Toxic Shock Syndrome, Tampon Absorbency, and Feminist Science
Sharra L. Vostral
September 6, 1980, twenty-five-year-old Patricia Kehm died from
complications due to Toxic Shock Syndrome (TSS). Her death, along with
seventy-three women and two thousand others sickened between 1970 and
1980 after using superabsorbent tampons, precipitated action ("Toxic
Shock Syndrome—United States, 1970–1980,"1981). In the short term, the
Food and Drug Administration (FDA) pressured Procter & Gamble to
recall Rely—the superabsorbent tampon with the highest rate of TSS—and
the company removed the tampons from store shelves (though other
superabsorbent tampons, including those from Playtex, Tambrands, and
Kimberly-Clark remained on the market). Product liability lawsuits,
including that of Kehm's family against Procter & Gamble, garnered
meager payouts to compensate for injuries and deaths. A less obvious
but long-lasting result was the establishment of the Tampon Task Force
in 1982. The task force, composed of manufacturers, consumer groups,
and feminist health advocates, sought to set uniform standards
concerning tampon absorption capabilities and deliver labeling
recommendations to the FDA. The importance of this was that higher
absorptions were linked to higher rates of TSS, but women did not have
an accurate way of knowing which tampons were more or less absorbent.
This essay examines how feminist science influenced the proceedings of
the Tampon Task Force and how feminist health advocates initiated the
On the task force was Esther Rome, one of the founders of the Boston Women's Health Book Collective (BWHBC) and co-authors of Our Bodies, Ourselves
(OBOS). Her inclusion marked an important departure from
regulation-as-usual with men and corporate representatives setting the
policy standards. Rome brought to the Tampon Task Force the same
tactics she deployed in writing Our Bodies, Ourselves.
From the BWHBC’s beginning, the founders set out to obtain and
distribute medical knowledge about women's health that had been the
exclusive purview of mostly male physicians, who were often
"condescending, paternalistic, judgmental and noninformative" (Boston
Women’s Health Book Collective, 1973). What these doctors would not
provide, the women set out to learn, discover, and take for their own
to share with other women. The scene would repeat itself on the Tampon
When manufacturers would not share data, were not forthcoming, and were
not even using menstrual blood for absorption tests, Rome solicited
feminist scientist Nancy Reame, a nursing professor at the University
of Michigan, to generate data on the consumer advocates' behalf.
Together with other Tampon Task Force members, they insisted upon
sharing data amongst all the scientists and the FDA regulators,
enacting an ethic of feminist science. Reame used heparinized blood
(blood treated with heparin so it does not coagulate quickly) instead
of saline to test tampon absorption rates. It was a watershed moment
for consumer groups, feminist health advocates, and women scientists,
with feminist science producing data and networks of knowledge based
upon the biological materiality of menstruating bodies. Thus, at this
historical moment when feminists challenged the universality and
androcentrism of medicine, the inclusion of a reified "woman" and an
understanding of essentialized "women's bodies" was a radical departure.1
Feminist ideas privileging women's knowledge and the materiality of
women's bodies were critical in shaping science during the 1980, in
the face of the unknowns related to Toxic Shock Syndrome.
In this case, feminist methods relied upon a universal biological
female as the basis for which to establish lab practices and tampon
absorbency standards. We now understand this essentialized reading of
the female body as conflating gender, sexed bodies, and experiences of
menstruation. It makes sense to think of people who have periods—as a
category—simply as "menstruators" (Bobel, 2010), rather than using
gender as a proxy. Menstruators might yield different ways of knowing
about periods, their management, and related health outcomes associated
with tampon use.
At the time, however, insistence that menstrual blood mattered informed
feminist science, which valued not only female bodies but also
common-sense research practices that incorporated real-life
applicability to menstruators. This approach challenged the privileged
position of "fastidious" science as described by epidemiologist Alvan
Feinstein, a shortcoming of which is to eliminate so many variables
that context—in this case, that of menstruating bodies—is erased.
Through feminist science, advocates challenged the process by which a
standard was established, the method by which variables were
controlled, and the disappearance of menstrual fluid from tests about
tampon absorbency. Feminist science yielded both usable and valid
outcomes, with results that disputed the design of the experiment upon
which standards were to be based.
