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Published on: July 1, 2013
Nine-Year Core Study Data for Sientra's FDA-Approved Round and Shaped Implants with High-Strength Cohesive Silicone
W Grant Stevens1, M Bradley Calobrace1, Jennifer Harrington1
1Dr Stevens is a Clinical Professor of Surgery, Division of Plastic Surgery, University of Southern California School of Medicine; and Director of the University of Southern California - Marina del Rey Aesthetic Surgery Fellowship Program, Los Angeles, CA. Dr Calobrace is a Gratis Clinical Faculty Member, Division of Plastic Surgery, University of Louisville, Louisville, KY, and Clinical Faculty Member, Division of Plastic Surgery, University of Kentucky, Lexington, KY. Dr Harrington is an Adjunct Professor of Surgery, Division of Plastic and Reconstructive Surgery, University of Minnesota, Minneapolis, MN, and Director of Plastic and Microvascular Surgery at North Memorial Hospital, Robbinsdale, MN. Dr Alizadeh is the Chief of Plastic and Reconstructive Surgery, Division of Plastic and Reconstructive Surgery, Westchester Medical Center and New York Medical College, Valhalla, NY. Dr Zeidler is a plastic surgeon in private practice in Campbell, CA. Ms d'Incelli is Vice President, Clinical Operations, Sientra, Inc., Santa Barbara, CA.
Background:
Since approval in March 2012, data on Sientra's (Santa Barbara, CA) silicone gel implants have been updated and published regularly to provide immediate visibility to the continued safety and performance of these devices. The 9 year follow-up data support the previously published data confirming the ongoing safety and efficacy of Sientra silicone gel breast implants.
Objectives:
The authors provide updated 9 year study data for Sientra's round and shaped silicone gel breast implants.
Methods:
The Core Study is an ongoing 10 year study that enrolled 1788 patients with 3506 Sientra implants across four indications (primary augmentation, revision-augmentation, primary reconstruction, and revision-reconstruction). For the safety analysis, Kaplan-Meier risk rates were calculated to evaluate postoperative complications, including all breast implant-related adverse effects. For the effectiveness analyses, results were presented through 8 years as patient satisfaction scores were assessed at even years.
Results:
Through 9 years, the overall risk of capsular contracture was 12.6%. Smooth devices (16.6%, 95% CI, 14.2%, 19.5%) had a statistically significantly higher rate of capsular contracture compared to textured devices (8.0%, 95% CI, 6.2%, 10.4%). Out of the 610 reoperations in 477 patients, over half of all reoperations were due to cosmetic reasons (n = 315; 51.6%). Patient satisfaction remains high through 8 years, with 90% of primary augmentation patients indicating their breast implants look natural and feel soft.
Conclusions:
The 9-year follow-up data from the ongoing Core Study of the Sientra portfolio of HSC and HSC+ silicone gel breast implants reaffirm the very strong safety profile as well as continued patient satisfaction.
Level Of Evidence:
2 Therapeutic.
