Friday, July 23, 2010

What does this tell you?

Silicon





Silicon has been viewed as a nemesis over the years, despite the ever-growing popularity of fillers for soft-tissue augmentation- liquid injectable silicone is still largely shunned, with its status as “permanent”, generating fear that any resultant problems will also be permanent.





Two indications have been demonstrated for which liquid silicone has receptive niches- HIV facial lipoatrophy and acne scars — permanent problems that indeed lend themselves to permanent solutions.





Many practitioners strictly use silicone for acne scarring because this is a lifelong disfiguring problem that silicone can easily correct permanently with just one or two injections, while the patient doesn't have to keep coming in for injections every six or eight months, if its use if for treatment of some disfigurement, the feeling of being comfortable using it off label is relatively harmless but not for anything else, such as wrinkling or age-related issues.





It is considered long-lasting and cosmetically elegant for many- it is not only considered to be the best filler for disfiguring scars, but for HIV specific facial lipoatrophy, nothing works better.





For either indication, one of the keys to the safe and effective use of silicone is to use the purest product available, and the only Food and Drug Administration (FDA)-approved product acceptable for injectable soft tissue augmentation is Silikon-1000, made by Alcon Labs. The highly purified liquid injectable form of silicone received approval in 1997 specifically for intraocular injection for tamponade of retinal detachment, but can be used off label, according to FDA guidelines regarding off-label use of medical devices.





Use of the microdroplet serial puncture injection technique is also been deemed critical for safe silicone use. Reports of silicone migration received extensive coverage in the media, this migration was largely due to the injection of large amounts of silicone at once, but the microdroplet injection technique can prevent that problem.





The technique is defined as 0.01 cc or less of the product injected into the immediate subdermal plane or deeper, at 2 mm to 5 mm intervals, through an aluminum hub 27 gauge needle (Kendall Monoject).





No second passes should be taken in the same plane, and the plunger of the needle should not be depressed until the needle is completely in the subdermal area of the skin. The needle should not be withdrawn before the microdroplet is completely deposited, to avoid tracking of liquid silicone in the dermis.





Only the most experienced doctor should be sought out to attempt intradermal injections due to the risk of persistent dermal nodules that may result with less than expert technique. Optimal correction of the area proceeds slowly as fibroplasia develops around the microdroplets. Small volumes should be injected at monthly intervals, and for facial lipoatrophy, an average of 2 cc should be used.





Other considerations





Another big consideration is liability coverage —liability carriers have varied policies regarding off-label use of this.





Likewise, informing and the obtaining of appropriate consent from patients is one of the most important aspects, and patients should be informed that liquid silicone is permanent. They must understand that optimal correction is not immediate and that adverse events could develop months to years in the future.





Adverse events that can occur include lumps, bumps and nodules, but most doctors who use silicone report that such events occur at an estimated rate of less than 1 percent.





Disclaimer:


This information is intended only as an introduction to this procedure. This information should not be used to determine whether you will have the procedure performed nor does it guarantee results of your elective surgery. Further details regarding surgical standards and procedures should be discussed with your physician

What does this tell you?
that silicone could be used as a filler, however special precaution needs to be taken when using it as a filler, and it is not necessarily approved by the FDA for this use.
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