Injection lipolysis

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The lipolysis , also fat away injection is a method for the treatment of small to medium fat deposits on the body and face, without surgical intervention. The term “injection lipolysis” was introduced in Germany in 2003 by the doctor Margrit Lettko and has since been the standard term for this therapy worldwide.

The method was previously also used to treat bags under the eyes, but is not recommended by Network Lipolysis in Germany. The Network Lipolysis is the association that has standardized the therapy of injection lipolysis and trains doctors worldwide. In the treatment of cellulite , injection lipolysis is used in a special way by injecting the active ingredient directly under the skin.

The injected preparation (trade name Lipostabil N ) is a mixture of phospholipids from soybeans , approved for the treatment of hyperlipidemia and for the prevention or treatment of fat embolism in surgery. The off-label application is supposed to destroy the excess fat cells.

The active ingredient is now produced in special pharmacies on the prescription of the treating doctors. The combination of phosphaditylcholine and deoxycholic acid has proven to be particularly effective and yet gentle.

According to the users, circumference reductions of 2 to 4 cm in the treated body regions are possible by using the fat-away syringe. The effectiveness of this treatment method was confirmed in a study in 2005. A more recent study, published in 2013, which was commissioned by the ASAPS (American Society of Aesthetic Plastic Surgery) and approved by the FDA, has also provided evidence of effectiveness through a half-side comparison study. If a more extensive effect is desired, this can be achieved by means of liposuction . The fat-away syringe is not a fully-fledged alternative to liposuction, but is suitable for smaller fat pads.

Mechanism of action

Originally there was the assumption that the polyenylphosphatidylcholine (PPC) contained in Lipostabil N is responsible for fat breakdown. This assumption was not unreasonable because Lipostabil was used as an agent against fat embolism . Adam Rotunda of UCLA (University of California) was the first to question this hypothesis. His investigations in vitro showed that the contained deoxycholic acid (DOC) can destroy the membrane of the fat cells. This first study was followed by others from the Universities of Regensburg and Bochum, which were able to validate this hypothesis.

One question about the mechanism of action is still open, whether and if which function the PPC fulfills. It is scientifically justified to ask what happens to the released fat after the destruction of the fat cells and whether PPC has an effect on the breakdown process. Based on the extensive studies on PPC, it can be assumed that PPC has a positive effect here: In principle, it can be assumed that every promoted fat loss process proceeds according to the same mechanisms, be it initiated by diet change, lipolysis or, as in our case, by lipodestruction. Lipases are involved in the breakdown process of released fats, such as lipoprotein lipase (LPL), but also lipoproteins and here in particular HDL , which can transport the fats into the liver for metabolism. In the liver, enzymes such as the hepatic triglyceride and phospholipases also ensure that fats are broken down further. The released fatty acids are then oxidized in the mitochondria to produce energy-rich molecules ( ATP ). How successful this process is depends, among other things, on how much fat released in addition to that ingested with food reaches the bloodstream and from there to the liver. If larger amounts are present or released, the functionality of the lipases and the transport to the liver for metabolism can be significantly disturbed due to overload. Here the essential phospholipids of PPC have proven their therapeutic effectiveness many times over. PPC has a significantly positive effect on the process described above at all levels.

safety

DOC is a toxic substance that cannot only destroy fat cells. In this respect, it is not surprising that the users have been asked repeatedly about the safety of the therapy since the beginning of the therapy. The BACD (British Association of Cosmetic Doctors) was the first organization to submit a statistical analysis. A little later, also in 2006, Diane Duncan sent out a questionnaire to many users around the world and obtained a much larger database. The globally active NETWORK Lipolysis has now also carried out 3 member surveys, the last of which was carried out in 2015 and represents the largest evaluation of safety and effectiveness to date with 29,889 patients and an extrapolated 74,600 treatments.

Basically, to be on the safe side, it can be said that it is a low-risk aesthetic procedure, if one wants to believe the statistical evaluations presented. In the 2015 Lipolysis Report, all complications were located between 0 and 1 per thousand. Almost all complications were reversible. However, there were two complications that were only partially reversible: abscesses and necrosis . Abscesses can occur with every injection, however, in the case of injection lipolysis according to the network protocol, it should be pointed out that at least 200 injections are made with a maximum dose and thus the risk is increased. In this respect, strict compliance with sterility is important. A major reason may also be that patients do not put on freshly laundered clothing after treatment, as is advised.

According to these statistics, necrosis occurs in every 10,000th patient or every 25,000th treatment. The network examined the causes in great detail, because every necrosis is one too many. The main cause can be seen as the reduction in the microcirculation in the treated and swollen area after treatment: for example, patients who drive for hours after treatment or put on compression girdles. Even tight jeans can trigger pressure necrosis. The microcirculation can also be reduced by, for example, a previously performed liposuction with associated scarring. Injection lipolysis can be used very well to correct small areas after liposuction. Another cause can be seen in the mechanical stress on the treated tissue, for example if, after a thigh treatment in cycling shorts, longer hikes are undertaken on holiday or the patient then goes to the gym. Necrosis can always be causally associated with either insufficient patient information or lack of reason on the part of the patient. However, as some authors rightly recommend, the practitioner should undergo very good training in order to avoid complications as far as possible. You should be informed about the side effects that occur with each injection lipolysis. These are: swelling for two to six days, redness, itching, bruises , moderate pain for about three to four days.

technology

After local disinfection and anesthesia of the areas to be treated, the combination of phosphatidylcholine (PPC) and deoxycholic acid (DOC) is injected directly into the adipose tissue using thin injection needles (outer diameter: 28–33 G , length: 6–12 mm) . This active ingredient, made from soybean oil , causes the fat to be broken down in the liver after the fat cells break down. Only a very small part is excreted via the kidneys.

