Policy Statement on Injectable Liquid Silicone

Policy Statement on Injectable Liquid Silicone

ERROR MSG(Approved by the Board of Directors December 1993)

The American Academy of Dermatology counsels members to abide by the position of the Food and Drug Administration (FDA). In the past, the Academy has neither reviewed the use of liquid silicone for cosmetic purposes nor taken a position on its efficacy or safety. The FDA has raised important issues pertaining to the health and safety of patients in whom the material is used. Until these issues are resolved, Academy officers support the FDA position.

Background

In December 1991, the US Food and Drug Administration announced through the FDA Medical Bulletin that the agency is concerned about the use of liquid silicone injections for cosmetic purposes. The FDA emphasized that it has not approved the use of liquid silicone for cosmetic purposes and "prohibits manufacturers or physicians from marketing or promoting unapproved products such as liquid silicone."

Sigulda hotelsThis was the first official indication that the FDA intended to halt the use of liquid silicone for cosmetic purposes. The FDAs concern pertains to potential adverse effects of liquid silicone injections, including possible movement of silicone to other parts of the body, inflammation and discoloration of surrounding tissues and the formation of granulomas.

Gran hotel LimerickAAD Actions to Date

The American Academy of Dermatology has taken three steps in response to the FDAs December 1991 announcement:

Notified the membership of the FDAs position through a Member Alert.
ERROR MSGTogether with the American Society for Dermatologic Surgery, appointed a task force to review all published or reported studies of the use of liquid silicone for cosmetic purposes.
Scheduled a meeting with the FDA to provide input and to explore how we can work with the FDA to resolve the issue.

The Joint Task Force has been asked to proceed as quickly as possible to carefully review all the scientific literature related to the use of liquid silicone for cosmetic purposes. The Joint Task Force will report on what is known, and what is not known, about the use of liquid silicone. Information from that report will be made available to all AAD members. We anticipate that the report of the Joint Task Force can be the basis of a consensus conference on injectable liquid silicone. Participation in such a conference will be one of the agenda items we will be discussing with the FDA.