Tissue-Separating Mesh A Comparative Guide

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1 Ethicon provides comprehensive solutions to advance hernia repair PROCEED Surgical Mesh with macroporous, partially absorbable monofilament construction has been trusted by surgeons for more than 10 years PROCEED More than 40 sites worldwide Ethicon Tissue-Separating Mesh A Comparative Guide Designed for strength and performance Physiologically designed for strong and comfortable healing1,6,13,14 Less foreign materials as well as bacteriostatic properties against bacteria commonly associated with SSI (MRSA, MRSE, VRE, and E. coli)8,18* C an promote potentially improved abdominal wall mobility with less inflammation, tissue attachment, and potential pain when compared to polypropylene mesh1,17 Proven patient outcomes In a study from the International Hernia Mesh Registry (IHMR), patients receiving laparoscopic hernia repair with PROCEED Mesh reported significant improvement in pain and movement limitations from baseline at 12 months postsurgery17 Results also showed low rates of complications (seromas/hematomas 10.5%, chronic discomfort 1.8%, 1 urinary infection) and hernia recurrence (3.5%) at 12-month follow-up17 The IHMR is a large international hernia registry.15 For more product information, go to For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert. *An in vitro study (24 hour study with inoculum challenge in the range of CFUs) demonstrated bacteriostatic properties of PROCEED Mesh against MRSA, MRSE, VRE, and E. coli. Data from a prospective, longitudinal study of 82 patients receiving open hernia repair using PROCEED Mesh from the IHMR.6,17 Complications included: 3.7% recurrence rate up to 12-month postoperative follow-up, 6.1% seroma, and 4.9% hematoma. Evidence shown in animal model. References: 1. Hutchinson RW, Chagnon M, Divilio LT. Preclinical Abdominal Adhesion Studies With PROCEED Surgical Mesh. Ethicon, Inc. 2. Klinge U, Klosterhalfen B. Modified classification of surgical meshes for hernia repair based on the analyses of 1,000 explanted meshes. Hernia. 2012;16(3): Bringman S, Tollens T, Murdoch J, Jones P, Mitchell J, McRoy L. Laparoscopic hernia repair surgery using a tissue-separating flat mesh (TSM) 12 month patient reported outcomes from the International Hernia Mesh Registry (IHMR). Poster presented at: 15th Annual Hernia Repair; March 13-16, 2013; Orlando, FL. 4. Bilsel Y, Abci I. The search for ideal hernia repair; mesh materials and types. Int J Surg. 2012;10(6): Klosterhalfen B, Junge K, Klinge U. The lightweight and large porous mesh concept for hernia repair. Expert Rev Med Devices. 2005;2(1): Holste JL. Are meshes with lightweight construction strong enough? Int Surg. 2005;90(suppl 3):S10-S PROCEED Surgical Mesh. Instructions for Use. Ethicon, Inc. 8. Bhende S. Study Report for Antibacterial Efficacy Evaluation of PROCEED Surgical Mesh using Parallel Streak Method. Jan. 18, Ethicon, Inc. 9. Symbotex Composite Mesh. Instructions for Use. Covidien, Inc. 10. Parietex Optimized Composite Mesh. Instructions for Use. Covidien, Inc. 11. Ventralight ST Mesh. Instructions for Use. Bard Davol, Inc. 12. Vailhe E. Mesh competitor testing, version 1 (AST , performance evaluation technical report) Ethicon, Inc. 13. Cobb WS, Burns JM, Kercher KW, Matthews BD, Norton HJ, Heniford BT. Normal intraabdominal pressure in healthy adults. J Surg Res. 2005;129(2): Klinge U, Klosterhalfen B, Birkenhauer V, Junge K, Conze J, Schumpelick V. Impact of polymer pore size on the interface scare formation in a rat model. J Surg Res. 2002;103(2): International Hernia Mesh Registry (IHMR). NIH Clinical Trials Registry Web site. Accessed May 17, Tollens T, Speybrouck S, Devroe K, et al. Comparison of recurrence rates in obese and non-obese patients undergoing ventral hernia repair with lighter-weight, partially absorbable mesh. Surg Technol Int. 2011;21: Berrevoet F, Fierens K, De Gols J, et al. Multicentric observational cohort study evaluating a composite mesh with incorporated oxidized regenerated cellulose in laparoscopic ventral hernia repair. Hernia. 2009;13(1): Deeken C, Abdo MS, Frisella MM, Matthews BD. Physicomechanical evaluation of absorbable and nonabsorbable barrier composite meshes for laparoscopic ventral hernia repair. Surg Endosc. 2011;25(5): Ethicon US, LLC. All rights reserved The third-party trademarks used herein are trademarks of their respective owners.

