PARIETEX MESH CLINICAL STUDIES COMPENDIUM

CLINICAL ARTICLES REVIEWED New Developments in Hernia Repair 1 Comparison of Tissue Integration Between Polyester and Polypropylene Prostheses in the Preperitoneal Space 3 Ultrasound Detection of Visceral Adhesions After Intraperitoneal Ventral Hernia Treatment 4 Intraperitoneal Treatment of Incisional and Umbilical Hernias Using an Innovative Composite Mesh 5 Complications Associated with the Plug-and-Patch Method of Inguinal Herniorrhaphy 6 PARIETEX MESH CLINICAL STUDIES COMPENDIUM

INTRODUCTION Hernia repair is evolving faster than ever due to new techniques and materials used to perform the procedures. Until recently, polypropylene mesh had been the material of choice for hernia repair. However, early results of using polyester mesh, developed by the leaders in the field, have contributed to the development and acceptance of new materials for physicians and patients. We now have solid evidence which enables us to look to the future with great excitement for hernia repair procedures. The clinical articles reviewed and summarized in this compendium are meant to give surgeons the answers they are looking for when it comes to the use of Parietex polyester mesh for hernia repair. The clinical results show that polyester is safe, efficacious and superior to polypropylene when it comes to tissue ingrowth, contraction and migration. These summaries may be ordered and distributed should you wish to investigate the information in more depth.

Clinical Articles Reviewed Source Reorder Number Title of Article WP000006M New Developments of Hernia Repair WP000004M Comparison of Tissue Integration between Polyester and Polypropylene Prostheses in the Preperitoneal space Rodrigo Gonzalez, MD, Bruce Ramshaw, MD WP000009M Intraperitoneal Treatment of Incisional and Umbilical Hernias using an Innovative Composite Mesh: four-year Results of a Prospective Clinical Trial J.G. Balique, et. Al WP000017M Ultrasound Detection of Visceral Adhesion after Intraperitoneal Ventral Hernia Treatment: A Comparative study of Protected vs. Unprotected Meshes J.P. Arnaud MD WP000003M Complications Associated with the Plug-and-Patch Method of Inguinal Herniorrhaphy K.A. LeBlanc, MD

Surgical Technology International XI, 2003 New Developments in Hernia Repair Guy R. Voeller, M.D., F.A.C.S. Professor of Surgery, University of Tennessee Memphis, Tennessee The Plug and Patch technique gained early favor due to its simplicity and low recurrence rates. Dr. Voeller does refer to a study from LeBlanc describing his study with feedback from twentysix surgeons experiences with 500 plug patients who had pain for four weeks postoperatively. TABLE I. Patients Requiring Excision 40 Dr. Guy Voeller describes the latest techniques and product offerings in this publication stating, One might think there cannot truly be anything new in hernia repair, but nothing could be further from the truth. Dr. Voeller analyzes inguinal herniorraphy and incision/ventral procedures. This article is a concise review of the latest technology and gives a solid update of the current state of hernia repair. OVERVIEW Anterior inguinal approaches have evolved from the time of Lichtenstein s onlay repair, Rutkow s plug and patch repair, and Dr. Amid s modifications to these repairs to date. Contraction of polypropylene mesh has been a concern and designs have been developed to offset this. Polyester mesh from Sofradim does not shrink as does the polypropylene. Dr. Voeller states, Lepere and colleagues analyzed 1972 inguinal hernia repairs using Parietex mesh and noted a recurrence rate of less than 1% and only one case of mesh infection. Migration of Plug 17 Small Bowel Obstruction 1 Recurrences due to Shrinkage 13 Dr. Voeller concludes, Perhaps this technique, whereas quick and easy to perform, may not allow as much freedom from exactness as the Lichtenstein type of repair. The PHS system does not perform as it is depicted. Dr. Voeller states that though the PHS system has been used successfully in more than 800 patients worldwide, it has the potential to ball up and be a source of chronic pain similar to the plug and patch results described above. Dr. Voeller highlights results from the Shouldice Clinic calling for use of autogenous tissue for primary hernia repairs and leave mesh for recurrent or difficult repairs. He also describes the posterior approach and the benefits of the preperitoneal approach made popular by Nyhus and Wantz in the U.S. He describes the Gridiron Open Approach as well. The laparoscopic repair of groin hernias are challenging but in experienced surgeons hands, the outcomes are as good as open repair. 1

