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

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 implant...

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Bibliographic Details
Published in:	Plastic and reconstructive surgery (1963) Vol. 130; no. 5; pp. 973 - 981
Main Authors:	Stevens, W. Grant, Harrington, Jennifer, Alizadeh, Kaveh, Berger, Lewis, Broadway, David, Hester, T. Roderick, Kress, Donald, d'Incelli, Rosalyn, Kuhne, JoAnn, Beckstrand, Maggi
Format:	Journal Article
Language:	English
Published:	Hagerstown, MD American Society of Plastic Surgeons 01-11-2012 Lippincott Williams & Wilkins
Subjects:	Biological and medical sciences Breast Implantation - adverse effects Breast Implants - adverse effects Device Approval Follow-Up Studies Humans Implant Capsular Contracture - epidemiology Medical sciences Patient Satisfaction Prosthesis Design Prosthesis Failure Quality of Life Reoperation Rupture Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases Treatment Implant Follow up study Surgery Clinical trial Food and Drug Administration Strength
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Summary:	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. 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. 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. 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. Therapeutic, IV.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23
ISSN:	0032-1052 1529-4242
DOI:	10.1097/PRS.0b013e31826b7d2f