Surgical Meshes and Methods of Fixation

Surgical Meshes andMethods of FixationSurgical Meshes andMethods of Fixation

George S. Ferzli MD, FACSProfessor of Surgery, State University of New York

George S. Ferzli MD, FACSProfessor of Surgery, State University of New York

We will cove biologic and synthetic meshes as well as closure of the defect during the course of the presentation.

Is the abdomen a weakness in the human race ?Is the abdomen a weakness in the human race ?

Incidence of Ventral HerniasIncidence of Ventral Hernias

• Around 10 % of all laparotomies will generate incisional hernias.

• The bigger the incision, the higher the risk.• ~77% are median hernias• ~17% are lateral hernias• ~6% are iliac hernias

• Direct closure have a high recurrences incidence (50%). The rate• increases (58%) with repair of recurrent hernias.

• Significant reduction in recurrences is achieved when meshes are used.

• Luijendijk RW, et al. A Comparison of Suture Repair with Mesh Repair for Incisional Hernia.NEJM 2000; 343:392-398

Factors influencing ventral hernia occurrence

Factors influencing ventral hernia occurrence

The most important functions of the abdominal wall are protection, compression and retention of the abdominal contents, flexion and rotation of the trunk and forced expiration.

Endogen Exogene Others

• Age > 45 Sutures emergency• BMI > 25 length of incision intra abdominal • previous operation contamination pressure• anemia Medication• shock Type of incision• smoker• Corticoïds• Aneurysm/Marfan• (+30% risks)

Hypothesis: In midline incisions closed with a single layer running suture, therate of wound complications is lower when a suture length to wound lengthratio of at least 4 is accomplished with a short stitch length rather than with along one.

Surgical site infection occurred in 35 of 343 patients (10.2%) in the long stitchgroup and in 17 of 326 (5.2%) in the short stitch group (P=0.2). Incisionalhernia was present in 49 of 272 patients (18.0%) in the lo9ng stitch group andin 14 of 250 (5.6%) in the short stitch group (P<.001).

Conclusion: In midline incisions closed with a running suture and having asuture length to wound length ratio of at least 4, current recommendations ofplacing stitches at least 10mm from the wound edge should be3 changed toavoid patient suffering and costly wound complications.

Effect of Stitch Length on Wound Complications After Closure of Midline Incisions; A Randomized Controlled StudyDaniel Millbourn, MD; Yucel Cengiz, MD, PhD; Leif A. Israelsson, MD, PhD

Effect of Stitch Length on Wound Complications After Closure of Midline Incisions; A Randomized Controlled Study, Millbourn, D MD; Cengiz, Y MD, PhD; Israelsson, L MD, PhD Arch Surg/vol 144 (No. 11), Nov 2009 www.archsurg.com

Table 2. Wound complications related to stitch length


Complication Long Short P Valuea

Wound dehiscence,

No. (%) of patients

1/381 (0.3) 0/356 .99

Surgical site infection No. (%)

35/343 (10.2) 17/326 (5.2) .02

Incisional hernia No. (%)

49/272 (18.0) 14/250 (5.6) .001

Stitch length

aFisher exact test.

Table 3. Significant predictors of surgical site infection

and incisional herniaa


Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); CI, confidence interval; OR odds ratio; SL, suture length; WL wound length

A Results of logistic regression analysis. All recorded variables were included in the model and removed by a backward reduction strategy if nonsignificant.

Predictor Regression Coefficient (SE) OR (95%CI)

Surgical site infection

Wound contamination 1.03 (0.48) 2.81 (1.09-7.25)

Being diabetic 1.01 (0.38) 2.73 (1.30-5.72)

Long stitch length 0.77 (0.31) 2.15 (1.17-3.96)

Incisional hernia

Male sex 0.76 (0.34) 2.14 (1.10-4.15)

Higher BMI 0.05 (0.02) 1.05 (1.01-1.10)

Longer operation time 0.005 (0.002) 1.01 (1.002-1.01)

Surgical site infection 1.16 (0.40) 3.18 (1.44-7.02)

SL to WL ratio <4 1.32 (0.52) 3.73 (1.36-10.26)

Long stitch length 1.44 (0.34) 4.24 (2.19-8.23)

Conclusions


When a long stitch length is used, the suture cuts through or compresses soft tissue included in the stitch. This increases the amount of devitalized tissue in the wound and may explain the correlation with infection. This also causes slackening of the suture, which allows the wound edges to separate and increases the risk of incisional hernia.

• Surgeons should place stitches 5-8 mm from the wound edge, with minimal tension applied to the suture.

• Midline incisions should be closed with a single layer, running monofilament suture and the SL to WL ratio should be at least 4. This ratio should be achieved with several small stitches that incorporate aponeurosis only.

Ventral hernia: anatomyVentral hernia: anatomy

In humans the intra-abdominal pressure ranges from 0,2kPa (resting) to 20 kPa (maximum).

In humans the intra-abdominal pressure ranges from 0,2kPa (resting) to 20 kPa (maximum).

Pressure

Abdominal Wall ElasticityAbdominal Wall Elasticity

• After the Intra-abdominal pressure,another important factor in the abdominal wall repair plays a role,it is the abdominal wall elasticity.

• The abdominal wall is elastic.

• The abdominal wall elasticity was studied by Pr Schumpelick and his team*

• He showed that the abdominal wall of a women is more elastic than the abdomen of a man.

*Hernia (2001) 5: 113-118

Ventral hernia mesh positioning: OnlayVentral hernia mesh positioning: Onlay

Ventral hernia mesh positioning: InlayVentral hernia mesh positioning: Inlay

Ventral hernia mesh positioning: UnderlayVentral hernia mesh positioning: Underlay

Ventral hernia mesh positioning: Intraperitoneal

Ventral hernia mesh positioning: Intraperitoneal

Types of prosthetics for hernia repair:


• Type 1: totally macroporous prosthesis, pores > 75 microns; example prolene, marlex

• Type 2: totally microporous prosthesis; pores < 10 microns; example gortex or dual mesh

• Type 3: macroporous prosthesis with microporous components; example Teflon, mersilene

• Type 4: biomaterials with submicronic pore size; example cilastic, cell gard

Polyglactene Mesh (vicryl mesh) Polyglactene Mesh (vicryl mesh)

• Alternative to nonabsorbable meshes

• Advantage host invasion and subsequent absorption of implant

• There is less infection complication, increase recurrence rate (satisfactory short term solution in infected hernias but not generally indicated when prolonged 10-side strength is

required)

Polypropylene BiomaterialsPolypropylene Biomaterials

• Angimesh, Angiologics, S. Martino Sicc., Italy

• Biomesh P1, Cousin Biotech, Wervicq-Sud, France


• Biomesh 3D, Cousin Biotech, Wervicq-Sud, France

• C-QUR (polypropylene / omega 3 fatty acid coating), Atrium, NH, USA• DynaMesh (polypropelene incorporated with polyvinylidene difluoride)

FEG, Aachen, Germany

• Hetra 1, 2, HerniaMesh, S.R.L., Torino, Italy

• Hermesh 3,4,5, HerniaMesh, S.R.L., Torino, Italy

• Intramesh NKI, NK2, NK8, Cousin Biotech, Wervicq-Sud, France

• Marlex, C.R.Bard, Inc., Cranston NJ, USA


• Parietene, Sofradim International, Villfranche-sur-Saone, France

• Proceed (polypropelene / polydiaxanone / oxidized regenerated cellulose), Ethicon, Somerville, NJ, USA

• Prolene, Ethicon, Somerville, NJ, USA

• Prolene Soft Mesh, Ethicon, Somerville, NJ, USA

• Prolite, Atrium Medical Corporation, Hudson, NH, USA

• Prolite Ultra, Atrium Medical Corporation, Hudson, NH, USA

• Surgipro (Monofilament), United States Surgical Corp,/Tyco, Norwalk, CT, USA

• Sepramesh (polypropylene mesh coated with Seprafilm - modified sodium hyaluronate and carboxymethylcellulose) Genzyme, MA, USA

• Surgipro (Multifilament), United States Surgical Corp./Tyco, Norwalk, CT, USA

• TiMesh (titanium-coated polypropylene) Medizintechnik GmbH, Nuremberg, Germany

• Trelex, Meadox Medical Corporation, Oakland, NJ, USA

• Ultrapro (Poliglecaprone-25 / Polypropylene), Ethicon, Somerville, NJ, USA

Polypropylene MeshPolypropylene Mesh

• Schmitt and Griman in 1967 first described successful use of polypropylene mesh in contaminated wounds

• Subsequent reports showed good initial healing but were fraught with long term complications

• Those complications are chronic infection, fistula formation, erosion into bowels or through skin grafts

• Jones and Jurkoyiun in 1989 reviewed 14 studies, 128 patients, and found 55 overall complication rate - enteric fistulization being the most common.

In Favor ofPolypropylene Mesh:


• Extensive fibroblast in growth , incorporation by the host and can be used in contaminated fields

Franklin ME et al. Lap ventral and incisional hernial repair. Surg Lap End

8(4):294-299 1998

285 lap ventral hernia and 520 lap inguinal hernia using IPOM with

polypropylene mesh. 1 fistula formation (0.14%), 4 mesh infections

(0.50%), and 6 reoperations for bowel obstruction secondary to mesh

adhesions (0.75%). Relaparoscopy 27 patients (19 incisional, 8

inguinal): 1/3 no adhesions, 1/3 mild adhesions, 1/3 severe.

