title: Clinical trial outcomes of high- and extra high-profile breast implants.
abstract: BACKGROUND
  Clinical data concerning potential risks and benefits associated with the use of high- and extra high-profile breast implants are lacking.
  
  
  OBJECTIVE
  The authors assess the risk of adverse events (AE) with high- and extra high-profile breast implants compared with low- to moderate-profile breast implants in patients enrolled in long-term clinical studies.
  
  
  METHODS
  Relative risks (RR) of capsular contracture (CC), moderate to severe malposition, and secondary procedure were calculated using Cox proportional hazards regression, adjusting for patient, procedure, and device characteristics among patients enrolled in the primary augmentation cohorts of the Core (NCT00689871; round, silicone-filled implants) and 410 (NCT00690339; shaped, highly cohesive silicone-filled implants) clinical studies. Study pooling provided comparisons of implant shape and fill, as well as contributed to relative outcome. Analyses were also stratified by preoperative breast measures.
  
  
  RESULTS
  In the Core study (N = 454; 907 implants; mean follow-up 7.2 years; 3669 person-years), and the combined Core and 410 studies (N = 4412; 8811 implants; mean follow-up 3.0 years; 14 528 person-years), risk of CC, secondary procedures, and mastopexy as a secondary procedure were reduced in high-profile versus low- to moderate-profile breast implants (P < .05). The risk of moderate to severe malposition was not significantly different between high-profile and low- to moderate-profile breast implants in the Core or combined studies (RR, 0.58 [95% confidence interval (CI), 0.22-1.51] and RR, 0.72 [95% CI, 0.31-1.70], respectively). Analyses stratified by preoperative breast measures did not indicate higher risk of CC, malposition, or secondary procedure among patients with either smaller (<17 cm) or larger (≥17 cm) preoperative measures.
  
  
  CONCLUSIONS
  Among primary augmentation patients with round, silicone-filled, or shaped, highly cohesive silicone-filled implants, high- and extra high-profile implants were associated with lower risks of CC, secondary procedures, and mastopexy and were not associated with greater risks of moderate to severe malposition versus low- to moderate-profile implants.
  
  
  METHODS
  3.
authors.affiliation: Global Safety & Epidemiology for Allergan, Inc, Irvine, California, USA.
authors.forename: Joan A
authors.initials: JA
authors.lastname: Largent
authors.forename: Neal R
authors.initials: NR
authors.lastname: Reisman
authors.forename: Hilton M
authors.initials: HM
authors.lastname: Kaplan
authors.forename: Michael G
authors.initials: MG
authors.lastname: Oefelein
authors.forename: Mark L
authors.initials: ML
authors.lastname: Jewell
mesh_terms: D000328:Adult; D019928:Breast Implantation / Q000379:methods*; D018427:Breast Implants; D002986:Clinical Trials as Topic; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D057910:Implant Capsular Contracture / Q000453:epidemiology*; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D011183:Postoperative Complications / Q000503:physiopathology / Q000601:surgery; D016016:Proportional Hazards Models; D011474:Prosthesis Design / Q000379:methods*; D011475:Prosthesis Failure; D018570:Risk Assessment; D020034:Silicone Gels / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D020034:Silicone Gels
keywords: anatomical pocket; breast surgery; capsular contracture; high-profile implant; malposition; secondary procedure