TY - JOUR
AU1 - Fortelny, R H
AU2 - Petter-Puchner, A H
AU3 - Glaser, K S
AU4 - Offner, F
AU5 - Benesch, T
AU6 - Rohr, M
AB - Abstract Background Polyvinylidene fluoride-coated polypropylene meshes have been developed specifically for intraperitoneal onlay mesh repair. They combine a macroporous design with biomechanical characteristics compatible with the abdominal wall and are reported to have favourable antiadhesive properties. This retrospective study reports complications related to one of these materials, DynaMesh®. Methods Twenty-nine patients underwent intraperitoneal onlay mesh repair with DynaMesh® at one of two hospitals. Patients characteristics, surgical procedures and postoperative analgesia were comparable at both sites. Results Six patients developed DynaMesh®-related complications that required surgical reintervention by laparotomy within 1 year of operation. Surgical reintervention was for adhesions in five patients and the mesh had to be explanted in three. One mesh was explanted because of early infection. Adhesions to DynaMesh® were found in two patients who had surgery for unrelated reasons. Conclusion Laparoscopic intraperitoneal onlay DynaMesh® repair was associated with a high rate of complications. Introduction Intraperitoneal onlay mesh repair has become an accepted treatment for incisional hernia1. The laparoscopic approach has distinct advantages over open repair techniques. These include detection of multiple occult defects, a reduced risk of mesh infection and closure of large defects when approximation of fascial edges cannot be achieved2,3. The efficacy and safety of intraperitoneal onlay mesh repair is dependent on the development of improved meshes and fixation devices. Expanded polytetrafluoroethylene (ePTFE) meshes have been used widely in intraperitoneal onlay mesh repair. However, because of their susceptibility to infection and moderate tissue integration they have now largely been replaced by modern coated meshes4. These meshes have good biocompatibility and antiadhesive properties, but are not transparent and do not allow a direct view of the defect, which may impair correct placement. Any coating is challenging for the application of new non-traumatizing fixation devices, such as fibrin sealant5,6. Suture fixation without harming the antiadhesive barrier can also be difficult and the impact of these mechanical barriers on tissue integration of the implant is not known7. Macroporosity and low weight improve tissue integration8. Macroporous meshes with fibrin sealant fixation have been used successfully in inguinal hernia repair6,9–11. The polyvinylidene fluoride (PVDF)-coated polypropylene (PP) mesh presented in this report is a macroporous mesh for intraperitoneal onlay mesh repair12,13. DynaMesh® (Dahlhausen, Cologne, Germany) is one of three macroporous meshes for intraperitoneal onlay mesh repair on the European market (others are TiMesh® strong, GfE, Nuremberg, Germany; and MotifMESH™, Proxy Biomedical, Galway, Ireland)13–17. DynaMesh® is a weight-reduced implant weighing 108 g/m2, in which PVDF fibres (visceral side) are interlinked with PP fibres (parietal side). The mesh was designed to prevent adhesions, but simultaneously to trigger the moderate initial inflammatory reaction required for fast implant integration. The present study reports the authors' initial experience with intraperitoneal onlay mesh repair using the PVDF-coated PP DynaMesh®. Methods The study included 29 patients who underwent intraperitoneal onlay mesh repair for incisional hernia under general anaesthesia consecutively at one of two hospitals. The ethics committees of the participating hospitals agreed to data processing without obtaining retrospective written informed consent, but one patient consented to publication of his histological data. Surgical procedures Before operation 1500 mg Curocef® (Glaxo Wellcome, Bad Odersloe, Germany) was administered as single-shot antibiotical prophylaxis. Intraperitoneal onlay mesh repair was carried out by experienced surgeons using DynaMesh® via a minilaparotomy with pneumoperitoneum of 11 mmHg. The operation was performed by a three-port technique with one 10-mm and two 5-mm trocars placed according to the location and size of the hernia. After visualization of the hernia, adherent bowel and omentum was dissected. The defect was not closed and the mesh size