Textured or smooth implants for submuscular breast augmentation: a controlled study.

Capsular contracture consistently has been the most frequently noted complication of submuscular and subglandular breast augmentation. The etiology of this complication is still unknown, although silicone bleed, hematoma, infection, foreign bodies, and surgical trauma have been implicated. In this prospective, double-blind study, 61 women undergoing submuscular breast augmentation were randomized between Dow Corning textured and smooth-walled silicone gel implants. Any consequent capsular contracture was assessed by an independent plastic surgeon and also by the patients themselves. Objective evaluation was made by applanation tonometry. It was found that depending on doctors, patients, and objective method used, 3 to 9 percent grade III and IV encapsulation followed submuscular augmentation with textured implants and 10 to 20 percent with smooth-walled implants after 1 year. The differences were significant according to both patient assessment and applanation tonometry but not according to the physicians' evaluations. There was no correlation of capsular contracture with the age of the patient, duration of the operation, or degree of blood loss. There was a small but inconclusive difference in capsular contracture rate that favored the placement of textured rather than smooth implants in the submuscular pocket.

RCT Entities:   Population Interventions Outcomes