The Safety of Silicone

See more information about the safety of silicone and silicone gel-filled breast implants. Find out more about some of the many uses of silicone in breast implants, as well as other devices used in the human body.

The History and Uses of Silicone

Silicone is a highly versatile substance that has many medical uses. Different types of silicone have been used for decades in a variety of medical devices, such as pacemakers and artificial joints.

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The Safety of Silicone and Silicone Gel-Filled Breast Implants

Silicone gel-filled breast implants are among the most extensively studied FDA-approved medical devices in existence. In the United States alone, Allergan has examined the safety of silicone gel-filled breast implants in more than 80,000 women.

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Silicone and Silicone Gel-Filled Breast Implants: The FDA's Evaluation

The United States Food and Drug Administration (FDA) approved silicone gel-filled breast implants after reviewing a vast amount of scientific data. These data consisted of results from extensive preclinical testing, four years of data on 715 women from Allergan's Core Clinical Study, and a European study that evaluated implant rupture prevalence rates beyond 10 years1. In addition, countless published, peer-reviewed studies and research support the safety of silicone and silicone gel-filled breast implants. The FDA also considered in their decision the opinions of advisory panels made up of outside experts.

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1 Hedén, P., et al. 2006. "Prevalence of rupture in Inamed silicone breast implants". Plast. Reconstr. Surg. 118:303-8.