Lipolysis NETWORK responds to ASAPS statement
The American Society for Aesthetic Plastic Surgery (ASAPS) has published a statement May 7, 2007. Here you are linked to the full text of the statement and the NETWORK's response. Here you will also find the statement of ASAL to the same issue.
The American Society for Aesthetic Plastic Surgery’s Position Statement On Injection Lipolysis (Lipodissolve Or Mesotherapy)
May 07, 2007
Recommendations For Aesthetic Society Members
Statement by the NETWORK-Lipolysis
At this time, the Aesthetic Society does not endorse the injection of phosphatidylcholine, deoxycholate or any other drugs, vitamins, plant extracts, hormones, etc. into subcutaneous fat as practiced in mesotherapy/Lipodissolve treatments. Such therapies not only lack objective proof of safety and efficacy; they also lack Food and Drug Administration (FDA) approval. Members should therefore refrain from adopting these treatments until the results of the ASERF-sponsored study are available to provide proof of safety and efficacy, or lack thereof.
If patients ask about these treatments, the scientific reality that currently exists should be explained to them, along with the caution to wait until something definitive is known. Until then, patients should be warned about seeking treatments from people who may not be qualified to administer hundreds of injections that require very precise placement.
Patients should also be informed that injection lipolysis will never be a real alternative to liposuction, which is known to be safe and effective. Liposuction can remove large volumes of fat in a single procedure and better accomplish full body contouring. Based on the pricing of multiple Lipodissolve sessions, we estimate that the cost of liposuction is comparable. Furthermore, the discomfort that follows liposuction is completed within a relatively short period of time, in contrast to repeated periods of pain, swelling, and bruising that seem to be associated with multiple injection lipolysis sessions.
“Mesotherapy” was developed in France in 1952 by Michel Pistor, who believed that the injection of various compounds into the dermis—in high local concentrations—could produce positive physiologic effects on the vascular and lymphatic systems. Mesotherapy injection solutions have historically contained various combinations of substances that may include vitamins, minerals, stimulants, plant extracts, vasodilators, hormones, enzymes, and drugs such as NSAIDs, theophylline and isoproterenol. These injections have been recommended for a wide range of conditions including pain management, sports injuries, cellulite, wrinkles, alopecia, psoriasis, weight loss, and body contouring.
For decades, mesotherapy was largely a European phenomenon, but it began to appear in the U.S. in the late 1990s. In traditional mesotherapy, the ingredients are injected into the deep dermis or mesoderm, but the mesoderm is not precisely defined. Web site descriptions of mesotherapy treatments offer only vague descriptions of the ingredients used, in what dosages, and for which indications, though one indication is to “dissolve unwanted local accumulations of fat.” Mesotherapy practitioners seem to have their own formulas, which are often kept secret or revealed only through fee-for-service physicians courses. The English-language peer-reviewed medical literature contains no reports on traditional mesotherapy, except for complications.
Treatments most properly called injection lipolysis have been commonly associated with the term mesotherapy. Both types of treatments claim to reduce or eliminate unwanted local accumulations of fat, but their ingredients and injection locations are different. Today, various terms for treatments that purport to “dissolve” fat seem to be used interchangeably, although mesotherapy has gained prominence in the public vernacular. A recent Google search for mesotherapy produced 516,000 listings while Lipodissolve returned 147,000 listings.
The growing recognition of terms like mesotherapy and Lipodissolve among the general public, which has been encouraged through advertising, has led to the formation of groups such as the American Society of Aesthetics and Mesotherapy, Network Lipolysis, European Network Lipodissolve, and the American Society for Aesthetic Lipodissolve. These groups are dedicated to teaching injection procedures through courses presented around the country, and they appear to be open to all MDs, regardless of training or board certification. Some of these MDs then train spa staff to perform treatments “under medical supervision.”
