Surgical Meshes and Methods of Fixation

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  • Can we safely perform a laparoscopic ventral hernia repair?
  • for either laparoscopic or open primary repair of ventral hernia
  • Recurrence as major end point
  • QoL As relates to HW vs LW meshes
  • What’s out there- polypropylene, polyester, PTFE
  • Surgical Meshes and Methods of Fixation

    1. 1. Surgical Meshes and Methods of Fixation George S. Ferzli MD, FACS Professor of Surgery, State University of New York
    2. 2. <ul><li>We will cove biologic and synthetic meshes as well as closure of the defect during the course of the presentation. </li></ul>
    3. 3. Is the abdomen a weakness in the human race ?
    4. 4. Incidence of Ventral Hernias <ul><li>Around 10 % of all laparotomies will generate incisional hernias. </li></ul><ul><li>The bigger the incision, the higher the risk. </li></ul><ul><li>~77% are median hernias </li></ul><ul><li>~17% are lateral hernias </li></ul><ul><li>~6% are iliac hernias </li></ul><ul><li>Direct closure have a high recurrences incidence (50%). The rate </li></ul><ul><li>increases (58%) with repair of recurrent hernias. </li></ul><ul><li>Significant reduction in recurrences is achieved when meshes are used. </li></ul><ul><li>Luijendijk RW, et al. A Comparison of Suture Repair with Mesh Repair for Incisional Hernia .NEJM 2000; 343:392-398 </li></ul>
    5. 5. Factors influencing ventral hernia occurrence <ul><li>The most important functions of the abdominal wall are protection, </li></ul><ul><li>compression and retention of the abdominal contents, flexion and rotation </li></ul><ul><li>of the trunk and forced expiration. </li></ul><ul><li>Endogen Exogene Others </li></ul><ul><li>Age > 45 Sutures emergency </li></ul><ul><li>BMI > 25 length of incision intra abdominal </li></ul><ul><li>previous operation contamination pressure </li></ul><ul><li>anemia Medication </li></ul><ul><li>shock Type of incision </li></ul><ul><li>smoker </li></ul><ul><li>Corticoïds </li></ul><ul><li>Aneurysm/Marfan </li></ul><ul><li>(+30% risks) </li></ul>
    6. 6. <ul><li>Hypothesis: In midline incisions closed with a single layer running suture, the </li></ul><ul><li>rate of wound complications is lower when a suture length to wound length </li></ul><ul><li>ratio of at least 4 is accomplished with a short stitch length rather than with a </li></ul><ul><li>long one. </li></ul><ul><li>Surgical site infection occurred in 35 of 343 patients (10.2%) in the long stitch </li></ul><ul><li>group and in 17 of 326 (5.2%) in the short stitch group (P=0.2). Incisional </li></ul><ul><li>hernia was present in 49 of 272 patients (18.0%) in the lo9ng stitch group and </li></ul><ul><li>in 14 of 250 (5.6%) in the short stitch group (P<.001). </li></ul><ul><li>Conclusion: In midline incisions closed with a running suture and having a </li></ul><ul><li>suture length to wound length ratio of at least 4, current recommendations of </li></ul><ul><li>placing stitches at least 10mm from the wound edge should be3 changed to </li></ul><ul><li>avoid patient suffering and costly wound complications. </li></ul>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
    7. 7. Table 2 . 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
    8. 8. Table 3 . 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)
    9. 9. 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.
    10. 10. Ventral hernia: anatomy
    11. 11. In humans the intra-abdominal pressure ranges from 0,2kPa (resting) to 20 kPa (maximum). Pressure
    12. 12. Abdominal Wall Elasticity <ul><li>After the Intra-abdominal pressure, </li></ul><ul><li>another important factor in the abdominal </li></ul><ul><li>wall repair plays a role,it is the abdominal </li></ul><ul><li>wall elasticity. </li></ul><ul><li>The abdominal wall is elastic. </li></ul><ul><li>The abdominal wall elasticity was </li></ul><ul><li>studied by Pr Schumpelick and his team* </li></ul><ul><li>He showed that the abdominal wall </li></ul><ul><li>of a women is more elastic than the </li></ul><ul><li>abdomen of a man. </li></ul>*Hernia (2001) 5: 113-118
    13. 13. Ventral hernia mesh positioning: Onlay
    14. 14. Ventral hernia mesh positioning: Inlay
    15. 15. Ventral hernia mesh positioning: Underlay
    16. 16. Ventral hernia mesh positioning: Intraperitoneal
    17. 17. Types of prosthetics for hernia repair: <ul><ul><li>Type 1: totally macroporous prosthesis, pores > 75 microns; example prolene, marlex </li></ul></ul><ul><ul><li>Type 2: totally microporous prosthesis; pores < 10 microns; example gortex or dual mesh </li></ul></ul><ul><ul><li>Type 3: macroporous prosthesis with microporous components; example Teflon, mersilene </li></ul></ul><ul><ul><li>Type 4: biomaterials with submicronic pore size; example cilastic, cell gard </li></ul></ul>
    18. 18. Polyglactene Mesh (vicryl mesh) <ul><ul><li>Alternative to nonabsorbable meshes </li></ul></ul><ul><ul><li>Advantage host invasion and subsequent absorption of implant </li></ul></ul><ul><ul><li>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) </li></ul></ul>
    19. 19. Polypropylene Biomaterials <ul><li>Angimesh , Angiologics, S. Martino Sicc., Italy </li></ul><ul><li>Biomesh P1 , Cousin Biotech, Wervicq-Sud, France </li></ul><ul><li>Biomesh P3 , Cousin Biotech, Wervicq-Sud, France </li></ul><ul><li>Biomesh 3D , Cousin Biotech, Wervicq-Sud, France </li></ul><ul><li>C-QUR (polypropylene / omega 3 fatty acid coating), Atrium, NH, USA </li></ul><ul><li>DynaMesh (polypropelene incorporated with polyvinylidene difluoride) FEG, Aachen, Germany </li></ul><ul><li>Hetra 1, 2, HerniaMesh, S.R.L., Torino, Italy </li></ul><ul><li>Hermesh 3,4,5, HerniaMesh, S.R.L., Torino, Italy </li></ul><ul><li>Intramesh NKI, NK2, NK8, Cousin Biotech, Wervicq-Sud, France </li></ul><ul><li>Marlex, C.R.Bard, Inc., Cranston NJ, USA </li></ul>
    20. 20. Polypropylene Biomaterials <ul><li>Parietene, Sofradim International, Villfranche-sur-Saone, France </li></ul><ul><li>Proceed (polypropelene / polydiaxanone / oxidized regenerated cellulose), Ethicon, Somerville, NJ, USA </li></ul><ul><li>Prolene , Ethicon, Somerville, NJ, USA </li></ul><ul><li>Prolene Soft Mesh , Ethicon, Somerville, NJ, USA </li></ul><ul><li>Prolite , Atrium Medical Corporation, Hudson, NH, USA </li></ul><ul><li>Prolite Ultra , Atrium Medical Corporation, Hudson, NH, USA </li></ul><ul><li>Surgipro (Monofilament), United States Surgical Corp,/Tyco, Norwalk, CT, USA </li></ul><ul><li>Sepramesh ( polypropylene mesh coated with Seprafilm - modified sodium hyaluronate and carboxymethylcellulose) Genzyme, MA, USA </li></ul><ul><li>Surgipro (Multifilament), United States Surgical Corp./Tyco, Norwalk, CT, USA </li></ul><ul><li>TiMesh (titanium-coated polypropylene) Medizintechnik GmbH, Nuremberg, Germany </li></ul><ul><li>Trelex, Meadox Medical Corporation, Oakland, NJ, USA </li></ul><ul><li>Ultrapro (Poliglecaprone-25 / Polypropylene) , Ethicon, Somerville, NJ, USA </li></ul>
    21. 21. Polypropylene Mesh <ul><ul><li>Schmitt and Griman in 1967 first described successful use of polypropylene mesh in contaminated wounds </li></ul></ul><ul><ul><li>Subsequent reports showed good initial healing but were fraught with long term complications </li></ul></ul><ul><ul><li>Those complications are chronic infection, fistula formation, erosion into bowels or through skin grafts </li></ul></ul><ul><ul><li>Jones and Jurkoyiun in 1989 reviewed 14 studies, 128 patients, and found 55 overall complication rate - enteric fistulization being the most common. </li></ul></ul>
    22. 22. In Favor of Polypropylene Mesh: <ul><ul><li>Extensive fibroblast in growth , incorporation by the host and can be used in contaminated fields </li></ul></ul><ul><li>Franklin ME et al. Lap ventral and incisional hernial repair. Surg Lap End 8(4):294-299 1998 </li></ul><ul><li>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. </li></ul><ul><ul><li>Chowbey PK et al. Lap ventral hernia repair J La Adv Surg </li></ul></ul><ul><ul><li>Tech 2000; 10:79-84 </li></ul></ul><ul><ul><li>Bingener J et al. Adhesion formation after laparoscopic ventral </li></ul></ul><ul><ul><li>incisional hernia repair with polypropylene mesh: a study using </li></ul></ul><ul><ul><li>abdominal ultrasound, JSLS (2004)8:127-131 </li></ul></ul>
    23. 23. Against polypropylene mesh: <ul><ul><li>It is extremely difficult to lyse adhesions to polypropylene without causing enterotomies* </li></ul></ul><ul><ul><li>Major complications with polypropylene not evident until years later </li></ul></ul><ul><ul><li>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 </li></ul></ul><ul><ul><ul><li>*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 </li></ul></ul></ul>
    24. 24. ePTFE Biomaterials <ul><li>DualMesh, W.L. Gore and Associates, Flagstaff, AZ, USA </li></ul><ul><li>DualMesh Emerge, W.L. Gore and Associates, Flagstaff, AZ, USA </li></ul><ul><li>DualMesh Plus , W.L. Gore and Associates, Flagstaff, AZ, USA </li></ul><ul><li>DaulMesh Plus Emerge , W.L. Gore and Associates, Flagstaff, AZ, USA </li></ul><ul><li>DualMesh with Holes , W.L. Gore and Associates, Flagstaff, AZ, USA </li></ul><ul><li>DualMesh Plus with Holes , W.L. Gore and Associates, Flagstaff, AZ, USA </li></ul><ul><li>Dulex , C.R. Bard, Inc., Cranston NJ, USA </li></ul><ul><li>Mycromesh , W.L. Gore and Associates, Flagstaff, AZ, USA </li></ul><ul><li>Mycromesh Plus , W.L. Gore and Associates, Flagstaff, AZ, USA </li></ul><ul><li>Reconix , C.R. Bard, Inc., Cranston NJ, USA </li></ul><ul><li>Soft Tissue Patch , W.L. Gore and Associates, Flagstaff, AZ, USA </li></ul>
