ASAL medical consultant: Open letter on Lipodissolve to the FDA

Mr. Robert Kang,
FDA Office of Compliance,
11919 Rockville Pike, hfd.310,
Rockville, MD. 20852

July 17, 2007

Dear Mr. Kang

Recently, the American Society of Aesthetic Plastic Surgeons [ASAPS] has issued a warning against injection therapy for fat reduction, including the practice of Lipodissolve, and communicated it to you. We, the advisory board of the American Society of Aesthetic Lipodissolve [ASAL], disagree with this warning and have responded to it with reason and scientific data [please see the enclosed response and relevant literature].

Please note that more than 50,000 Lipodissolve procedures [performed by trained physicians] did not lead to any death or serious complications. ASAPS assertion that this is anecdotal data is incorrect. ASAPS intends to perform its own study on 46 patients and try to draw “more valid” conclusions from that. It should be obvious to any one that data drawn from 50,000 procedures with the ASAL formula and technique, by trained physicians, is more valuable than a study of 46 patients by researcher who may be using different formula and technique, regardless of the format of the study.

ASAPS’s claim that liposuction is the only “safe” fat reduction procedure is also unrealistic. Although liposuction is a safe procedure in trained hands, its complications [lidocaine and epinephrine toxicities, thrombosis, fluid over load, fat embolism, complications of general anesthesia and death], have been well documented in medical literature. None of these complications have been reported after phosphtidylcholine [PC] based Lipodissolve. During the last 2 years or so the three undersigned ASAL physician board members have performed approximately 1200 lipodissolve procedures. The common side effects include: swelling and bruising lasting around 7-10 days and some tenderness lasting for several weeks. Less than 10% of the patients have nausea or lightheadedness [related to hyperventilation or vaso-vagal responses] during the first or the second day. There have been 3 incidences of skin breakdown, which healed, amounting to a rate of 0.25% and certainly not excessive compared to wound infections following liposuction or other surgical procedures. No long term health side effects have emerged. The board will accumulate further data from physicians who have been trained by ASAL. The important point is that none of the serious complications described with liposuction have occurred with Lipodissolve.

PC, an essential molecule in the cell membrane with many important functions, is also a component of bile where it assists the bile salts in breaking down the ingested fat cells and in the digestion of fat. At the same time it protects the adjacent biliary and intestinal mucosa from the corrosive action of bile salts [Gastroenterology. 2000 Jun;118(6):1179-86, J Gastroenterol.2004 Oct;39(10):955-60]. This is why in Lipodissolve, permanent damage to adjacent structures such as nerves and muscle has not been reported. PC has been used for liver health and to reduce alcohol related liver fat [Magy Seb. 2005 Dec;58(6):406-14, Dig Liver Dis. 2005 Nov;37(11):869-76] and for other benefits. It has been used intravenously as an effective treatment of fat embolism in Europe.

Since Lipodissolve is not a surgical procedure, one gets the impression that the ASAPS warning is a turf protective initiative. We believe that patient benefit and safety [based on existing scientific evidence], and not one’s medical specialty, should be the basis of all therapies. Sufficient evidence for such benefit and safety exists for Lipodissolve.

Sincerely,

Members of ASAL advisory board:

Khalid Mahmud, MD, FACP
[Internist-Hematologist-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:

"Lipodissolve" refers to a trademarked name for a non-surgical medical treatment and unique standardized protocols that orginates with ASAL. Various imitation procedures such as mesozap, mesotherapy, lipomelt, and unauthorized use of the Lipodissolve name in marketing by non-certified practitioners do not reflect actual Lipodissolve protocols or user data.

The safety of uncertified and unauthorized users may not pose an accurate description of Lipodissolve, or give accurate results.