent)

PVDF

p.10

Exce

llent

bio

com

patib

ility

Minim

al fo

reig

n bo

dy re

actio

n

p.10 p.10

Redu

ced

bacte

rial a

dher

ence

p.10

High

agein

g re

sista

nce

p.11

Optim

al dy

nam

omet

ry

p.13

No sc

ar p

late f

orm

atio

n

p.14

Reac

tive s

urfa

ce (a

) [m²/

m²]

1.28

p.12

Maxim

um st

abilit

y (b

) [N/c

m]

33

p.13

Elasti

city

(b) a

t 16

N/cm

[%]

Tear

pro

paga

tion

resis

tanc

e (c)

[N]

Text

ile p

oros

ity (d

) [%]

Effe

ctive

por

osity

(d) [%

]

Effe

ctive

por

osity

at 2

.5 N

/cm (d

) [%]

Classif

icatio

n (e)

49

p.13

23

p.13

73

p.14

69

p.15

59

p.15

1a

(a)-(e

) p.4

9

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22

Tailored Implants made of PVDF

DynaMesh®-ENDOLAP

Visceral Surgery

For all preperitoneal techniques for repair of the inguinal hernia: endoscopic (TEP), laparoscopic (TAPP) or open

Inguinal hernias

Use and properties

Field

of a

pplic

atio

n

inguinal

hernias

Prod

uct

ENDOLAP

Surg

ical a

ppro

ach

Surg

ical t

echn

ique

endoscopic /laparoscopic /

open

TEP /

TAPP

Mesh

posit

ion

extra-

peritoneal

Fixat

ion

none/suture/bonding/

stapler/tacker

Optim

al ha

ndlin

g

Optim

al pa

tient

safe

ty

p.8

Optim

al pa

tient

com

fort

p.8

Green

line m

arke

r

Atraum

atic

selve

dges

p.12

visib

le te

chno

logy

p.16

Applies to all product sizesOnly applies to selected product sizes

For special sizes and other package sizes please see the attached sheet.

Allow for sufficient overlap when selecting mesh size.

DynaMesh®-ENDOLAP Size: 10 cm x 15 cm PV101015F1 Unit = 1 EA / BX

PV101015F3 Unit = 3 EA / BX

PV101015F10 Unit = 10 EA / BX

Size: 12 cm x 15 cm PV101215F3 Unit = 3 EA / BX

PV101215F10 Unit = 10 EA / BX

Size: 13 cm x 15 cm PV101315F3 Unit = 3 EA / BX

Size: 13 cm x 17 cm PV101317F3 Unit = 3 EA / BX

PV101317F10 Unit = 10 EA / BX

Size: 15 cm x 15 cm PV101515F3 Unit = 3 EA / BX

PV101515F10 Unit = 10 EA / BX

DynaMesh®-ENDOLAP visible Size: 10 cm x 15 cm PV141015F1 Unit = 1 EA / BX

PV141015F10 Unit = 10 EA / BX

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23

Intraoperative unfolding The special textile construction makes it easy to insert the mesh

via the trocar and to unfold it intraoperatively. The antislip

surface and special selvedges ensure wrinkle-free positioning.

The green marker lines perform a dual function. They are used

for rapid orientation and visual monitoring of whether the mesh

is positioned tension-free.

Choice of method DynaMesh®-ENDOLAP was developed specifically for endoscopic

(TEP)1) and laparoscopic (TAPP) techniques. If the surgeon

considers fixation of the implant to be necessary, all these

methods are available to him/her.

Optimal pore sizeThe special warp-knitted structure results in very high textile

porosity. It is the basis for very good effective porosity (65%)

after the formation of foreign body granuloma, which prevents

scar plates while providing high patient comfort.

1) Image of surgery by kind permission of Dr. A. Kuthe,

DRK Hospital Clementinenhaus, Hanover

Perfectly structured mesh

visib

le te

chno

logy

Technical data

Polym

er (m

onof

ilam

ent)

PVDF

p.10

Exce

llent

bio

com

patib

ility

Minim

al fo

reig

n bo

dy re

actio

n

p.10 p.10

Redu

ced

bacte

rial a

dher

ence

p.10

High

agein

g re

sista

nce

p.11

Optim

al dy

nam

omet

ry

p.13

No sc

ar p

late f

orm

atio

n

p.14

Reac

tive s

urfa

ce (a

) [m²/

m²]

1.47

p.12

Maxim

um st

abilit

y (b

) [N/c

m]

33

p.13

Elasti

city

(b) a

t 16

N/cm

[%]

Tear

pro

paga

tion

resis

tanc

e (c)

[N]

Text

ile p

oros

ity (d

) [%]

Effe

ctive

por

osity

(d) [%

]

Effe

ctive

por

osity

at 2

.5 N

/cm (d

) [%]

Classif

icatio

n (e)

48

p.13

21

p.13

70

p.14

65

p.15

54

p.15

1a

(a)-(e

) p.4

9

Page 24: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

24

Tailored Implants made of PVDF

DynaMesh®-ENDOLAP 3D

Visceral Surgery

For endoscopic (TEP) and laparoscopic (TAPP) techniques for inguinal and femoral hernia repair

Inguinal hernias

Use and properties

Prod

uct

Field

of a

pplic

atio

n

Surg

ical a

ppro

ach

Surg

ical t

echn

ique

Mesh

posit

ion

Fixat

ion

Optim

al ha

ndlin

g

Optim

al pa

tient

safe

ty

Optim

al pa

tient

com

fort

Green

thre

ad an

d lin

e mar

ker

CURVATO

visib

le te

chno

logy

ENDOLAP 3D inguinal-

herniasendoscopic /

laparoscopicTEP /

TAPPextra-

peritoneal

none/suture/bonding/

stapler/tackerp.8 p.8 p.16

Applies to all product sizesOnly applies to selected product sizes

For special sizes and other package sizes please see the attached sheet.