required for a minimum overlap of 5 cm was marked with transfascial injection needles (Braun, Melsungen, Germany). In addition, the defect was palpated under laparoscopic vision, measured on the external abdominal wall and marked with a sterile pen. Tailoring of the DynaMesh® was avoided to prevent sharp margins. Non-resorbable sutures (2/0 Gore-Tex®, W. Gore, Flagstaff, Arizona, USA; or 2/0 Prolene®, Ethicon, Norderstedt, Germany) were placed every 5 cm around the circumference of the DynaMesh® before intra-abdominal placement. The mesh was then inserted via a trocar and placed over the defect. The correct position was verified through the pores of the mesh and by reference to the position of the needles. The sutures were then pulled with a suture passer device (Ethicon) and tied in the subcutaneous layer. Subsequently, the pneumoperitoneum was reduced to 8–9 mmHg to approximate the mesh to the peritoneum. Then the mesh was fixed circumferentially with spiral tacks (ProTack™; Covidien, Neustadt, Germany) at 1-cm intervals; the mesh corners were also fixed. In some patients the tacks were covered with fibrin sealant (Tissucol®; Baxter Biosciences, Vienna, Austria) to avoid adhesion formation. No sutures were placed suprapubically and only single sutures or tacks were used with care under the rib cage to prevent perforation of neighbouring structures. The operating field was inspected and trocars were removed under laparoscopic vision. Incisions were closed in anatomical layers. No drains were placed. Statistical analysis To rule out differences between patients operated on in the two units, Fisher's exact test was used to compare categorical data, and Student's unpaired t test and Mann–Whitney U test to compare normally and non-normally distributed continuous data respectively. P < 0·050 was considered significant. Statistical analysis was performed using SAS® software version 8.2 (SAS Institute, Cary, North Carolina, USA). Results Twenty-nine patients (14 men, 15 women) underwent intraperitoneal onlay mesh repair using DynaMesh® (Table 1). Patients from the two centres were similar in sex distribution (P = 1·000), age (P = 0·277), body mass index (P = 0·846) and mesh size (P = 0·287). There were no intraoperative complications and no conversion to open operation was required. Table 1 Clinical and operative data, and results of intraperitoneal onlay DynaMesh® repair . No. of patients* . Age (years)† 65 (37–83) Body mass index (kg/m2)† 33 (18–61) ASA grade  I 1  II 21  III 7 Indication  Primary hernia 18  First recurrence 9  Second recurrence 1  Third recurrence 1 Mesh size (cm2)† 600 (225–1050) Duration of operation (min)† 114 (25–214) Outcome after 1 year  No complications 23  Reoperation for small bowel obstruction 5  Reoperation owing to DynaMesh® infection 1  DynaMesh® explanted 3 . No. of patients* . Age (years)† 65 (37–83) Body mass index (kg/m2)† 33 (18–61) ASA grade  I 1  II 21  III 7 Indication  Primary hernia 18  First recurrence 9  Second recurrence 1  Third recurrence 1 Mesh size (cm2)† 600 (225–1050) Duration of operation (min)† 114 (25–214) Outcome after 1 year  No complications 23  Reoperation for small bowel obstruction 5  Reoperation owing to DynaMesh® infection 1  DynaMesh® explanted 3 * Unless indicated otherwise; † values are median (range). ASA, American Society of Anesthesiologists. Open in new tab Table 1 Clinical and operative data, and results of intraperitoneal onlay DynaMesh® repair . No. of patients* . Age (years)† 65 (37–83) Body mass index (kg/m2)† 33 (18–61) ASA grade  I 1  II 21  III 7 Indication  Primary hernia 18  First recurrence 9  Second recurrence 1  Third recurrence 1 Mesh size (cm2)† 600 (225–1050) Duration of operation (min)† 114 (25–214) Outcome after 1 year  No complications 23  Reoperation for small bowel obstruction 5  Reoperation owing to DynaMesh® infection 1  DynaMesh® explanted 3 . No. of patients* . Age (years)† 65 (37–83) Body mass index (kg/m2)† 33 (18–61) ASA grade  I 1  II 21  III 7 Indication  Primary hernia 18  First recurrence 9  Second recurrence 1  Third recurrence 1 Mesh size (cm2)† 600 (225–1050) Duration of operation (min)† 114 (25–214) Outcome after 1 year  No complications 23  Reoperation for small bowel obstruction 5  Reoperation owing to DynaMesh® infection 1  DynaMesh® explanted 3 * Unless indicated otherwise; † values are median (range). ASA, American Society of Anesthesiologists. Open in new tab Postoperative complications The immediate postoperative phase was unremarkable in all patients. Six patients developed complications related to the DynaMesh® (Figs 1 and 2). Ileus and adhesion formation was the leading problem in five patients, necessitating mesh explant in three. Small bowel obstruction occurred in the first week after surgery in one patient (Figs 1 and 2). Two patients developed severe symptoms of mechanical bowel obstruction that required reoperation, but the DynaMesh® was retained. One patient suffered from early mesh infection, requiring mesh explant. Pronounced adhesion formation to the implanted DynaMesh® was observed in two patients who had further surgery for other reasons. In one of these, adhesions to the mesh necessitated conversion of an elective laparoscopic cholecystectomy. Twenty-three patients were free from complications (as assessed by telephone interview) at the time of submission of this manuscript. Fig. 1 Open in new tabDownload slide Intraoperative laparoscopic views of mesh-penetrating adhesions between the DynaMesh® and small bowel: a small bowel firmly attached to the mesh, b multiple adhesions 1 week after surgery and c severe adhesions requiring mesh explantation Fig. 2 Open in new tabDownload slide Intraoperative view of a small bowel loop after the DynaMesh® had to be explanted owing to bowel obstruction caused by adhesions. The tunica muscularis could not be spared Histology Histological analysis of an explanted DynaMesh® during surgical reintervention on day 7 after operation confirmed the presence of bowel adhesions to the surface of the mesh and revealed a severe foreign body reaction (Fig. 3). Fig. 3 Open in new tabDownload slide Histological analysis of an explanted DynaMesh®. In some areas of the explanted mesh there was pronounced adhesion formation (cavities marked with an asterisk remain after cutting the samples). The adhesion site contained a proliferation of fibroblasts and myofibroblasts admixed with vascular capillaries (black arrows). Focally there was a remarkable exudate of fibrin (red arrow) (haematoxylin and eosin stain, original magnification × 200) Discussion Mesh-related complications have been reported since the introduction of intraperitoneal onlay mesh repair into clinical practice18,19. For more than a decade, many surgeons used ePTFE implants for this operation because of its antiadhesive and mechanical properties. However, ePTFE meshes are highly susceptible to infection, usually necessitating explantation4,18,19. The incidence of mesh infection ranges from 5 to 10 per cent after open ePTFE repair20,21. Further drawbacks of ePTFE are shrinkage, wrinkling and slow incorporation into surrounding tissue22. These problems prompted the development of new meshes, designed to combine antiadhesive characteristics with reduced susceptibility to infection and improved tissue integration1,23. Meshes for intraperitoneal onlay repair can be classified into three groups. First, biomeshes derived from organic animal or human materials, for example decellularized human dermis or porcine small intestine submucosa, are used predominantly in interlay or open intra-abdominal onlay mesh repair23–26. Such meshes are already used widely for hernia repair in infected fields, such as for closure of the abdomen in secondary peritonitis. However, concerns about their long-term biocompatibility and tissue integration remain27,28. Second, coated synthetic meshes are now most commonly used for open and laparoscopic intraperitoneal onlay mesh repair29. Considering the excellent results with these antiadhesive barriers, the ePTFE meshes will probably be replaced by new compounds, including collagen matrices, methylcellulose, polyglactic acid or alpha-omega-fatty acid layers30. A typical complication of these meshes is seroma owing to the impaired drainage of fluids. Finally, the smallest group of intraperitoneal onlay meshes comprises synthetic macroporous meshes without coating. DynaMesh® is an example and is advertised as having potential advantages in terms of cost, uninhibited drainage of fluids, versatility with atraumatic fixation devices and improved tissue integration12,14–16. The mesh has a visceral and a parietal side to combine fast integration and good antiadhesive properties, which provided the rationale for its use in