Use of the TODAY contraceptive sponge in the U.S. has been monitored in three ways since it became an OTC product in June, 1983: The Phase III clinical trials in the U.S. were extended for a second year (Life Table method efficacy rate for a second year of use = 96.6%; N = 103). The manufacturer has solicited comments and complaints from family planning professionals and from women who purchased sponges over-the-counter. One complaint has been received for every 33,000 sponges distributed, primarily related to removal difficulty, infection and allergy to spermicide. By December of 1984, there were an estimated 1.25 million sponge users in the U.S. Voluntary, spontaneous reporting to regulatory or health agencies has tracked case reports of toxic shock syndrome (TSS) in sponge users. To date 13 cases have been reported with over 25 million sponges sold. The risk of TSS in sponge users is thus very small and may not represent an increased risk over baseline.