DynaMesh®-ENDOLAP 3D Size: 09 cm x 14 cm PV130914F1 Unit = 1 EA / BX

PV130914F3 Unit = 3 EA / BX

Size: 10 cm x 15 cm regular PV131015F1 Unit = 1 EA / BX

PV131015F3 Unit = 3 EA / BX

Size: 12 cm x 17 cm PV131217F1 Unit = 1 EA / BX

PV131217F5 Unit = 5 EA / BX

DynaMesh®-ENDOLAP 3D visible Size: 10 cm x 15 cm PV121015F1 Unit = 1 EA / BX

PV121015F3 Unit = 3 EA / BX

Size: 12 cm x 17 cm PV121217F1 Unit = 1 EA / BX

Page 25: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

25

Optimised shapeThree-dimensionally shaped net

implants for repair of inguinal

and femoral hernias in TEP/TAPP

technique ensure time-saving and

efficient work for the surgeon

during the operation. With the

DynaMesh® visible technology,

which allows the position of the

implant to be checked after surgery

by MRI, an identical shape fitting

the patient‘s anatomy on both sides

(right and left) has been developed.

DynaMesh®-ENDOLAP 3D for

optimised handling

Standardised positioningIntegrated markers aligned to

anatomical ladnmarks (inguinal

ligament, inferior epigastric

vessels and external iliac vessels)

ensure simple, always correct and

standardised position of the implant.

DynaMesh®-ENDOLAP 3D for

maximum patient safety

CURVATOR®

The Curvator® technology has been

specially developed for implants that

are subject to high deformation after

surgery. The Curvator® technology

enables DynaMesh®-ENDOLAP 3D to

fit the anatomical conditions easily

without folds even in the most

critical areas.

DynaMesh®-ENDOLAP 3D for

maximum patient comfort

visib

le te

chno

logy

Technical data

Polym

er (m

onof

ilam

ent)

Exce

llent

bio

com

patib

ility

Minim

al fo

reig

n bo

dy re

actio

n

Redu

ced

bacte

rial a

dher

ence

High

agein

g re

sista

nce

Optim

al dy

nam

omet

ry

No sc

ar p

late f

orm

atio

n

Reac

tive s

urfa

ce (a) [m

²/m

²]

Maxim

um st

abilit

y (b

) [N/c

m]

Elasti

city (b

) at 1

6 N/c

m [

%]

Tear

pro

paga

tion

resis

tanc

e (c)

[N]

Text

ile p

oros

ity (d) [%

]

Effe

ctive

por

osity

(d) [%

]

Effe

ctive

por

osity

at 2,

5 N/c

m (d)

[%]

Classif

icatio

n (e)

(a)- (e

) p.4

9

PVDF 1,82 35 25 32 69*/63 66*/59 63*/57 1a

p.15p.15p.14p.13 p.13p.13p.14 p.12p.13p.11p.10p.10p.10p.10

*Values CURVATOR®

Page 26: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

26

Visceral Surgery

Contents

Implants for inguinal hernias

DynaMesh®-LICHTENSTEIN - Lichtenstein technique 20

DynaMesh®-ENDOLAP - preperitoneal techniques 22 TEP, TAPP

DynaMesh®-ENDOLAP 3D - preperitoneal techniques 24 TEP, TAPP

Implants for abdominal wall hernias

DynaMesh®-IPOM - intraperitoneal 28 Ventral hernia

DynaMesh®-CICAT - extraperitoneal 30

Hernia prophylaxis

Ventral hernia

Implants for umbilical hernias

DynaMesh®-IPOM - intraperitoneal 34

DynaMesh®-CICAT - extraperitoneal 35

Implants for parastomal hernias

DynaMesh®-IPST - intraperitoneal 38 Prophylaxis of parastomal hernia

Implantats for hiatus hernias

DynaMesh®-HIATUS 42 Repair of axial and para-oesophageal hernia

Literature 44

Page 27: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

DynaMesh®-CICAT

DynaMesh®-IPOM

27

Tailored Implants made of PVDF

Implants for

abdominal wall hernias

Page 28: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

28

DynaMesh®-IPOM

Tailored Implants made of PVDF

Visceral Surgery

For the intraperitoneal onlay mesh technique in hernia surgery

Optimal handling in laparoscopic and open techniques

Abdominal wall hernias

Abdominal wall hernia

For special sizes and other package sizes please see the attached sheet.

Field

of a

pplic

atio

n

abdominal

wall

Prod

uct

IPOM

Surg

ical a

ppro

ach

Surg

ical t

echn

ique

laparoscopic /open

IPOM

Mesh

posit

ion

intra-peritoneal

Fixat

ion

suture/stapler/tacker

Optim

al ha

ndlin

g

Optim

al pa

tient

safe

ty

p.8

Optim

al pa

tient

com

fort

p.8

Green

mar

ker t

hrea

d

PVDF b

arrie

r

visib

le te

chno

logy

p.16

Use and properties

Applies to all product sizesOnly applies to selected product sizes

For special sizes and other package sizes please see the attached sheet.

Allow for sufficient overlap when selecting mesh size.

