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Laparoscopic Ventral Hernia Repair: Mesh Options and Outcomes
Laparoscopic Ventral Hernia Repair: Mesh Options and Outcomes Jayme B. Stokes, MD, and Charles M. Friel, MD Laparoscopic ventral hernia repair (LVHR) offers a minimally invasive option for the repair of congenital or incisional abdominal wall hernias. A key component of LVHR is the placement of a prosthetic or biological mesh intraperitoneally to cover the defect without reapproximating the fascial edges with a primary suture repair. The optimum mesh provides high tensile strength, reducing the risk of recurrence, stimulates host tissue ingrowth without promoting adhesion or fistula formation, resists secondary infection and seroma formation, and is affordable. Numerous mesh materials are available on the market, each with specific advantages and disadvantages. However, no single mesh possesses all the qualities of the ideal mesh and relatively few studies have been performed comparing meshes of different materials and design. Currently, the choice of mesh continues to be driven by surgeon preference and individual clinical situation. Here, we review the properties and outcomes of mesh materials currently available for use in LVHR. Semin Colon Rectal Surg 20:118-124 © 2009 Elsevier Inc. All rights reserved.
V
entral hernias are a significant cause of morbidity following laparotomy occurring in approximately 2%-20% of patients,1-5 with an estimated 90,000 repairs performed annually in the USA.6 Classically, hernias have been repaired primarily via an open approach. Unfortunately, this method requires an additional laparotomy with possible component separation and often yields poor outcomes with 25%-53% of patients developing a recurrence.4,7 Such poor outcomes result in negative major social and economic consequences. Surgical treatment of ventral hernias has changed drastically over the past few decades following the development of minimally invasive laparoscopic techniques and prosthetic meshes for reinforcement of the abdominal wall. Laparoscopic ventral hernia repair (LVHR) appears to be superior to conventional open repair. Laparoscopy allows for minimal abdominal wall incisions, avoids extensive flap dissections, and obviates the need for drains near to the prosthetic repair. The benefits of these modifications in technique are realized in decreased pain, length of stay and recovery time, surgical site infections, blood loss, and improved cosmesis.8-13 The introduction of prosthetic, and more recently biological, meshes have ushered in the era of “tension-free” hernia repair. Many meshes are available for use in hernia repair with
Department of Surgery, University of Virginia Health System, Charlottesville, VA. Address reprint requests to Charles M. Friel, MD, Department of Surgery, University of Virginia Health System, 1215 Lee Street, Charlottesville, VA 22908. E-mail: [email protected]
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1043-1489/09/$-see front matter © 2009 Elsevier Inc. All rights reserved. doi:10.1053/j.scrs.2009.06.003
introductions of new mesh designs driven largely by industry occurring at a rapid rate. In LVHR, the prosthetic mesh is placed intraperitoneally and overlaps the defect by 3-5 cm. This method obviates the need for extensive tissue dissection and exposure, and the accompanying complications. Optimal mesh selection for hernia repair requires an in-depth knowledge of the advantages and disadvantages associated with the different meshes currently available. Current data regarding clinical outcomes of mesh material remain limited due in large part to the relatively infrequent major complications related to the use of mesh.14 This report presents a summary of currently available meshes for use in LVHR and a review of the literature regarding their use and safety profile.
Types of Mesh Available Since the introduction of prosthetic materials for use in the repair of hernias, surgeons have sought to identify the ideal mesh.15,16 Although no single product satisfies all the criteria of the optimal mesh, most authors agree on several characteristics.17,18 The ideal mesh should resist adhesion formation and bowel erosion, promote tissue ingrowth and incorporation while not altering abdominal wall compliance, and be hypoallergenic. Additionally, the mesh should be resistant to infection, shrinkage, seroma formation; cause minimal pain; and be noncarcinogenic. Table 1 summarizes the basic characteristics of the types of mesh available currently. More than 70 meshes for use in hernia repair are available on the market in a wide array of materials and designs.
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Table 1 Characteristics of Available Mesh Materials
Tissue in-growth Strength Bowel adhesion Infection susceptibility Abdominal wall compliance Use in contaminated field Cost
PP
PE
PTFE
Composite
Biomaterial
ⴙⴙⴙ ⴙⴙⴙ ⴙⴙⴙⴙ ⴙⴙ 0 ⴙⴙ ⴙ
ⴙⴙⴙ ⴙ ⴙⴙⴙ ⴙⴙ ⴙⴙ 0 ⴙ
ⴙ ⴙⴙ ⴙ ⴙⴙⴙⴙ ⴙⴙⴙ 0 ⴙⴙ
ⴙⴙⴙ ⴙⴙ ⴙ ⴙⴙⴙ ⴙⴙ 0 ⴙⴙⴙ
ⴙⴙ ⴙⴙ ⴙ ⴙ ⴙⴙⴙ ⴙⴙⴙ ⴙⴙⴙⴙ
Meshes typically are classified by material into 1 of the 2 following categories: (1) polymeric prosthetic meshes and (2) meshes made from specially prepared human or animal connective tissue.19 Polymeric prosthetic meshes consist of biocompatible materials made from polyester (PE), polypropylene (PP), expanded polytetrafluoroethylene (ePTFE), or laminated combinations of these polymers. Meshes for intraperitoneal use are typically engineered such that the visceral surface of the mesh has a smooth texture or is coated with a protective layer to resist adhesion formation, bowel erosion, and potential fistula formation (Table 2). The parietal side contains pores of various depths depending on the mesh to allow for tissue in-growth and incorporation into the abdominal wall. Monofilament meshes possess high tensile strength and bacterial resistance while multifilament meshes remain pliable and more readily conform to the abdominal wall.
Polypropylene PP has emerged as the gold standard to which all other mesh materials are compared secondary to its superior tensile strength.20 Pure PP meshes (Prolene [Ethicon, Inc, Somerville, NJ], Marlex [C.R. Bard, Inc, Murray Hill, NJ], Parietene, Visilex [C.R. Bard, Inc]) are manufactured by weaving filaments of PP polymers that have a tensile strength similar to that of steel, making them an excellent choice for reinforcement of abdominal fascia.14 The rigid strength properties inherent in PP mesh, however, limit its ability to conform to the abdominal wall and ease of use in laparoscopy where manipulation is required. Uncoated PP meshes incite a substantial host inflammatory reaction resulting in significant scar formation and increased risk of adhesion formation. Such an intense inflammatory response has led many authors to recommend against its use intraperitoneally and therefore is a poor choice for LVHR.17 Also, the inflammatory response and scar formation causes a 30%-50% reduction in size of PP meshes, necessitating a generous overlap of the fascial edges to accommodate the shrinkage in mesh diameter and prevent hernia recurrence.21,22 A significant advantage of PP mesh when used for other types of hernia repair is the ability to treat infections involving the mesh without removal of the mesh. Additionally, PP meshes are among the least expensive of available mesh materials.
Polyester PE meshes are made from a multifilament weave of nonabsorbable polyethylene terephthalate fibers. Unlike PP meshes,
PE meshes experience a significant reduction in tensile strength overtime, with reports of 31% and 25% strength remaining at 10 and 25 years, respectively.20 Such a reduction in strength over time raises concerns about the overall long-term integrity of the repair and the risk of recurrence. The multifilament weave of PE provides greater flexibility of the mesh and enhances its conformity to the abdominal wall, a significant advantage over the more rigid monofilament PP meshes. This weave engineering does place PE meshes at a greater risk of infection, however. Like multifilament woven suture, bacteria and contaminated fluids become trapped in the weave, allowing them to establish a niche that is relatively impenetrable by leukocytes.19 Like PP meshes, PE meshes are also a relatively inexpensive material for use in hernia repair.
