title: Sientra portfolio of Silimed brand shaped implants with high-strength silicone gel: a 5-year primary augmentation clinical study experience and a postapproval experience-results from a single-surgeon 108-patient series.
abstract: BACKGROUND
  The Sientra portfolio of silicone gel breast implants was approved by the Food and Drug Administration on March 9, 2012, and included the first approved shaped implants in the United States. The 5-year results from Sientra's Core Gel and Continued Access Study and the results of a single surgeon are presented.
  
  
  METHODS
  This analysis used the data of 640 shaped implants in 321 primary augmentation patients implanted by 16 study surgeons through 5 years. The Kaplan-Meier method was used to analyze safety endpoints. In addition, analysis is presented for a single surgeon's results of 213 shaped implants in 108 postapproval patients through up to 16 months of follow-up (9-month mean) using a separate frequency analysis.
  
  
  RESULTS
  The overall risk of rupture for primary augmentation patients through 5 years was 0.4%, the risk of infection was 1.4%, and the risk of capsular contracture (Baker grade III/IV) was 3.9%. Reported surgeon satisfaction was 100%, and patient satisfaction remained high. In the separate single-surgeon analysis, after 16 months, 4 of the 108 patients experienced a complication (3.7%) and 3 underwent a reoperation (2.8%). Complications included infection, ptosis (0.9%, each), and capsular contracture (1.9%).
  
  
  CONCLUSIONS
  The results of Sientra's large clinical study and the postapproval data from a single surgeon demonstrate the safety and effectiveness of Sientra's shaped implants. The review of the data and author's experience illustrate the ease of incorporating shaped implants into any surgical practice.
authors: Nashville, Tenn.; Westlake Village and Santa Barbara, Calif.; and Tampa, Fla. From the Plastic Surgery Center of Nashville; Westlake Cosmetic Surgery Center; Cosmetic and Reconstructive Surgery Center; and Sientra Inc.
authors: Melinda J
authors: MJ
authors: Haws
authors: Michael R
authors: MR
authors: Schwartz
authors: Lewis H
authors: LH
authors: Berger
authors: Kimber L
authors: KL
authors: Daulton
mesh_terms: D000328:Adult; D019928:Breast Implantation / Q000379:methods; D018427:Breast Implants; D005260:Female; D006801:Humans; D057910:Implant Capsular Contracture / Q000453:epidemiology; D017060:Patient Satisfaction; D011474:Prosthesis Design; D012086:Reoperation / Q000706:statistics & numerical data; D020034:Silicone Gels; D016896:Treatment Outcome
chemical_list: D020034:Silicone Gels