The Return of the Sponge: Women Are Still Waiting
"The Today Sponge has 10 times more nonoxynol-9 than other products," says the group's president, reproductive toxicologist Armand Lione, PhD. "It's a detergent, and there is growing concern about nonoxynol-9. It was hoped that it would kill off HIV, but the degeneration it causes to the wall of the vagina actually increases the possibility of infection."
Data on this are conflicting. Some lab studies did show that N-9 inactivates HIV, the virus that causes AIDS. And a related investigation of women using products containing the ingredient showed that N-9 reduced their risk of getting gonorrhea and chlamydia.
But a major study by the Joint United Nations Program on AIDS showed a 50% increased HIV infection rate in African prostitutes using N-9 gel, compared with those who used a placebo vaginal gel. These findings prompted the CDC to issue a "Dear Colleague" letter saying: "The adverse effects might not be seen at the same level among women who are using spermicides with N-9 less frequently or in different formulations. ... [However,] this study suggests that the use of N-9 for HIV prevention may be harmful." The letter went on to note that the CDC has never recommended N-9 alone for HIV prevention.
It should be kept in mind that the study participants were high-risk sex workers, who were advised to use one of the gels along with condoms. Still, the CDC and other health officials plan to meet to consider revising the official guidelines for the use of N-9 for HIV prevention, and for pregnancy prevention in some people at high risk for HIV.
So, with those concerns about N-9, how safe and effective is the vaginal sponge? The debate continues. But FDA research into side effects from the sponge, including toxic shock syndrome (TSS), show that the risk factor is very low. Among the most frequent side effects reported were difficulty in removing the sponge, vaginal discharge, and irritation.
Allendale Pharmaceuticals has already set up a Today TalkLine, a telephone hot line for women who experience problems with the sponge or who have questions about it. The company notes on its web site that the sponge "should not be left in place for more than 30 hours after insertion (which includes the six-hour waiting period after the last act of intercourse)" and that it should not be used during menstruation; immediately after childbirth, miscarriage, or other termination of pregnancy; or by women who have ever been diagnosed with toxic shock syndrome.
Diana Dell, MD, a Duke University assistant professor of obstetrics and gynecology, says many of her patients used the sponge during the 12 years it was on the market, and most were satisfied with it. "They liked the convenience," she tells WebMD. "Most of them were in the middle-age range, in stable relationships, had a couple of kids but weren't ready to have their tubes tied."