Hernia (2007) 11:481492 DOI 10.

1007/s10029-007-0282-8

R EV IE W

Choice of mesh for laparoscopic ventral hernia repair

J. R. Eriksen I. Ggenur J. Rosenberg

Received: 5 March 2007 / Accepted: 17 August 2007 / Published online: 11 September 2007 Springer-Verlag 2007

Abstract Background Surgical treatment of ventral hernias has changed dramatically over the past decades by the introduction of laparoscopy and prosthetic biomaterials for reinforcement of the abdominal wall. There are many meshes available on the market for laparoscopic ventral hernia repair (LVHR), and new meshes are introduced regularly. Experimental and clinical documentation for safety and eYcacy are, however, often not available for the clinician. The choice of mesh may therefore be diYcult in clinical practice. We present a review of the current literature regarding safety measures such as adhesions, Wstulas, and infections as well as the available data on pain, recurrence, mesh shrinkage, and seroma formation after LVHR. Methods The literature was searched systematically using PubMed/MEDLINE and EMBASE for controlled studies, prospective descriptive series and retrospective case series. Results The literature clearly points in the direction of very few mesh-related complications after LVHR. Experimental studies and theoretical considerations may argue for using a covered mesh, i.e., a composite mesh, or ePTFE for LVHR in humans, although it is important to stress that there are no human data at the moment to support this. Concerns about using pure polypropylene mesh in the intraperitoneal position may be re-evaluated with the experience of lightweight macropore meshes from open surgery in mind. There is a tendency towards greater shrinkage in ePTFE-based meshes but no diVerences seems to exist between diVerent mesh materials in other relevant outcome parameters from clinical series.

Conclusions The literature cannot give general recommendations for choice of mesh based on randomized controlled trials. The Wnal choice of mesh for LVHR will therefore typically be based on surgeons preference and cost while we await further data from randomized controlled clinical trials. Keywords Ventral hernia Surgical mesh Complications Laparoscopy Review

Introduction Surgical treatment of ventral hernias has changed dramatically over the past decades by the introduction of laparoscopy and prosthetic biomaterials for reinforcement of the abdominal wall. There is increasing evidence and acceptance that laparoscopic ventral hernia repair (LVHR, see Fig. 1) is superior to open repair in terms of postoperative infectious complications, length of stay, recurrence, blood loss, and cosmetic outcome [13]. Insertion of a prosthetic mesh for tension-free closure of the hernia defect is standard for laparoscopic repair. There are many meshes available on the market for LVHR, and new meshes are introduced regularly. A review of complication reports on the use of mesh for hernia repair from the Food and Drug Administrations Manufacturer User Facility Device Experience Database concludes that speciWc mesh materials are related to speciWc complications [4]. Experimental and clinical documentation for safety and eYcacy are, however, often not available for the clinician. The choice of mesh may therefore be diYcult in clinical practice. We present a review of the current literature regarding safety measures such as adhesions, Wstulas, and infections

J. R. Eriksen (&) I. Ggenur J. Rosenberg Department of Surgical Gastroenterology D, Gentofte Hospital, University of Copenhagen, Niels Andersens Vej 65, 2900 Hellerup, Denmark e-mail: jravn@dadlnet.dk

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Products on the market Currently there are more than 70 meshes for hernia repair available on the market. They can be classiWed into diVerent categories according to type of material, composition, and pore size [5]. Typically the meshes are made of one of three basic prosthetic materials: polypropylene (PP), polyester (PE) or expanded polytetraXuoroethylene (ePTFE). The pure PP meshes Prolene, Marlex, Parietene, etc., and the pure PE meshes such as Mersilene are not usually recommended for LVHR. It is generally accepted that pure PP or PE meshes should be covered by a protective membrane/Wlm against the viscera (degradable or non-degradable) to minimize adhesion formation and possible bowel erosion and Wstula formation. These, so-called composite meshes, and the ePTFE mesh as well, are commonly recommended for intraperitoneal use (see Table 1). Newer biological meshes have been introduced for intraperitoneal application, but the clinical experience with these absorbable meshes is limited. PTFE meshes Materials and methods The literature was searched systematically using PubMed/ MEDLINE and EMBASE for controlled studies, prospective descriptive series and retrospective case series. Search terms in the databases were laparoscopic ventral hernia repair and intraperitoneal mesh combined with mesh, pain, adhesions, seroma, recurrence, Wstulas, infection and shrinkage. Any additional relevant studies from the reference lists of these papers were also included. Only human and animal studies published after 1966 in English language were included. Studies with less than 50 patients, letters, editorials and practice guidelines were excluded. The Wrst ePTFE mesh for intraperitoneal use was the GoreTex soft tissue patch, but in 1993 the MycroMesh with pores all way through the mesh was introduced to allow better tissue ingrowth. The two-sided DualMesh was introduced in 1994, and it has afterwards been modiWed with large interstices and an irregular corduroy-like surface on the parietal side to increase tissue ingrowth. The DualMesh is available with incorporated antimicrobial agents (silver clorhexidine Wlm, type Plus). MotifMESH is a new macroporous non-woven mesh of condensed PTFE (cPTFE) for intraperitoneal application. Although the mesh is macroporous (fenestrated) it has a theoretically anti-adhesion barrier because of the PTFE content, but unfortunately no clinical data are available. The thickness of the MotifMESH is reduced by 90% compared with older ePTFE meshes. Composite PE meshes The optimal mesh for LVHR has yet to be found. It should from a theoretical point of view be non-carcinogenic and chemically inactive, cause no inXammation and change in mesh characteristics after tissue contact, cause no allergic or hypersensitivity reaction, be resistant to physical manipulation, and be sterilizable. From the surgeons (and patients) point of view, the optimal mesh should have certain characteristics such as minimal adhesion formation, excellent tissue ingrowth with minimal shrinkage, no infection or Wstula formation and promote minimal pain and seroma formation. Furthermore, it is important that the mesh causes no change in abdominal wall compliance, has a low price, and is easy to manipulate. The Parietex Composite mesh is composed of multiWlament PE with a resorbable collagen-oxidized Wlm made of oxidized atelocollagen type I, polyethylene glycol and glycerol, against the viscera. Composite PP meshes TiMesh is a titanium-coated lightweight (macroporous) PP mesh. Titanium is known for its good biocompatibility and should theoretically reduce adhesions. It is manufactured for intraperitoneal use although it has no real solid anti-adhesion barrier or micro-pore/no-pore site against the