Polytetrafluoroethylene Mesh In response to the lack of a mesh that could be placed intraperitoneally and the inadequacy of interposing omentum between the mesh and bowel, newer materials for mesh have been developed that are conducive for use in LVHR and suitable for intestinal contact. These newer materials include the synthetic, nonabsorbable ePTFE meshes, such as DualMesh (W.L. Gore & Associates, Inc, Flagstaff, AZ), DualMesh Plus (W.L. Gore & Associates, Inc, Flagstaff, AZ), MycroMesh (W.L. Gore & Associates, Inc, Flagstaff, AZ), Dulex (C.R. Bard, Inc, Murray Hill, NJ), and Reconix (C.R. Bard, Inc, Murray Hill, NJ). Compared to PP and PE meshes, ePTFE meshes have a smaller pore size that resists their incorporation into host tissues, thereby limiting the formation of intestinal adhesions.14,17,23 This smaller pore size also limits the incorporation of the mesh into the abdominal wall. Instead, ePTFE meshes become encapsulated by the host tissue, which results in a weaker overall strength of the hernia repair compared to other meshes.24-27 Additionally, encapsulation of the mesh prevents treatment of infections involving the mesh and requires that infected ePTFE be removed.28 To address the tissue ingrowth while retaining the adhesion resistant properties of the early ePTFE meshes, a new line of ePTFE meshes, such as MycroMesh and DualMesh, have been developed. These second-generation ePTFE meshes have been engineered with pores that traverse the entire thickness of the mesh, while DualMesh also has an irregular, abrasive surface on the parietal side while maintaining its adhesion-resistant properties on the visceral surfaces.19 An even newer line of ePTFE products includes MotifMesh (Proxy Biomedical Ltd, Ireland, United Kingdom), which integrates macropores
J. B. Stokes and C. M. Friel
120 Table 2 Meshes Available for Ventral Hernia Repair Product
Manufacturer
Composition
DualMesh DualMesh Plus
W.L. Gore W.L. Gore
MycroMesh MotifMESH Dulex Reconix Prolene Visilex Marlex Composix Composix E/X Composix Kugel SepraMesh
W.L. Gore Proxy Biomedical C.R. Bard C.R. Bard Ethicon C.R. Bard C.R. Bard C.R. Bard C.R. Bard
Dual-sided ePTFE Dual-sided ePTFE, antibiotic impregnated Dual-sided ePTFE cPTFE Dual-sided ePTFE Dual-sided ePTFE Polypropylene Polypropylene Polypropylene Polypropylene, ePTFE Polypropylene, ePTFE
C.R. Bard
Polypropylene, ePTFE
Genzyme
Polypropylene, HA/CMC laminate Glucamesh Brennen Medical Polypropylene, -glucan laminate Proceed Ethicon Polypropylene, oxidized regenerated cellulose Parietene Sofradim Polypropylene, Composite collagen laminate Dynamesh FEG Textiltechnik Polypropylene, polyvinylidene fluoride TiMesh GfE Medizintechnik Polypropylene, titanium GmbH coated C-QUR Atrium Medical Polypropylene, omegaCorporation 3 fatty acid coated Vypro II Johnson & Polypropylene, Johnson polyglactin coated Mersilene Ethicon Polyester Parietex Sofradim Polyester, collagen Composite type I laminate Intramesh Cousin Biotech Polyester, silicone W3 layer Glucatex Brennen Medical Polyester, -glucan laminate Surgisis Cook Porcine intestinal submucosa Tutomesh Tutogen Medical Bovine pericardium GmbH AlloDerm LifeCell Human acellular dermal matrix ePTFE, expanded polytetrafluoroethylene; cPTFE, condensed polytetrafluoroethylene; HA/CMC, hyaluronate/carboxymethylcellulose.
into a nonwoven polytetrafluoroethylene (PTFE) material to promote host tissue ingrowth while retaining the anti-adhesion characteristics of the PTFE. Unfortunately, the significant amount of engineering involved in the development of these materials make them significantly more expensive than either PP or PE meshes. Surgeons using tacking devices to affix these double-layered materials should take care to insure that an ap-
propriate tack with a long enough purchase is used to completely traverse the mesh and embed into the peritoneum.
Composite In response to the increasing use of laparoscopy for ventral hernia repairs and the inherent shortcomings of single-material meshes, manufacturers have designed newer “combination” materials for use in mesh design. These laminate meshes have been developed to achieve the goal of promoting abdominal wall ingrowth and thereby a strong repair, while limiting bowel erosion and adhesion formation. Composix mesh combines a PP parietal surface stitched with a thin layer of ePTFE facing the visceral surfaces. Other PPbased composite meshes include SepraMesh (Genzyme, Cambridge, MA), Proceed (Ethicon, Inc, Somerville, NJ), Glucamesh (Brennen Medical, LLC, St Paul, MN), and Parietene Composite (Sofradim, Trévoux, France). These laminates all use a PP mesh visceral layer whose parietal surface is coated with a layer of cellulose, collagen, or other absorbable material to prevent adhesion formation. Other PP-based composite meshes, such as TiMesh (GfE Medizintechnik GmbH, Nuremberg, Germany), use a titanium or other inert, nonabsorbable coating to prevent adhesion formation and allow for intraperitoneal placement. Other composite meshes, such as Parietex Composite (Sofradim, Trévoux, France), Intramesh W3 (Cousin Biotech, France), and Glucatex (Brennen Medical, LLC, St Paul, MN), use PE backbones for parietal surface tissue ingrowth with an absorbable coating (oxidized atelocollagen type I, polyethylene glycol, and glycerol) facing the intestinal surfaces. The effectiveness of these meshes at preventing adhesion formation remains unclear. While studies examining adhesion formation in animals have shown a reduction in adhesions following composite mesh implantation secondary to peritonealization of the mesh, other reports have demonstrated fewer adhesions with uncoated ePTFE mesh.29,30 Because of the 2-sided nature of composite meshes, due diligence is required in the operating room to insure proper orientation and avoid placement of PP or PE against the intestinal surfaces. Secondary to their PTFE component or other specialized visceral surface coating, composite meshes are comparable in expense to PTFE meshes.
Biological Mesh Biological meshes represent the newest materials developed for hernia repair. These meshes are derived from humans or other large animals and are made of decellularized living tissue composed of a collagen matrix. Two xenogeneic materials, made from modified porcine small intestine submucosa (Surgisis Cook Medical, Inc, Bloomington, IN) and acellular porcine dermal collagen, promote minimal adhesion formation and have been used successfully in LVHR.31,32 Biological meshes provide a scaffold for tissue ingrowth and remodeling, host collagen deposition and neovascularization, making them an excellent choice for abdominal wall conformation.33 Unlike the synthetic polymer meshes, biological meshes are significantly more susceptible to degradation by the host re-
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sulting in a decreased tensile strength over time. Xenogeneic tissues also carry the potential risk of disease transmission and immunologic rejection. Although a review of adverse events reported to the Food and Drug Administration (FDA) did not reveal any disease transmission following implantation, biomaterials did cause a significantly higher number of foreign body reactions than any other mesh material used.14 Because of its human derivation, AlloDerm (LifeCell Corp, Branchburg, NJ), an allogenic acellular dermal matrix, may reduce this risk of rejection.34 The improved incorporation of biological mesh into the host tissues over synthetic materials confers an increased ability to resist infections, allowing their use in contaminated fields. A downside to biological materials is their extraordinary cost, making them the most expensive materials available for hernia repair currently on the market.
seeding the mesh. The introduction of biological and absorbable meshes has provided a potential solution to this clinical dilemma. A recent case-control study comparing an acellular porcine dermal collagen matrix mesh to PP/PTFE composite mesh demonstrated no infections in the biological mesh, while 3 composite meshes required removal.31 In a series of 58 LVHR implantation of Surgisis into a contaminated field during ventral hernia repair yielded no mesh-related complications,32 while similar results have been reported with AlloDerm in the management of contaminated abdominal hernias.34 A laparoscopic approach appears to convey a protective advantage over open repair in regards to infection complications following hernia repair with mesh. Although no clinical data comparing infection resistance are available, the use of biomaterial meshes in high risk or contaminated settings appears beneficial.
Outcomes
Recurrence
Infection
Recurrence rates following ventral hernia repair range between 1% and 17%.6,8,10,32,35,38-51,54-60 Many factors, such as body habitus, comorbidities, size and number of hernia defects, steroid use, method of mesh fixation, and surgeon experience, can influence the rate of recurrences following LVHR. No studies prospectively comparing recurrence rates among different meshes have been performed, limiting available data to single-center, retrospective reports or experimental animal studies. In a study of recurrences following mesh implantation of rats, ePTFE mesh yielded the highest rate of recurrence likely because of the poor ingrowth of host fibrous tissue compared to the other materials.61 A retrospective, single institution reported a 6% recurrence rate among 71 LVHR.62 The authors of that study feel surgeon experience and fixation technique are important variables in preventing recurrences as each of their recurrences occurred early in their use of laparoscopy for ventral hernia repair and when they were using a less desirable method of securing the mesh to the abdominal wall.
