Ventral Hernia: Challenges and Choices

Ventral Hernia: Challenges and Choices George S. Ferzli MD, FACS Professor of Surgery, State University of New York

I will cover biologic and synthetic meshes as well as closure of the defect during the course of this presentation. I have nothing to disclose.

Is the Abdomen a Weakness in the Human Race ?

Incidence 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 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, the rate of wound complications is lower when a suture length to wound length ratio of at least 4 is accomplished with a short stitch length rather than with a long one. Surgical site infection occurred in 35 of 343 patients (10.2%) in the long stitch group and in 17 of 326 (5.2%) in the short stitch group (P=0.2). I ncisional hernia was present in 49 of 272 patients (18.0%) in the long stitch group and in 14 of 250 (5.6%) in the short stitch group (P<.001). Conclusion: In midline incisions closed with a running suture and having a suture length to wound length ratio of at least 4, current recommendations of placing stitches at least 10mm from the wound edge should be changed to avoid patient suffering and costly wound complications. Effect of Stitch Length on Wound Complications After Closure of Midline Incisions; A Randomized Controlled Study Daniel 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

Wound complications related to stitch length 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 Stitch length a Fisher exact test. Complication Long Short P Value a 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

Significant predictors of surgical site infection and incisional hernia a 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 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 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 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.

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

Abdominal 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: Onlay l

Ventral Hernia Mesh Positioning: Inlay l

Ventral Hernia Mesh Positioning: Underlay

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) Alternative to nonabsorbable meshes Advantage host invasion and subsequent absorption of implant There is less infection complication, but an increase in recurrence rate (satisfactory short term solution in infected hernias but not generally indicated when prolonged 10-side strength is required)

Polypropylene 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: 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: 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 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 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 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 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

Polyester and atelocollagen type 1, polyethylene glycol, glycerol (Parietex) 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 mm 2 840 mm 2 Shrinkage 17.4% 6.1% Parietex has stronger incorporation and is better at prevention of adhesions 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

Polyester and atelocollagen type 1, polyethylene glycol, glycerol (Parietex) 656 lap ventral hernia repairs with parietex Defects closed to reduce seroma formation 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

Ventral Hernia Repair Barrier Coated Mesh Competition BARD Ventralex Kugel Composix Composix E/X ETHICON Proceed ATRIUM C-Qur GORE Dualmesh GENZYME Sepramesh IP GfE TiMesh

Properties of Absorbable Barrier-Coated Meshes

Ventral hernia repair - Mesh portfolio Open Open/Lap Hiatal Parastomal Covidien PCO OS PCO PPC PCO2H Coming soon Bard Ventralex (umbilical) Kugel composix Composix E/X Composix L/P Crurasoft Bard CK Ethicon Proceed Gore Dual mesh Atrium C-Qur

Bard 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 Structure PTFE stitches makes the surface non continuous and create bridges between viscera and PP layers Easy to implant. Low anti-adhesion efficiency. Holes through stitching allows for adhesions .

Bard 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 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 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 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 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 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” All Lot Numbers December 2005 and January 2006 0010208 Bard® Composix® Kugel® Extra Large Oval, 7.7” x 9.7” All Lot Numbers December 2005 and January 2006 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 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 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 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 .

Timeline – The Progress of Peritoneal Healing Day 7- Neoperitoneum is formed within 7 to 10 days. Absorbable components have begun to break down.

Timeline – The Progress of Peritoneal Healing Day 14 - ORC is absorbed Peritoneum is fully restored

Timeline– The Progress of Peritoneal Healing 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 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 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 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 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

Gore 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 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 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 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)

GfE 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 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

Potential Mesh-Related Complications: Infection Intestinal adhesions Bowel obstructions Erosion of the prosthesis into the adjacent hollow viscous Contraction of prosthesis

Level of Complexity Grade 1 Low risk of infection Low risk of complications Grade 2 Smoker Immunosuppressed Obese Diabetic Grade 4 Active infection Infected mesh Grade 3 Contamination risk Stoma present Violation of bowel wall Previous Wound infection Grade 5 Traumatic 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 2 nd procedure for removal Synthetic Biologic

