Background: In February of 2001, Allergan (formerly Inamed) began an Investigational Device Exemption study of a shaped breast implant: the Style 410 highly cohesive silicone-filled breast implant.
Methods: Forty-eight plastic surgeons across the United States performed implantation on 941 subjects enrolled in a 10-year study. This prospective, nonrandomized study provided 3-year follow-up data, clinical outcomes, and satisfaction rates from this cohort of 492 primary augmentation, 225 breast reconstruction, and 224 breast revision subjects. Complications were reported and compared with those from current standard gel and saline implant studies.
Results: With greater than 85 percent follow-up compliance at 3 years, complication rates were low among augmentation subjects, with implant malposition being the most common (2.6 percent) and all other complications occurring in less than 2 percent of subjects. In the revision-augmentation group, the most common complications were capsular contracture (4.8 percent) and implant malposition (4.7 percent), with all other complications occurring in less than 4 percent. Asymmetry (8.7 percent) and capsular contracture (5.9 percent) were the only complications that occurred in more than 5 percent of reconstruction subjects. The overall risk of rupture across all cohorts was 1.0 percent by subject and 0.8 percent by implant. Subject satisfaction with implants was 98 percent for augmentation and 90 percent or higher for all other cohorts.
Conclusions: The Style 410 highly cohesive silicone implant has low complication rates and high satisfaction rates through 3 years after implantation. These results are significant in introducing more evidence-based medicine that will allow plastic surgeons and patients to make better informed decisions regarding implant options.