Use Of Biologic Mesh Research Articles

Use of biological meshes in abdominal wall reconstruction. Results of a survey in Germany

Surgical treatment of incisional hernia includes implantation of a mesh. The use of synthetic grafts in contaminated fields results in an increased risk of infection. In these cases a potential advantage is described for biological repair material. Evidence for this problem is lacking; therefore, we initiated a survey among surgeons in Germany concerning this question. A survey concerning indications, experience and techniques of using synthetic and biological meshes was sent to 60 surgical departments. The emphasis of the survey was on the differentiation of clean and contaminated fields. The survey was answered by 42 %. The use of biological repair material was preferred in clean-contaminated, contaminated and soiled fields. Synthetic meshes were preferred in clean, rarely in clean-contaminated and not in contaminated or soiled situations. Primary suture repair was chosen in clean fields and barely in contaminated fields. For closure of giant hernias a component separation technique (CST) was favored by the majority of respondents. A single stage repair was preferred by most of the surgeons even in cases with simultaneous stoma takedown. A total of 72 % of the respondents were satisfied with the use of biological repair material, but the reimbursement was considered to be inappropriate. Although the response rate was low, this survey gives an idea of the attitude towards the use of synthetic and biological meshes. Biological repair material is favored for hernia repair in contaminated or soiled fields. The advantage of this choice is a one stage repair despite the contamination. As the results of this survey are not able to provide arguments for the use of different meshes this question should be further investigated with a randomized controlled trial.

Learning curves in abdominal wall reconstruction with components separation: one step closer toward improving outcomes and reducing complications.

Learning curves are characterized by incremental improvement of a process, through repetition and reduction in variability, but can be disrupted with the emergence of new techniques and technologies. Abdominal wall reconstruction continues to evolve, with the introduction of components separation in the 1990s and biologic mesh in the 2000s. As such, attempts at innovation may impact the success of reconstructive outcomes and yield a changing set of complications. The purpose of this project was to describe the paradigm shift that has occurred in abdominal wall reconstruction during the past 10 years, focusing on the incorporation of new materials and methods. We reviewed 150 consecutive patients who underwent abdominal wall reconstruction of midline defects with components separation, from 2000 to 2010. Both univariate and multivariate logistic regression analyses were performed to identify risk factors for complications. Patients were stratified into the following periods: early (2000-2003), middle (2004-2006), and late (2007-2010). From 2000 to 2010, we performed 150 abdominal wall reconstructions with components separation [mean age, 50.2 years; body mass index (BMI), 30.4; size of defect, 357 cm; length of stay, 9.6 days; follow-up, 4.4 years]. Primary fascial closure was performed in 120 patients. Mesh was used in 114 patients in the following locations: overlay (n = 28), inlay (n = 30), underlay (n = 54), and unknown (n = 2). Complications occurred in a bimodal distribution, highest in 2001 (introduction of biologic mesh) and 2008 (conversion from underlay to overlay location). Age, sex, history of smoking, defect size, and length of stay were not associated with incidence of complications. Unadjusted risk factors for seroma (16.8%) were elevated BMI, of previous hernia repairs, use of overlay mesh, and late portion of the learning curve, with logistic regression supporting only late portion of the learning curve [odds ratio (OR), 4.3; 95% confidence interval (CI), 1.0-18.6] and BMI (OR, 1.17; 95% CI, 1.06-1.29). The only unadjusted risk factor for recurrence was location of mesh. Logistic regression, comparing underlay, inlay, and overlay mesh to no mesh, revealed that the use of underlay mesh predicted recurrence (OR, 3.0; 95% CI, 1.04-8.64). All P values were less than 0.05. The overall learning curve for a specific procedure, such as abdominal wall reconstruction, can be quite volatile, especially as innovative techniques and new technologies are introduced and incorporated into the surgeon's practice. Our current practice includes primary repair myofascial flap of the components separation and the use of biologic mesh as an overlay graft, anchored to the external oblique. This process of outcome improvement is not gradual but is often punctuated by periods of failure and redemption.

Complex ventral hernia repair using components separation with or without biologic mesh: a cost-utility analysis: reply.

