The Return of the Sponge: Women Are Still Waiting
WebMD News Archive
In response to public demand, the FDA even issued a statement in January 1995, shortly after production of the sponge ceased, that said: "The agency did not object to continued production of 'Today Sponge' under appropriate manufacturing and hygienic conditions. Longstanding public health standards, however, do not allow the marketing of contaminated products that present a potential risk of disease transmission."
But a small group of scientists called Associated Pharmacologists and Toxicologists has raised concerns about possible health risks of the sponge ever since the device was introduced in 1983. The organization submitted its latest petition to the FDA last April, asking that approval of the device be withdrawn. The group's members say that the amount of N-9 found in the sponge promotes the survival of disease-causing organisms in the vagina and leads to vaginal irritation and tissue damage.
"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.