NEW YORK (May 25, 2007): The medical consultans for the American Society of Aesthetic Lipodissolve (ASAL) responds to Dr Foad Nahai's announcement for the ASAPS, May 14, 2007: "American Society for Aesthetic Plastic Surgery Warns Patients to Steer Clear of Injection Fat Loss Treatments".

The American Society of Aesthetic Lipodissolve Response to American Society of Aesthetic Plastic Surgery The American Society of Aesthetic Lipodissolve (ASAL) objects to the inclusion of Lipodissolve™ in the recent warning against injection therapy (mesotherapy) for localized fat reduction issued by the American Society for Aesthetic Plastic Surgery (ASAPS). Lipodissolve™ was introduced by the founders of ASAL in 2001 as distinct from mesotherapy. The ASAL included ingredients that were safe and whose mechanisms were understood. The ASAL limited training only to physicians and their nurses to perform the procedure. The ASAL and its original cohort, the European Network, have trained more than 300 physicians in Europe, and so far, more than 200 physicians in the United States.

ASAPS is incorrect in stating that there are no data relative to the effectiveness and safety of the Lipodissolve™ procedure. More than 50,000 treatments have been reported in European and American peer-reviewed journals demonstrating objective evidence of improvement, based on actual measurements and images and a paucity of serious side effects. 1–6

Serious side effects reported with liposuction such as death, fluid overload, epinephrine and lidocaine toxicity, thrombosis, fat embolism, and complications of general anesthesia have not been reported with Lipodissolve™ therapy. 7

The main ingredient in the Lipodissolve™ formula is a lipid called phosphatidylcholine (PC), which is dissolved in a bile salt, called deoxycholate. When injected into the unwanted superficial body fat, deoxycholate helps break down the ingested fat cells and digests fat on a daily basis, as it does naturally in proximal duodenum. In the subcutaneous area, the dead fat cells are gradually removed by the body's physiologic repair mechanisms, the same way as after any trauma or liposuction, which leaves dead fat cells in the area to be removed by similar physiologic processes.

PC along with other phospholipids are significant dietary sources of essential fatty acids. Mammalian cell membranes are primarily composed of PC and other phospholipids that are mixed with cholesterol esters and salts to maintain fluidity. In other words, it is not a foreign or toxic substance.

ASAPS's statement that this procedure is not FDA approved is misleading. FDA approves drugs and devices, not procedures. ASAL maintains that there is no FDA approval requirement relative to phosphatidylcholine for two reasons:

1) It is a supplement that has been used for years for liver health, cholesterol, and other benefits. Supplements do not require FDA approval and can be administered by injection.

2) In Lipodissolve™, the ingredients are mixed by a compounding pharmacist upon a physician's order for specific patients, which does not require FDA approval (FDA Modernization Act Section 503a Compounding Pharmacy).

Lipodissolve™ is not a surgical procedure. Accordingly, ASAL has compiled an advisory board that includes credentialed physicians with diverse but relevant backgrounds in the fields of dermatology, aesthetic surgery, and internal medicine. These individuals are experienced clinicians, speakers, writers, researchers, and teachers, who provide advice regarding the procedure and its evolution. They conduct training workshops for other physicians in the United States. Thus far, the North American advisers have performed more than 2,000 lipodissolve procedures with satisfactory results in more than 90% of patients without any serious side effects. The ASAL has an ongoing monitoring process to record Lipodissolve™ procedures.

signed,

Khalid Mahmud, MD, FACP
[Internist-Hematologis-Oncologist-Specialist in Anti-aging and Preventive Medicine, former member FDA advisory committee, Device and Radiological Health]

Thomas Wright, MD, FACP, MACPh
[Internist, former research fellow in lipid metabolism]

Barry Lycka, MD, FRCP(C)
[Cosmetic and Dermatologic Surgeon, former vice president American Society of Cosmetic Dermatology]

Footnote:

Is Liposuction surgery the 'only safe' treatment to reduce body fat?

According to the U.S. Food & Drug Administration (FDA) announcement on liposuction surgery, the known adverse effects from plastic surgery to reduce fat deposits include: fatalities, skin death, embolism nerve compression, toxicity, fluid imbalance, infections, seroma, visceral punctuation (puncture wounds in the organs), and more. European data from Germany issued in media in 2005 reported that the astronomical number 1 in 10 cases of liposuction surgery were reported as cosmetic or medical 'complications'. An annual, detailed and objective follow-up report for public access in the U.S. on actual liposuction cases and complications are lacking. Follow-up data on long-term effects and patient feedback on liposuction surgery is further lacking.

Lipodissolve™ has no known cases or reports of patient fatalities or permanent adverse side-effects from regular and certified clinical use since 2004 in the US. The common and known side-effects include swelling, tenderness, bruising, hematomas, and hyperpigmentation. Rare side-effects include infections (none reported by members to date on standard ASAL Lipodissolve™ protocols), intermediate menorroeah, temporary dents, mild cholinergic reactions, allergic reactions (none reported to date with ASAL protocols).
An estimated 50,000+ Lipodissolve™ procedures are being performed every year in the US alone. The public demand for patient safety and a milder treatment option to surgery has been the aim of Lipodissolve™ development.