BACKGROUND A complex ventral hernia requiring abdominal wall reconstruction presents a challenging scenario to the surgeon. The use of biologic mesh in addition to performing a components separation (CS) is controversial. Our goal was to perform the first cost-utility analysis on the use of biologic mesh in addition to performing CS when performing complex ventral hernia repair. METHODS A comprehensive literature review was conducted to identify published complication and recurrence rates for ventral hernia repairs requiring CS with or without biologic mesh. The probabilities of the most common complications were combined with Medicare Current Procedural Terminology reimbursement codes, diagnosis related group reimbursement codes, and expert utility estimates to fit into a decision model to evaluate the cost utility of CS with and without biologic mesh in reconstructing ventral hernias. RESULTS The decision model revealed a baseline cost increase of $775.65 and a 0.0517 increase in the quality-adjusted life-years when using biologic mesh yielding an incremental cost-utility ratio of $15,002.90/quality-adjusted life-year. One-way sensitivity analysis revealed that using biologic mesh was cost-effective using Medicare reimbursement rates but not at retail costs. The maximum price of biologic mesh to be cost-effective was $1813.53. CONCLUSIONS The cost utility of biologic mesh when used with CS in ventral hernia repair is dependent on the financial perspective. It is cost-ineffective for hospitals and physicians paying retail costs but cost-effective for third-party payers providing Medicare reimbursement.

A Patient-Centered Appraisal of Outcomes following Abdominal Wall Reconstruction

Published assessment tools have attempted to investigate patient-centered outcomes after abdominal wall defect repairs, including quality-of-life measures, functional outcomes, pain assessment, and overall satisfaction scores; however, health-related quality of life following hernia repair remains unclear. The MEDLINE, PubMed, and Cochrane databases were queried and 880 articles were identified. Of these, 22 met inclusion/exclusion criteria. Analysis included health-related quality-of-life metrics focusing on quality of life, pain, physical function, overall satisfaction with surgery, impact of component separation, use of synthetic or biologic mesh, and emotional sequelae of an abdominal wall defect and repair. Twenty-two studies were reviewed; the mean study size was 117.7 patients (range, 14 to 402 patients). Mean and median ventral hernia defect sizes were 104.5 cm and 71.5 cm, respectively. All studies reported open repairs using synthetic mesh. The Short Form-36 was used most often (11 of 22) in comparison to other assessment methods. Patients had global improvement in quality of life, functionality, impact on social function, and patient satisfaction. Hernia recurrence was found to have a major negative impact on quality of life. Midline repair improved overall pain and abdominal wall functionality in both presurgical patients and those with hernia recurrence. Component separation techniques appear to have a positive impact on global health-related quality of life. Adopting an abdominal wall procedure-specific quality-of-life assessment tool as the standard is strongly recommended to gain a comprehensive understanding of abdominal wall defects and repairs. The available literature in open abdominal wall repair suggests an improved quality of life. Therapeutic, III.

Chitosan selectively promotes adhesion of myoblasts over fibroblasts

Treatment of ventral hernias frequently makes use of synthetic and biological meshes, often resulting in scar tissue formation and incomplete muscle regeneration. Chitosan has been shown to promote a regenerative response than a fibrotic response. The objective of this study is to determine the effects of chitosan on myoblast and fibroblast adhesion and the underlying mechanisms. Primary myoblast cells, embryonic fibroblasts, and 1:1 coculture of both cell types were seeded on chitosan-coated and uncoated tissue culture plates. The number of attached cells was measured at 5, 24, 48, and 72 h after seeding. At 5 h after seeding, expression and structural organization of actin, integrin β3, and integrin β1 were analyzed. With chitosan, primary fibroblasts had 2.7 times smaller F-actin fraction, and more primary myoblasts with higher expression of integrin β3 were seen. Moreover, a higher ratio of myoblasts to fibroblasts was seen with chitosan, with a ratio higher than one at 48 and 72 h after seeding and greater than a twofold increase in ratio when compared with uncoated plates. A higher organization of actin and integrin β3 network around nucleus of myoblasts was observed with chitosan, whereas reorganization in actin and integrin β1 network was observed in fibroblasts. In conclusion, chitosan promotes myoblast adhesion with higher expression of integrin β3 and inhibits fibroblast adhesion with reorganization of actin and integrin β1 network.