Chowbey PK et al. Lap ventral hernia repair J La Adv Surg

Tech 2000; 10:79-84

Bingener J et al. Adhesion formation after laparoscopic ventral

incisional hernia repair with polypropylene mesh: a study using

abdominal ultrasound, JSLS (2004)8:127-131

Against polypropylene mesh:Against polypropylene mesh:

• It is extremely difficult to lyse adhesions to polypropylene without causing enterotomies*

• Major complications with polypropylene not evident until years later

• 9 cases of mesh erosion fistula stainless steel (1) tantalum (1) mersilene (1) dexon (1) ppm (5). The time to the development of these fistulas ranged from 3 months to 14 years

*Losanoff JE et al. Entero-colocutaneous fistula: a late consequence of polypropylene mesh abdominal wall repair: case report and review of the literature, Hernia 2002; 6: 144-147

ePTFE BiomaterialsePTFE Biomaterials

• DualMesh, W.L. Gore and Associates, Flagstaff, AZ, USA

• DualMesh Emerge, W.L. Gore and Associates, Flagstaff, AZ, USA

• DualMesh Plus, W.L. Gore and Associates, Flagstaff, AZ, USA

• DaulMesh Plus Emerge, W.L. Gore and Associates, Flagstaff, AZ, USA

• DualMesh with Holes, W.L. Gore and Associates, Flagstaff, AZ, USA

• DualMesh Plus with Holes, W.L. Gore and Associates, Flagstaff, AZ, USA

• Dulex, C.R. Bard, Inc., Cranston NJ, USA

• Mycromesh, W.L. Gore and Associates, Flagstaff, AZ, USA

• Mycromesh Plus, W.L. Gore and Associates, Flagstaff, AZ, USA

• Reconix, C.R. Bard, Inc., Cranston NJ, USA

• Soft Tissue Patch, W.L. Gore and Associates, Flagstaff, AZ, USA

In Favor of ePTFEIn Favor of ePTFE

• Microporous, smooth texture minimizes tissue in-growth and limits adhesion formation and bowel injury

• Combined with a large pore second layer it can adhere well to the abdominal wall

Against ePTFEAgainst ePTFE

• Microporous construction limits ability of macrophages to destroy bacteria

• Mesh infection is not well treated by antibiotics and requires mesh removal

• Does not integrate well into host tissue when not combined with a large pore mesh

Polyester meshPolyester mesh

• Parietex (polyester and atelocollagen type 1, polyethylene glycol, glycerol) Covidien, Hamilton, Bermuda

• Polyester mesh incorporates well into the abdominal wall

• Collagen covering on the visceral surface protects bowel and dissolves as the polyester is incorporated

Polyester and atelocollagen type 1, polyethylene glycol, glycerol (Parietex)


• Retrospective study of the use of Parietex in laparoscopic ventral hernia repair

• n = 20 patients • Mean follow up - 10 months • No morbidity or mortality• No infections, rejections, fistulas, recurrences, or

alterations in bowel function• Parietex is safe for intra-abdominal use

Moreno-Egea A, Liron R Girela E, Aguayo JL. Laparoscopic repair of ventral and incisional hernias using a new composite mesh (Parietex): initial experience. 2001 Surg Laparoc Endosc Percutan Tech Apr;11(2):103-6



Comparison of Parietex with Sepramesh for ventral hernia repair

in rabbit model

Results at 5 months Parietx Sepramesh

•Strength

of incorporation 70.9N 31.5N•Bowel adhesions 0 4•Adhesion area 321 mm2 840 mm2

•Shrinkage 17.4% 6.1%

Parietex has stronger incorporation and is better at prevention of

adhesiona than sepra mesh, however it undergoes considerably more

shrinkage

Judge TW, Parker DM, Dinsmore RC. Abdominal wall hernia repair: A comparison of Sepramesh and Parietex composite mesh in a rabbit hernia model. J Am Coll Surg 2007, Feb;204(2):276-81



• Experience with 656 laparoscopic ventral hernia repairs with Parietex

• Hernia defect closed with sutures to reduce seroma and restore abdominal wall function

• Laparoscopic mesh repair performed with Parietex mesh

Chelala E. (2008) Personal correspondence



• Mean follow up 45 months• Recurrences 20 (3.04%)• “Second look” operation

for various reasons 70

• Adhesion free 38 (54.3%)• Minor adhesions 27 (38.6%)• Serosal adhesions 5 (7.1%)

Parietex is associated with low formation of dense adhesions

Chelala E. Personal correspondence

Open ventral hernia repairCompetition

Open ventral hernia repairCompetition

• BARDVentralexKugel ComposixComposix E/X

• ETHICONProceed

• ATRIUMC-Qur

• GOREDualmesh

• GENZYMESepramesh IP

• GfE TiMesh

Properties of Absorbable Barrier-Coated Meshes

Ventral hernia repair - Mesh portfolioVentral hernia repair - Mesh portfolio

Open Open/Lap Hiatal Parastomal

Covidien PCO OS PCOPPC

PCO2H Coming soon

Bard Ventralex (umbilical)Kugel composix

Composix E/XComposix L/P

Crurasoft Bard CK

Ethicon Proceed

Gore Dual mesh

Atrium C-Qur

Bard VentralexBard Ventralex

Designed for small ventral, umbilical, and epigastric hernia repairs

Self-expanding polypropylene & ePTFE patch with a memory recoil ring

Positioning straps to facilitate placement and suturing

Memory recoil ring enables the patch to be folded and later “pop open” and lay flat after insertion into the intra-abdominal space.

Available in 4, 6 and 8 cm diameter

Bard Ventralex / Composix structureBard Ventralex / Composix structure

• PTFE stitches makes the surface non continuous and create bridges between viscera and PP layers

Bard Ventralex rebuttalBard Ventralex rebuttal

Strengths

Easy to implant

Weaknesses

Low antiadhesion efficacy

PTFE stitches creates holes in the ePTFE layer allowing for adhesions

Bard Composix E/XBard Composix E/X

Two distinctly different sides: Polypropylene mesh on one side to promote tissue ingrowth and sub-micronic ePTFE on the other side to minimize adhesions to the prosthesis.

The 2 layers are stitched with PTFE monofilament.

Elliptically shaped design: Reduces the need to trim the mesh, saving time.

Low Profile: Makes it ideally suited for laparoscopic ventral hernia repairs.

Sealed Edge: Prevents exposure of the polypropylene mesh side from contact with the bowel, thus potentially reducing the chances of adhesions around the edge of the prosthesis.

Bard Composix E/X rebuttal Bard Composix E/X rebuttal

Strengths

Protected edge Elliptic shape

Weaknesses

Heavy weight PP induces high fibrosis.

Holes in the ePTFE side made by the PTFE stitches may create adhesions

Cannot be cut as the PP layer will be widely exposed

Low clinical efficacy (high rate of adhesions)

The two layers from the Bard Composix E/X were no longer attached, and tissue or adhesions were found frequently between the two layers. The mesh edges were lifted and not smoothly encapsulated as with the previous mesh materials. Adhesions from the caecum to the mesh were found in five of the 12 animals (42%)

Source: Gonzales study, Hernia 2004

Bard Composix LPBard Composix LP

Made with lightweight, low profile polypropylene Soft Mesh that is 60% lighter than traditional polypropylene mesh

Easier handling and laparoscopic insertion, all sizes can fit through a trocar

Optional Introducer Tool, which is packaged with larger sizes, makes insertion even easier

Two distinctly different sides: polypropylene Soft Mesh on one side to promote tissue ingrowth and sub-micronic ePTFE on the other side to minimize tissue attachment to the prosthesis

Sealed Edge: Overlap of ePTFE protects the edge of the mesh from visceral attachment

Bard composix L/P rebuttalBard composix L/P rebuttal

Strengths

Sealed edges Introducer tool Light PP mesh on parietal side

Weaknesses

Holes in the ePTFE side made by the PTFE stitches may create adhesions

Low clinical efficacy (high rate of adhesions)

Cannot be cut as the PP layer will be widely exposed

Bard Composix KugelBard Composix Kugel

Double layer of monofilament polypropylene. These two layers create a positioning pocket, which is used to guide the patch into the proper position.

On the other side is a barrier of ePTFE.

The PP layers and ePTFE are stitched with PTFE monofilament

The patch also contains a patent-protected "memory recoil ring," which causes the patch to spring open and maintain its shape during placement.

Bard Composix Kugel recallBard Composix Kugel recall

• Risk of rupture of the PET memory recoil ring• This can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal

fistulae (abnormal connections or passageways between the intestines and other organs).