    25. 25. In Favor of ePTFE <ul><li>Microporous, smooth texture minimizes tissue in-growth and limits adhesion formation and bowel injury </li></ul><ul><li>Combined with a large pore second layer it can adhere well to the abdominal wall </li></ul>
    26. 26. Against ePTFE <ul><li>Microporous construction limits ability of macrophages to destroy bacteria </li></ul><ul><li>Mesh infection is not well treated by antibiotics and requires mesh removal </li></ul><ul><li>Does not integrate well into host tissue when not combined with a large pore mesh </li></ul>
    27. 27. Polyester mesh <ul><li>Parietex (polyester and atelocollagen type 1, polyethylene glycol, glycerol) Covidien, Hamilton, Bermuda </li></ul><ul><li>Polyester mesh incorporates well into the abdominal wall </li></ul><ul><li>Collagen covering on the visceral surface protects bowel and dissolves as the polyester is incorporated </li></ul>
    28. 28. Polyester and atelocollagen type 1, polyethylene glycol, glycerol (Parietex) <ul><ul><ul><li>Retrospective study of the use of Parietex in laparoscopic ventral hernia repair </li></ul></ul></ul><ul><ul><ul><li>n = 20 patients </li></ul></ul></ul><ul><ul><ul><li>Mean follow up - 10 months </li></ul></ul></ul><ul><ul><ul><li>No morbidity or mortality </li></ul></ul></ul><ul><ul><ul><li>No infections, rejections, fistulas, recurrences, or alterations in bowel function </li></ul></ul></ul><ul><ul><ul><li>Parietex is safe for intra-abdominal use </li></ul></ul></ul><ul><ul><li>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 </li></ul></ul>
    29. 29. Polyester and atelocollagen type 1, polyethylene glycol, glycerol (Parietex) <ul><li>Comparison of Parietex with Sepramesh for ventral hernia repair </li></ul><ul><li>in rabbit model </li></ul><ul><li>Results at 5 months Parietx Sepramesh </li></ul><ul><ul><li>Strength </li></ul></ul><ul><ul><li>of incorporation 70.9N 31.5N </li></ul></ul><ul><ul><li>Bowel adhesions 0 4 </li></ul></ul><ul><ul><li>Adhesion area 321 mm 2 840 mm 2 </li></ul></ul><ul><ul><li>Shrinkage 17.4% 6.1% </li></ul></ul><ul><ul><li>Parietex has stronger incorporation and is better at prevention of </li></ul></ul><ul><ul><li>adhesiona than sepra mesh, however it undergoes considerably more </li></ul></ul><ul><ul><li>shrinkage </li></ul></ul>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
    30. 30. Polyester and atelocollagen type 1, polyethylene glycol, glycerol (Parietex) <ul><ul><li>Experience with 656 laparoscopic ventral hernia repairs with Parietex </li></ul></ul><ul><ul><li>Hernia defect closed with sutures to reduce seroma and restore abdominal wall function </li></ul></ul><ul><ul><li>Laparoscopic mesh repair performed with Parietex mesh </li></ul></ul>Chelala E. (2008) Personal correspondence
    31. 31. Polyester and atelocollagen type 1, polyethylene glycol, glycerol (Parietex) <ul><ul><li>Mean follow up 45 months </li></ul></ul><ul><ul><li>Recurrences 20 (3.04%) </li></ul></ul><ul><ul><li>“ Second look” operation </li></ul></ul><ul><ul><li>for various reasons 70 </li></ul></ul><ul><ul><ul><li>Adhesion free 38 (54.3%) </li></ul></ul></ul><ul><ul><ul><li>Minor adhesions 27 (38.6%) </li></ul></ul></ul><ul><ul><ul><li>Serosal adhesions 5 (7.1%) </li></ul></ul></ul><ul><ul><li>Parietex is associated with low formation of dense adhesions </li></ul></ul>Chelala E. Personal correspondence
    32. 32. Open ventral hernia repair Competition <ul><li>BARD </li></ul><ul><ul><li>Ventralex </li></ul></ul><ul><ul><li>Kugel Composix </li></ul></ul><ul><ul><li>Composix E/X </li></ul></ul><ul><li>ETHICON </li></ul><ul><ul><li>Proceed </li></ul></ul><ul><li>ATRIUM </li></ul><ul><ul><li>C-Qur </li></ul></ul><ul><li>GORE </li></ul><ul><ul><li>Dualmesh </li></ul></ul><ul><li>GENZYME </li></ul><ul><ul><li>Sepramesh IP </li></ul></ul><ul><li>GfE TiMesh </li></ul>
    33. 33. Properties of Absorbable Barrier-Coated Meshes
    34. 34. 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
    35. 35. Bard Ventralex <ul><li>Designed for small ventral, umbilical, and epigastric hernia repairs </li></ul><ul><li>Self-expanding polypropylene & ePTFE patch with a memory recoil ring </li></ul><ul><li>Positioning straps to facilitate placement and suturing </li></ul><ul><li>Memory recoil ring enables the patch to be folded and later “pop open” and lay flat after insertion into the intra-abdominal space. </li></ul><ul><li>Available in 4, 6 and 8 cm diameter </li></ul>
    36. 36. Bard Ventralex / Composix structure <ul><li>PTFE stitches makes the surface non continuous and create bridges between viscera and PP layers </li></ul>
    37. 37. Bard Ventralex rebuttal <ul><li>Strengths </li></ul><ul><li>Easy to implant </li></ul><ul><li>Weaknesses </li></ul><ul><li>Low antiadhesion efficacy </li></ul><ul><li>PTFE stitches creates holes in the ePTFE layer allowing for adhesions </li></ul>
    38. 38. Bard Composix E/X <ul><li>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. </li></ul><ul><li>The 2 layers are stitched with PTFE monofilament. </li></ul><ul><li>Elliptically shaped design: Reduces the need to trim the mesh, saving time. </li></ul><ul><li>Low Profile: Makes it ideally suited for laparoscopic ventral hernia repairs. </li></ul><ul><li>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. </li></ul>
    39. 39. Bard Composix E/X rebuttal <ul><li>Strengths </li></ul><ul><li>Protected edge </li></ul><ul><li>Elliptic shape </li></ul><ul><li>Weaknesses </li></ul><ul><li>Heavy weight PP induces high fibrosis. </li></ul><ul><li>Holes in the ePTFE side made by the PTFE stitches may create adhesions </li></ul><ul><li>Cannot be cut as the PP layer will be widely exposed </li></ul><ul><li>Low clinical efficacy (high rate of adhesions) </li></ul>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
    40. 40. Bard Composix LP <ul><li>Made with lightweight, low profile polypropylene Soft Mesh that is 60% lighter than traditional polypropylene mesh </li></ul><ul><li>Easier handling and laparoscopic insertion, all sizes can fit through a trocar </li></ul><ul><li>Optional Introducer Tool, which is packaged with larger sizes, makes insertion even easier </li></ul><ul><li>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 </li></ul><ul><li>Sealed Edge: Overlap of ePTFE protects the edge of the mesh from visceral attachment </li></ul>
    41. 41. Bard composix L/P rebuttal <ul><li>Strengths </li></ul><ul><li>Sealed edges </li></ul><ul><li>Introducer tool </li></ul><ul><li>Light PP mesh on parietal side </li></ul><ul><li>Weaknesses </li></ul><ul><li>Holes in the ePTFE side made by the PTFE stitches may create adhesions </li></ul><ul><li>Low clinical efficacy (high rate of adhesions) </li></ul><ul><li>Cannot be cut as the PP layer will be widely exposed </li></ul>
    42. 42. Bard Composix Kugel <ul><li>Double layer of monofilament polypropylene. These two layers create a positioning pocket, which is used to guide the patch into the proper position. </li></ul><ul><li>On the other side is a barrier of ePTFE. </li></ul><ul><li>The PP layers and ePTFE are stitched with PTFE monofilament </li></ul><ul><li>The patch also contains a patent-protected &quot;memory recoil ring,&quot; which causes the patch to spring open and maintain its shape during placement. </li></ul>
    43. 43. Bard Composix Kugel recall <ul><li>Risk of rupture of the PET memory recoil ring </li></ul><ul><li>This can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs). </li></ul>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
    44. 44. Bard Composix Kugel rebuttal <ul><li>Weaknesses </li></ul><ul><li>Kugel mesh too thick to be used laparoscopically (Ideal approach ) </li></ul><ul><li>Mesh shrinkage and migration is a potential problem (there are several recurrences but the mesh is not visualized laparoscopically) </li></ul><ul><li>Rupture of the memory recoil ring </li></ul><ul><li>Low clinical efficacy on anti adhesion prevention </li></ul><ul><li>Strengths </li></ul><ul><li>Memory effect for intraperitoneal placement </li></ul>
    45. 45. Ethicon Proceed <ul><li>Multilayered tissue separating mesh comprised of: </li></ul><ul><li>PROLENE* Soft polypropylene Mesh </li></ul><ul><li>Monofilament polypropylene encapsulated with polydioxanone (PDS) </li></ul><ul><ul><li>Designed for strength, durability, and adaptability </li></ul></ul><ul><li>Oxidized regenerated cellulose (ORC) fabric </li></ul><ul><ul><li>Minimizes tissue attachment </li></ul></ul><ul><ul><li>Plant-based material (non-animal) </li></ul></ul><ul><li>Absorbable polydioxanone (PDS) </li></ul><ul><ul><li>Creates a flexible, secure bond between the mesh and ORC layers </li></ul></ul>