Bacterial colonization and subsequent infection of prosthetic material used for hernia repair remains a significant concern of surgeons. Infection rates following LVHR range from 0% to 3.6%, which are significantly lower than the 6%-9% infection rates observed after open hernia repair.6,8,10,32,35-51 Most surgeons uniformly administer a single, prophylactic dose of antibiotics preoperatively when performing LVHR with mesh even though no data exist to support or refute this practice. Exposure of the mesh to bacteria before or during implantation, or subsequent seeding in vivo before incorporation into host tissues, allows for adherence of bacteria to the mesh and eventual infection. Several studies have examined the role of pore size and total mesh surface area in the development of mesh infection. In animal studies, infection with Streptococcus aureus was equal among materials with multifilament meshes (greater surface area) vs monofilament (less surface area) meshes, while micropore meshes were more likely to become infected compared to macropore meshes.52 It is believed the small pore size limits the ability of host leukocytes to infiltrate the mesh and neutralize the bacteria. Other animal investigations have compared the susceptibility of various meshes to infection. Following inoculation with S aureus, meshes were implanted into rats and left for 5 days before being explanted. Of the meshes investigated, DualMesh Plus resulted in the least rate of infection compared to composite meshes (Marlex, SepraMesh, Composix) and the biomaterial meshes (AlloDerm, Surgisis).53 Few data from human trials exist regarding comparison of infection rates among different meshes. In 1 retrospective study of mesh implantation in open hernia repair, Marlex mesh was associated with a significantly lower rate of infection than PTFE alone.28 A trend toward more infectious complications involving PTFE mesh compared to all other mesh types have been reported to the FDA (75% vs 41%, P ⫽ 0.07).14 The lack of resistance to infection is possibly due to the encapsulation and poor tissue ingrowth seen in PTFE, although data to support this are absent. Insertion of prosthetic mesh in the setting of contamination is generally contraindicated secondary to the high risk of
Seromas Seroma formation, often mistaken as a recurrence, is the most commonly reported complication (0.7%-93%) after LVHR or open incisional hernia repair.44,51,10,43 One study even demonstrated seroma formation within the first postoperative week in all patients undergoing LVHR with implantation of PTFE mesh, while others have shown persistent seromas in nearly 3% of patients.10,63 Typically, the hernia sac is left intact during LVHR and implantation of mesh stimulates an inflammatory reaction, resulting in fluid accumulation in the hernia sac. It is believed the tight weave of the mesh, especially micropore meshes, prevents drainage of the fluid into the peritoneal cavity, although no randomized or prospective trials have been performed evaluating different types of meshes and their resistance to seroma formation. Consensus regarding the definition of seromas, timing of evaluation, measurement of seromas, and eventual management continues to elude clinicians. Conventional teaching recommends against aspiration of seromas for diagnostic or therapeutic
J. B. Stokes and C. M. Friel
122 intentions because of the inherent risk of seeding a potentially sterile seroma and mesh and data that show most seromas resolve within 3 months of surgery.10,48,64 Electrocautery of the hernia before mesh placement has been demonstrated in a randomized controlled trial to reduce seroma formation.65
Postoperative Pain A significant advantage of LVHR over open repair is the reduction in postoperative pain, a major factor influencing the reduction in length of stay following surgery (median length of stay 2.4 vs 5.5 days).9,11,66-69 A correlation between increasing hernia size and postoperative pain has been observed in open hernia repair, yet this correlation is not present in LVHR.70 This observation is likely a result of the ability to repair larger ventral hernias using laparoscopic techniques similar to those used for smaller defects and avoids extensive dissection and larger abdominal incisions used in open repair of large hernias. Unlike other laparoscopic procedures, approximately 5%26% of patients undergoing LVHR do experience significant protracted postoperative pain lasting longer than 2 months, although no studies have examined this complication specifically.71 This is due in large part to the lack of uniformity in defining protracted or chronic pain. No particular mesh has been shown to cause more pain than other meshes in clinical studies, and a review of the FDA complications database showed no pain-related complications with Sepramesh or the biomaterials.14 Previous studies have reported lower rates of chronic pain following mesh repair with a lightweight mesh (PTFE, Vypro II, Johnson & Johnson Medical NV, Dilbeek, Belgium) compared to a heavier, stiffer mesh (Composix, Marlex).72-74 Several authors argue the transfascial sutures used to affix the mesh to the abdominal wall are more influential on the rate of chronic pain rather than the actual mesh material.19,70,75 The injection of local anesthesia or laparoscopic removal of the suture material after host tissue ingrowth of the mesh has been shown to improve or resolve prolonged pain.76 An additional source of chronic pain following LVHR with mesh could be a result of the shrinkage of the mesh; however, this has not been investigated. Immediate pain resolution and recovery from hernia repair appear to occur faster following a laparoscopic approach compared to open technique. The potential risk for prolonged postoperative pain (⬎6-8 weeks) is real and should be discussed with patients preoperatively. Lightweight meshes may provide a protective benefit; however, this should be investigated further in prospective trials.
Adhesions A major concern of placing prosthetic material into the peritoneal cavity is the intense inflammatory reaction and adhesion formation that occurs until neoperitonealization of the mesh.77 Numerous experimental animal models have been used to evaluate the propensity of various meshes to resist adhesion formation and no material has demonstrated complete adhesion prevention. A study comparing LVHR-com-
patible meshes showed the fewest number of adhesions occurred in mice bearing Tutomesh (Tutogen Medical GmbH, Germany), SepraMesh, and Parietex Composite.25 Additional studies in rabbits have shown fewer adhesions when DualMesh and Proceed were used compared with Proceed, Composix, Marlex, Mersilene (Ethicon, Inc, Somerville, NJ), Prolene, and Vypro II meshes.78,79 Studies evaluating the formation of adhesions in small animals that lack ventral hernias and have the mesh implanted via an open technique have been criticized for their seemingly lack of relevance to human LVHR. Perioperative ultrasound findings compared with a baseline preoperative ultrasound (negative-predictive value of 85%) have been used in clinical studies to evaluate adhesion formation following LVHR, which allows for all patients, not just those undergoing re-expoloration.80 Parietex mesh has been evaluated in 2 independent studies and demonstrated 86% of patients adhesion-free at 12 months and 95% adhesion-free at 3 years.55,80 Parietex mesh has also shown superior resistance to adhesion formation over Mersilene mesh (77% vs 18%, P ⬍ 0.05).81 Another study evaluated the incidence of adhesion formation following LVHR with ePTFE mesh and found only 9% of patients demonstrated significant visceral adhesions.82 Mesh-securing tacks and sutures represent a component of LVHR that may impact adhesion formation but their role has not yet been fully evaluated. Intraperitoneal adhesion formation after LVHR with mesh appears to occur less frequently when “bowelfriendly” meshes, such as PTFE or composite meshes, are used. Reducing or preventing adhesion formation hypothetically will lead to fewer postoperative small bowel obstructions after LVHR, although this correlation has yet to be demonstrated.
Fistulas Enterocutaneous fistulas are a potential source of significant morbidity and mortality (10%) after abdominal surgery and remain a lifelong risk after prosthetic mesh insertion, sometimes occurring up 14 years after implantation.83 Fistula formation after hernia repair is written almost entirely in literature about the open technique.84,85 Fistulas complicating open repair with mesh have been reported secondary to PP, ePTFE, Mersilene, Marlex meshes,36,83,85 while 1 study reported no fistulas in 136 patients undergoing repair with Prolene mesh.37 Reports of fistula formation after LVHR include 1 patient who underwent a PP mesh repair and 3 other patients who had ePTFE mesh implanted.45,60,66 Contrary to the belief that the significant host inflammatory response seen with PP meshes would lead to higher fistula rates when placed intraperitoneally, multiple studies have reported no fistulas after LVHR.32,50,59 Despite the concern of fistula formation in open repair of ventral hernias, fistulas appear to be a rare complication of LVHR. Because of the known lifelong risk of fistula formation after prosthetic mesh implantation and the relatively recent expansion of laparoscopy for hernia repair, it will be necessary to follow these patients to monitor for late development of fistulas.
