FDA Warnings on Nonoxynol-9 Re-Define Sponge Worthiness

Elaine’s date tries to convince her that he is “Sponge-Worthy”
The FDA has issued a new ruling requiring manufacturers of contraceptive and spermicidal products containing Nonoxynol-9 to warn users that Nonoxynol-9 does not protect against HIV or other STD’s. Labels must also warn that Nonoxynol-9 can irritate the vagina and rectum, which may increase the risk of contracting HIV/AIDS from an infected partner.

Nonoxyl-9 is the active ingredient in the contraceptive sponge. It’s also found in spermacidal jellies used with diaphragms and cervical caps, and in contraceptive inerts, foam and vaginal film.

Nonoxynol-9 is a surfactant, and acts to disrupt sperm membranes, thus preventing pregnancy. Contraceptive efficacy of N-9 containing spermicides ranges from 70% if used alone to 80-90% when used with a diaphragm. Advantages include absence of hormones and easy reversibility. The disadvantages are that they are less effective than hormonal methods, can cause irritation and can increase HIV transmission if your partner is HIV-infected.

So before you dip into your sponge stock or take out your diaphragm for a guy, better make sure he’s truly worthy and does not carry the HIV virus. If you’re not sure, forget the sponge or diaphragm and use a condom.

TBTAM’s Rules for Spermicide Use

  1. If you are at risk for HIV or if your partner’s HIV status is unknown to you, don’t use Nonoxynol-9 containing contraceptives. Use a non-spermicidal lubricated condom. If you want additional protection against pregnancy beyond that which condoms provide, look towards additional methods that don’t entail spermicide use, like the oral contraceptive.

  2. If you are at low risk for HIV infection, and especially if you know that your partner is HIV negative, go ahead and use whatever contraceptive works best for you, including spermicides, diaphragms and sponges.

  3. The best way to protect yourself against HIV infection is to limit your number of sexual partners, or as TBTAM has said again and again – Save sex for those you love. But since even someone you love could have HIV, both of you should get that HIV test before you stop using a condom or use spermicides.

The Road to the Ruing

We’ve known for some time that Nonoxynol-9 use can increase HIV transmission, from studies of sex-workers in Thailand and Africa, who were found to acquire HIV more often when they used Nonoxynol-9 spermacides along with condoms, compared to their counterparts who used just condoms.

In 2002, the CDC issued a warning against the use of Nonoxynol-9 for HIV or STD prevention, and advised against using spermicidal lubricated condoms for HIV prevention. In response, over a dozen condom manufacturers, including Planned Parenthood, stopped adding spermicides to their products, as did makers of personal lubricants.

But at the FDA, the issue became politicized, since it involved labeling on condoms.

Right-wing advocates of abstinence wanted the label to say that condoms don’t protect against AIDS. AIDS Advocacy Groups wanted to be sure that the labeling did not discourage condom use. Women’s groups were concerned that the warning against spermicides might be applied too broadly, causing women who were at low to no risk of HIV to turn away from effective contraception. Also at the table were the condom manufacturers, some of whom continued to manufacture spermicide-lubricated condoms on the grounds that these condoms are appropriate for couples without HIV. And, I suspect, the instability of the FDA leadership over recent years didn’t help the matter…

In 2003, the GAO, under pressure from the right wing lobbyists, issued a statement against the FDA, urging them to move forward on the labeling change. Four years later, the ruling is finally final.

The FDA warning goes beyond the 2000 CDC message to address the widespread use of Nonoxyl-9 in contraceptives, and to correct any remaining mis-perception that these spermicides protect against HIV.

The ruling also contains wording for condom labels that states that their consistent use greatly reduces, but does not eliminate, the risk of catching or spreading HIV. A nice compromise, I think, on that issue.
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The full FDA Ruling is posted on the FDA Website
Great info on Nonoxynol-9 from IBIS Reproductive Health

5 Responses to FDA Warnings on Nonoxynol-9 Re-Define Sponge Worthiness

  1. Hey TBTAM,
    Perfect post – as usual.

    Can you give us your impression why female condoms never took off to a significant extent? They give a bit of the control back to woman, and due to the nature and size and shape, I would think that men would prefer it too? (Never having had the experience myself, this is just an impression…)

    But, considering the now official warning, woman can take on a bit more control about proper condom usage with a female condom.

    Would love to hear your impressions as someone who is engaged in discussions with women about their sex lives on a regular basis…

  2. Schruggling –

    I think the female condom never took of because it’s, well, a female condom.

    I find that America women in general are not fond of putting things in their vaginas other than tampons, and even these some women are averse to. This explains why the Nuva Ring is not more popular than it is, despite the fact that in my practice experience, it’s an absolutely fabulous method combining the benefits of low dosing with freedomg from daily compliance and low rates of breakthrough bleeding and other side effects. Also why the diappragm has never been the top method, despite its ease of use, and high effectiveness in motivated couples.

    But the female condom is a great method for those who are willing to use it..

  3. Hi,

    The female condom, being polyurethane, makes a disconcerting “crinkling” noise during intercourse, and looks like a frat party joke. Also, it’s relatively expensive at about $3.50 a pop. Too bad, because it is a great idea. Thanks.

  4. Anonymous –

    I’m not sure the noise bothers everyone, or happens with everyone, and the expense may be worth it to some women. Condoms don’t look any prettier if you ask me. The important thing is that both of these methods are out there as an option. And the more options, the better the odds each woman or couple will find the right method for them.

    Peace, TBTAM

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