AEGiS-Chicago Tribune: Sculptra skin filler promising but largely untested

Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.

Sculptra skin filler promising but largely untested

Chicago Tribune - August 29, 2004
Julie Deardorff, Tribune staff reporter

Sculptra, the latest weapon against what has been called the modern scarlet letter--cheek wasting--consists of a chemical called synthetic polylactic acid that has been used in dissolvable stitches, bone screws and facial implants. But though it has been shown to increase skin thickness and add volume to facial tissue in a small sample of HIV-positive white men, other populations--including healthy ones--need to be tested. Men normally have thicker skin than women, while ethnicity is another variable. Irish skin, for example, is thinner than Asian skin, said Dr. Iliana Sweis of the North Shore Center for Plastic Surgery.

As a condition of approval by the Food and Drug Administration, the manufacturer, Dermik Laboratories, will study 100 patients, including at least 30 women and 30 people with dark skin, for five years to evaluate Sculptra's long-term safety. Long-term side effects are not known because follow-up data in the studies cited to the FDA were kept for only two years. Short-term reactions can include bleeding, hematomas, infections, abscesses and damage to the nerves, according to German doctor Ziya Saylan, who has used the product for several years and testified before the FDA.

"The material creates an inflammatory reaction by irritating the surrounding tissue," said Dr. Ed Lorenc, associate professor of plastic surgery at New York University Medical School, who, like Sweis, won't offer Sculptra to patients for purely cosmetic reasons. "That's where you get the effect. But [in HIV patients] the immune system is suppressed. How will that translate in someone who is not immune compromised?"

Time will tell, because doctors are free to prescribe it to healthy people for off-label use.

040829
CT040814

Copyright © 2004 - Chicago Tribune. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Chicago Tribune, Permissions Desk, 435 North Michigan Avenue, Chicago, IL 60611 http://www.chicagotribune.com

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, the Elton John AIDS Foundation, National Library of Medicine, Pacific Life Foundation, and donations from users like you.

Always watch for outdated information. This article first appeared in 2004. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2004. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .