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Injection lipolysis is a controversial cosmetic procedure in which drug mixtures are injected into patients with the goal of destroying fat cells. This practice, using drugs generally based on phosphatidylcholine and deoxycholate (PCDC), evolved from the initial intravenous use of those drug formulations to treat blood disorders.
In 1966, investigators noted that the intravenous infusion of PC-containing solutions could remove fat emboli. Later, a drug formulation called Lipostabil containing 5% PC and 4.75% deoxycholate (DC) was approved in Germany and used in the treatment of fat embolism, dyslipidemia, and alcohol-induced liver cirrhosis. The first report of Lipostabil injection for fat removal demonstrated that infra-orbital ("under the eyelid") fat could be removed by Lipostabil injection. While no placebo-controlled studies have demonstrated the safety or efficacy of this therapy, numerous retrospective studies of Lipostabil injections have reported the efficacy of this practice. The mixture is injected directly into the subcutaneous fat through multiple microinjections administered over multiple treatment sessions. The desired end result is the removal of localized fat deposits.
Restrictive action taken by FDA against Lipodissolve
On April 7, 2010, the US Food and Drug Administration issued Warning Letters to six U.S. based medical spas and a company in Brazil for making false or misleading statements on their Web sites about drugs they claim will eliminate fat in a procedure called "lipodissolve," or for otherwise misbranding lipodissolve products. "We are concerned that these companies are misleading consumers," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "It is important for anyone who is considering this voluntary procedure to understand that the products used to perform lipodissolve procedures are not approved by the FDA for fat removal."
For the complete FDA statement, see here .
To see the warning letter, see .
The FDA has received reports of adverse effects in persons who have had the procedure using these drugs, including permanent scarring, skin deformation, and deep painful knots under the skin in areas where the lipodissolve products have been injected. The warning letters were issued to the following U.S. companies: Monarch Medspa, King of Prussia, Pa; Spa 35, Boise, Idaho; Medical Cosmetic Enhancements, Chevy Chase, Md.; Innovative Directions in Health, Edina, Minn PURE Med Spa, Boca Raton, Fl.; and All About You Med Spa, Madison, Ind. The Brazilian company receiving a warning letter markets lipodissolve products on two Web sites: zipmed.net and mesoone.com.
The FDA is requesting a written response from the U.S. companies within 15 business days of receipt of the warning letters stating how they will correct these violations and prevent similar violations in the future. Each U.S. company has been informed in its warning letter that failure to promptly correct the violations may result in legal action. Each of the companies involved has been cited for a variety of regulatory violations, including making unsupported claims that the products have an outstanding safety record and are superior to other fat loss procedures, including liposuction. Additionally some of the letters indicate that the companies have made claim that lipodissolve products can be used to treat certain medical conditions, such as male breast enlargement, benign fatty growths known as lipomas, excess fat deposits and surgical deformities. The FDA is not aware of clinical evidence to support any of these claims.
Three medical associations have issued health warnings cautioning against the use of injection lypolysis, including the American Society of Plastic Surgeons (ASPS), the American Society for Aesthetic Plastic Surgery (ASAPS), and the American Society of Dermatologic Surgery (ASDS).
The Medicines and Healthcare Products Regulatory Agency, the governmental body regulating the manufacture and commercialization of drugs in the United Kingdom, issued a similar warning to physicians considering the use of these substances for cosmetic purposes, stating these drugs "are being unlawfully advertised in the UK as a cosmetic product for the reduction of fat." The MHRA also pointed out that considerable safety concerns remain because these agents have not been tested in controlled clinical trials. While British physicians can still inject Lipodissolve for fat removal, the drug cannot be promoted as a drug for that purpose. As of July, 2005, The Medical Protection Society, the organization that provides British doctors with legal advice and coverage against litigation costs and damages, ceased offering malpractice insurance for use of Lipodissolve because of safety concerns.
- Matarasso, A. and Pfeifer, T.M. (2005). "Mesotherapy for body contouring". Plast Reconstr Surg 115 (Pt 5): 1420–4. doi:10.1097/01.PRS.0000162227.94032.ED. PMID 15809611.
- Duncan, D.I.; Hasengschwandtner, F (2005). "Lipodissolve for Subcutaneous Fat Reduction and Skin Retraction". Aesthetic Surg J 25 (Pt 5): 530–543. doi:10.1016/j.asj.2005.07.009. PMID 19338857.