DynaMesh®-IPOM Size: d 12 cm round IP070012F1 Unit = 1 EA / BX

IP070012F3 Unit = 3 EA / BX

Size: 10 cm x 15 cm IP071015F1 Unit = 1 EA / BX

IP071015F3 Unit = 3 EA / BX

Size: 15 cm x 15 cm IP071515F1 Unit = 1 EA / BX

IP071515F3 Unit = 3 EA / BX

Size: 15 cm x 20 cm IP071520F1 Unit = 1 EA / BX

IP071520F3 Unit = 3 EA / BX

Size: 20 cm x 20 cm IP072020F1 Unit = 1 EA / BX

Size: 20 cm x 25 cm IP072025F1 Unit = 1 EA / BX

Size: 20 cm x 30 cm IP072030F1 Unit = 1 EA / BX

IP072030F3 Unit = 3 EA / BX

Size: 28 cm x 37 cm IP072837F1 Unit = 1 EA / BX

Size: 30 cm x 30 cm IP073030F1 Unit = 1 EA / BX

Size: 30 cm x 45 cm IP073045F1 Unit = 1 EA / BX

DynaMesh®-IPOM visible Size: 30 cm x 30 cm IP083030F1 Unit = 1 EA / BX

Page 29: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

29

Dual-layer composite meshDynaMesh®-IPOM is a dual-component structure specifically

developed for the IPOM technique; it is composed 88% of high

purity PVDF and 12% of polypropylene (PP). The parietal side (PP)

promotes rapid and safe ingrowth into the abdominal wall. The

PVDF layer on the visceral side forms a barrier to the intestines.

PVDF demonstrably decreases the risks of adhesions compared with

polypropylene [11] and thus reduces the risk of intestinal erosions.

If implantation of several meshes is required (as in the sandwich

technique, for example [9] ), the open-pore structure means that

implants can easily be overlapped.

Insertion in the correct position and directionThe parietal side (PP component) has a green marker thread and

must face the abdominal wall. The marker thread is located on

the front surface and simultaneously shows the correct direction

of the elasticity in the craniocaudal direction. The textile implant

can easily be cut to size extracorporeally and provided with

more fixation threads. DynaMesh®-IPOM facilitates intraoperative

handling by offering very high transparency. The high resilience

and minimal roll-up tendency enable optimal handling and fold-free

placement. It is recommended that the mesh is attached under pre-

tension to the abdominal wall while this is stretched during surgery.

Advantages for the patientsThe open pore mesh construction facilitates the break-down of seroma,

reduces scar plate formation and thus decreases postoperative pain. Minimal

mesh shrinkage is achieved and long-term surgical success with high patient

comfort ensured [9-14] through the open-pore and elastic mesh construction

made from PVDF, which offers long-term stability.

Green marker threadin the craniocaudal direction

attached to the parietal (PP) side.

Fold-free mesh positioning after

draining the pneumoperitoneum

Attachthe mesh

with added holding sutures

under pre-tension

Intraoperative view

Cross-sectional view

PP monofilament

PVDF monofilament

visib

le te

chno

logy

Polym

er (m

onof

ilam

ent)

visceral: PVDF [88%] parietal: PP [12%]

p.10

Exce

llent

bio

com

patib

ility

Minim

al fo

reig

n bo

dy re

actio

n

p.10 p.10

Redu

ced

bacte

rial a

dher

ence

p.10

High

agein

g re

sista

nce

p.11

Optim

al dy

nam

omet

ry

p.13

No sc

ar p

late f

orm

atio

n

p.14

Reac

tive s

urfa

ce (a

) [m²/

m²]

1.90

p.12

Maxim

um st

abilit

y (b

) [N/c

m]

74

p.13

Elasti

city

(b) a

t 16

N/cm

[%]

Tear

pro

paga

tion

resis

tanc

e (c)

[N]

Text

ile p

oros

ity (d

) [%]

Effe

ctive

por

osity

(d) [%

]

Effe

ctive

por

osity

at 2

.5 N

/cm (d

) [%]

Classif

icatio

n (e)

76

p.13

29

p.13

58

p.14

43

p.15

30

p.15

1a

(a)-(e

) p.4

9

Technical data

Page 30: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

30

Tailored Implants made of PVDF

DynaMesh®-CICAT

Visceral Surgery

For repair and prophylaxis of abdominal wall hernia with extraperitoneal mesh position

Abdominal wall hernias

Abdominal wall hernia

Use and properties

Field

of a

pplic

atio

n

abdominal

wall

Prod

uct

CICAT

Surg

ical a

ppro

ach

Surg

ical t

echn

ique

open /mini-open

MILOS

Mesh

posit

ion

extraperitoneal (sublay/onlay/

inlay)

Fixat

ion

suture /bonding

Optim

al ha

ndlin

g

Optim

al pa

tient

safe

ty

p.8

Optim

al pa

tient

com

fort

p.8

Green

line m

arke

r

Tri-e

lastic

ity

visib

le te

chno

logy

p.16

Applies to all product sizesOnly applies to selected product sizes

For special sizes and other package sizes please see the attached sheet.

Allow for sufficient overlap when selecting mesh size. (P) Prophylaxis

DynaMesh®-CICAT Size: d 10 cm round PV090010F3 Unit = 3 EA / BX

Size: 10 cm x 10 cm PV091010F3 Unit = 3 EA / BX

Size: 15 cm x 15 cm PV091515F3 Unit = 3 EA / BX

DynaMesh®-CICAT longitudinal

Size: 10 cm x 35 cm (P) PV091035F2 Unit = 2 EA / BX

Size: 15 cm x 25 cm PV091525F2 Unit = 2 EA / BX

PV091525F5 Unit = 5 EA / BX

Size: 15 cm x 30 cm PV091530F2 Unit = 2 EA / BX

PV091530F5 Unit = 5 EA / BX

Size: 18 cm x 40 cm PV091840F2 Unit = 2 EA / BX

Size: 20 cm x 30 cm PV092030F2 Unit = 2 EA / BX

PV092030F5 Unit = 5 EA / BX

Size: 30 cm x 45 cm PV093045F1 Unit = 1 EA / BX

PV093045F3 Unit = 3 EA / BX

Size: 45 cm x 60 cm PV094560F1 Unit = 1 EA / BX

DynaMesh®-CICAT transversal

Size: 40 cm x 20 cm PV094020F1 Unit = 1 EA / BX

DynaMesh®-CICAT visible Size: 20 cm x 30 cm PV162030F1 Unit = 1 EA / BX

Page 31: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

E3 E3

E2 E2

E2 E2

E1

E1

>

>

E1

E2

E3

E1 > E2 > E3

31

Optimally adapted tri-elasticityBecause of its tri-elasticity, which is adapted to

the anatomical and biomechanical properties

(dynamometry) of the human abdominal wall,

DynaMesh®-CICAT provides the highest possible degree

of patient comfort.