Aggressive marketing has led to the emergence of injection lipolysis centers, franchises, and spas around the country, which offer these treatments as an alternative to liposuction. However, none of these centers is regulated. The injection ingredients are inexpensive, easy to acquire, and require no licensing to dispense. The dangers of a lack of oversight regarding supposed “fat dissolving” injections is best illustrated in a Centers for Disease Control and Prevention report from 2005 describing “mesotherapy” treatments for cosmetic fat reduction that led to an outbreak of skin infections, drainage or ulceration at the injection sites following at-home injections by a physician from Colombia. 1 Although this incident is extreme, it demonstrates that some people will allow themselves to be injected with unknown and un-tested substances in a non-medical setting if they think it might reduce fat deposits.
Injection lipolysis is typically done with trade-named products such as Lipodissolve and Lipostabil or with private formulations provided by compounding pharmacies. The one common ingredient in all injection lipolysis formulations is phosphatidylcholine (PPC). Currently, PPC seems to be the primary component of injection lipolysis formulas used in Europe and South America, though vitamins and other ingredients such as buflomedil also may be added.
In the United States, sodium deoxycholate (DC)—a constituent of bile—is a second major ingredient used to keep the PPC soluble and in an injectable form without precipitating out of solution. Benzyl alcohol is added as a preservative and solubility factor. A typical Lipodissolve injection in the U.S. contains approximately 50 mg PPC, 42–47 mg DC, and the remainder benzyl alcohol.
In contrast to injections into the mesoderm, injection lipolysis treatments are delivered into the subcutaneous fat. In both cases, the depth of injection is critical to prevent damage to fascia and muscle, as well as deliver treatments to the proper location. Although 27–30 gauge needles and small syringes can be used to perform injections, devices called mesoguns have been developed to insure the proper depth and dose of injection. To date, mesoguns have not been approved by the FDA for use in the United States.
Mesotherapy and injection lipolysis protocols vary, but the most standard method involves drawing a grid on the area to be treated that is divided into 1 or 1.5 cm squares and then injecting each square with an identical technique. Typically, a series of injections is separated by 2 to 8 weeks, depending on the injection formula and location. Although the improved body contour results are attributed to the injections, diet and exercise are often recommended as part of the treatment plan. Consequently, it is difficult to determine whether any reduction in subcutaneous fat is attributable to the injections or to lifestyle changes.
The idea of reducing fat via injections seemed to be taken more seriously after 1999, when Patricia Rittes, a Brazilian dermatologist, published a case series describing injections of Lipostabil (primarily composed of phosphatidylcholine) into the fat pockets of the lower eyelids in 15 patients.2 Lipostabil is approved in Europe to treat lipid abnormalities, coronary plaque, and cirrhosis of the liver. It has also shown promise in shrinking lipomas through subcutaneous injections. Rittes’ before and after photographs show impressive shrinkage of the lower lid fat pads after 1 to 4 injections, and she has subsequently published clinical examples of Lipostabil injections in the abdomen, flanks and thighs that demonstrated improved contour and fat loss.3 In 2004, California dermatologists Albon and Rotunda conducted a similarly-designed study of 13 patients who received open-label injections into their lower eyelid fat pads.4 Their results were similar to those of Rittes, and their peer-reviewed publication was well done and appropriately cautious.
The most commonly-reported reactions to injection lipolysis are pain, tenderness to touch, redness, stinging/burning sensation, itching, edema, and bruising. These sequelae typically begin soon after treatment and last for several days. The lay press and internet sites dedicated to mesotherapy and injection lipolysis rarely report serious complications. However, there are numerous reports of complications documented in the medical literature, including atypical mycobacterium infection and granulomas. Urticaria pigmentosa following mesotherapy with procaine and plant extracts has also been documented. In addition, there are reports of injections done by lay people causing localized necrosis when extremely high doses are injected superficially in a small area.
Theory Of Action
Phosphatidylcholine (PPC) and sodium deoxycholate (DC) are both phospholipids, emulsifiers, and surfactants. Phosphatidylcholine is the most abundant phospholipid component of cell membranes, a precursor to acetylcholine, and a constituent of lipoproteins. Deoxycholate is a constituent of bile that solubilizes fat for absorption. Thus, both substances are naturally present in the human body. In addition, phosphatidylcholine and sodium deoxycholate are both approved by the FDA for use as surfactants and drug carriers, among other applications, but neither is approved for subcutaneous injection. Oral forms of PPC, including lethicin, are sold as over-the-counter nutritional supplements intended to improve health and treat disease.
