Industry News

Open letter on the subject of injection lipolysis

This is to inform the public about the current state of Injection Lipolysis’ therapeutic development.

 

This statement relates to the treatment and reduction of small fat deposits by injection of a solution of polyunsaturated phosphatidylcholine (lecithin) from soybean and deoxycholic acid (a bile acid), The procedure is also known under the name of Injection Lipolysis, Lipodissolve, Lipomelt.
This statement was signed by XX doctors from XX countries. The following organizations have adopted for their members the responsibility for the publication: NETWORK-Lipolysis (2000 members), ASNA ((x members), AestheticMD (x members)

This open letter, which is addressed to doctors, medical organizations, regulatory agencies, media and patients worldwide, also includes an opinion on the scientific significance of injection lipolysis.

We as the signatories of this open letter and as specialists in the medical field of injection lipolysis want to inform the public about the current state of its therapeutic development.

 

1. The injected compound is a known membrane therapeutic used for more than 50 years for the treatment of fat embolism, dyslipidemia/atherosclerosis and liver disease, among others. It is approved as a drug in many countries around the world under various brand names.

 

2. The compound is usually administered intravenously or orally. The administration of the compound for fat reduction is different in that it is injected subcutaneously in the affected regions. This deployment of a drug for other indications is a so-called off-label use. Off-label use is common practice in medicine and is used for example in cancer therapy or for any treatment when prescribed for children. In aesthetic medicine, for example, the treatment of wrinkles with botulinum toxin A (Botox) in most countries is still today used off-label.

 

3. In countries where the drug is not approved, for example in the U.S. or Australia, it can be prepared by a pharmacist by personal prescription which for centuries is a common right of every physician. This Compounding or production by Formula Magistralis referred to is legal and is treated in almost every country of the world as a valuable asset to the medical profession.

 

4. We, the signatories, understand the critical concerns of institutions and colleagues who oppose this novel therapy as it has not been properly scientifically evaluated until recently. We welcome questions of legitimate concern regarding the product and similarly reject unscientific or irrational opinions.

 

5. We recognise that responsible physicians have founded global organizations to collect and share scientific data relating to procedures and efficacy relating to the treatment. This includes the largest database relating to safety and the side effects of phosphatidylcholine. These organizations have cooperated with research institutes and universities in many countries to investigate the effectiveness of the therapy and have written numerous scientific publications on the subject.

 

6. The treatment is suitable for medical indications as well as for aesthetic fat reduction. These medical indications include: multiple lipomas and lipomatosis, cellulite, fat tissue disorders and HIV associated lipohypertrophy disorders. Other indication include, Dercum’s disease, xanthelasm treatments, and Madelung’s disease. It should be noted that less compound is normally required during aesthetic medicine procedures and consequently fewer potential side effects will be encountered.

 

7. As responsible physicians we always try whenever possible to provide our patients with the optimal procedural options for a defined clinical indication. Unfortunately, many patients are presently unnecessarily subjected to anaesthetic and surgical procedures to reduce fat. Many patients are opposed to surgical procedures for conditions such as multiple lipomatosis because of scar formation. Most physicians would agree that injection lipolysis should be considered as the first option.

 

8. We request all responsible institutions and regulatory authorities to reconsider their attitude towards injection lipolysis as a first line treatment of fat deposits. We request them to re-evaluate the accumulated data regarding safety and efficacy of phosphatidylcholine and only allow properly trained medical practitioners to use the treatment.

 

9. We request our colleagues who would like to use the therapy, to undergo a proper training course ran by physicians with experience of the compound. We also consider fundamental knowledge of the proper application as a “conditio sine qua non” of good efficacy without serious side effects.

 

10. We wish to state that the reason for this open letter is meant to advance scientific knowledge rather than using the compound for financial gain. We are aware that untrained doctors, nurses and aestheticians have previously brought this novel compound into disrepute and created complications from its misuse.

 

11. There are now more than 50 scientific publications available on the subject of injection lipolysis. These include multi-centre and double-blind studies. Scientific evidence to date show phosphatidylcholine to be an effective therapy with good safety and a low side effect profile as long as the doctors have undergone proper training.

 

12. Current data shows that more than 100,000 treatments have been documented. The rate of more serious complications is 0.0017%. The complication rate is extremely low compared to many other aesthetic therapies. There is no evidence of any mortalities associated with this compound.

 

13. Nevertheless, we assume that the procedure of injection lipolysis will continue to develop. During this period we expect there will be further improvements in treatment protocols and first approvals in some countries around the world.

 


 

