Avanti overcomes safety concerns raised by FDA. Food and Drug Administration. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023.

Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

Avanti overcomes safety concerns raised by FDA. Food and Drug Administration. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023.

AIDS Alert. 1995 Jan;10(1):4-6. Unique Identifier : AIDSLINE AIDS/95700022

Abstract: The Food and Drug Administration (FDA) scrutinized changes made to the Avanti polyurethane condom after it was first approved in 1989. Specifically, it questioned test results showing that the Avanti material did not biodegrade under relatively mild conditions. Certain polyurethanes can biodegrade under relatively mild conditions, and may release toluene diamine, a known carcinogen, and diaminodiphenylmethane, a potential toxin. According to one of the Avanti inventors, these chemicals do not exist in the condom, but FDA still required a full battery of toxicity tests. FDA also questioned the safety and reliability of the Avanti retention ring, used to prevent slipping, which is made of non-allergenic, synthetic rubber, and is encased in the polyurethane sheath, protecting it from oil-based lubricants. Durability tests show that the condom is stable for up to five years. The Avanti will have an expiration date of three years.

Keywords: Canada Condoms/ADVERSE EFFECTS/*STANDARDS Equipment Failure Human Male Materials Testing/METHODS Polyurethanes Safety United States United States Food and Drug Administration NEWSLETTER ARTICLE
950430
M9541102

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Boehringer Ingelheim, Bridgestone/Firestone Charitable Trust, Bristol-Myers Squibb Company, Elton John AIDS Foundation, Gill Foundation, the National Library of Medicine, Quest Diagnostics, Roche and Trimeris, and donations from users like you. Always watch for outdated information. This article first appeared in 1995. 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, 1995. 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. .