Fig. 1 The operative Weld view in laparoscopic ventral hernia repair. The thin-walled translucent hernia sac is clearly visible because of CO2 pneumoperitoneum

as well as the available data on pain, recurrence, mesh shrinkage and seroma formation after LVHR.

The ideal mesh

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Hernia (2007) 11:481492 Table 1 Meshes recommended for intraperitoneal use (not fulWlling) Group PTFE Name of mesh Mycromesh a,b Dualmesh Composite
a,b

483

Material ePTFE ePTFE cPTFE Polypropylene with beta glucan coat Polypropylene with ORC layer Polypropylene with resorbable layerc
a,b

Company name W. L. Gore W. L. Gore Proxy Biomedical Genzyme Ethicon Genzyme Sofradim Cousin Biotech C. R. Bard C. R. Bard Sofradim Cousin Biotech FEG Textiltechnik GfE Medizintechnik GmbH Atrium Medical Corp.

MotifMESH a,b Glucamesh a,b Proceed a,b Sepramesh a,b Parietene Composite Intramesh T1 b Dulex a,b Composix a,b Parietex Composite a,b Intramesh W3 TiMesh a,b C-QUR a,b
b

Polypropylene with collagen-coating Polypropylene/ePTFE Polypropylene/ePTFE Polypropylene/ePTFE Polyester with collagen-coating Polyester mesh with silicone layer Polypropylene/polyvinyliden Xuoride Polypropylene with titanium coat Polypropylene with omega 3 fatty acid coat

Dynamesh a,b

See Products on the market for detailed information about each mesh a Distributed in USA b Distributed in Europe

bowel loops. Parietene Composite mesh is a woven PP mesh with a protective collagen-oxidized Wlm on the visceral side. Composix mesh consists of a Marlex mesh with a thin layer of ePTFE stitched with polypropylene sutures to the visceral surface. Sepramesh is a polypropylene mesh coated on the visceral side with an absorbable barrier of sodium hyaluronate and carboxymethylcellulose. Proceed mesh is a Prolene soft mesh encapsulated in a polydioxanone polymer Wlm (PDS) covered by a layer of absorbable oxidised regenerated cellulose (ORC). Biological meshes Biological meshes are acellular materials derived from humans or animals with an intact extracellular matrix. They become vascularised and thereby have a theoretical ability to clear infections. Acellular porcine dermal collagen [6] and porcine small intestinal submucosa (Surgisis) has been used in LVHR with promising results [7], but the use of xenogeneic tissue carries a potential risk of immunologic rejection. Allogenic acellular dermal matrix (AlloDerm) can eliminate this risk [8]. Bovine tunica vaginalis and bovine pericardium (Lyoplant) represent other biomaterials tested in animal studies for abdominal wall hernia repair.

describes the size of fenestrations in the mesh and for DualMesh it describes the texture pattern. Macropore meshes (>75 m) gives better tissue ingrowth/host integration whereas a mesh with small pore size (<1075 m) or no pores carries a risk of encapsulation, thus resulting in decreased integration into the abdominal wall (see below). On the other hand, micropore meshes are traditionally thought of as causing a minimal amount of adhesions, while a macropore mesh may result in a disorganized neoperitonealization and therefore potentially cause more adhesions. Thus, not only the prosthetic material used but also the pore size determines the adhesive potential of a mesh. Based on these experimental data, the logic approach in LVHR is to place a macroporous mesh against the parietal peritoneum and a micropore/no-pore side against the viscera. In this context, no-pore refers to bio-Wlms (collagen, cellulose, etc.) and micropore to for example ePTFE. This goal can be obtained with a composite mesh and in some way by using the DualMesh. There are no clinical studies, however, to support this theory, but there are multiple experimental studies available regarding use of intraperitoneal mesh, adhesion formation and degree of host tissue inWltration into the mesh (strength of ingrowth) to support the choice of a two-sided mesh.