    46. 46. Ethicon – Proceed Mesh <ul><li>Lightweight Monofilament Construction </li></ul><ul><ul><li>Less foreign mass </li></ul></ul><ul><ul><li>Flexible scar tissue </li></ul></ul><ul><ul><li>Strong tissue incorporation </li></ul></ul><ul><li>Excellent Handling </li></ul><ul><ul><li>Low profile </li></ul></ul><ul><ul><li>Blue-striped surface distinguishes the parietal </li></ul></ul><ul><ul><li>from the visceral side </li></ul></ul><ul><li>Resists Bacterial Colonization </li></ul><ul><ul><li>No ePTFE </li></ul></ul><ul><ul><li>Lightweight, macro porous, monofilament mesh structure </li></ul></ul><ul><ul><li>Allows fluid flow-through </li></ul></ul><ul><li>Recovers to Original Shape Once Placed </li></ul><ul><ul><li>Easily deployed and positioned once inside abdominal cavity </li></ul></ul><ul><ul><li>Conforms to anatomy </li></ul></ul><ul><ul><li>Readily customized </li></ul></ul>
    47. 47. Timeline— The Progress of Peritoneal Healing <ul><li>Day 1- PROCEED mesh is implanted and the mesh begins to </li></ul><ul><li>incorporate into the abdominal wall. ORC forms a continuous gel that </li></ul><ul><li>physically separates mesh from underlying viscera surfaces, reducing </li></ul><ul><li>the severity and extent of tissue attachment. </li></ul>
    48. 48. Timeline— The Progress of Peritoneal Healing <ul><li>Day 7- Neoperitoneum is formed within 7 to 10 days. Absorbable </li></ul><ul><li>components have begun to break down. </li></ul>
    49. 49. Timeline— The Progress of Peritoneal Healing <ul><li>Day 14 - ORC is absorbed Peritoneum is fully restored </li></ul>
    50. 50. Timeline— The Progress of Peritoneal Healing <ul><li>Day 91- The PDS and ORC are completely absorbed. The remaining </li></ul><ul><li>polypropylene mesh is surrounded by fibroblasts and the neoperitoneum </li></ul><ul><li>is supported by a well-organized fibroblast bed. </li></ul>
    51. 51. PROCEED* Surgical Mesh Essential Prescribing Information <ul><li>Warnings: </li></ul><ul><li>When this mesh is used in infants, children, pregnant women, or </li></ul><ul><li>women planning pregnancies, the surgeon should be aware that this </li></ul><ul><li>product will not stretch significantly as the patient grows. PROCEED Mesh </li></ul><ul><li>should not be placed in a contaminated surgical site. The mesh may </li></ul><ul><li>not be used following planned intraoperative or accidental opening </li></ul><ul><li>of the gastrointestinal tract. PROCEED Mesh has an ORC component, </li></ul><ul><li>which must not be used in cases in which appropriate hemostasis </li></ul><ul><li>has not been established. Tissue attachment to the mesh can result if </li></ul><ul><li>appropriate hemostasis is not achieved. </li></ul>
    52. 52. Ethicon Proceed rebuttal <ul><li>Strengths </li></ul><ul><li>Weaknesses </li></ul><ul><li>Low clinical efficacy </li></ul><ul><li>Contraction of the Prolene Soft by 34% </li></ul><ul><li>No memory shape, difficult to manipulate, tends to adhere to tissue when wet, </li></ul><ul><li>Meticulous haemostasis must be achieved* </li></ul><ul><li>Low intra-op light, </li></ul><ul><li>No overlap over the edges, </li></ul><ul><li>De-lamination cases due to resorbable PDS may induce seroma, higher sepsis risk </li></ul><ul><li>Low resistance to suture </li></ul><ul><li>*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 </li></ul>
    53. 53. Atrium C-Qur and C-Qur edge <ul><li>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. </li></ul><ul><li>C-Qur edge features a reinforced edge design for enhanced fixation stability and ease of use. </li></ul><ul><li>Fatty acid may have antimicrobial properties. </li></ul><ul><li>Resorption of the coating occurred within 3 to 6 months </li></ul>
    54. 54. Atrium C-Qur and C-Qur edge rebuttal <ul><li>Strengths </li></ul><ul><li>Animal testing show minimal adhesion and good tissue integration </li></ul><ul><li>Fatty acid may have antimicrobial effect (not validated in clinicals) </li></ul><ul><li>Transparent, good visibility of landmarks </li></ul><ul><li>Weaknesses </li></ul><ul><li>Lack of human studies </li></ul>
    55. 55. 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.
    56. 56. Gore Dual mesh / Dual mesh Plus <ul><li>Gore Dual mesh is a dual layer of ePTFE </li></ul><ul><li>Visceral side is composed of ridges and valleys, called as Corduroy, to create porosity (22 µm). </li></ul><ul><li>The smooth visceral side of the material is brown. </li></ul><ul><li>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. </li></ul>
    57. 57. Gore Dual mesh rebuttal <ul><li>Strengths </li></ul><ul><li>Used for many years </li></ul><ul><li>Weaknesses </li></ul><ul><li>No tissue integration </li></ul><ul><li>High rate of seroma </li></ul><ul><li>Need strong fixation: tacks and sutures </li></ul><ul><li>Highest Shrinkage among material </li></ul><ul><li>High density </li></ul><ul><li>Opaque: cannot see the anatomical landmarks, vessel and nerves </li></ul><ul><li>Shiny surface under lap </li></ul><ul><li>“ The use of antimicrobial-impregnated ePTFE mesh with </li></ul><ul><li>silver/chlorhexidine in laparoscopic ventral hernia repair is </li></ul><ul><li>associated with noninfectious postoperative fever. In our </li></ul><ul><li>patients, the evaluation and management of these fevers </li></ul><ul><li>resulted in a significantly longer hospital stay.” </li></ul><ul><li>Cobbs, Am Surg. 2006 Dec;72(12):1205-8; </li></ul>
    58. 58. Genzyme Sepramesh IP <ul><li>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. </li></ul><ul><li>The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. </li></ul><ul><li>PGA Fibers maintain 50% of the reinforcement strength during the 1st 28 days </li></ul><ul><li>Bioresorbable coating protects for up to 14 days while peritoneum heals </li></ul><ul><li>Hydrogel swells to cover sutures, tacks and mesh edges </li></ul>
    59. 59. Genzyme Sepramesh IP rebuttal <ul><li>Strengths </li></ul><ul><li>Animal studies show low rate of adhesions </li></ul><ul><li>Good mechanical properties (burst strength and suture retention) </li></ul><ul><li>Translucent </li></ul><ul><li>Good memory shape </li></ul><ul><li>Weaknesses </li></ul><ul><li>Lack of human studies </li></ul><ul><li>Requires 12mm or 15mm trocar for lap insertion (8x15, 10x20, 15x20, 20x30) </li></ul>
    60. 60. Genzyme Sepramesh IP <ul><ul><li>In preclinical animal studies, Sepramesh®IP demonstrated tissue incorporation superior to ePTFE composite mesh.1 </li></ul></ul><ul><ul><li>In mechanical tests of burst strength and suture retention, Sepramesh®IP outperformed standard polypropylene mesh in both measures.1 </li></ul></ul>
    61. 61. Genzyme Sepramesh IP <ul><ul><li>Sepramesh®IP Versus </li></ul></ul><ul><ul><li>Other Meshes </li></ul></ul><ul><ul><li>In animal studies, Sepramesh®IP significantly outperformed alternative hernia repair products in protecting the bowel from adhering to the mesh.1 </li></ul></ul><ul><ul><li>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. </li></ul></ul>
    62. 62. GfE TiMesh <ul><li>GfE is a German company </li></ul><ul><li>TiMesh launched mid-2003 </li></ul><ul><li>Key Points </li></ul><ul><li>Monofilament polypropylene mesh completely coated in Titanium </li></ul><ul><li>Sold in two forms – Light and Extra light </li></ul><ul><li>Titanium is NOT an anti-adhesive </li></ul><ul><li>Product sold in Europe for years </li></ul><ul><li>Disadvantages </li></ul><ul><li>Very expensive (~$195 - $225/flat sheet) </li></ul>
    63. 63. 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
    64. 64. <ul><li>Questions???? </li></ul>
    65. 65. Biomeshes
    66. 66. 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
    67. 67. Massive Incisional Hernias
    68. 68. Repair Techniques <ul><li>Autologous Myocutaneous Flaps </li></ul><ul><ul><li>Morbidity and availability issues </li></ul></ul><ul><li>Tissue Bank Cadaveric Grafts </li></ul><ul><ul><li>Sterility and tissue quality issues </li></ul></ul><ul><ul><li>Impact of Alloderm </li></ul></ul><ul><li>Components Separation </li></ul><ul><li>Prosthetic Repair </li></ul><ul><li>Healing by Secondary or Tertiary Intention </li></ul>
    69. 69. Components Separation <ul><li>Developed by Dr. Ramirez in the late 80’s </li></ul><ul><li>Employs the use of autologous myofascial tissue to effect abdominal wall closure </li></ul><ul><li>Bilateral relaxation incisions 2cm lateral to the external oblique from costal margin to level of symphasis pubis </li></ul><ul><li>Blunt separation of external oblique layer from underlying internal oblique layer taking care not to interrupt vascular/nerve supply </li></ul><ul><li>May employ undermining of one or both posterior rectus sheaths to achieve further medial advancement </li></ul><ul><li>**Provides dynamic support of the abdominal girdle** </li></ul>
    70. 70. Components Separation
    71. 71. 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
    72. 73. Case Report
    73. 74. Components Separation <ul><li>The Ideal Reconstructive Approach Should: </li></ul><ul><ul><li>Specifically address the nature of the defect </li></ul></ul><ul><ul><li>Restore normal function </li></ul></ul><ul><ul><li>Maintain short- and long-term mechanical integrity (absence of recurrent herniation) </li></ul></ul><ul><ul><li>Have a low incidence of complications </li></ul></ul><ul><ul><li>Be reliable in sub-optimal (hostile) wound environments </li></ul></ul><ul><ul><li>Use autologous tissue </li></ul></ul>
    74. 75. 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.