Product Code

Description Lot Numbers

Recalled Date Recalled

0010206 Bard® Composix® Kugel® Extra Large Oval,8.7” x 10.7”

All Lot Numbers December 2005 and January 2006

0010207 Bard® Composix® Kugel® Extra Large Oval 10.8” x 13.7”


0010208 Bard® Composix® Kugel® Extra Large Oval, 7.7” x 9.7”


0010209 Bard® Composix® Kugel® Oval, 6.3” x 12.3”

All Lot Numbers March, 24, 2006

0010202 Bard® Composix® Kugel® Large Oval,5.4” x 7.0”

All Lot Numbers January 10, 2007

0010204 Bard® Composix® Kugel® Large Circle, 4.5”

All Lot Numbers January 10, 2007

Bard Composix Kugel rebuttal Bard Composix Kugel rebuttal

Weaknesses

Kugel mesh too thick to be used laparoscopically (Ideal approach )

Mesh shrinkage and migration is a potential problem (there are several recurrences but the mesh is not visualized laparoscopically)

Rupture of the memory recoil ring

Low clinical efficacy on anti adhesion prevention

Strengths

Memory effect for intraperitoneal placement

Ethicon ProceedEthicon Proceed

Multilayered tissue separating mesh comprised of:

PROLENE* Soft polypropylene Mesh Monofilament polypropylene

encapsulated with polydioxanone (PDS)

Designed for strength, durability, and adaptability

Oxidized regenerated cellulose (ORC) fabric

Minimizes tissue attachment

Plant-based material (non-animal) Absorbable polydioxanone (PDS)

Creates a flexible, secure bond between the mesh and ORC layers

Ethicon – Proceed MeshEthicon – Proceed Mesh

Lightweight Monofilament Construction Less foreign mass Flexible scar tissue Strong tissue incorporation

Excellent Handling Low profile Blue-striped surface distinguishes the parietal from the visceral side

Resists Bacterial Colonization No ePTFE Lightweight, macro porous, monofilament mesh structure Allows fluid flow-through

Recovers to Original Shape Once Placed Easily deployed and positioned once inside abdominal cavity Conforms to anatomy Readily customized

Timeline—The Progress of Peritoneal Healing


Day 1- PROCEED mesh is implanted and the mesh begins to

incorporate into the abdominal wall. ORC forms a continuous gel that

physically separates mesh from underlying viscera surfaces, reducing

the severity and extent of tissue attachment.



Day 7- Neoperitoneum is formed within 7 to 10 days. Absorbable

components have begun to break down.



Day 14 - ORC is absorbed Peritoneum is fully restored



Day 91- The PDS and ORC are completely absorbed. The remaining polypropylene mesh is surrounded by fibroblasts and the neoperitoneum is supported by a well-organized fibroblast bed.

PROCEED* Surgical Mesh Essential Prescribing Information

PROCEED* Surgical Mesh Essential Prescribing Information

Warnings: When this mesh is used in infants, children, pregnant women, or

women planning pregnancies, the surgeon should be aware that this

product will not stretch significantly as the patient grows. PROCEED Mesh

should not be placed in a contaminated surgical site. The mesh may

not be used following planned intraoperative or accidental opening

of the gastrointestinal tract. PROCEED Mesh has an ORC component,

which must not be used in cases in which appropriate hemostasis

has not been established. Tissue attachment to the mesh can result if

appropriate hemostasis is not achieved.

Ethicon Proceed rebuttalEthicon Proceed rebuttal

Strengths Weaknesses Low clinical efficacy Contraction of the Prolene Soft by 34% No memory shape, difficult to manipulate,

tends to adhere to tissue when wet, Meticulous haemostasis must be achieved* Low intra-op light, No overlap over the edges, De-lamination cases due to resorbable PDS

may induce seroma, higher sepsis risk Low resistance to suture

• *IFU WARNINGS PROCEED Mesh has an ORC component, which must not be used in cases in which appropriate hemostasis has not been established. Tissue attachment to the mesh can result if appropriate hemostasis is not achieved

Atrium C-Qur and C-Qur edgeAtrium C-Qur and C-Qur edge

Atrium’s new C-QUR™ Mesh technology combines lightweight ProLite Ultra™ polypropylene surgical mesh with a proprietary, highly purified Omega 3 fatty acid bio-absorbable coating.

C-Qur edge features a reinforced edge design for enhanced fixation stability and ease of use.

Fatty acid may have antimicrobial properties.

Resorption of the coating occurred within 3 to 6 months

Atrium C-Qur and C-Qur edge rebuttalAtrium C-Qur and C-Qur edge rebuttal

Strengths Animal testing show minimal

adhesion and good tissue integration

Fatty acid may have antimicrobial effect (not validated in clinicals)

Transparent, good visibility of landmarks

Weaknesses

Lack of human studies

Dualmesh®

Gore, Inc.

Dualmesh®

Gore, Inc.

GORE DUALMESH® Biomaterial is a soft, conformable, ePTFE sheet material that offers a unique, two-surface design intended for such applications. The biomaterial features two functionally distinct surfaces: a closed structure surface for reduced tissue attachment and a macro porous structure surface for faster tissue attachment.

Gore Dual mesh / Dual mesh PlusGore Dual mesh / Dual mesh Plus

Gore Dual mesh is a dual layer of ePTFE

Visceral side is composed of ridges and valleys, called as Corduroy, to create porosity (22 µm).

The smooth visceral side of the material is brown.

GORE-TEX® DUALMESH® PLUS Biomaterial is impregnated with two antimicrobial agents – chlorhexidine and silver – intended to inhibit bacterial colonization of the prosthesis for a period of up to ten days post-implantation.

Gore Dual mesh rebuttalGore Dual mesh rebuttal

Strengths Used for many years

Weaknesses

No tissue integration High rate of seroma Need strong fixation: tacks and sutures Highest Shrinkage among material High density Opaque: cannot see the anatomical landmarks,

vessel and nerves Shiny surface under lap

“The use of antimicrobial-impregnated ePTFE mesh with silver/chlorhexidine in laparoscopic ventral hernia repair is associated with noninfectious postoperative fever. In our patients, the evaluation and management of these fevers resulted in a significantly longer hospital stay.”

Cobbs, Am Surg. 2006 Dec;72(12):1205-8;

Genzyme Sepramesh IPGenzyme Sepramesh IP

Sepramesh™ IP Bioresorbable Coating / Permanent Mesh is co-knitted using polypropylene (PP) and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a PP surface and a PGA surface.

The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel.

PGA Fibers maintain 50% of the reinforcement strength during the 1st 28 days

Bioresorbable coating protects for up to 14 days while peritoneum heals

Hydrogel swells to cover sutures, tacks and mesh edges

Genzyme Sepramesh IP rebuttalGenzyme Sepramesh IP rebuttal

Strengths

Animal studies show low rate of adhesions

Good mechanical properties (burst strength and suture retention)

Translucent

Good memory shape

Weaknesses

Lack of human studies

Requires 12mm or 15mm trocar for lap insertion (8x15, 10x20, 15x20, 20x30)

Genzyme Sepramesh IPGenzyme Sepramesh IP

In preclinical animal studies, Sepramesh®IP demonstrated tissue incorporation superior to ePTFE composite mesh.1

In mechanical tests of burst strength and suture retention, Sepramesh®IP outperformed standard polypropylene mesh in both measures.1

Genzyme Sepramesh IP Genzyme Sepramesh IP

Sepramesh®IP Versus

Other Meshes

• In animal studies, Sepramesh®IP significantly outperformed alternative hernia repair products in protecting the bowel from adhering to the mesh.1

• Representative images from

preclinical animal studies demonstrate incidence of dense bowel adhesions to the mesh.1 The relevance of these findings to humans is not known.

GfE TiMeshGfE TiMesh

– GfE is a German company– TiMesh launched mid-2003

Key Points– Monofilament polypropylene mesh completely coated in Titanium– Sold in two forms – Light and Extra light– Titanium is NOT an anti-adhesive– Product sold in Europe for years

Disadvantages– Very expensive (~$195 - $225/flat sheet)

Competition evaluationCompetition evaluation

Covidien

Pariextex

Composite

Bard

Composix

E/X

Bard

Ventralex

Ethicon

Proceed

Atrium

C-Qur

Gore

Dualmesh

Genzyme

Sepramesh

IP

Adhesion

prevention +++ + + + ? + ++

Tissue

integration ++ + + + + - ++

Shrinkage+ + + + + - +

Elasticity++ - - + ? - +

Ease of

fixation ++ + ++ + + - +

Protected

edge Y Y Y N N N N

Questions????

Biomeshes

Biomesh Type Products, Manufacturers

Human acellular dermis AlloDerm®, LifeCell

Flex HDTM, J&J

AlloMaxTM, Davol

Xenogenic acellular dermis PermacolTM (porcine), Tissue Science Laboratories

SurgiMendTM (bovine,calf), TEI Biosciences

CollaMendTM, (porcine) Davol

XenMatriX® (porcine), Brennen Medical LLC;Brennenmed.com

StratticeTM, LifeCell

Porcine small intestinesubmucosa

Surgisis®, Cook Medical

FortaGen®, Organogenesis

Leve

l of C

ompl

exity

Grade 1Low risk of infection

Low risk of complications

Grade 2Smoker

Immunosuppressed

Obese

Diabetic

Grade 4Active infection

Infected meshGrade 3

Contamination risk

Stoma present

Violation of bowel wall

Previous Wound infection

Grade 5Traumatic fascia loss

Extensive fascia loss

Percent Performed Open

Patients with co-morbid conditions have up to 4x increase in wound-infection rates

Open incisional hernias are 10x more likely to have infection than a clean surgical case

Infected mesh commonly results in a 2nd procedure for removal

Synthetic

Biologic

Massive Incisional HerniasMassive Incisional Hernias

Repair TechniquesRepair Techniques

Autologous Myocutaneous Flaps

• Morbidity and availability issues

Tissue Bank Cadaveric Grafts

• Sterility and tissue quality issues

• Impact of Alloderm

Components Separation

Prosthetic Repair

Healing by Secondary or Tertiary Intention

Components SeparationComponents Separation

• Developed by Dr. Ramirez in the late 80’s

• Employs the use of autologous myofascial tissue to effect abdominal wall closure

• Bilateral relaxation incisions 2cm lateral to the external oblique from costal margin to level of symphasis pubis

• Blunt separation of external oblique layer from underlying internal oblique layer taking care not to interrupt vascular/nerve supply

• May employ undermining of one or both posterior rectus sheaths to achieve further medial advancement

**Provides dynamic support of the abdominal girdle**

Grevious MA. Cohen M. Shah SR. Rodriguez P. Structural and functional anatomy of the abdominal wall. Clinics in Plastic Surgery. 33(2):169-79, v, 2006 Apr.

