By Richard G. Glogau, M.D.
Lip enhancement can produce aesthetically pleasing results, but, increasingly, the procedure is being undertaken by ill-informed or untrained physicians and, more often, nonphysicians, who are using inappropriate fillers. The lack of experience and knowledge is threatening patient safety.
The Food and Drug Administration has never approved any therapy for lip augmentation—be it an injectable, such as botulinum toxin, or any of the collagen products on the market. Yet lip augmentation can be done safely, using the appropriate product.
However, the lack of a formal approval, the relative absence of regulatory oversight, and the profitability of administering injectables is making it possible for subpar and illegal practices to thrive.
Injectables are already the most popular cosmetic procedure—surgical or nonsurgical. Out of a total of 11.7 million cosmetic procedures in 2007, there were 2.7 million Botox Cosmetic (onabotulinumtoxinA) injections, and 1.4 million injections of hyaluronic acid products, according to the American Society for Aesthetic Plastic Surgery.
When it comes to lip augmentation, it is best to stay away from any product that lasts too long. Given the nature of the lip anatomy, the filler will sometimes not stay exactly where it was placed. That migration is much easier to address when a temporary filler, such as any of the hyaluronic acid–based products, Restylane (Medicis Aesthetics Inc.), Hylaform (Inamed Aesthetics), Juvéderm Ultra or Ultra Plus (Allergan Inc.), and Prevelle Silk (Mentor Corp.), are used.
Collagen injectables, such as Allergan's CosmoPlast and Zyderm, are easier to use superficially, and thus, in some ways, make it more feasible to sculpt the lip. But the hyaluronic acid injectables last at least 6 months, giving the patient a little bit more value.
The longest-lasting fillers are the synthetic products, which include Artefill (Suneva Medical Inc.), Radiesse (BioForm Medical Inc.), or Sculptra (Sanofi-Aventis). They are often presented to patients as a way to save money—because of the duration of the results, the patient can receive one treatment and be satisfied for at least a year, if not for a lifetime.
When the filler starts to migrate—which is always a danger with the lip—it can create unsightly lumps or bumps, sometimes leading to permanent disfigurement. Some patients may experience decreased sensitivity or granuloma reactions.
Clearly, with the use of the more permanent fillers, the risk-benefit ratio is exceeded. But there are plenty of patients being injected with these materials, often overseas, where hundreds of fillers are offered. Many patients are tempted to get injected when they're abroad, but they can return with problems and without any idea of what type of material was injected.
The filler manufacturers and the FDA have not stepped in to restrict inappropriate use of these products. The FDA does not regulate the practice of medicine, and the manufacturers must, by law, sell their products to anyone who has a medical license.
The problem is only likely to get worse, as the financial incentives that come with injectables are just too powerful for many to resist.
For now, cosmetic dermatologists should err on the side of safety and stick with the most appropriate lip augmentation products. Your patients will thank you in the long run.
Dr. Glogau is clinical professor of dermatology at the University of California, San Francisco. He is a paid consultant and clinical investigator for Allergan, Revance Thearpeutics, and Medicis. He has also served as a clinical investigator for Contura. To respond to this column, contact Dr. Glogau at sknews@elsevier.com.