Sientra breast implants may have had a rough patch in the past six months due to a voluntary cessation of manufacturing and distribution of their implants. But now that their breast implants have been fully cleared again by the FDA with no concerns about them or their manufacturing process, they are now again clinically available. As such, any long-term data that evaluates their safety and effectiveness is of interest to patients and plastic surgeons alike.
In the February 2016 issue of the Aesthetic Surgery Journal, an article was published entitled ‘Nine-Year Core Study Data for Sientra’s FDA-Approved Round and Shaped Implants with High-Strength Cohesive Silicone Gel’. In this paper, nine year follow-up data was evaluated for Sientra’s round and shaped silicone gel breast implants. This is part of a ten year study that initially enrolled almost 1,800 with just over 3,500 Sientra implants for primary, revision-augmentation, primary breast reconstruction and revision-reconstruction. The overall risk of capsular contracture was just under 13%. Smooth breast implants had a higher rate of capsular contracture (16%) compared to textured breast implants. (8%) Over 600 reoperations were done in 477 patients, of which half of the reoperations were done due to aesthetic reasons. In the primary augmentation group, the most common reason for reoperation was capsular contracture (25.%). In the revision-augmentation and the primary reconstruction cohorts, the most common reasons for reoperation were style/size change (18% and 21%, respectively). In the revision-reconstruction cohort, the most common reason was asymmetry (23%)
Across all four groups, magnetic resonance imaging (MRI) consisted of about 570 patients who undergo regular MRIs to assess for ruptures. The Sientra primary augmentation 10 year MRI rupture rate was 9.0%. The use of high-strength cohesive fill, shown to have higher stability as well as the increased gel-shell integration is an explanation of the low rupture ratess seen in this Sientra study.
Patient satisfaction remained high through eight years with 90% of primary augmentation patients indicating their breast implants look natural and feel soft. Primary augmentation ranked patient satisfaction highest for “Patient agrees that her breasts look natural and feel soft” at 90%, while the revision-augmentation ranked “Patient agrees that her breasts look natural and soft” the highest at 88%. The highest patient reported satisfaction within the reconstruction cohorts was “Patient thinks breast implants make her clothes fit better” at 86% primary reconstruction and 95% revision-reconstruction.
The nine year data for Sientra breast implants study shows a good safety and performance results that performs as well, if not better, than other breast implants on the market.
Dr. Barry Eppley
Indianapolis, Indiana