Motiva Ergonomix2 SmoothSilk - Silicone gel-filled breast implant, smooth-surface

Intended purpose

Establishment Labs Motiva Implants® Ergonomix2® sterile silicone breast implants are intended to be used in female patients for the following procedures: • Breast augmentation (primary and revision): Increases breast size and includes revision surgery to correct or improve the result of a previous breast-augmentation surgery • Breast reconstruction (primary and revision): Replaces breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast anomaly and includes revision surgery to correct or improve the results of a previous breast-reconstruction surgery

Functional description

Ergonomix2® devices principle of operation relies on the implant's ability to produce a volumetric increase in the mammary area for aesthetic or reconstructive purposes. The device is inserted into the breast during a surgical procedure. Different surgical approaches (inframammary, transaxillary, or periareolar incision) and implant placements (subglandular, submuscular, or subfascial) can be used. preoperative plan for matching the implant to patient tissue characteristics