Mesh pore size Prosthetic meshes are divided into macro- and micropore meshes according to their pore size [5]. The pore size

Strength of ingrowth The majority of tissue ingrowth and strength take place within 2 weeks after mesh insertion and thereafter increases

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slowly until 3 months postoperatively [9]. The biological response to prosthetic materials can be characterized morphologically by the formation of collagenous tissue, inXammation/foreign body reaction, neoperitonealization and neovascularization. The tissue reaction depends on the inserted prosthetic material and its pore size [10, 11]. Tensiometric tests have been used to determine the strength of ingrowth at the interface between the mesh and the abdominal wall/parietal peritoneum. Some investigators have used hand-held tensiometers, which may conXict with standard measurement conditions [12], and others have used advanced automatic computer-linked Newton meters. All data on this issue are based on experimental animal studies. Anatomical studies have deWned a required maximum limit of tensile strength of 16 N/cm2 to overcome physical demands, and this could be a reference to which future studies should be compared [10]. Many experimental studies have shown the superiority of PP meshes to all other mesh materials regarding strength of ingrowth to the surrounding tissue [13]. DiVerences in host tissue integration between diVerent PP meshes have been shown, but they all had higher tensile strength values than observed for ePTFE [11]. The ePTFE mesh may from a theoretical point of view incorporate less into the host tissue than other materials, because of the no-pore/micropore structure on the parietal side. It has been documented that ePTFE materials have a tendency to encapsulate instead of being integrated into the host abdominal wall [14]. Sepramesh has been compared with ePTFE in two experimental rabbit studies. After 1 month, Sepramesh had 30% stronger strength of incorporation (P = 0.01) [15] but no diVerence could be found after 5 months [16]. Other studies reported signiWcant less strength of mesh integration into the abdominal wall for ePTFE or ePTFE-containing meshes compared with other mesh materials [17, 18]. Comparison of ePTFE to AlloDerm was done in a 9-month follow-up ventral hernia pig model [19]. The AlloDermfascial interface had a signiWcant higher breaking strength than the ePTFEfascial interface (P = 0.04). Another biomaterial, bovine tunica vaginalis, has been shown to have similar long-term tensile strength characteristics as ePTFE, when tested in a rat model. Only one study reported signiWcantly higher meshhost interface strength of ePTFE compared with polypropylene mesh [12]. The study had certain methodological weaknesses. The mesh material was secured to the peritoneal surface of the anterior abdominal wall with continuous sutures and tensiometric testing was done by a hand-held tensiometer as early as on the third postoperative day. A midline laparotomy through a previously inserted mesh may be required if the patient has to undergo abdominal surgery for other conditions. This procedure may alter the meshhost interface integration. PP mesh and ePTFE were compared in an experimental rabbit study to test this

hypothesis. When the ePTFE mesh was cut through a longitudinal incision and repaired with sutures, there was a signiWcant loss of tensile strength compared to PP mesh. Scar tissue fused the cut edges together in the repaired areas of the PP mesh, but the ePTFE mesh was encapsulated without fusion [20]. In conclusion, these experimental data suggest that diVerent mesh materials diVer in their strength of integration into the host tissue, but the clinical relevance of these Wndings are unclear. A hernia recurrence after LVHR due to insuYcient mesh integration is hard to conWrm, because many other factors may inXuence the recurrence rate (Wxation, suYcient overlap, infection, patient-related factors, etc.).

Adhesions After intraperitoneal insertion of a prosthetic mesh, adhesions between the mesh and the greater omentum and/or organs may be formed until neoperitonealization of the mesh is complete in about 1 week [21]. Other factors than the mesh itself, such as Wxation materials, may contribute to the formation of adhesion after LVHR [22]. The tendency of diVerent mesh materials to form adhesions has been investigated in numerous experimental studies, but none of the meshes eliminated adhesion formation completely. Adhesions are often measured in terms of grade (% of mesh covered by adhesions) and type of adhesions (Wlmy, blunt/sharp dissection, solid organ or omental adhesions). Typically, these experimental studies have been performed using small animal models, undersized nonphysiologic mesh sizes and diVerent Wxation methods. It may be questioned whether the results from such small animal models with low intraabdominal pressure, no hernias and open surgical technique can be extrapolated to the clinical situation of LVHR in humans. Small animals Several studies have compared PP mesh with Parietene Composite, Sepramesh, DualMesh, Parietex, Composix and porcine dermal collagen (Permacol), and pure PP meshes were associated with signiWcantly more adhesions in all studies. Sepramesh was compared to DualMesh in three studies. In the studies by Johnson et al. [16] and Young et al. [15] there were no diVerence in adhesion formation but in the study by Matthews et al. [23] DualMesh formed less adhesions. Sepramesh was found superior to Composix mesh regarding adhesion formation in a rabbit ventral hernia model [11]. Another study by Gonzalez et al. [24] showed Parietex and Parietene Composite to produce fewer adhesions than Sepramesh.

