Safety and Performance of FILASILKTM Silk Surgical Suture in Real-World Surgical Practice: A Retrospective Observational Study

Background Silk remains one of the oldest and most versatile suture materials used in surgery. Despite advances in synthetic sutures, the clinical utility of natural non-absorbable silk remains relevant, particularly with modern processing enhancements. Objective This study aimed to evaluate the safety and performance of FilasilkTM (Meril Endo Surgery Pvt Ltd) sutures across various surgical specialties in a real-world clinical setting. Methods This was a retrospective, multi-centre, observational study conducted at three surgical centres in India between December 2018 and April 2023. A total of 163 patients who underwent soft tissue approximation or ligation procedures using the investigational silk suture were included. Primary outcomes included wound complications within one week, while secondary outcomes assessed complications and healing up to three months postoperatively. Results Of the 163 patients analysed, the mean age was 52.09±16.21 years, and males constituted 63.19% of the cohort. The most common procedures involved general, ophthalmic, and plastic surgeries. Wound dehiscence was noted in 4.29% of patients at one week, reducing to 3.07% at three months. Wound infection occurred in 1.84% of patients at one week, with no cases persisting at three months. Suture erosion (1.23%), hematoma (3.07%), and seroma (0.61%) were infrequent. Procedural complications such as breakage or inaccurate placement were rare (<2%). The suture demonstrated excellent biocompatibility, knot security, and handling across varied surgical contexts. Conclusion FilasilkTM sutures remain a clinically viable and environmentally sustainable alternative to synthetic materials. With low complication rates, favourable handling characteristics, and broad applicability, silk sutures continue to play a valuable role in modern surgical care.