Unapproved and Unregulated, So Don’t Believe the Marketing Hype

If it sounds too good to be true, it usually is… and time and again I find this to be the case when I research a new treatment or product that promises fabulous results, especially in the weight loss category. The latest example is a new treatment involving fat-dissolving injections, such as LipoDissolve, that bypass the need for diet and exercise and directly “dissolve” body fat. A few shots and voila, a firmer tummy, thighs or chin with no more effort on your part than writing a check and dealing with some pin-pricks.

BUYER BEWARE

This is a classic case of “buyer beware,” warns Audrey Kunin, MD, the founder and CEO of DERMAdoctor (www.dermadoctor.com) and coauthor of The DERMAdoctor Skinstruction Manual. In Kansas, these types of injections became extremely popular despite the Kansas State Board of Healing Arts’ attempt to ban them after numerous consumer complaints, making it the first state in the nation to limit the use of such fat-dissolving products. Elsewhere in the US, there is no regulation over these injections… no oversight as to their use or safety… no proof that they work… no FDA approval… not to mention that fat-dissolving injections are usually administered by technicians, not physicians. According to FDA spokesperson Sandy Walsh, “These are unapproved drugs for unapproved uses and the FDA cannot guarantee consumers’ safety. In fact, there are no FDA approved drugs to dissolve fat.”

UNAPPROVED USES ARE RISKY

Fat-dissolving injections contain chemicals such as phosphatidylcholine and sodium deoxycholate that supposedly work by permanently breaking down cells in the fatty layer under the skin. The shots cost about $1,000 to $2,000 per body part (not covered by insurance), and usually there are six injection sessions with two weeks between treatments. Both The American Society for Aesthetic Plastic Surgery and The American Society for Dermatologic Surgery have issued warnings about this procedure. According to Dr. Kunin, there have been reports of infections following injection, as well as local swelling, bruising, redness, allergic reaction and tender bumps. Elevated liver enzymes have also been reported.

Practitioners like to compare fat-dissolving injections to the early cosmetic use of Botox, but Dr. Kunin notes that Botox was already an FDA-approved product, albeit for a different use. In contrast, fat-dissolving injections utilize chemicals in an unregulated way — they are compounded by a pharmacist and are not subject to the same regulations as drug manufacturers. These types of procedures are promoted under assorted names including Lipostabil, LipoDissolve, Lipo-zap, Flab-Jab, Mesotherapy, Lipotherapy and Injection Lipolysis, to name a few. No matter the marketing, if and until there is a safe and medically proven method for dissolving fat, Dr. Kunin’s advice is clear: Stay away from these treatments.

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