Clear-cut use Safe positioningA requirement for lasting surgical success is that the implant must be correctly positioned. This is why we have

incorporated green orientation strips into the implant. They must always run in the craniocaudal direction.

Safe placement

The antislip surface ensures stable positioning of the mesh. It also facilitates handling and fixation. Excellent porosity allows direct contact of the

tissue layers through the mesh and promotes rapid incorporation.

Please note: for this reason, DynaMesh®-CICAT must not be placed intraperitoneally.

Safe for the patients

The unique properties of the mesh lead to more rapid convalescence, long-term safety and the highest possible patient comfort.

Stretch

Strength

Elasticity

longitudinal transversal

Repair

Prophylaxis (P)

visib

le te

chno

logy

Technical data

Polym

er (m

onof

ilam

ent)

PVDF

p.10

Exce

llent

bio

com

patib

ility

Minim

al fo

reig

n bo

dy re

actio

n

p.10 p.10

Redu

ced

bacte

rial a

dher

ence

p.10

High

agein

g re

sista

nce

p.11

Optim

al dy

nam

omet

ry

p.13

No sc

ar p

late f

orm

atio

n

p.14

Reac

tive s

urfa

ce (a

) [m²/

m²]

2.14

p.12

Maxim

um st

abilit

y (b

) [N/c

m]

46

p.13

Elasti

city

(b) a

t 16

N/cm

[%]

Tear

pro

paga

tion

resis

tanc

e (c)

[N]

Text

ile p

oros

ity (d

) [%]

Effe

ctive

por

osity

(d) [%

]

Effe

ctive

por

osity

at 2

.5 N

/cm (d

) [%]

Classif

icatio

n (e)

57

p.13

28

p.13

66

p.14

61

p.15

57

p.15

1a

(a)-(e

) p.4

9

Page 32: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

32

Visceral Surgery

Contents

Implants for inguinal hernias

DynaMesh®-LICHTENSTEIN - Lichtenstein technique 20

DynaMesh®-ENDOLAP - preperitoneal techniques 22 TEP, TAPP

DynaMesh®-ENDOLAP 3D - preperitoneal techniques 24 TEP, TAPP

Implants for abdominal wall hernias

DynaMesh®-IPOM - intraperitoneal 28 Ventral hernia

DynaMesh®-CICAT - extraperitoneal 30

Hernia prophylaxis

Ventral hernia

Implants for umbilical hernias

DynaMesh®-IPOM - intraperitoneal 34

DynaMesh®-CICAT - extraperitoneal 35

Implants for parastomal hernias

DynaMesh®-IPST - intraperitoneal 38 Prophylaxis of parastomal hernia

Implantats for hiatus hernias

DynaMesh®-HIATUS 42 Repair of axial and para-oesophageal hernia

Literature 44

Page 33: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

DynaMesh®-CICAT

DynaMesh®-IPOM

33

Tailored Implants made of PVDF

Implants for

umbilical hernias

Page 34: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

34

* Christoffersen MW, Helgstrand F, Rosenberg J, Kehlet H, Strandfelt P, Bisgaard T:

Long-term recurrence and chronic pain after repair for small umbilical or epigastric hernias: a regional cohort study.

Am J Surg 2014. DOI: 10.1016/j.amjsurg.2014.05.021

Tailored Implants made of PVDF

DynaMesh®-IPOM

Visceral Surgery

Umbilical hernias

For repair of umbilical hernia with intraperitoneal mesh position

Umbilical hernia

Use and properties

Field

of a

pplic

atio

n

abdominal

wall

Prod

uct

CICAT

Surg

ical a

ppro

ach

Surg

ical t

echn

ique

open /

mini open

PUMP /

MILOS

Mesh

posit

ion

extraperitoneal (subfascial/

sublay)

Fixat

ion

none/ suture /

bonding

Optim

al ha

ndlin

g

Optim

al pa

tient

safe

ty

p.8

Optim

al pa

tient

com

fort

p.8

Green

thre

ad1 an

d lin

e2 m

arke

r

Tri-e

lastic

ity

visib

le te

chno

logy

p.16

abdominal

wall IPOM laparoscopic /

openIPOM intra-

peritonealsuture/

stapler/tacker1

2

Applies to all product sizesOnly applies to selected product sizesDoes not apply

For further product information see DynaMesh®-IPOM page 28

A Danish register study was able to demonstrate that the risk of recurrence of small mesh-repaired

umbilical hernias with hernia gaps ≤ 2 cm is 50% lower compared to repair with sutures.*

For special sizes and other package sizes please see the attached sheet.

DynaMesh®-IPOM Size: 07 cm x 06 cm IP070706F5 Unit = 5 EA / BX

Size: d 12 cm round IP070012F1 Unit = 1 EA / BX

IP070012F3 Unit = 3 EA / BX

Size: 10 cm x 15 cm IP071015F1 Unit = 1 EA / BX

IP071015F3 Unit = 3 EA / BX

Size: 15 cm x 15 cm IP071515F1 Unit = 1 EA / BX

IP071515F3 Unit = 3 EA / BX

Allow for sufficient overlap when selecting mesh size.

Page 35: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

35

* Christoffersen MW, Helgstrand F, Rosenberg J, Kehlet H, Strandfelt P, Bisgaard T:

Long-term recurrence and chronic pain after repair for small umbilical or epigastric hernias: a regional cohort study.