Contrary to advertising claims, injection lipolysis does not “melt” or “dissolve” fat. Instead, PPC and/or DC appear to kill (lyse) adipocytes. It has been hypothesized that treatment with phosphatidylcholine and deoxycholate reduces subcutaneous fat either by adipocyte necrosis due to direct toxic or surfactant effects, or by mobilization of triglycerides secondary to activation of hormone sensitive lipase. Studies have found that subcutaneous adipose tissue following PPC/DC treatments shows evidence of nodules of fat necrosis, threadlike strands of scar tissue, cell-wall disruption, focal inflammation, and collagen deposition.5, 6
Rotunda et al. suggested that the detergent effect of sodium DC is the major active component of injection lipolysis preparations and is responsible for cell lysis of human keratinocyte and porcine fat tissue cultures.7 These data imply that the reduction of subcutaneous fat following DC injections is caused by a direct toxic effect on adipocyte membranes that induces necrosis, but not apoptosis. However, apoptosis caused by surfactant effects remains a theoretical mechanism of action. Moreover, the fact that many injection lipolysis formulations do not include deoxycholate suggests that PPC alone has some toxic effect on subcutaneous fat.
The induction of adipocyte necrosis has been confirmed by the presence of inflammation, the fact that many contiguous cells are involved, and the development of neovascularization. Although apoptosis caused by surfactant effects is a theoretical mechanism of action, it is unlikely to play a significant role because the dominant histological picture is consistent with necrosis.5, 8 Physicians who claim that injections cause apoptosis seem to be using the term loosely to mean cell death.
Both phosphatidylcholine and deoxycholate are known to lyse cells on direct contact without selectivity for fat cells. They can therefore induce necrosis of fascia and muscle as well. This means that injections must accurately place the agents in the superficial to mid-layer of fat and far enough away from muscle and fascia so that only fat cells are killed. In addition, the dose should be limited to a maximum of 2500 mg of PPC per treatment session to avoid systemic toxicity.
Patients typically complain of erythema and itching after the injections, which could be a manifestation of lipase activity or histamine release. However, there is no objective proof of lipase activity. Because the erythema and itching occur immediately after injection, these symptoms are almost certainly due to histamine release.
Some advocates of Lipodissolve therapy have claimed that the “dissolved” fat is eliminated via the urine or GI tract. This seems physiologically impossible unless a negative energy balance is also induced by diet and exercise. Fat is stored in adipocytes as triglycerides, and the body manages triglycerides and fatty acids in two ways: they are burned or they are stored. They are not excreted.
Phosphatidylcholine and deoxycholate are both approved by the FDA for use as surfactants and drug carriers. However, there is no FDA approval of either drug for subcutaneous injection for ANY purpose. Thus, the injection of PPC/DC is NOT an off-label use of a product approved for another indication. The FDA has occasionally issued warnings to some physicians advertising mesotherapy on their websites and demanded that the information be removed because the FDA has approved no such treatment in the U.S. The agency has also issued warnings to people known to import products such as Lipostabil on the same grounds. Yet advertising for mesotherapy/Lipodissolve continues to grow, and the ingredients are easy to purchase from compounding pharmacies.
Despite all the claims that mesotherapy/Lipodissolve treatments can safely and effectively eliminate unwanted subcutaneous fat deposits, this remains clinically unproven. There are no published peer-reviewed scientific reports of properly performed controlled prospective trials to confirm either safety or efficacy. Furthermore, we have no objective data on how these treatments produce the reported effects.
The ASAPS Mesotherapy Committee has contacted the FDA regarding their requirements for an ASERF-funded clinical trial of phosphatidylcholine and deoxycholic injections. Any study involving subcutaneous injection of these drugs requires FDA approval of an investigational new drug (IND) application plus IRB approval. The FDA is well aware that mesotherapy/Lipodissolve injections are growing in popularity, but the agency thus far has not exercised its enforcement power to restrict its use.
