Staphylococcal toxic shock syndrome is rare and the number of reported cases has declined significantly since the 1980s. Patrick Schlievert, who published a study on it in 2004, determined blah incidence at 3 to 4 out of 100,000 tampon-using females per year; the information supplied by manufacturers of sanitary products such as Tampax and Stayfree puts it at 1 to 17 of every 100,000 menstruating females per year.
The CDC has stopped tracking TSS. However, there was a rise in reported cases in the early 2000s: eight deaths from the syndrome in California in 2002 after three successive years of four deaths per year, and Schlievert's study found that cases in part of Minnesota more than tripled from 2000 to 2003. Even though ''S. aureus'' was isolated from mucosal sites in the patients, bacteria could not be isolated from the blood, cerebrospinal fluid, or urine, raising suspicion that a toxin was involved.
The authors of the study noted that reports of similar staphylococcal illnesses had appeared occasionally as far back as 1927. But the authors at the time failed to consider the possibility of a connection between toxic shock syndrome and tampon use, as three of the girls who were menstruating when the illness developed were using tampons. Many cases of TSS occurred after tampons were left in the woman using them.
Rely tampons
Following a controversial period of test marketing in Rochester and Fort Wayne, in August 1978 Procter and Gamble introduced superabsorbent Rely tampons to the United States market in response to women's demands for tampons that could contain an entire menstrual flow without leaking or replacement. Further, the tampon would "blossom" into a cup shape in the vagina in order to hold menstrual fluids without leakage.
In January 1980, epidemiologists in Wisconsin and Minnesota reported the appearance of TSS, mostly in menstruating women, to the CDC. ''S. aureus'' was successfully cultured from most of the women. A CDC task force investigated the epidemic as the number of reported cases rose throughout the summer of 1980, accompanied by widespread publicity. In September 1980, the CDC reported that users of Rely were at increased risk for developing TSS.
On September 22, 1980, Procter and Gamble recalled Rely following release of the CDC report. As part of the voluntary recall, Procter and Gamble entered into a consent agreement with the FDA "providing for a program for notification to consumers and retrieval of the product from the market." However, it was clear to other investigators that Rely was not the only culprit. Other regions of the United States saw increases in menstrual TSS before Rely was introduced. It was shown later that higher absorbency of tampons was associated with an increased risk for TSS, regardless of the chemical composition or the brand of the tampon. The sole exception was Rely, for which the risk for TSS was still higher when corrected for its absorbency. The ability of carboxymethylcellulose to filter the ''S. aureus'' toxin that causes TSS may account for the increased risk associated with Rely.:
- Body temperature > 38.9 °C (102.02 °F)
- Systolic blood pressure < 90 mmHg
- Diffuse rash, intense erythroderma, blanching ("boiled lobster") with subsequent desquamation, especially of the palms and soles
- Involvement of three or more organ systems:
- Gastrointestinal (vomiting, diarrhea)
- Mucous membrane hyperemia (vaginal, oral, conjunctival)
- Renal failure (serum creatinine > 2x normal)
- Hepatic inflammation (AST, ALT > 2x normal)
- Thrombocytopenia (platelet count < 100,000 / mm³)
- CNS involvement (confusion without any focal neurological findings)
Further Reading
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"Toxic shock syndrome"
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