Ten-year Core Study Data for Sientra's Food and Drug Administration-Approved Round and Shaped Breast Implants with Cohesive Silicone Gel.

Background: In March 2012, the United States Food and Drug Administration approved Sientra's application for premarket approval of its portfolio of round and shaped silicone gel breast implants based on data from the largest silicone gel breast implant study to date. This article presents the results of Sientra's Core Study at the conclusion of 10 years.

Methods: The Sientra Core Study was a 10-year, open-label, prospective, multicenter clinical study designed to assess the safety and effectiveness of Sientra's breast implants in augmentation and reconstruction. A total of 1,788 patients (3,506 implants) were enrolled, including 1,116 primary augmentation, 363 revision-augmentation, 225 primary reconstruction, and 84 revision-reconstruction.

Results: Across all cohorts, the rate of rupture by patient was 8.6%, the rate of Baker grade III/IV capsular contracture was 13.5%, and the rate of reoperation was 31.5%. The rate of capsular contracture was statistically significantly lower for textured devices [9.0%; 95% confidence interval (CI), 7.0-11.5%] compared with smooth devices (17.5%; 95% CI, 14.9-20.4%). There were no cases of breast implant-associated anaplastic large cell lymphoma. Primary reasons for reoperations included capsular contracture (18.8%), and style/size change (19.3%), with over 50% of the reoperations due to cosmetic reasons.

Conclusion: The 10-year results of Sientra's Core Study support a comprehensive safety and effectiveness profile of Sientra's portfolio of round and shaped breast implants.