    75. 76. 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. Need illustration
    76. 77. 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. Need illustration
    77. 78. 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. Need photos
    78. 79. 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. 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 Need graph
    79. 80. 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 Table 2. 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
    80. 81. 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
    81. 82. 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
    82. 83. • 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
    83. 84. 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.
    84. 85. 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: • 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.
    85. 86. 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.
    86. 87. <ul><li>Serious Complications Associated with Negative Pressure Wound Therapy Systems </li></ul><ul><ul><ul><ul><li>Date: November 13, 2009 </li></ul></ul></ul></ul><ul><li>Dear Healthcare Practitioner: </li></ul><ul><li>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. </li></ul>
    87. 88.   Table 1: NPWT is contraindicated for these wound types/conditions:  <ul><li>Necrotic tissue with eschar present </li></ul><ul><li>Untreated osteomyelitis </li></ul><ul><li>Non-enteric and unexplored fistulas </li></ul><ul><li>Malignancy in the wound </li></ul><ul><li>Exposed vasculature </li></ul><ul><li>Exposed nerves </li></ul><ul><li>Exposed anastomotic site </li></ul><ul><li>Exposed organs </li></ul>
    88. 89.   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
    89. 91. Potential Mesh-Related Complications: <ul><li>Infection </li></ul><ul><li>Intestinal adhesions </li></ul><ul><li>Bowel obstructions </li></ul><ul><li>Erosion of the prosthesis into the adjacent hollow viscous </li></ul><ul><li>Contraction of prosthesis </li></ul>
    90. 93. Material Functions for Soft Tissue Repair Synthetics Autografts <ul><li>Good mechanical properties </li></ul><ul><li>Low cost </li></ul><ul><li>High foreign body reaction </li></ul><ul><li>Infection up to 8% 1 </li></ul><ul><li>Can cause pain </li></ul><ul><li>Native Tissue </li></ul><ul><li>Good Mechanical Properties </li></ul><ul><li>Donor Site Morbidity </li></ul><ul><li>Many patients unqualified </li></ul><ul><li>Strong reinforcement </li></ul><ul><li>Biocompatible </li></ul><ul><li>Supports ingrowth </li></ul><ul><li>Ease of handling </li></ul><ul><li>Ability to vascularize </li></ul>Xeno/Allo graft
    91. 94. Tissue-Generated Biomaterials <ul><li>Human acellular dermis </li></ul><ul><li>Alloderm , LifeCell, Branchburg, NJ, USA </li></ul><ul><li>Flex HD , Ethicon, Somerville, NJ, USA </li></ul><ul><li>AlloMax , Davol, Cranston, NJ, USA </li></ul><ul><li>Xenogenic acellular dermis </li></ul><ul><li>Permacol (porcine), Tissue Science Laboratories, Aldershot, Hampshire, Eng. </li></ul><ul><li>SurgiMend (bovine), TEI Biosciences, Boston, MA, USA </li></ul><ul><li>CollaMend (porcine), Davol, Cranston, NJ, USA </li></ul><ul><li>XenMatriX (porcine), Brennen Medical LLC ST. Paul, MN, USA </li></ul><ul><li>Strattice , (porcine) LifeCell, Branchburg, NJ, USA </li></ul><ul><li>Porcine small intestinal submucosa </li></ul><ul><li>Surgisis , Cook Medical, West Lafayette, IN, USA </li></ul><ul><li>FortaGen , Organogenesis, Canton, MA, USA </li></ul>
    92. 95. Processing of Biomaterials <ul><li>Cadaveric, Bovine, Porcine , Equine : removal of all live cells and removal of all nuclear tissue to prevent rejection by the host. </li></ul><ul><li>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). </li></ul><ul><li>Crosslinked products are more resistant to collagenase degradation ( more stable in infected fields where collagenases are secreted by bacteria ). </li></ul><ul><li>Rapid dissolution in the presence of enteric contents ( fistulas ). </li></ul><ul><li>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 . </li></ul>
    93. 96. Cook ® Surgisis <ul><li>Surgisis ® Gold ™ (SIS) </li></ul><ul><li>Porcine intestinal material </li></ul><ul><li>Limited sizes – 7 cm x 10 cm up to 20 cm x 20 cm </li></ul><ul><li>Must be layered for large sizes </li></ul><ul><li>Not crosslinked </li></ul><ul><li>Perforated to allow in-growth </li></ul><ul><li>Reputation for not lasting </li></ul><ul><li>18 month shelf life </li></ul>http://www.cooksurgical.com/
    94. 97. Surgisis Mesh <ul><li>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 </li></ul><ul><li>The lack of permanent foreign material may decrease risk of mesh infection </li></ul>
    95. 98. SIS <ul><li>SIS remodels to a tissue with strength that exceeds that of the native tissue when used as a body wall repair device. </li></ul><ul><li>SIS aortic graphs with S. aureus – </li></ul><ul><li>no evidence of infection after 30 days </li></ul><ul><li>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 </li></ul><ul><li>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 </li></ul><ul><li>SIS was associated with improved graft patency, less infection, complete incorporation, and no false aneurysm formation when compared with PTFE in adult mongrel pigs. </li></ul><ul><ul><ul><li>T. Wright Jernigan et al. Ann Surg 2004;239: 733-740. </li></ul></ul></ul>
    96. 99. Texas Endosurgery Institute Experience with SIS <ul><ul><li>Prospective study of use of Surgisis mesh in potentially or grossly contaminated fields </li></ul></ul><ul><ul><li>Procedures all performed laparoscopically </li></ul></ul><ul><ul><li>116 patients (133 procedures performed) </li></ul></ul><ul><ul><li>Hernias included: </li></ul></ul><ul><ul><ul><li>Incisional 57 </li></ul></ul></ul><ul><ul><ul><li>Umbilical 38 </li></ul></ul></ul><ul><ul><ul><li>Inguinal 29 </li></ul></ul></ul><ul><ul><ul><li>Spigelian 4 </li></ul></ul></ul><ul><ul><ul><li>Femoral 3 </li></ul></ul></ul><ul><ul><ul><li>Parastomal 2 </li></ul></ul></ul><ul><ul><ul><li>> 2 different hernias repaired 13 </li></ul></ul></ul>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
    97. 100. Texas Endosurgery Institute Experience with SIS <ul><ul><li>Infected field 39 </li></ul></ul><ul><ul><li>Potentially contaminated field 94 </li></ul></ul><ul><ul><li>Hernia repairs with concurrent </li></ul></ul><ul><ul><li>contaminated procedure 91 </li></ul></ul><ul><ul><li>Intestinal obstruction 25 </li></ul></ul><ul><ul><li>Strangulated hernias 16 </li></ul></ul><ul><ul><li>Small bowel resections 17 </li></ul></ul><ul><ul><li>Hernia repairs with concurrent </li></ul></ul><ul><ul><li>removal of infected mesh 12 </li></ul></ul>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
    98. 101. Texas Endosurgery Institute Experience with SIS <ul><ul><li>85% 5-year follow-up </li></ul></ul><ul><ul><li>Recurrences 7 (5.26%) </li></ul></ul><ul><ul><li>Seromas (all resolved) 11 (8.2%) </li></ul></ul><ul><ul><li>Mild pain 10 (8%) </li></ul></ul><ul><ul><li>Wound infection 1 (0.75%) </li></ul></ul>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
    99. 102. Texas Endosurgery Institute Experience with SIS <ul><ul><li>6 Second looks performed </li></ul></ul><ul><ul><ul><li>5/6 - mesh totally integrated into tissue </li></ul></ul></ul><ul><ul><ul><li>Corroborated histologically </li></ul></ul></ul><ul><ul><li>SIS mesh in contaminated or potentially contaminated fields is a safe material for hernia repair with minimal recurrence </li></ul></ul>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
    100. 103. Texas Endosurgery Institute Experience with SIS <ul><ul><li>Results: </li></ul></ul><ul><ul><ul><li>Near complete incorporation by surrounding tissues with microscopic confirmation of the abundant ingrowth of collagen material and a solid healing plate </li></ul></ul></ul><ul><ul><ul><li>Tensile strength comparable to the nonabsorbable meshes while retaining the benefits of the absorbable meshes. (  infection and  adhesion) </li></ul></ul></ul>
    101. 104. FortaGen Organogenesis <ul><li>Porcine derived tissue : crosslinked collagen </li></ul><ul><li>Begin to infiltrate with cells by 30 days post-implant </li></ul><ul><li>Are substantially remodeled by 6 months </li></ul><ul><li>Are well-integrated at the suture line (provides a lasting graft-host tissue interface not dependent on permanent sutures) </li></ul><ul><li>Do not elicit a foreign body response </li></ul><ul><li>Are as strong as adjacent host tissue at 360 days </li></ul><ul><li>Do not re-herniate </li></ul>
    102. 105. LifeCell Alloderm <ul><li>AlloDerm ® </li></ul><ul><li>Cadaveric tissue </li></ul><ul><li>Limited sizes </li></ul><ul><li>High cost </li></ul><ul><li>Well established </li></ul><ul><li>Not regulated by FDA as a medical device </li></ul><ul><li>Claims are extreme </li></ul><ul><li>Migration from other surgical areas was natural </li></ul><ul><li>Regenerate is new phrase vs. resorption </li></ul>
    103. 106. 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 <ul><li>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. </li></ul><ul><li>Permacol and Peri-Guard, the mean defect area and thickness were virtually identical to when they were originally installed 6months earlier. </li></ul><ul><li>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). </li></ul><ul><li>Stretching, bulging, and translucency were routine with AlloDerm. </li></ul>
    104. 107. Davol - Allomax <ul><li>Acellular Human </li></ul><ul><li>dermal collagen. </li></ul><ul><li>Can be used in open and </li></ul><ul><li>In Laparoscopy. </li></ul><ul><li>Hydrates rapidly with </li></ul><ul><li>Immersion in saline </li></ul><ul><li>No unpleasant odor. </li></ul><ul><li>Supple with limited </li></ul><ul><li>Elasticity. </li></ul><ul><li>Available in different </li></ul><ul><li>Sizes. </li></ul>
    105. 108. 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.