- Kroupa, J. (1966). "Lipostabil in the prevention of fat embolism. (Experimental study)". Rozhl Chir 45 (Pt 7): 444–452.
- Schroder, D., Buttenschon, K., Herrmann, F., Brede, S. (1991). "Is there a drug treatment approach for prevention and therapy of fat embolism syndrome?". Klin Wochenschr 69 (Pt 26): 229–233.
- Stohlmacher, P., Haferland, W., and Gottschall, S. (1975). "Diffuse foam cell pneumonia following fatty embolism treated with lipostabil. A contribution to the pathology of therapy". Z Arztl Fortbild (Jena) 69 (5): 237–239.
- Klimov, A.N., Konstantinov, V.O., Lipovetsky, B.M., Kuznetsov, A.S., Lozovsky, V.T., Trufanov, V.F., Plavinsky, S.L., Gundermann, K.J., and Schumacher. R.. (1995). ""Essential" phospholipids versus nicotinic acid in the treatment of patients with type IIb hyperlipoproteinemia and ischemic heart disease". Cardiovasc Drugs Ther 9 (6): 779–784.. doi:10.1007/bf00879871.
- Lieber, C.S., Weiss, D.G., Groszmann, R., Paronetto, F., Schenker, S. (2003). "For the Veterans Affairs Cooperative Study 391 Group., II. Veterans Affairs Cooperative Study of polyenylphosphatidylcholine in alcoholic liver disease". Alcohol Clin Exp Res. 27: 1765–1772... doi:10.1097/01.alc.0000093743.03049.80.
- Rittes, P.G. (2001). "The use of phosphatidylcholine for correction of lower lid bulging due to prominent fat pads". Dermatologic Surgery 27 (4): 391–2. doi:10.1097/00042728-200104000-00014. PMID 11298713.
- Rotunda, A.M., M.M. Avram, and Avram, A.S. (2005). "Cellulite: Is there a role for injectables?". J Cosmet Laser Ther 7 (3–4): 147–54. doi:10.1080/14764170500430234.
- Ablon G, Rotunda, AM. (2004). "Treatment of lower eyelid fat pads using phosphatidylcholine: clinical trial and review". Dermatologic Surgery 30 (3): 422–7. doi:10.1097/00042728-200403000-00020. PMID 15008874.
- Hexsel, D., Serra, M., Mazzuco, R. (2003). "Phosphatidylcholine in the treatment of localized fat". Journal of Drugs in Dermatology 2 (5): 511–8. PMID 14558399.
- Rotunda, A.M., G. Ablon, and M.S. Kolodney (2005). "Lipomas treated with subcutaneous deoxycholate injections". Journal of the American Academy of Dermatology 53 (6): p. 973–8. doi:10.1016/j.jaad.2005.07.068. PMID 16310057.
- Rotunda, A.M. and M.S. Kolodney (2006). "Mesotherapy and Phosphatidylcholine Injections: Historical Clarification and Review". Dermatologic Surgery 32 (4): p. 465–480. doi:10.1111/j.1524-4725.2006.32100.x. PMID 16681654.
- Bechara, F.G., Sand, M., Hoffmann, K., Sand, D., Altmeyer, P., and Stucker, M. (2007). "Fat tissue after lipolysis of lipomas: a histopathological and immunohistochemical study". Journal of Cutaneous Pathology 34 (7): p. 552–7. doi:10.1111/j.1600-0560.2006.00651.x. PMID 17576334.
- Bechara, F.G., Sand, M., Altmeyer, P., and Hoffmann, K. (2006). "Intralesional lipolysis with phosphatidylcholine for the treatment of lipomas: pilot study". Arch Dermatol 142 (8): p. 1069–70.
- Bechara, F.G., Sand, M., Sand, D., Rotterdam, S., Stucker, M., Altmeyer, P., and Hoffmann, K. (2006). "Lipolysis of lipomas in patients with familial multiple lipomatosis: an ultrasonography-controlled trial". Journal of Cutaneous Medicine and Surgery 10 (4): p. 155–9. PMID 17234112.
- Lister, Sam (July 18, 2005). "Youre on your own if you give flab jab insurers warn doctors". The Times (London). Retrieved May 5, 2010.