Signatories


Dr. Patricia Rittes, Brazil; Dr. Franz Hasengschwandtner, Austria; Dr. Ghassan Farah, Israel; Dr. Maja Velimirov, Serbia; Dr. Uli Taucher, Germany; Johann W. Kees, MD, Germany; Dr. Peter Schwalbach, Germany; Dr. Jeon Cheol Woo, South Korea; Dr. Rudolf Moshammer, Austria; Dr. Klaus Blucke, Germany; Dr. Max Schmederer, Germany; Dr. Z. Linde-Krakowsky, Germany; Dr. Sam van Eden, Ireland; Dr. Georg Wiegand, Germany; Dr. Werner Fuchs, Austria; Dr. Nicolai Schreck, Germany; Prof. Hanan Elkahky, Egypt; Dr. Myoung Seok, South Korea; Dr. Justin Hao, Taiwan and PR China; Dr. Markus Oettli, Switzerland; Dr. Sameer Al Ali, United Arab Emirates; Dr. Rene Meili, Switzerland; Dr. Sigrid Suschka, Germany; Dr. Ulrich Ledermann, Switzerland; Dr. Heinrich Peters, Germany; Dr. King Hoen Tan, Netherlands; Prof. Ahmed Adel Noreldin, Egypt; Dr. Nidal Gazawi, Germany; Dr. Margrit Lettko, Germany; Dr. Henry Mittnacht, Germany; Dr. Jochen Raetzel, Germany; Dr. Nada Kolak, Australia; Prof. Martin Iglesias Morales, Mexico; Dr. Takahito Myojin, Japan; Dr. Selma Uygun-Kiene, Germany; Dr. Ralf Lechenmayr, Switzerland; Prof. Markus Steinert, Germany; Dr. Maged Awad, Saudi Arabia; Dr. Dirk Tschauder, Germany; Dr. Don Smeets, Netherlands; Dr. Sonnhild Zwetkow, Germany; Dr. Ninian Peckitt, New Zealand; Dr. Samir Botros, Saudi Arabia; Dr. Mirjam Dornacher, Germany; Dr. Jean-Luc Vigneron, France; Dr. George M. Calfas, Australia; Dr. Roland Voelin, Switzerland; Dr. Rafael Velasco Marin, Mexico; Dr. Anne Hundgeburth, Germany; Dr. Bernard Mole, France; Dr. Mariam Barsoum, Egypt; Dr. Louise Gauthier, Canada; Dr. Geoffrey Huertgen, Germany; Dr. Bea Brookes, United Kingdom; Dr. Hartmut Schulze, Germany; Dr. Jörg Kronitz, Germany; Dr. Fajer Klueh, Germany; Dr. Waleed Abo Bakre Mohmed, Egypt; Dr. Imke Plischko, Germany; Dr. Beate Moeckesch, Germany; Dr. Horst Gruebmeyer, Germany; Dr. Fatma Mohamed Eldeeb, Saudi Arabia; Dr. Klaus Theiler, Germany; Dr. Alfred Flamm. Germany; Dr. Michael Radenhausen, Switzerland; Dr. Edgar Deinlein, Germany; Dr. Christian Doering, Germany; Dr. Monika Dexheimer, Germany; Dr. Juergen Sprachmann, Germany; Dr. John Curran, United Kingdom; Dr. Kerstin Mirbach, Germany; Dr. Stefan W. Schulze-Minde, Germany; Dr. Goetz Soeder, Germany; Dr. Ulf Hallfeldt, Germany; Dr. Dejan Antonic, Serbia; Dr. Lothar Bosecker, Germany; Dr. Andreas Jesper, Germany; Dr. Karla Schuerer, Germany; Dr. Volker Heiland, Germany; Dr. Karl Laeuger, Germany; Dr. Jan Hundgeburth, Germany; Dr. Alexandra Koenig, Austria; Dr. Hans Neerings, Germany; Dr. Tanja Baumann, Germany; Dr. Linda Ptito, Canada; Dr. Siegfried Kubin, Germany; Dr. Maximilian Richter, Germany; Dr. K. Moessler, Germany; Dr. Alexander Magerl, Germany; Dr. Marcelo Baumueller, Italy; Dr. Birgitt Mertin, Germany; Dr. Virena Feige, Germany; Dr. Sabine Lowies-Skapczyk, Germany; Dr. Roger Elkhoury, Lebanon; Dr. Manfred Krenn, Austria; Dr. K.H. Horak, Germany; Dr. Ernst Lischka, Germany; Dr. Kam Singh, United Kingdom; Dr. Thomas Winter, Germany; Dr. Michael Ressel, Germany; Dr. Khaled Bahgat, Egypt; Dr. Peter Kessler, Germany; Dr. Robert Krueger, Germany; Dr. Elise Norden-Wainig, Austria; Dr. Uta Schlossberger, Germany; Dr. Jimmy Poon, Canada; Dr. T. Valentin-Ljolje, Germany; Dr. Hubert Tannenberg, Germany; Dr. Brunhilde Hackel, Germany; Dr. Sieglinde Lechner-Fuikok, Austria; Dr. Kathrin Friedl, Germany; Dr. Enas Al-Sebai Mohamed El-Feki, Egypt; Oliver Gekeler, MD, Germany; Dr. Jyotindra Shah, USA; Dr. Leon Levy Ezaguy, Israel; Dr. Bernhard Lux, Germany; Prof. Dr. Halis Bulent Tastan, Turkey; Dr. Dieter Roesler, Germany; Dr. Nilgoegen Oezmen, Turkey; Dr. Ulrike Haas, Austria; Dr. Peter Albiez, Germany; Dr. Regina Ewald, Austria; Dr. Gurmander Singh Kohli, USA; Peter Scharff, MD, Germany; Dr. Bruno de Meyere, Belgium; Dr. Oezcam Erdem, Turkey; Dr. Azza Aldosoky, Egypt; Dr. Marco Muggiani, Italy; Dr. Katina Waters, USA; Dr. Dimitra Dasiou-Plakida, Greece; Dr. Kim Short, USA; Dr. Hiroko Sugino, Japan; Dr. Emad El-Din M Samir, Egypt; Dr. Roy Shapiro, USA; Dr. Carlos Aragon-Rivas, Guatemala; Dr. Kim Min, South Korea; Dr. Said Ibrahim, Austria; Carol Cifelli, RN, USA; Dr. Wulf Saur, Germany; Dr. Corneel Vermeersch, Belgium; Dr. Alexander Glaessl, Germany; Dr. Maria Angelo-Khattar, United Arab Emirates; Dr. Gabriele Andrae, Austria; Dr. Ilona Schreiber, Germany; Dr. Gregor Pajaczek, Germany; Dr. Daniela Greiner, Germany; Dr. Claudia van der Lugt, Netherlands; Dr. Ines Verner, Israel; Dr. Elke Benedetto-Reisch, Austria; Dr. Jens Schweitzer, Germany; Dr. Aman Raja, United Kingdom; Dr. Manuel Jorge, Portugal; Dr. Holger Thelen, Germany; Dr. Sanja Toljan, Croatia; Dr. Joachim W. Picht, Germany; Dr. Leith Yahia, Germany; Dr. Paul Cronin, United Kingdom; Dr. Can Cengiz, Turkey; Dr. Patrick Treacy, Ireland; Dr. Dirk Schmitz, Germany; Dr. Rainer Tast, Germany; Dr. Susana Wibisono, Indonesia; Dr. Aziz Denian, Jordan; Dr. Carlos Alessandrini, Mexico; Dr. Brigitte Dams, Switzerland; Dr. Gabriele Dithmayr, Germany; Dr. Ronald Sarbacher, Germany; Dr. Waltraud Einwagner, Austria; Dr. Ayseguel Par, Turkey; Dr. Bernhard Filipcic, Germany; Dr. Peter Renner, Germany; Dr. L.E. Visser, Netherlands; Dr. Johannes Brandstetter, Austria; Dr. Paul Dewhirst, United Kingdom; Dr. Slavica Petrovska, Macedonia; Dr. Veronika von Liebe, Germany; Dr. Michael Wagener, Germany; Dr. Roger Ost, Luxembourg; Dr. Youssef Y. Farid, Egypt; Dr. Krystyna Lubelska, Poland; Dr. Kathrin G. Huppertz, Germany; Heinz Freier, M.Sc., Germany; Dr. Ebrahim Safavisohi, Iran; Dr. Ulrich Janke, Germany; Dr. Tarek Al Areeny, Egypt; Dr. Ingrid B. Riedel, Switzerland; Dr. John Madirazza, Australia; Prof. Dr. Ch. Werner, Germany; Dr. Stephan C. Truedsson, Norway; Dr. Miso Sikman, Slovenia; Dr. Stefan Siemund, Germany; Dr. Amel Barakat, Saudi Arabia; Dr. Sylvia Moeller, Germany; Dr. Martina Heidemann, Germany; Dr. David Jaa, Australia; Dr. Sascha Doerrmann, Switzerland; Dr. Vijay Bhaskar, India; Dr. Ismail Cassim, South Africa; Dr. Lilian Jessurun de Curiel, Mexico; Dr. Marc Nelissen, Belgium; Dr. Christopher Garrett, United Kingdom; Dr. Susanne Geissner, Germany; Dr. Wei-Ta Cheng, Taiwan; Dr. Pawel Surowiak, Poland; Dr. Thierry Marechal, France; Dr. Anne Moga, France; Dr. Susanne Gleissner, Germany; Dr. Gabriele Feller, Germany; Dr. Sherif Zalat, Egypt; Dr. Peter Hajduk, Czech Republic; Dr. Jaska M. Pitkanen, Finland; Dr. Barbara Schwab, Austria; Dr. Udo Juegelt, Germany; Dr. Suzanne Rydzik, Canada; Dr. Christopher Rowland Payne, United Kingdom; Dr. Michele Maneaud-Bayard, France; Dr. Gerhard Tuerk, Germany; Dr. Waleed Gamal Loka, Egypt; Dr. Nina Pannhausen, Germany; Dr. Johannes Mueller-Steinmann, Germany; Dr. Diana Csiskai, Germany; Dr. Roman Chubaty, USA; Dr. Ashraf, Badawi, Egypt; Dr. Amir Atalla, Egypt; Dr. Natalia Reich, Germany;Enclosure

 


 

List of publications

 

