Silicone-filled breast implants are investigational devices. An investigational device is one which has not been approved by the U.S. Food and Drug Administration (FDA). Although silicone-filled implants have been in use for nearly 30 years, the number of women who, now or in the past, have had silicone-filled breast implants is not known. Estimates generally exceed two million women.
The FDA is concerned that there is not enough information about possible health problems from the use of these devices. For this reason, the FDA has approved research studies that will permit manufacturers to make these devices available to collect study data on safety and effectiveness.
This study is designed to collect 5 years of data about possible health problems associated with breast implants. This data will be used to help determine if these implants are both safe and effective.
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