In The Cellulite Cure, this month’s cellulite BOTM, Dr. Lionel Bissoon explains how mesotherapy works on cellulite. The treatment involves multiple injections of small doses of pharmaceuticals, homeopathic medications, and vitamins into the mesoderm, the layer of tissue under the skin.
Mesotherapy is sometimes considered controversial because it’s not FDA approved. Usually when I hear a phrase like “not FDA approved” I immediately move on. I am inclined to err on the side of safety but, once again, the matter is not as straightforward as it first appears.
Chapter Ten in Dr. Bissoon’s book is entitled “Mesotherapy and the FDA.” Now you know how much you mean to me, dear CI readers, because I actually read this whole tedious chapter in order to summarize it here for you.
The entire chapter takes the form of a 13-page interview with former FDA Chief Counsel Peter Hutt. The opening question is “What was the origin of the Food and Drug Administration?” followed by “When did federal regulation of pharmaceutical products begin?” Riveting reading, for sure.
I will spare you all the details, and just tell you that mesotherapy is not FDA approved because the FDA is not responsible for approving medical techniques and procedures. The medications and devices used in mesotherapy are FDA approved, but the technique of injecting them into the skin to treat cellulite is not. Here’s a quote from Mr. Hutt to explain further:
FDA adopted a policy in 1972, and has reiterated it many times since then, that a physician has the lawful right to prescribe any FDA-approved drug for an unapproved use, as part of the practice of medicine.
This is where the media bias towards fast and uncomplicated news stories comes into play again. When a journalist wants to write an article on mesotherapy, they usually include a section about safety. Dr. Bissoon has had to explain the FDA issue many times, but the media usually cuts out the details of his answer and reports that mesotherapy “does not have FDA approval.”
This simple phrase conjures ideas of strange and experimental treatments with untested results and mysterious side effects. Yet mesotherapy has been used in Europe for over fifty years without any serious mishaps. According to Dr. Bissoon, only ten cases of mesotherapy-related infection have ever been reported in the medical literature.
Let me be clear, this post is about the issue of safety and FDA approval for mesotherapy. I am not recommending mesotherapy as an effective treatment for cellulite (that is a subject for a separate post altogether).
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