• 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: Dermatology 2008; 216: 180-1
• Bechara FG, Skrygan M, Kreuter A, Altmeyer P, et al: Cytokine mRNA levels in human fat tissue after injection lipolysis with phosphatidylcholine and deoxycholate. Arch. Dermatol. 2008; 300: 455-9
• Bechara FG, Sand M, Hoffmann K, Sand D, et al: Fat tissue after lipolysis of lipomas: a histopathological and immunohistochemical study. J. Cutan. Pathol. 2007; 34: 552-7
• Bechara FG, Sand M, Sand D, Rooterdam S, et al: Lipolysis of lipomas in patients with familial multiple lipomatosis: an ultrasonography-controlled trial. J. Cutan. Med. Surg. 2006; 10: 155-9
• Bechara FG, Sand M, Altmeyer P, Hoffmann K: Intralesional lipolysis with phosphatidylcholine for the treatment of lipomas: pilot study. Arch. Dermatol. 2006; 142: 1069-70
• Brown SA: The science of Mesotherapy: chemical anarchy. Aesthet. Surg. J. 2006; 26: 95-8
• Co AC, Abad-Casintahan MF, Espinoza-Thaebtharm A: Submental fat reduction by Mesotherapy using phosphatidylcholine alone vs. phosphatidylcholine and organic silicium: a pilot study. J. Cosm. Dermatol. 2007; 6: 250-7
• 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: Fat reduction using phosphatidylcholine/sodium deoxycholate injections: standard of practice. Aesthetic Plast. Surg. 2008; 32: 858-72
• Duncan DI, Chubaty R: Clinical safety data and standards of practice for injection lipolysis: a retrospective study. Aesthet. Surg. J. 2006; 26: 575-85
• Duncan DI, Hasengschwandtner F: Lipodissolve for subcutaneous fat reduction and skin retraction. Aesthet. Surg. J. 2005; 25: 530-43
• Gupta A, Lobocki C, Singh S, Robertson M, et al: Actions and comparative efficacy of phosphatidylcholine formulation and isolated sodium deoxycholate for different cell types. Aesthetic Plast. Surg. 2009; 33: 346-52
• Hasegawa T, Matsukura T, Ikeda S: Mesotherapy for benign symmetric lipomatosis. Aesthet. Plast. Surg. 2010; 34: 153-6
• 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: Detailed documentation of one lipolysis treatment: blood values, histology, and ultrasound findings. Aesthet. Surg. J. 2007; 27: 204-11
• Hasengschwandtner F: Injection lipolysis for effective reduction of localized fat in place of minor surgical lipoplasty. Aesthet. Surg. J. 2006; 26: 125-30
• Hasengschwandtner F: The subcutaneous injection of phosphatidylcholine for means of lipolysis. Lipodissolve – The non surgical liposculpture. Akt. Dermatol. 2005; 31: 549-52
• Hasengschwandtner F: Phosphatidylcholine treatment to induce lipolysis. J. Cosmet. Dermatol. 2005; 4: 308-13
• Heinrich K-G: Efficacy of injection of phosphatidylcholine into fat deposits – a non-surgical alternative to liposuction in body-contouring. Indian J. Plast. Surg. 2005; 38: 119-22
• Hexsel DM, Serra M, Dal’Forno T, Zechmeister do Prado D: Cosmetic uses of injectable phosphatidylcholine on the face. Otolaryng. Clin. N. Am. 2005; 38: 1119-29
• Hexsel D, Serra M, Mazzuco R, Dal’Forno T et al: Phosphatidylcholine in the treatment of localized fat. J. Drugs Dermatol. 2003; 2: 511-8
• Hunstad JP, De Souza M: Review of “the lipodissolve technique: clinical experience” and author’s comment. Clin. Plast. Surg. 2009; 36: 223-6
• Klein SM, Schreml S, Nerlich M, Prantl L: In vitro studies investigating the effect of subcutaneous phosphatidylcholine injections in the 3T3-L1 adipocyte model: lipolysis or lipid dissolution? Plast. Reconstr. Surg. 2009; 124: 419-27
• Klein SM, Prantl L, Berner A, Schreml S, et al: A new method to quantify the effect after subcutaneous injection of lipolytic substances. Aesthetic Plast. Surg. 2008; 32: 667-72; discussion 673-4
• Kopera D, Binder B, Toplak H, Kerl H, et al: Histopathologic changes after intralesional application of phosphatidylcholine for lipoma reduction – report of a case. Am. J. Dermatopathol. 2006; 28: 331-3
• Kopera D, Binder B, Toplak H: Intralesional lipolysis with phosphatidylcholine for the treatment of lipomas: pilot study. Arch. Dermatol. 2006; 142: 395-6
• 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: Mesotherapy and injection lipolysis. Clin. Plast. Surg. 2009; 36: 181-92
• 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: Phospholipids do not have lipolytic activity. A critical review. J. Cosmet. Laser Ther. 2008; 10: 114-8
• Myers P: The cosmetic use of phosphatidylcholine in the treatment of localized fat deposits. Cosmet. Dermatol. 2006; 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: Treatment of Aging neck with „Lipostabil“ endovena. J. Drugs Dermatol. 2009; 8: 937-9
• Rittes PG: The lipodissolve technique: clinical experience. Clin. Plast. Surg. 2009; 36: 215-21
• Rittes PG: Complications of Lipostabil endovena for treating localized fat deposits. Aesthet. Surg. J. 2007; 27: 146-9
• Rittes PG, Rittes J, Amary MFC: Injection of phosphatidylcholine in fat tissue: experimental study of local action in rabbits. Aesthetic Plast. Surg. 2006; 30: 474-8
• Rittes PG: The use of phosphatidylcholine for correction of localized fat deposits. Aesthetic Plast. Surg. 2003; 27: 315-8
• Rittes PG: The use of phosphatidylcholine for correction of lower lid bulging due to prominent fat pads. Dermatol. Surg. 2001; 27: 391-2
• Rose PT, Morgan M: Histological changes associated with Mesotherapy for fat dissolution. J. Cosmet. Laser Ther. 2005; 7: 17-9
• Rotunda AM: Injectable treatments for adipose tissue: terminology, mechanism, and tissue interaction. Lasers Surg. Med. 2009; 41: 714-20
• Rotunda AM, Weiss SR, Rivkin LS: Randomized double-blind clinical trial of subcutaneously injected deoxycholate versus a phosphatidylcholine-deoxycholate combination for the reduction of submental fat. Dermatol. Surg. 2009; 35: 792-803
• Rotunda, A; Scientific Studies Aim to Dispel Controversy Surrounding Injection Lipolysis, THE European Aesthetic Guide Autumn 2008, 74 – 84
• Rotunda AM, Kolodney MS: Mesotherapy and phosphatidylcholine injections: historical classification and review. Dermatol. Surg. 2006; 32: 465-80
• Rotunda AM, Ablon G, Kolodney MS: Lipomas treated with subcutaneous deoxycholate injections. J. Am. Acad. Dermatol. 2005; 53: 973-8
• Rotunda AM, Suzuki H, Moy RL, Kolodney MS: Detergent effects of sodium deoxycholate are a major feature of an Injectable phosphatidylcholine formulation used for localized fat dissolution. Dermatol. Surg. 2004; 30: 1001-8
• Salles AG, Valler CS, Ferreira MC: Histologic response to injected phosphatidylcholine in fat tissue: experimental study in a new rabbit model. Aesthetic Plast. Surg. 2006; 30: 479-84
• Salti G, Ghersetich I, Tantussi F, Bovani B et al: Phosphatidylcholine and sodium deoxycholate in the treatment of localized fat: a double-blind, randomized study. Dermatol. Surg. 2008; 34: 60-6
• Schuller-Petrovic S, Wölkart G, Höfler G, Neuhold N, et al: Tissue-toxic effects of phosphatidylcholine/deoxycholate after subcutaneous injection for fat dissolution in rats and a human volunteer. Dermatol. Surg. 2008; 34: 529-43
• Steinert M: Injektionslipolyse. DERMAforum, February 2009
• Treacy PJ, Goldberg DJ: Use of phosphatidylcholine for the correction of lower lid bulging due to prominent fad pads. J. Cosmet. Laser Ther. 2006; 8: 129-32
• Uygur F, Evinç R, Duman H: Is phosphatidylcholine harmful to the peripheral neural tissue? An experimental study in rats. Aesthet. J. Surg. 2008; 28: 663-7
• Young VL: Lipostabil: the effect of phosphatidylcholine on subcutaneous fat. Aesthet. Surg. J. 2003; 23: 413-7


 

News

ASPS study: Just Paper Waste?

US patients choose non-surgical options during recession
In contrary to the publication of the last ASPS study (see Lipolysis-News July 15, 2008) it seems to be a fact that the recession will touch aesthetic teatments, not only in US. Injection-Lipolysis should be an alternative offer for those patients who don’t want to undergo surgical procedures during this recession times.