Am J Surg 2014. DOI: 10.1016/j.amjsurg.2014.05.021

DynaMesh®-CICAT

Visceral Surgery

Umbilical hernias

For repair of umbilical hernia with extraperitoneal

mesh position

Umbilical hernia

visib

le te

chno

logy

Technical data

Polym

er (m

onof

ilam

ent)

PVDF

p.10

Exce

llent

bio

com

patib

ility

Minim

al fo

reig

n bo

dy re

actio

n

p.10 p.10

Redu

ced

bacte

rial a

dher

ence

p.10

High

agein

g re

sista

nce

p.11

Optim

al dy

nam

omet

ry

p.13

No sc

ar p

late f

orm

atio

n

p.14

Reac

tive s

urfa

ce (a

) [m²/

m²]

2.14

p.12

Maxim

um st

abilit

y (b

) [N/c

m]

46

p.13

Elasti

city

(b) a

t 16

N/cm

[%]

Tear

pro

paga

tion

resis

tanc

e (c)

[N]

Text

ile p

oros

ity (d

) [%]

Effe

ctive

por

osity

(d) [%

]

Effe

ctive

por

osity

at 2

.5 N

/cm (d

) [%]

Classif

icatio

n (e)

57

p.13

28

p.13

66

p.14

61

p.15

57

p.15

1a

(a)-(e

) p.4

9

visceral: PVDF [88%] parietal: PP [12%] 1.90 74 76 29 58 43 30 1a

For further product information see DynaMesh®-CICAT page 30

The green marker thread (cranio-caudal) is used

for orientation of the mesh

The antislip surface ensures stable positioning of the mesh

and renders optimal handling

Ideal porosity promotes rapid incorporation of the mesh

extraperitoneal (sublay)

extraperitoneal (subfascial)

For special sizes and other package sizes please see the attached sheet.

DynaMesh®-CICAT Size: 05 cm x 06 cm PV090506F5 Unit = 5 EA / BX

Size: d 10 cm round PV090010F3 Unit = 3 EA / BX

Size: 10 cm x 10 cm PV091010F3 Unit = 3 EA / BX

Size: 15 cm x 15 cm PV091515F3 Unit = 3 EA / BX

DynaMesh®-CICAT visible Size: 05 cm x 06 cm PV160506F5 Unit = 5 EA / BX

Allow for sufficient overlap when selecting mesh size.

Page 36: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

36

Visceral Surgery

Contents

Implants for inguinal hernias

DynaMesh®-LICHTENSTEIN - Lichtenstein technique 20

DynaMesh®-ENDOLAP - preperitoneal techniques 22 TEP, TAPP

DynaMesh®-ENDOLAP 3D - preperitoneal techniques 24 TEP, TAPP

Implants for abdominal wall hernias

DynaMesh®-IPOM - intraperitoneal 28 Ventral hernia

DynaMesh®-CICAT - extraperitoneal 30

Hernia prophylaxis

Ventral hernia

Implants for umbilical hernias

DynaMesh®-IPOM - intraperitoneal 34

DynaMesh®-CICAT - extraperitoneal 35

Implants for parastomal hernias

DynaMesh®-IPST - intraperitoneal 38 Prophylaxis of parastomal hernia

Implantats for hiatus hernias

DynaMesh®-HIATUS 42 Repair of axial and para-oesophageal hernia

Literature 44

Page 37: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

DynaMesh®-IPST

37

Tailored Implants made of PVDF

Implants for

parastomal hernias

Page 38: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

38

Tailored Implants made of PVDF

DynaMesh®-IPST

Visceral SurgeryProphylaxis of parastomal hernias

For the prevention of parastomal hernia with intraperitoneal mesh position

Use and properties

Field

of a

pplic

atio

n

parastomal

Prod

uct

IPST

Surg

ical a

ppro

ach

Surg

ical t

echn

ique

laparoscopic /open

IPOM

Mesh

posit

ion

intra-peritoneal

Fixat

ion

suture/stapler/tacker

Optim

al ha

ndlin

g

Optim

al pa

tient

safe

ty

p.8

Optim

al pa

tient

com

fort

p.8

Green

mar

ker t

hrea

d

PVDF b

arrie

r

visib

le te

chno

logy

p.16

Applies to all product sizesOnly applies to selected product sizes

For further product information see DynaMesh®-IPOM page 28

The DynaMesh®-IPOM product group is available for repair

of parastomal hernia with intraperitoneal mesh position in

keyhole, Sugerbaker or sandwich technique (see page 28).

The DynaMesh®-CICAT product group is available for repair

and prohylaxis of parastomal hernia with extraperitoneal

mesh position (sublay, onlay) (see page 30).

DynaMesh®-IPST Size: ø 2 cm x 15 cm x 15 cm IP070215F1 Unit = 1 EA / BX

Size: ø 3 cm x 16 cm x 16 cm IP070316F1 Unit = 1 EA / BX

Size: ø 4 cm x 17 cm x 17 cm IP070417F1 Unit = 1 EA / BX

Size: ø 2 cm x 25 cm x 25 cm IP070225F1 Unit = 1 EA / BX

DynaMesh®-IPST visible Size: ø 2 cm x 15 cm x 15 cm IP080215F1 Unit = 1 EA / BX

Size: ø 3 cm x 16 cm x 16 cm IP080316F1 Unit = 1 EA / BX

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39

Optimal handlingThe implant is made from a single piece of mesh for a

seamless junction with the intestinal cuff. DynaMesh®-

IPST is a three-dimensional preshaped implant providing

excellent elasticity and flexibility – which facilitates

stomaplasty preparation for the surgeon.

Optimal comfort In both open and laparoscopic operations, minimal tissue

irritation occurs when inserting and placing the implant.

This also applies to the period afterwards – a guarantee of

maximum patient comfort.

Optimal safetyThe dual-layer composite structure promotes rapid and

safe ingrowth into the abdominal wall while at the same

time reducing the risks of adhesions on the visceral side.

