2007 Lipodissolve Survey: Excellent safety data from 'adverse reaction' survey

New York, NY (APRIL 5, 2008) -- Over 400 ASAL certified physicians in the United States were issued questionnaires on their Lipodissolve treatments during 2007. The aim of the study was to investigate the potential side effects observed from ASAL Lipodissolve treatments. The total feedback from physicians reported an overwhelming level of safety from treatments. Less than 1% of all treatment cases reported adverse reactions. Adverse reactions were associated with changes to standard treatment protocols, demonstrating the importance in maintaining a standardized treatment regime.

Lipodissolve clinics with prior certification in ASAL Lipodissolve were contacted to provide data on Lipodissolve sessions from their clinical practice. Over 11,650 Lipodissolve treatments with the ASAL protocols were reported from 70 responders. The data focused on feedback with particular regard to observations on adverse side-effects from Lipodissolve injections.

As with any medical treatment, potential side effects (although shown to be mild from Lipodissolve injections) do exists and vary according to injection site, dose, frequency of injections, and the amount of physician expertise. Most side effects— such as slight pain, tenderness, or bruising at the injection site—are temporary and occur and often disappear within a few hours after treatment, with longer side effects remaining for an average of two weeks after treatment. The most common side effects from injections of the (i.e.) abdomen, include extensive swelling, slight burning immediately after injections, tenderness and temporary bruising; whilst a small number of cases experienced temporary nodules and hyper pigmentation which dissolved or disappeared after a few months.

Adverse effects: less than 1%

Recent feedback on Lipodissolve treatments from 2007 was issued by licensed physicians across the United States. The overwhelming responders confirmed adverse side effects to be extremely rare in their observations with Lipodissolve. The term 'adverse' was used to distinguish observations caused from treatments that required minor or major medical interference to correct or treat the complication. The physicians reported feeling very safe with the treatment overall and had positive results with the ASAL protocols and with high patient satisfaction. Some decrease in patient satisfaction, comfort, and posed safety concerns were reported in modified or changed treatment protocols although more specific details were omitted in several cases. As has been observed in the past, clinics reported about 6% of patients having no response to the treatment. Additional observations were made of the visual difference of cosmetic results, dependent on the origin of the pharmaceutical compounds. Examination of the feedback also led to the opinion that criticism against Lipodissolve had been exaggerated, and turf-protection was viewed as the main cause of this. The overall feedback from clinical observations concluded that the ASAL Lipodissolve protocols continue to be safe and more positive than imitation procedures. Imitation therapies such as mesotherapy or non-standard 'Lipodissolve' treatments contain various additional pharmaceutical agents including deoxycholate, as well as unknown medications.

Deoxycholate use

Of all reported treatments from this study, less than 1% of a total 11,650 cases involved adverse reactions. The survey was specific to feedback on adverse reactions. Prolonged pain was reported in 2% of cases out of 236 sessions and less than 1% of these reported pain lasting longer than two weeks, which was unusual.

The most noteworthy cases included observations of minor patches of skin necrosis. All in all, 0,017% of 11,650 cases reported serious skin breakdown. It’s necessary to add that almost all, except two cases, showed adjustments to the standard protocol, either in total injection volume of area treated or with addition of deoxcyholate and/or other substances.

Adding increased levels of deoxycholate is not a part of standard ASAL Lipodissolve protocol. It has not been recommended by the developers. In spite of this the individual use of additional deoxycholate in the treatment is popular amongst some clinical users. Deoxycholate in subcutaneous use started to grow in popularity in the United States in 2005 after aggressive promotion in various presentations. The product has been believed to give a more aggressive treatment method, although Lipodissolve developers have always been opposed to excessive deoxycholate being used in this treatment. Deoxycholate acid is highly potent and adds new risks to the treatments, with potential damage to muscles and tissue. The cosmetic results in deoxycholate use give insignificant improvement compared to the milder PPC use. Contrary to popular belief, deoxycholate has been shown to cause lipoclasis, not lipolysis. The substance is further limited in its potential use because of its toxic nature; it cannot be issued in sufficiently large volume as to be dramatically effective, making it rather pointless for subcutaneous cosmetic use. Apart from increased risks, the dissolvent acid causes substantially higher discomfort levels and pain, deterring patients from returning for further treatment sessions. Deoxycholate use has become popularized in the United States after commercially sponsored studies were published in 2004 [Dr Rotunda, Dr Roy; Dermatologic Surgery, Volume 30, Issue 7, Page 1001-1008, Jul 2004]. The substance was thereafter aggressively marketed to encourage its use in cosmetic procedures.

It would be reasonable to conclude that the overall total percentage of adverse reactions may have been lower if all 400+ certified physicians had responded to the survey.

