Electrospun polycaprolactone fibers encapsulating omega-3 and montelukast sodium to prevent capsular contracture in breast implant surgery

Capsular contracture (CC) is a common complication associated with breast implant surgery and is characterized by excessive fibrotic tissue formation around the implant. However, there is no established gold-standard treatment to prevent CC. This study aimed to prepare fish oil/montelukast sodium (MTKS)-loaded polycaprolactone (PCL) fibers and evaluate their effectiveness in preventing CC. PCL, a biocompatible and biodegradable material, was used to fabricate electrospun fibers incorporating fish oil, a source of omega-3 (ω3) polyunsaturated fatty acids (EPA and DHA), and MTKS, a leukotriene receptor antagonist. MTKS and ω3 were selected as therapeutic agents for their anti-inflammatory and anti-fibrotic properties. The fibers underwent characterization using FT-IR, HPLC, SEM, water contact angle, XRD, and TGA. These methods confirmed structural integrity, encapsulation and stability of fish oil, and optimal hydrophilic surface properties for reducing bacterial adhesion to implants. In vitro drug release studies demonstrated the controlled and prolonged release profile of ω3 and a faster release pattern with MTKS. In vivo experiments using a rat model with mini-implants coated with the fibers revealed a significant reduction in fibrotic capsule tissue formation and inflammatory responses compared to control groups after 90 days. Histological and gene expression analyses confirmed these findings. Second-harmonic generation imaging demonstrated that ω3 and MTKS facilitated favorable collagen organization, leading to late-stage fibrosis with a thinner, more compliant capsule, and enhanced biocompatibility. Our findings suggest that PCL-ω3-MTKS fibers regulate inflammatory and fibrotic pathways, improve collagen organization, and reduce the risk of CC. Additionally, ω3-MTKS demonstrated synergistic efficacy in impeding fibrosis. This innovative strategy offers a promising therapeutic approach to mitigate CC and improve outcomes in breast implant surgeries.