title: Natrelle style 410 form-stable silicone breast implants: core study results at 6 years.
abstract: BACKGROUND
  The Natrelle Style 410 shaped, form-stable silicone gel implant (Allergan, Inc; Irvine, California) has been the subject of a pivotal study that supports potential US Food and Drug Administration approval of the device. The 3-year results of this study were reported previously.
  
  
  OBJECTIVE
  The authors update the safety and effectiveness findings for the Natrelle Style 410 implants through 6 years of study.
  
  
  METHODS
  This prospective, nonrandomized, multicenter study included 941 patients (492 primary augmentations, 156 revision-augmentations, 225 primary reconstructions, and 68 revision-reconstructions). Since the original 3-year report, follow-up visits have been conducted annually. Kaplan-Meier risk rates were calculated for local complications, reoperations, and explantations. One-third of the subjects were enrolled in the magnetic resonance imaging (MRI) cohort and underwent biannual MRI rupture screening. Effectiveness was measured by subject satisfaction on a 5-point scale.
  
  
  RESULTS
  As expected after breast implantation, capsular contracture (CC) was one of the most common complications, with 6-year risk rates of 4.6% for augmentation, 6.9% for revision-augmentation, 10.7% for reconstruction, and 18.3% for revision-reconstruction. The rates for CC among augmentations and revision-augmentations were significantly lower with the Natrelle 410 implants than with other standard gel implants. The rupture rate (confirmed plus suspected) across all cohorts was 6.4% by subject and 3.8% by implant. The most common reasons for reoperation were style or size change (augmentation), implant malposition (revision-augmentation), scarring (reconstruction), and CC (revision-reconstruction). The satisfaction rate exceeded 80% in all cohorts.
  
  
  CONCLUSIONS
  These fifth-generation, form-stable implants represent another option to achieve desired aesthetic outcomes with minimal complications.
authors: Department of Plastic Surgery, Loma Linda University School of Medicine, California, USA. gpm@maxwellaesthetics.com
authors: G Patrick
authors: GP
authors: Maxwell
authors: Bruce W
authors: BW
authors: Van Natta
authors: Diane K
authors: DK
authors: Murphy
authors: Araceli
authors: A
authors: Slicton
authors: Bradley P
authors: BP
authors: Bengtson
mesh_terms: D000328:Adult; D019928:Breast Implantation / Q000009:adverse effects / Q000295:instrumentation*; D018427:Breast Implants; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008279:Magnetic Resonance Imaging; D008875:Middle Aged; D061214:Patient Safety; D017060:Patient Satisfaction; D011183:Postoperative Complications / Q000209:etiology / Q000601:surgery; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012086:Reoperation; D018570:Risk Assessment; D012307:Risk Factors; D020034:Silicone Gels; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D020034:Silicone Gels