Long-term Outcomes of Poly-4-Hydroxybutyrate (P4HB) in Aesthetic Breast Surgery: An International Experience.

Abstract

Poly-4-hydroxybutyrate (P4HB), a naturally occurring component of human connective tissue, serves as a biomedically produced thermoplastic polyester scaffold that has been used in many surgical subspecialties. The utilization of P4HB in cosmetic and reconstructive breast surgery has been popularized internationally for the past 12 years. The purpose of this study was to assess and report long-term international outcomes of P4HB use in aesthetic breast surgery. A standardized retrospective outcome review was completed from the records of 5 international surgeons, each with significant expertise in using P4HB. A total of 621 patients were included in the review. Average follow-up was 1.33 years (range, 1-9.3 years). Most patients had P4HB placed during primary breast surgery (n = 460; 74%); primary procedures included augmentation-mastopexy (n = 253), mastopexy (n = 125), and breast reduction (n = 71). A subset (n = 161; 26%) of patients had P4HB placed during breast revisions, including revision augmentation-mastopexy (n = 81), revision augmentation (n = 73), and mastopexy with implant removal (n = 7). The main indications for revision included recurrent ptosis (n = 166), implant malposition (n = 64), and capsular contracture (n = 61). An overall complication rate of 3.7% (n = 23) was observed, the most common being delayed wound healing (n = 7) and hypertrophic scarring (n = 5). Of the overall complications, device-related complications associated with P4HB were observed only in 5 patients (0.8%), while non-device-related complications were seen in 18 patients (2.9%). This study suggests there is a defined role for the use of P4HB in both primary and revision aesthetic breast surgery; its use does not appear to increase the inherent complication risk of cosmetic breast surgery.