Silicone gel-filled breast prostheses; silicone inflatable breast prostheses: patient risk information--FDA. Notice.

The Food and Drug Administration (FDA) is issuing a notice to promote the dissemination of information on risks associated with silicone gel-filled breast prostheses and silicone inflatable ("saline-filled") breast prostheses to women considering having the devices implanted. This notice addresses an important public health issue presented by the continued marketing and implantation of these unapproved devices. FDA has identified significant deficiencies in premarket approval applications for silicone gel-filled breast prostheses. FDA will regard breast prostheses as misbranded under the Federal Food, Drug, and Cosmetic Act (the act) if their labeling does not provide adequate written information to patients on the risks associated with these devices. Such information should be written so as to be easily comprehensible to most patients and should be provided to patients prior to scheduling implantation, so that patients have sufficient time to review the information and discuss it with their physicians. To satisfy the requirements of the act, such patient risk information must set out the known, suspected, and potential risks associated with implantation of these devices. This notice includes suggested patient risk information sheets as guidance.