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.
[more to come, please check back]
NEXT TOPIC: What Is BIA-ALCL?
Dr. Dembny is a Member of the American Society of Plastic Surgeons
The American Society of Plastic Surgeons (ASPS) is the largest organization of board-certified plastic surgeons in the world and the foremost authority on cosmetic and reconstructive plastic surgery. The ASPS is the definitive voice of the plastic surgery specialty...
Dr. Dembny is a Member of The American Society for Aesthetic Plastic Surgery
Membership in The American Society for Aesthetic Plastic Surgery (ASAPS) remains an exclusive privilege for those board certified plastic surgeons who concentrate their practices in performing cosmetic plastic surgery of the face and the entire body. Only one-quarter...