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The Current State of Prophylactic Mesh Augmentation: Outcomes, Risk Modeling, Barriers to Adoption, and the Future of Risk Reductive Surgery
Michael A. Lanni, BS, Michael G. Tecce, DO, Valeriy Shubinets, MD, Michael N. Mirzabeigi, MD, Joseph M. Serletti, MD, John P. Fischer, MD.
University of Pennsylvania, Philadelphia, PA, USA.

BACKGROUND: With the high incidence and insufficient treatments leading to disproportionately high morbidity and cost associated with the incisional hernia after laparotomy, it is crucial to investigate hernia prevention. Prophylactic mesh augmentation (PMA) is the implantation of mesh at index laparotomy to decrease a patient’s risk for developing incisional hernia (IH). The current body of evidence lacks standard guidelines for patient selection, mesh placement, and material choice. The purpose of this study is to identify areas of research needed to formulate a clinical framework and to foster responsible and appropriate of use of new technology and surgical techniques.
METHODS: We conducted a comprehensive literature search of Scopus and PubMed and a search of clinicaltrials.gov for articles and trials related to using PMA for incisional hernia risk reduction. Our review was further supplemented by including select papers on biomechanical properties of mesh, animal models, cost-practicality, patient-reported outcomes, risk-modeling, surgical techniques, and available materials related to PMA.
RESULTS: Review of 551 unique articles and 357 trials yielded numerous empirical studies (Table 1).Various options exist for mesh placement (Figure 1). Advantages and drawbacks of different mesh locations and types must be carefully considered (Tables 2 and 3). Multiple studies report that there was significant decrease in IH incidence with PMA compared to suture closure, although seromas have been associated with onlay mesh positioning. No multicenter randomized control trial (MCRCT) has been conducted in the United States to date. Only two such trials are currently active, but they are inconsistent in examining PMA variables or defining IH.
Table 1. Literature review results for PMA trials and comparative studies
Author and SettingStudy PeriodDesignDetailsConclusions
Bevis 2010 UK2003-2007RCT n=85Retrorectus, PolypropylenePMA reduced the rate of IH after open AAA repair without increasing the rate ofcomplications (p=0.002)
Llaguna 2011 USA2005-2007Comparative n=134Retrorectus, BiologicPMA appears to reduce the incidence of IH in patients with multiple risk factors forIH (p=0.014)
Bali 2015 Greece2007-2009RCT n=40Onlay, BiologicPMA during AAA repair showed effectiveness and low complication rate inpreventing IH (p< 0.008) laparotomies is feasible for the prevention of IH withoutadding a substantial morbidity, even in the presence of contamination or infections(p=0.0001)
Argudo 2014 Spain2009-2010Comparative n=266Onlay, Partially AbsorbablePMA for closure of emergency midline laparotomies is feasible for the prevention ofIH without adding a substantial morbidity, even in the presence of contamination orinfections (p=0.0001)
García-Ureña 2015 Spain2009-2011RCT n=107Onlay, PolypropyleneOnly PMA decreases the incidence of IH without adding morbidity (p=0.011)
CaroTarrago 2014 Spain2009-2012RCT n=160Onlay, PolypropylenePMA prevents IH independently of other factors (p< 0.0001)
Timmermans 2015 Netherlands2009-2012RCT n=480Onlay and Retrorectus, PolypropyleneShorttermresults show PMA can be considered a safe procedure an increase inseroma formation after onlay placement, but no increased risk of surgical siteinfection
PREBIOUS SpainActiveMCRCT Anticipated n=435BiologicPrimary outcome is incisional hernia occurrence after 2 years postoperatively.Secondary outcomes include postoperative complications, pain, and quality of life.
PRIMA Trial NetherlandsActiveMCRTC Anticipated n=435Onlay and Retrorectus, PolypropylenePrimary outcome is incisional hernia occurrence after 2 years postoperatively.Secondary outcomes include postoperative complications, pain, and quality of life.
Table 2. Advantages and Drawbacks of Different Mesh Positions
OnlaySimple; Fast; No visceral contact with meshMore recurrence after repairs; Increased risk for seroma; Risks exposure and infection
Sublay (Retrorectus or Preperitoneal)Resistant to intra-abdominal pressure; Even distribution of tension; No cutaneous or visceral exposureTechnical challenge; Increased operative time
UnderlayResistant to intra-abdominal pressure; Even distribution of tension; No cutaneous exposureRisk of bowel-related complications; Technical challenge
Table 3. Comparison of Mesh Materials
Mesh TypeAdvantagesDrawbacks
SyntheticsCheap; Tensile strength; Composite barriersVisceral Damage; Poor infection resistance; Complicates future procedures; Increased mesh pain
BiologicsIncreased infection resistance; Strong incorporationBulging; Decreased tensile strength; Cost
BioabsorbablesHandles like synthetics; Increased infection resistance; Early tensile strength; Resorbs after wound heals; Less likely to cause chronic painLack of long-term data; Cost

There are clear indications for the use of PMA, with evident cost-utility and models for selecting high-risk patients, but treatment guidelines are lacking. Widespread adoption of PMA requires large scale pragmatic MCRCT research and CPT coding. Given the American Medical Association's recent approcal of a catagory III CPT code (0437T) to be implemented July 2016, the current outloook for PMA research in the US is positive. Beyond this, stakeholder collaboration is paramount for progress (Figure 2). The first step in breaking down the barriers preventing the use of PMA in a high-risk cohort of patients will be gaining awareness to build momentum for PMA adoption worldwide.

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