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Related Experiment Videos

Making a difference in the breast implant issue.

L McCain

    Plastic Surgical Nursing : Official Journal of the American Society of Plastic and Reconstructive Surgical Nurses
    |January 1, 1992
    PubMed
    Summary

    Patient advocacy and nursing expertise influenced the Food and Drug Administration's (FDA) decision on silicone gel-filled breast implants. Their testimony supported continued market availability pending further safety research.

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    Area of Science:

    • Medical Devices
    • Patient Advocacy
    • Regulatory Science

    Background:

    • The safety of silicone gel-filled breast implants became a significant public concern, prompting an investigation by the Food and Drug Administration (FDA).
    • Public discourse and media attention heightened the need for evidence-based information regarding breast implant safety.

    Purpose of the Study:

    • To detail the advocacy efforts of nurses, patients, and physicians in educating lawmakers and FDA panels on breast implant safety.
    • To highlight the impact of patient and nursing involvement in regulatory decision-making processes.

    Main Methods:

    • Direct engagement with lawmakers and congressional staff on Capitol Hill.
    • Testimony provided before an FDA panel investigating silicone gel-filled breast implant safety.

    Main Results:

    • The group's efforts contributed to the FDA panel's recommendation to maintain breast implants on the market.
    • The decision was contingent upon the availability of further research into implant safety.

    Conclusions:

    • Nurses and patients can significantly influence regulatory decisions concerning medical devices.
    • Patient advocacy and expert testimony are crucial in informing policy on medical device safety.

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