Safety Follow-up Study in Subjects With Silicone Gel-filled Breast Implants as Compared Both to Saline-filled Breast Implants and to National Norms



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:10/17/2018
Start Date:November 1, 2006
End Date:October 31, 2028
Contact:Clinical Trials Registry Team
Email:IR-CTRegistration@allergan.com
Phone:877‐277‐8566

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Trial Summary
Trial Overview
Inclusion Criteria

Breast Implant Follow-up Study: A 10- Year Observational Study of the Safety of Allergan Silicone Gel-filled Breast Implants as Compared Both to Saline-Filled Breast Implants and to National Norms

Ten year safety study examining rates of rare adverse events, child bearing issues, effects
of mammography, MRI compliance and results, and long-term benefit of silicone-filled breast
implants.


Inclusion Criteria:

- Female, age 18 years or older (22 or older for breast augmentation patients)

- Fluency and literacy in English or Spanish

Exclusion Criteria:

- Are transgender

- If a saline implant patient, have a current or past unilateral or bilateral silicone
breast implant

- Investigator decision that patient is not a suitable candidate for a long-term
observational study
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