Poly-4-hydroxybutyrate (Phasix™) mesh onlay in complex abdominal wall repair

Area of Science:

• Biomaterials Science
• Surgical Innovation
• Regenerative Medicine

Background:

• Poly-4-hydroxybutyric acid (P4HB) is a hydrolytically degradable biosynthetic polymer.
• P4HB can be fabricated into meshes for soft tissue reinforcement.
• This study evaluates P4HB mesh in complex abdominal wall repair (CAWR).

Purpose of the Study:

• To assess the initial clinical experience of using P4HB mesh in CAWR.
• To evaluate postoperative outcomes, including hernia recurrence and complications.
• To determine the safety and efficacy of P4HB mesh in a challenging patient cohort.

Main Methods:

• Prospective follow-up of patients undergoing CAWR between June 2014 and May 2017.
• Inclusion criteria: component separation with fascial edge repair and P4HB mesh onlay.
• Data collection on hernia recurrence, infection, re-operation, and seroma rates.

Main Results:

• 105 patients (mean age 59.2 years, 52% with prior hernia repair, 71% ASA 3+) were included.
• Median follow-up was 36 months; 17% experienced hernia recurrence.
• Low rates of mesh infection (0%), superficial infection (5%), re-operation (2.8%), and seroma (6%) were observed.

Conclusions:

• P4HB mesh demonstrates a low rate of hernia recurrence and common complications in CAWR.
• The mesh showed a low infection rate, with no complete mesh removals needed, even in contaminated fields.
• P4HB mesh is a viable option for soft tissue reinforcement in complex abdominal wall reconstruction, even in high-risk patients.