    106. 109. Permacol <ul><li>Permacol is made from porcine dermis collagen and elastin </li></ul><ul><li>Cells, cell debris, RNA and DNA are removed during a patented manufacturing process a crosslinking step renders the collagen resistant to collagenase </li></ul><ul><li>Crosslinked ( with non-calcifying HDMI ) in its native state, collagen architecture and structure is maintained </li></ul><ul><li>Permacol is not reconstituted. </li></ul><ul><li>Porcine collagen is in its original 3D form. </li></ul><ul><li>It has a bad odor. Must be hydrated in saline. </li></ul>
    107. 110. Permacol Supplied sterile, hydrated & ready-to-use Flexible and strong Flat, continuous collagen sheet Easily cut to desired shape
    108. 111. Patented process used to manufacture Permacol Porcine dermis Extraction of Cells, RNA, DNA Collagen structure maintained Crosslinking for durability Extraction of fat Permacol
    109. 112. Strattice lifecell <ul><li>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. </li></ul><ul><li>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. </li></ul><ul><li>Must be soaked for two minutes at room temperature in Lactated Ringer. </li></ul><ul><li>Use permanent sutures with at least 3 to 5 cm underlay. </li></ul><ul><li>Must be in contact with healthy tissues to permit regeneration. </li></ul>
    110. 113. Davol – CollaMend <ul><li>Regulatory status </li></ul><ul><ul><li>510(k) clearance </li></ul></ul><ul><ul><li>Substantial equivalence using Permacol ® </li></ul></ul><ul><ul><li>as predicate device </li></ul></ul><ul><li>Basic characteristics </li></ul><ul><ul><li>Porcine dermal collagen </li></ul></ul><ul><ul><li>Processed to render it acellular </li></ul></ul><ul><ul><li>Crosslinked using EDC (Carbodiimide) </li></ul></ul><ul><ul><li>Freeze-dried </li></ul></ul><ul><ul><li>Sterile (EtO - Ethylene Oxide) </li></ul></ul><ul><li>Four ventral hernia sizes (up to 20.3cm x 25.4cm) </li></ul><ul><li>Clinical experience </li></ul><ul><ul><li>No published papers to date on clinical or pre-clinical experience </li></ul></ul>
    111. 114. Davol - Xenmatrix <ul><li>Porcine Dermis </li></ul><ul><li>Cellular material is removed without a significant loss in strength. </li></ul><ul><li>It is not cross -linked. </li></ul><ul><li>Open structure supports tissue ingrowth and increased elasticity. </li></ul><ul><li>Maintains significant strength in animal model 2-8 weeks </li></ul><ul><li>Post-implantation in animal model </li></ul><ul><li>Favorable clinical results have been reported with the use </li></ul><ul><li>of Xenmatrix. </li></ul><ul><li>Pomahac et al:Use of non cross linked porcine dermal scaffold in abdominal wall reconstruction Am J Surg 2009 </li></ul>
    112. 115. 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.
    113. 116. 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.
    114. 117. In favor of tissue-generated biomesh : <ul><ul><li>Coverage for exposed viscera (open abdomen) </li></ul></ul><ul><ul><li>May reduce fistula formation </li></ul></ul><ul><ul><li>May promote wound vascularization and contraction </li></ul></ul><ul><ul><li>May be more resistant to infection (use in contaminated fields?) </li></ul></ul>
    115. 118. Against tissue-generated biomesh: <ul><ul><li>Clinical experience in laparoscopy is limited </li></ul></ul><ul><ul><li>High cost </li></ul></ul><ul><ul><li>Long-term tensile strength is unknown </li></ul></ul><ul><ul><li>Poor collagen I/III ratios in the replaced and remodeled fascia </li></ul></ul><ul><ul><li>Recurrence profile is unknown </li></ul></ul><ul><ul><li>Risk of failure in smokers ,diabetics , steroid users ,morbid obese and in heavily infected wounds. </li></ul></ul><ul><ul><li>Peri-operative prep time </li></ul></ul><ul><ul><li>Theoretical potential to transmit viral or prior infection </li></ul></ul><ul><ul><li>Allergy or hypersensitivity </li></ul></ul><ul><ul><li>Unacceptable cosmetic results because of stretching of the elastin fibers </li></ul></ul><ul><ul><li>Religious or ethical prohibitions </li></ul></ul>
    116. 119. <ul><li>Tensile strength </li></ul><ul><li>Pliability </li></ul><ul><li>Ease of manipulation </li></ul><ul><li>Durability </li></ul><ul><li>Degree of tissue in-growth </li></ul><ul><li>Infection rate </li></ul><ul><li>Inflammatory response / adhesion formation </li></ul><ul><li>Seroma formation </li></ul><ul><li>Cost </li></ul><ul><li>The ideal mesh has yet to be developed and the management of complex ventral hernias remains a challenge. </li></ul>Conclusion: are we there yet?
    117. 120. Questions???
    118. 121. Methods of Mesh Fixation <ul><ul><li>Staples </li></ul></ul><ul><ul><li>Tacks </li></ul></ul><ul><ul><li>Laser-assisted tissue welding </li></ul></ul><ul><ul><li>Fibrin sealant (Tisseel) </li></ul></ul><ul><ul><li>Glue </li></ul></ul><ul><ul><li>Salute “Q” ring (Onux Medical , Inc.) </li></ul></ul><ul><ul><li>Mitek anchor </li></ul></ul><ul><ul><li>Sutures </li></ul></ul>
    119. 122. Tacks <ul><li>3.8 mm depth of penetrations (staples 2mm) </li></ul><ul><li>Sheer force resistance 4 times more than staples </li></ul><ul><li>Protruding end in contact with bowel will result in tear and perforation ( Ladurner R. Mussack T. Surg Endosc 2004 April) </li></ul><ul><li>Small bowel obstruction next to a spiral tack (Bower C.E. et al. Surg Endosc 2004 18:672-675 ) </li></ul>
    120. 123. Absorbable Tacks <ul><li>Advantage </li></ul><ul><ul><li>Dissolve in conjunction with mesh incorporation </li></ul></ul><ul><ul><li>Theoretical benefit of decreased pain with tack absorption </li></ul></ul><ul><li>Disadvantage </li></ul><ul><ul><li>Cost </li></ul></ul>
    121. 124. Absorbable Tacks AbsorbaTack (Covidien) Permasorb (Davol / Bard)
    122. 125. Metal Tacks <ul><li>Advantage </li></ul><ul><ul><li>Strength </li></ul></ul><ul><ul><li>Cost </li></ul></ul><ul><li>Disadvantage </li></ul><ul><ul><li>Adhesion formation </li></ul></ul><ul><ul><li>Bowel injury </li></ul></ul><ul><ul><li>Pain </li></ul></ul><ul><ul><li>“ Tack hernia” </li></ul></ul>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
    123. 126. Metal Tacks Salute II (ONUX Medical) Protack (US Surgical) Endo Universal (Covidien)
    124. 127. Metal Tacks <ul><li>Study of anchoring capacity of 3 fixation devices </li></ul><ul><ul><li>Salute, Pro-Tack, Endo Universal </li></ul></ul><ul><li>Fixed pressure applied to device while stapling layers of thin sponge </li></ul><ul><li>Fixation capacity of stapler significantly lower than coil and helix </li></ul><ul><li>Coil and helix had same fixation capacity </li></ul>Takeyuki M, et al. Comparison of anchoring capacity of mesh fixation devices in ventral hernia surgery. 2008 Surg Endosc Accepted for press.
