title: Natrelle round silicone breast implants: Core Study results at 10 years.
abstract: BACKGROUND
  Allergan's Natrelle round silicone-filled breast implants were approved by the U.S. Food and Drug Administration in 2006 based on interim results from the Core Study; final 10-year study results are now available.
  
  
  METHODS
  Seven hundred fifteen subjects were implanted with smooth and Biocell textured Natrelle round silicone implants and attended clinic visits at 0 to 4 weeks, 6 months, 1 year, and annually through 10 years. Approximately one-third of subjects underwent magnetic resonance imaging at years 1, 3, 5, 7, and 9 to assess rupture.
  
  
  RESULTS
  Complication rates showed modest increases over the previously published 6-year rates. The Kaplan-Meier capsular contracture rate was 18.9 percent for augmentation, 28.7 percent for revision-augmentation, and 24.6 percent for reconstruction. Among augmentation subjects, capsular contracture was significantly lower (p = 0.023) for submuscular (15.7 percent) versus subglandular (26.3 percent) placement. The overall rupture rate in the magnetic resonance imaging cohort was 13.0 percent for subjects and 7.7 percent for implants. By the end of the study, 81.8 percent of augmentation subjects still had an original implant in place. Using a five-point scale, 94.2 percent of augmentation, 83.8 percent of revision-augmentation, and 90.7 percent of reconstruction subjects reported being satisfied or definitely satisfied with their implants. Significant improvement over baseline was also seen in overall breast satisfaction and satisfaction with breast size, shape, feel, and how well they matched.
  
  
  CONCLUSIONS
  The 10-year data from the Natrelle Core Study, which can guide surgeons and patients in decision-making, demonstrate safety and high levels of patient satisfaction.
  
  
  METHODS
  Therapeutic, III.
authors.affiliation: Washington, D.C.; and Santa Barbara, Calif. From the Department of Plastic Surgery, Georgetown University Hospital; and Allergan, Inc.
authors.forename: Scott L
authors.initials: SL
authors.lastname: Spear
authors.forename: Diane K
authors.initials: DK
authors.lastname: Murphy
mesh_terms: D019928:Breast Implantation / Q000379:methods; D018427:Breast Implants; D001943:Breast Neoplasms / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D057910:Implant Capsular Contracture / Q000453:epidemiology*; D008279:Magnetic Resonance Imaging; D017060:Patient Satisfaction; D011474:Prosthesis Design; D012086:Reoperation