BACKGROUND: Breast augmentation has been an integral part of plastic surgeons practices for over 40 years. Although devices have evolved, patient outcomes are still not ideal, as documented in multiple premarket approval clinical trials. Unlike many other areas of surgery, the practice of breast augmentation has suffered from the lack of a defined process for patient management. The purpose of this study was to clinically define and evaluate the process of breast augmentation and analyze patient outcomes using these practices compared with existing premarket approval trial data. METHODS: Three hundred consecutive primary breast augmentations from 2001 to 2005 were followed prospectively. Each patient underwent a defined process of breast augmentation including structured patient education and informed consent; tissue-based preoperative planning consultation; refined surgical technique; and structured postoperative instructions, management, and follow-up. RESULTS: The mean follow-up was 2.1 years. The most common complications were rippling and palpability, soft-tissue stretch, and hypersensitivity. The overall reoperation rate was 3.7 percent for the entire group and 4.7 percent and 2.9 percent for saline and form-stable cohesive gel implants, respectively. CONCLUSIONS: Optimizing patient outcomes in breast augmentation requires defining the overall process to allow for enhanced patient outcomes. This is the first report that defines and integrates the entire process comprehensively that is validated by outcomes data. This process is transferable to other surgeons and, using this algorithm, patient outcomes in this study were superior to premarket approval clinical trial data. In summary, approaching this procedure with a global process produces superior patient outcomes in breast augmentation.
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