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SILICONE INJECTIONS |
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Microdroplet liquid silicone injections build soft-tissue by encouraging the production of new collagen, the skin’s natural structural protein. Silicone injections are used primarily to fill depressions such as wrinkles and certain acne and chicken pox scars. They can also be used to enhance the natural contours of areas such as lips and cheekbones, and to treat contour defects that result from heredity, surgery, trauma or aging. Background Medical-grade Liquid Injectable Silicone (LIS) is a man-made polymer that has been used in a variety of medical applications for many decades. LIS is a clear, colorless, highly purified, thick liquid. Because it is sterile and non-allergenic, normally no test injection is required. The therapeutic value of microdroplet LIS for building soft-tissue is well established. For over 40 years, it has received wide support in the medical literature3 . In December 1998, a specially appointed National Science Panel (composed of four eminent scientists from the disciplines of immunology, epidemiology, toxicology and rheumatology reported its unanimous conclusion that there was no evidence linking silicone in breast implants to any systemic disease. The Panel’s report was based on a yearlong analysis of the most rigorously tested and relevant scientific information available. How LIS Builds Soft-Tissue Microdroplets of LIS are injected into the skin at multiple points (the microdroplet serial-puncture technique) with a slender, sterile needle. Because LIS is chemically inert, it remains a liquid after injection and is not altered or changed by the body. Over a period of months, microdroplets of LIS stimulate skin cells (known as fibroblasts) to produce new collagen around each microdroplet. Once a microdroplet is surrounded, collagen production stops. Through repeated injections over several months the combination of LIS microdroplets and new collagen gradually fills depressions. Slight swelling may be seen immediately after injection, giving the appearance of instant improvement; however, this swelling subsides in several days. Frequency Of Visits At the onset of treatment, visits are usually spaced at one-month intervals. Ordinarily, desired improvement is not achieved until after several visits. The number of treatments depends on the depth of the depression(s) or the degree to which a facial (or other) contour is to be enhanced. As the desired degree of soft-tissue augmentation is approached, visits are scheduled at three- to six-month intervals, or longer. Because LIS and the collagen it stimulates are long lasting, it is important to allow sufficient time to elapse between treatments to observe the amount of soft-tissue formed and thus avoid overcorrection (see Possible Side Effects below). Furthermore, although LIS corrects previous loss of soft-tissue, it cannot prevent future loss caused by aging and repetitive facial muscle action. Maintenance injections at six- to twelve-month intervals may be desired to treat additional soft-tissue loss as time passes. Current Legal Status LIS is legally marketed in the United States as an FDA approved medical device. Although LIS is not explicitly approved for building soft-tissue, a 1997 amendment to the Federal Food, Drug & Cosmetic Act6 states that "Nothing in [the FD&C Act] shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship." In autumn 1998, the FDA acknowledged that the Orentreich Medical Group, LLP may use legally marketed LIS in conformance with this new statute. All LIS at 0MG is legally marketed under the FD&C Act and thus complies with these new legal requirements. Clarification Of Common Misconceptions About LIS Although rare, drift (movement or shifting) of LIS has occurred after large volumes were injected using certain techniques. In contrast, drift of LIS does not occur with the microdroplet serial-puncture technique, the only technique used at 0MG.
Although rare, drift (movement or shifting) of LIS has occurred after large volumes were injected using certain techniques. In contrast, drift of LIS does not occur witht he microdroplet serial-puncture technique, the only technique used at OMG. Foreign-body reactions have occurred after injection of adulterated liquid silicone. Some practitioners intentionally, but misguidedly, adulterate liquid silicone with oils (such as olive, sesame or mineral oil) in the belief that the mixture would improve results; instead such oils have produced foreign-body reactions. In contrast, foreign-body reactions do not occur when using only pure, sterile UIS, the only LIS administered at 0MG.
Please read the related 0MG Patient Information Sheets for details on the above therapies.
And there is also:
1. Selmanowitz VJ, Orentreich N: Medical-Grade Fluid Silicone. The Journal of Dermatologic Su1~e!y and Oncoiogy 3:597-611, 1977. 2. Aronsohn RB: A 22 Year Experience with the Use of Silicone Injections. The American Journal of Cosmetic Surgery 1:21- 28, 1984. 3. Webster RC et al.: Injectable silicone for small augmentations. Twenty-year experience in humans. The American Journal of Cosmetic Surgery 1:1-10, 1984. 4. Orentreich DS, Orentreich N: Injectable Fluid Silicone, In RK Roenigk, and HH Roemgk, Dermatok~gic Surgery: Principles and Practice. Marcel Dekker 1988, pp. 1349-1395. 5. Physician's Current Procedural Terminology, 4th Edition, Page 99. The American Medical Association, Chicago, Illinois, 1990. 6. The Food and Drug Administration Modernization Act of 1997, enacted by Pub. U. No. 105-115, 111 Stat. 2295 (1997). 7. 21 U.S.C. §396, Section 906, enacted by Pub. U. No. 105-115, §214, 111 Stat. 2348 (1997).
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