Shifting the Goalpost in Ventral Hernia Care: 5-year Outcomes after Ventral Hernia Repair with Poly-4-hydroxybutyrate Mesh

Fully resorbable poly-4-hydroxybutyrate (P4HB) mesh for soft tissue repair and reconstruction: A scoping review

“…The majority of the identified publications ( n = 50/79; 63%) involved clinical studies describing the use of P4HB mesh in plastic and reconstructive surgery ( n = 10) ( 13 – 15 , 18 – 21 , 56 , 61 , 64 ) or general surgery applications ( n = 40) ( 11 , 12 , 27 – 31 , 50 – 55 , 57 – 60 , 62 , 63 , 65 – 85 ) as shown in Figure 2 , and Table 1 . In the area of plastic and reconstructive surgery, P4HB meshes have been utilized primarily in cosmetic breast applications ( 21 ) including mastopexy/reduction mammaplasty ( 18 , 19 ), prevention of bulge at the donor site on the abdominal wall ( 14 , 64 ), support of the lower pole ( 13 , 20 , 56 ), tissue expander-based reconstruction ( 15 ), and 3-D mesh breast reconstruction with autologous fat grafting ( 61 ).…”

“…P4HB meshes have been utilized extensively in general surgery for a wide variety of hernia repair and abdominal wall reconstruction applications ( 11 , 12 , 27 – 31 , 50 – 55 , 57 – 60 , 62 , 63 , 65 – 85 ). A small number of studies ( n = 2 in each group) evaluated P4HB mesh for incisional hernia prophylaxis ( 27 , 54 ) and inguinal hernia repair ( Table 1 , and Table 2 ) ( 11 , 28 ).…”

“…Most of the general surgery studies identified by this literature review ( n = 31/40; 78%) utilized P4HB mesh in the repair of ventral/incisional hernias, primarily at the midline ( Table 1 and Table 3 ) ( 12 , 30 , 31 , 50 – 53 , 55 , 59 , 60 , 62 , 63 , 65 – 78 , 81 – 85 ). Primary fascial closure was planned in all cases, with definitive repair as the goal.…”

“…It should be noted that clinical outcomes were evaluated in patients along the entire continuum of Centers for Disease Control (CDC) wound classes ( 33 ) and Ventral Hernia Working Group (VHWG) grades ( 34 , 35 ), ranging from clean cases at low risk of postoperative complications to contaminated/dirty cases at high risk of postoperative complications ( Table 4 ). Systematic reviews ( 59 ), commentaries ( 86 ), and clinical studies of CDC Class I (clean) cases only ( 51 , 65 ) comprised a small number of articles, with the majority of the identified clinical studies describing complex cases with elevated CDC wound class or comorbidities placing patients at high risk of postoperative complications ( n = 13) ( 12 , 30 , 31 , 50 , 52 , 55 , 60 , 62 , 71 , 75 , 76 , 83 , 85 ) or “off-label” use of P4HB mesh to repair ventral/incisional hernias in potentially contaminated or contaminated fields ( n = 15) ( 11 , 53 , 63 , 66 – 70 , 72 – 74 , 77 , 78 , 81 , 82 , 84 ). After a thorough evaluation of the clinical studies identified by this scoping review, several major themes emerged, namely: (1) P4HB mesh provides long-term strength at the repair site, leading to acceptable rates of recurrence as compared to higher-risk cohorts and those repaired with non-synthetic biomaterials ( 30 , 31 , 66 , 70 , 75 , 76 ); (2) P4HB mesh performs favorably in contaminated settings where permanent synthetic mesh use may be higher risk or contraindicated, resulting in low incidence of surgical site infection (SSI) ( 70 , 76 , 90 ); and (3) P4HB mesh represents an alternative for ventral/incisional hernia repair relative to biologic meshes and when permanent synthetic mesh complications are taken into consideration ( 30 , 69 ).…”

“…P4HB performed favorably in the setting of contamination, resulting in low incidence of surgical site infection (SSI). Recent long-term studies, including Roth ( 31 ) and Talwar ( 85 ), also demonstrated improvement in long-term quality of life metrics.…”