TSS: What Can You Rely On?

By Jean Loria

Toxic-shock syndrome (TSS) is the name of a bacterial infection women get during their period. Symptoms vary from headache, dizzyness, rash, skin peeling, high fever, vomiting and diarrhea and the disease can progress to shock and death. More than 600 women have officially had the disease this year. Fifty million of us are at risk for next year. That's because we use tampons.

Classified as a medical device, tampons are subject to FDA regulations. They've been around and in our bodies for 40 years and we possess bottom line control of the industry. Seventy percent of menstruating women in America use tampons. Each year we politely spend over a billion dollars a year for them.

Despite this, when pressed for full disclosure of just the tampon components, Tampax Inc. and Kimberly-Clarke Corp. had the audacity to refuse, based on "proprietary reasons" and because it would somehow be "inappropriate, to say the least”. Trade secrets and third party invocations do little to instill confidence in the consumer and obscure the issue of accountability.

Formerly, with the exception of an occasional article on possible asbestos contamination or the limited wave of interest in menstrual sponges and other alternatives, tampon corporations have been free to manufacture and deoderize their throw-away products. The advent of TSS may or may not significantly change the flow of the industry. But there should be some discomfort. TSS is a serious disease, not a media event momentarily thrilling the American public until we accept yet another unnecessary health risk.

The association of tampons with TSS is admittedly a complex problem. The extreme degree of ignorance surrounding the problem points to inadequate safeguards in the development, manufacture and marketing of tampons. Equally inadequate are the current investigation of TSS and information made available to women concerning the disease.

Cases of TSS have been recognized since 1975 with an apparently increasing incidence. TSS was first described in children and has occurred in men due to local infection in a few instances. As of September 1980, 299 cases of TSS were reported to the Center for Disease Control (CDC in Atlanta). Seventeen percent of these cases were diagnosed in July and August, 1980. The latest CDC release totals the case number at 652. The June, 1980 CDC report says that, "the risk of TSS appears to be low" with an incidence of about 3 per 100,000 menstruating women per year. Follow-up in September reports the rate to be an underestimate for three reasons: 1) incomplete reporting of cases, 2) the rate was based on severe cases meeting a strict case definition, and 3) not all women of menstrual age are actually menstruating.

The Utah State Department of Health estimates the risk at 10 to 15 per 100,000. The ovarian cancer rate is 13 per 100,000. With a case fatality ratio ranging from 3% to 13%, and a recurrence rate of 30%, TSS is "a cause for concern, particularly since TSS occurs almost exclusively in previously healthy young women".

One wonders at the implication of this last statement. Must a disease that primarily affects women have a case-fatality ratio of 100% and/or be surgically profitable to be seriously investigated?

In addition to uncertainties in the incidence data, the role of tampons in the etiology of the disease is, many moons later, still poorly defined. In July, the CDC reports to us, "The finding that no particular brand of tampon is associated with unusually high risk reduces the likelihood that the tampon carries or introduces the causative agent." In September, we read, "preliminary results of the most recent CDC study” indicate not only “that there are differences

in the brand of tampons used by TSS patients and controls" but there is "an increased risk associated with the use of Rely tampons" manufactured by Proctor and Gamble. These contradictory findings were both derived from only 50 telephone interviews. Ralph Nader's Washington-based Health Research Group has provided a clue to the CDC's inability to recognize the correspondence of TSS and specific brands of tampons in the earlier study. Proctor and Gamble, in a July letter to the Food and Drug Administration (FDA), indicated they were "planning an experiment using a reformulated version" of Rely. Had the FDA informed the CDC of a possible health hazard connected with the "experiment," the CDC might have anticipated an increased TSS risk with Rely tampons in July rather than in September. Three days following the release of the September CDC report, Proctor and Gamble withdrew Rely from the market in one of the largest consumer product recalls ever. In October, Proctor and Gamble

Warning: The Surgeon General Has Determined That This Device is Dangerous to Your Health

agreed to sponsor a media campaign to inform women of the link between Rely and TSS. Yet in the same breath, a spokesman defended Rely as "a superior product. All its ingredients as well as the total product have been exhaustively tested to prove its safety". So now we have an undetermined risk for a sometimes fatal syndrome associated somehow with the use of a "superior product".

Proctor and Gamble, the Department of Health and Human Services, the commissioner of the FDA, and the director of the Bureau of Medical Devices are defendants in several major lawsuits. However, prosecution of Proctor and Gamble is nowhere near an endpoint.

Cases of TSS continue to be reported, and tam-

pons of different brands have been associated with TSS. TSS is associated with the presence of the bacteria Staphylococccus aureus. The role of tampons in the etiology of TSS is unknown. Possible links between tampons, S. aureus and TSS include 1) transfer of the bacteria into the vagina from the fingers or the opening to the vagina, 2) the tampon could provide an environment conducive to the growth of the bacteria, 3) the applicator and/or the material of the tampon could cause lacerations supporting local growth of the bacteria in the vagina.

Not using tampons greatly reduces the risk of TSS. Switching to regular and using tampons only during part of the menstrual period are the recommendations for those who choose to continue using them. Unfortunately, natural sea sponges are not a promising alternative; one case of TSS occurred in a woman who used them.

The worst thing that we can do is passively accept the situation. In its November bulletin, the FDA has

proposed that all tampon manufacturers print a warning on the package. Direct pressure on the tampon corporations would be more appropriate.

Write to: Lillian Yan

or call:

Bureau of Medical Devices HFK-470

Food and Drug Administration

8757 Georgia Avenue

Silver Springs, MD 20910 301-427-7555

and tell them that you don't want a warning on the label just the contents.

xxxxxxx

What About Sea Sponges?

New York(LNS)—Ever since recent reports linked deaths from toxic shock syndrome with the use of tampons, interest has heightened in natural sponges as an alternative to tampons. It was hoped that sea sponges were safer as they didn't include the chemical additives found in tampons. But preliminary studies indicate that the sponges present health problems of their own. Last week, the Emma Goldman Clinic for Women in Iowa City, Iowa suspended sales of the natural sponges when a state health laboratory found they contained sand, bacteria and other potentially dangerous substances.

Results of lowa State Hygienic Laboratory tests showed that the sponges absorbed matter from their environment-the polluted ocean. Dr. Mary Gilchrist, a microbiologist who tested the sponges, warned that it was impossible to tell what chemicals could be found in any given sponge because it would depend on where the sponge was harvested and on recent human activities in the area. Insecticide and chemical dumps, sewage overflow, oil spills and a multitude of other human additions to the oceans could be absorbed by the sponges. The particular sponges tested by the lowa lab contained hydrocarbons related to oil spills, bacteria common to sewage,

and nicotine, among other things. The sponges also contained sand particles embedded in the sponge fibers that can't be washed out but are released as the sponge deteriorates over time, and a natural layer made up of glass-like material that is microscopically sharp and a possible irritant.

Gilchrist stressed that women should make their own choice about using the sponges, especially where chemicals are concerned. "The levels they are released at are a low level where no one knows what could happen." As for avoiding bacterial infection, she advised sterilizing the sponges in a pressure cooker. The bacteria found in the sponges are not related to toxic shock syndrome, but "sea sponges are probably not the way to avoid toxic shock either."

The clinic will hold off on selling sea sponges until the staff has had more time to consider the problem. "We're concerned that the same study wasn't done for tampons,' said Paula Klein, a clinic spokesperson. "Because sponges are a women controlled business right now, we're sure the FDA and tampon manufacturers would just as soon see them off the market. But of course, we're also concerned with "women's health.

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December, 1980/What She Wants/Page 5