Background

When one considers the number of patients affected, the rate of failure, and the cost and morbidity of repair, laparotomy failure and subsequent incisional hernia formation may represent the single greatest failure of modern surgical practice. Despite the emergence of minimally invasive approaches, a full-thickness incision through the abdominal wall tissues, a laparotomy, is still ubiquitous in surgical specialties ranging from general surgery to gynecology. Unfortunately, approximately 20% of laparotomy closures will result in an incisional hernia.1 With over 2 million laparotomies performed in the U.S. each year, the annual incidence of incisional hernia formation has been estimated at between 400,000 and 500,000 per year, and over 348,000 hernia repairs are performed annually.1
Once a hernia occurs, it can be a challenging problem to fix. Primary mesh-reinforced hernia repairs have demonstrated recurrence rates upwards of 32%.1 Patients who experience recurrence following an initial repair are susceptible to a vicious cycle, as each subsequent repair presents greater technical challenges, compounds costs, and carries an increased risk for recurrence. In 2006, annual costs associated with incisional hernia repair were estimated at $3.2 billion, as patients who developed an incisional hernia averaged $98,424 in combined care costs.2 It has been estimated that each 1% reduction in the rate of hernia formation would yield $32 million in direct cost savings, even when physician fees and lost productivity costs were excluded.1
The high incidence, significant morbidity, and costly care of incisional hernia after laparotomy make it crucial to investigate strategies for hernia prevention. At its core, incisional hernia is the result of suture pull-through, which results in early fascial dehiscence and failed healing of the abdominal wall tissues.3 While all patients are vulnerable to laparotomy failure, patients undergoing laparotomies for trauma and emergency surgery are particularly susceptible to hernia formation due to the circumstances surrounding the laparotomy. The incidence of incisional hernia following emergency laparotomy has been reported to be as high as 50%.4
Over the past 100 years, various techniques and materials have aimed to prevent the phenomenon of suture pull-through, but none has proven universally effective. Prophylactic mesh augmentation (PMA) of the laparotomy closure has emerged as the most recent strategy to combat this significant and persistent problem. Although a growing body of literature has demonstrated the efficacy of PMA for hernia prevention,5,6 increased surgical site complications and added technical complexity has limited widespread use of the technique. Likewise, concern for infection of the planar mesh used in PMA precludes its use in a contaminated or emergent setting. As a result, no material or technique has been proven to reliably prevent incisional hernia formation following emergent or contaminated laparotomies. As a result, a costly strategy of reactive repair has remained the standard of care.
The cost-utility of prophylactic mesh, and specifically synthetic mesh, has recently been assessed by Fischer et al,2 in which the primary fascial suture repair was compared with PMA in high-risk abdominal surgery patients. The results of the aforementioned study demonstrated an absolute reduction of hernia formation of 15% with prophylactic mesh and that PMA was less costly when the cost of treating all complications was considered; furthermore, prophylactic mesh continues to be the dominant strategy across a wide range of willingness-to-pay thresholds and robust Monte-Carlo sensitivity analyses.
"Specifically, in the base case scenario, PMA was cost-effective up to a mesh price of $3,700, assuming a willingness-to-pay of $50,000 per quality-adjusted life-year and a risk reduction of 15%, but the price of mesh could be as high as $10,000 for higher willingness-to-pay and risk reductions."2,7
Overall these finding strongly suggest that PMA has the potential for significant health care saving, particularly when used in high-risk patients. This study and other emerging evidence supporting the efficacy of PMA techniques provide convincing data that mesh reinforcement can augment the biomechanical integrity of fascial closure and reduce IH risk with acceptable risks of complications and at an overall significant benefit to society.2

To address this gap in available technologies for hernia prevention, a novel implantable device, Duramesh Suturable Mesh, has been purposely designed to provide the durability of a planar mesh repair, with less foreign material and easier placement. It is designed to limit acute and chronic suture pull-through and resulting gap formation, which is believed to be the root cause of surgical failures across multiple surgical specialties.