ASAL administration states, "The secret of Lipodissolve is not to simply inject any phosphatidylcholine. Several factors are significant in the manufacturing process including raw materials used and how the product is processed during compounding to be effective. The active ingredient has no toxicity reports in extensive international studies from many years in intravenous and oral use. The substance is known to be rapidly absorbed, rapidly metabolized, and rapidly cleared from plasma and tissues. Intravenous studies confirm that the product is tolerated even in high doses on a daily basis. Lipodissolve contain lower doses and a single treatment dose about once a month. Daily doses are discouraged for several reasons. The high safety reports do not make the treatment guaranteed risk free and risk factors are very much dependent on patient cases, contraindication groups, etc. Allergic reactions are the immediate risk with any medical treatment. Other factors include the knowledge and skill of the provider, safe and reliable medical supplies, and very important; how patients manage and maintain the injected areas after treatments, etc., to mention a few. It is important that patients disclose all past medical history during consultation and inform their physicians of any supplements or medications they may be on, as it may indicate potential outcome that would otherwise remain unknown. But overall, Lipodissolve compared to most cosmetic treatments, have excellent safety record with minimal immediate risks known to us in the past four years of international feedback."

Long-term studies are lacking in Lipodissolve use, but exist on medical use of phosphatidylcholine for injectable use.

What does this tell us?

ASAL Lipodissolve injections are considerably safe compared to most cosmetic medical treatments available. The side effects of Lipodissolve injections are usually exactly as indicated they may be and swelling, bruising and tenderness are all common in other medical treatments. It cannot be ruled out that adverse reactions are more commonly prevalent in 'experimentation' where the standard ASAL Lipodissolve protocols are either changed or adjusted. It's crucial to inject into the right area and avoid muscles, and follow the protocols with the appropriate recommended dosage.

None of the clinics responding to the feedback had any monetary compensation, or were offered any products, discounts, or benefits. All feedback was voluntary and objective. ASAL has received no commercial support from manufacturers or companies related to any Lipodissolve data, products, marketing, or feedback response.

This report is prepared to be published at a later date in more detail.

Journal Publications and References:

(Related Lipodissolve and PPC studies)
1. Fat tissue after lipolysis of lipomas: A histopathological and
immunohistochemical study.
J Cutan Pathol 2006

2. Lipodissolve for Subcutaneous Fat Reduction and Skin Retraction.
Aesthetic Surg J 2005; 25:530-543.

3 PC treatment to induce lipolysis.
Journal of Cosmetic Dermatology Volume 4, Issue 4, Page 308-313, Dec 2005.

4. Lipomas treated with subcutaneous deoxycholate injections.
J.Am Acad Dermatol,53(6):973-8, dec 2005

5. Cosmetic Use of Injectable PC on the Face. Otolaryngol Clin N Am 38 (2005) 1119-1129

6. Examination of blood values after subcutaneous administration of PC.
Academy of cosmetic surgeons, EACS, Austria

7. Treatment of lower eyelid fat pads using PC: clinical trial and review.
Dermatol Surg 2004; 30: 422-7.

8. The use of PC for correction of localized fat deposits.
Aesthetic Plast Surg 2003; 27: 315-8.

9. PC in the treatment of localized fat.
J Drugs Dermatol 2003; 2 : 511-8.

10. The use of PC for correction of lower lid bulging due to prominent fat pads.
Dermatol Surg 2001; 27 : 391-2.

11. Efficiancy of Injections of PC into Fat Deposits: A Non-surgical Alternative in Body-contouring?
Scientific Presentation, 'Operative Dermatology' Congress, 28-31 October, 2004, Frankfurt Germany.

13. The effect of PC on subcutaneous fat.
Aesthet Surg J 2003;23: 413-7.

14. Intralesional Lipolysis with Phosphatidylcholine
for the Treatment of Lipomas.
Arch Dermatol, Mar 2006; 142: 395 - 396

15. Injection lipolysis for effective reduction of localized fat in place of minor surgical lipoplasty.
Volume 26, Issue 2, (March 2006-April 2006)

(Biochemical/Pharmaceutical Studies)
1. A mixed micellar formulation suitable for the parenteral administration of Taxol.
Alkan-Onyuksel H, Ramakrishnan S, Chai HB, Pezzuto JM. Pharm Res 1994, 2003;11: 206-12.

2. Preclinical safety evaluation of intravenously administered mixed micelles.
Teelmann K, Schlappi B, Schupbach M, Kistler A. Arzneimittelforschung 1984;34: 1517-23.

3. Increasing drug solubility by means of bile salt-phosphatidylcholine-based mixed micelles.
Hammad MA, Muller BW. Eur J Pharm Biopharm 1998;46: 361-7.

4. Structural and kinetic studies on the solubilization of lecithin by sodium deoxycholate.
Lichtenberg D, Zilberman Y, Greenzaid P, Zamir S. Biochemistry 1979;18: 3517-25.

5. Investigation on mixed micelle and liposome preparations for parental use on soya phosphatidylcholine. Durr M, Hager J, Lohr JP. Eur J Pharm Biopharm 1994;40: 147-56.