Mesh options for laparoscopic ventral hernia repair
Conclusions Laparoscopic repair of ventral hernias convey significant advantages over open repair as evidenced by the improved outcomes and significantly fewer complications. Implantation of mesh to correct the fascial defect has also demonstrated an improvement in overall quality of hernia repair compared to primary suture repair. Although many mesh options of various compositions, strengths, and pore sizes are available, the ideal mesh continues to elude manufacturers and surgeons. Additionally, the literature regarding the characteristics and outcomes of available mesh materials does not lend itself to a wholesale recommendation of 1 mesh over any others. Many of the meshes on the market perform exceptionally well with regard to tissue ingrowth, retention of tensile strength, and resistance to adhesion formation and infection with relatively few complications. The introduction of biological materials in recent years represents an exciting time in hernia management. Their combination of excellent tissue ingrowth, effective neovascularization, and ability to clear infections begins to approach the qualities needed for the “ideal” mesh. In this review we present the advantages and disadvantages of meshes currently available for intraperitoneal and LVHR use. An awareness and understanding of the characteristics of the products available allow the surgeon to choose a mesh appropriate for the individual clinical situation.
References 1. Mudge M, Hughes LE: Incisional hernia: A 10 year prospective study of incidence and attitudes. Br J Surg 72:70-71, 1985 2. Read RC, Yoder G: Recent trends in the management of incisional herniation. Arch Surg 124:485-488, 1989 3. Bucknall TE, Cox PJ, Ellis H: Burst abdomen and incisional hernia: A prospective study of 1129 major laparotomies. Br Med J Clin Res Ed 284:931-933, 1982 4. Hesselink VJ, Luijendijk RW, de Wilt JH, et al: An evaluation of risk factors in incisional hernia recurrence. Surg Gynecol Obstet 176:228234, 1993 5. Santora TA, Roslyn JJ: Incisional hernia. Surg Clin North Am 73:557570, 1993 6. Toy FK, Bailey RW, Carey S, et al: Prospective, multicenter study of laparoscopic ventral hernioplasty. Preliminary results. Surg Endosc 12: 955-959, 1998 7. Stoppa RE: The treatment of complicated groin and incisional hernias. World J Surg 13:545-554, 1989 8. Park A, Birch DW, Lovrics P: Laparoscopic and open incisional hernia repair: A comparison study. Surgery 124:816-821, 1998 9. Ramshaw BJ, Esartia P, Schwab J, et al: Comparison of laparoscopic and open ventral herniorrhaphy. Am Surg 65:827-831, 1999 10. Heniford BT, Park A, Ramshaw BJ, et al: Laparoscopic repair of ventral hernias: Nine years’ experience with 850 consecutive hernias. Ann Surg 238:391-399, 2003 11. Carbajo MA, Martin del Olmo JC, Blanco JI, et al: Laparoscopic treatment vs open surgery in the solution of major incisional and abdominal wall hernias with mesh. Surg Endosc 13:250-252, 1999 12. Misra MC, Bansal VK, Kulkarni MP, et al: Comparison of laparoscopic and open repair of incisional and primary ventral hernia: Results of a prospective randomized study. Surg Endosc 20:1839-1845, 2006 13. Barbaros U, Asoglu O, Seven R, et al: The comparison of laparoscopic and open ventral hernia repairs: A prospective randomized study. Hernia 11:51-56, 2007 14. Robinson TN, Clarke JH, Schoen J, et al: Major mesh-related complications following hernia repair: Events reported to the Food and Drug Administration. Surg Endosc 19:1556-1560, 2005
123 15. Usher FC, Allen JE Jr, Crosthwait RW, et al: Polypropylene monofilament. A new, biologically inert suture for closing contaminated wounds. J Am Med Assoc 179:780-782, 1962 16. Wolstenholme JT: Use of commercial Dacron fabric in the repair of inguinal hernias and abdominal wall defects. AMA Arch Surg 73:10041008, 1956 17. Matthews BD, Pratt BL, Pollinger HS, et al: Assessment of adhesion formation to intra-abdominal polypropylene mesh and polytetrafluoroethylene mesh. J Surg Res 114:126-132, 2003 18. Schumpelick V, Klinge U: Prosthetic implants for hernia repair. Br J Surg 90:1457-1458, 2003 19. Eriksen JR, Gogenur I, Rosenberg J: Choice of mesh for laparoscopic ventral hernia repair. Hernia 11:481-492, 2007 20. Bellon JM, Bujan J, Contreras LA, et al: Comparison of a new type of polytetrafluoroethylene patch (MycroMesh) and polypropylene prosthesis (marlex) for repair of abdominal wall defects. J Am Coll Surg 183:11-18, 1996 21. Gonzalez R, Fugate K, McClusky D III, et al: Relationship between tissue ingrowth and mesh contraction. World J Surg 29:1038-1043, 2005 22. Klinge U, Klosterhalfen B, Muller M, et al: Shrinking of polypropylene mesh in vivo: An experimental study in dogs. Eur J Surg 164:965-969, 1998 23. Bujan J, Contreras LA, Carrera-San MA, et al: The behavior of different types of polytetrafluoroethylene (PTFE) prostheses in the reparative scarring process of abdominal wall defects. Histol Histopathol 12:683690, 1997 24. Young RM, Gustafson R, Dinsmore RC: Sepramesh v Dualmesh for abdominal wall hernia repairs in a rabbit model. Curr Surg 61:77-79, 2004 25. Burger JW, Halm JA, Wijsmuller AR, et al: Evaluation of new prosthetic meshes for ventral hernia repair. Surg Endosc 20:1320-1325, 2006 26. McGinty JJ, Hogle NJ, McCarthy H, et al: A comparative study of adhesion formation and abdominal wall ingrowth after laparoscopic ventral hernia repair in a porcine model using multiple types of mesh. Surg Endosc 19:786-790, 2005 27. Silverman RP, Li EN, Holton LH III, et al: Ventral hernia repair using allogenic acellular dermal matrix in a swine model. Hernia 8:336-342, 2004 28. Diaz JJ Jr, Gray BW, Dobson JM, et al: Repair of giant abdominal hernias: Does the type of prosthesis matter? Am Surg 70:396-401, 2004 29. Baptista ML, Bonsack ME, Delaney JP: Seprafilm reduces adhesions to polypropylene mesh. Surgery 128:86-92, 2000 30. Luijendijk RW, Hop WC, van den Tol MP, et al: A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med 343:392398, 2000 31. Cobb GA, Shaffer J: Cross-linked acellular porcine dermal collagen implant in laparoscopic ventral hernia repair: Case-controlled study of operative variables and early complications. Int Surg 90:S24-S29, 2005 (suppl) 32. Franklin ME Jr, Gonzalez JJ Jr, Glass JL, et al: Laparoscopic ventral and incisional hernia repair: An 11-year experience. Hernia 8:23-27, 2004 33. Menon NG, Rodriguez ED, Byrnes CK, et al: Revascularization of human acellular dermis in full-thickness abdominal wall reconstruction in the rabbit model. Ann Plast Surg 50:523-527, 2003 34. Butler CE, Langstein HN, Kronowitz SJ: Pelvic, abdominal, and chest wall reconstruction with AlloDerm in patients at increased risk for mesh-related complications. Plast Reconstr Surg 116:1263-1275, 2005, discussion, 1276-1277 35. Kyzer S, Alis M, Aloni Y, et al: Laparoscopic repair of postoperation ventral hernia. Early postoperation results. Surg Endosc 13:928-931, 1999 36. Bauer JJ, Harris MT, Kreel I, et al: Twelve-year experience with expanded polytetrafluoroethylene in the repair of abdominal wall defects. Mt Sinai. J Med 66:20-25, 1999 37. Vrijland WW, Jeekel J, Steyerberg EW, et al: Intraperitoneal polypropylene mesh repair of incisional hernia is not associated with enterocutaneous fistula. Br J Surg 87:348-352, 2000 38. Eid GM, Prince JM, Mattar SG, et al: Medium-term follow-up confirms the safety and durability of laparoscopic ventral hernia repair with PTFE. Surgery 134:599-603, 2003; discussion, 603-604
124 39. Aura T, Habib E, Mekkaoui M, et al: Laparoscopic tension-free repair of anterior abdominal wall incisional and ventral hernias with an intraperitoneal Gore-Tex mesh: Prospective study and review of the literature. J Laparoendosc Adv Surg Tech A 12:263-267, 2002 40. Rosen M, Brody F, Ponsky J, et al: Recurrence after laparoscopic ventral hernia repair. Surg Endosc 17:123-128, 2003 41. Bower CE, Reade CC, Kirby LW, et al: Complications of laparoscopic incisional-ventral hernia repair: The experience of a single institution. Surg Endosc 18:672675, 2004 42. Kirshtein B, Lantsberg L, Avinoach E, et al: Laparoscopic repair of large incisional hernias. Surg Endosc 16:1717-1719, 2002 43. Topart P, Ferrand L, Vandenbroucke F, et al: Laparoscopic ventral hernia repair with the GoreTex Dualmesh: Long-term results and review of the literature. Hernia 9:348-352, 2005 44. Berger D, Bientzle M, Muller A: Postoperative complications after laparoscopic incisional hernia repair. Incidence and treatment. Surg Endosc 16:1720-1723, 2002 45. Bageacu S, Blanc P, Breton C, et al: Laparoscopic repair of incisional hernia: A retrospective study of 159 patients. Surg Endosc 16:345-348, 2002 46. McKinlay RD, Park A: Laparoscopic ventral incisional hernia repair: A more effective alternative to conventional repair of recurrent incisional hernia. J Gastrointest Surg 8:670-674, 2004 47. Olmi S, Erba L, Magnone S, et al: Prospective clinical study of laparoscopic treatment of incisional and ventral hernia using a composite