The treatment can be done on an outpatient basis. The side effects are always temporary swelling for about two to three days, redness and burning, and bruises. About 5% of the patients do not respond at all to the active ingredient and a further 10–15% only respond less.

Legality of treatment EU and USA

The method is criticized because of the lack of testing and possible risks, especially necrosis . Occurring necrosis can almost always be traced back to a treatment error (no possibility of expansion of the treated tissue) or patient error (e.g. wearing too tight clothing). The chemical agents used (phosphatidylcholine with DOC) are not approved for this application and are therefore an "off-label use". The ampoules require a prescription in the EU, the ampoules are no longer available in Germany.

That is why the situation within the EU and the USA - with regard to the active ingredient combination PPC / DOC - has aligned. In both continents there is the legal and quite common possibility of having a prescription produced by a pharmacy equipped for this purpose. In Germany this is referred to as Formula Magistralis or Magistraliter recipe, in English-speaking countries the term is compounding. Both mean the same thing. In the USA, the FDA has warned companies against misleading claims and against the distribution of unapproved preparations.

In 2015, the FDA approved the drug Kybella ™ for the treatment of the double chin in the USA. Kybella ™ now only contains one active ingredient, namely deoxycholic acid. The company Kythera, which received approval, was bought by Allergan in 2016 .

Individual evidence

  1. ↑ Instructions for use Lipostabil N iv 5ml, ENR: 0619194, Artesan Pharma 2009.
  2. ↑ K. Hoffmann: Injection lipolysis - simply squirt away fat deposits. ( Memento of the original from December 13, 2014 in the Internet Archive ) Info: The archive link was automatically inserted and not yet checked. Please check the original and archive link according to the instructions and then remove this notice. In: dermatologist. 61 (10), 2010, pp. 847-855. doi: 10.1007 / s00105-010-1984-x @1@ 2Template: Webachiv / IABot / www.springermedizin.de
  3. ↑ K.-G. Heinrich: Efficacy of injections of phosphatidylcholine into fat deposits - a non-surgical alternative to liposuction in body-contouring . In: Indian J Plast Surg . tape 38 , no. 2 , 2005, p. 118-121 .
  4. ↑ DN Reeds, S. Mohammed, S. Klein, CB Boswell et al .: Metabolic and structural effects of phosphatidylcholine and deoxycholate injections on subcutaneous fat: a randomized, controlled trial . In: Aesthet. Surg. J. Band 33 , 2013, p. 411-413 .
  5. ↑ A. Rotunda, H. Suzuki, RL Moy, MS Kolodney: Detergent effects of sodium deoxycholate are a major feature of an injectable phosphatidylcholine formulation used for localized fat dissolution . In: Dermacol Surg . tape 30 , no. 7 , 2004, p. 1001-1008 .
  6. ↑ SM Klein, S. Schreml, M. Nerlich, L. Prantl: In vitro studies investigating the effect of subcutaneous phosphatidylcholine injections in the 3T3-L1 adipocyte model: lipolysis or lipid dissolution? In: Plast Reconstr Surg . tape 124 , no. 2 , 2009, p. 419-427 .
  7. ↑ FG Bechara, M. Skrygan, A. Kreuter, P. Altmeyer et al: Cytokine mRNA levels in human fat tissue after injection lipolysis with phosphatidylcholine and deoxycholate . In: Plast Arch. Dermatol . tape 300 , 2008, p. 455-459 .
  8. ^ Karl-Josef Gundermann, Franz Hasengschwandtner, Margrit Lettko, Jörg Faulhaber: The Role of Polyenylphosphatidylcholine (PPC) for the Reduction of Fat Pads in Deoxycholate Containing Injectables . In: Medical Research Archives . Vol. 5, Issue 8, August 2017, doi : 10.18103 / mra.v5i8.1441 .
  9. ↑ M. Palmer, J. Curran, P. Bowler: Clinical experience and safety using phosphatidylcholine injections for the localized reduction of subcutaneous fat: a multicentre, retrospective UK study . In: J. Cosmet. Dermatol. tape 5 , 2006, p. 218-226 .
  10. ↑ DI Duncan, R. Chubaty: Clinical safety data and standards of practice for injection lipolysis: a retrospective study . In: Aesthet. Surg. J. Band 26 , 2006, p. 575-585 .
  11. ↑ M. Weidmann, M. Lettko, L. Prantl: Injection lipolysis . In: J Ästhet Chir. 2016, doi : 10.1007 / s12631-016-0047-2 .
  12. ^ P. Rittes: The Use of Phosphatidylcholine for Correction of Localized Fat Deposits . In: Aesth Plast Surg . No. 27 , 2003, p. 315-318 .
  13. ↑ Assessment: Phospholipids from soybeans. ( Memento of the original from May 3, 2016 in the Internet Archive ) Info: The archive link was automatically inserted and not yet checked. Please check the original and archive link according to the instructions and then remove this notice. In: Arznei-Telegram drug database. dated April 26, 2011, accessed October 14, 2014.  @1@ 2Template: Webachiv / IABot / arznei-telegramm.de
  14. ↑ FDA Issues Warning Letters for Drugs Promoted in Fat Elimination Procedure. Press release April 7, 2010.