The elastic funnel with no sharp selvedges leads to more

secure integration of the terminal segment of bowel and

reliably prevents parastomal hernia formation [15] [61].

visib

le te

chno

logy

Technical data

Polym

er (m

onof

ilam

ent)

visceral: PVDF [88%] parietal: PP [12%]

p.10

Exce

llent

bio

com

patib

ility

Minim

al fo

reig

n bo

dy re

actio

n

p.10 p.10

Redu

ced

bacte

rial a

dher

ence

p.10

High

agein

g re

sista

nce

p.11

Optim

al dy

nam

omet

ry

p.13

No sc

ar p

late f

orm

atio

n

p.14

Reac

tive s

urfa

ce (a

) [m²/

m²]

1.90

p.12

Maxim

um st

abilit

y (b

) [N/c

m]

74

p.13

Elasti

city

(b) a

t 16

N/cm

[%]

Tear

pro

paga

tion

resis

tanc

e (c)

[N]

Text

ile p

oros

ity (d

) [%]

Effe

ctive

por

osity

(d) [%

]

Effe

ctive

por

osity

at 2

.5 N

/cm (d

) [%]

Classif

icatio

n (e)

76

p.13

29

p.13

58

p.14

43

p.15

30

p.15

1a

(a)-(e

) p.4

9

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40

Visceral Surgery

Contents

Implants for inguinal hernias

DynaMesh®-LICHTENSTEIN - Lichtenstein technique 20

DynaMesh®-ENDOLAP - preperitoneal techniques 22 TEP, TAPP

DynaMesh®-ENDOLAP 3D - preperitoneal techniques 24 TEP, TAPP

Implants for abdominal wall hernias

DynaMesh®-IPOM - intraperitoneal 28 Ventral hernia

DynaMesh®-CICAT - extraperitoneal 30

Hernia prophylaxis

Ventral hernia

Implants for umbilical hernias

DynaMesh®-IPOM - intraperitoneal 34

DynaMesh®-CICAT - extraperitoneal 35

Implants for parastomal hernias

DynaMesh®-IPST - intraperitoneal 38 Prophylaxis of parastomal hernia

Implantats for hiatus hernias

DynaMesh®-HIATUS 42 Repair of axial and para-oesophageal hernia

Literature 44

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DynaMesh®-HIATUS

41

Tailored Implants made of PVDF

visibleMRI

HIATUS

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42

DynaMesh®-HIATUS

Tailored Implants made of PVDF

Visceral Surgery

visibleMRI

Hiatus hernias

For repair of axial and para-oesophageal hernia

Use and properties

Prod

uct

Field

of a

pplic

atio

n

Surg

ical a

ppro

ach

Surg

ical t

echn

ique

Mesh

posit

ion

Fixat

ion

Optim

al ha

ndlin

g

Optim

al pa

tient

safe

ty

Optim

al pa

tient

com

fort

Green

line m

arke

r

Atraum

atic

selve

dges

visib

le te

chno

logy

HIATUS Diaphragm laparoscopic _ onlaysuture /

bonding /tacker

p.8For more information see the specified pages of the DynaMesh® HERNIAS catalogue p.8 p.16

For maximum patient safety all DynaMesh®-HIATUS implants come with

DynaMesh® visible technology (see page 17).

The stable construction and the highly effective porosity are

a substantial part of keeping the opening for the oesophagus

(red marker) virtually constant even over the long term.

Sophisticated design for effective prevention of

mesh erosion for maximum patient safety

The region of the hiatus oesophagus is extremely mobile

due to respiration and swallowing. The placement of

mesh implants in this region of high mobility demands

mature technology for effective prevention of mesh

erosion. DynaMesh®-HIATUS has been specially

designed for the repair of such extremely demanding

hiatus hernias.

The sophisticated construction of the implant

combines three technologies and thus ensures

the maximum degree of patient safety.

DynaMesh®-HIATUS Size: 07 cm x 12 cm PV610712F1 Unit = 1 EA / BX

PV610712F3 Unit = 3 EA / BX

Size: 08 cm x 13 cm PV610813F1 Unit = 1 EA / BX

PV610813F3 Unit = 3 EA / BX

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43

Shape stability under loadConventional mesh structures are deformed under

load. Constriction of the mesh in the region of the

hiatus may reduce the distance between mesh implant

and oesophagus, eventually causing mesh erosion.

DynaMesh®-HIATUS is based on a sophisticated textile

design with rectangular pores, which even under load

retain a high degree of shape stability.

High effective porosityMesh implants tend to shrink after incorporation in vivo.

DynaMesh®-HIATUS has a high effective porosity, which

ensures that the mesh implant is thoroughly incorporated.

During incorporation the use of the proven and highly

biocompatible PVDF polymer ensures that scarring is

kept to a minimum. The good incorporation of the

mesh implants combined with little scarring leads to

minimisation of mesh shrinkage and permanently

high flexibility of the incorporated implant.

Smooth, warp-knitted mesh marginsIf the mesh does come into contact with the oesophagus

in spite of all measures to prevent it, DynaMesh®-HIATUS

has smooth mesh margins that minimise the danger

of mesh erosion.

visib

le te

chno

logy

Technical data

Polym

er (m

onof

ilam

ent)

Exce

llent

bio

com

patib

ility

Minim

al fo

reig

n bo

dy re

actio

ns

Redu

ced

bacte

rial a

dher

ence

High

agein

g re

sista

nce

Optim

al dy

nam

omet

ry

No sc

ar p

late f

orm

atio

n

Reac

tive s

urfa

ce (a) [m

²/m

²]

Maxim

um st

abilit

y (b

) [N/c

m]

Elasti

city (b

) at 1

6 N/c

m [

%]

Text

ile p

oros

ity (d) [%

]

Effe

ctive

por

osity

(d) [%

]

Effe

ctive

por

osity

at 2,

5 N/c

m (d)

[%]

Classif

icatio

n (e)

(a)- (e

) p.4

9

PVDF

p.14p.13p.11p.10p.10p.10p.10

1,9

p.12

58

p.13

13

p.13

71

p.14

68

p.15

68

p.15

1a

Page 44: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

Polymer PVDF as Implant Material

1. Klinge U, Klosterhalfen B, Öttinger A P, Junge K, Schumpelick V:

PVDF as a new Polymer for the Construction of Surgical Meshes

Biomaterials 23/16: 3487-3493; ©Elsevier, NL (2002)

2. Klink C D, Junge K, Binnebösel M, Alizai H P, Otto J, Neumann U P, Klinge U:

Comparison of Long-Term Biocompatibility of PVDF and PP Meshes

Journal of Investigative Surgery, 24: 292-299, DOI 10.3109/08941939.2011.589883;

©Informa Healthcare, Inc. USA (2011)

3. Gerullis H, Georgas E, Eimer C, Goretzki P E, Lammers B J, Klosterhalfen B,

Borós M, Wishahi M, Heusch G, Otto T:

Evaluation of Biocompatibility of Alloplastic Materials:

Development of a Tissue Culture in Vitro Test System

Surgical Technology International XXI; ©Universal Medical Press, Inc. USA (2012)

10. Berger D, Bientzle M:

Polyvinylidene Fluoride: A suitable Mesh Material for Laparoscopic Incisional and

Parastomal Hernia Repair!

A prospective, observational study with 344 patients

Hernia 13/2: 167-72, DOI 10.1007/s10029-008-0435-4; ©Springer-Verlag (8/2008)

11. Junge K, Binnebösel M, Rosch R, Jansen M, Kämmer D, Otto J, Schumpelick V, Klinge U:

Adhesion Formation of a Polyvinylidenfluoride/Polypropylene Mesh for Intra-Abdominal

Placement in a Rodent Animal Model

Surgical Endoscopy 23: 327–333, DOI 10.1007/s00464-008-9923-y;

©Springer Science+Business Media (4/2008)

27. Mary C, Marois Y, King MW, et al:

Comparison of the in vivo behavior of polyvinylidene fluoride and polypropylene sutures used

in vascular surgery.

ASAIO J 44:199–206 (1998)

52. Silva RA, Silva PA, Carvalho ME:

Degradation studies of some polymeric biomaterials: Polypropylene (PP) and

polyvinylidene difluoride (PVDF).

THERMEC 2006, Pts 1-5 539–543:573–576 (2007)

68. Conze J, Junge K, Weiss C, et al

New polymer for intra-abdominal meshes--PVDF copolymer. J Biomed Mater Res Part B Appl Biomater

87:321–328. (2008)

44

Visceral SurgeryLiterature

Page 45: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

Product Design – Essential Mesh Parameters

6. Mühl T, Binnebösel M, Klinge U, Goedderz T:

New Objective Measurement to Characterize the Porosity of Textile Implants

Journal of Biomedical Materials Research Part B: Applied Biomaterials: 176-183, DOI 10.1002/jbmb;

©Wiley Periodicals, Inc. (5/2007)

8. Klinge U, Klosterhalfen B:

Modified Classification of Surgical Meshes for Hernia Repair

Based on the Analyses of 1,000 Explanted Meshes

Hernia 16: 251-258, DOI 10.1007/s10029-0913-6; ©Springer-Verlag (4/2012)

25. Klosterhalfen B, Junge K, Klinge U:

The lightweight and large porous mesh concept for hernia repair.

Expert Rev Med Devices 2:103–117. (2005)

53. Zhu L-M, Schuster P, Klinge U:

An overview of crucial mesh parameters.

World Journal of Gastrointestinal Surgery (2015)

Inguinal Hernia TreatmentDynaMesh®-ENDOLAP, DynaMesh®-ENDOLAP 3D and DynaMesh®-LICHTENSTEIN

16. Junge K, Binnebösel M, Kauffmann C, Rosch R, Klink C, Trotha K, Schoth F,

Schumpelick V, Klinge U:

Damage to the Spermatic Cord by the Lichtenstein and TAPP Procedures in a Pig Model

Surgical Endoscopy 25/1: 146-52, DOI 10.1007/s00464-010-1148-1;

©Springer Science+Business Media (6/2010)

67. Garcia-Pastor P, Porrero-Carro J, et al:

Prospective Multicenter Blinded Randomized Study Comparing PP and PVDF Mesh Implants in

Lichtenstein Procedure with Respect to Pain and Recurrence.

JSM Surgical Procedures 1: (2018)

Ventral Hernia TreatmentDynaMesh®-IPOM and DynaMesh®-CICAT

14. Berger D, Bientzle M:

Principles of laparoscopic repair of ventral hernias.

European Surgery 38:393–398. (2006)

55. Kohler A, Lavanchy JL, Lenoir U, et al:

Effectiveness of Prophylactic Intraperitoneal Mesh Implantation for Prevention of

Incisional Hernia in Patients Undergoing Open Abdominal Surgery: A Randomized Clinical Trial.

JAMA Surgery 154:109. (2019)

45

Literature

Page 46: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

56. Köhler G, Pallwein-Prettner L, Koch OO, et al:

Magnetic Resonance–Visible Meshes for Laparoscopic Ventral Hernia Repair.

JSLS : Journal of the Society of Laparoendoscopic Surgeons 19:e2014.00175. (2015)

57. Muysoms F, Beckers R, Kyle-Leinhase I:

Prospective cohort study on mesh shrinkage measured with MRI after laparoscopic ventral hernia

repair with an intraperitoneal iron oxide-loaded PVDF mesh.

Surgical Endoscopy 32:2822–2830. (2018)

58 Verbo A, Pafundi P, Manno A, et al:

Polyvinylidene Fluoride Mesh (PVDF, DynaMesh®-IPOM) in The Laparoscopic Treatment of Incisional

Hernia: A Prospective Comparative Trial versus Gore® ePTFE DUALMESH® Plus.