mesh: Indications, complications and results. Hernia 10:243-247, 2006 48. LeBlanc KA, Whitaker JM, Bellanger DE, et al: Laparoscopic incisional and ventral hernioplasty: Lessons learned from 200 patients. Hernia 7:118-124, 2003 49. Frantzides CT, Carlson MA, Zografakis JG, et al: Minimally invasive incisional herniorrhaphy: A review of 208 cases. Surg Endosc 18:14881491, 2004 50. Yavuz N, Ipek T, As A, et al: Laparoscopic repair of ventral and incisional hernias: Our experience in 150 patients. J Laparoendosc Adv Surg Tech A 15:601-605, 2005 51. Cobb WS, Kercher KW, Matthews BD, et al: Laparoscopic ventral hernia repair: A single center experience. Hernia 10:236-242, 2006 52. Klinge U, Junge K, Spellerberg B, et al: Do multifilament alloplastic meshes increase the infection rate? Analysis of the polymeric surface, the bacteria adherence, and the in vivo consequences in a rat model. J Biomed Mater Res 63:765-771, 2002 53. Carbonell AM, Matthews BD, Dreau D, et al: The susceptibility of prosthetic biomaterials to infection. Surg Endosc 19:430-435, 2005 54. Sanchez LJ, Bencini L, Moretti R: Recurrences after laparoscopic ventral hernia repair: Results and critical review. Hernia 8:138-143, 2004 55. Moreno-Egea A, Torralba JA, Girela E, et al: Immediate, early, and late morbidity with laparoscopic ventral hernia repair and tolerance to composite mesh. Surg Laparosc Endosc Percutan Tech 14:130-135, 2004 56. Ujiki MB, Weinberger J, Varghese TK, et al: One hundred consecutive laparoscopic ventral hernia repairs. Am J Surg 188:593-597, 2004 57. Ben-Haim M, Kuriansky J, Tal R, et al: Pitfalls and complications with laparoscopic intraperitoneal expanded polytetrafluoroethylene patch repair of postoperative ventral hernia. Surg Endosc 16:785-788, 2002 58. Morales-Conde S, Cadet H, Cano A, et al: Laparoscopic ventral hernia repair without sutures—Double crown technique: Our experience after 140 cases with a mean follow-up of 40 months. Int Surg 90:S56-S62, 2005 (suppl) 59. Chowbey PK, Sharma A, Khullar R, et al: Laparoscopic ventral hernia repair. J Laparoendosc Adv Surg Tech A 10:79-84, 2002 60. Carbajo MA, Martp del Olmo JC, Blanco JI, et al: Laparoscopic approach to incisional hernia. Surg Endosc 17:118-122, 2003 61. Simmermacher RK, Schakenraad JM, Bleichrodt RP: Reherniation after repair of the abdominal wall with expanded polytetrafluoroethylene. J Am Coll Surg 178:613-616, 1994 62. Gananadha S, Samra JS, Smith GS, et al: Laparoscopic ePTFE mesh repair of incisional and ventral hernias. Aust NZ J Surg 78:907-913, 2008
J. B. Stokes and C. M. Friel 63. Susmallian S, Gewurtz G, Ezri T, et al: Seroma after laparoscopic repair of hernia with PTFE patch: Is it really a complication? Hernia 5:139144, 2001 64. Morales-Conde S: Laparoscopic ventral hernia repair: Advances and limitations. Semin Laparosc Surg 11:191-200, 2004 65. Tsimoyiannis EC, Siakas P, Glantzounis G, et al: Seroma in laparoscopic ventral hernioplasty. Surg Laparosc Endosc Percutan Tech 11: 317-321, 2001 66. DeMaria EJ, Moss JM, Sugerman HJ: Laparoscopic intraperitoneal polytetrafluoroethylene (PTFE) prosthetic patch repair of ventral hernia. Prospective comparison to open prefascial polypropylene mesh repair. Surg Endosc 14:326-329, 2000 67. Chari R, Chari V, Eisenstat M, et al: A case controlled study of laparoscopic incisional hernia repair. Surg Endosc 14:117-119, 2000 68. Holzman MD, Purut CM, Reintgen K, et al: Laparoscopic ventral and incisional hernioplasty. Surg Endosc 11:32-35, 1997 69. Bickel A, Eitan A: A simplified laparoscopic technique for mesh placement in ventral hernia repair. Surg Endosc 13:532-534, 1999 70. Lomanto D, Iyer SG, Shabbir A, et al: Laparoscopic versus open ventral hernia mesh repair: A prospective study. Surg Endosc 20:1030-1035, 2006 71. Carbonell AM, Harold KL, Mahmutovic AJ, et al: Local injection for the treatment of suture site pain after laparoscopic ventral hernia repair. Am Surg 69:688-691, 2003; discussion, 691-692 72. LeBlanc KA, Whitaker JM: Management of chronic postoperative pain following incisional hernia repair with Composix mesh: A report of two cases. Hernia 6:194-197, 2002 73. Welty G, Klinge U, Klosterhalfen B, et al: Functional impairment and complaints following incisional hernia repair with different polypropylene meshes. Hernia 5:142-147, 2001 74. Schmidbauer S, Ladurner R, Hallfeldt KK, et al: Heavy-weight versus low-weight polypropylene meshes for open sublay mesh repair of incisional hernia. Eur J Med Res 10:247-253, 2005 75. Pierce RA, Spitler JA, Frisella MM, et al: Pooled data analysis of laparoscopic vs open ventral hernia repair: 14 years of patient data accrual. Surg Endosc 21:378-386, 2007 76. Beldi G, Ipaktchi R, Wagner M, et al: Laparoscopic ventral hernia repair is safe and cost effective. Surg Endosc 20:92-95, 2006 77. Matthews BD, Pratt BL, Backus CL, et al: Comparison of adhesion formation to intra-abdominal mesh after laparoscopic adhesiolysis in the New Zealand White rabbit. Am Surg 68:936-940, 2002; discussion, 941 78. Harrell AG, Novitsky YW, Peindl RD, et al: Prospective evaluation of adhesion formation and shrinkage of intra-abdominal prosthetics in a rabbit model. Am Surg 72:808-813, 2006; discussion, 813-814 79. Kiudelis M, Jonciauskiene J, Deduchovas O, et al: Effects of different kinds of meshes on postoperative adhesion formation in the New Zealand White rabbit. Hernia 11:19-23, 2007 80. Balique JG, Benchetrit S, Bouillot JL, et al: Intraperitoneal treatment of incisional and umbilical hernias using an innovative composite mesh: Four-year results of a prospective multicenter clinical trial. Hernia 9:68-74, 2005 81. Arnaud JP, Hennekinne-Mucci S, Pessaux P, et al: Ultrasound detection of visceral adhesion after intraperitoneal ventral hernia treatment: A comparative study of protected versus unprotected meshes. Hernia 7:85-88, 2003 82. Koehler RH, Begos D, Berger D, et al: Minimal adhesions to ePTFE mesh after laparoscopic ventral incisional hernia repair: Reoperative findings in 65 cases. JSLS 7:335-340, 2003 83. Chew DK, Choi LH, Rogers AM: Enterocutaneous fistula 14 years after prosthetic mesh repair of a ventral incisional hernia: A lifelong risk? Surgery 127:352-353, 2000 84. Draus JM Jr, Huss SA, Harty NJ, et al: Enterocutaneous fistula: Are treatments improving? Surgery 140:570-576, 2006; discussion, 576578 85. Leber GE, Garb JL, Alexander AI, et al: Long-term complications associated with prosthetic repair of incisional hernias. Arch Surg 133:378382, 1998
V
entral hernias are a significant cause of morbidity following laparotomy occurring in approximately 2%-20% of patients,1-5 with an estimated 90,000 repairs performed annually in the USA.6 Classically, hernias have been repaired primarily via an open approach. Unfortunately, this method requires an additional laparotomy with possible component separation and often yields poor outcomes with 25%-53% of patients developing a recurrence.4,7 Such poor outcomes result in negative major social and economic consequences. Surgical treatment of ventral hernias has changed drastically over the past few decades following the development of minimally invasive laparoscopic techniques and prosthetic meshes for reinforcement of the abdominal wall. Laparoscopic ventral hernia repair (LVHR) appears to be superior to conventional open repair. Laparoscopy allows for minimal abdominal wall incisions, avoids extensive flap dissections, and obviates the need for drains near to the prosthetic repair. The benefits of these modifications in technique are realized in decreased pain, length of stay and recovery time, surgical site infections, blood loss, and improved cosmesis.8-13 The introduction of prosthetic, and more recently biological, meshes have ushered in the era of “tension-free” hernia repair. Many meshes are available for use in hernia repair with
Department of Surgery, University of Virginia Health System, Charlottesville, VA. Address reprint requests to Charles M. Friel, MD, Department of Surgery, University of Virginia Health System, 1215 Lee Street, Charlottesville, VA 22908. E-mail: [email protected]
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1043-1489/09/$-see front matter © 2009 Elsevier Inc. All rights reserved. doi:10.1053/j.scrs.2009.06.003
introductions of new mesh designs driven largely by industry occurring at a rapid rate. In LVHR, the prosthetic mesh is placed intraperitoneally and overlaps the defect by 3-5 cm. This method obviates the need for extensive tissue dissection and exposure, and the accompanying complications. Optimal mesh selection for hernia repair requires an in-depth knowledge of the advantages and disadvantages associated with the different meshes currently available. Current data regarding clinical outcomes of mesh material remain limited due in large part to the relatively infrequent major complications related to the use of mesh.14 This report presents a summary of currently available meshes for use in LVHR and a review of the literature regarding their use and safety profile.