2 Introduction TSMs commonly used for ventral hernia repair What are key considerations in selecting a mesh for ventral hernia repair? This guide discusses PROCEED Surgical Mesh versus competitive tissue-separating meshes (TSMs) from Medtronic and Bard Davol Inc. TSMs (also called composite meshes) are composed of more than 1 material and are designed to: 1,2 Promote tissue ingrowth/tissue integration 1 Separate the mesh from internal viscera to reduce tissue attachment to the mesh 1 The TSMs mentioned in this guide all have a permanent component and an absorbable component. PROCEED MESH Preimplantation PROCEED Surgical Mesh 7 The first macroporous mesh with an absorbable tissue-separating barrier In an in vitro study, PROCEED Mesh demonstrated bacteriostatic properties against bacteria commonly found in surgical site infections (MRSA, MRSE, VRE, and E. coli) 8 * Blue stripes aid placement orientation Trusted by surgeons for more than 10 years Key considerations *An in vitro study (24 hour study with inoculum challenge in the range of CFUs) demonstrated bacteriostatic properties of PROCEED Mesh against MRSA, MRSE, VRE, and E. coli. Mesh construction (eg, type of polymer, filament, absorbable barrier, pore size) 1 Ease of use 1 Biomechanical properties (eg, flexibility, tensile strength) 1 Medtronic Bard Davol Size of hernia defect 3 Patient characteristics (eg, obesity, comorbidities) 3 Proven patient outcomes and quality of life (QoL) 4 Postabsorption Symbotex Composite Mesh Parietex Optimized Composite Mesh Ventralight ST Mesh Impact of mesh fixation technique In addition, adequate fixation and mesh overlap are critical to help prevent hernia recurrence. 5 Follow the product s Instructions for Use. Permanent transfascial sutures may supplement absorbable straps, screws, or tacks, based on surgeon s judgment. 5,6 Absorbable oxidized regenerated cellulose (ORC) physically separates the mesh from underlying tissue and organs during the wound-healing process, while the nonabsorbable component remains for strong extended support. 7 * 3D monofilament polyester textile with absorbable, continuous, hydrophilic film 9 3D multifilament polyester mesh with resorbable collagen barrier 10 Monofilament polypropylene with absorbable hydrogel barrier 11 *Shown in an animal model. 2 3

3 Mesh construction Pore size Mesh construction Porosity Larger pore size is a key characteristic of macroporous, partially absorbable meshes Pore size is the distance between mesh fibers. In meshes with a smaller pore size less than 1 mm the gaps between mesh fibers are not sufficient to prevent bridging of scar tissue.² In meshes with a pore size greater than 1 mm, bridging of scar tissue is more likely to be avoided. Although a scar plate forms with all meshes, it will be less dense when there is less bridging After tissue integration, the scar is more flexible and causes less mesh sensation Porosity is an important measurement in evaluating adequate long-term tissue ingrowth Tissue-separating meshes are made of multiple materials to help separate the mesh from internal viscera while allowing for tissue ingrowth/tissue integration. 1 The initial porosity the ratio of free surface to polymer surface influences the area of good pores after ingrowth. The percentage of initial porosity is calculated by dividing the pore area by the total area. An initial porosity of at least 60% is recommended for achieving an effective degraded porosity porosity after ingrowth.² PROCEED Surgical Mesh measurement of good tissue ingrowth² Pore area (Initial) Porosity = [%] Total area Degraded porosity of commonly used TSMs 12 PROCEED Mesh 66.9% PROCEED Surgical Mesh Pore size: 3.5 ± 2.5 mm 12 Symbotex Composite Mesh Pore size: 3.3 mm ± 2.3 mm 12 Parietex Optimized Composite Mesh Pore size: 1.29 ± 0.15 mm (3D view) 12 Ventralight ST Mesh Pore size: 0.84 ± 0.04 mm 12 Pore size is important in calculating porosity. Initial porosity is defined by the ratio of free surface to polymer surface. Porosity represents only the area of good pores after ingrowth. Symbotex 57.3% Pore sizes and mesh densities are calculated following absorption of absorbable film or PGA acid (post implantation) Ventralight ST 42.5% PROCEED Mesh: medium-density (44 g/m 2 ) PROLENE Soft Polypropylene Mesh; Symbotex Composite Mesh: medium-density (66 g/m 2 ) monofilament polyester; Parietex Optimized Composite Mesh: medium-density (90 g/m 2 ) multifilament polyester; Ventralight ST Mesh: medium-density (64 g/m 2 ) monofilament polypropylene. 7,12 Parietex 23.5% 4 5