Most important in evaluating studies is to assess the experience of the surgeons involved, states Voeller. The posterior approach is the soundest physiological way to reinforce the myopectineal area. This fact cannot be disputed. Fibrin Glues: Dr. Voeller cites examples of successful outcomes in pigs and patients, however the cost may be the same as tacking devices, the time and steps to prepare make it less beneficial than tacking. He adds, We have never had to re-operate on any patient for pain due to a tack in more than 2000 TEP inguinal hernia repairs. POLYESTER MESH Dr. Voeller reports that he used it (three dimensional mesh) in his last 500 repairs and had no infections and only one recurrence. Three patients were operated on for unrelated reasons to their OPEN VENTRAL REPAIRS This procedure has a high rate of recurrence with reports of up to 45%, with 63% with no mesh and 38% with mesh. His emphasis is on the fact sutures should be used with fixation to secure the mesh. He also believes that heavyweight polypropylene meshes should not be used. For this reason, (contraction), we do not believe any polypropylene-based meshes even those coated with non-adhesive membranes should be used for V/I hernia, whether open or laparoscopic, writes Dr. Voeller. He further cites examples of using this mesh in a laparoscopic approach, stating, Most heavyweight polypropylene-based meshes are bulky and cannot be rolled up and placed through a 10mm port much less a 5mm site as can eptfe and polyester meshes. He references the multicenter trial in France of 80 patients that showed no complications due to the intraperitoneal placement of the mesh. original hernia repair, and it was noted that the mesh had not contracted or shrunk. It was also still as soft and pliable as when it was inserted. Dr. Voeller believes this is an important factor in mesh selection, both for inguinal and incisional hernias. Polypropylene meshes shrink, contract, stiffen as they do so. Dr. CONCLUSION This publication has strong evidence to support the use of laparoscopic techniques and the use of Parietex mesh for successful hernia repair. Voeller then proceeds to discuss the complications this contraction can lead to for the patient. 2

The American Surgeon. June 2003 Comparison of Tissue Integration between Polyester and Polypropylene Prostheses in the Preperitoneal Space Rodrigo Gonzalez, MD, Bruce Ramshaw, MD Date: Feb, 2003 This study compared multiple performance characteristics in Polyester and Polypropylene mesh in six pigs. The mesh used was Parietex two dimensional weave (PF) and Parietex three dimensional weave (PS) and Marlex mesh from C.R. Bard (PP). It describes how Parietex is different in the weave make-up from older polyester mesh types. CONCLUSION The results of our survey indicate an increased quantity and quality of the inflammatory reaction for PPO mesh, which result in restriction of the abdominal wall mobility. This inflammatory reaction may have negative consequences in the long-term clinical results. OVERVIEW Twelve-week explants from an animal revealed neovascularization and peripheral encapsulation were absent to limited for polyester two dimensional weave and moderate to severe for polypropylene. Inflammatory response is the first step in the tissue healing process. Polyester and polypropylene both elicit a response, however the polyester three dimensional weave showed the highest amount of response and the greatest amount of connective tissue leading to tissue ingrowth. Polypropylene exhibited the greatest amount of encapsulation and this can lead to increase rigidity In addition, the scar formation that follows the inflammatory reaction after implantation of the PP meshes has been proposed to be the basis of the stiffness associated with the altered physiology of the abdominal wall. The introduction of a new biomaterial may provide an alternative that could help reduce the complication and recurrence rates found after inguinal repair with PP meshes. The front page summary states it best stating, Both Polyester prostheses (PFF and PS), have better tissue integration, than the PP mesh, as evidenced by the higher amount of connective tissue and lower extent of fibrous encapsulation. and reduced abdominal wall compliance. 3

Hernia 2003 Ultrasound Detection of Visceral Adhesion after Intraperitoneal Ventral Hernia Treatment: A Comparative study of Protected vs. Unprotected Meshes J.P. Arnaud MD, S. Hennekinne-Mucci MD, P. Pessaux MD, J.J. Tuech MD, C. Aube MD Ventral hernia repair patients are at particularly high risk for visceral attachments due to unprotected mesh materials used during ventral hernia repair. It has been reported that 100 percent of patients undergoing ventral hernia repair with untreated mesh have visceral attachments. CONCLUSION This comparative clinical study demonstrates a significant reduction of visceral attachments with Parietex mesh that is treated with oxidized atelocollagen type I + Polyethylene glycol + Glycerol in the intraperitoneal treatment of ventral hernias. OVERVIEW This clinical article compares Parietex, a three dimensional polyester mesh with a hydrophilic film from Autosuture versus an uncoated polyester mesh called Mersilene from Ethicon. The authors are looking to see which mesh offers fewer visceral attachments to the abdominal wall through ultrasonic examination. They were able to show that 77% of patients in the Mersilene group had severe visceral attachments versus only 18% of patients in the Parietex group showed weak visceral attachments. TABLE I. Postoperative Ultrasound Results Parietex group compared to the Mersilene group, 18% vs. 77% (P<0.0001). 4