External Oblique

Internal Oblique

Transversus Abdominis

Rectus Abdominis

Components Separation

Case Report Case Report


The Ideal Reconstructive Approach Should:

Specifically address the nature of the defect Restore normal function Maintain short- and long-term mechanical integrity

(absence of recurrent herniation) Have a low incidence of complications Be reliable in sub-optimal (hostile) wound environments Use autologous tissue

Abdominal Wall Reconstruction: Lessons Learned From 200 “Components Separation” Procedures

Jason H. Ko, MD; Edward C. Wang, PhD; David M. Salvay, MS; Benjamin C. Paul, BA; Gregory A. Dumanian, MD

Abdominal Wall Reconstruction: Lessons Learned From 200 “Components Separation” Procedures. Ko, J, MD; Wang, E, PhD; Salvay, D, MS; Paul. B, BA; Dumanian, G, MD ArchSurg/vol 144 (No. 11), Nov 2009 www.archsurg.com

Conclusions:

Large complex hernias can be reliably repaired using the components separation technique despite the presence of open wounds, the need for bowel surgery and numerous co-morbidities. The long-term strength of the hernia repair is not augmented by acellular cadaveric dermis but seems to be improved with soft polypropylene mesh.


Figure 1. Modified “components separation” technique using bilateral transverse subcostal incisions to access the external oblique muscle and fascia . A, Using a narrow Deaver retractor and a Bovie cautery with and extender, the external oblique muscle and fascia are divided superiorly (above the rib cage) and inferiorly. B, At the caudal aspect of the midline incision, the cut edge of the external oblique muscle and fascia is delivered using manual traction for complete release.

Need illustration


Figure 2 “Components separation” technique with midline approximation of the rectus abdominus muscles. A, No mesh. B, Acellular cadaveric dermis underlay. C, Soft polypropylene mesh underlay.

Need illustration


Figure 3 A 41-year old man with a history of a perforated appendix treated through a midline incision who later developed an incisional hernia. A, Preoperative oblique view after a hernia repair with polypropylene mesh by another surgeon. B, Preoperative computed tomography scan demonstrating the small bowel herniating to the right of the polypropylene mesh, with wide displacement of the rectus abdominus muscles. C, Six-month postoperative oblique view demonstrates restoration of abdominal wall continuity. D, Postoperative anterior view demonstates stable midline closure and bilateral transverse subcostal incision scars.

Need photos

Figure 4. Predictors of hernia recurrence and major and minor complications using logistic regression controlling for mesh type and follow-up duration. Error bars represent 95% confidence intervals. BMI indicates body mass index.


Need graph

Abbreviation: NA, not applicable.a Includes patients in whom components separation was performed concurrently with panniculectomy or parastomal hernia repair.a Major complications include hematoma, infection that requires incision and drainage, repeated operation for any complication, myocardial infarction, pulmonary embolus and death.c Minor complications include cellulitis, seroma that requires aspiration, skin sloughing and wound breakdown.d Fisher exact test for categorical variables and the F text for continuous variables.e Statistically significant.


Table 2.

Rates of Recurrence and Complications Based on Type of “Component Separation” Repaira

Type of Repairs

Patients No.

Follow-up Mean mo

Recurrence No. (%)

Time to Recurrence

Mean mo

Major Complications

No. (%)b

Minor Complications

No. (%)c

No mesh 158 9.6 36 (22.8) 14.3 40 (25.3) 30 (19.0)

Poly

propylene

6 5.4 1 (16.7) 9.9 1 916.7) 2 (33.3)

Cadaveric dermis

18 14.7 6 (33.3) 17.8 4 (22.2) 3 (16.7)

Soft polypropylene

18 13.8 0 NA 3 (16.7) 3 (16.76)

Total 200 10.3 43 (21.5) 14.8 48 (24.0) 38 (19.0)

P valued 0.20 0.04e 0.92 0.92 0.80

The components separation technique many be an ideal hernia repair for large defects because it weakens or loosens the contracted sides of the abdominal wall to augment the midline repair. Increased lateral wall compliance may reverse the lateral abdominal wall disuse atrophy and fibrosis seen in animal incisional hernia models.


Observations

The midline movement of tissue with the components separation technique permits the excision of all scarred and inflamed tissues.


Observations

• The hernia recurrence rate with a cadaveric dermis underlay was even higher than that for primary closure. At the time of repeated operation the cadaveric dermis was often difficult to find and when present, large holes in the material itself, were often noted.

• Cadaveric dermis alone does not provide long-lasting or durable results in abdominal wall reconstruction and should therefore, be reserved for contaminated wounds, where a prosthetic mesh is best avoided.


Observations


Conclusions:

• A major lesson learned over the years is that handling of the skin is important, especially in patients with an elevated BMI. Wide undermining of the skin to release the oblique musculature disrupts the perforator blood flow to the midline abdominal skin, thereby contributing to wound complications in these patients.


Conclusions:

• Senior author Gregory Dumanian adapted his surgical technique to perform the external oblique releases through bilateral transverse subcostal incisions to avoid wide undermining, an evolution of the technique of “periumbilical perforator preservation.” Releases take only 15-20 minutes to perform and avoid the setup of endoscopic equipment.


Conclusions:

• Another skin-handling technique is to perform a panniculotomy at the time of the components separation for morbidly obese patients with infraumbilical hernias (repairs of hernias that extend above the umbilicus are generally performed using vertical midline incisions).

A third improvement for skin handling is the use of short-term subatomospheric pressure dressings as immediate postoperative dressings in patients with an elevated BMI, gross contamination and large suprapubic dead spaces. This “semi-closed” technique for skin management had led to decreased seroma formation and infections in addition to allowing access to the midline fascial closure in the immediate postoperative period.

Serious Complications Associated with Negative Pressure Wound Therapy Systems

Date: November 13, 2009

Dear Healthcare Practitioner:

This is to alert you to deaths and serious complications, especially bleeding and infection, associated with the use of Negative Pressure Wound Therapy (NPWT) systems, and to provide recommendations to reduce the risk. Although rare, these complications can occur wherever NPWT systems are used, including acute and long-term healthcare facilities and at home. FDA has received reports of six deaths and 77 injuries associated with NPWT systems over the past two years.

Table 1: NPWT is contraindicated for these wound types/conditions:

• Necrotic tissue with eschar present

• Untreated osteomyelitis

• Non-enteric and unexplored fistulas • Malignancy in the wound • Exposed vasculature • Exposed nerves

• Exposed anastomotic site

• Exposed organs

Table 2: Patient risk factors/characteristics to consider before NPWT use: Patients at high risk for bleeding and hemorrhage

Patients on anticoagulants or platelet aggregation inhibitors

Patients with:

Friable vessels and infected blood vessels

• Vascular anastomosis • Infected wounds • Osteomyelitis • Exposed organs, vessels, nerves, tendon, and ligaments • Sharp edges in the wound (i.e. bone fragments) • Spinal cord injury (stimulation of sympathetic nervous system) • Enteric fistulas

Patients requiring:

MRI Hyperbaric chamber Defibrillation patient size and weight use near vagus nerve (bradycardia) circumferential dressing application mode of therapy- intermittent versus continuous negative pressure

Potential Mesh-Related Complications:Potential Mesh-Related Complications:

• Infection

• Intestinal adhesions

• Bowel obstructions

• Erosion of the prosthesis into the adjacent hollow viscous

• Contraction of prosthesis

Material Functions for Soft Tissue RepairMaterial Functions for Soft Tissue Repair

Synthetics Autografts

•Good mechanical properties

•Low cost

•High foreign body reaction

•Infection up to 8%1

•Can cause pain

•Native Tissue

•Good Mechanical Properties

•Donor Site Morbidity

•Many patients unqualified

•Strong reinforcement

•Biocompatible

•Supports ingrowth

•Ease of handling

•Ability to vascularize

Xeno/Allo graft

Tissue-Generated BiomaterialsTissue-Generated Biomaterials

Human acellular dermis• Alloderm, LifeCell, Branchburg, NJ, USA• Flex HD, Ethicon, Somerville, NJ, USA• AlloMax, Davol, Cranston, NJ, USA

Xenogenic acellular dermis• Permacol (porcine), Tissue Science Laboratories, Aldershot, Hampshire, Eng.• SurgiMend (bovine), TEI Biosciences, Boston, MA, USA• CollaMend (porcine), Davol, Cranston, NJ, USA• XenMatriX (porcine), Brennen Medical LLC ST. Paul, MN, USA • Strattice, (porcine) LifeCell, Branchburg, NJ, USA

Porcine small intestinal submucosa• Surgisis, Cook Medical, West Lafayette, IN, USA• FortaGen, Organogenesis, Canton, MA, USA

Processing of BiomaterialsProcessing of Biomaterials

• Cadaveric, Bovine, Porcine , Equine : removal of all live cells and removal of all nuclear tissue to prevent rejection by the host.

• Cross-linking: serve to form either an intermolecular or an intramolecular cross-link between two aminoacids along protein structure ( HDMI and EDC are in common use).

