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The Return of the Sponge: Women Are Still Waiting

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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."

As to the safety of sponges and N-9, Dell says many forms of irritation can increase a woman's risk of contracting HIV. "Any product could irritate the vagina, including the male penis," she says. "This is due to the [skin abrasion] associated with intercourse. This also makes a women eight times more likely to get HIV from an infected man then for a man to get it from a woman."

She doesn't believe that the sponge is dangerous, because it uses the same active ingredient as other barrier methods and foams and gels -- N-9. "I don't think [the sponge] would be approved by the FDA if there was a significant danger," Dell says.

As to the efficacy of contraceptive methods, Dell says, "The problem with barrier methods is for those people who are passionate and in a hurry." The sponge is less effective than other contraceptives, such as hormonal implants or injections, birth control pills, and the IUD, but promises more convenience and lower cost. According to the FDA, use of the sponge brought the same one-year pregnancy rate as a diaphragm, cervical cap, or female condom. The sponge was more effective than spermicide alone, but less effective than the male condom.

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