Primary Augmentation
hypertrophic scarring, nipple reduction, capsular contracture, infection, rupture, hematoma/seroma, hematoma
BREAST CANCER, INFECTION, SECONDARY, DELAYED WOUND HEALING, HEMATOMA, COMPLICATIONS
Any reoperation was estimated to have occurred for 9.7% of primary augmentation patients. The “any reoperation” data set included any secondary procedure in the vicinity of the breast, such as patient-requested reoperations including implant size change and patient dissatisfaction with appearance, as well as contralateral breast procedures and staged reconstruction procedures. The rate of implant-related reoperation in the primary augmentation cohort was 1.5% (where implant-related reoperations were defined as capsular contracture, wrinkling/rippling, infection, hematoma/seroma, and rupture—see discussion for further explanation). The most frequent complications in this cohort were explantation (2.3%, all of which were replaced with a study device), asymmetry (2.3%), hypertrophic scarring (2.3%), and Baker Grade III/IV capsular contracture (1.5%). Delayed wound healing, erythema/inflammation, implant size change, nipple reduction, and suicide each occurred at a rate of 0.8%. New diagnosis of non–breast cancer, hematoma, and extrusion each occurred at a rate of 0.7%. No other complications, including rupture, infection, implant malposition/displacement, and wrinkling/rippling, were reported through 3 years of follow-up.