Action is being taken on the state level, however. In April 2007, the Kansas Board of Healing Arts passed a temporary regulation that bars Lipodissolve treatments. The state acted because Lipodissolve is becoming more widely available at medical spas within the state but is not approved by the FDA and lacks regulation. Use of a PPC/DC combination is permitted in the context of a clinical trial operating under an IND, and physicians may order individualized prescriptions from a compounding pharmacy designed for a specific patient, which means that “bulk” purchases of the compound will not be possible.
Confusion remains about use of a formulation compounded by a pharmacy. Injecting a compounded product may indeed be legal since PPC and DC are both approved for other uses. At the same time, the compounding of 2 legal drugs produces a “new” drug that is not approved for subcutaneous injection. Pharmacies may therefore have to decide whether they want to take on the added liability and risks associated with selling a non-approved drug.
What Needs To Be Done
News about mesotherapy/Lipodissolve treatments has spread throughout the country and large numbers of people seek the treatments as an alternative to liposuction that is allegedly cheaper and requires less down-time. Injections of PPC/DC to reduce subcutaneous fat has basically become a thriving business, despite the fact that there are no well-designed studies to document its safety and efficacy, not to mention the absence of FDA approval.
Because of ASAPS concerns for patient safety, ASERF has provided funding for a small study (20 subjects) to be conducted under FDA supervision that seeks approval of an IND application. The study protocol was originally submitted in Spring 2006 and revised and re-submitted in March 2007 after addressing numerous agency concerns that arose from the original application. The study will follow patients for 46 weeks to evaluate the efficacy of injection lipolysis treatments with PPC/DC, as well as collect data on local and systemic reactions and any long-term complications. During the study period, subjects will be asked not to change their diet or exercise routine. Study participants will have blood samples, abdominal subcutaneous tissue biopsy specimens, and MRI examinations analyzed before and after injection lipolysis treatments for the following purposes:
1. Determine whether there is a change in body composition with respect to local and total body mass;
2. Examine adipose tissue metabolic function by measuring adipocyte proliferation and cellular function, production of inflammatory cytokines, and macrophage infiltration;
3. Look for systemic markers of metabolism (plasma glucose, insulin, free fatty acids, triglycerides), and inflammatory markers (C-reactive protein, leptin, TNF-α, IL-6); and
4. Examine possible mechanisms responsible for PPC/DC-mediated fat reduction, including adipocyte apoptosis and/or necrosis.
Multiple variables related to efficacy will be measured at regular intervals throughout the study, including abdominal circumference, skin fold thickness, standardized photographic changes, and weight. The expected side effects of PPC/DC injections will be determined, and patient satisfaction with the treatments will be measured.
If (and when) the submitted study protocol receives FDA approval, the investigation can begin immediately under the IND application. Once completed, the results will be published in the Aesthetic Surgery Journal and presented at an annual ASAPS meeting.
1. Furlong W, Cunanan BA, Weymouth LA, et al. Outbreak of mesotherapy-associated skin reactions—District of Columbia area, January-February 2005. MMWR 2005 Nov. 11; 54(44):1127-30.
2. Rittes PG. The use of phosphatidylcholine for correction of lower lid bulging due to prominent fat pads. Dermatol Surg 2001;27(4):391-92.
3. Rittes PG. The use of phosphatidylcholine for correction of localized fat deposits. Aesthetic Plast Surg 2003;27(4):315-18.
4. Ablon G, Rotunda AM. Treatment of lower eyelid fat pads using phosphatidylcholine: clinical trial and review. Dermatol Surg 2004;30(3):422-27.
5. Duncan DI, Hasengschwandter F. Lipodissolve for subcutaneous fat reduction and skin retraction Aesthetic Surg J 2005;25:530-43.
6. Rose PT, Morgan M. Histological changes associated with mesotherapy for fat dissolution. J Cosmet Laser Ther 2005;7(1):17-19.