• Crosslinked products are more resistant to collagenase degradation ( more stable in infected fields where collagenases are secreted by bacteria ).

• Rapid dissolution in the presence of enteric contents ( fistulas ).

• Must be placed in direct contact with healthy tissue ( no infection,fluid or dead tissue ) and under no tension . They should not be used in bridging the defects .

Cook® SurgisisCook® Surgisis

• Surgisis® Gold™ (SIS)

• Porcine intestinal material• Limited sizes – 7 cm x 10 cm up to 20

cm x 20 cm• Must be layered for large sizes• Not crosslinked• Perforated to allow in-growth• Reputation for not lasting• 18 month shelf life

http://www.cooksurgical.com/

Surgisis MeshSurgisis Mesh

• Four-ply prosthetic mesh derived from porcine small intestine submucosa, naturally occurring extracellular matrix that is easily absorbed, supports new vessel growth, and fosters cellular differentiation

• The lack of permanent foreign material may decrease risk of

mesh infection

SISSIS

• SIS remodels to a tissue with strength that exceeds that of the native tissue when used as a body wall repair device.

• SIS aortic graphs with S. aureus –

no evidence of infection after 30 days

Bodylak et al. Comparison of the resistance to infection of intestinal submucosa arterial grafts versus PTFE arterial prosthesis in a dog model. J Vasc Surg: 19; 465, 1994

Bodylak et al. Strength over time of a resorbable bioscaffold for body wall repair in a dog model. J Surg Res 99 (2): 282-287 2001

SIS was associated with improved graft patency, less infection, complete incorporation, and no false aneurysm formation when compared with PTFE in adult mongrel pigs.

T. Wright Jernigan et al. Ann Surg 2004;239: 733-740.

Texas Endosurgery Institute Experience with SIS


Prospective study of use of Surgisis mesh in potentially or grossly contaminated fields

• Procedures all performed laparoscopically • 116 patients (133 procedures performed)

• Hernias included: • Incisional 57

• Umbilical 38• Inguinal 29• Spigelian 4• Femoral 3• Parastomal 2• > 2 different hernias repaired 13

Franklin ME, et al.The use of porcine small intestinal submucosa as a prosthetic material for laparoscopic hernia repair in infected and potentially contaminated fields: long-term follow-up. Surg Endosc 2008 Sep;22(9):1941-6



• Infected field 39• Potentially contaminated field 94• Hernia repairs with concurrent

contaminated procedure 91• Intestinal obstruction 25• Strangulated hernias 16• Small bowel resections 17• Hernia repairs with concurrent

removal of infected mesh 12

Franklin ME, et al.The use of porcine small intestinal submucosa as a prosthetic material for laparoscopic hernia repair in infected and potentially contaminated fields: long-term follow-up. Surg Endosc 2008 Sept;22(9):1941-6



• 85% 5-year follow-up • Recurrences 7 (5.26%)• Seromas (all resolved) 11 (8.2%)• Mild pain 10 (8%)• Wound infection 1 (0.75%)




• 6 Second looks performed

• 5/6 - mesh totally integrated into tissue• Corroborated histologically

• SIS mesh in contaminated or potentially contaminated fields is a safe material for hernia repair with minimal recurrence




Results:• Near complete incorporation by surrounding tissues with

microscopic confirmation of the abundant ingrowth of collagen material and a solid healing plate

• Tensile strength comparable to the nonabsorbable meshes while retaining the benefits of the absorbable

meshes. ( infection and adhesion)

FortaGen OrganogenesisFortaGen Organogenesis

• Porcine derived tissue : crosslinked collagen• Begin to infiltrate with cells by 30 days post-implant• Are substantially remodeled by 6 months• Are well-integrated at the suture line (provides a lasting graft-

host tissue interface not dependent on permanent sutures)• Do not elicit a foreign body response• Are as strong as adjacent host tissue at 360 days• Do not re-herniate

LifeCell AllodermLifeCell Alloderm

AlloDerm®

• Cadaveric tissue

• Limited sizes

• High cost

• Well established

• Not regulated by FDA as a medical device

• Claims are extreme

• Migration from other surgical areas was natural

• Regenerate is new phrase vs. resorption

Alloderm Bulge Alloderm Translucency Gaertner, W et al. Experimental Evaluation of Four Biologic Prostheses for Ventral Hernia Repair. J Gastrointest Surg July 2007

Comparison of Biologic Grafts – Overview of Gaertner Study

Comparison of Biologic Grafts – Overview of Gaertner Study

•Thickness at the defect area diminished significantly at 6 months with both Veritas and AlloDerm (P<0.05), so much so that they became translucent.•Permacol and Peri-Guard, the mean defect area and thickness were virtually identical to when they were originally installed 6months earlier. •Tensile strength of the material itself after 6 months was significantly reduced for the non-cross-linked prostheses (Veritas and AlloDerm) compared to the cross-linked prostheses (Peri-Guard and Permacol). •Stretching, bulging, and translucency were routine with AlloDerm.

Davol - Allomax Davol - Allomax

Acellular Human

dermal collagen.

Can be used in open and

In Laparoscopy.

Hydrates rapidly with

Immersion in saline

No unpleasant odor.

Supple with limited

Elasticity.

Available in different

Sizes.

FlexHD Musculo-Skeletal Foundation ( MTF )

Acellular dermal matrix fromHuman allograft skin.

Alliance between Ethicon and Musculoskeletal transplantFoundation ( MTF ).

Prehydrated with no need forRefrigeration.

Permacol Permacol

• Permacol is made from porcine dermis collagen and elastin

• Cells, cell debris, RNA and DNA are removed during a patented manufacturing process a crosslinking step renders the collagen resistant to collagenase

• Crosslinked ( with non-calcifying HDMI ) in its native state, collagen architecture and structure is maintained

• Permacol is not reconstituted.

• Porcine collagen is in its original 3D form.

• It has a bad odor. Must be hydrated in saline.

Permacol Permacol

Supplied sterile, hydrated & ready-to-use

Flexible and strong

Flat, continuous collagen sheet

Easily cut to desired shape

Porcine dermis

Extraction of Cells,

RNA, DNA

Collagen structure

maintained

Crosslinking for durability

Extraction of fat

Patented process used to manufacture Permacol

Patented process used to manufacture Permacol

Permacol

Strattice lifecell Strattice lifecell

• Strattice® Reconstructive Tissue Matrix is a surgical mesh that is derived from porcine skin and is processed and preserved in a phosphate buffered aqueous solution containing matrix stabilizers.

• Place device in maximum possible contact with healthy, well-vascularized tissue to promote cell ingrowth and tissue remodeling. Always use sterile gloved hands or forceps when handling Strattice.

• Must be soaked for two minutes at room temperature in Lactated Ringer.

• Use permanent sutures with at least 3 to 5 cm underlay.

• Must be in contact with healthy tissues to permit regeneration.

Davol – CollaMendDavol – CollaMend

• Regulatory status• 510(k) clearance• Substantial equivalence using Permacol®

as predicate device• Basic characteristics

• Porcine dermal collagen• Processed to render it acellular• Crosslinked using EDC (Carbodiimide)• Freeze-dried• Sterile (EtO - Ethylene Oxide)

• Four ventral hernia sizes (up to 20.3cm x 25.4cm)• Clinical experience

• No published papers to date on clinical or pre-clinical experience

Davol - XenmatrixDavol - Xenmatrix

Porcine Dermis

Cellular material is removed without a significant loss in strength.

It is not cross -linked.

Open structure supports tissue ingrowth and increased elasticity.

Maintains significant strength in animal model 2-8 weeks

Post-implantation in animal model

Favorable clinical results have been reported with the use

of Xenmatrix.

Pomahac et al:Use of non cross linked porcine dermal scaffold in abdominal wall reconstruction Am J Surg 2009

CRYOLIFE PROPATCH

Decellularized Bovine pericardium.

Fully Hydrated and kept at room temperature.

0.6 mm Thick.

Multiple pre-shaped sizes.

High sutures retention strength.

Biological scaffold.

Surgimend TEI

Fetal Bobine.

Can be used in open and laparoscopic surgery

Available in different sizes as large as 25x 40 cm.

Can be placed in any direction or side.

Hydration 60 seconds in saline room temperature.

In favor of tissue-generated biomesh:In favor of tissue-generated biomesh:

• Coverage for exposed viscera (open abdomen)

• May reduce fistula formation

• May promote wound vascularization and contraction

• May be more resistant to infection (use in contaminated fields?)

Against tissue-generated biomesh:

Against tissue-generated biomesh:

• Clinical experience in laparoscopy is limited• High cost• Long-term tensile strength is unknown• Poor collagen I/III ratios in the replaced and remodeled fascia• Recurrence profile is unknown• Risk of failure in smokers ,diabetics , steroid users ,morbid

obese and in heavily infected wounds. • Peri-operative prep time• Theoretical potential to transmit viral or prior infection• Allergy or hypersensitivity• Unacceptable cosmetic results because of stretching of the

elastin fibers• Religious or ethical prohibitions

• Tensile strength• Pliability • Ease of manipulation• Durability• Degree of tissue in-growth• Infection rate• Inflammatory response / adhesion formation• Seroma formation• Cost

• The ideal mesh has yet to be developed and the management of complex ventral hernias remains a challenge.

Conclusion: are we there yet?Conclusion: are we there yet?

Questions???Questions???