    125. 128. Disadvantages of Metal Tacks <ul><li>Tack Hernia </li></ul><ul><li>Report of two cases of new hernias encountered at the site of Pro-Tack helical tack insertion </li></ul>LeBlanc KA. Tack hernia: A new entity. JSLS 7: 383 -387
    126. 129. Disadvantages of Metal Tacks <ul><li>Adhesion formation </li></ul><ul><li>Comparison of adhesion formation in hernia repair in an animal model using Pro-Tack vs. Salute tacker for mesh fixation </li></ul><ul><li>Density of adhesions was greater with Pro-Tack </li></ul>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
    127. 130. Disadvantages of Metal Tacks <ul><li>Bowel injury </li></ul><ul><li>Bowel erosion with colo-cutaneous fistula formation originating from surgery in proximity of colon </li></ul>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
    128. 131. In Favor of Suturing: <ul><ul><li>Accurate mesh placement </li></ul></ul><ul><ul><li>Recurrence prevention </li></ul></ul><ul><ul><li>Tacks can migrate </li></ul></ul><ul><ul><li>Sutures stronger than tacks (4 mm in length) </li></ul></ul>
    129. 132. Against suturing: <ul><ul><li>Increased OR time </li></ul></ul><ul><ul><li>Abdominal wall bleeding/hematoma </li></ul></ul><ul><ul><li>Suture site pain </li></ul></ul><ul><ul><li>Cosmetic dimpling of skin </li></ul></ul><ul><ul><li>Lengthy learning curve </li></ul></ul>
    130. 133. Mitek Anchor <ul><ul><li>Originally designed to secure soft tissue to bones as described for orthopedic shoulder repair </li></ul></ul><ul><ul><li>It could play a role in repairing hernias near the costal margin </li></ul></ul>
    131. 134. Laser Welding <ul><ul><li>Novel technology using laser-assisted tissue welding to anchor mesh to peritoneum </li></ul></ul><ul><ul><li>Solder fixation of mesh is feasible </li></ul></ul><ul><ul><li>No statistical difference noted between stapled or soldered </li></ul></ul><ul><ul><li>Lanzafame R. et al. Rochester General Hospital Denver 2004 </li></ul></ul><ul><ul><li>Sages </li></ul></ul>
    132. 135. Fibrin Sealant (Tisseel) <ul><ul><li>Biodegradable adhesive formed from the combination of fibrinogen and thrombin leading to the formation of polymerized fibrin chains </li></ul></ul><ul><ul><li>After application, it is broken down by fibrinolysis and replaced by fibrotic layer </li></ul></ul><ul><ul><li>Anti-fibrinolytic agents like aprotinin are added in order to enhance lifespan </li></ul></ul><ul><ul><li>In addition to its hemostatic action, the fibrinogen component gives the product its strengthening and adhesive properties and the thrombin promotes fibroblasts proliferation </li></ul></ul>
    133. 136. 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
    134. 137. Tisseel v. Tacks staples as mesh fixation in TEP: a retrospective analysis. Phillippe AT et al. Centre Hospitalier de Brest, Denver Sages 2004   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 — —
    135. 138. Glue <ul><li>N butyl 2-cyanoacrylate glue for the fixation of polypropylene mesh in laparoscopic hernia repair </li></ul>Jourdan IC, Bailey ME. Surg Laparoscop Endoscop 1998; 8:291-3
    136. 139. “ Q” Ring <ul><ul><li>Incisional and umbilical hernias </li></ul></ul><ul><ul><li>Inguinal hernias </li></ul></ul><ul><ul><li>Vaginal sling </li></ul></ul>
    137. 140. Conclusions: <ul><li>The ideal mesh is one that does not promote infection or adhesions yet provides strength </li></ul><ul><li>The ideal method of of fixation is one that does not increase morbidity </li></ul>
    138. 141. <ul><li>“ If we could artificially produce tissues of </li></ul><ul><li>the density and toughness of fascia, the </li></ul><ul><li>secret of the radical cure of hernia would </li></ul><ul><li>be discovered”. </li></ul><ul><li>Theodore Billroth, 1857 </li></ul>
    139. 142. Conclusions <ul><li>We still have not developed the ideal mesh or fixation </li></ul><ul><li>material </li></ul><ul><li>Problems associate with current meshes: </li></ul><ul><ul><li>Infection </li></ul></ul><ul><ul><li>Recurrence </li></ul></ul><ul><ul><li>Seroma </li></ul></ul><ul><ul><li>Adhesion formation </li></ul></ul><ul><li>Problems associate with current tacks: </li></ul><ul><ul><li>Pain </li></ul></ul><ul><ul><li>Mesh migration </li></ul></ul><ul><ul><li>Poor fixation </li></ul></ul>
    140. 143. Polyester and atelocollagen type 1, polyethylene glycol, glycerol (Parietex) <ul><ul><li>Mean follow up 45 months </li></ul></ul><ul><ul><li>Recurrences 20 (3.04%) </li></ul></ul><ul><ul><li>“ Second look” operation </li></ul></ul><ul><ul><li>for various reasons 70 </li></ul></ul><ul><ul><ul><li>Adhesion free 38 (54.3%) </li></ul></ul></ul><ul><ul><ul><li>Minor adhesions 27 (38.6%) </li></ul></ul></ul><ul><ul><ul><li>Serosal adhesions 5 (7.1%) </li></ul></ul></ul><ul><ul><li>Parietex is associated with low formation of dense adhesions </li></ul></ul>Chelala E. Personal correspondence
    141. 144. Safety <ul><li>Bowel injury: Meta-analysis of 6 RCT showed more bowel injuries in LVHR with a relative risk of almost 2 over OVHR </li></ul><ul><li>Bleeding complications: Less bleeding complications in LVHR in 5 RCT </li></ul><ul><li>Infected mesh requiring removal of mesh: Five times as likely in OVHR than LVHR in 7 RCT </li></ul><ul><li>Erosion and/or fistula formation: Very rare with PTFE and barrier meshes </li></ul>
    142. 145. 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%
    143. 146. Safety <ul><li>Review of 5245 patients entered into NSQIP (between 2005 and 2006) with comparable ASA class, wound class, and age revealed: </li></ul><ul><ul><li>No difference in return to OR within 30 days [2.6% vs. 2.6%] </li></ul></ul><ul><ul><li>Less deep infections in the laparoscopic group [0.5% vs. 1.6% p=0.001] </li></ul></ul>Hwang, CS, Journal of Surgical Research, 3/2009
    144. 147. Durability <ul><li>No significant difference in rate of recurrence at follow up times ranging from 6 months to 41 months in pooled RCTs, </li></ul><ul><li>Lower recurrence rates in nonrandomized controlled studies </li></ul>Forbes, SS, British Journal of Surgery, 3/2009
    145. 148. Forbes, SS, British Journal of Surgery, 3/2009 Randomized Hernia 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%)
    146. 149. Non-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%)
    147. 150. Recurrence Rates Randomized control Trials Non-randomized comparative studies
    148. 151. Efficacy <ul><li>Advantages of LVHR </li></ul><ul><ul><li>Improved visualization of abdominal wall </li></ul></ul><ul><ul><li>Recognizing occult hernias </li></ul></ul><ul><ul><li>Fewer overall complications </li></ul></ul><ul><li>Disadvantages of LVHR </li></ul><ul><ul><li>Mesh placed in abdominal cavity </li></ul></ul><ul><ul><li>Cost </li></ul></ul><ul><ul><li>OR time </li></ul></ul><ul><ul><li>Not Cosmetic </li></ul></ul>Surgery Clinics, 2/2008 Ramshaw….
    149. 152. Efficacy <ul><li>Results in multiple RCTs comparing laparoscopic mesh repair with open mesh repair are equivalent or superior regarding the following complications </li></ul><ul><ul><li>Seroma </li></ul></ul><ul><ul><li>Infection </li></ul></ul><ul><ul><li>Ileus </li></ul></ul><ul><ul><li>Neuralgia </li></ul></ul>
    150. 153. Procedure – entry <ul><li>Hassan </li></ul><ul><li>Veress needle </li></ul><ul><li>LUQ cutdown/veress </li></ul><ul><li>Remote from hernia site </li></ul>
    151. 154. 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%
    152. 155. Efficiency – Cost <ul><li>LVHR more expensive procedure </li></ul><ul><ul><li>$2237 vs $664 in one study of 884 pts </li></ul></ul><ul><li>Length of stay (LOS): significantly shorter in almost all RCTs </li></ul><ul><li>Overall cost for procedure plus hospitalization likely lower </li></ul>Surgery Clinics, 2/2008
    153. 156. Efficiency – OR Time <ul><li>Longer or times non-randomized trials: 149 minutes vs. 89 minutes </li></ul><ul><ul><li>NSQIP data from 2005-2006: 103 minutes vs. 95 minutes 1 </li></ul></ul><ul><li>Overall shorter times in pooled RCTs: 72 minutes vs. 115 minutes 2 </li></ul><ul><li>May be dependent on surgeon’s learning curve </li></ul><ul><li>Hwang, CS, Journal of Surgical Research, 3/2009 </li></ul><ul><li>2. Forbes, SS, British Journal of Surgery, 3/2009 </li></ul>
    154. 157. Quality <ul><li>Earlier return to work </li></ul><ul><li>Less post-operative narcotic requirements </li></ul><ul><li>Foreign body sensation? </li></ul>
    155. 158. Choosing Your Patients <ul><li>Starting out </li></ul><ul><ul><li>Smaller hernias: <10cm transverse separation </li></ul></ul><ul><ul><li>Not morbidly obese </li></ul></ul><ul><ul><li>Fewer abdominal surgeries </li></ul></ul><ul><ul><li>Avoid previous open repair </li></ul></ul>Heniford et al, Am . Surg. 2003
    156. 159. Procedure – Preparation <ul><li>Consider bowel prep </li></ul><ul><li>Pre-operative antibiotic prophylaxis </li></ul><ul><li>Foley catheter </li></ul><ul><li>NGT </li></ul><ul><li>DVT prophylaxis: SCDs, heparin </li></ul>
    157. 160. Procedure – Patient positioning <ul><li>Tuck arms at side </li></ul><ul><li>Secure patient to table </li></ul><ul><li>Consider footboard </li></ul><ul><li>Consider ioban drape </li></ul>
    158. 161. Procedure – fixation <ul><li>Sutures </li></ul><ul><li>Tacks: metal, absorbable </li></ul><ul><li>Staples </li></ul><ul><li>Laser-assisted tissue welding </li></ul><ul><li>Fibrin sealant (Tisseel) </li></ul><ul><li>Glue </li></ul><ul><li>Salute “Q” ring (Onux medical , inc.) </li></ul><ul><li>Mitek anchor </li></ul>
    159. 162. Procedure – LOA, reduce hernia <ul><li>Sharp </li></ul><ul><li>Minimal electrocautery </li></ul>
    160. 163. Procedure – sizing defect/mesh <ul><li>What is the best way to measure the mesh? </li></ul><ul><li>3 options: Intracorporeal with pneumoperitoneum, extracorporeal with pneumoperitoneum, extracorporeal desufflated </li></ul><ul><li>With extracorporeal measurement, the diameter of the outer (skin) circle is larger than the inner (peritoneal) circle. </li></ul><ul><li>This difference is proportional to the size of the patient. </li></ul><ul><li>Result is overestimation of hernia size and mesh by 1.7 to 3.1 cm </li></ul>
    161. 164. Procedure- sizing defect/mesh <ul><li>Covering entire original incision as well as hernia defect may decrease recurrence </li></ul><ul><li>Study LVHR with 8 recurrences all noted to be at original incision site. </li></ul>Wassener et al
    162. 165. Procedure—Choosing a mesh <ul><li>Allows for tension-free restoration of abdominal wall structure </li></ul><ul><li>Goal of the mesh is to become incorporated into surrounding tissue </li></ul><ul><li>Ideal mesh: inert, strong, sterile, not modified by body tissue, inexpensive </li></ul>
    163. 166. Choosing a Mesh <ul><li>Biologic derived graft vs. Synthetic mesh vs. Synthetic + coating (barrier mesh) </li></ul><ul><li>Absorbable vs. Non-absorbable vs. Combined/composite </li></ul><ul><li>Pore size, filament </li></ul><ul><li>Light weight (LW) vs. Heavy weight HW </li></ul><ul><li>Knitted vs. Woven vs. Expanded </li></ul>
    164. 167. Choosing a Mesh <ul><li>Biologic derived graft: </li></ul><ul><li>Synthetic mesh </li></ul><ul><li>Synthetic + coating (barrier mesh) </li></ul>
    165. 168. Choosing a Mesh Porosity Macro >75 microns Micro <10 microns Submicro <1 micron F I lament mono I polypropylene II Gore-Tex IV Multi III some polypropylene, polyester
    166. 169. Procedure – intra-op complication <ul><li>Bowel injury </li></ul><ul><ul><li>Contamination  repair injury and delay hernia repair </li></ul></ul><ul><ul><li>No spillage  repair hernia </li></ul></ul><ul><ul><li>Delayed bowel injury  remove mesh and delay repair </li></ul></ul><ul><li>Bladder injury  repair hernia </li></ul>Ramshaw et al..