Biological Mesh in Contaminated Fields—Overuse without Data: A Systematic Review of Their Use in Abdominal Wall Reconstruction

Ventral hernia repair in contaminated fields is a significant problem for surgeons. We performed a systematic review regarding the use of biological mesh in contaminated fields for abdominal wall reconstruction. The primary end points were recurrence and infection of the hernia repair. An independent search of scientific papers in the English language was performed by three reviewers. Articles were chosen based on reference to ventral hernias, their use in infected fields, and in human subjects. Papers were scored using the Methodological Index for Non-Randomized Studies and those with a score of 8 or more were combined to evaluate the end points. A total of 16 studies from six different mesh products met our criteria. These papers comprised 554 patients with an overall infection rate of 24 per cent and a recurrence rate of 20 per cent. The largest study used 116 patients. All papers were case series. Overall the data for use of biological mesh products in contaminated fields are limited. Further controlled studies are needed to address this important and clinically relevant question. Caution should be used when using biological mesh products in infected fields because there is a paucity of controlled data and none have U.S. Food and Drug Administration approval for use in infected fields.

Biologic Versus Nonbiologic Mesh in Ventral Hernia Repair: A Systematic Review and Meta‐analysis

The current standard of treatment for most ventral hernias is a mesh-based repair. Little is known about the safety and efficacy of biologic versus nonbiologic grafts. A meta-analysis was performed to examine two primary outcomes: recurrence and wound complication rates. Electronic databases and reference lists of relevant articles were systematically searched for all clinical trials and cohort studies published between January 1990 and January 2012. A total of eight retrospective studies, with 1,229 patients, were included in the final analysis. Biologic grafts had significantly fewer infectious wound complications (p < 0.00001). However, the recurrence rates of biologic and nonbiologic mesh were not different. In subgroup analysis, there was no difference in recurrence rates and wound complications between human-derived and porcine-derived biologic grafts. Use of biologic mesh for ventral hernia repair results in less infectious wound complications but similar recurrence rates compared to nonbiologic mesh. This supports the application of biologic mesh for ventral hernia repair in high-risk patients or patients with a previous history of wound infection only when the significant additional cost of these materials can be justified and synthetic mesh is considered inappropriate.

A Systematic Review of Outcomes Following Repair of Complex Ventral Incisional Hernias With Biologic Mesh

Repair of contaminated/infected ventral incisional hernias is marked by high rates of recurrence, complications, and/or explantation of synthetic mesh. Biologic mesh products are recommended for repair to permit reconstruction and reduce complications. A systematic review of PubMed, EMBASE, and Cochrane databases identified English-language articles reporting postoperative outcomes (e.g., hernia recurrence, infection, mesh explantation) in patients undergoing contaminated/infected ventral incisional herniorrhaphy. Eleven studies met inclusion criteria and contained quantitative outcome data. All were retrospective chart reviews of biologic mesh use (mostly human acellular dermal matrix). Hernia recurrence and wound infection rates were highly variable and inconsistently reported across studies. Mesh explantation was rarely reported. Outcome variability is likely owing to heterogenous patient populations, surgical technique variations, and follow-up duration. Biologic mesh use in contaminated/infected herniorrhaphy was marked by low reported rates of secondary surgeries for infected mesh removal. Data from large, well-controlled, prospective trials with biologic mesh products are needed.

Multi-staged repair of contaminated primary and recurrent giant incisional herniae in the same hospital admission: A proposal for a new approach

