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Updated: Jun 24, 2026

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Published on: June 27, 2014

Injectable silicone returns to the United States.

S R Coleman

    Aesthetic Surgery Journal
    |April 1, 2009
    PubMed
    Summary
    This summary is machine-generated.

    Practitioners use unapproved liquid silicone oil for cosmetic purposes. A clinical study is now investigating injectable silicone oil for soft tissue augmentation, providing historical context for this off-label application.

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    Published on: March 14, 2019

    Area of Science:

    • Plastic Surgery
    • Ophthalmology
    • Biomaterials

    Background:

    • Liquid silicone oil is FDA-approved for retinal detachment treatment.
    • Its off-label use for cosmetic indications is prevalent in the US.
    • This practice raises safety and regulatory concerns.

    Purpose of the Study:

    • To discuss the off-label use of liquid silicone oil for aesthetic purposes.
    • To provide historical context for injectable silicone oil in soft tissue augmentation.
    • To highlight the current FDA-approved clinical study.

    Main Methods:

    • Review of off-label injection practices.
    • Historical analysis of silicone use in cosmetic procedures.
    • Discussion of regulatory status and clinical trials.

    Main Results:

    • Liquid silicone oil is being used cosmetically despite lack of FDA approval for such indications.
    • A clinical study is underway to evaluate injectable silicone oil for soft tissue augmentation.
    • The historical context reveals a pattern of exploring silicone for aesthetic enhancement.

    Conclusions:

    • The off-label use of liquid silicone oil for cosmetic purposes is a significant concern.
    • Ongoing clinical studies aim to establish the safety and efficacy of injectable silicone oil for augmentation.
    • Regulatory oversight and approved indications remain critical for patient safety.