Toxic shock syndrome and tampons

Pediatricians James Todd and Mark Fishaut of the Children's Hospital of Denver named the toxic shock syndrome in 1978 and linked it to Staphylococcus aureus. The illness brought high fever, a sunburn-like rash, peeling skin, low blood pressure and abnormalities in several organ systems. In May 1980 investigators reported 55 cases to CDC. Fifty-two were in women, and in 38 of the 40 women whose menstrual history was known, the illness had begun during a period.

A follow-up report in June described three studies, case-control studies in Wisconsin and Utah and a national CDC study, each finding that women with the syndrome were more likely than controls to have used tampons. The CDC study, published in December by K. N. Shands and colleagues, interviewed 52 patients and 52 matched controls by telephone. All 52 patients and 44 controls used tampons, and patients were more likely to use them throughout menstruation. It found no significant difference by brand or labeled absorbency. A separate study reported in the same paper isolated S. aureus from 62 of 64 women with the syndrome and from 7 of 71 vaginal cultures taken from healthy controls.

Later studies showed that the risk was substantially greater with Rely, a Procter & Gamble tampon made of polyester foam and cross-linked carboxymethylcellulose, and that it rose with absorbency. The manufacturer withdrew Rely in September 1980, and it came off store shelves on 22 September. It had been test-marketed in Fort Wayne, Indiana, in 1974, before the 1976 Medical Device Amendments required premarket approval for new devices.

In 1980, 890 cases were reported, 812 of them menstrual, and 38 of 772 women with menstrual cases died. Manufacturers lowered absorbency, and in 1982 the FDA required labels advising women to use the lowest absorbency they needed. Very high absorbency tampons, used by 42 percent of tampon users in 1980, were used by 1 percent in 1986. By 1989 reports had fallen to 61 cases, 45 of them menstrual, and in 1988 and 1989 no woman with menstrual toxic shock syndrome died.