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FDA Panel Endorses New Female Condom

Posted by Chrissie Cole
Thursday, December 18, 2008 12:10 AM EST
Category: Major Medical
Tags: FDA and Prescription Drugs, Sexually Transmitted Disease, Women's Health, Female Condom, FC2, Public Health

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IMAGE SOURCE: © Wikimedia Commons / FC2 female condom / author: Anka Grzywacz

A Food and Drug Administration (FDA) advisory panel has approved a new, cheaper version of the FC1 female condom.

If the FDA agrees with the panel’s recommendation, as expected, the contraceptive – designed to protect women from sexually transmitted diseases – could be become available by mid-2009 in the U.S.

The panel unanimously voted 15-0 for approval.

The product has been unpopular in the past, largely because it is priced much higher than the traditional male condom, which is free on many college campuses. Female condoms, however, cost about $3.

The cost of the second generation product is expected to be 30 percent less than the current version, making female condoms more affordable to public health organizations and individuals, said Mary Ann Leeper, strategic adviser to Female Health Co., the Chicago firm that manufactures the product.

Users also complained that it was difficult to insert, slippery and sometimes squeaky during sexual intercourse.

The second generation is quieter, with panelists saying the new, softer material could attract more American women.

"When discussing the product with my patients ... the biggest concern they have is that it's noisy ... 'snap, crackle, pop'," said Paula Hillard, a gynecologist at Stanford University Medical Center.

The current product requires welding sheets of polyurethane to form a sheath, then welding rings at each end. The second generation product, made of synthetic rubber, uses a simpler method similar to male condoms that should cut costs, the company said.

The agency first approved the original female condom, known as FC1 (female condom 1), in May 1993. Since its approval, 165 million FC1 Female Condoms have been distributed in 142 countries.

The company is hopeful that the second generation product, known as FC2 (female condom 2), will expand market and sales, Leeper said. Over 22 million FC2 female condoms have been distributed in 77 countries.

A dozen or more health advocates urged the panel to support FC2 saying its use was crucial to help more women protect themselves. The female product, unlike male condoms, can be inserted well before sexual intercourse.

“For women, this is more than just controlling pregnancy: It’s about protecting their health and potentially saving lives,” said Catherine Christeller, executive director of the Chicago Women’s AIDS Project, one of the organizations listed.

HIV attacks normal, healthy genital tissue, suggests a newly released study by U.S. researchers, which offers new insights into how the virus spreads. Women and female adolescents account for 26 percent of all new HIV cases in the U.S. #


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