Abstract / Summary
Background/Objectives: Post-traumatic nasal pyramid reconstruction is challenging in patients with severe deformity and exhausted autologous graft options, particularly after multiple failed surgeries. Custom-made titanium implants may offer precise structural support, but data on their mucosal integration and ultrastructural tissue response in nasal reconstruction are lacking. The aim of this study is to describe what is, to the best of our knowledge, the first reported case of nasal pyramid reconstruction using an IPS (Individual Patient Solutions) custom-made titanium implant and to evaluate peri-implant tissue response with transmission electron microscopy (TEM). Methods: A 50-year-old male military personnel with long-standing saddle-nose deformity, nasal obstruction, and prior failed graft-based reconstructions underwent open rhinoplasty with placement of a patient-specific titanium implant designed with three-dimensional virtual surgical planning on the basis of established nasal anthropometric parameters and manufactured as a custom-made device under Regulation (EU) 2017/745. The implant reconstructed the nasal dorsum from nasion to tip and was stabilized with cortical screws; an additional thin titanium plate was used for tip support. Biopsies of nasal mucosa and adjacent connective tissue obtained 24 months postoperatively were processed for TEM to assess epithelial, stromal, vascular, and implant–tissue interface characteristics. Results: Clinically, nasal airway patency improved immediately after packing removal, with restoration of nasal contour and stable functional and aesthetic outcomes at 24-month follow-up without complications. Ultra-structurally, the respiratory epithelium showed preserved stratification, intact basal and ciliated cells, normal nuclei and mitochondria, and organized extracellular matrix closely opposed to discrete titanium particles, without granulomatous foreign-body reaction, dense inflammatory infiltrate, or fibrotic encapsulation. Focal ciliary damage, cytoplasmic vacuolization, lamina propria thickening, and vascular elastic lamina remodeling were interpreted as adaptive or transient stress-related changes rather than chronic implant toxicity. Conclusions: Custom-made IPS titanium implants can provide stable structural support, satisfactory functional and aesthetic outcomes, and a well-tolerated mucosal interface in complex post-traumatic nasal pyramid reconstruction after failed graft-based surgeries. The ultrastructural findings are being consistent with good local tolerance of the implant at 24 months, showing predominantly preserved epithelial and stromal architecture with only focal, adaptive stress-related changes rather than chronic implant-related toxicity. However, as this is a single case assessed without conventional histology, immunohistochemistry or objective measurement of nasal airflow, these observations cannot establish biocompatibility, efficacy or long-term safety, and require confirmation in larger series with longer follow-up.