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Related Experiment Videos

Danger: implants.

S Findlay, D Podolsky

    U.S. News & World Report
    |July 30, 1992
    PubMed
    Summary
    This summary is machine-generated.

    The U.S. Food and Drug Administration (FDA) is reviewing 130 high-risk medical devices, including penile implants, due to insufficient safety and effectiveness data. Penile implants require closer examination based on FDA data analysis.

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    Area of Science:

    • Medical Device Regulation
    • Public Health Policy
    • Biomedical Engineering

    Background:

    • The term "medical devices" encompasses a wide range of products, from implants to equipment.
    • Approximately 130 categories of high-risk medical devices lack sufficient proof of safety and effectiveness.
    • Many of these devices were in use before the Food and Drug Administration (FDA) gained regulatory authority in 1976.

    Purpose of the Study:

    • To investigate the safety and effectiveness of high-risk medical devices.
    • To highlight specific devices undergoing FDA scrutiny.
    • To analyze FDA data on selected medical devices.

    Main Methods:

    • Review of FDA data obtained through the Freedom of Information Act.
    • In-depth computer analysis of device data.

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  • Focus on five high-risk device categories slated for FDA review.

    • Main Results:

    • Saline-filled breast implants, inflatable penile implants, testicular implants, heart-bypass pumps, and cranial stimulators are prioritized for FDA review.
    • Computer analysis indicated that penile implants warrant particular scrutiny.
    • The FDA is intensifying its regulatory oversight of medical devices.

    Conclusions:

    • The FDA's enhanced scrutiny of medical devices is a critical step in ensuring public safety.
    • Penile implants represent a category of medical devices requiring further investigation.
    • The review process aims to address the lack of safety and effectiveness data for numerous high-risk devices.