Randquist C, Jaeger M, Stavrou D. Six-year evaluation of Motiva round and Ergonomix SmoothSilk surface silicone breast implants: a two-center, two-surgeon outcome analysis of 1053 primary and secondary breast augmentations and augmentation mastopexy. Aesthet Surg J. 2023;43(3):295-307. doi: 10.1093/asj/sjac276
Disclosure
Dr. Epstein is a paid investigator in the Motiva U.S. FDA clinical trial and is compensated by Establishment Labs to train surgeons on the Preservé breast augmentation technique. He discloses this relationship in all public communications involving Motiva or Preservé. Dr. Epstein owns stock in Establishment Labs.
What This Study Found
Looking back across six years and two surgical practices, this study followed 1,053 women who had primary or repeat breast augmentation with Motiva's smooth-surface implants. The overall device-related complication rate was low, and it dropped further once the surgeons refined a few technical details in 2018.
Key Findings
- 1,053 primary and secondary augmentations and augmentation-with-lift procedures, April 2015 through December 2020
- Two centers, two surgeons (Sweden and Cyprus)
- Low device-related complication rate across all six years
- Complication rate declined significantly after surgical technique adjustments made in 2018
- Provides technical guidance for transitioning a practice from textured to smooth-surface implants
Why This Matters for Preservé Patients
This is long-term, large-scale, real-world safety data on the implant itself, separate from the tissue-preservation surgical technique. It's a good complement to the shorter but more surgically-focused studies elsewhere in this library, and it's worth being precise on the page that this is implant-level data, not Dr. Epstein's own surgical series.