Surgical technology international 28:147–151 (2016)

Parastomal Hernia TreatmentDynaMesh®-IPOM and DynaMesh®-IPST

9. Berger D, Bientzle M:

Laparoscopic Repair of Parastomal Hernias: A Single Surgeon’s Experience in 66 Patients.

Diseases of the Colon & Rectum 50:1668–1673. (2007)

12. Berger D:

Laparoskopische Reparation der parastomalen Hernie.

Der Chirurg 81:988–992. (2010)

15. Berger D:

Prevention of parastomal hernias by prophylactic use of a specially designed intraperitoneal onlay

mesh (Dynamesh IPST®).

Hernia 12:243–246. (2007)

59. Conde-Muíño R, Díez J-L, Martínez A, et al:

Preventing parastomal hernias with systematic intraperitoneal specifically designed mesh.

BMC Surgery 17:. (2017)

60. Fischer I, Wundsam H, Mitteregger M, Köhler G:

Parastomal Hernia Repair with a 3D Funnel Intraperitoneal Mesh Device and Same-Sided Stoma

Relocation: Results of 56 Cases.

World Journal of Surgery 41:3212–3217. (2017)

61. Köhler G, Hofmann A, Lechner M, et al:

Prevention of parastomal hernias with 3D funnel meshes in intraperitoneal onlay position by

placement during initial stoma formation.

Hernia 20:151–159. (2016)

62. Köhler G, Wundsam H, Pallwein-Prettner L, et al:

Magnetic resonance visible 3-D funnel meshes for laparoscopic parastomal hernia prevention

and treatment.

European Surgery 47:127–132. (2015)

46

Visceral Surgery

Page 47: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

63. Köhler G, Emmanuel K:

Laparoscopic stoma relocation for parastomal hernia treatment by using a magnetic resonance

visible three-dimensional implant.

ANZ Journal of Surgery 87:411–412. (2017)

64. Köhler G, Fischer I, Wundsam H :

A Novel Technique for Parastomal Hernia Repair Combining a Laparoscopic and

Ostomy-Opening Approach.

Journal of Laparoendoscopic & Advanced Surgical Techniques 28:209–214. (2018)

65 Köhler G, Mayer F, Wundsam H, et al:

Changes in the Surgical Management of Parastomal Hernias Over 15 Years: Results of 135 Cases.

World Journal of Surgery 39:2795–2804. (2015)

66 Zhang H, Xie J, Miao J, Wu H:

Hybrid Approaches for Complex Parastomal Hernia Repair.

Journal of the College of Physicians and Surgeons Pakistan 26:72–73 (2016)

Hiatal Hernia TreatmentDynaMesh®-HIATUS

51. Köhler G, Pallwein-Prettner L, Lechner M, et al:

First human magnetic resonance visualisation of prosthetics for laparoscopic large hiatal hernia

repair.

Hernia 19:975–982. (2015)

DynaMesh® visible Technology

7. Hansen NL, Barabasch A, Distelmaier M, et al:

First In-Human Magnetic Resonance Visualization of Surgical Mesh Implants for Inguinal Hernia

Treatment.

Invest Radiol. (2013)

29. Kuehnert N, Kraemer NA, Otto J, et al:

In vivo MRI visualization of mesh shrinkage using surgical implants loaded with

superparamagnetic iron oxides.

Surgical Endoscopy 26:1468–1475. (2011)

51. Köhler G, Pallwein-Prettner L, Lechner M, et al:

First human magnetic resonance visualisation of prosthetics for laparoscopic large hiatal

hernia repair.

Hernia 19:975–982. (2015)

56. Köhler G, Pallwein-Prettner L, Koch OO, et al:

Magnetic Resonance–Visible Meshes for Laparoscopic Ventral Hernia Repair.

JSLS : Journal of the Society of Laparoendoscopic Surgeons 19:e2014.00175. h (2015)

47

Literature

Page 48: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

57. Muysoms F, Beckers R, Kyle-Leinhase I:

Prospective cohort study on mesh shrinkage measured with MRI after laparoscopic ventral hernia

repair with an intraperitoneal iron oxide-loaded PVDF mesh.

Surgical Endoscopy 32:2822–2830. (2018)

62. Köhler G, Wundsam H, Pallwein-Prettner L, et al:

Magnetic resonance visible 3-D funnel meshes for laparoscopic parastomal hernia prevention and

treatment.

European Surgery 47:127–132. (2015)

69. Kuehnert N, Otto J, Conze J, et al:

Time-Dependent Changes of Magnetic Resonance ImagingYVisible Mesh Implants in Patients

(2014)

70. Hansen NL, Ciritsis A, Otto J, et al:

Utility of Magnetic Resonance Imaging to Monitor Surgical Meshes: Correlating Imaging and

Clinical Outcome of Patients Undergoing Inguinal Hernia Repair.

Invest Radiol. (2015)

48

Visceral Surgery

See our video library on our web site at

http://en.dyna-mesh.com/videos-gb/

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49

Legends for the technical data

(a) Ratio of implant reactive surface area (thread surface) to implant surface area (see p. 12)

(b) measured in the strip tensile test(c) modified trouser tear test(d) the Mühl method [6](e) Klinge’s classification [8]

Literature

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50

Visceral Surgery

Page 51: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

www.dyna-mesh.com 51

Notes

Page 52: Legal information - DynaMesh · 2019-08-05 · The textile structures warp-knitted from this are the second guarantee. Very high body compatibility PVDF filaments have excellent biocompatibility

www.dyna-mesh.com

KA

001e

n01_

2019

-03-

01_d

4

890

en01

hergestellt durch / manufactured by / fabriqué par / fabricado por / fabbricato da

FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH

Prager Ring 7052070 Aachen, Germany

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