Repair of primary and recurrent giant incisional herniae is extremely challenging and more so in the face of surgical field contamination. Literature supports the single- and multi-staged approaches including the use of biological meshes for these difficult patients with their associated benefits and limitations. This is a retrospective analysis of a prospective study of five patients who were successfully treated through a multi-staged approach but in the same hospital admission, not previously described, for the repair of contaminated primary and recurrent giant incisional herniae in a district general hospital between 2009 and 2012. Patient demographics including their BMI and ASA, previous and current operative history including complications and follow-up were collected in a secure database. The first stage involved the eradication of contamination, and the second stage was the definitive hernia repair with the new generation-coated synthetic meshes. Of the five patients, three were men and two women with a mean age of 58 (45–74) years. Two patients had grade 4 while the remaining had grade 3 hernia as per the hernia grading system with a mean BMI of 35 (30–46). All patients required extensive adhesiolysis, bowel resection and anastomoses and wash out. Hernial defect was measured as 204* (105–440) cm2, size of mesh implant was 568* (375–930) cm2 and the total duration of operation (1st + 2nd Stage) was 354* (270–540) min. Duration of hospital stay was 11* (7–19) days with a follow-up of 17* (6–36) months. We believe that our multi-staged approach in the same hospital admission (for the repair of contaminated primary and recurrent giant incisional herniae), excludes the disadvantages of a true multi-staged approach and simultaneously minimises the risks and complications associated with a single-staged repair, can be adopted for these challenging patients for a successful outcome (* indicates mean).

Outcome of Abdominal Wall Hernia Repair with Permacol™ Biologic Mesh

The use of biologic mesh in abdominal wall operations has gained popularity despite a paucity of outcome data. We aimed to review the experience of a large healthcare organization with Permacol™. A retrospective study was conducted of patients who underwent abdominal hernia repair with Permacol™ in 14 Southern California hospitals. One hundred ninety-five patients were analyzed over a 4-year period. Operations included ventral/incisional hernia repairs, ostomy closures, parastomal hernia repairs, and inguinal hernia repairs. In 50 per cent of the patients, Permacol™ was used to reinforce a primary fascial repair and in 50 per cent as a fascial bridge. The overall complication rate was 39.5 per cent. The complication rate was higher in patients with infected versus clean wounds, body mass index (BMI) 40 kg/m(2) or greater versus BMI less than 40 kg/m(2), in patients with prior mesh repair, and when mesh was used as a fascial bridge. With a mean follow-up of 2.1 years, morbid obesity was associated with a higher recurrence. To date this is the largest study on the use of Permacol™ in abdominal wall hernia repair. In our patient population undergoing heterogeneous operations with a majority of wounds as Class II or higher, use of Permacol™ did not eliminate wound morbidity or prevent recurrence, especially in morbidly obese patients.

Fascia Lata Allografts as Biological Mesh in Abdominal Wall Repair

The use of biological meshes in management of infected abdominal hernias or in abdominal fields at high risk of infection (potentially contaminated or with relevant comorbidities) is well established. Available products include xenogenic patches or decellularized dermal allografts. Despite their biomechanical features, banked fascial allografts have not been investigated yet in this setting. The authors evaluated the safety and effectiveness of banked fascia lata allografts as biological meshes in abdominal wall repair. A consecutive series of patients affected by abdominal wall defects and who were candidates for repair by means of a biological mesh and treated in the authors' institution with banked fascia lata allografts were reviewed retrospectively. Data from clinical and instrumental follow-up evaluations up to 48 months (average, 23 months) were analyzed. Twenty-one patients (aged 1 to 86 years) with abdominal wall defects resulting from traumatic (n = 1), neoplastic (n = 6), or multiple previous laparotomies (n = 14) were treated from January of 2008 to October of 2012. Operations had no relevant postoperative complications. At clinical/instrumental follow-up examinations, no major signs of recurrence, laxity, infection of grafts, or other related pathologic symptoms were recorded. Three patients suffered from temporary minor complications (e.g., wound seroma, partial cutaneous dehiscence). At instrumental (computed tomographic scan or magnetic resonance imaging) evaluations, the neofascial tissue appeared stable until medium-term follow-up (3 to 6 months), later being gradually degraded and apparently replaced by host tissue. According to limited preliminary outcomes, banked fascia lata allografts seem to provide a biocompatible, safe, and effective alternative to other biological meshes. Therapeutic, IV.

