10 Liquid injectable silicone
Summary and Key Features
• Two forms of highly purified injectable liquid silicone (Silikon-1000 and Adatosil-5000) are FDA-approved for intraocular tamponade of retinal detachment.
• Both products may be legally injected off-label for skin augmentation, according to the 1997 FDA Modernization Act
• Industrial liquid silicone, including ‘medical grade’ industrial liquid silicone, may contain contaminants that cause granulomatous reactions
• Industrial grade liquid silicone should never be injected into the human body
• Three rules should always be followed when using liquid injectable silicone for skin augmentation, as follows.
• Rule 1: Inject only FDA-approved highly purified liquid silicone
• Rule 2: Employ only microdroplet technique
• Rule 3: Inject limited amounts of volume at monthly intervals or longer
• There is much evidence supporting the safety and efficacy of liquid injectable silicone for HIV-associated lipoatrophy
• With proper protocol, serious adverse events are rare and are usually treatable
Indications and patient selection
Although there are currently no FDA-approved cosmetic indications for HPLIS, it may be legally injected off-label for the augmentation of HIV-associated facial lipoatrophy, nasolabial folds, labiomental folds, mid-malar depressions, lip atrophy, hemifacial atrophy, acne scarring, other atrophic scarring, age-related atrophy of the hands, corns and calluses of the feet, and healed diabetic neuropathic foot ulcers (see the studies by Orentreich, Balkin, and Fulton et al) (Figs 10.1–10.4). HPLIS is specifically contraindicated for injection into the breast, eyelids, or bound-down scars or injection into an actively inflamed site. Its safety has not been studied in pregnant women. It should not be injected into patients with chronic bacterial sinusitis, dental caries, other active bacterial infection, or in those who may be predisposed to trauma in the treated area. Additionally, HPLIS is not a substitute for surgical lifting, chemical or laser resurfacing, dermabrasion, or treatment of dynamic rhytides with botulinum toxin. The ideal patient is one with appropriate insight into the permanent and off-label nature of LIS, a realistic attitude regarding achievable results, in good physical health, and compliant with recommendations. Patients seeking immediate correction or temporary augmentation should be treated with temporary fillers. Serious consideration by both the patient and physician must be given to the longevity of results obtained with HPLIS. Although permanent fillers may be preferred to temporary fillers owing to their longevity, one must consider the possibility that personal and societal aesthetic goals may change over time. Furthermore, an undesirable result will be unlikely to diminish with time and may be difficult to correct.