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    021836

    TSS reported in 4 users of contraceptive sponge.

    Ob Gyn News. 1984 Mar 15-31; 19(6):3.

    4 cases of toxic shock syndrome (TSS) were reported late last year among users of the new Today vaginal contraceptive sponge, according to the Centers for Disease Control. Although it has not been conclusively determined that TSS is associated with contraceptive sponge use, physicians should be aware "that a potential problem may exist," the CDC says. Bruce Vorhauer, Ph.D., founder and president of the device's manufacturer, VLI Corporation, Irvine, California, said the CDC report indicates that the contraceptive sponge was used improperly in at least 3 of the cases. In 1 case, a California woman left the contraceptive sponge in place for 32 hours and had difficulty removing it; another California woman left the sponge in place for 5 days. According to instructions included with the sponge, it should not be left in place for longer than 30 hours, Dr. Vorhauer said in a telephone interview with this newspaper. In another case, a Georgia woman used the sponge for the 1st time 37 days postpartum. The company had recommended that postpartal women, who may be at an increased risk of developing TSS, should seek a physician's advice before using the contraceptive sponge. In the 4th case, an Oregon woman reported TSS symptoms following tearing of the sponge during several unsuccessful attempts to remove it, the investigator said. All of the women had fever, hypotension, diffuse rash, desquamation, nausea, vomiting, myalgias, mucus-membrane hyperemia, and vaginal discharge, according to the CDC report. Vaginal culture in each case revealed Staphylococcus aureus, a bacterium believed to be responsible for TSS. None of the women were menstruating at the reported onset of the symptoms. Each of the patients was hospitalized and treated with intravenous fluids and antimicrobial agents. All of the women recovered. Although VLI is seeking to determine whether the illnesses reported to the CDC were in fact TSS, it has agreed to highlight the warning about TSS on the sponge's package insert and place a similar warning on the outer wrapper of the product (Ob. Gyn. News, Jan. 15, 1984, p.43). Since early 1984, more than 8 million of the contraceptive sponges have been distributed nationwide, and there are more than 400,000 users, he pointed out. The sponges are expected to be available in every state soon, Dr. Vorhauer said. (full text)
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