Is Mesotherapy FDA Approved?

There is no conclusive, authoritative information that exists (such as unbiased, peer-reviewed clinical studies that meets the standards of an accepted medical journal) that measures both the efficacy and safety of mesotherapy. Some doctors will tell you mesotherapy is FDA approved because the individual ingredients that are compounded (mixed together) to make mesotherapy may be FDA approved for unrelated purposes, but the FDA hasn't approved mixing and then injecting these ingredients... more

Mesotherapy in the U.S. is most often promoted for cellulite treatment or fat reduction, but it is quite controversial. It is not FDA-approved, but legal because the ingredients are, though for completely different and unrelated procedures. There are some studies ongoing, but the most recent published data has not provided any reason to think that it is safe and effective.

Many dermatologists and plastic surgeons worry about Mesotherapy because they do not understand the outcomes of the treatment. Mesotherapy is a minimally invasive procedure which employs a series of multiple injections of pharmaceutical and homeopathic chemical agents into the selective areas of fat, inducing fat cells to rupture and cause cellular death. A patient may feel burning and irritation at the injection site and experience swelling at the time of the injections and immediately... more

Mesotherapy arrived to United States in the 1990's and since than it has been questioned as far as its safety and effectiveness. Since the arrival it has also been seeking the FDA approval. The Food and Drug Administration has approved many commonly used drugs used in mesotherapy like Aminophylline, Yohimbine, Procaine, Lidocaine, L-Carnitine, but not for the use as a liquid solution for the injections directly into the skin. There are some compounds used by the mesotherapy practitioners... more

Mesotherapy is not FDA approved, although legal as the ingredients are approved. We would definitely not recommend the use of this procedure as no conclusive study exists of its safety or efficacy. Even among its proponents, there is agreement that mesotherapy is often misused as some practitioners tend to use it for large areas, which is definitely beyond the scope of the procedure.