Monday, July 02, 2007

Doctors Are Warning Against Lipodissolve

Physicians are warning patients to avoid cosmetic fat-busting injections known as lipodissolve, according to the Daily Herald. The injections are not approved by the FDA and both their safety and effectiveness have yet to be proven in scientific trials.

The injections are being offered by medical spas, which are often designed to look like plastic surgeon offices, but often provide treatments that either are not FDA approved or are not being used in accordance with the FDA label.

NetSweat.com Comments: There is no reason to pay for an unproven treatment, especially when you are essentially making yourself a guinea pig. If you don't like the cellulite on your body, eat healthier and exercise more. Diet and fitness are the only proven ways to get rid of excess cellulite.

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6 Comments:

At July 03, 2007, Anonymous Anonymous said...

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

 
At July 12, 2007, Anonymous Anonymous said...

I recently had this done, but I did my research first. The 2 main ingredients are fda approved alone, just not for this pupose, mainly because no one has sought fda approval. I went to a very reputable office in the area and found out that lipodissolve is all they do. It's headed up by a plastic surgeon so that made me feel comfortable. So far I've lost one and a half inches on my belly. I'm thrilled. There was barely any pain. Only for about the first day. After that, I was fine. I'm going in for treatment number three in 3 weeks. I'm already down one pant size. I would defnitely recommend it.

 
At July 12, 2007, Blogger Netsweat.com said...

We're posting comments unedited.

What we've seen with many treatments and supplements that are not FDA approved are supporters who make it seem like the lack of FDA approval is not big deal.

The FDA has stringent requirements for approval, and while not perfect, do improve safety. When a product has not been submitted to the FDA, the risks are unknown.

We will again reiterate what we said in our original post, anyone who takes lipodissolve is making themselves a guinea pig for the companies selling it and the doctors administrating it.

 
At July 12, 2007, Anonymous Anonymous said...

I was trying to find more information about lipodissolve and I keep reading more and more about all of the things you were saying regarding that fact that the product isn’t FDA approved for the specific purpose of fat reduction. Someone recently said that the ingredients (PCDC) are approved by the FDA for another purpose...do you know what this purpose is or what drugs it's used in? I keep hearing contradictory things. Plus, all these places I am coming across that perform the lipodissolve procedure seem to disregard this fact of the drug being unapproved in all of their advertisements, making it seem as if it’s normal for solutions being injected in the body to be unregulated. Any thoughts on all of this? Check out this article I found in the Wall Street Journal. “http://online.wsj.com/article/SB118160554567831887-search.html?KEYWORDS=rundle”
And also, here is a site I keep running across that seems to point to some pretty pertinent info. www.lipotreatmentfacts.org. Any feedback would be helpful. Thanks.

 
At July 13, 2007, Anonymous Anonymous said...

It's my understanding that someone actually needs to seek fda approval, the fda doesn't just look into this stuff on their own. Since the two main ingredients are fda approved for use in other medical products, no one has sought approval. The pharmacies that produce this stuff are regulated by the state, so it's not like you're just injecting an unsafe substance into your body. I think people should be more concerned about who is doing the injections. I keep hearing commercials from day spas and other doing this. How much training do these people have? If I were you, I would look for someone that's been doing this for a while and that specializes in this procedure. Make sure that you are evaluated by a doctor and that a doctor is on premise.

 
At October 02, 2007, Blogger Lasik Counselor said...

Hi, I have had a Lipoma for over a decade. A Lipoima is a conglomerate of fatty fibrous tissue. I did not believe LipoDissoslve would work in breaking it down and sure enough about 2 weeks after my first treatment I began to notice some significant shrinkage in the lipoma. I still will need 1 or 2 more treatments to completely dissolve it but thank God it worked. The micro-injections did not hurt but it did hurt like heck a few minutes after the shots. It kind of took me by surprise on how bad the area hurt. It felt like my are was run over by a School Bus. The swelling went completely down within a 24 hour period. It was sore and tender for several days. The shots only injected 1/2 cc of LipoDissolve. I can only imagine the pain of people who get 30 to 45 cc's of LipoDissolve at one time. I have LipoDissolve educational information posted at LipoDissolve Local Info If anyone has any LipoDissole questions please let me know. Thanks

 

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