7. 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;30:1001-08.
8. Hasengschwandtner F, Furtmueller F, Spanbauer M, Silye R. Detailed documentation of one lipolysis treatment: blood values, histology, and ultrasound findings. Aesthetic Surg J 2007;27:204-11.
in response to the warning against injection lipolysis by the
American Society for Aesthetic Plastic Surgery (ASAPS)
and the statement by the Society of May 7, 2007.
Medical & Scientific Advisory Board
Dr. Franz Hasengschwandtner
The ASAPS has expressed a view concerning the subject of injection lipolysis in a detailed statement.
The NETWORK-Lipolysis has naturally also published this statement on its homepage, in line with our philosophy of actively addressing all views that deserve to be taken seriously, even if they adopt a critical stance towards injection lipolysis.
We have been in contact with the ASAPS for over a year now, and have furnished them with all the documentational material at our disposal.
We now wish to respond to the ASAPS warning as follows:
1. We support without reservation the research on the part of the ASAPS into injection lipolysis. The planned study involving 20 patients should shed further light on how injection lipolysis, the results of which we can see every day in the patients treated by us, actually works. We therefore once again reiterate our offer to cooperate in this important sector. We will also provide the investigating physicians with all the research results of our university cooperation partners as soon as they are available to us. We will also be pleased to contribute our many years of experience in working with injection lipolysis in order to formulate a study design that is able to produce objective results. To this end, we also offer the ASERF, who will conduct the study, the NETWORK Lipolysis treatment standards which are in use throughout the world for patient selection, patient information, dosages, depth and spacing of injections and also treatment intervals, for use in the study. We are prepared to make the protocols applied by the NETWORK-Lipolysis available.
2. For the sake of the patients’ safety, we are also willing to provide the phosphatidylcholine that corresponds to the original Lipostabil N® and is produced for the members of the NETWORK by MasterPharm®, LLC, NY, for use by the ASERF in the study. Analysis by the NETWORK-Lipolysis of various other PPC samples available on the market has shown that other PPC mixtures do not have the quality specified by the NETWORK-Lipolysis and produced by MasterPharm®, and also contain differing proportions of deoxycholic acid and/or benzyl alcohol. PPC formulations with other mixing proportions or compositions indisputably – and clearly measurably and visibly – increase the side effects and substantially diminish the achievable results.
3. We support the ASAPS in its efforts to put a stop to unprofessional treatment by nurses in spas and cosmetic institutes. Lipolysis treatment should always be carried out by or under the direct supervision of trained physicians only. To protect the patients, the NETWORK-Lipolysis also opposes the treatment of patients by doctors who have not undergone specific training in lipolysis therapy to the standard offered throughout the world by the NETWORK-Lipolysis. Patients must not be made guinea pigs. We wish to draw emphatic attention to the fact that the cases of severe complications described by the ASAPS were not the result of treatment provided by physicians in the NETWORK-Lipolysis.
4. We doctors in the NETWORK-Lipolysis are committed to ensuring that the patients are fully and comprehensively informed, and we therefore reject untrue or misleading advertising. Anyone who offers lipolysis as a means of weight reduction is deceiving the patients, not informing them. Misleading advertising campaigns only produce disappointed and dissatisfied patients. Injection lipolysis is only suitable for the treatment of small, circumscribed areas of fat that will not respond to either changes in diet or physical exercise. In all its training workshops, the NETWORK-Lipolysis continues to recommend that larger areas of fat be dealt with by liposuction, and in such cases advises all members to enter into collaboration with a good plastic surgeon.
5. Concerning the issue of safety, our position differs from the view of the ASAPS, and we therefore wish to present it in detail as follows.
5.1. The drug Lipostabil N® is licensed in Germany for the treatment of fat embolism and has been in use there for this indication for decades. All treatments provided by our members are conducted on the basis of this medication. In the USA, a phosphatidylcholine compound is produced by MasterPharm® which is comparable to Lipostabil N® in composition and quality. There are other producers and other formulations. There is no argument that strict standards are applied for the registration of drugs, in Germany as in the USA. All toxicological studies were carried when this drug was first registered. The reaction of the organism as a whole was also studied for the indication as a medication for the treatment of embolism.