    167. 170. Competitive Literature PubMed Update 1,2 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 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
    168. 171. Way the Biological Hernia World Will be <ul><li>Allograft </li></ul><ul><ul><li>Lifecell (Alloderm) </li></ul></ul><ul><ul><li>Musculoskeletal Transplant Foundation (MTF) (FlexHD) </li></ul></ul><ul><ul><li>Davol (AlloMax) </li></ul></ul><ul><li>Xenograft </li></ul><ul><ul><li>Cook (Surgisis) </li></ul></ul><ul><ul><li>TissueScience (Permacol) </li></ul></ul><ul><ul><li>TEI (Surgimend) </li></ul></ul><ul><ul><li>Brennen (Xenmatrix) </li></ul></ul><ul><ul><li>CryoLife (ProPatch) </li></ul></ul><ul><ul><li>Davol (CollaMend) </li></ul></ul><ul><ul><li>Lifecell (Strattice) </li></ul></ul>
    169. 172. Types of prosthetics for hernia repair: <ul><ul><li>Type 1: totally macroporous prosthesis, pores > 75 microns; example prolene, marlex </li></ul></ul><ul><ul><li>Type 2: totally microporous prosthesis; pores < 10 microns; example gortex or dual mesh </li></ul></ul><ul><ul><li>Type 3: macroporous prosthesis with microporous components; example Teflon, mersilene </li></ul></ul><ul><ul><li>Type 4: biomaterials with submicronic pore size; example cilastic, cell gard </li></ul></ul>
    170. 173. Polypropylene Biomaterials <ul><li>Angimesh , Angiologics, S. Martino Sicc., Italy </li></ul><ul><li>Biomesh P1 , Cousin Biotech, Wervicq-Sud, France </li></ul><ul><li>Biomesh P3 , Cousin Biotech, Wervicq-Sud, France </li></ul><ul><li>Biomesh 3D , Cousin Biotech, Wervicq-Sud, France </li></ul><ul><li>C-QUR (polypropylene / omega 3 fatty acid coating), Atrium, NH, USA </li></ul><ul><li>DynaMesh (polypropelene incorporated with polyvinylidene difluoride) FEG, Aachen, Germany </li></ul><ul><li>Hetra 1, 2, HerniaMesh, S.R.L., Torino, Italy </li></ul><ul><li>Hermesh 3,4,5, HerniaMesh, S.R.L., Torino, Italy </li></ul><ul><li>Intramesh NKI, NK2, NK8, Cousin Biotech, Wervicq-Sud, France </li></ul><ul><li>Marlex, C.R.Bard, Inc., Cranston NJ, USA </li></ul>
    171. 174. Polypropylene Biomaterials <ul><li>Parietene, Sofradim International, Villfranche-sur-Saone, France </li></ul><ul><li>Proceed (polypropelene / polydiaxanone / oxidized regenerated cellulose), Ethicon, Somerville, NJ, USA </li></ul><ul><li>Prolene , Ethicon, Somerville, NJ, USA </li></ul><ul><li>Prolene Soft Mesh , Ethicon, Somerville, NJ, USA </li></ul><ul><li>Prolite , Atrium Medical Corporation, Hudson, NH, USA </li></ul><ul><li>Prolite Ultra , Atrium Medical Corporation, Hudson, NH, USA </li></ul><ul><li>Surgipro (Monofilament), United States Surgical Corp,/Tyco, Norwalk, CT, USA </li></ul><ul><li>Sepramesh ( polypropylene mesh coated with Seprafilm - modified sodium hyaluronate and carboxymethylcellulose) Genzyme, MA, USA </li></ul><ul><li>Surgipro (Multifilament), United States Surgical Corp./Tyco, Norwalk, CT, USA </li></ul><ul><li>TiMesh (titanium-coated polypropylene) Medizintechnik GmbH, Nuremberg, Germany </li></ul><ul><li>Trelex, Meadox Medical Corporation, Oakland, NJ, USA </li></ul><ul><li>Ultrapro (Poliglecaprone-25 / Polypropylene) , Ethicon, Somerville, NJ, USA </li></ul>
    172. 175. Polypropylene Mesh <ul><ul><li>Schmitt and Griman in 1967 first described successful use of polypropylene mesh in contaminated wounds </li></ul></ul><ul><ul><li>Subsequent reports showed good initial healing but were fraught with long term complications </li></ul></ul><ul><ul><li>Those complications are chronic infection, fistula formation, erosion into bowels or through skin grafts </li></ul></ul><ul><ul><li>Jones and Jurkoyiun in 1989 reviewed 14 studies, 128 patients, and found 55 overall complication rate - enteric fistulization being the most common. </li></ul></ul>
    173. 176. In Favor of Polypropylene Mesh: <ul><ul><li>Extensive fibroblast ingrowth </li></ul></ul><ul><ul><li>Complete host tissue incorporation </li></ul></ul><ul><ul><li>Cheaper than PTFE </li></ul></ul>
    174. 177. In Favor of Polypropylene Mesh: <ul><ul><li>Can be used in contaminated fields </li></ul></ul><ul><ul><li>Chowbey PK et al. Lap ventral hernia repair J La Adv Surg </li></ul></ul><ul><ul><li>Tech 2000; 10:79-84 </li></ul></ul><ul><ul><li>Bingener J et al. Adhesion formation after laparoscopic ventral </li></ul></ul><ul><ul><li>incisional hernia repair with polypropylene mesh: a study using </li></ul></ul><ul><ul><li>abdominal ultrasound, JSLS (2004)8:127-131 </li></ul></ul>
    175. 178. In Favor of Polypropylene Mesh: <ul><li>Can be used in contaminated fields </li></ul><ul><li>Franklin ME et al. Lap ventral and incisional hernial repair. Surg Lap End 8(4):294-299 1998 </li></ul><ul><li>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 </li></ul>
    176. 179. Against polypropylene mesh: <ul><ul><li>It is extremely difficult to lyse adhesions to polypropylene without causing enterotomies* </li></ul></ul><ul><ul><li>Major complications with polypropylene not evident until years later </li></ul></ul><ul><ul><li>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 </li></ul></ul><ul><ul><ul><li>*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 </li></ul></ul></ul>
    177. 180. Against polypropylene mesh: <ul><ul><li>Dual mesh allows fibroblastic penetration and subsequent collagen deposition </li></ul></ul>Leblanc KA et al. Tissue attachment strength of prosthetic meshes used in ventral and incisional hernia repair. Surg Endo 2002; 16(11):1542-1546
    178. 181. ePTFE Biomaterials <ul><li>DualMesh, W.L. Gore and Associates, Flagstaff, AZ, USA </li></ul><ul><li>DualMesh Emerge, W.L. Gore and Associates, Flagstaff, AZ, USA </li></ul><ul><li>DualMesh Plus , W.L. Gore and Associates, Flagstaff, AZ, USA </li></ul><ul><li>DaulMesh Plus Emerge , W.L. Gore and Associates, Flagstaff, AZ, USA </li></ul><ul><li>DualMesh with Holes , W.L. Gore and Associates, Flagstaff, AZ, USA </li></ul><ul><li>DualMesh Plus with Holes , W.L. Gore and Associates, Flagstaff, AZ, USA </li></ul><ul><li>Dulex , C.R. Bard, Inc., Cranston NJ, USA </li></ul><ul><li>Mycromesh , W.L. Gore and Associates, Flagstaff, AZ, USA </li></ul><ul><li>Mycromesh Plus , W.L. Gore and Associates, Flagstaff, AZ, USA </li></ul><ul><li>Reconix , C.R. Bard, Inc., Cranston NJ, USA </li></ul><ul><li>Soft Tissue Patch , W.L. Gore and Associates, Flagstaff, AZ, USA </li></ul>
    179. 182. In Favor of ePTFE <ul><li>Microporous, smooth texture minimizes tissue in-growth and limits adhesion formation and bowel injury </li></ul><ul><li>Combined with a large pore second layer it can adhere well to the abdominal wall </li></ul>
    180. 183. Against ePTFE <ul><li>Microporous construction limits ability of macrophages to destroy bacteria </li></ul><ul><li>Mesh infection is not well treated by antibiotics and requires mesh removal </li></ul><ul><li>Does not integrate well into host tissue when not combined with a large pore mesh </li></ul>
    181. 184. <ul><li>Laparoscopic ventral hernia repair with PTFE compared to open repair prefascial repair with polypropylene is associated with: </li></ul><ul><ul><li>Less pain </li></ul></ul><ul><ul><li>Shorter hospital stay </li></ul></ul><ul><ul><li>Lower total cost </li></ul></ul><ul><li>Complication rates were equivalent </li></ul><ul><li>Despite two reoperations in the PTFE group, overall costs remained lower </li></ul>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
    182. 185. <ul><li>Laparoscopic hernia repair with PTFE has low recurrence but may be associated with significant complications and morbidity </li></ul><ul><li>This technique requires meticulous technique and advanced laparoscopic skills </li></ul>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
    183. 186. Polyglactene Mesh (vicryl mesh) <ul><ul><li>Alternative to nonabsorbable meshes </li></ul></ul><ul><ul><li>Advantage host invasion and subsequent absorption of implant </li></ul></ul><ul><ul><li>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) </li></ul></ul>
    184. 187. Polyester mesh <ul><li>Parietex (polyester and atelocollagen type 1, polyethylene glycol, glycerol) Covidien, Hamilton, Bermuda </li></ul><ul><li>Polyester mesh incorporates well into the abdominal wall </li></ul><ul><li>Collagen covering on the visceral surface protects bowel and dissolves as the polyester is incorporated </li></ul>