Methods of Mesh FixationMethods of Mesh Fixation

• Staples• Tacks• Laser-assisted tissue welding• Fibrin sealant (Tisseel)• Glue• Salute “Q” ring (Onux Medical , Inc.)• Mitek anchor• Sutures

TacksTacks

• 3.8 mm depth of penetrations (staples 2mm)

• Sheer force resistance 4 times more than staples

• Protruding end in contact with bowel will result in tear and perforation (Ladurner R. Mussack T. Surg Endosc 2004 April)

• Small bowel obstruction next to a spiral tack (Bower C.E. et al. Surg Endosc 2004 18:672-675 )

Absorbable TacksAbsorbable Tacks

Advantage • Dissolve in conjunction with mesh incorporation

• Theoretical benefit of decreased pain with tack absorption

Disadvantage• Cost

Absorbable TacksAbsorbable Tacks

AbsorbaTack (Covidien)

Permasorb (Davol / Bard)

Metal TacksMetal Tacks

Advantage • Strength• Cost

Disadvantage• Adhesion formation• Bowel injury• Pain• “Tack hernia”

LeBlanc KA, Stout RW, Kearney MT, Paulson DB. Comparison of adhesion formation associated w Pro-Tack versus a new mesh fixation device, Salute. 2003 Surg Endosc 17: 1409 –1417

LeBlanc KA. Tack hernia: A new entity. JSLS 7: 383 -387


Salute II (ONUX Medical)

Protack (US Surgical)

Endo Universal (Covidien)


• Study of anchoring capacity of 3 fixation devices• Salute, Pro-Tack, Endo Universal

• Fixed pressure applied to device while stapling layers of thin sponge

• Fixation capacity of stapler significantly lower than coil and helix

• Coil and helix had same fixation capacity

Takeyuki M, et al. Comparison of anchoring capacity of mesh fixation devices in ventral hernia surgery. 2008 Surg Endosc Accepted for press.

Disadvantages of Metal TacksDisadvantages of Metal Tacks

Tack Hernia • Report of two cases of new

hernias encountered at the site of Pro-Tack helical tack insertion

LeBlanc KA. Tack hernia: A new entity. JSLS 7: 383 -387


Adhesion formation • Comparison of adhesion formation in hernia repair

in an animal model using Pro-Tack vs. Salute tacker for mesh fixation

• Density of adhesions was greater with Pro-Tack

LeBlanc KA, Stout RW, Kearney MT, Paulson DB. Comparison of adhesion formation associated w Pro-Tack versus a new mesh fixation device, Salute. 2003 Surg Endosc 17: 1409 –1417


Bowel injury • Bowel erosion with colo-cutaneous fistula

formation originating from surgery in proximity of colon

De Maria EJ, Moss JM, Sugarman HJ. Laparoscopic intraperitoneal polytetraluoroethylene (PTFE) prosthetic patch repair of ventral hernia, Prospective comparison to open prefascial polypropylene mesh repair. Surg Endosc 2000, 14:326-329

In Favor of Suturing:In Favor of Suturing:

• Accurate mesh placement

• Recurrence prevention

• Tacks can migrate

• Sutures stronger than tacks (4 mm in length)

Against suturing: Against suturing:

• Increased OR time

• Abdominal wall bleeding/hematoma

• Suture site pain

• Cosmetic dimpling of skin

• Lengthy learning curve

Mitek AnchorMitek Anchor

• Originally designed to secure soft tissue to bones as described for orthopedic shoulder repair

• It could play a role in repairing hernias near the costal margin

Laser WeldingLaser Welding

• Novel technology using laser-assisted tissue welding to anchor mesh to peritoneum

• Solder fixation of mesh is feasible

• No statistical difference noted between stapled or soldered

Lanzafame R. et al. Rochester General Hospital Denver 2004

Sages

Fibrin Sealant (Tisseel)Fibrin Sealant (Tisseel)

• Biodegradable adhesive formed from the combination of fibrinogen and thrombin leading to the formation of polymerized fibrin chains

• After application, it is broken down by fibrinolysis and replaced by fibrotic layer

• Anti-fibrinolytic agents like aprotinin are added in order to enhance lifespan

• In addition to its hemostatic action, the fibrinogen component gives the product its strengthening and adhesive properties and the thrombin promotes fibroblasts proliferation

Fibrin Sealant (Tisseel)Fibrin Sealant (Tisseel)

Spotnitz 1990 Cardio thoracic

Kjaergard 1992 Cardio thoracic

Byrne 1995 Promote wound healing

Fernandez 1996 Reinforce high-risk anastomosis

Holcomb 1997 Cardio-thoracic trauma

Ohwada 1998 Prevent pancreatic fistulas

Thistlethwaite 1999 Air leaks thoracic procedures

Katkhouda 2002 Mesh fixation

66 patients with polyester mesh + 2cc tisseel

102 patients with polyester mesh + tacks

Post-op pain 4.5% 14.7% (p=0.037)

Seroma 12% 9.8%

Recurrence — —

Operative time — —

Hospital stay — —

Tisseel v. Tacks staples as mesh fixation in TEP: a retrospective analysis. Phillippe AT et al. Centre Hospitalier de Brest, Denver Sages 2004

GlueGlue

• N butyl 2-cyanoacrylate glue for the fixation of polypropylene mesh in laparoscopic hernia repair

Jourdan IC, Bailey ME. Surg Laparoscop Endoscop 1998; 8:291-3

“Q” Ring“Q” Ring

• Incisional and umbilical hernias

• Inguinal hernias

• Vaginal sling

Conclusions:Conclusions:

• The ideal mesh is one that does not promote infection or adhesions yet provides strength

• The ideal method of of fixation is one that does not increase morbidity

“If we could artificially produce tissues of

the density and toughness of fascia, the

secret of the radical cure of hernia would

be discovered”.

Theodore Billroth, 1857

ConclusionsConclusions

We still have not developed the ideal mesh or fixationmaterial

Problems associate with current meshes:

• Infection• Recurrence • Seroma• Adhesion formation

Problems associate with current tacks:

• Pain• Mesh migration• Poor fixation



• Mean follow up 45 months• Recurrences 20 (3.04%)• “Second look” operation

for various reasons 70

• Adhesion free 38 (54.3%)• Minor adhesions 27 (38.6%)• Serosal adhesions 5 (7.1%)

Parietex is associated with low formation of dense adhesions

Chelala E. Personal correspondence

SafetySafety

• Bowel injury: Meta-analysis of 6 RCT showed more bowel injuries in LVHR with a relative risk of almost 2 over OVHR

• Bleeding complications: Less bleeding complications in LVHR in 5 RCT

• Infected mesh requiring removal of mesh: Five times as likely in OVHR than LVHR in 7 RCT

• Erosion and/or fistula formation: Very rare with PTFE and barrier meshes

Reference Bowel injury Bleeding complications

Infected mesh requiring removal

Lap Open Lap Open Lap open

Asencio 2008 1/45 0/39 1 0 0 0

Barbaros 2007 1/23 0/23 1 0 1 4

Carbajo 1999 0/30 2/30 1 6 0 3

Misra 2006 0/33 0/33 0 0

Navarra 2007 0/12 0/12 0 0

Olmi 2007 4/85 0/85 0 1 1 0

Moreno-Egea 2002

0/11 4/11 0 0

Pring 2008 0/30 2/24

Total 6/228

2.7%

2/222

0.9%

3/194

1.5%

11/188

5.7%

2/269

0.7%

9/257

3.5%

SafetySafety

• Review of 5245 patients entered into NSQIP (between 2005 and 2006) with comparable ASA class, wound class, and age revealed:• No difference in return to OR within 30 days [2.6% vs. 2.6%]• Less deep infections in the laparoscopic group [0.5% vs.

1.6% p=0.001]

Hwang, CS, Journal of Surgical Research, 3/2009

DurabilityDurability

• No significant difference in rate of recurrence at follow up times ranging from 6 months to 41 months in pooled RCTs,

• Lower recurrence rates in nonrandomized controlled studies

Forbes, SS, British Journal of Surgery, 3/2009

RandomizedHernia recurrence Mean follow

up

Control Trials Lap Open in months

Asencio 2008 4 of 41 3 of 38

Barbaros 2007 0 of 23 1 of 23 19

Carbajo 1999 0 of 30 2 of 30 27

Misra 2006 2 of 32 1 of 30 13

Olmi 2007 2 of 85 1 of 85 24

Pring 2008 1 of 30 1 of 24

Total 9 of 241 (3.7%)

9 of 230 (3.9%)

Forbes, SS, British Journal of Surgery, 3/2009

Non-randomized comparative studiesNon-randomized comparative studies

Trial Recurrence Mean follow up in months

Lap Open

DeMaria 1 of 21 0 of 18 >12

Holzman 2 of 21 2 of 16 19

Ramshaw 2 of 79 36 of 174 21

Total 5 of 121 (4.1%) 38 of 208 (18%)

Recurrence RatesRecurrence Rates

0%

5%

10%

15%

20%

25%

Asencio Barbaros Carbajo Misra Olmi Pring DeMaria Holzman Ramshaw

lap

open

Randomized control Trials Non-randomized comparative studies

Efficacy Efficacy

• Advantages of LVHR• Improved visualization of abdominal wall• Recognizing occult hernias• Fewer overall complications

• Disadvantages of LVHR• Mesh placed in abdominal cavity• Cost• OR time• Not Cosmetic

Surgery Clinics, 2/2008Ramshaw….