The following commentary was written by Eve Oxberry for the Aesthetic Medicine Newsletter:

The impending recession is causing more US consumers to delay plastic surgery and consider non-surgical options, according to the latest consumer survey carried out by the American Society of Plastic Surgeons (ASPS).

The association polled 100 women who were considering plastic surgery in March and then again in October and found that 59% said recent changes in the economy have had an impact on their plans for plastic surgery, compared with 50% in March. Also, 48%, of women surveyed during October said that the economic slowdown had made them less likely to book a consultation with a cosmetic surgeon, a marked increase of 18% since March, when 30% felt that way.

Possibly the most significant result for the aesthetic medicine industry, however, is that 27% said they were considering less expensive options, compared with 20% earlier in the year.
Richard D’Amico, ASPS president, commented, “It appears more consumers are choosing the less invasive cosmetic procedures, both to give them a boost or to buy time if they need to postpone a more costly invasive surgical procedure because of the economic downturn.”

In a concurrent survey among its surgeon members, ASPS discovered that while 62% reported a decrease in plastic surgery proceduresperformed, some 73% reported an increased or stable demand for procedures such as botulinum toxin, chemical peels and dermal fillers.

“It is very clear the economy is affecting the demand for surgical cosmetic procedures. We are hearing that from consumers and plastic surgeons,” said Dr D’Amico. “There is good news here regarding the cosmetic medicine aspect of our members’ practices. And while ASPS member surgeons are feeling the impact of the economy, we anticipate the historic bounce when patients return as the economy improves.”

30.10.08 16:37

 


 

FDA approves Botulinumtoxin (Botox / Allergan) for Headache Prophylaxis in Chronic Migraine

Again the indication list of Botulinumtoxin A has been increased….

The very powerful neuro toxin Botulinumtoxin A has found its way into the public by its use in Aesthetic Medicine to treat all kind of folds. The first approval by the FDA 21 years ago was for blepharospasm. Later followed the glabella folds and severe underarm sweatings called hyperhidrosis.

Today the FDA approved it for the prophylaxis of chronic migraine. The approval for chronic migraine was based on results of the phase 3 Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) program, which was made up of 2 double-blind, placebo-controlled clinical trials that included 1384 adults from 122 centers in North America and Europe, a statement from Allergan notes.

The study showed that the number of days respectively hours in patients suffering from migraine has been significantly reduced. 2 % of the treated patients had side effect and adverse reactions against the material.

Source: Medscape Medical News
Author: Susan Jeffrey

 


 

Open letter from the Medical & Scientific Advisory Board, the Board of Representatives, the Board of Trainers of the Lipolysis NETWORK and the Directorial Board of the ISL – International Society of Lipolysis Therapy – on the situation in the UK.

Published in the February issue of Aesthetic Medicine.

What has been happening over the last two years in the UK can be considered from an international standpoint as simply bewildering, a deliberate misinformation campaign, or serious interference in the fundamental freedoms of the medical profession. It depends on the perspective from which the activities of institutions and the media are viewed, as far as injection lipolysis is concerned.

Our British colleagues’ attempts to counter denunciation and polemics with scientific facts are particularly to be admired. Many thanks to the entire NETWORK for their courage and support.

We’d like to contribute some important and highly relevant information on this subject:

* Off-label use of a drug is a medically and ethically justifiable form of treatment, common in other fields of medicine, as well as in aesthetic medicine. The use of drugs at the practitioner’s discretion and on their responsibility is particularly widespread in the UK, even in paediatric medicine. Practitioners concerned must, however, inform the patient comprehensively and objectively of all the risks involved, including those that are highly unlikely. The practitioner must also be medically and scientifically convinced that the treatment chosen will not do the patient any harm. Our British colleagues’ statistics are one of the bases on which this is decided. The Lipolysis Network has a database of a current approximately 60,000 treatments administered by professional medical practitioners applying our protocols and the standards prescribed by our Medical Advisory Board. Our Treatment Failures Research Group has, to date, documented just four cases of improper treatment. Two of them involved injection into scarred tissue with poor blood circulation previously subjected to liposuction. One was a case in which an abscess resulted from lack of sterility and one of excessively deep injection causing temporary side effects. No other such cases are known. All four cases mentioned have nothing to do with the treatment as such but with individual errors made by individual doctors. Due to none of these circumstances can we therefore advise against this treatment.

* From our standpoint it is part of every doctor’s duty of care to advise patients of ALL the treatment alternatives for their specific problem or condition. Advising a patient that liposuction is the sole remedy for fat is now, professionally, simply not acceptable. This form of treatment, although in expert hands generally very safe, does involve some serious risks and has been known to cause cases of death, injuries and deformations but is accepted without adverse comment, although treatment with phosphatidylcholine has been subjected to restrictions or even completely forbidden. To our point of view this is not justified. It is justified only by claiming that the producer of Lipostabil N includes the information in their accompanying literature that it is not suitable for subcutaneous administration. Our research has revealed that the producer is obliged to print this warning for legal reasons regardless of its veracity. It does not mean that subcutaneous administration would result in any harm to human health. If the competent authorities in the UK had informed themselves of the legal situation in Germany they would be well aware of this. These justifications might have been used to restrict doctors’ independent professional decisions and to ban a form of treatment that we believe is a preferable alternative, and in the better interests of patients, in some cases, to liposuction. In our view the patient should always have the right to decide the form of treatment to be used in their specific case.

* This kind of scientifically untenable intervention on the part of the State is incomprehensible when viewed from an international perspective. However, we do not find the situation in the UK merely perplexing. The actions of the competent authorities have led to most medical practitioners administering this form of treatment having their insurance coverage abruptly and non-negotiably withdrawn by all available UK medical indemnity providers. Following this, our network needed eighteen months to obtain Europe-wide cover for its members. That cover includes our UK members if they adhere to our protocols and have undergone specialised training by our trainers. However, we are now concerned that the authorities may continue to take other unreasonable measures to try to restrict professional independence and try to block this treatment.

* The expert doctors in the Lipolysis Network are dedicated to achieving exact clarity regarding the effects, side effects and possible alternatives to this treatment. Their membership dues are, in part, now being used to fund groundbreaking research at the University of Regensburg, the full results of which will be available in eighteen months time, at the latest. Further studies and research are being undertaken at the following universities: Bochum (lipomas), Cairo (cellulite) and Rome (‘buffalo hump’ in HIV patients). This research by our members has the goal of further clarifying the potential and the limitations of this new form of treatment. It is already known that toxicity cannot occur, as research on this was required before the drug was authorised for use. Last year, there were a total of twelve publications on injection lipolysis in internationally respected, peer-reviewed, medical journals, two of them by British colleagues. Mr. Ninian Peckitt, FRCS, FFD, RCS, FDS, RCS, a member of our Scientific Advisory Board, has written a book containing his detailed hypothesis on how injection lipolysis works. The longer the British authorities maintain their absolute opposition, the more untenable they are making their position appear internationally. We therefore believe it essential that both the MHRA and the GMC look in detail at all the currently available data and information, in the international medical community, and carry out an informed review of their opinions regarding injection lipolysis as a matter of urgency. We are open for any kind of exchange.

* The type of campaign we have seen, that includes the police searching the practices of professional medical practitioners, in order to intimidate or attemt to incriminate them, is alien to international medical colleagues . Denunciation of disliked colleagues for competitive reasons is encouraged by such actions, despite the denounced having behaved correctly, in our view, both professionally and ethically. Every country naturally has its own laws but whether these police actions comply with current European law, in our view, needs investigation.

* Disregard for European law by UK institutions seems to have been occuring in the case of injection lipolysis. What’s all behind that? According to the International Apotheke Hamburg they are permitted under EU law to export any drug approved in any EU country – such as Lipostabil – to any prescription chemist in any other EU country. What it is used for is irrelevant. The MHRA ban on such imports for prescription chemists would therefore seem to be a breach of EU law. The question is to what extent our British colleagues are prepared to put up with such seemingly unreasonable and possibly unlawful restrictions and when they will defend their professional freedoms? If the UK authorities continue to act as they have done so far, then at some point the patience of our British colleagues will surely snap. This is particularly the case here, as fundamental rights are at risk, and the question of whether injection lipolysis is to serve as a precedent for the future restriction of professional liberties must, in our view, be challenged.

