ABSTRACT

An ideal biocompatible soft-tissue augmentation implant should fulfill certain criteria.

1. Easily obtainable by qualified persons at reasonable cost

2. Capable of fabrication in the form desired 3. Capable of repeated sterilization and prolonged sto-

rage at room temperature 4. Easily implanted 5. Self-limiting fibroblastic response 6. Not physically modified by soft tissue 7. Chemically inert 8. Does not invoke inflammation or foreign body

reaction 9. Does not produce amaurosis when injected into facial

skin 10. Nontoxic 11. Noncarcinogenic 12. Nonteratogenic 13. Produces no state of allergy or hypersensitivity 14. Capable of resisting mechanical strains 15. Physical consistency of treated tissue indistinguish-

able from normal tissue 16. Long-term persistence of tissue contour restoration 17. Not subject to latent degenerative or calcific changes 18. Persistence in the originally deposited location with

minimal or no absorption even with movement of the part

Satisfying these ideal specifications, polydimethylsiloxane fluid of 350 centistokes (cs) is, at present, the safest and most efficacious of all available autogenous and nonautogenous tissue-compatible materials for lifelong dermal and subdermal injection within the human body. Except for number 8 listed above, silicone fluid fulfills these criteria. With rare exception, pure, filtered, sterilized silicone fluid (‘‘injectable-grade’’) provokes inflammation or foreign-body reaction only to the desirable extent of producing intentional beneficial fibroplasia and hence soft tissue augmentation.