Repair Techniques Tissue Bank Cadaveric Grafts Sterility and tissue quality issues Autologous Myocutaneous Flaps Morbidity and availability issues Healing by Secondary or Tertiary Intention Components Separation

Material 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 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 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 ® Surgisis Surgisis ® Gold ™ (SIS) Porcine intestinal material (small intestine submucosa) 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 /

SIS 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

Texas Endosurgery Institute Experience with SIS 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

Texas Endosurgery Institute Experience with SIS 85% 5-year follow-up Recurrences 7 (5.26%) Seromas (all resolved) 11 (8.2%) Mild pain 10 (8%) Wound infection 1 (0.75%) 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

Texas Endosurgery Institute Experience with SIS 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 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

Texas Endosurgery Institute Experience with SIS 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 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 Alloderm AlloDerm ® Cadaveric tissue Limited sizes High cost Well established Not regulated by FDA as a medical device

Comparison of Biologic Grafts – Overview of Gaertner Study Alloderm Bulge Alloderm Translucency Gaertner, W et al. Experimental Evaluation of Four Biologic Prostheses for Ventral Hernia Repair. J Gastrointest Surg July 2007 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 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 from Human allograft skin . Alliance between Ethicon and Musculoskeletal transplant Foundation (MTF). Prehydrated with no need for refrigeration .

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 Supplied sterile, hydrated & ready-to-use Flexible and strong Flat, continuous collagen sheet Easily cut to desired shape

Patented Process used to Manufacture Permacol Porcine dermis Extraction of Cells, RNA, DNA Collagen structure maintained Crosslinking for durability Extraction of fat Permacol

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 – 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 - 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 Bovine Can be used in open and laparoscopic surgery Available in different sizes as large as 25x 40cm Can be placed in any direction or side Hydration 60 seconds in saline room temperature

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: 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

Components 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

Components Separation 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 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.

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 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.

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 • 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.

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 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.

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 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.

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 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.

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. 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 Rates of Recurrence and Complications Based on Type of “Component Separation” Repair a Type of Repairs Patients No. Follow-up Mean mo Recurrence No. (%) Time to Recurrence Mean mo Major ComplicationsNo. (%) 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 value d 0.20 0.04 e 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. 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 Observations

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

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: • 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.

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 : • 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 P atients with: F riable vessels and infected blood vessels • V ascular anastomosis • I nfected wounds • O steomyelitis • E xposed organs, vessels, nerves, tendon, and ligaments • S harp edges in the wound (i.e. bone fragments) • S pinal cord injury (stimulation of sympathetic nervous system) • E nteric fistulas P atients 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

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?

Am J Surg. 2009 Jan;197(1):64-72. Epub 2008 Jul 9.Laparoscopic versus open repair of incisional/ventral hernia: a meta-analysis.Sajid MS, Bokhari SA, Mallick AS, Cheek E, Baig MK.: Am J Surg . 2009 Sep;198(3):463. BACKGROUND : The aim of this article is to analyze laparoscopic versus open repair of incisional/ventral hernia (IVH). METHODS: A systematic review of the literature was undertaken to analyze clinical trials on IVH. RESULTS: Five randomized controlled trials involving a total of 366 patients were analyzed. There were 183 patients in each group. Open repair of IVH was associated with significantly higher complication rates and longer hospital stays than laparoscopic repair. There was also some evidence that surgical times may be longer for open repair of IVH. However, statistically there was no difference in wound pain or recurrence rates. CONCLUSIONS: Laparoscopic repair of IVH is safe, with fewer complications and shorter hospital stays, and possibly a shorter surgical time . However, postoperative pain and recurrence rates are similar for both techniques. Hence, the laparoscopic approach may be considered for IVH repair if technically feasible, but more trials with longer follow-up evaluations are required to strengthen the evidence.PMID: 18614144 [PubMed - indexed for MEDLINE]

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