The Allergan Core Study is the primary clinical study for INAMED® Silicone-Filled Breast Implants. Individual outcomes cannot be predicted by the study, but expectations, benefits, and chances for a particular negative event may become more clear. The study took place over a 10-year period and was performed to determine the safety and value of the use of silicone breast implants in breast augmentation, breast reconstruction, and breast revision, whether after enlargement or augmentation patients.
Silicone breast implant patients were seen weekly for a month, at half a year, and then yearly for 10 years. Safety evaluated through noting the incidence of complications, like infection, capsular contracture, silicone implant rupture, and the need for more surgery. Benefits were ascertained via patient satisfaction and quality of life measures. The Allergan Core Study of INAMED® Silicone-Filled Breast Implants involved 715 patients. Procedures performed included 455 primary silicone breast augmentations, 147 revision-augmentations, 98 breast reconstructions, and 15 revision-reconstructions. Silent rupture was assessed via MRI in 158 primary silicone breast augmentation patients, 50 revision-augmentation patients, 51 primary breast reconstruction patients, and 5 revision-reconstruction patients. The imaging was performed at year after operation, and then at 2 year intervals. It was designed to end at year 9 after surgery, and is updated on a rolling basis. The study has thus far reported on the first four years.