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  • Title: Sponge subject of research, controversy in second year.
    Journal: Contracept Technol Update; 1985 Jul; 6(7):93-6. PubMed ID: 12280148.
    Abstract:
    The Today contraceptive sponge is the leading over-the-counter contraceptive for women after 2 years on the market, despite continuing questions about its efficacy and suspected link to toxic shock syndrome (TSS). About 1.5 million women use the sponge and more than 35 million sponges have been sold since the method was approved by the US Food and Drug Administration in 1983. The sponge, made of polyurethane and containing 1 gm of nonoxynol-9 spermicide, has 3 contraceptive features: spermicide release, formation of a barrier over the cervix, and absorption of vaginal secretions and semen. Among concerns that have arisen in the sponge's 2nd year are results of US trials comparing the sponge and diaphragm which showed pregnancy rates for parous users that were twice as high as those of nulliparous users; an in vitro study which concluded that growth and toxin production of TSS-associated staphylococcus aureus is limited in sponge users; changes in the package insert to highlight efficacy data and warnings; and an increase of about 25% in the price of the sponge. The sponge's package insert claims that the life table pregnancy rates among women using the sponge correctly and consistently decline from 8.9-10.7% in the 1st year to 3.4% in the 2nd year. US trials involved about 200 parous women, while worldwide trials including over 800 parous women showed no differences in effectiveness rates by parity. Defenders of the sponge argue that in the US, motivational factors involve age and marital status as well as parity. Some researchers have suggested that parous women may need a larger sponge, possibly because of weaker vaginal muscle tone, but the manufacturer, VLI Corporation, will probably not change the size of the sponge. Recent comparisons of diaphragms and cervical caps, both fitted methods, have also shown a statistically greater pregancy rate among parous women. Laboratory analyses conducted by VLI Corportation's department of research and development showed that the sponge inhibited growth and toxin production of 7 toxigenic strains of S. aureus under all experimental conditions. Researchers believed the citrate buffering system and the nonoxynol-9 in the sponge caused the antibacterial activity. A spokesman for the Centers for Disease Control however stated that 20 definite and 10-15 probable cases of TSS in sponge users have been recorded since 1983. A CDC spokesman said that the chances of getting TSS were about 1 in 1 million for sponge users, but advised that women not use the sponge during menstruation, postpartum, or if there is a history of TSS. The sponge should be completely removed within 30 hours, with medical assistance if necessary. Users should be aware of TSS warning signs.
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