FDA Takes Steps to Dissolve Claims on Lipodissolve
April 13, 2010 Health & Fitness
| The Mesotherapy mantra: Inject to eject fat and cellulite from the body. |
Liposuction and tummy tucks have always been the plastic surgery forerunners when it comes to quick-fix weight loss. But what if you could lose inches and sculpt the “perfect” body merely from a few injections that aim to melt away the fat? Sounds promising, doesn’t it? But this procedure, known as Lipodissolve or Mesotherapy, has been a hotly-debated topic that’s recently caught the attention of the FDA.
Mesotherapy is a non-invasive, non-surgical procedure developed in France during the 1950’s, whereby a cocktail of vitamins, herbs, and fat emulsifying chemicals such as phosphatidylcholine or sodium dioxycholate are injected superficially in the subcutaneous layer (the layer of fatty tissue just underneath the skin). Mesotherapy boasts the ability of being able to reduce fat in “spot” treatments, particularly in problem areas such as the “love handles,” thighs, buttocks, arms, neck, and chin. Additionally, it is claimed that mesotherapy can drastically reduce cellulite, eliminate wrinkles, remove scarring, and even stimulate hair growth. The main goal of injecting these substances is to dissolve the fat layers by breaking down the bonds in fat cells into liquid form that can be eliminated from the body through 1) the kidneys and 2) the bowels.
Is it safe?
That’s the issue that caught the attention of the FDA. Mesotherapy is the subject of much debate and critique because many establishments have been advertising it as an alternative to traditional plastic surgery and liposuction. When prospective patients are hear the magic words “painless,” “safe & effective,” “no surgery,” “no down-time,” and “no anesthesia,” of course it sparks an immediate interest. What prospective patients need to be aware of is that although the substances and chemicals used in the mesotherapy “cocktail” may be FDA approved, these substances are being used off-label, and not for treatments they have been approved for. It is also important to know that the “cocktail” recipe is dependent upon the discretion of the injector; he or she chooses the substances and concentrations. Therefore, there is really no regulation or standard as to what is being injected into the body. Furthermore, very little research has been done on how these chemicals positively or negatively affect the body and its systems. Additionally, people need to be aware of unexpectedside effects that may result from this procedure. Side effects include, but are not limited to:
- permanent scarring
- allergic reactions
- skin deformation
- Skin ulcerations
- deep subcutaneous painful knots at injection sites
Because of the potential dangers associated with this treatment, the FDA is cracking down on some medi-spas that assert that mesotherapy is “safe and effective” and “superior to liposuction.” On April 7, 2010 the FDA issued warning letters to six medi-spas and a Brazilian company regarding unsupported claims and misleading statements used in the procedure. These establishments were instructed to respond within 2 weeks about how they will correct these violations and prevent future ones from occurring, and failure to do so will result in legal action. Kathleen Anderson, deputy director of the FDA Division of New Drugs and Labeling Compliance states, “They make it sound so good and so safe.[It is claimed to] dissolve fat– melts it away with no side effects– and they have done thousands of procedures, and it really sells well. We are concerned because we have had reports of complications and we have no good data that say this is safe and effective.”
There is really not enough data to prove how safe mesotherapy injections are, despite the all the hype and promises. Many companies are unethically promoting treatments that have no substantial proof of safety or efficacy, and certain chemicals that are FDA approved are being utilized for other things. The public needs to be aware of the truth and have a bit of skepticism about such procedures so they can avoid being lured by misleading information and fancy marketing. The bottom line is, quick-fix body sculpting has its risks, and the only way to safely reach that dream-bod without any health risk is through a healthy diet, traditional exercise, discipline, and the occasional blood, sweat, and tears!
Credits:
FDA Warns About Lipodissolve Product Claims. http://www.fda.gov/ForConsumers/default.htm
cosmesurge.com
http://ehub.journalism.ku.edu
Comments (17)
When you have cellulite and you wish to discover a means of treating it then, there is a pure approach of serving to to reduce it. Taking common cardio exercises will help scale back the appearance of cellulite as a result of operating and swimming helps to burn fat in addition to strengthen and tone the muscles. As cellulite types on the highest of muscle tissues cardio workout routines can scale back the formation of fats that helps to minimise its appearance.
This is a very important topic… thank you for discussing it in an honest unbiased way, and thank you for pointing out the MAIN ISSUE… safety! Everyone is always focused on whether or not these nonsurgical treatments work, but the first thing we should figure out is whether or not they are safe. As you pointed out, there are no regulations or standards for dosages, concentrations, or even who is qualified to administer these treatments. This should be a red flag for all of us.
There are some other excellent articles about this subject on http://LipoBeauty.com for anyone interested.
[...] LipoDissolve is the third noninvasive way to get rid of unnecessary bodyfat, but is it any better than Zeltiq or Zerona? Not a chance. If you have LipoDissolve, your doctor (or “practitioner”) will give you hundreds (or thousands) of injections of a mixture of chemicals that are similar to the ones that your gallbladder uses to dissolve the fat that you eat. These chemicals supposedly dissolve the fat under your skin in the same way they dissolve it in your intestine, but they don’t seem to do much when they’re used for cosmetic purposes. LipoDissolve is less expensive than Zeltiq or Zerona, but it unfortunately doesn’t work any better. Plus, it’s more painful because real needles are used, and it’s NOT approved by the FDA because of concerns over safety! [...]
This is a very important topic… thank you for discussing it in an honest unbiased way, and thank you for pointing out the MAIN ISSUE… safety! Everyone is always focused on whether or not these nonsurgical treatments work, but the first thing we should figure out is whether or not they are safe. As you pointed out, there are no regulations or standards for dosages, concentrations, or even who is qualified to administer these treatments. This should be a red flag for all of us.
There are some other excellent articles about this subject on http://LipoBeauty.com for anyone interested.
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I’m planning on getting a tummy tuck can you recommend a plastic surgery doctor in the phoenix area?
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I think the key to losing weight is doing exercises that you find fun and your actually enjoying doing it. Some workouts you feel like your just doing it to lose weight but you can’t stand the workout. Dancing is fun and a way to drop the pounds as well as have fun as your losing the weight.
I definitely agree with you Kasula13. Finding a niche exercise such as dance, yoga, or whatever it may be that a person enjoys is the best way to lose weight in an enjoyable way!. For me, bellydance has not only been my form of exercise, but my sanctuary from stress as well!
Looking good is difficult. People will astounish me on what they will do. It’s not for me to judge.
I have been victim to cellulite for ages and if I have discovered one fact it’s that diet and exercise is the only real way to help get rid of it.
People who consider liposuction is a reduce weight procedure are mistaken, and they cannot use it instead of conventional approaches of reducing bodyweight. Liposuction is a surgical process carried out by competent doctors to sculpt the figure, not get rid of too much weight. Only little quantities of fat are eliminated through a lipo procedure so the affected person actually does not shed many pounds.
A tummy tuck is a surgical procedure completed to flatten the belly and stomach muscles. It makes the glance and exist fit and healthy. There is a partial abdomen tuck and there is a well-rounded one. Each has a different recuperation time. A miniature may consider about weekly whilst the full generate consider up to weeks to recover from.
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