4 Mesh construction Materials PROCEED Surgical Mesh is a macroporous, partially absorbable, tissue-separating mesh PROCEED Surgical Mesh ORC, tissue incorporation, and bacteriostatic properties PROCEED Mesh is distinctive. 1 It combines large-pore mesh knitted with monofilament fibers with natural, absorbable tissue-separating technology It may enable patients to heal more naturally with a strong, comfortable repair Day 1 Day 14 Day 90 Material composition of PROCEED Mesh 1,7 Parietal Side 1 1. PDS (polydioxanone) Suture polymer film 2. PROLENE Soft Polypropylene Mesh 3. PDS Suture polymer film PDS Suture polymer film PROLENE Soft Mesh The ORC forms a continuous gel that physically separates the mesh from visceral surfaces. 1 The ORC is almost completely absorbed, and the PDS (polydioxanone) Suture polymer film is in the process of breaking down. 1 The ORC is completely absorbed, absorption of the PDS Suture polymer film is nearly complete, and the remaining polypropylene mesh is surrounded by fibroblasts Oxidized regenerated cellulose (ORC) knitted fabric The nonabsorbable polypropylene mesh side (parietal indicated by the blue stripes) allows for tissue ingrowth, while the ORC* side (visceral) minimizes tissue attachment to the mesh by providing a bioresorbable layer that physically separates the polypropylene mesh from underlying tissue and organ surfaces during wound healing. Visceral Side 1 PDS Suture polymer film Oxidized regenerated cellulose (ORC) PROCEED Mesh post-op experience (rabbit model) 1 After implantation, although PROCEED Mesh came in contact with blood, it maintained its functional characteristics At day 14, PROCEED Mesh was completely covered by a neoperitoneum PROCEED Mesh adhesion and adhesion severity scores were: PROCEED Mesh inhibits the growth of bacteria commonly associated with surgical site infections ORC is known to produce acidic ph, and a lower ph is a physiological detriment to the survival of microorganisms. Superior to polypropylene mesh and numerically better than Sepramesh Similar to Bard Composix and GORE DUALMESH In an in vitro study, PROCEED Mesh demonstrated bacteriostatic properties against bacteria commonly found in surgical site infections (MRSA, MRSE, VRE, and E. coli). 8 * *ORC is a plant-based material that forms a continuous gel, physically separating the mesh from underlying viscera. ORC is broken down by hydrolysis into carbon dioxide and water and is absorbed within 4 weeks.7 PROCEED Mesh has an ORC component that should not be used in presence of uncontrolled and/or active bleeding as fibrinous exudates may increase the chance of adhesion formation *An in vitro study (24 hour study with inoculum challenge in the range of CFU s) demonstrated bacteriostatic properties of PROCEED Mesh against MRSA, MRSE, VRE, and E. coli. 6 7

5 Biomechanical properties Patient outcomes and quality of life TSMs vary in their strength profile Adequate strength is necessary in a mesh to provide a durable repair with potentially improved patient comfort and reduced complications. Commonly used meshes vary in their tensile strength due to differences in density, pore size, and textile structure. 2,3 PROCEED Surgical Mesh is physiologically designed for strong and comfortable healing 1,6,13,14 Pressure (mm Hg) Comparison of maximum intra-abdominal pressure in healthy adults with mesh burst strength 6,13* 27 Standing MAXIMUM INTRA-ABDOMINAL PRESSURE 34 Bench press 64 Valsalva 127 Coughing 252 Jumping 620 ETHICON PROCEED Mesh PROCEED Mesh gives patients the reassurance of a strong repair * Strength requirements may not be the same in certain patient populations, such as those who are obese. Data from a prospective, longitudinal study of 157 patients receiving laparoscopic hernia repair using PROCEED Mesh from the IHMR. Hernia types repaired included incisional/ventral (75.1%), epigastric (5.1%), umbilical (18.5%) and trocar (1.3%). 