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Table 1. Classification of U.S. Food and Drug Administration–Approved Injectables

Lemperle, Gottfried M.D., Ph.D.; Rullan, Peter P. M.D.; Gauthier-Hazan, Nelly M.D.

doi: 10.1097/01.prs.0000234672.69287.77
COSMETIC: ORIGINAL ARTICLES

Summary: All fillers are associated with the risk of both early and late complications. Early side effects such as swelling, redness, and bruising occur after intradermal or subdermal injections. The patient has to be aware of and accept these risks. Adverse events that last longer than 2 weeks can be attributable to technical shortcomings (e.g., too superficial an implantation of a long-lasting filler substance). Such adverse events can be treated with intradermal 5-fluorouracil, steroid injections, vascular lasers, or intense pulsed light, and later with dermabrasion or shaving. Late adverse events also include immunologic phenomena such as late-onset allergy and nonallergic foreign body granuloma. Both react well to intralesional steroid injections, which often have to be repeated to establish the right dose. Surgical excisions shall remain the last option and are indicated for hard lumps in the lips and visible hard nodules or hard granuloma in the subcutaneous fat.

San Diego and Chula Vista, Calif.; and Paris, France

From the Division of Plastic Surgery, University of California, Dermatology Institute, and a private cosmetic practice.

Received for publication March 12, 2006; accepted May 12, 2006.

For a complete list of the FDA status and approved uses for the fillers mentioned in this supplement, please see Table 1. As of this article’s acceptance for publication in Plastic and Reconstructive Surgery, ArteFill, a product of Artes Medical, had not yet been approved by the FDA. For further information, please visit the following Web sites: www.plasticsurgery.org/news_room/press_releases/Injectables-at-a-Glance.cfm or www.surgery.org/press/news-release.php?iid=320&section=news-botox.

Table 1

Table 1

Gottfried Lemperle, M.D., Ph.D., 302 Prospect Street, Suite 1, La Jolla, Calif. 92037, glemperle@aol.com

©2006American Society of Plastic Surgeons