Complex Abdominal Wall Reconstruction

Complex abdominal wall reconstruction (AWR) remains challenging. Techniques for repair are numerous and include primary fascial approximation, separation of components (SOC), and use of various biologic and synthetic meshes. Given the vast expanse of available techniques and lack of consistent algorithms, an analysis of outcomes in AWR is presented. A retrospective review was performed of complex AWRs performed by 2 surgeons at a single institution from July 2008 to October of 2011. Outcome differences for hernia repairs specifically addressing SOC with an acellular dermis inlay (retrorectus), underlay, or overlay mesh, as well as interposition biologic mesh placement were included. A total of 66 patients were identified. The average body mass index in this population was 35.5 kg/m. The average age was 53.7 years, with 62% females and 38% males. The overall rate of tobacco use history was 48%. Twenty-eight percent were diabetic. The overall hernia recurrence rate was 16%. Patients having SOC with inlay (retrorectus) mesh had a hernia recurrence rate of 9%. Hernia recurrence in those with SOC and biologic mesh reinforcement as an underlay or onlay was 12%; in those without mesh reinforcement, 22%; and for those with a biologic mesh interposition, 40%. The results of this review show that hernia recurrence rates are decreased with primary fascial repair. Further reduction occurs when biologic mesh reinforcement is used. The lowest recurrence rates were seen in the group with SOC and a porcine biologic mesh inlay. Abdominal wall reconstruction is challenging and with continued outcomes review a refined algorithm can be achieved. Therapeutic: III.

Single-Institution Financial Analysis of Biologic Versus Synthetic Mesh Hernia Repair: A Retrospective Analysis of Patients Readmitted for Hernia Repair.

The advent and proliferation of commercially available biologic mesh material has expanded the repertoire of hernia repair materials available to the surgeon. Given the higher initial cost of these mesh materials relative to synthetic materials such as polypropylene, there has been debate regarding the purported benefit of the use of biologic mesh. This study is a single-institution review of complex hernia repairs using both biologic and synthetic mesh materials. The patients included in the analyses were admitted to the institution at least twice for management of hernia; this permitted specific evaluation of a given diagnosis, hernia, in the same patient, but at different points in time. In a subset of patients, hernia repair was performed upon the second admission with conversion from biologic or synthetic mesh, which had been placed at the initial repair. The objective of this study was to evaluate the financial implications of mesh choice. Specific parameters reviewed included type of mesh used, total costs of hospitalization, direct cost associated with the hernia repair, total collections, and percentage of collections relative to total charges. Through such analysis, our aim was to determine whether there were any variances in revenue and costs associated with the application of either mesh material or the associated clinical scenarios.

Day‐case laparoscopic ventral rectopexy: an achievable reality

Laparoscopic ventral rectopexy (LVR) is a non-resectional technique for selected patients with full-thickness rectal prolapse and obstructed defaecation syndrome. Despite its challenges, LVR can be performed with relatively minimal patient trauma thus creating the potential for same-day discharge. Our aim was to assess the safety of day-case LVR and identify factors associated with same-day discharge. Data were prospectively collected on all patients (n = 120) from June 2008 to October 2011. Variables included demographics, perioperative details and postoperative course. Primary outcome was length of stay and secondary outcome was symptom improvement at the latest outpatient follow-up. Patients discharged the same day after LVR were compared with those who stayed overnight or longer. Indications included rectocele and internal prolapse (47%), full-thickness rectal prolapse (44%) and other (9%). Mean operative time was 97 min, same-day discharge occurred with 23% (n = 27) and 67% (n = 80) were discharged on postoperative day 1. In terms of complications, 89% had none, 8% minor and 3% major, including one 24-h readmission for pain. Logistic regression identified younger age (P = 0.054) and private insurance status (P < 0.001) as being significantly associated with same-day discharge. Although surgical indication (P < 0.001), no prior hysterectomy (P = 0.012) and use of biological mesh (P = 0.012) had significant association they were probably confounded by age. In selected patients with rectal prolapse or obstructed defaecation, same-day discharge after LVR is feasible and safe. Our analysis identified quicker discharge in the private system with younger patients. Nevertheless, in unselected patients 90% were discharged by the first operative day.

