Abstract

Plastic surgeons and manufacturers of breast implants have been examining the complication and reoperation rates of primary breast augmentations for more than 18 years. The seemingly high rates reported by the manufacturers to the United States Food and Drug Administration (FDA) were the impetus for this multicenter study. This paper reports on data pooled from three plastic surgery practices that were geographically distributed across the United States and examines the reoperation rate, time to reoperation, the reason for reoperation, and specific complications in 177 consecutive primary breast augmentation patients. These data are statistically compared to the manufacturers' 2005 and 2008 FDA data. In addition, the significance of selected variables from our data are examined as predictors for reoperation. Data were retrospectively collected from 177 consecutive primary breast augmentations performed between 2001 and 2004 from three surgical practices. Direct physician-to-patient follow-up periods ranged from 12 to 58 months, with 100% of patients having at least one year of follow-up. Each practice extracted chart data on variables and complications, including reoperations. These data were independently collated and sent to an independent biostatistician for analysis. Our three year Kaplan-Meier (KM) reoperation rate (8%) and capsular contracture rate (2%) were both lower than the manufacturers' KM 3-year rates for reoperation (13%-21%) and capsular contracture (8.2%-9%). Logistic regression identified only simultaneous mastopexy and preexisting ptosis as predictors of reoperation.

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