I get a lot of questions on mesotherapy, and its related techniques such as Lipodissolve. I do not perform this procedure but have been following it ever since I heard of it back during my year in Los Angeles (4 years ago). For those of you interested, here is a list of articles about mesotherapy, starting with the ones I recommend the most by the two main plastic surgery societies:American Society of Plastic Surgeons article
American Society for Aesthetic Plastic Surgery article
My blog article
Wall Street Journal
U.S. News and World Report
New Beauty Magazine
Plastic Surgery 101 - Dr. Rob Oliver's posts
Thanks for reading.
Michigan-based Plastic Surgeon
Anthony Youn, M.D.:
7 comments:
American Society of Aesthetic Lipodissolve Responds to American Society of Aesthetic Plastic Surgery
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 Lipolysis”, 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, several thousand 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 digests 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 a patient, 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.
References:
1. Hasengschwandtner, F. Phosphatidylcholine treatment to induce lipolysis. 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
Tony,
Looks like I'm not the only one to mesotharapy-blog spam :)
I read through several of your posts related to lipodissolve and started doing a little research on my own, including talking with other plastic surgeons. You obviously have a bias against this procedure as you fail to mention any of the studies (including several published by the American Society for Aesthetic Plastic Surgery) that speak to the safety and efficacy of lipodissolve. You provide no links or mention of any of the positive news stories. One I found listed many research articles (http://www.lipotherapyinstitute.org/MedResearch.aspx). Sure you are entitled to your opinion but it would help us all if you presented a balanced and unbiased picture instead of what appears to be promoting your own agenda. Why are you posting an opinion if you have never performed the procedure?
LMN
LMN,
I won't speak for Dr. Youn, but I think you're missing the point re. many peoples's reluctance to jump on this bandwagon.
There is a real paucity of good basic science research involving mesotherpy and there is a long-history of non-standardized "voodoo" ingedients that have injected for this purpose. The fact that you are (currently) able to inject substances FAR, FAR away from their FDA- approved indications for use should give pregnant pause for thought.
I encourage you to be patient with your enthusiasm or interest in this type of treatment and wait for the IRB-directed research studies to come in. A year from now this topic may be discussed in a completely different context where we're focusing on how to get the best results then on whether it should be done at all (as is being debated now).
For what it's worth, people who actually do body-contouring procedures are much less impressed with the results we see then are people who hear about it in the media.
The difficulty with mesotherapy and its related procedures is not that there aren't stories and small scale studies that are positive about it. These do exist, and I am familiar with them. BUT, my main issues with it are: 1) there are no 'large' scale scientific studies which have proven that it actually works. 2) there are no 'large' scale scientific studies which have proven that it is safe. 3) there is no standardization to mesotherapy, and any yahoo doctor (family doc, dermatologist, cosmetic or plastic surgeon) can inject whatever mixtures they want into whomever they want and call it mesotherapy. I've been interviewed by the media on mesotherapy and I do believe that IF it works, it can be a very important tool in body contouring. But, let's not get too excited about it just yet. As Dr. Oliver states, lets do the FDA approved studies with IRB approval to really figure this thing out once and for all. Finally, I am concerned about any treatment where I have anecdotally seen poor results in patients who have come to my practice. For example, it is not right for a doctor in my area to convince a patient to pay $4000 for injections into her panniculus (hanging and drooping skin of the abdomen), claiming it will make the excess skin and fat disappear. This is just plain dishonest and wrong. Are all injectors of mesotherapy like this? I am sure not, but this has been some of my experience. This blog is about my opinions (and is stated on the front page), so if you don't agree with them I encourage dialogue. Communication is always a good thing!
Lets discuss the comments by the ASAL:
1)there is currently no standardization for these injectable cocktails-why not?
2)there is no basic science data looking at what happens to these injectables or to the fat and its byproducts-why not?
3) the Europeans have had 30 years(or so they claim) to accumulate such data-why haven't they?
4)anecdotal evidence is meaningless- it took over a decade of hard-core science to get silicone back on the US market
5)the most recent article in the Aesthetic Journal showed extremely mediocre results-I suggest anonymous read it!
5)there is only one method to safely and permanently removing fat-liposuction. For those non-plastic surgeons who simply want a "piece of the pie"-accept this fact. If you want to practice plastic surgery then go do a fellowship!
7) Lipodissolve, msotherapy, or whatever term you care to use-it makes no difference. There simply is no nonsurgical substitute for liposuction...period.
Regarding your questions, I had to give some feedback as I recently spoke with a doctor about Lipodissolve. He gave some good arguments on this procedure that I took notes on. I also had a few friends try this treatment (one is a nurse) and they were very happy with it.
1. What is called Lipodissolve has been standardized for a few years now, and not as you state. It is mesotherapy that is not standardized (the doctor said this is why the two should not be mistaken as one and the same treatment).
2. There are several scientific articles already published on Lipodissolve (I read some); from dispersion studies, to histopathology, blood values, ultrasound studies and recently, university studies on lipoma use which is very detailed. This cannot be fully discarded as 'baseless' studies.
3. There has been no "30 years to claim data" as you state. Again, you confuse two different treatments as one and the same. Mesotherapy is what's been around forever, but was only used in sports medicine. It was not used in cosmetic use until quite recently.
According to the doctor, Lipodissolve was unique for combatting fat deposits with injections and the therapy seem to have been available for patients only since 2004. Still there are reports of several thousands of cases that testify to actual results and no serious, adverse reactions. So I'm not sure where you get information from that there are no studies and so on.
Certainly more data will come forth over the years on new treatments like this.
4. How can you claim liposuction is the "only safe" way to reduce fat? My friends are scared to death of liposuction, and so am I. See FDAs notice on liposuction and risks involved. Read what actual patients say on forums! Very few have good feedback but say they have all sorts of problems from liposuction. Some have gained more weight, many complain of constant fluctuating fluid weight after they had liposuction, that never seems to get cured and has caused some form of imbalance. Others say the skin and tissue is much worse and they wish they never had it done as it cannot be corrected. It's a well known fact that patients die from liposuction, so what safety do you refer to by claiming liposuction more safe than some small injections? And where exactly are the ASAPS annual data on complications, actual patient feedback, death from surgery and so forth? When I wanted to have liposuction in the past I looked for weeks to find some data and there was nothing to be found on their website. The only data they collect is how much money clinics are earning from it from patient volume! Hardly what me as a patient wants to know.
I'd give this Lipodissolve or any new treatment a chance anyday. You have to wonder why some doctors are against new treatments if they have no background in them.
PTM
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