Making cosmetic dermatology safer

February 1, 2008

Over the past five years, the words "mesotherapy" and "LipoDissolve" have become a part of mainstream lingo, appearing on billboards, TV and in newspaper ads.

Key Points

Over the past five years, the words "mesotherapy" and "LipoDissolve" have become a part of mainstream lingo, appearing on billboards, TV and in newspaper ads.

While this procedure promises a quick recovery and little or no pain, the reality may be different when one looks at the Web site of the St. Louis Better Business Bureau, which tallied 103 complaints against Fig, one of the two main distributors of this product and owner of many franchises bearing the name LipoDissolve.

I should note at this point that I want to believe that this process is eventually going to be successful.

It is a paradigm-changing procedure, and potentially one that will be a welcome addition to the armamentarium of dermatology procedures - but only once it is proven safe and effective!

As the immediate past president of the American Society of Cosmetic Dermatology and Aesthetic Surgery, and a practicing dermatologist/cosmetic surgeon, I have too much respect for the field to downplay patient safety.

Having witnessed the downturn in cosmetic surgery that happened after publicized liposuction deaths in 1998 and the fake Botox scare of 2005, I take very seriously that any product we use on patients should be thoroughly tested prior to introduction.

As part of my practice, I perform clinical trials on many compounds and realize the incredible expense and effort that companies devote to bringing a product such as this to market.

In fact, as a disclosure, I am currently working with a company, Kythera, which is going through this rigorous process to bring a similar compound to market, which is one reason that I became aware of this debate and the lack of approval of the forms of PC/DC on the market.

Kythera will have to abide by FDA regulations, and may or may not succeed after investing millions of dollars in testing.

The currently available forms of PC/DC, some of which are in kits that can easily be purchased over the Internet and self-injected, are produced by a shadowy network of pharmacies located in the United States, Brazil and Europe.

Since the materials and process have had absolutely no FDA oversight, there can and have been errors, some of which have resulted in potential lifelong disfigurement for those unfortunate individuals who were desperately trying for a simple alternative to liposuction.

Having spoken with several of these individuals, I can say that the result has changed their lives dramatically, and they would give anything to erase the long period of suffering while they went from doctor to doctor looking for a solution to LipoDissolve-related problems.

It doesn't help that these problems resulted from the injection of a foreign substance that is already gone, and a group of nonmedical injectors or corporate apologists wish to sweep bad results under the rug.

Recently, I have worked with Nebraska State Sen. Rich Pahls to introduce legislation in my state to ban the use of any unapproved forms of PC/DC.

This has come too late for many, including one young woman from Lincoln, Neb., who was injected in the back room of a salon and suffered severe disfigurement, which has been documented in the minutes of the recent successful effort to ban aspects of LipoDissolve in Kansas.

While there is sometimes a distrust of the FDA and its intentions in dermatology circles - especially after recent draconian restrictions on topical immunomodulators and Accutane, and potential challenges to the use of hydroquinone - it is only reasonable to look for a balance in the area of scrutiny of PC/DC.