Preliminary (3 years) experience with smooth wall silicone gel implants for primary breast augmentation.

The goal of this study is to obtain data concerning the incidence of capsular contracture and reoperation rates in patients having primary breast augmentation utilizing modern low-bleed smooth-wall silicone gel implants. Data were collected retrospectively and consisted of 44 patients who underwent primary breast augmentation using smooth silicone gel implants (Mentor Corporation) in the period between 2001 and 2003. Of the 131 patients identified, 44 patients fit the criteria of primary breast augmentation. Secondary cases and primary augmentation with mastopexy were excluded from this study. This group of patients is still followed, and the data are being updated periodically. A total of 44 patients underwent primary breast augmentation. Average age was 32 years (range, 19-57). Average follow-up was 34 months (range, 28-40). Average operative time was 52 minutes. The inframammary incision was used in 65% of patients and the areolar incision in 35%. The subglandular position was used in 35% of patients versus the submuscular position in 65%. Nine patients (20%) developed capsular contracture. Six patients (13.6%) had Baker 3 capsular contracture, which required revision. Four of the 9 patients with capsular contracture had implants placed in the submuscular space and 5 in the subglandular position. Relative to the implant position, 4 patients (9%) with implants placed in the submuscular position developed capsular contracture. Relative to the subglandular position, 5 patients (11.3%) with implants placed in the subglandular position developed capsular contracture. Eight patients (19%) required implant revision, 6 patients for capsular contracture, and 2 patients requested size change. Preliminary data from this study indicate that the use of the new generation of gel implants yields less capsular contracture, as well as decreased revision rates. Subglandular placement of gel implants did not significantly increase the risk of capsular contracture. Longer follow-up and multicenter studies are still needed to confirm these findings. This cumulative data could challenge the current status of gel implant moratorium imposed by the incidence of capsular contracture and revision rates.