Laboratorios Vertex S.A.S. is a Colombian company with more than eighteen years of experience dedicated to the design, development, and manufacturing of silicone implantable medical devices. Its history began in 2007 under the name SIMA Zona Franca S.A., later evolving into SIMA INC S.A.S., and finally, since 2022, consolidating as Laboratorios Vertex S.A.S. This evolution reflects a continuous process of business growth, technological modernization, and expansion of production capabilities within the healthcare sector.
Operations take place in the Bogotá Free Trade Zone, where the company operates with ISO 7 cleanrooms and strict document controls, allowing manufacturing under international standards and ensuring full traceability. The company operates as an Industrial User of Goods and Services, complying with free-trade zone regulations. Its main economic activity is the manufacturing of medical instruments and materials, complemented by the ability to import, export, and commercialize its own products.
Laboratorios Vertex is a Colombian manufacturer certified by INVIMA, both in its production plant and in the products it manufactures and markets. This certification ensures that all processes meet national regulatory guidelines, international quality standards, strict technical validations, and the document controls required for implantable devices. This regulatory strength supports the company’s historical trajectory in the silicone implant sector in Colombia and the region.
Throughout its development, the company has created various implant lines that are now widely recognized in the market: SIMA® breast implants, with more than fifteen years of proven clinical use and performance; VOLUP-A® gluteal implants, designed to offer anatomical projection with mechanical stability; PHACYAL® facial implants, used in aesthetic and reconstructive procedures; and the new generation of SIBRIN® breast implants, currently undergoing sanitary registration and designed to incorporate significant improvements in cohesiveness, durability, and biomechanical behavior.
In recent years, Laboratorios Vertex has expanded its scope from aesthetic implants to advanced biomedical engineering, developing implantable devices for complex conditions of the abdominal cavity and urinary system. These include ARCA+®, a peritoneo–vesical shunt for the management of refractory ascites; Bladex®, designed for uretero–abdominal diversion; Bladex+®, for uretero–ureteral diversion; and ARCA DC+®, a dual system for drainage and fluid administration into the peritoneum. These devices integrate materials engineering, mechanical modeling, validations based on ASTM and ISO standards, biocompatibility testing, and design practices centered on patient safety.
The company benefits from the direct involvement of a plastic surgeon with extensive experience in the clinical use of silicone implants and devices, whose medical perspective provides a deep understanding of the real behavior of these products in patients. Based on this clinical insight, an interdisciplinary engineering team develops, validates, and optimizes each device, integrating technical knowledge, biomedical materials, and design practices focused on safety and functional performance. This synergy has enabled Laboratorios Vertex to become a national reference in the manufacturing of implantable devices, with international projection and a continuous innovation process.
Laboratorios Vertex S.A.S. continues to consolidate itself as a highly specialized Colombian company committed to science, engineering, and health. Its mission is to offer safe, reliable, and innovative solutions that positively impact patients’ quality of life, maintaining certified processes and a long-term vision for technological development.
Author: Camilo Hernández – Manufacturing Director – Colombia
