Details

Autor(en) / Beteiligte

• McGuire, Patricia
• Reisman, Neal R
• Murphy, Diane K

Titel

Risk Factor Analysis for Capsular Contracture, Malposition, and Late Seroma in Subjects Receiving Natrelle 410 Form-Stable Silicone Breast Implants

Ist Teil von

• Plastic and reconstructive surgery (1963), 2017-01, Vol.139 (1), p.1-9

Ort / Verlag

United States: American Society of Plastic Surgeons

Erscheinungsjahr

2017

Quelle

MEDLINE

Beschreibungen/Notizen

• BACKGROUND:Natrelle® 410 silicone breast implants are approved in the US for breast augmentation, reconstruction, and revision. METHODS:In two ongoing, prospective, multicenter 10-year studies, 17,656 subjects received Natrelle 410 implants for augmentation (n=5059), revision-augmentation (n=2632), reconstruction (n=7502), or revision-reconstruction (n=2463). Capsular contracture, implant malposition, and late seroma were documented. Cox proportional hazards regression analyses evaluated potential associations between subject-, implant-, and surgery-related factors and these complications. RESULTS:Median follow-up was 4.1, 2.6, 2.1, and 2.3 years in the augmentation, revision-augmentation, reconstruction, and revision-reconstruction cohorts, respectively. Incidence of capsular contracture across cohorts ranged from 2.3% to 4.1%, malposition from 1.5% to 2.7%, and late seroma from 0.1% to 0.2%. Significant risk factors for capsular contracture were subglandular implant placement, periareolar incision site, and older device age in the augmentation cohort (p < 0.0001), older subject age in the revision-augmentation cohort (p < 0.0001), and higher body mass index (p = 0.0026) and no Betadine pocket irrigation (p = 0.0006) in the reconstruction cohort. Significant risk factors for malposition were longer incision size in the augmentation cohort (p = 0.0003), capsulectomy at time of implantation in the reconstruction cohort (p = 0.0028), and implantations performed in physicians’ offices versus hospitals or stand-alone surgical facilities in both revision cohorts (p < 0.0001). Incidence of late seroma was too low to perform risk factor analysis. CONCLUSIONS:These data reaffirm the safety of Natrelle 410 implants. Knowledge of risk factors for capsular contracture and implant malposition offers guidance for reducing complications and optimizing outcomes.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially.