Nonsurgical fat removal options limited

Mesotherapy, a non-surgical option, is an injection method for various drugs and drug cocktails geared toward specific cosmetic purposes, and lipolytic lasers. However, neither option possesses adequate research to support its clinical use, according to Lisa M. Donofrio, M.D., associate clinical professor, dermatology, Yale University School of Medicine, and partner at The Savin Center for Dermatology and Cosmetic Surgery in New Haven, Conn.

Regarding mesotherapy, she says, "I have great concerns for both safety and efficacy."

Mesotherapy got its start more than 50 years ago in France as a technique for injecting drugs into the mesoderm (the archaic name for that part of skin derived from the mesoderm embryologically) to treat problems such as tinnitus and pain. Since then, published medical indications for mesotherapy have included musculoskeletal disorders and vascular diseases.

In recent years, however, a variety of practitioners including dermatologists, plastic surgeons, OB/GYN's and emergency room medicine specialists have begun touting mesotherapy with promises that it can achieve everything from weight loss and nonsurgical fat reduction to wrinkle reduction and hair restoration.

In such applications, Dr. Donofrio says that, "to my knowledge and from the patients I have seen, patients are not getting results. How can it be ethical to market something that has not been proven safe or effective?"

She emphasizes that presently, no standardized formulations or injection techniques for mesotherapy exist; therefore, data collection regarding the efficacy and safety of this technique with various drug cocktails is lacking.

One paper

One of the few papers published on this topic in English appeared in bariatric medical literature.

In this study, researchers injected isoproterenol into the thighs of 28 obese women. Although the injected thighs showed decreased girth compared to thighs treated with a placebo, the most statistically significant reduction occurred in patients who also had lost weight (Greenway FL, Bray GA. Clin Ther. 1987;9(6):663-669.).

Other concerns with the safety and efficacy of mesotherapy cocktails include the fact that many of their ingredients - which can include oral and topical medications, as well as vitamins and herbs - are said to be sterilized for use parenterally.

"After heat sterilization," Dr. Donofrio asks, "do these drugs change to an inactive or potentially toxic compound?"

Additional concerns Dr. Donofrio expresses include the possibility that some oral drugs might need to be ingested and undergo conjugation by the liver to become active at all. She also says she wonders if these drugs are truly sterile, and what quality control procedures manufacturers use to assure this, as well as whether drugs intended for topical use require epidermal enzymes for activation.

Correct doses

Correct therapeutic dosages for mesotherapy also remain to be determined.

"When one considers the multiple studies that were done to find the safe dose of lidocaine use in tumescent anesthesia," she says, "one can appreciate the amount of data required to assess safety."

Furthermore, she notes that some mesotherapy drugs are lipid soluble, while others aren't. And it's unclear, she says, which pharmacokinetic law applies to which drug. The potential for drug interactions also raises concerns including whether drugs intended for solo use negate or perhaps intensify each other's effects in combination, and whether drugs used in mesotherapy cocktails interact with medications patients may already be taking for other conditions.

Additionally, Dr. Donofrio notes that in medical literature, reported complications from mesotherapy have included atypical mycobacterial infections, as well as skin atrophy and necrosis.