The effect of Biocell texturing and povidone-iodine irrigation on capsular contracture around saline-inflatable breast implants.

We performed a prospective, concurrently controlled, and blinded 4-year clinical study on 60 patient volunteers to determine the effects of two independent variables, McGhan's Biocell texturization and Betadine antibacterial irrigation, on the incidence of fibrous capsular contracture around saline-inflatable implants following retromammary augmentation. Each patient was randomly assigned both a textured and a smooth implant and both saline and Betadine irrigation so that each patient served as her own control. The textured devices irrigated with Betadine experienced an overall incidence of contracture of only 4 percent compared with 50 percent for the smooth devices irrigated with saline solution. The Betadine-irrigated devices in general had a lower incidence of contracture than the saline-irrigated devices, and the textured-surface devices in general had a lower incidence of contracture than the smooth devices. Antibacterial irrigation and surface texturization may work in a cumulative manner to reduce the early incidence of capsular contracture.

RCT Entities:   Population Interventions Outcomes