The Rise of Toxic Shock Syndrome
By the 1970s, two separate but significant events converged. First, the
new illness of Toxic Shock Syndrome was identified in 1978 (Todd,
1978). Second, synthetic materials had begun to displace cotton in
tampon composition creating a category called "superabsorbent" (Tierno,
2001). Although TSS is not exclusive to people who menstruate, by
September of 1980 the Centers for Disease Control (CDC) declared that
TSS was associated with superabsorbent tampons ("Follow-up on
Toxic-Shock Syndrome," 1980), thus the majority of cases affected them.
Although many theories emerged to explain this new link, Mike
Osterholm, an epidemiologist working for the state of Minnesota during
the 1980s, determined that superabsorbent tampons captured and held
air—specifically, oxygen (Osterholm, 1982). Tampons, especially
superabsorbent ones, introduced enough oxygen into the usually
anaerobic vaginal canal to change its ecology and promote the growth of
Staphlococcus aureus, the bacterium responsible for tampon-related TSS, in those women who happened to carry this particular strain of bacterium.
Pat Schlievert, a microbiologist, identified the co-factors of the
tampon creating an aerobic vagina and the naturally occurring higher pH
during menses as contributing to TSS. The conditions were ideal not
only for reproduction of the S. aureus
bacterium, but also the production of the toxin TSST-1 (Schlievert,
1981). When the toxin transferred into the bloodstream, and if the
woman lacked the requisite antibodies and titers for it, it could
precipitate organ failure and shock, thus the illness Toxic Shock
Syndrome. The three elements of oxygen, bacterium, and lack of
antibodies were required for TSS to foment. In general, more white
women were affected since they were a larger part of the population,
but the CDC reported cases of TSS across categories of race and
ethnicity (MMWR, 1983). Toxic Shock Syndrome occurs in about 1 in
100,000 women, making it a rare occurrence, and cases are not
necessarily terminal when treated early enough with antibiotics
(Hajjeh, 1990). However, for a small segment of women, the risk is
All of this, though, has taken years to understand and was
science-in-the-making during the early 1980s. Scientists scrambled to
understand the most rudimentary elements of the illness and its
transmission. By the fall of 1980, it was clear was that something
potentially deadly was going on with tampons. Procter & Gamble
removed its successful tampon Rely from production and sales, and the
CDC and the FDA recommended that women use the least absorbent tampon
possible (CDC, 1980; Vostral, 2011). The FDA did not want to suggest
banning tampons, due in part to their long safety record since the
1930s. However, without accurate information and labeling, there was no
way for women to determine which tampon to purchase with the lowest
absorbency. They could not follow guidelines to avoid tampon-related
TSS, short of abandoning tampons altogether.
Feminist Interventions in TSS
Women needed accurate information about tampons, and quickly. The FDA
held responsibility for safety and labeling, and reached out to ASTM
for assistance. Currently known just by its initials, ASTM (American
Society for Testing and Materials) is a professional organization that
develops voluntary consensus standards concerning materials,
engineering, and testing practices. Everything from steel gauge to
screw threads requires agreed-upon standards, and as a technology,
tampons were now the focus of negotiation. ASTM had a special committee
known as F-4 to develop standards for medical devices, and tampons fell
under its purview. Standard setting usually included industry
representatives, with ASTM helping to build consensus among
Important at this moment was the inclusion not only of producers but
users and representatives of "general interest." ASTM partnered in a
new cooperative program with the National Consumers League (NCL) to
include layperson consumer input into the standard setting process.
Becky LeBuhn (at the time Cohen), was the consumer representative from
the NCL on the F-4 medical devices committee. She encouraged the F-4
committee to agree to the FDA's request to develop a tampon standard,
but pointed out that with no other women on the committee, only she
qualified as an actual user. A group purporting to represent consumers
needed actual tampon users in the standards development effort; an
all-male chorus was insufficient. Through the NCL, LeBuhn volunteered
to "assemble a group of women, including representatives of women's
health and advocacy organizations" to participate on the task force and
make sure women's health and safety concerns were on the table (LeBuhn,
2017). In this case it was not just competing industries potentially
vying to maintain the upper hand of a design or process but also
consumer groups and feminist health advocates who had a stake in their
personal safety and well-being.
