Summary: Soft-tissue augmentation has seen a renaissance of interest, as an increasing number of patients seek aesthetic improvement without major downtime. Although injectable agents for soft-tissue augmentation have been widely available for more than 20 years, the renewed interest has been fueled in part by the introduction of botulinum toxin type A. The unequivocal establishment of predictable and aesthetic results, initially and primarily in the upper face, created a need for an agent that would work equally well in the lower face and that could be administered in an office setting. The marriage of these two injectables (hyaluronic acid and botulinum toxin type A) began with the escalating popularity of both of these substances individually and the realization that a more global aesthetic enhancement is provided by combining these agents in custom proportions to achieve maximum aesthetic effects. Although the authors discuss most of the related, available hyaluronic acid and botulinum toxin agents, their clinical experiences, and the scientific data regarding these products, they realize that the discussions have been weighted toward the products that have been available for use in the United States the longest. In this article, they attempt to explain some of the results of prior (to U.S. Food and Drug Administration approval) studies that have been the subject themselves of some confusion, and provide a rationale for using hyaluronic acids and botulinum toxin for facial enhancement independently and in combination.
Los Angeles, Calif.; and Boca Raton, Fla.
From the Department of Medicine and Dermatology, University of California, Los Angeles, and Aesthetic Eyelid Plastic Surgery.
FDA Status and Approved Uses: Hyaluronic acid products are FDA approved for filling moderate to severe facial wrinkles and folds around the nose and mouth. Restylane is FDA approved as an injectable gel to treat facial wrinkles. Juvéderm (Ultra and Ultra Plus) is FDA approved. Hylaform is approved by the FDA for injection into the mid- to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). Captique is FDA approved for injection into the mid- to deep dermis for correction of moderate to severe facial wrinkles. Botox is FDA approved for use in the glabellar region. All other uses are considered off-label.
Received for publication March 3, 2006; accepted September 11, 2006.
Steven Fagien, M.D., 660 Glades Road, Suite 210, Boca Raton, Fla. 33431, email@example.com