EfficacyEfficacy

• Results in multiple RCTs comparing laparoscopic mesh repair with open mesh repair are equivalent or superior regarding the following complications• Seroma • Infection• Ileus• Neuralgia

Procedure – entry Procedure – entry

• Hassan• Veress needle• LUQ cutdown/veress• Remote from hernia site

Randomized Seroma Infection Ileus Neuralgia

Control Trial Lap Open Lap Open Lap Open Lap Open

Barbaros et al. 2007

4/23 0/23 1/23 5/23 1/23 0/23

Carbajo et al. 1999

4/30 20/30

Misra et al. 2006

4/33 1/33 2/33 9/33 0/33 0/33

Navarro et al. 2007

2/12 0/12 0/12 1/12

Olmi et al. 2007

6/85 3/85 4/85 8/85

Pring et al. 2008

5/30 8/24

Total 12% 15%

Efficiency – CostEfficiency – Cost

• LVHR more expensive procedure

• $2237 vs $664 in one study of 884 pts• Length of stay (LOS): significantly shorter in almost all RCTs• Overall cost for procedure plus hospitalization likely lower

Surgery Clinics, 2/2008

Efficiency – OR TimeEfficiency – OR Time

• Longer or times non-randomized trials: 149 minutes vs. 89 minutes• NSQIP data from 2005-2006: 103 minutes vs. 95 minutes1

• Overall shorter times in pooled RCTs: 72 minutes vs. 115 minutes2

• May be dependent on surgeon’s learning curve

1. Hwang, CS, Journal of Surgical Research, 3/2009 2. 2. Forbes, SS, British Journal of Surgery, 3/2009

QualityQuality

• Earlier return to work• Less post-operative narcotic requirements• Foreign body sensation?

Choosing Your PatientsChoosing Your Patients

• Starting out• Smaller hernias: <10cm transverse separation• Not morbidly obese• Fewer abdominal surgeries• Avoid previous open repair

Heniford et al, Am . Surg. 2003

Procedure – PreparationProcedure – Preparation

• Consider bowel prep• Pre-operative antibiotic prophylaxis• Foley catheter• NGT• DVT prophylaxis: SCDs, heparin

Procedure – Patient positioningProcedure – Patient positioning

• Tuck arms at side• Secure patient to table• Consider footboard• Consider ioban drape

Procedure – fixation Procedure – fixation

• Sutures • Tacks: metal, absorbable• Staples• Laser-assisted tissue welding• Fibrin sealant (Tisseel)• Glue• Salute “Q” ring (Onux medical , inc.)• Mitek anchor

Procedure – LOA, reduce herniaProcedure – LOA, reduce hernia

• Sharp• Minimal electrocautery

Procedure – sizing defect/meshProcedure – sizing defect/mesh

• What is the best way to measure the mesh?

• 3 options: Intracorporeal with pneumoperitoneum, extracorporeal with pneumoperitoneum, extracorporeal desufflated

• With extracorporeal measurement, the diameter of the outer (skin) circle is larger than the inner (peritoneal) circle.

• This difference is proportional to the size of the patient.

• Result is overestimation of hernia size and mesh by 1.7 to 3.1 cm

Procedure- sizing defect/meshProcedure- sizing defect/mesh

• Covering entire original incision as well as hernia defect may decrease recurrence

• Study LVHR with 8 recurrences all noted to be at original incision site.

Wassener et al

Procedure—Choosing a meshProcedure—Choosing a mesh

• Allows for tension-free restoration of abdominal wall structure• Goal of the mesh is to become incorporated into surrounding

tissue• Ideal mesh: inert, strong, sterile, not modified by body tissue,

inexpensive

Choosing a MeshChoosing a Mesh

• Biologic derived graft vs. Synthetic mesh vs. Synthetic + coating (barrier mesh)

• Absorbable vs. Non-absorbable vs. Combined/composite• Pore size, filament • Light weight (LW) vs. Heavy weight HW• Knitted vs. Woven vs. Expanded


• Biologic derived graft: • Synthetic mesh• Synthetic + coating (barrier mesh)


Porosity

Macro

>75 microns

Micro

<10 microns

Submicro

<1 micron

F I lament

monoI

polypropylene

II

Gore-Tex

IV

Multi

III

some polypropylene,

polyester

Procedure – intra-op complicationProcedure – intra-op complication

• Bowel injury• Contamination repair injury and delay hernia repair• No spillage repair hernia• Delayed bowel injury remove mesh and delay repair

• Bladder injury repair hernia

Ramshaw et al..

Competitive Literature PubMed Update1,2Competitive Literature PubMed Update1,2

Implant Brand Name

All Articles Hernia Articles Hernia Articles

(Last 12 Months)

Alloderm 282 36 10

Permacol 89 17 10

Surgisis 68 31 11

TissueMend 4 0 0

Strattice 0 0 0

Collamend 0 0 0

1 May include duplicate records; records not necessarily exclusive of other products; number of patients and type of study not analyzed; animal and human

2 Using searches of the form “brand OR brandtrade”

Note: non-comprehensive search; some relevant articles do not include brand names in searchable fields

Way the Biological Hernia World Will be

Way the Biological Hernia World Will be

Allograft• Lifecell (Alloderm)

• Musculoskeletal Transplant Foundation (MTF) (FlexHD)

• Davol (AlloMax)

Xenograft• Cook (Surgisis)

• TissueScience (Permacol)

• TEI (Surgimend)

• Brennen (Xenmatrix)

• CryoLife (ProPatch)

• Davol (CollaMend)

• Lifecell (Strattice)



• Type 1: totally macroporous prosthesis, pores > 75 microns; example prolene, marlex

• Type 2: totally microporous prosthesis; pores < 10 microns; example gortex or dual mesh

• Type 3: macroporous prosthesis with microporous components; example Teflon, mersilene

• Type 4: biomaterials with submicronic pore size; example cilastic, cell gard


• Angimesh, Angiologics, S. Martino Sicc., Italy



• Biomesh 3D, Cousin Biotech, Wervicq-Sud, France

• C-QUR (polypropylene / omega 3 fatty acid coating), Atrium, NH, USA• DynaMesh (polypropelene incorporated with polyvinylidene difluoride)

FEG, Aachen, Germany

• Hetra 1, 2, HerniaMesh, S.R.L., Torino, Italy

• Hermesh 3,4,5, HerniaMesh, S.R.L., Torino, Italy

• Intramesh NKI, NK2, NK8, Cousin Biotech, Wervicq-Sud, France

• Marlex, C.R.Bard, Inc., Cranston NJ, USA


• Parietene, Sofradim International, Villfranche-sur-Saone, France

• Proceed (polypropelene / polydiaxanone / oxidized regenerated cellulose), Ethicon, Somerville, NJ, USA

• Prolene, Ethicon, Somerville, NJ, USA

• Prolene Soft Mesh, Ethicon, Somerville, NJ, USA

• Prolite, Atrium Medical Corporation, Hudson, NH, USA

• Prolite Ultra, Atrium Medical Corporation, Hudson, NH, USA

• Surgipro (Monofilament), United States Surgical Corp,/Tyco, Norwalk, CT, USA

• Sepramesh (polypropylene mesh coated with Seprafilm - modified sodium hyaluronate and carboxymethylcellulose) Genzyme, MA, USA

• Surgipro (Multifilament), United States Surgical Corp./Tyco, Norwalk, CT, USA

• TiMesh (titanium-coated polypropylene) Medizintechnik GmbH, Nuremberg, Germany

• Trelex, Meadox Medical Corporation, Oakland, NJ, USA

• Ultrapro (Poliglecaprone-25 / Polypropylene), Ethicon, Somerville, NJ, USA

Polypropylene MeshPolypropylene Mesh

• Schmitt and Griman in 1967 first described successful use of polypropylene mesh in contaminated wounds

• Subsequent reports showed good initial healing but were fraught with long term complications

• Those complications are chronic infection, fistula formation, erosion into bowels or through skin grafts

• Jones and Jurkoyiun in 1989 reviewed 14 studies, 128 patients, and found 55 overall complication rate - enteric fistulization being the most common.

In Favor of Polypropylene Mesh:

In Favor of Polypropylene Mesh:

• Extensive fibroblast ingrowth

• Complete host tissue incorporation

• Cheaper than PTFE



• Can be used in contaminated fields

Chowbey PK et al. Lap ventral hernia repair J La Adv Surg

Tech 2000; 10:79-84

Bingener J et al. Adhesion formation after laparoscopic ventral

incisional hernia repair with polypropylene mesh: a study using

abdominal ultrasound, JSLS (2004)8:127-131




Franklin ME et al. Lap ventral and incisional hernial repair. Surg Lap

End 8(4):294-299 1998

• 285 lap ventral hernia and 520 lap inguinal hernia using IPOM with




inguinal): 1/3 no adhesions, 1/3 mild adhesions, 1/3 severe


• It is extremely difficult to lyse adhesions to polypropylene without causing enterotomies*

• Major complications with polypropylene not evident until years later

• 9 cases of mesh erosion fistula stainless steel (1) tantalum (1) mersilene (1) dexon (1) ppm (5). The time to the development of these fistulas ranged from 3 months to 14 years

*Losanoff JE et al. Entero-colocutaneous fistula: a late consequence of polypropylene mesh abdominal wall repair: case report and review of the literature, Hernia 2002; 6: 144-147