5.2. The main question at issue is, therefore, whether a subcutaneous injection into fatty tissue produces different reactions than intravenous application. All the studies conducted by our doctors unequivocally show that there are no other or different reactions by the body as a whole. Very large numbers of blood and liver tests have been conducted by our members. No negative deviations have been found.
5.3. An important question that does need to be fully investigated is whether injection into the wrong place, e.g. muscle or nerve tissue, provokes significant side-effects. If we were not absolutely convinced that destruction of such tissue can be completely ruled out, we would not apply this treatment. According to our knowledge, only fat cells are susceptible to the lipolytic process and are destroyed.
5.4. However, incorrect performance of the treatment, for instance injection into the fascia, can indeed result in painful and long-lasting side-effects, such as nodulation. Patients should therefore only be treated by doctors who have undergone special training; self-treatment by the patients themselves or treatment given by untrained doctors must be condemned. Also in the field of liposuction, the issue of qualified training is of huge importance for the quality of the results, especially when the treatment is offered by doctors from different specialization backgrounds.
5.5. Two studies on safety have been conducted by NETWORK members, both of which have already been published 1. Both publications are based on a large number of treatments, the British study documenting over 10,000 treatments, the American study by our representative Dr. Diane Irvine Duncan, of Fort Collins, no fewer than 56,000 treatments. Together with the patient observations gathered by the NETWORK itself, we now have a database of some 80,000 treatments worldwide. In terms of complications brought about by our members, our “Treatment Error and Emergency Treatment” Research Group, headed by Claus-Peter Meissner, MD, has hitherto only documented the following cases:
• 2 necroses caused by the treatment of scar tissue with poor blood circulation, undertaken to correct previous liposuction treatment
• 2 injections into nerve tissue, in clear breach of our protocols, resulting in long-lasting pain for the patients concerned
• 1 abscess as a result of inadequate disinfection, such as can occur with any injection.
No other complications involving NETWORK members were documented. However, our work group does have knowledge of, and has documented, various severe complications resulting from self-treatment and treatment by doctors who have not received training in the therapy.
We are not able to perceive that lipolysis treatment, provided it is performed by properly trained doctors, is a source of hazard to the patients. Rather, we are of the opinion that the statistical data that has been collected and analyzed unequivocally shows that the side-effects are limited and reversible. We can therefore not accept the warning of the ASAPS against injection lipolysis, as treatment by liposuction, the ASAPS’ sole preferred method, is itself accompanied by not insubstantial risks, especially when the operating surgeons have not received the appropriate training. All aesthetic surgeons are thoroughly familiar with the data on the risks and complications of liposuction. Nevertheless, liposuction today enjoys acceptance throughout the world because the training, developments in the therapy and quality assurance by many organizations and societies have made liposuction a surgical procedure with a manageable level of risk. The NETWORK-Lipolysis is seeking to pursue the same path for what, compared to liposuction, is the still young therapy of injection lipolysis.
American Society of Aesthetic Lipodissolve Responds to American Society of Aesthetic Plastic Surgery – written by the ASAL Medical Advisors
The American Society of Aesthetic Lipodissolve [ASAL] objects to the inclusion of “Lipodissolve” in the recent warning against injection therapy (MESOTHERAPY) for localized fat reduction issued by the American Society of Aesthetic Plastic Surgery [ASAPS]. The procedure, Lipodissolve was introduced by the founders of ASAL in 2001 as distinct from “Mesotherapy”. The ASAL took care to include ingredients which were safe and whose mechanism of action was understood. The ASAL diligently limited training only to physicians and their nurses to perform the procedure. The ASAL and its original cohort, “Network Lypolysis”, thus trained more than 300 physician in Europe, and so far, more than 200 physicians in the United States.