- Ablon G, Rotunda AM "Treatment of lower eyelid fat pads using phosphatidylcholine: clinical trial and review. Dermatol Surg 2004; 30: 422-7
- Atiyeh BS, Ibrahim AE, Dibo SA "Cosmetic Mesotherapy between scientific evidence, science fiction, and lucrative business. Aesthet Plast Surg 2008; 32: 842-9
- Bechara, FG; Georgas, D; Sand, M; Tomi, N; et al. (2008). Dermatology 216: 180–1. doi:10.1159/000111519. Missing or empty
- Bechara, FG; Skrygan, M; Kreuter, A; Altmeyer, P; et al. (2008). "Cytokine mRNA levels in human fat tissue after injection lipolysis with phosphatidylcholine and deoxycholate". Arch Dermatol 300: 455–9. doi:10.1007/s00403-008-0869-7.
- Bechara, FG; Sand, M; Hoffmann, K; Sand, D; et al. (2007). "Fat tissue after lipolysis of lipomas: a histopathological and immunohistochemical study". J Cutan Pathol 34 (7): 552–7. doi:10.1111/j.1600-0560.2006.00651.x. PMID 17576334.
- Bechara, FG; Sand, M; Sand, D; Rooterdam, S; et al. (2006). "Lipolysis of lipomas in patients with familial multiple lipomatosis: an ultrasonography-controlled trial". J Cutan Med Surg 10: 155–9.
- Bechara, FG; Sand, M; Altmeyer, P; Hoffmann, K (2006). "Intralesional lipolysis with phosphatidylcholine for the treatment of lipomas: pilot study". Arch Dermatol 142: 1069–70.
- Brown, SA (2006). "The science of Mesotherapy: chemical anarchy". Aesthet Surg J 26: 95–8. doi:10.1016/j.asj.2005.12.003.
- Co, AC; Abad-Casintahan, MF; Espinoza-Thaebtharm, A (2007). "Submental fat reduction by Mesotherapy using phosphatidylcholine alone vs. phosphatidylcholine and organic silicium: a pilot study". J Cosm Dermatol 6: 250–7. doi:10.1111/j.1473-2165.2007.00343.x.
- Duncan D, Rubin JP, Golitz L, Badylak S, et al "Refinement of technique in injection lipolysis based on scientific studies and clinical evaluation. Clin Plast Surg 2009; 36: 195-209,v-vi; discussion 211-3
- Duncan, DI; Palmer, M (2008). "Fat reduction using phosphatidylcholine/sodium deoxycholate injections: standard of practice". Aesthet Plast Surg 32: 858–72. doi:10.1007/s00266-008-9188-9.
- Duncan, DI; Chubaty, R (2006). "Clinical safety data and standards of practice for injection lipolysis: a retrospective study". Aesthet Surg J 26: 575–85. doi:10.1016/j.asj.2006.08.006.
- Duncan, DI; Hasengschwandtner, F (2005). "Lipodissolve for subcutaneous fat reduction and skin retraction". Aesthet Surg J 25 (5): 530–43. doi:10.1016/j.asj.2005.07.009. PMID 19338857.
- Gupta, A; Lobocki, C; Singh, S; Robertson, M; et al. (2009). "Actions and comparative efficacy of phosphatidylcholine formulation and isolated sodium deoxycholate for different cell types". Aesthet Plast Surg 33: 346–52. doi:10.1007/s00266-008-9301-0.
- Hasegawa, T; Matsukura, T; Ikeda, S (2010). "Mesotherapy for benign symmetric lipomatosis". Aesthet Plast Surg 34 (2): 153–6. doi:10.1007/s00266-009-9374-4. PMID 19488808.
- Hasengschwandtner F "Fat melting injections – The latest scientific findings, terms and methods. Kosmetische Medizin 2009; #2: 10-5
- Hasengschwandtner F, Brandl D "Phosphatidylcholine. NETWORK-Lipolysis, 2009, http://www.network-lipolysis.com/index.php?id=1513
- Hasengschwandtner, F; Furtmueller, F; Spanbauer, M; Silye, R (2007). "Detailed documentation of one lipolysis treatment: blood values, histology, and ultrasound findings". Aesthet Surg J 27: 204–11. doi:10.1016/j.asj.2007.01.010.
- Hasengschwandtner, F (2006). "Injection lipolysis for effective reduction of localized fat in place of minor surgical lipoplasty". Aesthet Surg J 26: 125–30. doi:10.1016/j.asj.2006.01.008.
- Hasengschwandtner, F (2005). "The subcutaneous injection of phosphatidylcholine for means of lipolysis. Lipodissolve – The non surgical liposculpture". Akt Dermatol 31: 549–52.
