Cellulite Mesotherapy

A Cautious Look At Mesotherapy For Fat Reduction

Mesotherapy is a controversial technique in which substances are injected into the layer of fat and connective tissue under the skin. It was originally used for pain relief, but in recent years it has been widely promoted to "rejuvenate" the skin, "melt the fat", reduce "cellulite" and give other contour to the body.

The injected ingredients may include agents that are used to open the blood vessels, nonsteroidal anti-inflammatory drugs, enzymes, nutrients, antibiotics and hormones. Treatment sessions consist of multiple small injections of a liquid formula in the area(s) of interest through a fine needle attached to a syringe or a syringe gun. The depth and the quantity applied in every injection, and the treatment intervals vary according to the condition being treated.

Searching on Google, I found rates ranging from $130 to $600 per body part, per session, plus the charge for the first consultation.

It is recommended for a person to have 3-15 sessions. Mesotherapy is not covered by health insurance. Most who practice this are doctors, but others are inexperienced non-medical staff.

The main ingredient in the liquid is phosphatidylcholine, a compound derived from soy, also a component of cell membranes in many organisms, including humans. Deoxycholate is a natural bile salt used to maintain phosphatidylcholine water soluble. The ratio of the two compounds in a given formula may differ substantially from one supplier to another. Some also add small amounts of other drugs, vitamins, and/or herbs. The safety or efficacy of these in the removal of fat has not been scientifically proven.

Phosphatidylcholine is a prescription drug marketed as Lipostabil, it is authorized for intravenous use in Germany in the treatment of blockages of blood vessels by dissolving fat particles (fat embolism). It is not licensed for subcutaneous injection in cosmetic surgery, a procedure that its manufacturer, Sanofi-Aventis, warns in its product sheet. In the United States, where Lipostabil lacks FDA approval, providers can get their compounds from pharmacies that blend the ingredients that are requested.


Adverse Reports

A laboratory study comparing the effects of phosphatidylcholine and sodium deoxycholate, and two common laboratory detergents noted that phosphatidylcholine can disrupt the cells. However, the researchers thought deoxycholate was more potent and said doctors should be cautious until adequate safety data is available.

Adverse reactions to cosmetic mesotherapy have been reported. Adverse events include localized swelling, redness, bruising, irregular contours, and tender nodules under the skin. Hives and other skin reactions to injectable drugs and mycobacterial infections have also been reported. Systemic side effects of phosphatidylcholine are mild transient elevations of liver values and even nausea and vomiting after large volume injections. A major British law firm is representing a young woman who is suing a surgeon who injected Lipostabil. The lawsuit states that she developed an infection in both legs which required hospitalization for surgical repair, that she lost more than 4 months of work (due to pain), and has extensive scarring requiring additional surgery.

The Better Business Bureau of Eastern Missouri and Southern Illinois has received more than 400 complaints about FIG (working under the name of Advanced Lipo Dissolve Center), which operates in clinics in Missouri and other states. Most of the problems are due to failure in reimbursements, but some complainants reported that the procedure was ineffective and caused swelling and pain. FIG closed most of its clinics in December 2007 and subsequently filed for bankruptcy.

In April 2008, the television network ABC in its "20/20" show highlighted the story of three women who developed serious complications after Lipodissolve injections. Two of them were treated in FIG, and the other one was treated at Pure Med Spa in St. Louis. Journalists who went to Pure Med Spa with hidden cameras noted that possible clients were not adequately warned about the complications of such procedures.

Groups of professionals representing plastic surgeons and dermatologists in the United States have warned about mesotherapy.

  • In 2005, the American Society of Plastic Surgeons and the Device and Technology Assessment (DATA) published a report advising patients to be wary of mesotherapy until the safety and efficacy of the procedure were confirmed.

  • In 2006, the American Society for Dermatologic Surgery concluded:

    • Despite the growing popularity of mesotherapy, there are limited data available and information is not randomly obtained, double-blind controlled studies unequivocally establish that the procedure is safe and effective for medical and aesthetic conditions.

    • Localized diet and exercises for resistant fat deposits can be safely improved by surgical body contouring procedures such as tumescent liposuction.

    • There are many causes for aging including photoaging and changes due to old age, and there are now many alternatives approved by the FDA to address the stigma of facial aging. Mesotherapy ultimately may become a viable complement or option on these concerns, but the study will be discussed further before this technique can be approved.

    • Controlled research is recommended to determine the optimal formulation and treatment regimes, as well as the effectiveness, safety and a better understanding of the mechanisms of action of this procedure.

  • In 2007, the American Society for Aesthetic Plastic Surgery warned about the use of procedures through injections to lose fat until data were available to demonstrate safety and effectiveness. To help solve the problem the Foundation for Education and Research of Cosmetic Surgery is sponsoring a clinical study controlled through placebos that will follow 20 patients for 46 weeks to evaluate the effectiveness of phosphatidylcholine/deoxycholate and thus collect data on local and systemic reactions, as well as long-term complications.


Regulatory Actions

In 2003, the FDA warned a Lipostabil salesman, that it was an unapproved new drug, and it was illegal on the market without FDA approval. That same year, the Brazilian National Agency concluded that data were lacking scientific support and prohibited its use for spot fat reduction. The Department of Health in Canada issued a similar warning in 2004. The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has stated that Lipostabil cannot be legally imported or advertised for cosmetic purposes.

In August 2007, the Kansas State Board of Healing Arts voted to consider the use of mesotherapy for aesthetic purposes as "dishonorable conduct" unless it is part of a clinical trial approved by the FDA under the application of a New Drug under Research. However, FIG obtained a court order blocking the ban until the Council go to a public hearing.


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