Final study results of bioabsorbable mesh shows significant improvement in patient quality of life while offering cost-savings to hospitals and payors
FLAGSTAFF, Ariz. - Monday, January 4th 2016 [ME NewsWire]
(BUSINESS WIRE)-- W. L. Gore & Associates, Inc. (Gore) today announced final results of a long-term, prospective, multicenter study evaluating the use of GORE® BIO-A® Tissue Reinforcement, a bioabsorbable mesh, in complex ventral hernia (CVH) repair in patients with contaminated fields. Michael Rosen, MD, Cleveland Clinic, the lead investigator of the study, published the research in the Annals of Surgery.
Patients scheduled to undergo CVH repair often have a poor quality of life preoperatively because of a GI fistula, mesh infection, or non-healing abdominal wound. With a sample size of more than 100 patients, these study results showed improved quality of life and a favorable hernia recurrence rate of only 17 percent after 24 months when using the GORE BIO-A Tissue Reinforcement. Typically, in this type of patient population, the recurrence rate is as high as 39 percent with a biologic mesh. Additionally, by using in lieu of a permanent, synthetic mesh, the GORE BIO-A Tissue Reinforcement lessens long-term complications in part because it does not necessitate removal of the mesh.
“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 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 synthetic 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.
GORE BIO-A Tissue Reinforcement, as a biosynthetic mesh, also provides cost savings over a biologic mesh that has a high cost due to the harvesting of tissues from cadavers, pigs, cows, and then the subsequent processing to remove cells to protect patients from possible viral contamination.
“This study proves for the first time something we have believed all along: a biosynthetic mesh can be equivalent or better than a biologic,” 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. Special editorial features include “Advances in Surgical Technique,” which provides up-to-the-minute coverage of current clinical issues, and monthly review articles that cover the most current practice concerns.
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. For more information, visit www.goremedical.com.
GORE® and BIO-A® are trademarks of W. L. Gore & Associates.
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Chempetitive Group for W. L. Gore & Associates