• Dual mesh allows fibroblastic penetration and subsequent collagen deposition

Leblanc KA et al. Tissue attachment strength of prosthetic meshes used in ventral and incisional hernia repair. Surg Endo 2002; 16(11):1542-1546

ePTFE BiomaterialsePTFE Biomaterials

• DualMesh, W.L. Gore and Associates, Flagstaff, AZ, USA

• DualMesh Emerge, W.L. Gore and Associates, Flagstaff, AZ, USA

• DualMesh Plus, W.L. Gore and Associates, Flagstaff, AZ, USA

• DaulMesh Plus Emerge, W.L. Gore and Associates, Flagstaff, AZ, USA

• DualMesh with Holes, W.L. Gore and Associates, Flagstaff, AZ, USA

• DualMesh Plus with Holes, W.L. Gore and Associates, Flagstaff, AZ, USA

• Dulex, C.R. Bard, Inc., Cranston NJ, USA

• Mycromesh, W.L. Gore and Associates, Flagstaff, AZ, USA

• Mycromesh Plus, W.L. Gore and Associates, Flagstaff, AZ, USA

• Reconix, C.R. Bard, Inc., Cranston NJ, USA

• Soft Tissue Patch, W.L. Gore and Associates, Flagstaff, AZ, USA

In Favor of ePTFEIn Favor of ePTFE

• Microporous, smooth texture minimizes tissue in-growth and limits adhesion formation and bowel injury

• Combined with a large pore second layer it can adhere well to the abdominal wall

Against ePTFEAgainst ePTFE

• Microporous construction limits ability of macrophages to destroy bacteria

• Mesh infection is not well treated by antibiotics and requires mesh removal

• Does not integrate well into host tissue when not combined with a large pore mesh

• Laparoscopic ventral hernia repair with PTFE compared to open repair prefascial repair with polypropylene is associated with: • Less pain• Shorter hospital stay• Lower total cost

• Complication rates were equivalent• Despite two reoperations in the PTFE group, overall costs

remained lower


• Laparoscopic hernia repair with PTFE has low recurrence but may be associated with significant complications and morbidity

• This technique requires meticulous technique and advanced laparoscopic skills

Ben-Haim M, et al. Pitfalls and complications with laparoscopic intraperitoneal expanded polytetrafluoroethylene patch repair of postoperative ventral hernia. Surg Endosc 2002, 16(5) 785-788

Polyglactene Mesh (vicryl mesh) Polyglactene Mesh (vicryl mesh)

• Alternative to nonabsorbable meshes

• Advantage host invasion and subsequent absorption of implant

• There is less infection complication, increase recurrence rate (satisfactory short term solution in infected hernias but not generally indicated when prolonged 10-side strength is

required)

Polyester meshPolyester mesh

• Parietex (polyester and atelocollagen type 1, polyethylene glycol, glycerol) Covidien, Hamilton, Bermuda

• Polyester mesh incorporates well into the abdominal wall

• Collagen covering on the visceral surface protects bowel and dissolves as the polyester is incorporated



Comparison of Parietex with Sepramesh for ventral hernia repair

in rabbit model

Results at 5 months Parietx Sepramesh

•Strength

of incorporation 70.9N 31.5N•Bowel adhesions 0 4•Adhesion area 321 mm2 840 mm2

•Shrinkage 17.4% 6.1%

Parietex has stronger incorporation and is better at prevention of

adhesiona than sepra mesh, however it undergoes considerably more

shrinkage

Judge TW, Parker DM, Dinsmore RC. Abdominal wall hernia repair: A comparison of Sepramesh and Parietex composite mesh in a rabbit hernia model. J Am Coll Surg 2007, Feb;204(2):276-81



• Retrospective study of the use of Parietex in laparoscopic ventral hernia repair

• n = 20 patients • Mean follow up - 10 months • No morbidity or mortality• No infections, rejections, fistulas, recurrences, or

alterations in bowel function• Parietex is safe for intra-abdominal use

Moreno-Egea A, Liron R Girela E, Aguayo JL. Laparoscopic repair of ventral and incisional hernias using a new composite mesh (Parietex): initial experience. 2001 Surg Laparoc Endosc Percutan Tech Apr;11(2):103-6



• Experience with 656 laparoscopic ventral hernia repairs with Parietex

• Hernia defect closed with sutures to reduce seroma and restore abdominal wall function

• Laparoscopic mesh repair performed with Parietex mesh

Chelala E. (2008) Personal correspondence

• Repair of abdominal wound defects remains a challenge to the general surgeon.

• Suture repair of ventral hernia is associated with low infection rate but carries a risk of recurrence of 43%

• The rate increases to 58% with repair of recurrent hernia.

Luijendijk RW, et al. A Comparison of Suture Repair with Mesh Repair for Incisional Hernia.NEJM 2000; 343:392-398


• Dual mesh allows fibroblastic penetration and subsequent collagen deposition

Leblanc KA et al. Tissue attachment strength of prosthetic meshes used in ventral and incisional hernia repair. Surg Endo 2002; 16(11):1542-1546

• The use of mesh drastically reduces recurrence but is associated with a risk of infection of about 9%

• The laparoscopic approach to mesh placement reduces the infection rate to as low as 0.7%

Yerdel MA, et al. Effect of single-dose prophylactic ampicillin and sulbactum on wound infection after tension-free inguinal hernia repair with polypropylene mesh: the randomized, double blind, prospective trial. AA Surg 2001; 223: 26 – 33

Heniford BT, et al. Laparoscopic repairs of ventral hernias: nine years experience with 850 consecutive hernias. Ann Surg 2003; 238:391-400

Ventral Hernia Mesh




Franklin ME et al. Lap ventral and incisional hernial repair. Surg Lap

End 8(4):294-299 1998

• 285 lap ventral hernia and 520 lap inguinal hernia using IPOM with




inguinal): 1/3 no adhesions, 1/3 mild adhesions, 1/3 severe

• Laparoscopic ventral hernia repair with PTFE compared to open repair prefascial repair with polypropylene is associated with: • Less pain• Shorter hospital stay• Lower total cost

• Complication rates were equivalent• Despite two reoperations in the PTFE group, overall costs

remained lower


• Laparoscopic hernia repair with PTFE has low recurrence but may be associated with significant complications and morbidity

• This technique requires meticulous technique and advanced laparoscopic skills

Ben-Haim M, et al. Pitfalls and complications with laparoscopic intraperitoneal expanded polytetrafluoroethylene patch repair of postoperative ventral hernia. Surg Endosc 2002, 16(5) 785-788

Biologic Competition Biologic Competition

• The number of competitors offering biologic implant grafts has increased dramatically over the past few years

• In 2004, there were three key biologic products, currently there are approximately 14 products produced by 13 companies....more to come….

• J&J/Ethicon will sell FlexHDTM (MTF) to the hernia repair market – others?

• On July 2, 2007, Mentor launched NeoFormTM (Tutogen) for breast reconstruction, will they cross over into the abdomen for tram flap reinforcement?

• LifeCell – non-crosslinked porcine graft StratticeTM in early 2008

Cook Surgisis - How Do We Compete?

Cook Surgisis - How Do We Compete?

• Focus on crosslinked stability and durability of Permacol

• Question the need for perforations – do they weaken the product?

• Put Permacol in the surgeon’s hand and ask for comparison with Surgisis

• Does surgeon recall past Surgisis cases – what was his/her experience?

Cook SurgisisCook Surgisis

• Strengths• Market name and reach of sales force• Broad line, low prices• Porcine model versus cadaveric

• Weaknesses• Complicated manufacturing process• Not crosslinked so not as stable or strong as Permacol



72 patients: 29 male, 43 female

• Incisional hernia - 41

(1 post-op wound infection)

• Colovesical fistula - 1

• Paraoesaphageal hernia - 15

• Inguinal hernia - 14

• Spigelian hernia - 1

What about AlloDerm Issues?What about AlloDerm Issues?

• New AlloDerm instructions recommend “significant tension” – with a “tension free” repair technique……• Trying to minimize issues of laxity

• Recent studies with longer follow-up times are showing that AlloDerm presents significant problems (TSL 310)• Jin, et al; “bridging repairs”, recurrence rates high at 60%, “not worth

the high cost” - average $7,901 per patient• “Use only to reinforce primary fascial closure” – but still have

recurrence rate of 21%

AlloDerm - How Do We Compete?AlloDerm - How Do We Compete?

• Size matters!• Permacol takes less time intraoperatively - no sewing on large

repairs

• No waiting for rehydration, a problem especially if the surgeon underestimates required coverage size • No need to estimate “expansion” during surgery

• Permacol meets the needs for complicated cases

• Permacol is manufactured and marketed under strict FDA regulations

• Permacol has all of the advantages of a biologic with the added strength of crosslinking

• Lower cost per case

Description of ProductDescription of Product

• Permacol is a sterile off-white, hydrated, tough but flexible flat sheet of acellular, crosslinked, porcine dermal collagen and its constituent elastin fibers.

• Crosslinked with non-calcifying HDMI

• Porcine collagen in its original 3-D form.

• Permacol is a surgical implant and a medical device.

• Permacol is indicated for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes.

• FDA 510(k) concurrence for permanent implantation into human tissue for specific indications.

Permacol AdvantagesPermacol Advantages

Versus AlloDerm• Crosslinking for dimensional stability, resistance to collagenase and

long-term results• Ease of use, handling and cost effective in the OR• Pricing • Sizes

Versus CollaMend• Track Record – clinicals and experience • Sizes, better product shape and handling• Well trained and knowledgeable sales force

Versus Surgisis and all the others• Crosslinking, resistance to collagenase and long-term results • Ease of use, handling and cost effective in the OR• Sizes

Surgical Meshes and Methods of Fixation

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Transcript of Surgical Meshes and Methods of Fixation