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485

A recent experimental study in 200 rats compared the majority of meshes available for LVHR [17]. A 2.5 3.5 cm pieces of the following meshes were tested: Prolene, DualMesh, Ultrapro, TiMesh, Sepramesh, Parietex Composite, Proceed and Tutomesh. Adhesion formation was evaluated on day 7 and 30 post-implantation. Tutomesh, Sepramesh and Parietex Composite showed the smallest amount of adhesions on day 30. Harrell et al. [25] implanted 44 cm pieces of mesh in 30 rabbits and adhesion formation was assessed after 1, 4, 8 and 16 weeks through a 2 mm laparoscope. DualMesh had signiWcantly less adhesions than Proceed, Composix and Marlex at all times. There were no diVerence in adhesions between Proceed and Composix mesh. Another newly published adhesion study in rabbits showed signiWcantly lower adhesion degrees with Proceed and ePTFE mesh compared with Mersilene, Prolene and Vypro mesh, measured 4 weeks post implantation [26]. Large animals Only a few experimental studies have been performed in large animals with proper mesh size and laparoscopic technique. In one study, eight pigs had Prolene, Parietex and DualMesh meshes placed in the intraperitoneal position and the outcome parameters were measured after 4 weeks. The Parietex mesh produced the fewest adhesions [18]. A recent study by DuVy et al. [27] compared Composix and Parietex Composite mesh in eight pigs after 4 weeks follow-up. Through a mini-laparotomy, bowel abrasion was performed prior to laparoscopic placement of 10 15 cm mesh pieces. The Parietex mesh induced a signiWcantly smaller area of adhesions and less adhesion density than the Composix mesh. In another recent study comparing TiMesh and DualMesh after 3 months follow-up, there was no diVerence in adhesion formation [28]. Likewise, no diVerence in adhesion formation between ePTFE and AlloDerm was found in a pig study evaluated 3 and 9 months post implantation [19]. The largest laparoscopic animal study regarding adhesion formation was performed in 21 pigs [29]. DualMesh, Sepramesh and Prolene mesh was tested and Sepramesh had signiWcantly fewer adhesions on day 28 than PP mesh. No signiWcant diVerence between Prolene/DualMesh or Sepramesh/DualMesh was found. The hypothesis that the amount of PP material inXuences the amount of adhesions formed (because of diVerent local inXammatory response in light- and heavy weight PP meshes) was tested in a pig study (n = 20) by Zieren et al. [30]. They found no diVerence in adhesion formation between lightweight Vypro mesh (macropore PP) and heavy-weight Prolene (micropore PP) mesh in the intraperitoneal position.

Human studies Few studies concerning intraperitoneal adhesions after LVHR have been published. In a prospective ventral hernia study by Balique et al. [31], 29 of 80 patients had a laparoscopic operation using Parietex mesh. Adhesion formation was evaluated 12 months after surgery by ultrasound (US) examination. The validation of the US method was performed by comparing a preoperative US examination with the perioperative Wndings, and showed a negative predictive value of 85% and a positive predictive value of 67%. Evaluated by this method, it was shown that 86% of the patients were adhesion-free after 12 months. Moreno-Egea et al. [32] used Parietex mesh in 86 consecutive patients. They found that nearly 95% of the patients were adhesionfree 3 years after LVHR. The dynamic ultrasound technique has also been used by others. After laparoscopic ventral hernia repair with PP mesh and omental interposition 65% of the patients were adhesion-free after 14 months follow-up and only one patient had visceral adhesions [33]. In a case-control study, patients with intraperitoneal Parietex and Mersilene mesh was compared [34]. Seventyseven percent of the patients in the Mersilene group exhibited visceral adhesions to the mesh compared with 18% in the Parietex group (P < 0.001). In a retrospective uncontrolled study, Kohler et al. [35] measured the occurrence of adhesions to ePTFE mesh at reoperation in patients who previously had a LVRH. Sixty-Wve patients where operated by nine diVerent surgeons in a 10-year follow-up period. Ninety-one percent of the patients were described having no or only Wlmy intraabdominal adhesions at the reoperation. A correlation between mesh induced intraabdominal adhesions and ileus or Wstulas after LVHR has not been shown, although small bowel obstruction after LVHR has been reported in diVerent series [36]. The causes of obstruction were adhesions to Wxation materials (tacks), interposition of small bowel between the abdominal wall and the mesh and Wbrinous adhesions to the mesh, among others. In conclusion, the literature supports a tendency towards fewer adhesions when using composite meshes or ePTFE for LVHR. However, the clinical relevance of adhesions after LVRH is not known and experimental studies of adhesions after LVHR may be a surrogate outcome parameter for safety. Of more clinical concern is ingrowth into the mesh, because it leads to diYcult re-operations if necessary and potential Wstula formation.

Fistulas Formation of an enterocutaneous Wstula is a serious complication with a mortality rate up to 10% [37]. Concerns about

