REPORT
Substantial clinical experience with GORE ® BIO-A® Tissue Reinforcement has been presented at society meetings and forums. In a retrospective comparison of GORE® BIO-A® Tissue Reinforcement with no tissue reinforcement for ostomy closure, the rate of infections was low but similar in both groups. However, the authors noted that opening of the wound to treat the infection did not require removal of the mesh. All 3 recurrences in a study of 28 patients occurred in those who did not receive GORE® BIO-A® Tissue Reinforcement.28 In an early series of 34 cases of hernia repair with GORE ® BIO-A® Tissue Reinforcement, of which 47% were recurrent hernia repairs, there were no recurrences in up to 2 years of follow-up. Although only a few patients in this series had contaminated wounds, outcomes were not different in this subgroup.29 In a smaller study of abdominal wall reconstruction in a series of 5 patients, all of whom had a contaminated surgical field, there were no complications or recurrences at 6 months.30 In 2 complicated patients, who required relatively large sheets of GORE® BIO-A® Tissue Reinforcement mesh, reported outcomes also were favorable.31 One patient had a small bowel obstruction and perforation with numerous intraabdominal abscesses. In the other, an abscess and enterocutaneous fistula required drainage before placement of the mesh. No complications were observed in a 7-month follow-up, according to the authors.31 The authors noted the low cost of GORE® BIO-A® Tissue Reinforcement in relation to biologics and the ability to place the mesh without soaking or other preparation were listed as potential advantages over biologic prostheses.31 Together, these experiences, which document a growing clinical experience with GORE® BIO-A® Tissue Reinforcement in diverse settings and patient types, have provided the impetus for larger, systematic studies with long-term follow-up. When such studies are stratified for important variables, such as the size of the wound repair, patient comorbidities, and the relative contamination status of the operative field, the data have the potential to provide an evidence base for surgical mesh selection.
GORE® BIO-A® Tissue Reinforcement: Experience in Hiatal Hernias and Beyond The advantages of a bioabsorbable biosynthetic mesh in abdominal wall repair are likely to be applicable to other surgical repairs where tissue reinforcement may be of value but where a permanent prosthesis poses an unacceptable risk for complications. Published studies and clinical series presented in abstract form have chronicled the experience with GORE ® BIO-A® Tissue Reinforcement for a variety of
applications. The greatest experience has been in hiatal hernia repairs,32 but large paraesophageal repairs, stoma fixation, and repair of traumatic injuries also have been published 33 or are being pursued. “The experience with GORE® BIO-A® Tissue Reinforcement at many centers has been largely confined to ventral hernia repair, but the qualities of resorption are attractive for other types of surgeries. This is an area where we may see an expansion of the use of this product and other biosynthetic meshes,” Dr. Heniford said. Other clinical applications where tissue reinforcement may be of benefit, such as stoma or traumatic wound repair, have been proposed. In such procedures, the value of synthetic mesh has been limited by concern for complications from permanent placement of foreign-body material. With biosynthetic mesh that offers predictable performance—particularly complete resorption—at a lower cost than biologic meshes, the clinical applications may expand. The growing experience with biosynthetic mesh in hiatal hernia repair has provided evidence of good short-term results for this indication but may be equally important for suggesting that this material has potential applications outside of abdominal wall repair.
Economics of Tissue Reinforcement The relative efficacy of different types of surgical mesh under specific clinical circumstances has enormous implications for health care costs. Although the acquisition costs of surgical mesh products range widely, total costs are informed by a long list of variables ranging from operating time to failure rates. The difference in cost has been important motivation for developing biosynthetic surgical mesh as an alternative to biologics. The acquisition cost of a square centimeter of biologic mesh has been estimated to be approximately 5 times greater than that of a biosynthetic mesh.7 If surgical outcomes achieved with biosynthetic mesh are comparable to those achieved with biologic prostheses, the relative cost advantage of the biosynthetic material may be beyond the cost of acquisition. Unlike biologic mesh, which often requires preoperative preparation that may affect operating room (OR) efficiency,34 a biosynthetic mesh such as GORE® BIO-A® Tissue Reinforcement is designed to be used without having to perform preoperative tasks, such as soaking.16 “Cost was a major driver for us to move away from biologics in cases where we feel that biosynthetic mesh will perform as well. At our center, the cost of a biosynthetic mesh is a small fraction of that of a biologic,” Dr. Jacobsen reported. Mesh costs have a potentially large effect on the bottom line in hospitals where a high number of ventral hernia repairs are performed, according to a recent financial analysis. In this
9