Intra-abdominal hypertension and the abdominal compartment syndrome: updated consensus definitions and clinical practice guidelines from the World Society of the Abdominal Compartment Syndrome

PurposeTo update the World Society of the Abdominal Compartment Syndrome (WSACS) consensus definitions and management statements relating to intra-abdominal hypertension (IAH) and the abdominal compartment syndrome (ACS).MethodsWe conducted systematic or structured reviews to identify relevant studies relating to IAH or ACS. Updated consensus definitions and management statements were then derived using a modified Delphi method and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) guidelines, respectively. Quality of evidence was graded from high (A) to very low (D) and management statements from strong RECOMMENDATIONS (desirable effects clearly outweigh potential undesirable ones) to weaker SUGGESTIONS (potential risks and benefits of the intervention are less clear).ResultsIn addition to reviewing the consensus definitions proposed in 2006, the WSACS defined the open abdomen, lateralization of the abdominal musculature, polycompartment syndrome, and abdominal compliance, and proposed an open abdomen classification system. RECOMMENDATIONS included intra-abdominal pressure (IAP) measurement, avoidance of sustained IAH, protocolized IAP monitoring and management, decompressive laparotomy for overt ACS, and negative pressure wound therapy and efforts to achieve same-hospital-stay fascial closure among patients with an open abdomen. SUGGESTIONS included use of medical therapies and percutaneous catheter drainage for treatment of IAH/ACS, considering the association between body position and IAP, attempts to avoid a positive fluid balance after initial patient resuscitation, use of enhanced ratios of plasma to red blood cells and prophylactic open abdominal strategies, and avoidance of routine early biologic mesh use among patients with open abdominal wounds. NO RECOMMENDATIONS were possible regarding monitoring of abdominal perfusion pressure or the use of diuretics, renal replacement therapies, albumin, or acute component-parts separation.ConclusionAlthough IAH and ACS are common and frequently associated with poor outcomes, the overall quality of evidence available to guide development of RECOMMENDATIONS was generally low. Appropriately designed intervention trials are urgently needed for patients with IAH and ACS.Electronic supplementary materialThe online version of this article (doi:10.1007/s00134-013-2906-z) contains supplementary material, which is available to authorized users.

Hiatal hernia repair with biologic mesh reinforcement reduces recurrence rate in small hiatal hernias

The utility of mesh reinforcement for small hiatal hernia found especially during antireflux surgery is unknown. Initial reports for the use of biological mesh for crural reinforcement during repair for defects greater than 5 cm have been shown to decrease recurrence rates. This study compares patients with small hiatal hernias who underwent onlay biologic mesh buttress repair versus those with suture cruroplasty alone. This is a single-institution retrospective review of all patients undergoing repair of hiatal hernia measuring 1-5 cm between 2002 and 2009. The patients were evaluated based on surgical repair: one group undergoing crural reinforcement with onlay biologic mesh and other group with suture cruroplasty only. Seventy patients with hiatal hernia measuring 1-5 cm were identified. Thirty-eight patients had hernia repair with biologic mesh, and 32 patients had repair with suture cruroplasty only. Recurrence rate at 1 year was 16% (5/32) in patients who had suture cruroplasty only and 0% (0/38) in the group with crural reinforcement with absorbable mesh (statistically significant, P = 0.017). Suture cruroplasty alone appears to be inadequate for hiatal hernias measuring 1-5 cm with significant recurrence rate and failure of antireflux surgery. Crural reinforcement with absorbable mesh may reduce hiatal hernia recurrence rate in small hiatal hernias.

The use of Permacol for the reconstruction of a complex thoraco-abdominal wall defect from a recurrent leiomyosarcoma

Complex thoraco-abdominal wall defects following tumor resection create a unique reconstructive challenge, which centers on anatomically re-establishing the thoracic and abdominal compartments to prevent visceral herniation. Autologous tissue may not be available or adequate to reconstruct these defects; therefore, the use of alternative options, such as non-autologous material, is often necessary. To our knowledge, very little has been described about the use of biologic mesh for the reconstruction of large thoracic defects. We present a review of the literature and present a novel approach to address a difficult defect with the use of cross-linked porcine dermal collagen (Permacol) to bridge a thoraco-abdominal defect while stabilizing the diaphragm. Level of Evidence: Level V, therapeutic study.

