Monday, October 27, 2008

Mesotherapy, Lipo-Dissolve, or Injection Lipolysis, Lipozap, Kybella

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Mesotherapy involves the injection of medications under the skin. It has been widely used in Europe for years to treat cellulite, psoriasis or spot reduce fat, amid unsubstantiated claims. One subset of this treatment modality is injection lipolysis where a mixture of phosphatidylcholine(lecithin), isoproterenol, deoxycholate, blood vessel dilators, nonsteroidal anti-inflammatory agents, enzymes (such as collagenase or hyaluronidase), aminophylline, caffeine, L-carnitine, buflomedil, calcitonin, vitamins, minerals and hormones in varying combinations are injected into the fat layer under the skin to destroy fat cells. Some of these medications stimulate fat cells to break apart fat molecules contained in the cells. However fat cells in some areas like the thighs and hips are more resistant to this stimulation. The true mechanism of action of some of the medications remains unknown. Multiple injections are made into the treated area per session and sessions are performed a few weeks apart. Some or all of the injected medications are frequently not FDA approved for injection.

Mesotherapy, Lipo-Dissolve, lipodissolve, lipozap, lipotherapy or injection lipolysis is touted by some as a non-surgical replacement for liposuction. The lure of such spot reduction of fat without surgery, recovery time, dieting or exercise is quite appealing to prospective patients.

The medical literature contains several reports of infection after mesotherapy. In all cases, the reported infecting organisms were mycobacteria. Multidrug treatment regimens and, in some cases, surgical excision were necessary to successfully treat the infections. There are a large number of protocols or treatment formulas used in mesotherapy. Because each protocol differs from doctor to doctor, it is not possible to test the effect of each formula as a standard protocol for injection lipolysis.

As of late 2008, there are no English language medical journal articles proving the safety or effectiveness of this therapy. No pharmaceutical drug is approved by the U.S. Food and Drug Administration for use in mesotherapy for body contouring. The use of such medications in this manner is considered “off label” and as such it is illegal to commercially advertise non-approved or off label use. Injectable phosphatidylcholine is not approved in the United States for any use. Injectable phosphatidylcholine is manufactured by Aventis Pharmaceuticals (Paris, France) and marketed under the trade name Lipostabil. It is available in several countries outside the United States and can be obtained via the Internet. Isoproterenol (injectable) is approved by the U.S. Food and Drug Administration for the treatment of asthma, shock, and high blood pressure in the lungs and for the temporary control of a slow heart rate the affects blood pressure. Collagenase is approved in the United States for removing dead tissue from skin ulcers and severely burned areas.

In March of 2008 the Kansas Board of Healing Arts, which regulates licensed physicians in the state, prohibited the use of phosphatydalcholine and/or deoxycholate unless as part of an FDA approved clinic trial or as an individual prescription for a specific patient supplied and combined at a pharmacy. In February 2008 the Nebraska legislature introduced a bill prohibiting the injection of these medications for the purpose of reducing or eliminating local fat accumulation, but postponed the bill at its April recess.

In April 2010 Kathleen Anderson, the deputy director of the FDA's Division of New Drugs and Labeling Compliance in reference to proponents of mesotherapy stated: "They make it sound so good and so safe. [They claim] it dissolves fat -- melts it away with no side effects -- and they have done thousands of procedures, and it really sells well. We are really concerned because we have had reports of complications, and we have no good data that say this is safe and this is effective." Side effects reported to the FDA included permanent scarring and deep, painful knots under the skin in areas where the lipodissolve cocktail had been injected.

The FDA then warned six U.S companies:

* Monarch Medspa in King of Prussia, Pa.
* Spa 35 in Boise, Idaho
* Medical Cosmetic Enhancements in Chevy Chase, Md.
* Innovative Directions in Health in Edina, Minn.
* PURE Med Spa in Boca Raton, Fla.
* All About You Med Spa in Madison, Ind.

that if they did not take steps to correct the violations within 15 days, the FDA would seize the products or order an injunction to legally stop the companies from continuing to make these false and misleading claims. Some of the medical spa companies had advertised that the same products could be used to treat a variety of medical conditions such as gynecomastia, lipomas and some surgical deformities.

Addendum December 30, 2012
KYTHERA Biopharmaceuticals Inc's ATX-101 is undergoing trials for the injectable treatment of fat under the chin and so far has been proven to be safe. Study participants received ATX-101 (2mg/cm2) for up to six treatments spaced 28 days apart. The interim results included subjects who had completed Visit 9, or 3 months after the last injection. They are so early in the process that the product does not have a commercial name yet. My personable opinion is there is little use for this because it takes 6 treatments each about a month apart to achieve the result you get with a single 20 minute liposuction surgery that can often be performed under local anesthetic unless the injections are really cheap.

Addendum April 30, 2015
The medication was approved by the FDA this week and will be called Kybella. Patients may receive up to 50 injections in a single treatment, with up to six single treatments administered no less than one month apart. The drug shouldn't be diluted or mixed with other compounds, and its use is not without risk because when it is improperly used, Kybella can destroy non-fat cells along with fat cells. It can cause serious side effects, including nerve injury in the jaw that can cause an uneven smile or facial muscle weakness, and trouble swallowing. The most common side effects of Kybella include swelling, bruising, pain, numbness, redness and areas of hardness in the treatment area. the FDA warned that people who've had prior plastic or other surgery in the area around the chin should only use Kybella with caution. The FDA also warned consumers about counterfeit forms of Kybella. The drug "is being distributed in a dispensing pack that has a unique hologram on the vial label. My opinion has not changed since 2012 but I now believe this medication will become more popular than Botox because it will be injected all over the body not just under the chin despite FDA warnings against doing so.

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1 comment:

  1. very informative post about Mesotherapy thanks for share with us Dr Aaron Stone


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