Biologic Mesh: When and Why—A Critical Appraisal

Abstract

The US markets for soft tissue repair report prepared by the Millennium Research Group estimates that 305,900 ventral hernias were performed in the United States in 2006 [1], reaffirming ventral hernia repair as one of the most common procedures in general surgery. The 10-year cumulative rate of recurrence for suture repair of ventral hernias is as high as 63 %, which contributes to the high incidence of repair [2]. Significant risk factors for recurrence include surgical technique, history of previous failed hernia repairs, large hernia size, obesity, smoking habits, and patient comorbidities that contribute to diminished soft tissue integrity. To reduce recurrence to a 10-year cumulative rate <32 %, level A and B evidence supports reinforcement with synthetic or biologic materials for all incisional ventral hernia repairs [2, 3]. Likely attributable to evidence-based recommendations for material reinforcement, it is estimated that synthetic or biologic reinforcement materials were used in nearly 95 % of the ventral hernias performed in the United States in 2006 [1]. Market analysts predict a 7 % annual growth rate in the The US markets for soft tissue repair report prepared by the Millennium Research Group estimates that 305,900 ventral hernias were performed in the United States in 2006 [1], reaffirming ventral hernia repair as one of the most common procedures in general surgery. The 10-year cumulative rate of recurrence for suture repair of ventral hernias is as high as 63 %, which contributes to the high incidence of repair [2]. Significant risk factors for recurrence include surgical technique, history of previous failed hernia repairs, large hernia size, obesity, smoking habits, and patient comorbidities that contribute to diminished soft tissue integrity. To reduce recurrence to a 10-year cumulative rate <32 %, level A and B evidence supports reinforcement with synthetic or biologic materials for all incisional ventral hernia repairs [2, 3]. Likely attributable to evidence-based recommendations for material reinforcement, it is estimated that synthetic or biologic reinforcement materials were used in nearly 95 % of the ventral hernias performed in the United States in 2006 [1]. Market analysts predict a 7 % annual growth rate in the $1 billion United States soft tissue repair device industry, largely impelled by costly biologic scaffold materials for ventral hernia repair. The aging patient population, the prevalence of comorbidities contributing to diminished soft tissue integrity, the high incidence of obesity, and the rising demand for bariatric procedures with high potential for sequelae of incisional ventral hernias are major factors driving the anticipated market expansion for ventral hernia reinforcement materials. In particular, demand for biologic scaffold materials is expected to expand based on preclinical evidence that biologic materials enable revascularization of soft tissue repair sites and improved pathogen clearance in contaminated and infected surgical sites [4, 5] and clinical evidence that biologic materials do not necessarily require removal when exposed or infected [6–8]. billion United States soft tissue repair device industry, largely impelled by costly biologic scaffold materials for ventral hernia repair. The aging patient population, the prevalence of comorbidities contributing to diminished soft tissue integrity, the high incidence of obesity, and the rising demand for bariatric procedures with high potential for sequelae of incisional ventral hernias are major factors driving the anticipated market expansion for ventral hernia reinforcement materials. In particular, demand for biologic scaffold materials is expected to expand based on preclinical evidence that biologic materials enable revascularization of soft tissue repair sites and improved pathogen clearance in contaminated and infected surgical sites [4, 5] and clinical evidence that biologic materials do not necessarily require removal when exposed or infected [6–8].