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increased risk of Wstula formation when using pure PP and PE mesh in the intraperitoneal position have been evoked by the publication of a few case reports and uncontrolled retrospective series in open ventral hernia repair [37, 38]. The often-cited study by Leber et al. [38] was a retrospective study in 200 patients after open incisional hernia repair. Sixty percent of the operations were performed with an onlay technique and diVerent meshes were used (Marlex, Prolene and ePTFE). Five Wstulas were reported after Mersilene mesh (pure PE) compared with no Wstulas after the other meshes (P = 0.02). Colocutaneous Wstula due to PP mesh, Mersilene and ePTFE [39] has been reported, and Wstula formation has been reported up to 14 years after open repair with a Marlex mesh [40]. Mesh-related Wstulation is a late complication and may be a life-long risk after insertion of a prosthetic mesh. On the other hand, Vrijland et al. [41] found no Wstulas after open ventral hernia repair with Prolene mesh placed intraperitoneally in 136 patients with a median follow-up period of 34 months. The above-mentioned situation in open repairs does not apply for most cases of elective laparoscopic ventral hernia repair. Although, pure PP mesh is not routinely used for LVHR in Europe and the USA, it is still used in other parts of the world. In this context it is interesting that Wstulas has been reported several times after open and laparoscopic inguinal hernia repair with PP mesh and after plug-repair with PP material in umbilical hernia. Only four cases of Wstulas have been reported after LVHR and none of these have been published as speciWc case reports. A colocutaneous Wstula after ePTFE mesh insertion has been reported by DeMaria et al. [42]. Bageacu et al. [43] reported 2 enterocutaneous Wstulas in 159 patients reviewed retrospectively with a 49 months follow-up period. Both PP and ePTFE mesh were used. Carbajo et al. [44] reported a small-bowel Wstula with ePTFE mesh in a large prospective study with a 44 months follow-up period. These Wstulas may have developed from tacks or missed/delayed serosal bowel injuries and not from the mesh itself. Large prospective and retrospective studies (n = 736) with pure PP mesh placed in the intraperitoneal position have not shown any Wstulas [4547]. However, the followup period in these studies is limited (range 3247 months) but comparable to other series with diVerent mesh types (see Table 2). The only study that has addressed a correlation between a speciWc mesh (Composix mesh) and Wstulas was based on 252 voluntarily reports of adverse meshrelated events to the FDA database from 1996 to 2004 [4]. Detailed information about patients, type of surgery, potential contamination and total number of operations using speciWc meshes was unknown. It is possible that reports of Wstulas with pure PP and PE mesh (after open repair) represents a positive publication bias, over-reporting Wstulas, as these meshes have been

used for a much longer time period than other mesh types. The mechanism of Wstula formation after open versus laparoscopic ventral hernia repair may also diVer because of the increased risk of mesh infection in open repair. Nevertheless, prospective studies regarding Wstula formation with a long follow-up period after LVHR are missing. Based on the sparse literature on mesh-related Wstulas there are no data to support abandoning PP meshes for intraperitoneal use in LVHR.

Infection Although many surgeons routinely administer a single prophylactic dose of antibiotic preoperatively to reduce infectious complications after LVHR, no studies support its use. A meta-analysis from 2006 could not show any eVect of antibiotic prophylaxis after groin hernia surgery (open and laparoscopic) and no valid conclusion could be made for LVHR because no high-quality studies were available [68]. In general, adherence of bacteria to the mesh is needed to produce an infection. The greater total surface area in a multiWlament based mesh (for example PE based meshes) will theoretically increase the risk of bacteria adherence as known from studies comparing multiWlament versus monoWlament sutures [69]. However, regarding intraperitoneal mesh placement, no diVerence in infection rate after experimental contamination of mono- and multiWlament meshes with Staphylococcus aureus in rats was found [70] but micropore mesh material has been associated with higher infection rates, compared with macropore mesh materials [5]. This was explained by the bacterias adhesion and penetration of the small pores, which cannot be penetrated by leukocytes, thus protecting it from immunological clearance. In a recent experimental study, seven diVerent meshes were tested for resistance against inoculation with Staphylococcus aureus. After 5 days the rats were sacriWced and meshes were investigated. DualMesh Plus showed to be least susceptible to bacterial adhesion compared with AlloDerm, DualMesh, Sepramesh, Surgisis, Composix and Marlex mesh [71]. The use of antibioticimpregnated meshes has not been investigated in randomized human trials and the clinical relevance is unknown. The incidence of mesh infection varies between 6 and 9% after open ventral hernia repair [39, 41]. The ePTFE mesh had a signiWcant higher infection rate than Marlex mesh in a controlled retrospective study (n = 37) published by Diaz et al. [72] in 2004. The mesh infection rate after LVHR has been reported to be from 0 to 3.6% (see Table 2). A large prospective study (n = 850) by Heniford et al. [67] using ePTFE mesh reported a mesh infection rate of 0.6% and Franklin et al.

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Hernia (2007) 11:481492 Table 2 Published series of laparoscopic ventral hernia repair with 50 or more patients No. of patients 50 53 56 79 85 86 86 96 97 100 100 103 140 144 146 150 150 159 170 178 200 202 208 270 277 384 850 References Follow-up (months) 19 12 24 34 18 42 37 30 3 6.5 19 26 40 7 27 32 15 49 25 29 36 35 24 44 21 47 20 Mesh materiala Parietex ePTFE ePTFE ePTFE ePTFE Parietex ePTFE ePTFE ePTFE ePTFE ePTFE ePTFE ePTFE ePTFE ePTFE PPM ePTFE PPM, ePTFE ePTFE Parietex ePTFE PPM PPM/ePTFE. ePTFE ePTFE ePTFE PPM ePTFE Pain (%) c c 3.6 3.8
c c

487

Recurrence (%) 2 1.8 10.7 5 3.5 3.5 7 17 6 2 2 3.9 2.1 4 5.8 3 2.7 15.7 5.9 2.5 4 1 1.4 4.4 4.7 2.9 4.7

Seroma (%) 10 c 3.6 3.8 9 5.8 14.1 4 13 1 11

c

LOS (days) 2 3.3 3.4 1.7 4

c

Infection (%)b 0 1.9 3.6 0 c c 0 2.1 c 2 c 1.9 c 1.4 0.7 c 0 0 1.8 0.6 1.5 c 0 0 0.7 0.3 0.6

