D.M. Duffy, MD
Asst. Clinical Professor of Medicine (Dermatology) UCLA
Assoc. Clinical Professor of Medicine (Dermatology) USC
Cosmetic and Dermatologic Surgery, Torrance, California, USA
Adatosil® is a viscous silicone oil which was granted FDA approval in 1994. This designation removes the legal obstacles to usage for soft tissue augmentation. However, physicians are advised to exercise discretion when using this product. There are several caveats which govern its use, including several contraindications, as well as difficult technical application.
This product, an extremely viscous silicone oil, is labeled for ophthalmologic usage. After many years of controversy, the FDA granted approval in 1994, to Adatosil® (Escalon Medical Corporation, Chicago). This designation removes the legal obstacles to usage for soft tissue augmentation. Caveats to the legal status include the fact that this product cannot be advertised, and the decision to use it must be based upon the unique needs of the patient1.
At 5,000 centistokes viscosity, Adatosil® is roughly 14 times as viscous as the 350 centistoke variety that was used for years without FDA approval. It is too viscous to be injected with a needle under 26 gauge in size. A large diameter 1 cc Luer-lock syringe (B-D-W12811) is usually employed, containing only 0.2cc attached to a zyplast assist done to maximize leverage. Pretreatment with EMLA® Cream will minimize discomfort. Lip treatment should be preceded by a local anesthetic in the circumoral area.
Because of the force needed to inject this viscous material, great care should be taken when injecting the glabella to avoid intravascular injection. In addition, all forms of permanent implants may interact with bacterial or viral infection or allergic phenomena. Lip augmentation should be avoided in patients with histories of dental carries or other oral problems, or those with multiple allergies. A less viscous product is under development, which will make this easier to use. Aspirin or NSAIDs must be avoided for two weeks before injections. Patients who participate in contact sports, those with histories of repeated infections, and those taking anti-coagulants may be inappropriate candidates for silicone injections.
Physicians are advised to use discretion when using this product. This includes careful pre- and post-treatment counselling as well as explanations to the patients about risks and benefits and the need for repeated treatments to achieve maximum results. Physicians would be well advised to discuss their plans with their malpractice carriers, and they should be familiar with the indications and drawbacks for liquid silicone as outlined in a recent publication2. Patients who have had prior nonFDA approved silicone implants should not receive this product since subsequent problems with the existing silicone may then be attributed to the Adatosil®. Practitioners also need to use careful technique because fluid viscosity makes postinjection dispersion more difficult. Any practitioner wishing to use this filler should undergo proper training.
In the United States, the cost of Adatosil® to clinical practitioners is approximately $450 per 10 ml vial. Patients in the United States can expect to pay between $350 and $550 for each treatment, depending on the type of treatment they are receiving and volume utilized.
- Personal Communication — Food & Drug Administration, February, 1999.
- Duffy DM, Injectable Liquid Silicone: New Perspectives. In Tissue Augmentation in Clinical Practice: Procedures and Techniques. Edited by Klein AW, Marcel Dekker, Inc., New York, New York; pp. 237–267 (1998).