The Optimal Filler: Immediate and Long-Term Results With Emulsified Silicone(1,000 centistokes) With Cross-Linked Hyaluronic Acid

November 2012 | Volume 11 | Issue 11 | Original Article | 1336 | Copyright © November 2012


Abstract
Background: Silicone is one of the oldest and longest lasting of the dermal fillers. Microdroplet silicone injections have proven to be safe and effective. This paper describes how to obtain microdroplet silicone (1,000 centistokes) in a consistent manner, including a discussion of its efficacy and safety.
Methods and Materials: A simple, permanent method of tissue augmentation is described. U.S. Food and Drug Administration- approved liquid silicone (Silikon®) is emulsified with cross-linked hyaluronic acid through a Luer-Lok to Luer-Lok connector between two 3-cc syringes. This stable emulsion is injected through a 27G needle or through a 25G or 27G microcannula into the middermis, subcutaneous tissue, or periosteum.
Results: The results of 95 cases are described. The emulsion is most beneficial for distensible acne valleys, nasolabial folds, glabellar frown lines, augmentation of the vermilion border of the lips, and projection of the nose, cheekbones, and chin. Exterior nasal deviations and soft tissue defects are also improved. Complications are minimal and include temporary bruising, erythema, and mild edema. Any temporary small nodules are easily leveled with massage. Occasionally, it takes a repeat session at 1 month to completely elevate depressions. The resulting elevations remain stable during the 2-year follow-up period. No silicone granulomas have developed.
Conclusions: This methodology has replaced many indications for temporary, semipermanent, or permanent fillers.

J Drugs Dermatol. 2012;11(11):1336-1341.

INTRODUCTION

The use of emulsified medical-grade silicone (Silikon®; Alcon Pharmaceuticals, Fort Worth, TX) with crosslinked hyaluronic acid (HA) is described. Previous studies have demonstrated the benefits of silicone fillers.1-5 More than 20,000 cases have been documented.6,7 Unfortunately, overinjection by untrained physicians or unlicensed laymen have tainted the benefits of silicone.8,9 Used correctly, it is a safe permanent filler. By way of overview, most syringes and needle tips are siliconized, and microinjections of this silicone during daily injections by diabetics over a lifetime have never resulted in problems.10 Previous investigators have coined the term microdroplet silicone injections, which translated to small droplets injected with small-bore needles over multiple sessions.11 Facial plastic surgeons often touch up a defect in a face-lift or rhinoplasty during a follow-up office visit with microdroplet silicone injections (R. C. Webster MD, oral communication, January 15, 1985).
To avoid the possibility of injecting "lakes" of silicone, the authors have developed a simple method to emulsify silicone with cross-linked HA through a Luer-Lok attachment between two 3-cc syringes. This solves the problem of overdelivery of silicone, as only microdroplets are available. The U.S. Food and Drug Administration (FDA) has approved silicone (Silikon®) for use as an intraocular injection for a detached or torn retina.12-14 The use of this product for tissue augmentation is considered off-label by the FDA.15 For additional safety, the vials of medical-grade silicone from Alcon are equipped with a silicone stopper, which has solved the problems faced by previous investigators of adulteration of the liquid silicone by contaminates leached from rubber stoppers.
The purpose of this report is to inform the cosmetic surgeon about methodology and pitfall avoidance. The results in 95 patients with emulsified silicone microdroplet injections are reviewed (Table 1).

METHODS

Patient Selection

Any facial defect can be examined for filling. Broad-based facial scars that pass the "pinch test" are good candidates for filling (Figure 1). Nasal defects, smoker's lines, glabellar frown lines, nasolabial folds, depressed scars, or poorly defined cheekbones or chins can be improved. Patients on isotretinoin, who are pregnant or nursing, or who have skin infections or systemic diseases such as uncontrolled diabetes are not candidates.

Informed Consent

The risks and benefits of this procedure and the risks and benefits of alternative treatments, including no treatment at all, are discussed with the patient. Patients are told to stop blood thinners that may cause bruising 2 weeks before procedures. All questions are answered. The facial defects are document-