Types of Mesh Available Since the introduction of prosthetic materials for use in the repair of hernias, surgeons have sought to identify the ideal mesh.15,16 Although no single product satisfies all the criteria of the optimal mesh, most authors agree on several characteristics.17,18 The ideal mesh should resist adhesion formation and bowel erosion, promote tissue ingrowth and incorporation while not altering abdominal wall compliance, and be hypoallergenic. Additionally, the mesh should be resistant to infection, shrinkage, seroma formation; cause minimal pain; and be noncarcinogenic. Table 1 summarizes the basic characteristics of the types of mesh available currently. More than 70 meshes for use in hernia repair are available on the market in a wide array of materials and designs.
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Table 1 Characteristics of Available Mesh Materials
Tissue in-growth Strength Bowel adhesion Infection susceptibility Abdominal wall compliance Use in contaminated field Cost
PP
PE
PTFE
Composite
Biomaterial
ⴙⴙⴙ ⴙⴙⴙ ⴙⴙⴙⴙ ⴙⴙ 0 ⴙⴙ ⴙ
ⴙⴙⴙ ⴙ ⴙⴙⴙ ⴙⴙ ⴙⴙ 0 ⴙ
ⴙ ⴙⴙ ⴙ ⴙⴙⴙⴙ ⴙⴙⴙ 0 ⴙⴙ
ⴙⴙⴙ ⴙⴙ ⴙ ⴙⴙⴙ ⴙⴙ 0 ⴙⴙⴙ
ⴙⴙ ⴙⴙ ⴙ ⴙ ⴙⴙⴙ ⴙⴙⴙ ⴙⴙⴙⴙ
Meshes typically are classified by material into 1 of the 2 following categories: (1) polymeric prosthetic meshes and (2) meshes made from specially prepared human or animal connective tissue.19 Polymeric prosthetic meshes consist of biocompatible materials made from polyester (PE), polypropylene (PP), expanded polytetrafluoroethylene (ePTFE), or laminated combinations of these polymers. Meshes for intraperitoneal use are typically engineered such that the visceral surface of the mesh has a smooth texture or is coated with a protective layer to resist adhesion formation, bowel erosion, and potential fistula formation (Table 2). The parietal side contains pores of various depths depending on the mesh to allow for tissue in-growth and incorporation into the abdominal wall. Monofilament meshes possess high tensile strength and bacterial resistance while multifilament meshes remain pliable and more readily conform to the abdominal wall.
Polypropylene PP has emerged as the gold standard to which all other mesh materials are compared secondary to its superior tensile strength.20 Pure PP meshes (Prolene [Ethicon, Inc, Somerville, NJ], Marlex [C.R. Bard, Inc, Murray Hill, NJ], Parietene, Visilex [C.R. Bard, Inc]) are manufactured by weaving filaments of PP polymers that have a tensile strength similar to that of steel, making them an excellent choice for reinforcement of abdominal fascia.14 The rigid strength properties inherent in PP mesh, however, limit its ability to conform to the abdominal wall and ease of use in laparoscopy where manipulation is required. Uncoated PP meshes incite a substantial host inflammatory reaction resulting in significant scar formation and increased risk of adhesion formation. Such an intense inflammatory response has led many authors to recommend against its use intraperitoneally and therefore is a poor choice for LVHR.17 Also, the inflammatory response and scar formation causes a 30%-50% reduction in size of PP meshes, necessitating a generous overlap of the fascial edges to accommodate the shrinkage in mesh diameter and prevent hernia recurrence.21,22 A significant advantage of PP mesh when used for other types of hernia repair is the ability to treat infections involving the mesh without removal of the mesh. Additionally, PP meshes are among the least expensive of available mesh materials.
Polyester PE meshes are made from a multifilament weave of nonabsorbable polyethylene terephthalate fibers. Unlike PP meshes,
PE meshes experience a significant reduction in tensile strength overtime, with reports of 31% and 25% strength remaining at 10 and 25 years, respectively.20 Such a reduction in strength over time raises concerns about the overall long-term integrity of the repair and the risk of recurrence. The multifilament weave of PE provides greater flexibility of the mesh and enhances its conformity to the abdominal wall, a significant advantage over the more rigid monofilament PP meshes. This weave engineering does place PE meshes at a greater risk of infection, however. Like multifilament woven suture, bacteria and contaminated fluids become trapped in the weave, allowing them to establish a niche that is relatively impenetrable by leukocytes.19 Like PP meshes, PE meshes are also a relatively inexpensive material for use in hernia repair.