Lomanto [48] Kyzer [36] Park [49] Eid [50] Sanchez [51] Moreno-Egea [32] Aura [52] Rosen [53] Ujiki [54] Bower [55] Ben-Heim [56] Kirshtein [57] Morales-Conde [58] Toy [59] Topart [60] Yavuz [45] Berger [61] Bageacu [43] McKinlay [62] Olmi [63] LeBlanc [64] Cowbey [47] Frantzides [65] Carbajo [44] Cobb [66] Franklin [46] Heniford [67]

5.9 c 3 c
c c

4.8 1.8 2 5 3 c 2 4.9 2.5 9 3.5 2.2 2.1 1.25 1.8 1.4 1.5 3 2.9 2.3
c

c c 20.7 1.3
c

2.1 16 8 3 93 15.9 3.5 4.4 7.5 1832 c 11.8 0.7 3 2.6

26 1.2 1.9 4.5 c c 7.4 3.2 2 1.6

LOS length of stay in hospital, PPM polypropylene mesh, ePTFE expanded polytetraXuoroethylene a Predominant mesh used b Requiring mesh removal c Not speciWed

[46] reported a 0.3% infection rate using mainly PP mesh in a prospective study with 47 months follow-up period. Three randomized trials comparing open and laparoscopic repair of incisional hernias all showed signiWcantly fewer infectious complications in the laparoscopic groups [13]. These Wndings are comparable to many non-randomized controlled series [73]. In the study by Beldi et al. [73] 92 consecutive patients had an open ventral hernia repair using Vypro mesh and 49 consecutive patients had LVHR using a Parietene Composite mesh. In the open group 13 patients had a surgical site infection compared with one in the laparoscopic group (P = 0.03). Mesh placement in potentially contaminated Welds is another problem that surgeons have to consider in some patients. In situations of removal of an infected mesh, operation for strangulated hernia or LVHR plus another simul-

taneously performed procedure, insertion of a mesh is not generally recommended because of the risk of infectious complications. Biological meshes are absorbable and without permanent foreign body material and may be an alternative in these situations. Franklin et al. [7] published a series of 58 laparoscopic hernia repairs (mostly ventral hernias) using Surgisis with a 19 months median follow-up period. Fifty-six percent of the procedures were performed in potentially or grossly contaminated Welds and there were no reported mesh-related complications. AlloDerm has also been used successfully in the closure of contaminated abdominal hernias [8] and Cobb et al. [6] published a series of 55 LVHRs using cross-linked acellular porcine dermal collagen matrix (CPDC). This group was compared to a historical group with PP/ePTFE composite mesh. No infectious complications were observed in the CPDC-group but

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in the control group three meshes had to be removed due to infection. It seems obvious that open ventral hernia repair carries a substantial risk of infection and subsequent removal of the mesh compared with the laparoscopic technique. The protective mechanism of the peritoneal cavity against infection may be of major importance and could explain the lower infection rate observed in LVHR. No randomized clinical study comparing diVerent mesh materials and their susceptibility to infection in LVHR has been published.

LVHR in order to rationalize further controlled interventional studies to improve outcome after LVHR.

Recurrence Numerous uncontrolled personal series of LVHR have been published. The recurrence rates vary between 1 and 17% with a mean rate of 4.5% (208 recurrences in 4,574 LVHRs, see Table 2). Many of the studies have been published by enthusiastic surgeons within the Weld of LVHR and it may therefore be diYcult to extrapolate these results to daily clinical practice. There are no obvious link between the reported recurrence rates and the mesh material used. No experimental animal studies or human studies comparing diVerent mesh materials regarding recurrence have been published. Such studies are indeed diYcult to perform because the cause of hernia recurrence after LVHR may be multi-factorial. Patients co-morbidity, hernia size, wound infection, steroid use, previous hernia repair, surgical technique and improper mesh Wxation with insuYcient mesh overlap (minimum 3 cm) at the fascial margin of the hernia may be factors of importance. The only study published is an experimental rat study comparing ePTFE and PP mesh in open repair [75]. The authors found signiWcantly higher recurrence rate when ePTFE was used after 8 weeks. By histological examinations the authors were able to conclude that insuYcient ingrowth of Wbrocollagenous tissue into the ePTFE mesh caused the reherniations. In conclusion, no obvious diVerence in recurrence rate exists between diVerent mesh materials, but no randomized trials have been conducted so far. Since the mesh material seems to be of minor importance in terms of hernia recurrence after LVHR, studies should be conducted to test whether transfascial sutures reduce the recurrence rate.

