Is Mesotherapy FDA Approved?

The doctor I saw said mesotherapy is FDA approved and showed me pictures of people who looked so much younger when they had it injected in their faces. They really looked good! I am considering the treatment and want to know, is it true that mesotherapy is FDA approved?

Doctor Answers 6

Mesotherapy is not FDA approved

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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.

Mesotherapy or any compounded substance, whether it is comprised of medications, supplements or both, is unsafe and should not be injected into your body for any reason.

Eugene Plastic Surgeon
4.3 out of 5 stars 14 reviews

Mesotherapy in the U.S. is most often promoted for...

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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.

Richard Baxter, MD
Seattle Plastic Surgeon
4.9 out of 5 stars 59 reviews

Mesotherapy is not FDA approved

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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 that do not have the FDA approval like vitamins, minerals, biotin. There are not considered drug or foods. So far there are no new updates on the subject from FDA.

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Beware! Mesotherapy is not FDA approved

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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 afterwards. The most common agents injected are Phosphatidylcholine/Sodium Deoxycholate.

Personally, I have been very interested in Mesotherapy, but I am reluctant to use it until I know I can expect a consistent positive outcome. Therefore, I must recommend that you be extremely cautious. If you remain insistent on Mesotherapy, you should seek treatment by physicians who are properly trained and certified by The American Board of Aesthetic Mesotherapy.

Mesotherapy is not FDA approved. The FDA cannot control the use of practitioners performing Mesotherapy because this practice falls under the jurisdiction of state medical boards. Therefore, check with your state medical boards to see if Mesotherapy treatments are permitted.

Thank you for your question, and I hope this helps.

Stephen A. Goldstein, MD
Englewood Plastic Surgeon

Mesotherapy is not FDA-approved

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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.

Kris M. Reddy, MD, FACS
West Palm Beach Plastic Surgeon
4.5 out of 5 stars 56 reviews

Mesotherapy Beware!

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If there are questions about the safety and effectiveness, and mesotherapy is NOT approved by the FDA, then what is this "American Board of Aesthetic Mesotherapy"?!

It certainly is not a board recognized by the American Board of Medical Specialties of the AMA and should not have any relevance just because they call it "American Board of...". Any group of physicians can get together and somehow form a "Board". Check with your local medical societies or the AMA.

In spite of this there are ongoing studies to define if mesotherapy can be safe and effective and under what conditions. I for one would not want to be the guinea pig.

Theodore Katz, MD, FACS
Philadelphia Plastic Surgeon

These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.