In summary, silicone fluid, solid RTV Silastic silicone rubber, and gel-like mixtures of the two were individually studied and found to provoke similar host-tissue responses in the liquid, solid, and gel states. The sole exception was a variable diminution in the residual amount of the fluid silicone injected. Each variation after injection showed physical properties quite similar to the bony and soft tissues present around the head and neck; that is, the RTV silicone rubber could blend quite easily with bony and hard muscle contours, the silicone-rubber-Silastic fluid mixtures were not dissimilar from muscle and glandular tissue, and the fluid silicone, after injection, blended extremely well with the soft subcutaneous areas. Since the Federal Food and Drug Administration has listed the injectable silicone fluid and RTV Silastic materials as drugs rather than prostheses, injection of these materials in humans has been halted in this clinic. This has seriously hampered the study and use in the clinical correction of deformities of the head and neck such as defects of the calvarium, forehead, and malar and mandibular regions, as well as the correction of extensive tissue deformities after hemiatrophy of the face, the removal of large deep tumors, severe surgical losses of tissue, and the correction of late enophthalmos. In view of the microscopic findings presented it is hoped that the F.D.A. will soon release this new drug to a more extensive clinical investigation.