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Press release from the American Society for Aesthetic Plastic Surgery (ASAPS) October 8, 2002

NEW YORK, NY (October 8, 2002) - It is the American Society for Aesthetic Plastic Surgery's (ASAPS') position that, currently, lipoplasty (liposuction) is the only proven method for the permanent reduction of fat deposits. Recently, however, there have been articles in popular consumer magazines describing the injection of phosphatidylcholine, a phospholipid that is known by the trade name of Lipostabil. Claims state that this substance dissolves fat without the need for surgical intervention. ASAPS cautions that the safety and effectiveness of this procedure are unproven. Licensed physicians may legally offer treatments involving off-label uses of many pharmacologic substances, as long as such substances have been approved by the Food and Drug Administration for other uses and there is no specific prohibition of the intended off-label use. Currently, however, Lipostabil is not approved for any use in this country. In addition, there does not appear to be sufficient scientific and clinical data to substantiate the safety and effectiveness of phosphatidylcholine (Lipostabil) as a fat-dissolving treatment.  Lipostabil was not developed as a fat-dissolving agent. . The only published study using phosphatidylcholine for this purpose treated only 30 patients (on their lower lids), with a maximum follow-up of two years. The published photographs demonstrating visible reduction of the very small amounts of excess fat contained in the lower eyelid seem promising, but the study lacked controls, and the results have yet to be duplicated in other peer-reviewed studies.  Specific questions regarding phosphatidylcholine (Lipostabil) should be answered before its safe use on patients can be assured:  How can it be assured that the appropriate amount of fat - neither too little nor too much -- is dissolved? (It should be noted that current techniques in cosmetic eyelid surgery tend to favor greater preservation of fat tissue in the lower eyelid, with optimal correction often achieved by a combination of minimal fat removal and repositioning or suturing of fatty tissues.)    If phosphatidylcholine dissolves fatty tissue, does it also dissolve other tissue? How is delivery of the substance limited to only the target tissues? While phosphatidylcholine is a naturally occurring compound that is present in the body, what problems might be encountered by adding an uncontrolled amount of the substance?   The injection of phosphatidylcholine into subcutaneous tissues can potentially trigger the release of enzymes (lipases), which break down lipids or act as an emulsifier or detergent to dissolve cell membranes and intracellular fats. Either of these mechanisms may trigger the release of histamines, which tend to produce itching and redness; these may be short-term side effects, but are there also long-term side-effects? Given the chemical makeup of the substance, is there the possibility that side-effects could include leakage of cell membranes or even cell death?  A great deal of the currently published research in aesthetic plastic surgery focuses on the development of minimally invasive procedures that can improve a patient's appearance with fewer risks and shorter recovery than traditional surgery. The way in which safety and effectiveness of new procedures is determined, in preparation for their widespread use in properly selected patients, is through careful scientific and clinical research. Such research is evaluated through publication of results in reputable, peer-reviewed medical journals and presentation of results at medical meetings such as those sponsored by ASAPS and other accredited Continuing Medical Education sponsors.  As the leading society of plastic surgeons certified by the American Board of Plastic Surgery, who specialize in aesthetic (cosmetic) surgery, ASAPS believes that research into new cosmetic surgical and nonsurgical treatments with potential benefits to patients is important and should be conducted responsibly by qualified physicians, according to established scientific and ethical guidelines that are accepted medical practice in this country. If patients are involved in clinical trials of new procedures, they must be provided with adequate data for their full informed consent. The Aesthetic Surgery Research and Education Foundation (ASERF), in conjunction with ASAPS, observes these guidelines in funding research and evaluating new techniques/technology in order to help ensure patient safety and treatment efficacy.  As the leading provider of Continuing Medical Education in cosmetic plastic surgery to board-certified plastic surgeons, ASAPS encourages open-mindedness in regard to any new modalities, but the public must be cautious in regarding such treatments as "harmless" without scientific evidence of their safety and efficacy. It may take some time before important questions about the use of phosphatidylcholine for body contouring are answered by independent researchers.

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The American Society for Aesthetic Plastic Surgery (ASAPS) is the leading organization of plastic surgeons certified by the American Board of Plastic Surgery (ABPS) who specialize in cosmetic surgery of the face and the entire body.

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