Health Problem: A hernia is a bulge or protrusion of an organ, intestine, or fatty tissue through a muscle or connective tissue. Hernias can occur in many places, including the abdomen (ventral hernia), within the abdomen (hiatal hernia), inner groin (inguinal hernia), outer groin (femoral hernia), umbilical area, or at a site of an incision or scar. The pathophysiological mechanisms are not entirely known, but primary hernias are likely a result of a connective tissue failure whereas secondary hernias (e.g., incisional hernias) are most frequently due to surgical failure.
Technology Description: Biologic mesh is derived from human tissue (allograft) or animal (porcine or bovine) tissue (xenograft) and may be used in hernia repair with the intent of reducing the risk of problems associated with synthetic mesh, including infection, foreign body reaction, stiffness, adhesion, and fibrosis. Products differ in the tissue source, material size and thickness, and processing. Biologic mesh provides an extracellular scaffold to support the integration process and reconstruction of healthy tissue. Biologic mesh is intended to allow for neovascularization and neocellularization by infiltration of native fibroblasts, deposition of new collagen, and tissue regeneration.
Controversy: The use of biologic mesh for hernia repair remains controversial due to a lack of strong comparative evidence demonstrating superiority versus synthetic mesh, despite the greater cost. These products have been brought to market into the United States through pathways that either do not require demonstration of their safety and efficacy (for human-derived biologic products) or through a pathway that allows them to be cleared through substantial equivalence to products already on the market, including synthetic mesh products (for animal-derived biologic products). There is no clear consensus among surgeons regarding appropriate indications for biologic mesh, including whether it is superior in the treatment of infected or contaminated hernias. Further, biologic mesh is far more costly than synthetic counterparts.
Key Questions: For patients undergoing surgical repair of inguinal or ventral hernia:
- How do clinical outcomes of biologic mesh compare with those of synthetic mesh?
- How do clinical outcomes of different biologic mesh products compare?
- What complications are associated with biologic mesh, and how do they compare with those associated with synthetic mesh and among biologic products?
- Have definitive patient selection criteria for biologic mesh been established?
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