Risk Factor Analysis for Capsular Contracture, Malposition, and Late Seroma in Subjects Receiving Natrelle 410 Form-Stable Silicone Breast Implants.
BACKGROUND
Natrelle 410 silicone breast implants are approved in the United States 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 percent; malposition, 1.5 to 2.7 percent; and late seroma, 0.1 to 0.2 percent. 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 povidone-iodine 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 the time of implantation in the reconstruction cohort (p = 0.0028), and implantations performed in physicians' offices versus hospitals or standalone surgical facilities in both revision cohorts (p < 0.0001). The 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.


METHODS
Risk, II.
St. Louis, Mo.; Houston, Texas; and Irvine, Calif.|From Parkcrest Plastic Surgery; Baylor College of Medicine; and Allergan, Inc.
Patricia
P
McGuire
St. Louis, Mo.; Houston, Texas; and Irvine, Calif.|From Parkcrest Plastic Surgery; Baylor College of Medicine; and Allergan, Inc.
Neal R
NR
Reisman
St. Louis, Mo.; Houston, Texas; and Irvine, Calif.|From Parkcrest Plastic Surgery; Baylor College of Medicine; and Allergan, Inc.
Diane K
DK
Murphy
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019928:Breast Implantation / Q000295:instrumentation*; D018427:Breast Implants; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D057910:Implant Capsular Contracture / Q000453:epidemiology / Q000209:etiology*; D015994:Incidence; D008875:Middle Aged; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012307:Risk Factors; D049291:Seroma / Q000453:epidemiology / Q000209:etiology*; D020034:Silicone Gels; D055815:Young Adult
D020034:Silicone Gels