ASAPS President, Peter Fodor , MD, says the product is promising enough that he plans to discuss it at the upcoming 17 th Biennial Congress of the International Society of Aesthetic Plastic Surgery (ISAPS) which meets in August in Houston.

“The concept behind the LipoSonix device is to allow the surgeon to non-invasively disrupt and selectively reduce fatty tissue,” says Dr. Fodor. “Ultimately, I believe this technology could revolutionize the approach to body sculpting."

Leroy Young , MD, Chair of ASAPS Nonsurgical Procedures Committee notes that the LipoSonix device represents an extension of the medical uses of ultrasonic energy. “We know that it is possible to disrupt fatty tissues,” he says. “What we need is clinical trials approved by the Food and Drug Administration (FDA) to define its applications. For example,” he continues, “we need to know who would be appropriate candidates for this procedure, and what areas can be treated. We also need to know if there are areas that need to be excluded. Finally,” he says, “we need to find out the potential long-term consequences of its use and any potential complications.”

Dr. Fodor agrees. “The LipoSonix device is intriguing and appears to be safe, but questions remain. For example,” he says, “surgeons would need to be able to control the depth of the effects. There needs to be further research to determine if the procedure could affect cells other than fat cells. Controlled scientific studies are necessary to ensure safety and validate the results.”

Similar questions have been raised about Ultrashape, another device that employs ultrasound to treat localized fat deposits noninvasively. Claims as to the safety and efficacy of this product have so far not been substantiated by scientific clinical trials in the United States .

Additionally, 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.

Specific questions should be answered before any of these products can be safety used:

How can it be assured that the appropriate amount of fat – neither too little nor too much -- is dissolved?

If fatty tissue is being dissolved, is other tissue also affected? How is delivery limited to only the target tissues?

What are the short-term and long-term side-effects? Is there the possibility that side-effects could include 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.

Dr. Fodor serves as Chair of the LipoSonix Scientific Advisory Board but has no financial interest in the company and its products.

This document has been updated from October, 2002.

Toll-free referral line: 888.ASAPS.11 (272.7711). Web site: www.surgery.org

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