77.7% (n=122) were primary repairs. In a study of patients from the International Hernia Mesh Registry (IHMR), on average those receiving hernia repair with PROCEED Mesh reported significant improvement in pain and movement limitations from baseline at 12 months postsurgery. 3 Ethicon a vision to advance hernia repair The Ethicon-sponsored IHMR is a large international data registry with a vision to advance hernia repair. The IHMR provides prospective, longitudinal, patient-reported data on ventral (primary, incisional) and inguinal hernia repairs for more than 4300 patients and reflects patient outcomes as seen in clinical practice. The registry includes Ethicon and non-ethicon products. 15 The IHMR uses the Carolinas Comfort Scale, a validated, hernia-specific QoL tool for assessing early and long-term symptoms following hernia repair 16 IHMR data are independently collected and managed by a third party 15 Low rate of recurrence in an IHMR laparoscopy study 3 PROCEED Mesh delivered a strong and durable repair for up to 1 year postsurgery and had a low rate of recurrence (1.3%) in 157 patients undergoing hernia repair. 3 In the same study, PROCEED Mesh significantly improved patient comfort at 1 year postsurgery versus presurgery 4 Patient-reported symptomatic pain at baseline and 12 months postoperatively Number of patients Preoperative 12 months postoperative Carolinas Comfort Scale score Mean pain score and 95% confidence interval Preoperative 1 month postoperative 6 months postoperative^ Change from baseline ^-0.66 (1.16SD) P<0.001; ~ (1.27) P< months postoperative ~ 8 9

6 Observational results in obese and nonobese patients Laparoscopic ventral hernia repair A 2011 retrospective analysis of data from 86 obese and nonobese patients who underwent hernia repair using PROCEED Surgical Mesh demonstrated equivalent rates of recurrence. 16 * Number of patients Percentage Seroma % Cellulitis lleus Persistence of pain 1 1.2% % 1.2% In a multicenter observational study from 2004 to 2006, PROCEED Surgical Mesh was evaluated in 114 patients (mean age 45 years) who underwent a laparoscopic ventral hernia repair. The mean follow-up period was 27 months. 17 There were no major complications related to the mesh 17 Surgeons identified these advantages with PROCEED Mesh in performing laparoscopic hernia repair: 17 Good compliance Excellent laparoscopic handling characteristics Good local tolerance Surgery results Recurrence rates % * A retrospective analysis to compare the recurrence rate in obese (n=31) and nonobese (n=47) patients who underwent laparoscopic repair of hernias using PROCEED Mesh. Two obese patients and 6 nonobese patients underwent open-technique hernia repair. Transfascial sutures and staples were used in tandem with the double crown technique. There were no recurrences in the 23 patients with BMI >/= 32 According to the investigators, the equivalent recurrence rates between the obese and nonobese populations in this study indicated that PROCEED Mesh possesses adequate strength for use in obese patients 16 Mean hernia defect size Mean mesh size used Major intraoperative complications or organ damage Severe bleeding Conversions to open repair or death Postoperative complications Seromas/hematomas Chronic pain (>6 months) Recurrence * Urinary Retention 24 cm 2 (range cm 2 ) 306 cm 2 (range cm 2 ) None None None 12 (10.5%) 2 (1.8%) 4 (3.5%) 1 (0.9%) * Three of the patients who had recurrences had a second laparoscopic procedure with an extra sheet using PROCEED Mesh without further complications. Procedures covered in this study include primary hernia repairs (umbilical, epigastric, and Spigel) and incisional hernia repairs. Both tacks and transfacial sutures were used according to the surgeon s preference