- Hasengschwandtner, F (2005). "Phosphatidylcholine treatment to induce lipolysis". J Cosmet Dermatol 4: 308–13. doi:10.1111/j.1473-2165.2005.00211.x.
- Heinrich, K-G (2005). "Efficacy of injection of phosphatidylcholine into fat deposits – a non-surgical alternative to liposuction in body-contouring". Indian J Plast Surg 38: 119–22.
- Hexsel, DM; Serra, M; Dal'Forno, T; Zechmeister; Prado, D (2005). "Cosmetic uses of injectable phosphatidylcholine on the face". Otolaryng Clin N Am 38: 1119–29. doi:10.1016/j.otc.2005.05.002.
- Hexsel, D; Serra, M; Mazzuco, R; Dal'Forno, T; et al. (2003). "Phosphatidylcholine in the treatment of localized fat". J Drugs Dermatol 2: 511–8.
- Hunstad, JP; De Souza, M (2009). "Review of "the lipodissolve technique: clinical experience" and author's comment". Clin Plast Surg 36: 223–6. doi:10.1016/j.cps.2008.12.001.
- Klein, SM; Schreml, S; Nerlich, M; Prantl, L (2009). "In vitro studies investigating the effect of subcutaneous phosphatidylcholine injections in the 3T3-L1 adipocyte model: lipolysis or lipid dissolution?". Plast Reconstr Surg 124: 419–27. doi:10.1097/prs.0b013e3181adce61.
- Klein SM, Prantl L, Berner A, Schreml S, et al: A new method to quantify the effect after subcutaneous injection of lipolytic substances. Aesthet Plast Surg 2008; 32: 667-72; discussion 673-4
- Kopera, D; Binder, B; Toplak, H; Kerl, H; et al. (2006). "Histopathologic changes after intralesional application of phosphatidylcholine for lipoma reduction – report of a case". Am J Dermatopathol 28: 331–3. doi:10.1097/00000372-200608000-00007.
- Kopera, D; Binder, B; Toplak, H (2006). "Intralesional lipolysis with phosphatidylcholine for the treatment of lipomas: pilot study". Arch Dermatol 142: 395–6. doi:10.1001/archderm.142.3.395.
- Maggiori S "Traitement mésothérapique des xanthelasmas à la phosphatidilcoline polyinsaturée. 5th Cong. Int. Mésothérapie, Paris/France 1988, Oct.07-09, p. 364
- Matarasso, A; Pfeifer, TM (2009). "Mesotherapy and injection lipolysis". Clin Plast Surg 36: 181–92. doi:10.1016/j.cps.2008.11.002.
- Matarasso A, Pfeifer TM, and the Plastic Surgery Educational Foundation DATA Committee: Mesotherapy for body contouring" Plast. Reconstr. Surg 2005; 115: 1420-4
- Motolese, P (2008). "Phospholipids do not have lipolytic activity. A critical review". J Cosmet Laser Ther 10: 114–8. doi:10.1080/14764170802074680.
- Myers, P (2006). "The cosmetic use of phosphatidylcholine in the treatment of localized fat deposits". Cosmet Dermatol 19: 416–20.
- Peckitt N "Evidenced Based Practice: Phosphatidylcholine – A Review of Evidence for the Mode of Action in Injection Lipolysis. Jeremy Mills Publishing, 2005
- Olbertz F-W "Injektionslipolyse – ein Erfahrungsbericht nach einjähriger Anwendung. Frauenarzt 2007; 48: 576-7
- Palmer M, Curran J, Bowler P "Clinical experience and safety using phosphatidylcholine injections for the localized reduction of subcutaneous fat: a multicentre, retrospective UK study. J Cosmet Dermatol 2006; 5: 218-26
- Rein P "Injektionslipolyse mit Phosphatidylcholin – Erfahrungen mit der „Fett-Weg-Spritze". Der Deutsche Dermatologe 2006; #9: 619-20
- Rittes, PG; Rittes, C (2009). "Treatment of Aging neck with "Lipostabil" endovena". J Drugs Dermatol 8: 937–9.
- Rittes, PG (2009). "The lipodissolve technique: clinical experience". Clin Plast Surg 36: 215–21. doi:10.1016/j.cps.2008.11.003.
- Rittes, PG (2007). "Complications of Lipostabil endovena for treating localized fat deposits". Aesthet Surg J 27: 146–9. doi:10.1016/j.asj.2007.01.005.
