Number: 170 Topic: The Consequences of Implantation of Silicone Gel Breast Devices <desc> Description: Document will discuss the use of silicone gel breast implants manufactured by Dow-Corning Corporation and recipient`s concerns regarding future medical problems that may occur as a result of manufacturing defects or lack of proper testing before approval for general public use. <narr> Narrative: To be relevant a document must provide pertinent data on the risks associated with silicone gel breast implants, including identified residual effects. Documents that identify Dow-Corning Corporation as the manufacturer of the device are particularly significant. Statements issued by the FDA regarding implant`s safety and reliability, and technological advances in testing procedures to assist in the identification of future problem areas are considered relevant. Pending or concluded litigation against the Dow-Corning Corporation which has been initiated by implant recipients is not relevant unless it provides a specific strategy of the Corporation to alert the public to the risks involved. Foreign government's actions regarding the use of silicone gel implants are not relevant.