The recent FDA inquest on the safety and efficacy of dermal fillers has freaked-out the likes of Allergan, which makes several such products, including Juvederm; Sanofi Aventis SA, which makes Sculptra; Medicis, the maker of Restylane and Perlane; Artes Medical, which makes Artefill; and BioForm Medical, which sells Radiesse. 

Product labels on popular cosmetic wrinkle fillers should be strengthened to warn consumers about scarring and other problems that can crop up weeks or years after receiving the treatments, the FDA said November 18, 2008.

The panel said current product labels on fillers approved to plump certain facial lines are inadequate and only discuss immediate and temporary side effects, such as swelling. While an FDA review of reported adverse events associated with dermal fillers showed many expected side effects like temporary swelling and redness, the agency said “there are a number of adverse events that are serious and unexpected.”

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Las Vegas-based cosmetic surgeon Stephen Seldon and his office manager/wife, Deborah, are on trial for signing agreements with patients confirming that he would use Botox, but instead injecting them with a cheaper, nongovernment-approved product called TRItox. (Hat Tip: Las Vegas Review Journal.)

The couple is charged with mail fraud and misbranding a drug held for sale. According to the government, during a 1-year period that ended in October 2004, the couple purchased 19,000 units of TRItox for $36,925, half the cost of Botox. Seldon is more accurately an ear, nose, and throat specialist who apparently has dabbled in cosmetic surgery.

"The defendants were interested in padding their bank accounts and, in doing so, used their patients as guinea pigs," Assistant US Attorney Crane Pomerantz told jurors, referring to the use of TRItox.

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The Beverly Hills Rhinoplasty Surgery Blog published a worthwhile critique of a 2007 report -- published in the Archives of Dermatology -- that claimed that the injection of crosslinked hyaluronic acid fillers, such as  Restylane and Juvederm, stimulated new collagen production. A new study looked at the injection of Radiesse and found no increase in collagen production.

Peyman Solieman, MD, and Jason Litner, MD, FRCSC, write:

We decided to review both papers to see if we could find the source of the discrepancy, and we think we may have. It seems that those who cite the original Restylane paper may not have noticed that, in the study, volunteers had an entire syringe of Restylane injected in one small area identified on the forearm. One to three separate sites were injected this way and then samples were taken that showed increased collagen production. Why is this important?

Simply put, this study does not make a lot of sense for at least 2 reasons. First, and most important, no one injects an entire syringe of Restylane into one designated area. It is generally used in the face to fill in wrinkles distributed over some distance. Since the doctors propose that mechanical stretch is the reason they think new collagen production is induced, we now can discern that it would take a whole lot of Restylane to be injected into any one area of the face to allow for collagen production. Not only would this likely be cost prohibitive, but it would also counter normal aesthetics. Second, the study used the forearm of participants to examine the effects, and we know that skin from different areas of the body respond differently to injection of these fillers.

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