Postoperative pain No studies have focused speciWcally on pain after LVHR. Postoperative pain has been described in many descriptive studies with incidences up to 26% (see Table 2). Often, clear deWnitions of pain, pain location, method and time of pain measurement and prescribed postoperative medication were not described. Studies with detailed measurement of postoperative pain and convalescence after LVHR are obviously needed. An indirect measure of postoperative pain could be the length of stay in hospital which varies between 1 and 9 days in the published series (Table 2). Some authors have described successfully planned outpatient LVHR with low readmission rates. Whether the mesh itself contributes to pain after LVHR as a result of local inXammation and the bodys reaction to the foreign material is unclear, but there is no evidence that one type of mesh causes more pain than others. The impact of polypropylene amount in the mesh on postoperative pain/discomfort has been investigated for open incisional hernia repair and Lichtenstein hernia repair. In these procedures there was a tendency towards less chronic pain when lightweight meshes were used. LeBlanc et al. [74] reported two cases with persistent pain after intraperitoneal Composix mesh placement. Both meshes were removed and replaced with ePTFE meshes. The patients recovered uneventfully without pain. Mechanical Wxation devices may also cause postoperative pain, but again, no comparative study between diVerent Wxation techniques has been conducted in LVHR. Transfascial sutures for additional mesh Wxation are used by several surgeons and have been found as a likely explanation for prolonged pain (>68 weeks) after LVHR in some patients. This problem has been solved by local anaesthetic injections or even laparoscopic removal of suture material [73]. Mesh contraction/shrinkage resulting in tension on the abdominal wall could be another cause of chronic pain, but this hypothesis has not been investigated. Thus, pain after LVHR may be considerable and has to be included in patient information and planning of the perioperative regimen for this patient category. Future studies should in detail describe pain patterns after

Seroma In LVHR a mesh is placed to cover the hernia defect. The hernia sac is left untouched and thereby Xuids can collect in the subcutaneous dead space/hernia sac resulting in a seroma. Host inXammatory reaction to the implanted material and haematoma may contribute to the formation of a seroma. Micropore meshes may have a higher tendency to form seromas than macropore materials, because passive drainage of the Xuid to the peritoneal cavity through the mesh is diminished, but no study conWrms this theory. The incidence of seroma formation after LVHR is extremely varying and is reported to be between 0.7 and 93% (see Table 2). Such varying incidence is primarily due to heterogeneous deWnitions and methods of measuring seromas and the time of measurement after the operation.

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No randomized or prospective controlled trials have been conducted comparing diVerent mesh materials and their susceptibility to form seromas. Thus, there is no evidence that certain mesh types result in higher seroma rates than others. When ultrasound examination is used to detect seromas, Susmallian et al. [76] showed that all patients undergoing LVHR with ePTFE mesh developed a seroma in the Wrst postoperative week. Symptomatic seroma causing abdominal discomfort and pain was detected by clinical examination in 35% of the patients and 20% of the patients had persistent seromas after 3 months. In another prospective study seromas were measured by computer tomography scan (CT scan). One-week postoperatively 95% of the patients had a seroma and all seromas disappeared within 3 months after LVHR [77]. Tsimoyiannis et al. [78] showed in a randomized trial in 51 patients undergoing LVHR with ePTFE mesh that intraoperative electro-coagulation at the hernia sac reduced seroma formation from 25 to 4%, detected by clinical examination and CT scan. In the largest series by Heniford et al. [67] 2.6% of the patients had prolonged seromas. Therefore, seroma formation still remains an important clinical problem in a few patients after LVHR and randomized clinical trials, testing diVerent prophylactic procedures should be performed.

for PE mesh, P < 0.006 [80]. One retrospective human study evaluating mesh shrinkage at open re-operation after primary open ventral hernia repair in 77 patients has been published [82]. Fifty-eight percent of micropore PP mesh, 5% of macropore PP mesh and 57% of ePTFE meshes were noted to be heavily shrunken at the time of reoperation. To conclude, most mesh materials undergo some degree of shrinkage after implantation in living tissue. Mesh shrinkage has been related to hernia recurrence and the degree of shrinkage varies between diVerent mesh materials with a tendency towards most shrinkage occurring after ePTFE implantation. The causal factors behind mesh shrinkage are not fully known, but contraction as a consequence of the physiological wound healing process, pore size and weight of the mesh (total mesh material) may play a role [81]. The shrinkage of speciWc mesh materials may have implications for the overlap needed to adequately repair a ventral hernia.

Future Through the years, great eVort has been put into the challenge of creating a mesh that completely fulWls the criterias for the ideal mesh. Biologic mesh materials have been introduced and the preliminary results are encouraging. These acellular materials have an intact extracellular matrix that facilitates the ingrowth of connective tissue thus improving the strength of mesh integration. Furthermore they become vascularised and thereby have the theoretical ability to clear bacteria growth/infections. Unfortunately, biologic meshes are quite expensive at the moment. In the future, bioactive meshes with local drug release such as growth factors may be introduced to further optimize mesh integration.

Shrinkage The tendency of prosthetic materials to shrink/contract over time has been studied in several animal studies. The phenomenon is a well-known clinical observation at reoperation in patients with formerly inserted mesh. Though, some authors have questioned if all materials shrink when implanted in the human body and some may even expand, as shown by structural alterations in the size of the mesh pores when aVected by diVerent (body) Xuids [79]. Three small animal studies with small mesh sizes (2.5 4 cm in diameter) showed signiWcantly greater shrinkage of ePTFE mesh compared with other mesh types (Proceed, Marlex and Composix [25], Proceed, Prolene, Ultrapro, TiMesh, Sepramesh and Parietex [17] and Sepramesh [16]). Two laparoscopic studies with intraperitoneal insertion of more clinical relevant mesh sizes (10 15 cm) have been conducted in pigs, and the results were similar. The ePTFE mesh shrank 37% compared with Parietex (21%) and PP mesh (6%) (P < 0.001) after 1 month [18], and 44% after 3 months compared with TiMesh (18%) (P < 0.006) [28]. A 5-months follow-up study in rabbits showed 51% shrinkage of ePTFE mesh [16]. In another experimental study with PP materials tested for shrinkage in the extraperitoneal position, shrinkage was measured to 3346% [80, 81] compared with 13%

