Toxic-Shock Syndrome and the Vaginal Contraceptive Sponge

Four reported cases of toxic-shock syndrome (TSS) meeting CDC criteria (1) occurred in late 1983 among users of the vaginal contraceptive sponge (Today*). The first patient, a Georgia resident, developed symptoms on October 16, while using a sponge for the first time. She was 37 days post-partum. The second patient, from Oregon, developed symptoms on November 14 following several unsuccessful attempts at sponge removal that resulted in fragmentation of the product. The third case occurred on November 20 in a woman from California; the sponge had been in place 32 hours and was removed with difficulty. The fourth case, also from California, occurred on December 10 in a woman who had left the sponge in place for 5 days. Patients ranged in age from 20 to 29 years; all were white, non-Hispanic. None was menstruating at the time symptoms developed.

All patients manifested fever, hypotension, diffuse rash, desquamation, nausea, vomiting, myalgias, mucous membrane hyperemia, and vaginal discharge. All were hospitalized and treated with intravenous fluids and antimicrobial agents, and all recovered. Vaginal cultures in every case were positive for Staphylococcus aureus.

The Today Vaginal Contraceptive Sponge was introduced to the over-the-counter market in June 1983. The sponge is made of polyurethane impregnated with the spermicide nonoxynol-9 and is intended to provide 24 hours of contraception. The manufacturer (VLI Corporation) estimates that, as of December 1983, 5 million sponges had been used by more than 250,000 women in 24 western and southern states. During clinical trials, the average woman using only this method of contraception used 10 sponges per month. At the time the sponge was licensed, the U.S. Food and Drug Administration (FDA) required that the package insert contain a warning that clinical trials had not been large enough to assess the risk of TSS and that users should seek medical care if symptoms compatible with TSS developed. Instructions for sponge use indicate that it should not be left in place for more than 30 hours.

Following a meeting with FDA representatives on December 16, the manufacturer highlighted the warning on the package insert and placed a similar warning on the outer box.

Women who use contraceptive sponges should read the package insert carefully and follow the manufacturer's directions. Users who experience difficulty removing a sponge and/or sponge fragmentation should consult a physician. Women who have had TSS, particularly if it was associated with the use of a contraceptive sponge or tampon, should also consult a physician before beginning or resuming use of either. Similarly, post-partum women, who may be at increased risk of developing TSS, should seek medical advice before using the contraceptive sponge. Reported by GA Faich, S Sobel, J Bilstad, National Center for Drugs and Biologics, U.S. Food and Drug Administration, Rockville, Maryland; Respiratory and Special Pathogens Epidemiology Br, Div of Bacterial Diseases, Center for Infectious Diseases, CDC.

Editorial Note

Editorial Note: This report of four TSS cases among women using the contraceptive sponge is presented to inform physicians that a potential problem may exist and to encourage the reporting of additional cases. Given the small number of known cases and the potential reporting biases, the risk of TSS associated with contraceptive-sponge use remains uncertain.

All contraception methods, as well as unprotected intercourse, involve risk either from the methods themselves or from unintended pregnancy. The contraceptive sponge is an effective means of contraception, with a failure rate similar to that for diaphragms (2); thus, the overall magnitude of the health risks associated with contraceptive-sponge use, including TSS, should be compared with the health risks of other methods of contraception and unprotected intercourse.

If one assumes that the four cases reported so far were all attributable to contraceptive sponges, a minimum estimate of the incidence of nonmenstrual TSS associated with sponge use would be 10 cases (95% CI Poisson distribution, 3-20) per year per 100,000 women who use contraceptive sponges as their only method of contraception. (In comparison, five to 10 menstrual cases per year are expected among 100,000 women who use tampons (3)). Current mortality from TSS is 3%; therefore, 0.3 deaths (0.1-0.8) per year would be expected from these 10 cases of TSS among contraceptive-sponge users, in addition to an estimated 1.2 deaths related to pregnancy due to contraceptive-sponge failure. The overall number of deaths (1.5) attributable to contraceptive-sponge use would thus be comparable to the number of deaths associated with the use of other effective contraception methods (range 0.1-5.2/100,000 women 20-29 years of age, depending on method used) and less than the risk of death from pregnancy among women using no contraception (8.3/100,000 women 20-29 years of age) (4).

Although not included in these calculations, the use of contraception methods other than the contraceptive sponge may also affect the risk of developing TSS. For example, cases of nonmenstrual TSS among diaphragm users have been reported previously (5-7), and, to date, 18 definite and five probable cases associated with diaphragm use have been reported to CDC. Conversely, the use of oral contraceptives may reduce the risk of developing menstrual TSS (8).

Physicians and other health personnel are requested to report all suspected TSS cases to their state health departments, which will forward copies of the reports to CDC. Pending revision of the TSS report form, the method of contraception in suspected cases should be included in the "other information" section of the current form. TSS report forms can be obtained from local and state health departments or directly from CDC (telephone 404-329-3687).

References

1. Reingold AL, Hargrett NT, Shands KN, et al. Toxic shock syndrome surveillance in the United States, 1980 to 198l. Ann Intern Med 1982;96(6 Pt 2):875-80.

2. Edelman DA. Nonprescription vaginal contraception. Int J Gynaecol Obstet 1980;18:340-4.

3. Davis JP, Chesney PJ, Wand PJ, LaVenture M, and the Investigation and Laboratory Team. Toxic-shock syndrome: epidemiologic features, recurrence, risk factors, and prevention. N Engl J Med 1980;303:1429-35.

4. Fertility control and the risk of death. In: Ory HW, Forrest JD, Lincoln R., eds. Making choices: evaluating the health risks and benefits of birth control methods. New York, Washington, D.C.: The Alan Guttmacher Institute, 1983;33-42.

5. Baehler EA, Dillon WP, Cumbo TJ, Lee RV. Prolonged use of a diaphragm and toxic shock syndrome. Fertil Steril 1982;38:248-50.

6. Loomis L, Feder HM Jr. Toxic-shock syndrome associated with diaphragm use. N Engl J Med (letter) 305;1981:1585.

7. Jaffe R. Toxic-shock syndrome associated with diaphragm use. N Engl J Med (letter) 305;1981:1585-6.

8. Shelton JD, Higgins JE. Contraception and toxic-shock syndrome: a reanalysis. Contraception 1981;24:631-4. *Use of trade names is for identification only and does not imply endorsement by the Public Health Service or the U.S. Department of Health and Human Services.

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