Background: The formation of a fibrous capsule around a silicone breast implant is part of a physiologic foreign body reaction after breast augmentation. In contrast, the formation of a capsular contracture is a local complication of unknown cause. This study aimed to discover whether the surface structure of the implant (textured vs smooth) has any impact on the formation of a capsular contracture.
Methods: This prospective study included 48 female patients with unilateral capsular fibrosis grades 1 to 4 in Baker's clinical scaling system. Of these patients, 14 received implants with a textured surface (Mentor), and 34 received implants with a smooth surface (Mentor). The implants all were placed in a submuscular position by the same experienced plastic surgeon. The clinical data were assessed using standardized patient questionnaires. For histologic diagnosis, operatively excised capsular tissue was examined. Preoperatively, venous blood samples for determining serum hyaluronan concentrations were taken from the patients. The control group consisted of 20 patients without capsular fibrosis.
Results: The separate analysis of clinical data for the patients with textured and those with smooth-surfaced breast implants showed a slightly reduced degree of symptoms for the patients with textured silicone breast implants, as compared with those who had smooth-surfaced implants. The histologic assessment of the fibrosis showed a symmetric distribution for Wilflingseder scores 1 to 3 (29% each), whereas 13% of the capsular tissues could be assigned to Wilflingseder score 4. In contrast, the histologic assessment of the patients with smooth-surfaced implants predominantly showed a Wilflingseder score of 3 (65%). The serologic investigations via enzyme-linked immunoassay (ELISA) showed serum hyaluronan concentrations of 10 to 57 ng/ml (25.0 +/- 11.7 ng/ml). Therefore, no statistically significant differences in terms of serum hyaluronan levels could be determined between the two groups of patients. In comparison with the control group, the patients with implants showed elevated serum hyaluronan levels (p < 0.05).
Conclusions: The histologic examination and serum hyaluronan concentration analysis showed no statistically significant difference between smooth-surfaced and textured implants (Mentor) with respect to the development of capsular contracture. On the other hand, the severity of capsular contracture showed a positive linear correlation with the degree of local inflammatory reactions, which were independent of the implant surface.