* We have heard that UK journalists have been acting to denounce individual doctors. This seems to us a reversion to behaviour long since consigned to uncivilised times of the past. We welcome open discussion – dissident opinions might after all be of value to us – and are not opposed to public polemics. However, if doctors are to be unlaterally ‘investigated’ by journalists without any specialised knowledge, and then publicly pilloried and defamed, this seems to us to go beyond the boundaries of any ethical behaviour and we can only express our disgust towards it. British society will have to tolerate being asked whether it wishes to surrender its liberties in this way. This seems to us incredible in view of the UK’s long democratic traditions. It should, in our view, be prevented – especially in the medical field. Governmental interference seems to us to have no place in the doctor-patient relationship.
We’d like to state our views on the legality of the treatment in the UK.

A doctor may inform the general public of the potential of body shaping or fat reduction, although doctors should fully respect the MHRA’s warning that, in their opinion, advertising and promotion of injections to reduce fat is unlawful. During a consultation, a doctor has an ethical duty to inform his or her patients of all available treatment alternatives – including injection lipolysis. This includes those practitioners who offer only cosmetic surgery. The doctor must always inform the patient comprehensively of all possible risks and side effects of all treatments to be considered, so that the patient can come to their own conclusions. Ethical practitioners may not influence those conclusions but must stick to comprehensive information alone. Every doctor has the right to issue a patient a personal prescription for Lipostabil. Every patient has the right to order such a drug, provided it is approved in any EU country, from a prescription chemist in another EU country and to import it. Every doctor has the right, if a patient so requests, to administer this drug to the patient subcutaneously provided the doctor is certain this will not harm the patient and that the drug used is appropriate for the symptoms presented.

Medizinalrat Dr. Franz Hasengschwandtner , Austria Medical and Scientific Director NETWORK-Lipolysis Chairman of ISL
Dr. Diane Duncan, USA, Scientific Advisory Board NETWORK-Lipolysis
Bernhard Bieniek, MD, Germany, Medical Advisory Board NETWORK-Lipolysis
Dr. Horst Grübmeyer, Germany, Medical Advisory Board NETWORK-Lipolysis
Claus-Peter Meissner, MD, Germany, Medical Advisory Board NETWORK-Lipolysis
Dr. Patricia Ogilvie, Germany, Medical Advisory Board NETWORK-Lipolysis
Dr. Georg Popp, Germany, Medical Advisory Board NETWORK-Lipolysis
Dr. Eva Wegrostek, Austria, Medical Advisory Board NETWORK-Lipolysis
Dr. Claudia van der Lugt, Netherlands, Medical Advisory Board NETWORK-Lipolysis, Directorial Board ISL
Dr. Lucy Glancey, United Kingdom, Medical Advisory Board NETWORK-Lipolysis
Dr. Patrick Treacy, Ireland, Medical Advisory Board NETWORK-Lipolysis
Dr. Swapan Chowdhury, Australia, National Representative NETWORK-Lipolysis
Dr. Michael Zacharia, Australia, National Representative NETWORK-Lipolysis
Prof. Nor El-Din, Egypt, National Representative NETWORK-Lipolysis
Dr. Marc Nelissen, Belgium, National Representative NETWORK-Lipolysis
Dr. Rodrigo Sierra, Chile, National Representative NETWORK-Lipolysis
Dr. Bernhard Lux, Germany, National Representative NETWORK-Lipolysis
Dr. Jaako Pitkanen, Finland, National Representative NETWORK-Lipolysis
Dr. Thierry Marechal, France, National Representative NETWORK-Lipolysis
Dr. Konstantinos Gritzalas, Greece, National Representative NETWORK-Lipolysis
Dr. Spyridon Ioannides, Greece, National Representative NETWORK-Lipolysis,Directorial Board ISL
Dr. Mark Palmer, United Kingdom, National Representative NETWORK-Lipolysis
Dr. Kam Singh, United Kingdom, National Representative NETWORK-Lipolysis
Dr. Ghaus Jilani, United Kingdom, National Representative NETWORK-Lipolysis
Prof. Roy de Vita, Italy, National Representative NETWORK-Lipolysis, Directorial Board ISL
Dr. Roberto Zunica, Italy, National Representative NETWORK-Lipolysis
Dr. Hiroko Sugino, Japan, National Representative NETWORK-Lipolysis
Dr. Sinisa Glumicic, Croatia, National Representative NETWORK-Lipolysis
Dr. Roger Elkhoury, Libanon, National Representative NETWORK-Lipolysis
Dr. Hans-Nielsen Hauge, Norway, National Representative NETWORK-Lipolysis
Dr. Doris Grablowitz, Austria, National Representative NETWORK-Lipolysis
Dr. Sylvia Orasche, Austria, National Representative NETWORK-Lipolysis
Dr. Eva Kärnsby, Sweden, National Representative NETWORK-Lipolysis
Dr. Roland Voëlin, Switzerland, National Representative NETWORK-Lipolysis
Dr. Jim Wong, Singapore, National Representative NETWORK-Lipolysis
Dr. Justin Hao, Taiwan, National Representative NETWORK-Lipolysis
Dr. Setthakarn Attakonpan, Thailand, National Representative NETWORK-Lipolysis, Directorial Board ISL
Dr. Ercin Özüntürk, Turkey, National Representative NETWORK-Lipolysis, Directorial Board ISL
Dr. Maria Angelo-Khattar, Dubai, National Representative NETWORK-Lipolysis
Prof. Dr. Harryono Judodihardjo, United Kingdom, Directorial Board ISL
P.D. Dr. med. Thomas J. Galla, Germany, Directorial Board ISL

 


 

US-Study: Huge Escalation for Aesthetic Treatments Forecasted

“The NETWORK is strategically good orientated”, commentary from NETWORK
Speaker Dirk Brandl

 

Next to the facts: The study with the title “Economic Analysis of the Future Growth of Cosmetic Surgery Procedures”, was published in the June issue of Plastic and Reconstructive Surgery magazine by Tom S. Liu und Timothy Miller.
The study props on the yearly statistical figures published by the ASPS (American Society of Plastic Surgeons) from 1992 to 2005.

The result: the number of all aesthetical treatments will quadruple by 2015. The authors come to the conclusion that other variables like economic development will have no effect on the result. Another conclusion of the study is: Minimal invasive und non invasive treatments are graining ground where operative practices are declining in comparison to minimal invasive therapy options.

As a born sceptic I would like to face the already intoned jubilations from the president of the ASPS, Richard D’Amico with common sense and detailed view.

 

1. I agree that for a lot of people their appearance is becoming very important then the individual is becoming a commodity and that their appearance has becoming an important economical factor in our capitalistic developed states. That even more people value their appearance is a sign of intuitive realization and reflection to this development.

 

2. The statistics show: we are getting older (in the industrial countries) and the population is increasing (in developing countries). The relative new Anti Aging field has its right. Equally entitled is aesthetical medicine that offers an important contribution, so that elder people have the ability to feel attractive and their well being and appearance can be changed. It goes too far to claim that aesthetical medicine is a branch of Anti Aging. These older people who are mentally fit, purse sports sometimes daringly, who enjoy life have the right to entitlement to aesthetical medicine and therefore pose a growing market.

 

3. Our members for a number of years have formulated that a rethink has had to happen because more patients prefer gentle form of aesthetical treatment. Operative practices are declining. The changes in the priorities were long foreseeable. Our members have experienced that patients have been treated with Injection-Lipolysis because Liposuction does not come in question. I believe that a good executed operation must not involve a high risk. Anaesthesia has developed better methods of narcosis and has reduced the risks. The emphasis is on a well executed operation independent of the medical field. Patients want indulgent treatments and doctors who have adjusted to this trend will successfully treat these patients and the example is our members who have developed and qualified.

