The Study of the Safety and Effectiveness of Motiva SmoothSilk Silicone Gel-Filled Breast Implants in Patients Undergoing Primary and Revisional Breast Augmentation: Three-Year Clinical Data.

ABSTRACT:

Background

Silicone breast implant design has evolved over the last 50 years. Regulatory bodies including the FDA require data to support the modifications designed to improve the safety, efficacy, longevity, and biocompatibility of breast implants.

Objectives

The authors reviewed the 3-year data on the safety and effectiveness of Motiva (Establishment Labs Holdings, Inc., Alajuela, Costa Rica) SmoothSilk silicone gel-filled breast implants submitted to the FDA. The current submitted data include the primary breast augmentation and revisional augmentation cohorts.

Methods

The Motiva IDE is a prospective, single-arm, multicenter, 10-year pivotal study in which data are collected on breast augmentation, reconstruction, and revisional surgery. Three-year data were submit

SUBMITTER: Glicksman C 

PROVIDER: S-EPMC11565863 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature