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A prospective, controlled, and blinded clinical study was performed on 56 patient volunteers to determine the effects of two independent variables--the Siltex textured inflatable implant and povidone-iodine irrigation--on the incidence of fibrous capsular contracture following retromammary augmentation. Each patient was randomly assigned both textured and smooth implants and povidone-iodine and saline irrigation, so that each patient served as her own control. The Siltex devices experienced an incidence of class III-IV contracture of only 2 percent, as compared with an incidence of 40 percent around the smooth devices. Most patients, however, preferred the smooth devices despite the higher contracture incidence because the Siltex device was more easily palpable. Povidone-iodine did not reduce the final incidence of contracture. It appeared to delay the onset of contracture, but not with statistical significance.
Burkhardt et al. (Wed,) studied this question.