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Five-Year Follow-Up Data from the U.S. Clinical Trial for Sientra's U.S. Food and Drug Administration–Approved Silimed® Brand Round and Shaped Implants with High-Strength Silicone Gel

Stevens, W. Grant M.D.; Harrington, Jennifer M.D.; Alizadeh, Kaveh M.D.; Berger, Lewis M.D.; Broadway, David M.D.; Hester, T. Roderick M.D.; Kress, Donald M.D.; d'Incelli, Rosalyn B.A.; Kuhne, JoAnn M.S.N.; Beckstrand, Maggi M.P.H.

Plastic & Reconstructive Surgery: November 2012 - Volume 130 - Issue 5 - p 973–981
doi: 10.1097/PRS.0b013e31826b7d2f
Breast: Original Articles
Discussion
Basic
Advanced

Background: In March of 2012, the U.S. Food and Drug Administration approved Sientra's application for premarket approval for its Silimed brand silicone gel implants, based on data from the largest silicone gel breast implant study to date. This was the first approval for shaped silicone gel breast implants. This article presents the results of Sientra's study through 5 years.

Methods: Sientra's study is an ongoing, 10-year, open-label, prospective, multicenter clinical study designed to assess the safety and effectiveness of Sientra's implants in patients undergoing augmentation and reconstruction. A total of 1788 subjects were implanted with 3506 implants, including 1116 primary augmentation, 363 revision-augmentation, 225 primary reconstruction, and 84 revision-reconstruction subjects. Physical evaluations and complications were recorded at each visit. Effectiveness was measured by postimplantation bra cup size and assessment of subject satisfaction and quality of life. Of the 1788 subjects, 571 underwent magnetic resonance imaging to assess silent rupture. Safety endpoints were analyzed using the Kaplan-Meier method.

Results: Across all cohorts, the risk of rupture was 1.8 percent (95 percent CI, 1.2 to 2.6 percent), the risk of capsular contracture (Baker grade III/IV) was 9.0 percent (95 percent CI, 7.6 to 10.6 percent), and the risk of reoperation was 23.8 percent (95 percent CI, 21.8 to 26.0 percent). Over 99 percent of surgeons reported satisfaction with the postoperative results, and subject satisfaction remained high 5 years after implantation.

Conclusion: The 5-year results of Sientra's study continue to provide a comprehensive safety and effectiveness profile of Sientra's portfolio of Silimed brand shaped and round implants.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Los Angeles, Marina del Rey, Santa Barbara, Calif.; Minneapolis–Saint Paul, Minn.; Garden City, N.Y.; Tampa, Fla.; Lone Tree, Colo.; Atlanta, Ga.; and Frederick, Md.

From the Division of Plastic Surgery, University of Southern California School of Medicine; Marina Plastic Surgery; Harrington Plastic Surgery; the University of Minnesota; Long Island Plastic Surgical Group; Cosmetic and Reconstructive Surgery Center; Bod:Evolve; Paces Plastic Surgery; Plastic Surgery One; Sientra; and MB Stats, LLC.

Received for publication July 6, 2012; accepted July 24, 2012.

Disclosure: Drs. Stevens, Harrington, Alizadeh, Berger, Broadway, Hester, and Kress are clinical study investigators for Sientra and received standard research support for conducting this study. Ms. d'Incelli and Ms. Kuhne are employees of Sientra. Ms. Beckstrand is a Sientra consultant.

W. Grant Stevens, M.D.; Marina Plastic Surgery Associates, 4464 Lincon Boulevard, Suite 552, Marina del Rey, Calif. 90292, drstevens@hotmail.com

Rosalyn d'Incelli, B.A.; Clinical Operations, Sientra, 6769 Hollister Avenue, Suite 201, Santa Barbara, Calif. 93117, rosalyn.dincelli@sientra.com

©2012American Society of Plastic Surgeons