Achieving a zero percent reoperation rate at 3 years in a 50-consecutive-case augmentation mammaplasty premarket approval study.

[BACKGROUND] Excessively high reoperation rates in breast augmentation premarket approval studies are a major concern of patients and the U.S. Food and Drug Administration. Over the past two decades, reoperation rates have remained between 13 and 20 percent at 3 years in three different premarket approval studies for three different types of implant devices, indicating that high reoperation rates are not device dependent. The hypothesis of this study was that implementing specific peer-reviewed and published processes can significantly reduce reoperation rates in a premarket approval study.

[METHODS] Fifty consecutive primary breast augmentation patients were enrolled in a premarket approval study for the Inamed Style 410 form stable, cohesive gel implant. All patients were treated specifically according to the premarket approval protocol. The series was monitored throughout the study by an independent clinical review organization and by a U.S. Food and Drug Administration inspection of the patient records on site at the author's practice. Specific content and processes were applied to patient management in patient education and informed consent, patient and surgeon decision-making processes, preoperative assessment and operative planning, implant selection based on individual patient tissue characteristics, surgical techniques, and postoperative care techniques.

[RESULTS] Follow-up was 100 percent (50 of 50 patients) at 1 year, 98 percent (49 of 50 patients) at 2 years (one patient could not be reached), and 94 percent (47 of 50 patients) at 3 years. No reoperations were performed on any patient followed at 3 years in the 50-consecutive-patient series.

[CONCLUSION] Implementing the peer-reviewed and published processes described in this study, no reoperations were performed in a prospective 50-consecutive-case series of primary augmentation mammaplasty patients in a premarket approval study with 94 percent follow-up at 3 years.