ASAPS is incorrect in stating that there are no data relative to the effectiveness and safety of the procedure. As it relates to Lipodissolve, more than 50,000 treatment sessions have been reported in European and American peer reviewed journals demonstrating: a] objective evidence of improvement, based on actual measurements and pictures, in approximately 90% of the patients, and b] a paucity of serious side effects.1-4,6,7 Serious side effects reported with liposuction such as death, fluid overload, epinephrine and lidocaine toxicity, thrombosis, fat embolism and complications of general anesthesia have not been reported with Lipodissolve therapy.5
The main ingredient in the Lipodissolve formula is phosphatidylcholine [PC], a lipid. It is dissolved in a bile salt [deoxycholate], which is how it exists in bile where it helps to breakdown the ingested fat cells and digest fat on a daily basis. When injected in to the unwanted superficial body fat, it similarly breaks down fat cells and “digests fat”, as it does naturally in proximal duodenum. In the subcutaneous area the dead fat cells are then gradually removed by the body’s physiologic repair mechanisms, the same way as after any trauma or even after liposuction which leaves dead fat cells in the area to be removed by similar physiologic processes. PC along with other phospholipids are significant dietary source of essential fatty acids. Mammalian cell membranes are primarily composed of PC and other phospholipids mixed with cholesterol esters and salts to maintain fluidity. In other words it is not some foreign or toxic substance.
ASAPS’s statement that this “procedure is not FDA approved” is misleading. FDA approves drugs and devices, not procedures. ASAL maintains that there is no FDA approval requirement relative to phosphatidylcholine for two reasons. One, it is a “supplement” and as such has been used for years for liver health, cholesterol and other possible benefits. Supplements do not require FDA approval and can be administered by injection,(as are vitamins and minerals as in Meyer’s cocktail, intravenous nutrition or hyper-alimentation consisting of amino acids, vitamins, minerals, lipids, and others. Second, in Lipodissolve, the ingredients are mixed by a compounding pharmacist upon a physician’s order for specific patients, which does not require FDA approval [FDA Modernization Act Section 503a Compounding Pharmacy].
Lipodissolve is not a surgical procedure. Accordingly, ASAL has compiled an advisory board that includes highly credentialed physicians with diverse but relevant backgrounds in the fields of dermatology, aesthetic surgery and internal medicine. These individuals are experienced clinicians, speakers, writers, researchers and teachers, and provide advice regarding the procedure and its evolution. They conduct training workshops for other physicians in the U.S. So far the North American advisers have performed more than 2,000 Lipodissolve procedures with satisfactory results in more than 90% of the patients – without any serious side effects. The ASAL has an on going monitoring process to record these events.
1. Hasengschwandtner,F. Phosphatidylcholine treatment to induce lypolysis. Journal of Cosmetic Dermatology, 2005; 4:308-313
2. Duncan, ID, Hasengschwandtner,F. Lipodissolve for Subcutaneous Fat Reduction and Skin Retraction. Aesthetic Surgery Journal, 2005-September/October; 25(5):530-43
3. Heinrich, K-G. Efficacy of Injections of Phosphatidylcholine into Fat Deposits, A non-surgical alternative to liposuction in body contouring. Presented as a scientific publication at the convention “Operative Dermatology” at Frankfurt, October 28-31, 2004
4. 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. Journal of Cosmetic Dermatology, 2006; 5:218-25
5. Platt, MS, et.al. Deaths associated with liposuction: case reports and review of the
literature. Journal Forensic Science. 2002, Jan; 47(1):205-7
6. Duncan,DI,Chubaty,R,Clinical Safety Data and Standards of Practice for Injection Lipolysis: A Retrospective Aesthetic Surgery J, 2006;26:000.
7. Hasengschwandtner,F, Furtmueller,F, Spanbaner,M,Silye,R.Detailed Documentation of Lipolysis Treatment: Blood Values,Histology, and Ultrasound Findings.Aesthetic Surgery J 2007, 27:204-211
The American Society of Aesthetic Lipodissolve [ASAL] Medical Advisors object to the recent warning against Lipodissolve brought on by the American Society of Aesthetic Plastic Surgery. Lipodissolve is a safe and effective non-surgical treatment to remove localized fat.