Polytetrafluoroethylene Mesh In response to the lack of a mesh that could be placed intraperitoneally and the inadequacy of interposing omentum between the mesh and bowel, newer materials for mesh have been developed that are conducive for use in LVHR and suitable for intestinal contact. These newer materials include the synthetic, nonabsorbable ePTFE meshes, such as DualMesh (W.L. Gore & Associates, Inc, Flagstaff, AZ), DualMesh Plus (W.L. Gore & Associates, Inc, Flagstaff, AZ), MycroMesh (W.L. Gore & Associates, Inc, Flagstaff, AZ), Dulex (C.R. Bard, Inc, Murray Hill, NJ), and Reconix (C.R. Bard, Inc, Murray Hill, NJ). Compared to PP and PE meshes, ePTFE meshes have a smaller pore size that resists their incorporation into host tissues, thereby limiting the formation of intestinal adhesions.14,17,23 This smaller pore size also limits the incorporation of the mesh into the abdominal wall. Instead, ePTFE meshes become encapsulated by the host tissue, which results in a weaker overall strength of the hernia repair compared to other meshes.24-27 Additionally, encapsulation of the mesh prevents treatment of infections involving the mesh and requires that infected ePTFE be removed.28 To address the tissue ingrowth while retaining the adhesion resistant properties of the early ePTFE meshes, a new line of ePTFE meshes, such as MycroMesh and DualMesh, have been developed. These second-generation ePTFE meshes have been engineered with pores that traverse the entire thickness of the mesh, while DualMesh also has an irregular, abrasive surface on the parietal side while maintaining its adhesion-resistant properties on the visceral surfaces.19 An even newer line of ePTFE products includes MotifMesh (Proxy Biomedical Ltd, Ireland, United Kingdom), which integrates macropores
J. B. Stokes and C. M. Friel
120 Table 2 Meshes Available for Ventral Hernia Repair Product
Manufacturer
Composition
DualMesh DualMesh Plus
W.L. Gore W.L. Gore
MycroMesh MotifMESH Dulex Reconix Prolene Visilex Marlex Composix Composix E/X Composix Kugel SepraMesh
W.L. Gore Proxy Biomedical C.R. Bard C.R. Bard Ethicon C.R. Bard C.R. Bard C.R. Bard C.R. Bard
Dual-sided ePTFE Dual-sided ePTFE, antibiotic impregnated Dual-sided ePTFE cPTFE Dual-sided ePTFE Dual-sided ePTFE Polypropylene Polypropylene Polypropylene Polypropylene, ePTFE Polypropylene, ePTFE
C.R. Bard
Polypropylene, ePTFE
Genzyme
Polypropylene, HA/CMC laminate Glucamesh Brennen Medical Polypropylene, -glucan laminate Proceed Ethicon Polypropylene, oxidized regenerated cellulose Parietene Sofradim Polypropylene, Composite collagen laminate Dynamesh FEG Textiltechnik Polypropylene, polyvinylidene fluoride TiMesh GfE Medizintechnik Polypropylene, titanium GmbH coated C-QUR Atrium Medical Polypropylene, omegaCorporation 3 fatty acid coated Vypro II Johnson & Polypropylene, Johnson polyglactin coated Mersilene Ethicon Polyester Parietex Sofradim Polyester, collagen Composite type I laminate Intramesh Cousin Biotech Polyester, silicone W3 layer Glucatex Brennen Medical Polyester, -glucan laminate Surgisis Cook Porcine intestinal submucosa Tutomesh Tutogen Medical Bovine pericardium GmbH AlloDerm LifeCell Human acellular dermal matrix ePTFE, expanded polytetrafluoroethylene; cPTFE, condensed polytetrafluoroethylene; HA/CMC, hyaluronate/carboxymethylcellulose.
into a nonwoven polytetrafluoroethylene (PTFE) material to promote host tissue ingrowth while retaining the anti-adhesion characteristics of the PTFE. Unfortunately, the significant amount of engineering involved in the development of these materials make them significantly more expensive than either PP or PE meshes. Surgeons using tacking devices to affix these double-layered materials should take care to insure that an ap-
propriate tack with a long enough purchase is used to completely traverse the mesh and embed into the peritoneum.
Composite In response to the increasing use of laparoscopy for ventral hernia repairs and the inherent shortcomings of single-material meshes, manufacturers have designed newer “combination” materials for use in mesh design. These laminate meshes have been developed to achieve the goal of promoting abdominal wall ingrowth and thereby a strong repair, while limiting bowel erosion and adhesion formation. Composix mesh combines a PP parietal surface stitched with a thin layer of ePTFE facing the visceral surfaces. Other PPbased composite meshes include SepraMesh (Genzyme, Cambridge, MA), Proceed (Ethicon, Inc, Somerville, NJ), Glucamesh (Brennen Medical, LLC, St Paul, MN), and Parietene Composite (Sofradim, Trévoux, France). These laminates all use a PP mesh visceral layer whose parietal surface is coated with a layer of cellulose, collagen, or other absorbable material to prevent adhesion formation. Other PP-based composite meshes, such as TiMesh (GfE Medizintechnik GmbH, Nuremberg, Germany), use a titanium or other inert, nonabsorbable coating to prevent adhesion formation and allow for intraperitoneal placement. Other composite meshes, such as Parietex Composite (Sofradim, Trévoux, France), Intramesh W3 (Cousin Biotech, France), and Glucatex (Brennen Medical, LLC, St Paul, MN), use PE backbones for parietal surface tissue ingrowth with an absorbable coating (oxidized atelocollagen type I, polyethylene glycol, and glycerol) facing the intestinal surfaces. The effectiveness of these meshes at preventing adhesion formation remains unclear. While studies examining adhesion formation in animals have shown a reduction in adhesions following composite mesh implantation secondary to peritonealization of the mesh, other reports have demonstrated fewer adhesions with uncoated ePTFE mesh.29,30 Because of the 2-sided nature of composite meshes, due diligence is required in the operating room to insure proper orientation and avoid placement of PP or PE against the intestinal surfaces. Secondary to their PTFE component or other specialized visceral surface coating, composite meshes are comparable in expense to PTFE meshes.
Biological Mesh Biological meshes represent the newest materials developed for hernia repair. These meshes are derived from humans or other large animals and are made of decellularized living tissue composed of a collagen matrix. Two xenogeneic materials, made from modified porcine small intestine submucosa (Surgisis Cook Medical, Inc, Bloomington, IN) and acellular porcine dermal collagen, promote minimal adhesion formation and have been used successfully in LVHR.31,32 Biological meshes provide a scaffold for tissue ingrowth and remodeling, host collagen deposition and neovascularization, making them an excellent choice for abdominal wall conformation.33 Unlike the synthetic polymer meshes, biological meshes are significantly more susceptible to degradation by the host re-
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sulting in a decreased tensile strength over time. Xenogeneic tissues also carry the potential risk of disease transmission and immunologic rejection. Although a review of adverse events reported to the Food and Drug Administration (FDA) did not reveal any disease transmission following implantation, biomaterials did cause a significantly higher number of foreign body reactions than any other mesh material used.14 Because of its human derivation, AlloDerm (LifeCell Corp, Branchburg, NJ), an allogenic acellular dermal matrix, may reduce this risk of rejection.34 The improved incorporation of biological mesh into the host tissues over synthetic materials confers an increased ability to resist infections, allowing their use in contaminated fields. A downside to biological materials is their extraordinary cost, making them the most expensive materials available for hernia repair currently on the market.
seeding the mesh. The introduction of biological and absorbable meshes has provided a potential solution to this clinical dilemma. A recent case-control study comparing an acellular porcine dermal collagen matrix mesh to PP/PTFE composite mesh demonstrated no infections in the biological mesh, while 3 composite meshes required removal.31 In a series of 58 LVHR implantation of Surgisis into a contaminated field during ventral hernia repair yielded no mesh-related complications,32 while similar results have been reported with AlloDerm in the management of contaminated abdominal hernias.34 A laparoscopic approach appears to convey a protective advantage over open repair in regards to infection complications following hernia repair with mesh. Although no clinical data comparing infection resistance are available, the use of biomaterial meshes in high risk or contaminated settings appears beneficial.
Outcomes
Recurrence
Infection
Recurrence rates following ventral hernia repair range between 1% and 17%.6,8,10,32,35,38-51,54-60 Many factors, such as body habitus, comorbidities, size and number of hernia defects, steroid use, method of mesh fixation, and surgeon experience, can influence the rate of recurrences following LVHR. No studies prospectively comparing recurrence rates among different meshes have been performed, limiting available data to single-center, retrospective reports or experimental animal studies. In a study of recurrences following mesh implantation of rats, ePTFE mesh yielded the highest rate of recurrence likely because of the poor ingrowth of host fibrous tissue compared to the other materials.61 A retrospective, single institution reported a 6% recurrence rate among 71 LVHR.62 The authors of that study feel surgeon experience and fixation technique are important variables in preventing recurrences as each of their recurrences occurred early in their use of laparoscopy for ventral hernia repair and when they were using a less desirable method of securing the mesh to the abdominal wall.