Conclusions The literature clearly points in the direction of very few mesh related complications in LVHR. There have been reports of major complications such as Wstulas and mesh infections, but the incidence of these complications seems relatively low compared to open repair, regardless of the type of mesh used. Experimental studies and theoretical considerations may argue for using a covered mesh, i.e., a composite mesh, or ePTFE for LVHR in humans, although it is important to stress that there are no human data at the moment to support this. Concerns about using PP mesh in the intraperitoneal position may be re-evaluated with the experience of lightweight macropore meshes from open surgery in mind. This mesh has resulted in less pain, induces less inXammation

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Hernia (2007) 11:481492 prostheses in the reparative scarring process of abdominal wall defects. Histol Histopathol 12:683690 Young RM, Gustafson R, Dinsmore RC (2004) Sepramesh vs. Dualmesh for abdominal wall hernia repairs in a rabbit model. Curr Surg 61:7779 Johnson EK, Hoyt CH, Dinsmore RC (2004) Abdominal wall hernia repair: a long-term comparison of Sepramesh and Dualmesh in a rabbit hernia model. Am Surg 70:657661 Burger JW, Halm JA, Wijsmuller AR, ten Raa S, Jeekel J (2006) Evaluation of new prosthetic meshes for ventral hernia repair. Surg Endosc 20:13201325 McGinty JJ, Hogle NJ, McCarthy H, Fowler DL (2005) 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 19:786790 Silverman RP, Li EN, Holton LH III, Sawan KT, Goldberg NH (2004) Ventral hernia repair using allogenic acellular dermal matrix in a swine model. Hernia 8:336342 Bellon JM, Contreras LA, Bujan J, Pascual G, Carrera-San Martin A (1999) EVect of relaparotomy through previously integrated polypropylene and polytetraXuoroethylene experimental implants in the abdominal wall. J Am Coll Surg 188:466472 Matthews BD, Pratt BL, Backus CL, Kercher KW, Heniford BT (2002) Comparison of adhesion formation to intra-abdominal mesh after laparoscopic adhesiolysis in the New Zealand White rabbit. Am Surg 68:936940 Memisoglu K, Saribeyoglu K, Pekmezci S, Karahasanoglu T, Sen B, Bayrak I, Arbak S, Sirvanci S (2006) Mesh Wxation devices and formation of intraperitoneal adhesions. J Laparoendosc Adv Surg Tech A 16:439444 Matthews BD, Mostafa G, Carbonell AM, Joels CS, Kercher KW, Austin C, Norton HJ, Heniford BT (2005) Evaluation of adhesion formation and host tissue response to intra-abdominal polytetraXuoroethylene mesh and composite prosthetic mesh. J Surg Res 123:227234 Gonzalez R, Rodeheaver GT, Moody DL, Foresman PA, Ramshaw BJ (2004) Resistance to adhesion formation: a comparative study of treated and untreated mesh products placed in the abdominal cavity. Hernia 8:213219 Harrell AG, Novitsky YW, Peindl RD, Cobb WS, Austin CE, Cristiano JA, Norton JH, Kercher KW, Heniford BT (2006) Prospective evaluation of adhesion formation and shrinkage of intra-abdominal prosthetics in a rabbit model. Am Surg 72:808 813 Kiudelis M, Jonciauskiene J, Deduchovas O, Radziunas A, Mickevicius A, Janciauskas D, Petrovas S, Endzinas Z, Pundzius J (2006) EVects of diVerent kinds of meshes on postoperative adhesion formation in the New Zealand White rabbit. Hernia (Epub ahead of print) DuVy AJ, Hogle NJ, LaPerle KM, Fowler DL (2004) Comparison of two composite meshes using two Wxation devices in a porcine laparoscopic ventral hernia repair model. Hernia 8:358364 Schug-Pass C, Tamme C, Tannapfel A, Kockerling F (2006) A lightweight polypropylene mesh (TiMesh) for laparoscopic intraperitoneal repair of abdominal wall hernias: comparison of biocompatibility with the DualMesh in an experimental study using the porcine model. Surg Endosc 20:402409 Borrazzo EC, Belmont MF, BoVa D, Fowler DL (2004) EVect of prosthetic material on adhesion formation after laparoscopic ventral hernia repair in a porcine model. Hernia 8:108112 Zieren J, Neuss H, Ablassmaier B, Muller JM (2002) Adhesions after intraperitoneal mesh repair in pigs: Prolene vs. Vypro. J Laparoendosc Adv Surg Tech A 12:249252 Balique JG, Benchetrit S, Bouillot JL, Flament JB, Gouillat C, Jarsaillon P, Lepere M, Mantion G, Arnaud JP, Magne E, Brunetti F (2005) Intraperitoneal treatment of incisional and umbilical

because of less implanted mesh material and thereby potentially forms fewer adhesions. Thus, the literature can not give general recommendations for choice of mesh based on randomized controlled trials and no diVerence seems to exist in relevant outcome parameters from clinical series between diVerent mesh materials. The Wnal choice of mesh for LVHR will therefore typically be based on surgeons preference and cost while we await further data from randomized controlled clinical trials.

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