Breast Implant Clinical Studies
Allergan Core Study for Round Silicone Gel-Filled Breast Implants
The Allergan Core Study is the primary clinical study for Natrelle silicone gel-filled breast implants. The Allergan Core Study for round gel implants began in 1999; it is a 10-year study designed to assess the safety and effectiveness of breast implants in augmentation, reconstruction, and revision procedures. The Allergan Core Study consists of 715 patients; this includes 455 primary augmentation patients, 147 revision-augmentation patients, 98 primary reconstruction patients, and 15 revision-reconstruction patients. Patient follow-up was at 0-4 weeks, 6 months, 12 months, 24 months, and annually through 10 years.
Only results through 7 completed years have been reported and published by Allergan.
This page will summarize the major clinical trials, performed by the manufacturers, detailing complication and re-operation rates for saline and silicone gel breast implants.
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History of Breast Augmentation and Breast Implants in the United States
Breast Implant Timeline 1890: Written descriptions of breast augmentations with paraffin wax injections and the use of glass balls, but it is not known when this was first performed. 1895: Austrian-German surgeon, Victor Czerny, harvests a benign fatty tumor from a...
Silicone Gel Breast Implants – Report of the Independent Review Group
Silicone Gel Breast Implants – Report of the Independent Review Group, 1998 In response to concerns expressed by women about a possible link between silicone gel breast implants and health problems, the British Minister of Health asked the Chief Medical Officer to...