A Step Forward Toward the Understanding of the Long-Term Pathogenesis of Double Capsule Formation in Macrotextured Implants: A Prospective Histological Analysis.

Background: Although increasingly reported in the literature, most plastic surgeons cannot define the etiology of double capsules. Often an incidental finding at implant exchange, double capsules are frequently associated with macrotextured devices. Several mechanisms have been proposed, including at the forefront that shearing causes a delamination of the periprosthetic capsule into a double capsule.

Objectives: This study was designed to confirm the hypothesis that mechanical forces are involved in formation of double capsules by histological analysis.

Methods: A prospective analysis of consecutive implants with double capsules removed over 2 years was performed. Data collected at the time of surgery included Baker classification, reason for explant, implant manufacturer and style, and any presence of a seroma associated with the capsule. Specimens were sent for analysis by histology utilizing hematoxylin and eosin and alpha-smooth muscle actin staining techniques.

Results: Eight double capsules were collected for specimen analysis. All capsules demonstrated evidence of granulation tissue, alpha-smooth muscle actin positive myofibroblasts, and folds with embedded texture. Fibrosis surrounded weak areas with presence of layering and splitting, creating a potential space that is prone to separation. Tears and folds from granulomatous reaction are also present within the outer layer of the double capsule, which can only be explained by a mechanical shearing force as a pathogenic mechanism.

Conclusions: Understanding the pathogenesis of double capsules may allow plastic surgeons to refine their indications for macrotextured implants while providing guidance to patients on avoidance of activities that produce shear-forces. The findings support the hypothesis that shearing forces delaminate the capsule into 2 separate distinct capsules.