Device Category Dossier

Silicone gel-filled breast implant, smooth-surface

Device Category Dossier for Silicone gel-filled breast implant, smooth-surface. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Silicone gel-filled breast implants are sterile silicone prostheses intended for use in female patients to increase breast size or replace breast tissue removed due to cancer, trauma, or failed development from severe breast anomaly. These devices are used for primary and revision breast augmentation and breast reconstruction procedures, including revision surgery to correct or improve previous augmentation or reconstruction outcomes.