- Rittes, PG; Rittes, J; Amary, MFC (2006). "Injection of phosphatidylcholine in fat tissue: experimental study of local action in rabbits". Aesthet Plast Surg 30 (4): 474–8. doi:10.1007/s00266-005-0170-5. PMID 16858660.
- Rittes, PG (2003). "The use of phosphatidylcholine for correction of localized fat deposits". Aesthet Plast Surg 27: 315–8. doi:10.1007/s00266-003-3033-y.
- Rittes, PG (2001). "The use of phosphatidylcholine for correction of lower lid bulging due to prominent fat pads". Dermatol Surg 27: 391–2. doi:10.1046/j.1524-4725.2001.00282.x.
- Rose, PT; Morgan, M (2005). "Histological changes associated with Mesotherapy for fat dissolution". J Cosmet Laser Ther 7: 17–9. doi:10.1080/14764170510037743.
- Rotunda, AM (2009). "Injectable treatments for adipose tissue: terminology, mechanism, and tissue interaction". Lasers Surg Med 41: 714–20. doi:10.1002/lsm.20807.
- Rotunda, AM; Weiss, SR; Rivkin, LS (2009). "Randomized double-blind clinical trial of subcutaneously injected deoxycholate versus a phosphatidylcholine-deoxycholate combination for the reduction of submental fat". Dermatol Surg 35: 792–803. doi:10.1111/j.1524-4725.2009.01130.x.
- Rotunda, A; Scientific Studies Aim to Dispel Controversy Surrounding Injection Lipolysis, The European Aesthetic Guide Autumn 2008, 74 – 84
- Rotunda, AM; Kolodney, MS (2006). "Mesotherapy and phosphatidylcholine injections: historical classification and review". Dermatol Surg 32 (4): 465–80. doi:10.1111/j.1524-4725.2006.32100.x. PMID 16681654.
- Rotunda, AM; Ablon, G; Kolodney, MS (2005). "Lipomas treated with subcutaneous deoxycholate injections". J Am Acad Dermatol 53 (6): 973–8. doi:10.1016/j.jaad.2005.07.068. PMID 16310057.
- Rotunda, AM; Suzuki, H; Moy, RL; Kolodney, MS (2004). "Detergent effects of sodium deoxycholate are a major feature of an Injectable phosphatidylcholine formulation used for localized fat dissolution". Dermatol Surg 30: 1001–8. doi:10.1097/00042728-200407000-00008.
- Salles, AG; Valler, CS; Ferreira, MC (2006). "Histologic response to injected phosphatidylcholine in fat tissue: experimental study in a new rabbit model". Aesthet Plast Surg 30: 479–84. doi:10.1007/s00266-005-0210-1.
- Salti, G; Ghersetich, I; Tantussi, F; Bovani, B; et al. (2008). "Phosphatidylcholine and sodium deoxycholate in the treatment of localized fat: a double-blind, randomized study". Dermatol Surg 34: 60–6. doi:10.1111/j.1524-4725.2007.34009.x.
- Schuller-Petrovic, S; Wölkart, G; Höfler, G; Neuhold, N; et al. (2008). "Tissue-toxic effects of phosphatidylcholine/deoxycholate after subcutaneous injection for fat dissolution in rats and a human volunteer". Dermatol Surg 34: 529–43. doi:10.1097/00042728-200804000-00011.
- Steinert M "Injektionslipolyse. DERMAforum, February 2009
- Treacy, PJ; Goldberg, DJ (2006). "Use of phosphatidylcholine for the correction of lower lid bulging due to prominent fad pads". J Cosmet Laser Ther 8: 129–32. doi:10.1080/14764170600891756.
- Uygur, F; Evinç, R; Duman, H (2008). "Is phosphatidylcholine harmful to the peripheral neural tissue? An experimental study in rats". Aesthet J Surg 28: 663–7. doi:10.1016/j.asj.2008.07.002.
- Young, VL (2003). "Lipostabil: the effect of phosphatidylcholine on subcutaneous fat". Aesthet Surg J 23: 413–7. doi:10.1016/s1090-820x(03)00211-5.
- US Food and Drug Administration Enforcement Actions Against Lipodissolve (April 7, 2010): 
- Allure (magazine) online: Article about fake reviews
- MSNBC: July 30, 2007: 
- CBS The Early Show (July 25, 2007):
- Washingtonian (July 2007): 
- NPR (June 28, 2007): 
- Washington Post (June 26, 2007): 
- Washington Post Express (May 29, 2007): 
- WTTG Fox 5 (May 4, 2007): 
- CBS Baltimore (February 6, 2007):