Three-Year Intermediate Results of a Prospective Multicenter Study Investigating the use of Smooth, Semi-Smooth, Microtextured and Macrotextured Implants from a Single Manufacturer in Breast Augmentation and Reconstruction Procedures.

Silicone gel-filled implants exist in a wide range of shapes and textures, and yet there are relatively few long-term large-scale studies, particularly on recently developed "semi-smooth" implants. The present study fills this gap by presenting the 3-year findings from an ongoing 10-year multicenter prospective study on breast implants with four different surface types: smooth, semi-smooth, microtextured, and macrotextured. A total of 908 patients were recruited in 15 investigational sites across Europe and divided into three groups: 653 primary augmentations in Group 1, 144 revision augmentations in Group 2, and 111 reconstructions in Group 3.

A 10-Year Prospective Study of Implant-Based Breast Augmentation and Reconstruction.

Observational studies are essential for ensuring patient safety, decreasing complications, and developing better surgical techniques and implants. The primary objective of this study is to demonstrate the safety and efficacy of Sebbin breast implants in both augmentation and reconstruction cohorts. This prospective, multicenter, observational 10-year study conducted in France included 205 patients (385 implants) who underwent breast augmentation (n = 166) or reconstruction (n = 39) with Sebbin round silicone gel implants.