Wound healing/Plastic surgeryEvaluation of adhesion formation and host tissue response to intra-abdominal polytetrafluoroethylene mesh and composite prosthetic mesh11
Introduction
Laparoscopic ventral hernia repair is an intraperitoneal technique that uses a prosthetic biomaterial to repair abdominal wall defects without wide fascial dissection and flap creation. The prosthetic biomaterial is placed intraperitoneally and anchored to the posterior abdominal wall with transabdominal sutures, titanium spiral tacks (Protack™, United States Surgical, Norwalk, CT), or nitinol anchors (EndoAnchor™, Ethicon Endo-Surgery, Cincinnati, OH). The challenges in teaching laparoscopic procedures such as laparoscopic ventral hernia repair to established surgeons have been demonstrated through minimally invasive workshops and course participant proctoring, and this technique has evolved during the past decade to be feasible and safe [1, 2]. In a prospective, randomized trial comparing laparoscopic ventral hernia repair to open ventral hernia repair, Carbajo et al. documented in short-term follow-up that laparoscopic ventral hernia repair was as effective as open repair [3]. Several recent clinical studies have provided evidence supporting low recurrence rates and low wound infection rates when incisional hernias were repaired laparoscopically [4, 5, 6]. Despite the excellent results and low recurrence rates obtained with the laparoscopic repair of ventral hernias, the placement of prosthetic biomaterials into the peritoneal cavity has not been standard surgical practice since the widespread use of macroporous polypropylene mesh began four decades ago. The development of intra-abdominal adhesions, bowel obstruction, and enterocutaneous fistula are among the potentially severe complications related to the intraperitoneal placement of macroporous prosthetic biomaterials [7, 8]. In the largest series of laparoscopic ventral hernia repairs reported to date (n = 850), Heniford et al. used expanded polytetrafluoroethylene (ePTFE) mesh (GORE-TEX® DualMesh, W.L. Gore & Associates, Flagstaff, AZ) in 97% of cases [9]. The microporous architecture of polytetrafluoroethylene provides a reliable material for intraperitoneal placement, since this construct prevents cellular penetration of the intestine or abdominal viscera. Koehler et al. reported minimal adhesions to ePTFE mesh after laparoscopic ventral hernia repair in 65 reoperative cases with a mean mesh implantation time of 420 days (range, 2–1739 days) [10] Nevertheless, the apprehension to place prosthetic biomaterials intraperitoneally has energized biomedical research toward the development of novel, adhesion-resistant biomaterials (“composite mesh”) for laparoscopic and open ventral hernia repair.
One innovative, composite mesh developed for application in ventral hernia repair is Sepramesh™ (Genzyme Corp, Cambridge, MA). Sepramesh™ is a dual-component prosthetic biomaterial composed of macroporous polypropylene coated with a bioresorbable, nonimmunogenic membrane of sodium hyaluronate and carboxymethylcellulose (Seprafilm®, Genzyme, Cambridge, MA). Seprafilm® was designed to provide protection against intra-abdominal adhesion formation throughout the critical period of re-mesothelialization during the first postoperative week. This antiadhesive material forms a physical barrier on damaged surfaces and prevents adherence between opposing tissues. The physical barrier allows injured tissues to heal separately from each other. In addition, the sodium hyaluronate and carboxymethylcellulose membrane is negatively charged and hydrophilic, molecular properties that promote the separation of healing tissues. Another unique composite mesh developed for ventral hernia repair is Bard®Composix™ (C.R. Bard, Inc., Murray Hill, NJ). Bard®Composix™ is constructed of macroporous polypropylene bonded to ePTFE. Polytetrafluoroethylene is a hydrophobic fluoropolymer with microporous architecture. The microporous construct resists cellular penetration and tissue ingrowth and functions as the antiadhesive barrier. Sepramesh™ and Bard®Composix have macroporous polypropylene to provide a construct for cellular ingrowth, differentiating themselves from the laminar, microporous DualMesh® constructed exclusively of PTFE with different architecture on the peritoneal (intra-abdominal) and parietal (abdominal wall) surfaces of the mesh. The macroporous mesh potentially increases the amount of fibrous ingrowth and long-term strength of the repair, but evidence is lacking.
The purpose of this study was to measure the extent of adhesion formation to ePTFE mesh (DualMesh®) and two composite meshes, ePTFE and polypropylene (Bard®Composix™) and hyaluronic acid/carboxymethylcellulose and polypropylene (Sepramesh™) after their intra-abdominal placement on an intact peritoneum, simulating laparoscopic ventral hernia repair, and to evaluate host tissue response to the prosthetic biomaterials.
Section snippets
Animals and mesh placement
Thirty New Zealand white rabbits weighing 3 to 4 kg (Robinson Service, Inc., Clemmons, NC) were used for this study and maintained in accordance with National Research Council Guidelines [11]. Experimental protocols were approved by the Institutional Animal Care and Use Committee at the Carolinas Medical Center, Charlotte, North Carolina. The experimental technique has been described previously [12]. Each rabbit was anesthetized by an intramuscular injection of acetylpromazine (0.5 mg/kg) and
Results
There were no mesh-related complications in the study, and all 30 animals completed the 16-week protocol. The mean adhesion scores for the biosurgical composite meshes and ePTFE mesh at 7 days, 3 weeks, 9 weeks, and 16 weeks are summarized in Table 2. The mean adhesion score for the ePTFE mesh was significantly less (P < 0.05) than the biosurgical composite meshes at each time interval. There were no differences in the mean adhesion scores between the two biosurgical composite meshes at any of
Discussion
The bioreactivity of a prosthetic biomaterial used for open or laparoscopic ventral hernia repair is determined by unique properties of the implanted medical device, such as its chemical composition, surface chemistry, porosity, and spatial structure. The intraperitoneal host tissue response to the prosthetic biomaterial also determines its biocompatibility. Potential pathologic response to these materials is a major concern. Polypropylene mesh promotes the rapid penetration of fibrous tissue
Conclusions
In a model that simulates laparoscopic ventral hernia repair where mesh is placed intra-abdominally against an intact peritoneum, fewer adhesions developed during 4-months’ follow-up to the microporous ePTFE mesh (DualMesh®) than to the biosurgical composite meshes composed of ePTFE and polypropylene (Bard®Composix™) and hyaluronic acid/carboxymethylcellulose and polypropylene (Sepramesh™). Quantitative measurements of inflammation, tissue ingrowth, and mesothelialization were equivalent for
Acknowledgment
We thank the professional administrative and editorial assistance of Cissy Moore-Swartz, Department of General Surgery, Carolinas Medical Center, in the preparation of this work.
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Supported by the Society of American Gastrointestinal Endoscopic Surgeons, Los Angeles, California.