Selected Text from theAPT Petition on the Safety of the Today Sponge For the full text of the petition, click here |
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Sidebar 2: The Amount of N-9 Released by the Today Sponge.The manufacturer has adopted a convenient fiction that the Today Sponge releases only 125 mg of N-9 during each use. Since each Sponge contains a reservoir of 1,000 mg of N-9, the suggestion of a single number for the amount of N-9 released is immediately suspect. As was pointed out by Dr. William J McCann, in his Medical Officers Review of the Today Sponge for the FDA (FDA, 1983b): ”there is substantial variation in the amount of N-9 eluted from the sponge over time in the individual patient, due in great part to the variation in the amount of vaginal fluids absorbed, seminal fluid absorption, menstrual blood absorbed, numbers of coital episodes and the measure of wetting of the sponge prior to insertion.” Despite the broad array of factors that contribute to “substantial variation” in the amount of N-9 released, the FDA has left unchallenged the assertion that 125 mg of N-9 represents the typical N-9 exposure associated with the use of a Today Sponge. It would seem inherently more credible if the amount released was represented by an upper and lower range of values for a typical user. 125 mg of N-9 is far too small to represent the center of the typical range of exposures derived from the Sponge. |
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