Hernia 2005 Intraperitoneal Treatment of Incisional and Umbilical Hernias using an Innovative Composite Mesh: Four-Year Results of a Prospective Clinical Trial J.G. Balique, S. Benchetrit, J.L. Bouillot, J. B. Flament, C. Gouillat, P. Jarsaillon, M. Lepere, G. Mantion, J.P. Arnaud, E. Magne, F. Brunetti In this multicenter, prospective, four-year clinical trial, the main objective was to test the anti-attaching capability of Sofradim Parietex Composite mesh. Of eighty patients from eleven centers total, sixty-one (76%) were included for incisional hernia and 19 (24%) for umbilical hernia. Fifty-one (64%) were operated via laparotomy and 29 (36%) via laparoscopic surgery. OVERVIEW To assess the absence of visceral attachments, an ultrasound (US) specific examination was initially validated and then used during follow-up. After twelve months, 86% of patients were ultrasonically adhesion free. No complications related to post-perioperative mesh visceral attachments were reported. Fifty-six patients were clinically evaluated after forty-eight months with no complication such as occlusion or fistula. The Parietex Composite mesh was utilized. A continuous, smooth, hydrophilic and resorbable film is grafted to the three dimensional, multi-fiber polyester base. This film completely covers one side of the reinforcement and protects the viscera from TABLE I. Long Term Clinical Results Four Year clinical results 48 plus/minus Mean follow-up (months) 6 months Patients Evaluated 56 (75.7%) Unrelated death 4 (5.4%) Lost to follow-up 14 (18.9%) Complications Occlusion 0 Fistula / Mesh Sepsis 0 Direct recurrence 1 (1.8%) CONCLUSION It has been shown that Parietex Composite Mesh efficiently reduces the risk of visceral attachments. Due to its unique properties, 86% of patients were free of visceral attachment after one year. The results of this study concerning major complications are totally different from the observations of the Leber study, which reported seven (3.5%) long-term enterocutaneous fistula with 3.3 years of modern median time. Results confirm the interest of modern protected materials when combined with adequate techniques. direct contact with the textile during tissue integration. 5

Hernia 2003 Complications Associated with the Plug-and-Patch Method of Inguinal Herniorrhaphy K.A. LeBlanc, MD TABLE II. Complications related to migration of the plug Out of internal ring 9 Into scrotum 4 Into preperitoneal space 1 Into peritoneal space - At internal ring 1 Small bowel obstruction 1 Dr. LeBlanc surveyed members of the American Hernia Society seeking feedback on the plug and patch method of inguinal herniorraphy. There were thirty-two respondents (6 = no issues, 26 = issues). There were 590 patients included in the analysis. OVERVIEW TABLE III. Other complications Lateral herniation with a reversed plug 2 Deep venous thrombosis at the site of the plug 2 Localized abscess 1 Small bowel fistualization 1 Recurrence due to shrinkage of the plug 13 Recurrence rates with inguinal hernia repair varies from.5% to 20%. Plug and Patch is a quick and easy procedure. Patients may experience prolonged pain after this type of repair. Potential cause may be attributable to the shrinkage and migration of the plug producing pain and the potential for recurrence of the hernia. TABLE I. Pain complications after plug-and-patch inguinal herniorrhaphy Postoperative pain >4 weeks (not incapacitating) 503 Postoperative pain requiring incision for relief 40 Pain (Incapacitating but not removed) 5 Pain with orgasm (dysejaculation) 2 CONCLUSION Dr. LeBlanc notes, A recent article compared the plug-and-patch technique with the Lichtenstein repair in a prospective double-blind randomized fashion. This revealed that there was a statistically significant difference in the amount of pain in the patients with the plug-and-patch repair compared with the Lichtenstein group after one year. Furthermore, There were three times more patients who had pain limiting their normal activities after one year in the former group. Removal of the patch was required in 5.6% of the plug-and-patch patients because of this pain. Dr. LeBlanc indicates that a variety of problems occur with this procedure and are probably underreported. Neuralgia 5 6

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