intraperitoneal onlay mesh repair in this and other12,13 studies. Berger and Bientzle12 reported good results in a large cohort of 297 patients, but these results could not be reproduced in the present series. Of note, the other studies12,13 reported that surgical reintervention was required in few patients but that haematoma and seroma formation was common. The results achieved with DynaMesh® in the present study were analysed within the first year of operation. One-fifth of patients developed severe complications, mostly adhesion related (ileus and bowel obstruction). Surgical reintervention was required in these patients and confirmed that the cause was related to the DynaMesh®. The pattern of adhesions to DynaMesh® was remarkable because of frequent involvement of the whole mesh surface. This was in contrast to the more common clinical finding after intraperitoneal onlay mesh repair of adhesions being restricted to ‘hot spots’, such as the mesh margins and protruding fixation devices15,31. Notably, adhesions that led to clinical symptoms such as ileus were formed as early as within 1 week of surgery. Based on current literature on peritoneal healing and adhesion formation32,33, the present results may be explained by adhesions transgressing the DynaMesh®. It is known that peritoneal defects (such as those resulting from dissection of the hernia sac during intraperitoneal onlay mesh repair) may be colonized by mesothelial cells floating in the abdominal cavity. This physiological mechanism guarantees rapid reperitonealization even of large defects. Various factors can influence the healing process negatively, such as infection, mechanical stress or foreign materials, and this may lead to adhesion formation. The last two of these factors invariably occur after intraperitoneal onlay mesh repair. The visceral side of DynaMesh® has a saw-tooth profile, and it seems likely that movements of the bowel and abdominal wall cause a unidirectional irritation of the visceral peritoneum (Fig. 4). Fig. 4 Open in new tabDownload slide Diagram of DynaMesh® published by the manufacturer showing that the surface of the mesh is not smooth; the woven structure of polypropylene (PP) and polyvinylidene fluoride (PVDF) forms saw-tooth-like protrusions (indicated by red zigzag) In contrast to meshes coated with non-porous barriers, adhesions could attach to the abdominal wall and protrude through the DynaMesh® pores. PVDF might therefore be adequate in blocking adhesions to the mesh fibres but still be insufficient in preventing mesh-penetrating adhesions. These considerations are supported by studies on synthetic porous intraperitoneal onlay mesh repair12,13. This hypothesis could also explain why adhesion formation found with DynaMesh® was so pronounced. It is common knowledge that the fibrin sealant coating of tacks is not standard in intraperitoneal onlay mesh repair. It seems likely that adhesion formation might have been even more severe without additional tack coating34. Although this is a retrospective analysis it indicates that care should be taken to detect complications when using new meshes in intraperitoneal onlay mesh repair. Acknowledgements R.H.F. and A.H.P.-P. contributed equally to this manuscript. The authors thank James Crawford Ferguson and Christopher May for revision of the manuscript. None of the authors has any commercial interest in publishing this report or any professional affiliation to a medical company. References 1 Lomanto D , Iyer SG, Shabbir A, Cheah WK. Laparoscopic versus open ventral hernia mesh repair: a prospective study . Surg Endosc 2006 ; 20 : 1030 – 1035 . Google Scholar Crossref Search ADS PubMed WorldCat 2 Jin J , Rosen MJ. Laparoscopic versus open ventral hernia repair . 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Google Scholar OpenURL Placeholder Text WorldCat Copyright © 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model) Copyright © 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
TI - Adverse effects of polyvinylidene fluoride-coated polypropylene mesh used for laparoscopic intraperitoneal onlay repair of incisional hernia
JF - British Journal of Surgery
DO - 10.1002/bjs.7082
DA - 2010-06-02
UR - https://www.deepdyve.com/lp/oxford-university-press/adverse-effects-of-polyvinylidene-fluoride-coated-polypropylene-mesh-h2SqQnhUUg
SP - 1140
EP - 1145
VL - 97
IS - 7
DP - DeepDyve
ER -