Bacterial colonization and subsequent infection of prosthetic material used for hernia repair remains a significant concern of surgeons. Infection rates following LVHR range from 0% to 3.6%, which are significantly lower than the 6%-9% infection rates observed after open hernia repair.6,8,10,32,35-51 Most surgeons uniformly administer a single, prophylactic dose of antibiotics preoperatively when performing LVHR with mesh even though no data exist to support or refute this practice. Exposure of the mesh to bacteria before or during implantation, or subsequent seeding in vivo before incorporation into host tissues, allows for adherence of bacteria to the mesh and eventual infection. Several studies have examined the role of pore size and total mesh surface area in the development of mesh infection. In animal studies, infection with Streptococcus aureus was equal among materials with multifilament meshes (greater surface area) vs monofilament (less surface area) meshes, while micropore meshes were more likely to become infected compared to macropore meshes.52 It is believed the small pore size limits the ability of host leukocytes to infiltrate the mesh and neutralize the bacteria. Other animal investigations have compared the susceptibility of various meshes to infection. Following inoculation with S aureus, meshes were implanted into rats and left for 5 days before being explanted. Of the meshes investigated, DualMesh Plus resulted in the least rate of infection compared to composite meshes (Marlex, SepraMesh, Composix) and the biomaterial meshes (AlloDerm, Surgisis).53 Few data from human trials exist regarding comparison of infection rates among different meshes. In 1 retrospective study of mesh implantation in open hernia repair, Marlex mesh was associated with a significantly lower rate of infection than PTFE alone.28 A trend toward more infectious complications involving PTFE mesh compared to all other mesh types have been reported to the FDA (75% vs 41%, P ⫽ 0.07).14 The lack of resistance to infection is possibly due to the encapsulation and poor tissue ingrowth seen in PTFE, although data to support this are absent. Insertion of prosthetic mesh in the setting of contamination is generally contraindicated secondary to the high risk of
Seromas Seroma formation, often mistaken as a recurrence, is the most commonly reported complication (0.7%-93%) after LVHR or open incisional hernia repair.44,51,10,43 One study even demonstrated seroma formation within the first postoperative week in all patients undergoing LVHR with implantation of PTFE mesh, while others have shown persistent seromas in nearly 3% of patients.10,63 Typically, the hernia sac is left intact during LVHR and implantation of mesh stimulates an inflammatory reaction, resulting in fluid accumulation in the hernia sac. It is believed the tight weave of the mesh, especially micropore meshes, prevents drainage of the fluid into the peritoneal cavity, although no randomized or prospective trials have been performed evaluating different types of meshes and their resistance to seroma formation. Consensus regarding the definition of seromas, timing of evaluation, measurement of seromas, and eventual management continues to elude clinicians. Conventional teaching recommends against aspiration of seromas for diagnostic or therapeutic
J. B. Stokes and C. M. Friel
122 intentions because of the inherent risk of seeding a potentially sterile seroma and mesh and data that show most seromas resolve within 3 months of surgery.10,48,64 Electrocautery of the hernia before mesh placement has been demonstrated in a randomized controlled trial to reduce seroma formation.65
Postoperative Pain A significant advantage of LVHR over open repair is the reduction in postoperative pain, a major factor influencing the reduction in length of stay following surgery (median length of stay 2.4 vs 5.5 days).9,11,66-69 A correlation between increasing hernia size and postoperative pain has been observed in open hernia repair, yet this correlation is not present in LVHR.70 This observation is likely a result of the ability to repair larger ventral hernias using laparoscopic techniques similar to those used for smaller defects and avoids extensive dissection and larger abdominal incisions used in open repair of large hernias. Unlike other laparoscopic procedures, approximately 5%26% of patients undergoing LVHR do experience significant protracted postoperative pain lasting longer than 2 months, although no studies have examined this complication specifically.71 This is due in large part to the lack of uniformity in defining protracted or chronic pain. No particular mesh has been shown to cause more pain than other meshes in clinical studies, and a review of the FDA complications database showed no pain-related complications with Sepramesh or the biomaterials.14 Previous studies have reported lower rates of chronic pain following mesh repair with a lightweight mesh (PTFE, Vypro II, Johnson & Johnson Medical NV, Dilbeek, Belgium) compared to a heavier, stiffer mesh (Composix, Marlex).72-74 Several authors argue the transfascial sutures used to affix the mesh to the abdominal wall are more influential on the rate of chronic pain rather than the actual mesh material.19,70,75 The injection of local anesthesia or laparoscopic removal of the suture material after host tissue ingrowth of the mesh has been shown to improve or resolve prolonged pain.76 An additional source of chronic pain following LVHR with mesh could be a result of the shrinkage of the mesh; however, this has not been investigated. Immediate pain resolution and recovery from hernia repair appear to occur faster following a laparoscopic approach compared to open technique. The potential risk for prolonged postoperative pain (⬎6-8 weeks) is real and should be discussed with patients preoperatively. Lightweight meshes may provide a protective benefit; however, this should be investigated further in prospective trials.
Adhesions A major concern of placing prosthetic material into the peritoneal cavity is the intense inflammatory reaction and adhesion formation that occurs until neoperitonealization of the mesh.77 Numerous experimental animal models have been used to evaluate the propensity of various meshes to resist adhesion formation and no material has demonstrated complete adhesion prevention. A study comparing LVHR-com-
patible meshes showed the fewest number of adhesions occurred in mice bearing Tutomesh (Tutogen Medical GmbH, Germany), SepraMesh, and Parietex Composite.25 Additional studies in rabbits have shown fewer adhesions when DualMesh and Proceed were used compared with Proceed, Composix, Marlex, Mersilene (Ethicon, Inc, Somerville, NJ), Prolene, and Vypro II meshes.78,79 Studies evaluating the formation of adhesions in small animals that lack ventral hernias and have the mesh implanted via an open technique have been criticized for their seemingly lack of relevance to human LVHR. Perioperative ultrasound findings compared with a baseline preoperative ultrasound (negative-predictive value of 85%) have been used in clinical studies to evaluate adhesion formation following LVHR, which allows for all patients, not just those undergoing re-expoloration.80 Parietex mesh has been evaluated in 2 independent studies and demonstrated 86% of patients adhesion-free at 12 months and 95% adhesion-free at 3 years.55,80 Parietex mesh has also shown superior resistance to adhesion formation over Mersilene mesh (77% vs 18%, P ⬍ 0.05).81 Another study evaluated the incidence of adhesion formation following LVHR with ePTFE mesh and found only 9% of patients demonstrated significant visceral adhesions.82 Mesh-securing tacks and sutures represent a component of LVHR that may impact adhesion formation but their role has not yet been fully evaluated. Intraperitoneal adhesion formation after LVHR with mesh appears to occur less frequently when “bowelfriendly” meshes, such as PTFE or composite meshes, are used. Reducing or preventing adhesion formation hypothetically will lead to fewer postoperative small bowel obstructions after LVHR, although this correlation has yet to be demonstrated.
Fistulas Enterocutaneous fistulas are a potential source of significant morbidity and mortality (10%) after abdominal surgery and remain a lifelong risk after prosthetic mesh insertion, sometimes occurring up 14 years after implantation.83 Fistula formation after hernia repair is written almost entirely in literature about the open technique.84,85 Fistulas complicating open repair with mesh have been reported secondary to PP, ePTFE, Mersilene, Marlex meshes,36,83,85 while 1 study reported no fistulas in 136 patients undergoing repair with Prolene mesh.37 Reports of fistula formation after LVHR include 1 patient who underwent a PP mesh repair and 3 other patients who had ePTFE mesh implanted.45,60,66 Contrary to the belief that the significant host inflammatory response seen with PP meshes would lead to higher fistula rates when placed intraperitoneally, multiple studies have reported no fistulas after LVHR.32,50,59 Despite the concern of fistula formation in open repair of ventral hernias, fistulas appear to be a rare complication of LVHR. Because of the known lifelong risk of fistula formation after prosthetic mesh implantation and the relatively recent expansion of laparoscopy for hernia repair, it will be necessary to follow these patients to monitor for late development of fistulas.
Mesh options for laparoscopic ventral hernia repair
Conclusions Laparoscopic repair of ventral hernias convey significant advantages over open repair as evidenced by the improved outcomes and significantly fewer complications. Implantation of mesh to correct the fascial defect has also demonstrated an improvement in overall quality of hernia repair compared to primary suture repair. Although many mesh options of various compositions, strengths, and pore sizes are available, the ideal mesh continues to elude manufacturers and surgeons. Additionally, the literature regarding the characteristics and outcomes of available mesh materials does not lend itself to a wholesale recommendation of 1 mesh over any others. Many of the meshes on the market perform exceptionally well with regard to tissue ingrowth, retention of tensile strength, and resistance to adhesion formation and infection with relatively few complications. The introduction of biological materials in recent years represents an exciting time in hernia management. Their combination of excellent tissue ingrowth, effective neovascularization, and ability to clear infections begins to approach the qualities needed for the “ideal” mesh. In this review we present the advantages and disadvantages of meshes currently available for intraperitoneal and LVHR use. An awareness and understanding of the characteristics of the products available allow the surgeon to choose a mesh appropriate for the individual clinical situation.
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