Device Dossier

Motiva Ergonomix Round SilkSurface/Smoothsilk without Qid - Silicone gel-filled breast implant, smooth-surface

Device Dossier for Motiva Ergonomix Round SilkSurface/Smoothsilk without Qid - Silicone gel-filled breast implant, smooth-surface (Silicone gel-filled…

Intended purpose

Establishment Labs Sterile Silicone Breast Implants Motiva Implant Matrix® are indicated for the following procedures in female patients: • Breast augmentation for women of at least 18 years old, including previous augmentation to increase the breast size and revision surgery to correct or improve the result of a previous breast augmentation surgery. • Breast Reconstruction. Breast reconstruction, including previous reconstruction to replace breast tissue that has been removed due to cancer or trauma, or that has failed to develop properly due to a severe breast anomaly, as well as revision surgery to correct or improve the results of a previous breast reconstruction surgery.

Functional description

Motiva Implants clinical function is to increase/substitute the breast area volume through a surgical procedure, by a volumetric filling effect for breast implant surgery. Motiva Implants are constructed of successive cross-linked layers of silicone elastomer and a low diffusion barrier shell technology that provides these implants their strength, elasticity, & integrity. All implants are composed of the described shell, a patch, & highly viscous & highly elastic silicone gel proprietary formula

TGA Public Summary