    185. 188. Polyester and atelocollagen type 1, polyethylene glycol, glycerol (Parietex) <ul><li>Comparison of Parietex with Sepramesh for ventral hernia repair </li></ul><ul><li>in rabbit model </li></ul><ul><li>Results at 5 months Parietx Sepramesh </li></ul><ul><ul><li>Strength </li></ul></ul><ul><ul><li>of incorporation 70.9N 31.5N </li></ul></ul><ul><ul><li>Bowel adhesions 0 4 </li></ul></ul><ul><ul><li>Adhesion area 321 mm 2 840 mm 2 </li></ul></ul><ul><ul><li>Shrinkage 17.4% 6.1% </li></ul></ul><ul><ul><li>Parietex has stronger incorporation and is better at prevention of </li></ul></ul><ul><ul><li>adhesiona than sepra mesh, however it undergoes considerably more </li></ul></ul><ul><ul><li>shrinkage </li></ul></ul>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
    186. 189. Polyester and atelocollagen type 1, polyethylene glycol, glycerol (Parietex) <ul><ul><ul><li>Retrospective study of the use of Parietex in laparoscopic ventral hernia repair </li></ul></ul></ul><ul><ul><ul><li>n = 20 patients </li></ul></ul></ul><ul><ul><ul><li>Mean follow up - 10 months </li></ul></ul></ul><ul><ul><ul><li>No morbidity or mortality </li></ul></ul></ul><ul><ul><ul><li>No infections, rejections, fistulas, recurrences, or alterations in bowel function </li></ul></ul></ul><ul><ul><ul><li>Parietex is safe for intra-abdominal use </li></ul></ul></ul><ul><ul><li>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 </li></ul></ul>
    187. 190. Polyester and atelocollagen type 1, polyethylene glycol, glycerol (Parietex) <ul><ul><li>Experience with 656 laparoscopic ventral hernia repairs with Parietex </li></ul></ul><ul><ul><li>Hernia defect closed with sutures to reduce seroma and restore abdominal wall function </li></ul></ul><ul><ul><li>Laparoscopic mesh repair performed with Parietex mesh </li></ul></ul>Chelala E. (2008) Personal correspondence
    188. 191. <ul><li>Repair of abdominal wound defects remains a challenge to the general surgeon. </li></ul><ul><li>Suture repair of ventral hernia is associated with low infection rate but carries a risk of recurrence of 43% </li></ul><ul><li>The rate increases to 58% with repair of recurrent hernia. </li></ul>Luijendijk RW, et al. A Comparison of Suture Repair with Mesh Repair for Incisional Hernia .NEJM 2000; 343:392-398
    189. 192. Against polypropylene mesh: <ul><ul><li>Dual mesh allows fibroblastic penetration and subsequent collagen deposition </li></ul></ul>Leblanc KA et al. Tissue attachment strength of prosthetic meshes used in ventral and incisional hernia repair. Surg Endo 2002; 16(11):1542-1546
    190. 193. <ul><li>The use of mesh drastically reduces recurrence but is associated with a risk of infection of about 9% </li></ul><ul><li>The laparoscopic approach to mesh placement reduces the infection rate to as low as 0.7% </li></ul>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
    191. 194. In Favor of Polypropylene Mesh: <ul><li>Can be used in contaminated fields </li></ul><ul><li>Franklin ME et al. Lap ventral and incisional hernial repair. Surg Lap End 8(4):294-299 1998 </li></ul><ul><li>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 </li></ul>
    192. 195. <ul><li>Laparoscopic ventral hernia repair with PTFE compared to open repair prefascial repair with polypropylene is associated with: </li></ul><ul><ul><li>Less pain </li></ul></ul><ul><ul><li>Shorter hospital stay </li></ul></ul><ul><ul><li>Lower total cost </li></ul></ul><ul><li>Complication rates were equivalent </li></ul><ul><li>Despite two reoperations in the PTFE group, overall costs remained lower </li></ul>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
    193. 196. <ul><li>Laparoscopic hernia repair with PTFE has low recurrence but may be associated with significant complications and morbidity </li></ul><ul><li>This technique requires meticulous technique and advanced laparoscopic skills </li></ul>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
    194. 197. Biologic Competition <ul><li>The number of competitors offering biologic implant grafts has increased dramatically over the past few years </li></ul><ul><li>In 2004, there were three key biologic products, currently there are approximately 14 products produced by 13 companies....more to come…. </li></ul><ul><li>J&J/Ethicon will sell FlexHD TM (MTF) to the hernia repair market – others? </li></ul><ul><li>On July 2, 2007, Mentor launched NeoForm TM (Tutogen) for breast reconstruction, will they cross over into the abdomen for tram flap reinforcement? </li></ul><ul><li>LifeCell – non-crosslinked porcine graft Strattice TM in early 2008 </li></ul>
    195. 198. Cook Surgisis - How Do We Compete? <ul><li>Focus on crosslinked stability and durability of Permacol </li></ul><ul><li>Question the need for perforations – do they weaken the product? </li></ul><ul><li>Put Permacol in the surgeon’s hand and ask for comparison with Surgisis </li></ul><ul><li>Does surgeon recall past Surgisis cases – what was his/her experience? </li></ul>
    196. 199. Cook Surgisis <ul><li>Strengths </li></ul><ul><ul><li>Market name and reach of sales force </li></ul></ul><ul><ul><li>Broad line, low prices </li></ul></ul><ul><ul><li>Porcine model versus cadaveric </li></ul></ul><ul><li>Weaknesses </li></ul><ul><ul><li>Complicated manufacturing process </li></ul></ul><ul><ul><li>Not crosslinked so not as stable or strong as Permacol </li></ul></ul>
    197. 200. Texas Endosurgery Institute Experience with SIS <ul><ul><li>72 patients: 29 male, 43 female </li></ul></ul><ul><ul><li>Incisional hernia - 41 </li></ul></ul><ul><ul><li>(1 post-op wound infection) </li></ul></ul><ul><ul><li>Colovesical fistula - 1 </li></ul></ul><ul><ul><li>Paraoesaphageal hernia - 15 </li></ul></ul><ul><ul><li>Inguinal hernia - 14 </li></ul></ul><ul><ul><li>Spigelian hernia - 1 </li></ul></ul>
    198. 201. What about AlloDerm Issues? <ul><li>New AlloDerm instructions recommend “significant tension” – with a “tension free” repair technique…… </li></ul><ul><ul><li>Trying to minimize issues of laxity </li></ul></ul><ul><li>Recent studies with longer follow-up times are showing that AlloDerm presents significant problems (TSL 310) </li></ul><ul><ul><li>Jin, et al; “bridging repairs”, recurrence rates high at 60%, “not worth the high cost” - average $7,901 per patient </li></ul></ul><ul><ul><li>“ Use only to reinforce primary fascial closure” – but still have recurrence rate of 21% </li></ul></ul>
    199. 202. AlloDerm - How Do We Compete? <ul><li>Size matters! </li></ul><ul><ul><li>Permacol takes less time intraoperatively - no sewing on large repairs </li></ul></ul><ul><li>No waiting for rehydration, a problem especially if the surgeon underestimates required coverage size </li></ul><ul><ul><li>No need to estimate “expansion” during surgery </li></ul></ul><ul><li>Permacol meets the needs for complicated cases </li></ul><ul><li>Permacol is manufactured and marketed under strict FDA regulations </li></ul><ul><li>Permacol has all of the advantages of a biologic with the added strength of crosslinking </li></ul><ul><li>Lower cost per case </li></ul>
    200. 203. Description of Product <ul><li>Permacol is a sterile off-white, hydrated, tough but flexible flat sheet of </li></ul><ul><li>acellular, crosslinked, porcine dermal collagen and its constituent elastin </li></ul><ul><li>fibers. </li></ul><ul><li>Crosslinked with non-calcifying HDMI </li></ul><ul><li>Porcine collagen in its original 3-D form. </li></ul><ul><li>Permacol is a surgical implant and a medical device. </li></ul><ul><li>Permacol is indicated for use as a soft tissue patch to reinforce soft </li></ul><ul><li>tissue where weakness exists and for the surgical repair of damaged or </li></ul><ul><li>ruptured soft tissue membranes. </li></ul><ul><li>FDA 510(k) concurrence for permanent implantation into human tissue </li></ul><ul><li>for specific indications. </li></ul>
    201. 204. Permacol Advantages <ul><li>Versus AlloDerm </li></ul><ul><li>Crosslinking for dimensional stability, resistance to collagenase and long-term results </li></ul><ul><li>Ease of use, handling and cost effective in the OR </li></ul><ul><li>Pricing </li></ul><ul><li>Sizes </li></ul><ul><li>Versus CollaMend </li></ul><ul><li>Track Record – clinicals and experience </li></ul><ul><li>Sizes, better product shape and handling </li></ul><ul><li>Well trained and knowledgeable sales force </li></ul><ul><li>Versus Surgisis and all the others </li></ul><ul><li>Crosslinking, resistance to collagenase and long-term results </li></ul><ul><li>Ease of use, handling and cost effective in the OR </li></ul><ul><li>Sizes </li></ul>

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