Multi-staged repair of contaminated primary and recurrent giant incisional herniae in the same hospital admission: a proposal for a new approach

Repair of primary and recurrent giant incisional herniae is extremely challenging and more so in the face of surgical field contamination. Literature supports the single- and multi-staged approaches including the use of biological meshes for these difficult patients with their associated benefits and limitations. This is a retrospective analysis of a prospective study of five patients who were successfully treated through a multi-staged approach but in the same hospital admission, not previously described, for the repair of contaminated primary and recurrent giant incisional herniae in a district general hospital between 2009 and 2012. Patient demographics including their BMI and ASA, previous and current operative history including complications and follow-up were collected in a secure database. The first stage involved the eradication of contamination, and the second stage was the definitive hernia repair with the new generation-coated synthetic meshes. Of the five patients, three were men and two women with a mean age of 58 (45-74) years. Two patients had grade 4 while the remaining had grade 3 hernia as per the hernia grading system with a mean BMI of 35 (30-46). All patients required extensive adhesiolysis, bowel resection and anastomoses and wash out. Hernial defect was measured as 204* (105-440) cm(2), size of mesh implant was 568* (375-930) cm(2) and the total duration of operation (1st + 2nd Stage) was 354* (270-540) min. Duration of hospital stay was 11* (7-19) days with a follow-up of 17* (6-36) months. We believe that our multi-staged approach in the same hospital admission (for the repair of contaminated primary and recurrent giant incisional herniae), excludes the disadvantages of a true multi-staged approach and simultaneously minimises the risks and complications associated with a single-staged repair, can be adopted for these challenging patients for a successful outcome (* indicates mean).

A critical review of biologic mesh use in ventral hernia repairs under contaminated conditions

We used an evidence-based approach to determine whether the promotions and claims of superiority of biologic mesh over synthetic mesh use in ventral hernia repairs (VHRs) under contaminated conditions were sound and valid. We searched the Medline database to specifically identify review articles relating to biologic mesh and VHR and critically reviewed these studies using an evidence-based approach. For the past 45 years, four clinical reviews and one systematic review have included biologic meshes as part of a larger discussion on available prosthetics for VHR. All reviews supported biologic mesh use, especially in the setting of contaminated fields. Yet, the primary literature included in these reviews and served as the basis for these conclusions consisted entirely of case series and case reports, which have the lowest level of evidence in determining scientific validity. Furthermore, the FDA has neither cleared nor approved this particular use. The cumulative data regarding biologic mesh use in VHRs under contaminated conditions does not support the claim that it is better than synthetic mesh used under the same conditions. The highly promoted and at least moderately utilized practice of placing biologic mesh in contamination is being done outside of the original intended use, and a re-evaluation of or possible moratorium on biologic mesh use in hernia surgery is seriously warranted. Alternatively, an industry-sponsored national registry of patients in whom ventral hernia repairs involved biologic mesh would substantively add to our understanding regarding how these intriguing biomaterials are being used and their overall clinical efficacy.

Use of biological mesh versus standard wound care in infected incisional ventral hernias, the SIMBIOSE study: a study protocol for a randomized multicenter controlled trial

BackgroundIn infected incisional ventral hernias (IVHs), the use of a synthetic non-absorbable mesh is not recommended and biological meshes hold promise. However, the level of evidence for their safety and efficacy remains low.MethodsThe SIMBIOSE trial is a multicenter, phase III, randomized, controlled trial comparing the use of a biological mesh versus traditional wound care in patients with an IVH. The primary end point is 6-month infectious and/or wound morbidity. Secondary end points are wound infection and recurrent hernia rates, post-operative pain, quality of life, time to heal, reoperation need, impact of the cross-linked mesh structure, and a medico-economic evaluation. One hundred patients need to be included.ResultsThe main results expected with biological mesh use are a significant decrease of post-operative morbidity, hernia recurrence, time to heal, and costs with an improved quality of life.ConclusionsFor the first time, the impact of biological meshes in the treatment of IVHs will be evaluated in an academic, randomized, phase III trial to provide scientific evidence ( NCT01594450).Trial registrationClinicalTrial.gov, NCT01594450