Complications After Patient-specific Implants for Facial Contouring and Augmentation: A Systematic Review and Meta-analysis.

BACKGROUND: Patient-specific implants (PSIs) made from titanium (Ti) or polyetheretherketone (PEEK) are increasingly used for craniofacial contouring and reconstruction. We compared clinical outcomes between Ti and PEEK PSIs. METHODS: We searched PubMed, Embase, and Cochrane Library for clinical studies of Ti and PEEK PSIs used for facial reconstruction/augmentation. Single-arm random-effects meta-analyses estimated pooled event rates, and subgroup tests compared materials. Primary outcomes were overall complications, infection, explantation, and healing-related issues. Secondary outcomes were placement accuracy and patient satisfaction. This review followed PRISMA 2020 (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and MOOSE (Meta-analysis of Observational Studies in Epidemiology) guidelines. RESULTS: Twenty-nine studies comprising 392 patients and 543 implants (447 PEEK; 96 Ti) met the inclusion criteria. Pooled overall complication rates were 6.94% (95% confidence interval 2.38-12.98) for PEEK and 4.77% (95% confidence interval 0.05-13.66) for Ti. Infection occurred in 1.51% versus 0.33%, implant removal in 0.73% versus 0.00%, and healing-related issues in 2.61% versus 2.54% (PEEK versus Ti). Under random-effects, between-material subgroup tests were nonsignificant for overall complications (P = 0.58), infection (P = 0.35), explantation (P = 0.24), and healing-related issues (P = 0.88). Patient-reported satisfaction (0-100 scale) improved from a mean of 41.8 preoperatively to 75.4 postoperatively for PEEK; placement accuracy averaged 2.23 mm, where reported, and Ti data were sparse. Mean follow-up across studies was 27.8 months. CONCLUSIONS: Ti and PEEK PSIs demonstrate low complication rates with no clear material superiority once between-study variability is considered. Material selection should be individualized to the anatomical site, imaging needs, and revision plans. Prospective, standardized, head-to-head studies with longer follow-up are needed.