Patient-specific implants for craniomaxillofacial surgery: A manufacturer's experience

Abstract

Additive manufacturing technologies have enabled the development of customised implants for craniomaxillofacial applications using biomaterials such as polymethylmethacrylate (PMMA), porous high-density polyethylene (pHDPE), and titanium mesh. This study aims to report an Australian manufacturer's experience in developing, designing and supplying patient-specific craniomaxillofacial implants over 23 years and summarise feedback received from clinicians. The authors conducted a retrospective review of the manufacturer's implant database of orders placed for custom craniomaxillofacial implants between 1996 and 2019. The variables collected included material, country of order, gender, patient age, and reported complications, which included a measure of custom implant “fit” and adverse events. The development of critical checkpoints in the custom manufacturing process that minimise clinical or logistical non-conformities is highlighted and discussed. A total of 4120 patient-specific implants were supplied, of which 2689 were manufactured from PMMA, 885 from titanium mesh, and 546 from pHDPE. The majority of the implants were used in Australia (2260), United Kingdom (412), Germany (377), and New Zealand (338). PMMA was the preferred material for cranial implants whereas pHDPE was preferred for maxillofacial applications. Age or gender did not influence the material choice. Implant “fit” and adverse outcomes were used as a metric of implant performance. Between 2007 and 2019 there were 37 infections (0.98%) and 164 non-conformities recorded of which 75 (1.8%) were related to implant ‘fit’. Our experience demonstrates a safe, reliable, and clinically streamlined manufacturing process which supports surgeons that require bespoke craniomaxillofacial solutions for reconstruction surgery.

Segmental Resection With Primary Reconstruction Using a Patient-Specific Implant for Unicystic Ameloblastoma: A One-Year Follow-Up Case Report

“…They are classified based on the materials used, such as polymethylmethacrylate (PMMA), porous highdensity polyethylene (pHDPE), and titanium mesh. Previous studies have demonstrated their clinical and surgical efficacy [6]. This case report presents the clinical presentation of a 22-year-old female patient with a mural-type unicystic ameloblastoma situated in the posterior region of the left mandible.…”

Bioactive Scaffolds as a Promising Alternative for Enhancing Critical-Size Bone Defect Regeneration in the Craniomaxillofacial Region

“…The synthetic polymers polyether ether ketone (PEEK), poly­(methyl methacrylate) (PMMA), and porous high-density polyethylene (pHDPE) have been widely used to treat large cranial defects, specifically for brain protection and shape restoration instead of promoting bone regeneration because they are osteoconductive but not osteoinductive . Other synthetic polymers tested to a lesser extent in vivo are the nonresorbable and cytocompatible material polystyrene (PS), and poly­(ethylene- co -vinyl alcohol)/poly­(δ-valerolactone) (PEVAV) .…”

“…Additionally, surface modifications have conferred osteoinductivity and have reduced metal ion release improving their biocompatibility . Nowadays, titanium meshes are frequently placed and fixed with screws around grafted materials in CSDs, peri-implant defects, and alveolar ridge augmentations. , …”

Laser Sintering Approaches for Bone Tissue Engineering

“…The "ideal" BTE scaffold should also modulate cellular interactions, promote vascularisation, and replicate the mechanical properties at the target site [5,6]. Additionally, the preparation and sterilisation techniques need to comply with industry and regulatory standards [7]. To this end, this review explores the structure and function of bone, as well as the current strategies used to treat defects.…”