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?
Why is a board certified plastic surgeon important for my breast augmentation?
I recently saw a woman in consultation for a failed saline breast implant. She had her breast augmentation performed seven years earlier by a surgeon who advertises like a plastic surgeon, but is not board certified in plastic surgery. And as far as I am aware, has...
Do I need to change my breast implants after 10 years?
During breast augmentation consultations women frequently make a comment, or ask a question, about having to change their breast implants every 10 years. The comment or question is usually worded in such a way that they have the understanding that breast implants need...