Flagstaff, Ariz. (January 4, 2016) — W. L. Gore & Associates, Inc. (Gore) today announced final results of a long-term, prospective, multicenter study 1 evaluating the use of GORE® BIO-A® Tissue Reinforcement, a biosynthetic mesh, in complex ventral hernia (CVH) repair in patients with contaminated wounds. Results of the study led by lead investigator Michael Rosen, MD, Cleveland Clinic, was accepted for publication in the Annals of Surgery.
Patients scheduled to undergo CVH repair often have a poor quality of life preoperatively because of a gastrointestinal fistula, mesh infection, or non-healing abdominal wound. With more than 100 patients enrolled, these study results showed improved quality of life and intact hernia repairs in 83 percent of patients when using GORE® BIO-A® Tissue Reinforcement. Typically, in this type of patient population, the recurrence rate is as high as 30 percent2 with a biologic mesh. The investigators reported that no biosynthetic required complete removal due to infection.
“I think this study represents an important step forward in defining the most appropriate way to reconstruct complex abdominal wall defects,” said Dr. Rosen. “Bio A [GORE® BIO-A® Tissue Reinforcement] performed very well in this challenging group of patients and will provide a cost-effective alternative for reconstructive surgeons.”
GORE® BIO-A® Tissue Reinforcement, as a biosynthetic mesh, also provides cost savings over a biologic mesh. Biologic mesh is often more expensive than biosynthetic mesh due to the complexity of harvesting tissue from cadavers or animal sources, as well as the subsequent processing and storage requirements to avoid the risks of viral contamination.
GORE® BIO-A® Tissue Reinforcement is a uniquely designed web of biocompatible synthetic polymers that is gradually absorbed by the body, while its 3D matrix of open, highly interconnected pores facilitates tissue generation and healing. As a biosynthetic tissue scaffold, it is not derived from human or animal tissue but engineered for uniformity, consistency, and versatility. Clinical evidence demonstrates that the scaffold is replaced with favorable type I collagen.
“This study demonstrates for the first time something we have believed all along: a biosynthetic mesh offers specific advantages when compared with a biologic mesh,” said Ron Anderson, General Surgical Products Business Unit Leader. “By being both more cost-effective for hospitals and payors while also improving quality of life for patients, GORE® BIO-A® Tissue Reinforcement is truly advancing healthcare and the way we treat CVH.”
Annals of Surgery, the world’s most highly referenced surgery journal, provides the international medical community with information on significant contributions to the advancement of surgical science and practice. Surgeons look to Annals of Surgery first for innovations in practice and technique.
- Rosen M, Bauer JJ, Harmaty M, et al. Multicenter, prospective, longitudinal study of the recurrence, surgical site infection, and quality of life after contaminated ventral hernia repair using biosynthetic absorbable mesh: the COBRA Study. Annals of Surgery. In press.
- Rosen M, Carbonell A, Cobb W, et al. Multicenter prospective longitudinal trial evaluating recurrence, surgical site infection and quality of life after contaminated ventral hernia repair using biosynthetic absorbable mesh. Presented at the 1st World Conference on Abdominal Wall Hernia Surgery; April 25-29, 2015; Milan, Italy. Hernia2015;19(2)Supplement 2:S106. CO16:03.
At Gore Medical, we have provided creative therapeutic solutions to complex medical problems for 40 years. During that time, 40 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. Our extensive family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia and soft tissue reconstruction, staple line reinforcement materials, and sutures for use in vascular, cardiac, and general surgery. We are one of a select few companies to appear on all of the U.S. “100 Best Companies to Work For” lists since the rankings debuted in 1984.
GORE® and BIO-A® are trademarks of W. L. Gore & Associates.