title: Two-year outcomes with a novel, double-lumen, saline-filled breast implant.
abstract: BACKGROUND
  A double-lumen, saline-filled breast implant with a baffle structure (IDEAL IMPLANT Saline-Filled Breast Implant; Ideal Implant Incorporated, Irving, Texas) was developed to overcome the limitations of single-lumen saline implants by controlling saline movement and providing internal support to the implant edge and upper pole.
  
  
  OBJECTIVE
  The authors report 2-year data from a 10-year US clinical trial evaluating the safety and effectiveness of this investigational implant.
  
  
  METHODS
  Women seeking primary breast augmentation or replacement of existing augmentation implants were enrolled between February 2009 and February 2010 at 35 private practice sites, where the women underwent surgery to receive the new technology implant. Data collection included incidence and grade of capsular contracture (CC) and wrinkling as well as patient- and surgeon-reported satisfaction measures. All clinical data were reported as Kaplan-Meier risk rates of first occurrence, per patient, in each cohort.
  
  
  RESULTS
  Two-year follow-up visits were completed by 472 of 502 enrolled women (94.0%), 378 of whom had undergone primary breast augmentation and 94 of whom had received replacement augmentation. Patient-reported satisfaction with the outcome was 94.3% for primary augmentations and 92.3% for replacement augmentations; surgeon-reported satisfaction was also high (96.5% and 93.4%, respectively). Baker Grade III and IV CC rates were 3.8% (primary) and 8.2% (replacement), whereas moderate-to-severe wrinkling was 3.8% (primary) and 12.0% (replacement). Deflations occurred in 4.8% of primary augmentations and 3.3% of replacement augmentations. No deflations were caused by a shell fold flaw.
  
  
  CONCLUSIONS
  Two-year data from 472 women indicate that this double-lumen saline implant containing a baffle structure has a low rate of wrinkling and a lower rate of CC at 2 years than was reported for current single-lumen saline implants at 1 year.
authors.affiliation: University of Southern California, Irvine, USA.
authors.forename: Larry S
authors.initials: LS
authors.lastname: Nichter
authors.forename: Robert S
authors.initials: RS
authors.lastname: Hamas
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D019928:Breast Implantation / Q000379:methods*; D018427:Breast Implants; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D057910:Implant Capsular Contracture / Q000453:epidemiology*; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D017060:Patient Satisfaction; D011475:Prosthesis Failure; D012086:Reoperation; D012965:Sodium Chloride; D055815:Young Adult
chemical_list: D012965:Sodium Chloride