3D Printing of Drug-Loaded Thermoplastic Polyurethane Meshes: A Potential Material for Soft Tissue Reinforcement in Vaginal Surgery.

Juan Domínguez-Robles,Eneko Larrañeta,Luca Casettari,Caterina Mancinelli,Elena Mancuso,Dimitrios A Lamprou,Inmaculada García-Romero,Brendan F Gilmore

doi:10.3390/pharmaceutics12010063

Juan Domínguez-Robles, Eneko Larrañeta + Show 6 more

Open Access

https://doi.org/10.3390/pharmaceutics12010063

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Abstract

Current strategies to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI), include the surgical implantation of vaginal meshes. Recently, there have been multiple reports of issues generated by these meshes conventionally made of poly(propylene). This material is not the ideal candidate, due to its mechanical properties leading to complications such as chronic pain and infection. In the present manuscript, we propose the use of an alternative material, thermoplastic polyurethane (TPU), loaded with an antibiotic in combination with fused deposition modelling (FDM) to prepare safer vaginal meshes. For this purpose, TPU filaments containing levofloxacin (LFX) in various concentrations (e.g., 0.25%, 0.5%, and 1%) were produced by extrusion. These filaments were used to 3D print vaginal meshes. The printed meshes were fully characterized through different tests/analyses such as fracture force studies, attenuated total reflection-Fourier transform infrared, thermal analysis, scanning electron microscopy, X-ray microcomputed tomography (μCT), release studies and microbiology testing. The results showed that LFX was uniformly distributed within the TPU matrix, regardless the concentration loaded. The mechanical properties showed that poly(propylene) (PP) is a tougher material with a lower elasticity than TPU, which seemed to be a more suitable material due to its elasticity. In addition, the printed meshes showed a significant bacteriostatic activity on both Staphylococcus aureus and Escherichia coli cultures, minimising the risk of infection after implanting them. Therefore, the incorporation of LFX to the TPU matrix can be used to prepare anti-infective vaginal meshes with enhanced mechanical properties compared with current PP vaginal meshes.

Highlights

Pelvic organ prolapse (POP) and stress urinary incontinence (SUI), are two very common disorders affecting 30–40% of women worldwide, mainly with the increase in age [1]
Vaginal meshes are commonly made of poly(propylene) (PP) or polyester, materials that are already used for hernia repair [5,6]
Elastollan® thermoplastic polyurethane (TPU) 80A pellets were used for this study and kindly provided by DistruPol Ltd. (A Univar Company, Co., Dublin, Ireland)

Summary

Introduction

Pelvic organ prolapse (POP) and stress urinary incontinence (SUI), are two very common disorders affecting 30–40% of women worldwide, mainly with the increase in age [1]. Since the population is growing gradually older, with the passage of time there will be an increase in the incidence of POP of 46% between 2010 and 2050 [2] They are not lethal diseases, these two pathologies negatively influence the quality of life of women, including their social, sexual, physical and psychological well-being [1,3]. Vaginal meshes are commonly made of poly(propylene) (PP) or polyester, materials that are already used for hernia repair [5,6] These materials are safe for hernia repair, but their safety was not properly tested for pelvic floor applications [5]. They were approved by the US FDA [5,6]. Important movements and morphological changes occur during a woman’s life, and as a result, the material used to repair the pelvic floor must be biocompatible, and able to tolerate the stress and tension associated with such a dynamic environment and at the same time flexible and elastic [5]

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