 

4. The emerging changes are not considered sufficiently during qualification. There are next to no universities for minimal invasive treatment- the Dermatology primes in some countries a laudable exception – and the preparation and anchorage of standard treatment protocols are neglected. Every working aesthetical physician knows of these coherencies and when societies endeavour for changes and consensus conferences have recently taken place. However we are still a long way away from world wide acknowledged standards and independent qualifications. The firms and product orientated qualification through single devices and product manufacturers (Filler, Meso, Botulinumtoxin A, Laser, Peelings, etc) should be criticised and those who offer firm and product independent qualification such as those who sponsor our Globalhealth Academy should be praised. As always on our agenda is: The development of worldwide treatment standards and qualification according to the national conditions (the number of offered Fillers varies in Europe and the USA because of the differences in admission requirements vary). One thing can be certified: while the aesthetical market expands more physicians from other fields will offer aesthetical treatments the rising demands will be followed by numerical offer.

 

5. The statistical calculations should not block the view because the situation can change as prognosis. Keep an eye on the economical development. I believe a lot of factors could change this prognosis and that the global economy will play a critical role. The analysis in my eyes goes forward in a mechanistically approach. Network thinking and theory generation of the complex systems should motivate a different point of view that is sceptical. When we take our perceptions to the chaos theory seriously we should take into consideration that the smallest changes in linked networks can have aggravating effects (Butterfly Effect) and can influence the network structures. In the Network we have the development in our our hands and can influence it because we have recognised the immense possibilities which slumber in synergy education and cooperation, treasures that are there for the taking so we can take on the development contentedly.

 

Those of you who reconcile my elementary analysis should think about – together with us – how we can influence the future challenges in the world wide cooperation and solidarity and what necessary steps we need to take. We will continue the way which we have developed for our Network: worldwide protocols and objective training, independent training free from sponsorship interests, development of this therapy with many members without competitive thinking.
When capitalism at economic level forces us to be competitive, then synergetic thinking and acting is the right answer. Welcome to the Network.


 

Liposuction without surgery?
European methods deemed the largest discovery in aesthetic medicine since Botox.

From the American Society for Aesthetic Surgery

 

It is the American Society for Aesthetic Plastic Surgery’s position that, currently, lipoplasty or liposuction is the only proven method of fat deposits.

Recently, however, there have been articles in popular consumer magazines and in major news channels describing the method of nonsurgical lipoplasty through two methods called lipodissolve and mesotherapy.

Just then we’d gotten used to the idea of Botox, along comes a new trendy injectable. Beauty junkies and their doctors are buzzing about lipodissolve and mesotherapy, when a cocktail of substances are used in multiple small superficial injections for body contouring.

“We started using it under the eyes” said Dr. Soren White, medical director at Skinclinic, the Upper East Side medispa in New York. “Now we use it for hips and love handles.”

“Lipodissolve,” as dermatologist Steven Victor calls it, “is meant for small medium areas of body fat.

“In France, the method of mesotherapy is applied for body-fat reduction while the patient is allowed to continue his or her binge favourite fatty foods. Obviously a suggestion that is not popularly imitated in this country where physicians use mesotherapy in conjunction with diet and exercise.

“Only topical anesthesia is required and bruising lasts just a few days. The formulas used in lipodissolve and mesotherapy are manufactured in the United States and are approved by the Food and Drug Administration, although the procedure requires they be used off-label.

“Licensed physicians may legally offer treatments involving off-label uses of many pharmacologic substances have been approved by the FDA for other uses, and there is no specific prohibition of the intended off-label use.”

Claims and European clinical research state that can dissolve fat without the need for surgical intervention. Some doctors are holding off. “We want more data,” Alan Matarasso, a plastic surgeon, said. Two to five sessions are generally recommended, at about 300 Dollars for upper arms and facial procedures and 350 to 550 Dollars each for abdomen with some clinics in Beverly Hills charging double.

“With lipo, you remove fat cells permanently.” Howard Sobel, a dermatologist said, “With these shots, we don’t know if it will come back.”

But Sobel an Matarasso may see wishes fulfilled sooner than they had conceived. A European research team led by Austrian physician Dr. Franz Hasengschwandtner claims to have the clinical results to put to rest many doubts.

That evidence will be demonstrated for the first time in this country at a convention setup for medical professionals.

The meeting will include representations from the world-renowned Dr. Patricia Rittes, clinic research director Dr. Hasengschwandtner and Paris’s expert on aesthetic mesotherapy, Dr. Alain Lejeunie.

Hasengschwandtner’s collected data not only claims that the procedures of lipodissolve are safer than nearly all aesthetic procedures, but the results are surprising, permanent and natural looking.

15/12 2005
Your Body, Mind & Soul
December, 2005

 


 

New European Lipodissolve Therapy Replaces Surgical Lipoplasty Procedures

A representative for the American Society of Aesthetic Lipodissolve state, “Lipodissolve is the most effective therapy for reduction of localized fat without surgery known so far.”

London, UK (PRWEB) July 28, 2005 — Lipodissolve, or Lipolysis as it is known in Europe, is a concept which allows physicians to inject mild substances direct into fat to initiate a process when the fat is dissolved from the fat cells without damaging the cells and without any need of surgery. This therapy was initially developed by Italian physicians to reduce cholesterol deposits of the eyelids (Xanthelasma). The idea was later introduced at the 5th International Meeting of Mesotherapy in1988. In 2001 Dr Franz Hasengschwandtner began developing the, then slow, therapy further and made it into an effective therapy aimed to replace select cases of surgical lipoplasty. Dr Hasengschwandtner is the foremost specialist on Lipodissolve today and give presentations and seminars to plastic surgeons world-wide.

The therapy, known as Lipodissolve in English, has undergone tremendous improvements since its initial introduction to the medical community in the 1980’s. “Lipodissolve has improved so much from our trials and studies in Europe that now, many patients get final results even after one single session,” says ASAL’s research director, Dr. Hasengschwandtner, “Previously the same therapy would require anywhere from 8-20 visits.”

The therapy can reduce localized fat on nearly any procedure, often only addressed by surgery. The results on facial procedures in particular are exceptional, and many of Dr Hasengschwandtner’s patients have a drastic improvement from this mild and simple therapy, taking years off the face and rejuvenating the skin and complexion. “In combination with a total makeover, alternated with Botox and Restylane, Lipodissolve can perform wonders without the risks, costs or discomforts of surgery.”

Within the European medical community, Lipodissolve has been hailed as the “most exceptional discovery in cosmetic medicine since Botox.”

 


 

BACKGROUND

The Dispute about Flabjab Injection:
Much Clamour, Still Only a Few Facts and Dubious Self-Treatments
by Swanett Koops

 

To come to the point at once: as a matter of fact, flabjab injections dissolving undesired fat deposits in the face, at the belly or legs has not been officially approved. It seems, however, that this does not bother the users. An off-lable use is, of course, nothing new – what’s more important is that this injection fulfills an ardently longed for dream of mankind that has (up to now) been unfulfilled. Instead of all this torture with diets and sports the fat is simply injected away. It is said that this is possible with Lipostabil® containing phosphatidylcholine won from the soy bean and approved for intravenous therapy of fat embolisms.

In 1995, the Brazilian physician Dr. Patricia Rittes, however, had the idea that the medica-ment is able to do even more: the intravenous fat dissolving substance could also have an ef-fect under the skin, exactly there where fat is disturbing much more often than in the artery or vein.

Network-Lipolysis wants to approach the issue scientifically

Meanwhile, the fat-away injection enjoys great popularity in the whole world rather than only in Brazil. In Europe, it is above all the Austrian Medizinalrat (senior medical officer) Dr. Franz Hasengschwandtner, general practitioner, Kneipp-physician and graduated expert for nutrition, who gathers many active fat-dissolving colleagues round himself who joined up in Network-Lipolysis (www.netzwerk-lipolyse.de).

According to its own statements, Network-Lipolysis wants to approach the issue of lipodis-solve injections soberly and seriously. Here, Dr. Hasengschwandtner also published the Lipolysis Report 03 where the treatments of 187 patients are documented. His assessment: “ In any case, I can confirm the method’s effectiveness”.

Exactly this, however, is one of the most important controversial questions: neither effective-ness nor tolerance of flabjab injections have up to now been evidenced scientifically to a suf-ficient degree. “As long as no standardized studies inclusive of monitoring have been con-ducted a responsibility for the therapy cannot be accepted according to today’s standards”, this is what Dr. Gerhard Sattler, head physician of the Rosenpark-Clinic in Darmstadt be-lieves. “It’s totally unclarified what happens under the skin after the injection!”, criticizes Dr. Klaus Exner, instructor and President of the Association of German Plastic Surgeons (VDPC) and head physician of the plastic surgery department at the Markus Hospital in Frank-furt/Main.

According to the opinion of the critics, it is true that some fatty tissue disappears after the application – the costs for one injection amount to approx. 300 Euros – and that the skin thightens. But first of all, animal studies were necessary in order to prove that the injection is harmless. Furthermore, the plastic surgeon does not believe in the necessary effectiveness: “At the belly and tigh, this is nonsense anyway because it’s almost nothing what can be elimi-nated there.”

The outcome of a study conducted by Prof. Johannes Huber of the University Women’s Clinic of Vienna and Prof. Sylvia Kirchengast, anthropologist at the University of Vienna, however, supposes something else. During Huber’s study – according to his own statements his first one – the effect of the injection was scientifically investigated, namely by means of DXA (dual-X-ray absorptiometry)-measurements of the reduction of body fat, and with more than 70 per-cent of 60 treated women a reduction of the body fat portion in the treated region of one or more percentage points was measured. With some women, the fat portion decreased by more than eight percent. And Sattler, too, who also made some smaller treatments – “otherwise I could not make any statement in this respect” – could record positive results.

Who wants to be beautiful has to suffer – and this also applies to the Study of Vienna. Accord-ing to Kirchengast, skin reddenings, bruisings and slight sensations of pressure were recorded. With almost all women, however, the symptoms disappeared after two days. It seems, how-ever, as if not everyone gets off so lightly – but this can, of course, also be due to inproper applications.

Sattler, for instance, talks about reports about skin necrosis if the substance is injected too close under the skin. And the physician Dr. Mitra Hegge had to close her doctor’s office for one week after a self-treatment because she was heavily deformed due to swollen lower eye-lids after injections into her tear sacs – the region where Rittes made her first injection at-tempts (Der Deutsche Dermatologe 4, 2004, p. 278).

 

Criticism with respect to the injection above all comes from plastic surgeons

Huber comments this uncheering result and says that he would not use the medicament in such sensitive regions like the face. He supposes that the heavy criticism that above all comes from plastic surgeons is caused by the fear that the liposuction clientele could fade away.

Disputes or not – flabjab injections seem to experience a boom. On the one hand, there are already some colleagues in Germany who accept treatments: the physicians’ list of Network-Lipolysis alone contains more than 50 names. But it is also before the mirrors in the bathroom at home where phosphatidylcholine is injected into the fat without any participation of doctors and obviously in a completely carefree manner. Citation in a www forum: “Hi girls, who wants to purchase a package Lipostabil® 5×5 ml inclusive of syringes and cannulas at a low price? In a fit of enthusiasm, I have purchased too much of it and now, there is one package left. Give notice please! My self-treatment was quite successful and the result is o.k. Best re-gards, Gerhild.” And another interested woman wants to know: “How much do I have to in-ject per treatment and body region? I just need to know how much I have to order.”

 

Pharmaceutic Company dissociates itself from cosmetic application

It continues to be exciting how things concerning flabjab injections will go on. According to the statements of Dr. Christian Nauert, employee of the competent pharmaceutic company Casella-med, the company is dissociating itself from the application of the medicament in the cosmetic field. In the product information sheet it is explicitly pointed out that phosphatidyl-choline must not be applied subcutaneously. Sattler, however, sees an happy-end for the flab-jab injection, and this in spite of all criticism. “Lipostabil® will become great. It will rate high like Botox®.


 

CONCLUSION

 

Since a female doctor from Brazil has used the substance phosphatidylcholine to eliminate tear sacs for the first time in 1995 although it is only approved for the dissolution of fat embo-lisms a hot discussion about flabjab injections has broken out. The critics complain that nei-ther effectiveness nor tolerance have been proven. The advocates, on the other hand, regard the flabjab injection as an effective and cost-advantageous option to eliminate disturbing fat deposits. The users – in most cases women – also acquire the substance from the www and inject it themselves.


 

COMMENTARY

Flabjab Dispute Lags Behind Reality
by Swanett Koops


Reality has overtaken discussions: while physicians and scientists are quarreling about sense and nonsense of flabjab injections women purchase the freely available medicament Liposta-bil® in the www and inject the substance under their skin themselves.
Completely carefree or desparately looking at one single aim: as simple as never before on the way to the dream figure. And this although it does not take much phantasy to imagine conse-quences like infections and necroses which can be triggered by the fat dissolving agent if in-jections into the fatty tissue are made improperly.
The boom of the flabjab injections can no longer be stopped. For this reason, colleagues should concentrate their efforts to make a scientific approach to the issue of lipodissolve rather than quarreling. Now, the physicians of the University Clinic of Vienna made a first step with their study.
The therapy either proves its value in future during further studies or it establishes itself to a degree that it is no longer used in the bathroom at home but in the offices of trained doctors. Otherwise, an insufficient effect, a bad tolerance and dangerous side-effects must be made public to a degree that users voluntarily no longer want to apply flabjab injections.

 


 

Temporary Injunction obtained against Association of Plastic Surgeons

Verden – For months now, the associations of plastic surgeons have disseminated untrue facts about the new treatment method associated with the “flabjab-injection”, and now massive consequences are threatening for “GDÄPC” and “VDPC” if these associations and their members continue to spread such information. By means of a temporary injunction and under penalty of an administrative fine of € 250,000, the District Court of Verden has now prohib-ited the associations from repeating all these complaints disseminated up to now via press releases and in interviews.

Again and again, the associations concerned reported about massive side-effects connected with the flabjab injection towards representatives of the media, for instance about dents, cysts or even harm to the inherited material. Instead, liposuction was praised as the only riskless and appropriate possibility to eliminate fat. Up to now, however, the responsible persons failed to offer the media precise evidences supporting these statements – not only that no in-jured patient could be found, what is more: the medical literature does not include any report about the above-mentioned side-effects. On the contrary – the general reliability of the applied substance that is also used by health practitioners has been scientifically supported for several times. Medical examinations carried out with 500 patients did not reveal any harm or injury. As a matter of fact, the treatment method existing for almost ten years now turned out to be a gentle method with positive effects experienced by some thousands of patients, also in Ger-many.

As one of the most experienced users in Germany, Dr. Gunther Steitz, general practitioner, obtained the temporary injunction in order to stop the purposive creation of insecurity among the public by the plastic surgeons and to return to a balanced and serious discussion about the topic in question. In this connection, Dr. Steitz asks all media to gain an own objective and thorough impression of the injection’s mode of action, to gather the publicly available infor-mation about the active substance and to request evidences supporting the negative statements of the plastic surgeons. In this connection, he also draws the attention to an independent study of the University Clinic of Vienna which will offer additional objective scientific results about the new treatment method in a few weeks.

