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FDA & Hydrogel Implants

The U.S. Food and Drug Administration (FDA) has authority over the production of drugs, medical devices and cosmetics in the United States. Breast implants, including implants filled with hydrogel polymers, fall under this authority. The FDA has not approved use of hydrogel implants in the United States.

  1. Hydrogel Implants

    • Hydrogel implants consist of a outer layer of silicone filled with hydrogel, a type of polymer. According to research at the Sart Tilman University Hospital in Belgium, published in the "Acta Chirurgica Belgica" journal in 2004, hydrogel implants have some advantages, such as being more lifelike than saline implants, as well as not being susceptible to bacterial growth.

    FDA's Role

    • Breast implants are considered to be medical devices, so the FDA must improve them before they can be marketed to the U.S. public. A manufacturer must demonstrate to the FDA that it has solid evidence that shows the device's safety and effectiveness or that the device functions in the same manner as an already-approved device.

    Status

    • The FDA has not approved any form of hydrogel implant use in humans. Only silicone and saline-filled breast implants have been approved. Because of this hydrogel implants are not available in the United States. However, they are available in parts of Europe, Asia and South America.

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