District Court Puts an End to Untrue Statements about the New Flabjab Injection
April 27, 2004

 


 

“Scientific Evaluation of Lipodissolve Injections”

(Flabjab Injection according to Dr. Steitz)

Orientation of the study in terms of contents:

Densiometry is a recognized method to diagnose the risk of osteoporosis. According to the same principle, the proportion of muscle and fat tissue can be documented for each body re-gion. Thus, the dexa-deniometrical measurement is the “most expensive” weighing device of the world. The University Clinic of Vienna owns such a device; it does not only display the mineral content of the bone to an objective degree but also the fat-muscle distribution. By means of this device, 50 patients are subjected to a dexa-measurement prior to the lecithin injection (flabjab injection) as well as after the third lecithin injection. If it can be assumed that the injected lecithin stimulates the “reverse transportation” of fatty acid and cholesterol to the liver an objective assessment of the therapeutic effect is possible on the basis of these measurements.

At the same time, the male hormones are being determined because they form a precondition for lipolysis. This factor is likely to get a special role in future because it can be proceeded from the assumption that a lecithin injection has the desired success if the androgen hormone situation is in good order.

Comment

on the press release of the German Association of Aesthetic-Plastic Surgery, registered association (DGÄPC), of January of 2004 and on similar statements of other representatives of interests of plastic surgeons.
Dr. Gunther Steitz, March 16, 2004
Claim 1: The fat-dissolving active substance of the so-called “flabjab injection”is called phosphatidylcholine. Said substance has been used for many years to reduce an increased cholesterol level.
Phosphatidylcholine is not only used for cholesterol disorder. It also proved to be an effective substance against arteriosclerosis, high blood pressure, liver problems, dementia as well as multiple sclerosis. The phospholides form a part of each cell membrane. The substance has been successfully used for many years without any side-effects within a wide medical spectrum – from the general practitioner via surgeons to health practitioners.

Claim 2: In Germany, the active substance has not been officially approved for dissolving greater quantities of fat tissue. Anyway, the treatment may only be carried out on the basis of a special informed consent to be given by the patient.
As a matter of fact, the pure active substance cannot be “approved” in this connection. It is rather the medicament Lipostabil that has been approved in Germany for many years now. As far as the special use as “flabjab injection” is concerned the approval of this recent treatment method still has to be obtained for Germany. For this reason, we have to do it with an “off-label use” here. This means that an increased quantity of information must be given by the treating doctor. This off-label use is a usual procedure in the whole world. We are already familiar with such a procedure because of the injections with Botox, an anti-wrinkle agent not yet approved for cosmetic purposes in Germany. This original neurotoxin has been used by the DGÄPC members – always provided that the respective patient explicitly gives his or her written consent – for thousands of times and the non-approval has never been regarded as an obstacle.

Claim 3: Side-effects, dosage and tolerance of the “flabjab injection” have not yet been investigated to a sufficient degree. The active substance as “fat dissolving agent” is just being tested for less serious cases.
Since 1995, the “flabjab injection” has been used with more than 15,000 patients in the whole world, and up to date, the medical literature as a whole does not include a single case of side-effects going beyond a sensation of burning, reddenings or slight swellings in the injection area. Dr. Rittes, the inventor, also published a patient study about effectiveness and tolerance in the technical magazine Aesthetic Plastic Surgery which was already known to the public but ignored by the German associations of plastic surgeons. About 500 patients had been observed for more than four years – the problems suggested by the interest groups did not occur in any one case. Apart from that, the University of Vienna is conducting a scientific study about the method and mode of action. Said study began in February of 2004. For more information about studies as well as detailed reports about self-treatments made by the treating doctors please have a look at www.fett-wegspritze.de.

Claim 4: The “flabjab injection” does not represent an alternative to liposuction.
The “flabjab injection” cannot be compared with the liposuction method; it rather represents a new and gentle possibility to have disturbing fat deposits eliminated – and all this without any side-effects. On the other hand, an article in the Medical Tribune of Febr. 13, 2004 reports about the massive risks connected with liposuction. According to current investigations of the University of Bochum, twelve persons died after liposuction only in the period from 1998 to 2002. In more than 40 further cases, severe complications occurred, and the scientists experienced numerous cases of effects at the belly wall, thrombosis etc. Even if the treatments were faultless the method of subcutaneous liposuction represents a much higher burden for the organism than lipodissolve injections do it. This fact illuminates the intention of the associations to protect their “market” against soft and more gentle methods than liposuction when they do all this public relations work – at the expense of their patients’ health. Always remember: with respect to the application of the “flabjab injection” no evidence of lasting side-effects has been published in the medical literature of the world since 1995; the medicament has been used for years now with success and without any side-effects in form of intravenous interventions as well as in medical science (mesotherapy). Independent studies already proved that the substance does not have any toxic effect in the body and does not trigger any mutagenic effects.

Claim 5: The active substance decomposes the fat in the course of a chemical reaction. In contrast to liposuction, the decomposed fat remains in the body and has to be catabolized. In case of greater quantities, the body is not able to transport the “waste” away sufficiently. This may result in bad inflammations and cyst formations, and in these cases, a surgical intervention exceeding the degree of liposuction becomes necessary.
As already stated in claim 3, more than 15,000 patients have been treated with the flabjab injection in the whole world during the past nine years. Among plastic surgeons, it is again and again alleged that these injections trigger “deformations”, “cysts” or “bad inflammations”. This statement is not correct. The associations and surgeons fail to produce the corresponding evidences to the media or the treating doctors. Currently, some doctors investigate the legal possibilities to pursue such statements representing a harm for the image of the treating doctors.

Claim 6: The physician is not able to control the fat dissolution by injections because he cannot assess the individually appropriate dosage. The deposited fat differs from human being to human being and even from body part to body part. Each person reacts differently on the substance.
For this reason, the treatment may leave ugly holes or nods only after the injection of small quantities.
Within the past nine months, about 2,000 patients have been advised informed and – in most cases – also treated by the team around Dr. Gunther Steitz in Germany. In none of these cases any lasting side-effects occurred. In almost every case, however, the fat deposits at the treated regions were reduced to a clearly visible and perceptible degree. Apart from that, the treated body regions now show a clearly visible lifting of the skin. No one of the about 2,000 treatments triggered any “ugly holes”, “nods” or any other big or small deformations. On an average, treatments lasted 15-20 minutes only, anesthetizations were not necessary, and immediately after the treatment the patients were able to start with their daily routines without any restriction. The currently available independent studies about the active substance and the medicament as well as the experience gathered over many years with the flabjab injections demonstrate that further harms cannot be expected.

Claim 7: Serious plastic surgeons refuse to apply the so-called “injection lipolysis”.
This statement, too, is not true. Following initial attempts to manipulate the public opinion in the U.S.A. a great number of plastic surgeons now started to accompany the procedure – rather critically. Meanwhile, there even exist many reputed plastic surgeons who make use of this method as an alternative to liposuction or for small fat regions. This is also the case in Austria and Germany. During the past months, for instance, many plastic surgeons decided to attend courses about “flabjab injections” and to offer the treatment. For more information please look at www.injektions-lipolyse.de.

Claim 8: It is only in case of liposuction that the doctor is able to control the fat quantity to be eliminated individually and the body contours of the patient.
The difference between liposuction and the flabjab injections is that in case of liposuction the fat is eliminated directly (with known side-effects) whereas the flabjab injection triggers a natural procedure during which the body fat is decomposed over several weeks. The purposive application at a certain body region is possible in both cases – the approx. 2,000 patients treated with the flabjab injections according to Dr. Steitz were always treated at a certain body region – and with a very exact result all down the line.

Claim 9: Patients should only have treated themselves by an experienced plastic surgeon.
“I fully agree if the treatment consists of liposuction or other cosmetic-surgical interventions”, says Dr. Gunther Steitz. “But whenever it is a matter of influenza, gastrointestinal problems or metabolism procedures in connection with injections – and this is the case with the flabjab injection – general practitioners still are the first contact persons of their patients. They still feel committed to recommend the gentlest method for their patients”. In view of the above-mentioned statement, it is particularly interesting that there already exist numerous plastic surgeons applying the flabjab injection. In many cases, they were trained by general practitioners having gathered a high degree of knowledge about this procedure…

Place: University Clinic of Vienna
Study manager: Prof. Dr. Johannes Huber
Study start: as from February of 2004
Number of subjects: 50 patients