The Tampon Task Force as it came to be known met in January of 1982,
seven more times throughout that year, and for the next three years to
develop "a tampon standard as expediously (sic) as possible" (Ellis,
1982). The following manufacturers, consumer groups, and women's health
advocates composed the group: Johnson & Johnson, Kimberly-Clark
Corporation, Tambrands, Inc., Playtex International, BWHBC, Coalition
for the Medical Rights for Women, Empire State Consumer Association,
National Consumers League, National Women's Health Network, and Woman
Health International. Though the advocacy groups had a unified front,
this essay focuses upon the involvement of the BWHBC through its papers
archived at the Arthur & Elizabeth Schlesinger Library at Harvard
Well known for its signature book Our Bodies, Ourselves,
the BWHBC began in 1969 in Boston as a grassroots group of twelve women
sharing frustrations about medical paternalism and the active
withholding of information by physicians. The collective grew into a
nonprofit, and shaped the women's health movement during the
1970s. BWHBC goals included providing health and medical information in
an accurate and understandable way so that women could make informed
decisions about birth control, pregnancy, and sexual health, for
instance, and thus become their own health experts. Within the history
of women’s rights, this is characterized as the "difference" approach;
that is, placing the female body at the center of politics, knowledge,
and power as opposed to the "equality" approach that deemphasizes
female biology, in part due to the legacy of discrimination based upon
it (Kline, 2010). Embracing difference, BWHBC advocated for the
normalcy of women's life events, from birthing to aging, and challenged
frameworks that unnecessarily pathologized their bodies.
The relationship of tampons to TSS and women's health was therefore a
serious concern for BWHBC. Esther Rome had already published a
menstruation brochure written in red ink, and was very concerned about
the link between menstruation, tampons, and TSS. Rome was a
well-informed feminist activist, and an important voice to include on
the Tampon Task Force. Her colleague and co-author of the 1984 edition
of OBOS, Jill Wolhandler, participated intermittently as well. The
BWHBC was a significant advocacy group; with its heft representing
women, calling upon them for letter writing campaigns, and publishing
and distributing Our Bodies, Ourselves, the FDA and manufacturers could not easily dismiss their concerns.
In addition to the consumer representatives, lawyers for the different
parties attended meetings as well. David Swankin was general counsel
for the National Consumers League, and Becky LeBuhn recruited him to
the task force. He attended all the meetings and corresponded with the
FDA and manufacturers and represented their interests. Swankin was the
first executive director of the White House Office of Consumer Affairs
under Lyndon Johnson, and later worked at the US Department of Labor.
Swankin emphasized the dramatic divide between the consumers and
manufacturers: "I cannot overstate the cultural gap that governed this
entire thing. So there were legal considerations because of what was
going on with Toxic Shock, [and] the cultural thing that just was
overwhelming, overwhelming [emphasis in original]” (Swankin, 2016).
This "cultural thing" was not just the emergence of an active consumer
rights contingent but feminism-in-action. The feminist advocates
challenged assumptions, questioned language, and embodied a new
approach. Together, they required the men to acknowledge and bear
witness to the materiality and biological functioning of their bodies.
Swankin recalled that an FDA representative came to one of the first
meetings and said "you know, everything is a balance in medicine, even
an aspirin can kill you." This approach was not well received by the
advocates or Rome herself. Swankin remembered Rome arguing:
me", she says "I think that is probably true, but this is not medicine.
It [menstruation] is a normal everyday process that half the world goes
through and to treat it like an illness and therefore to say what you
have is a risk/benefit, it is a risk you have to take into account,
there is no benefit."And they did not like that.
Justifying risk to
treat an infection or illness with medicine was one thing; a healthy
person assuming the risk of death by wearing a superabsorbent tampon
was quite another. Thus, the standpoints of the manufacturers, the FDA,
and consumer advocates were quite stark. Characterizing their competing
positions, Swankin compared them to entrenched international
adversaries. "So right away it was like dealing with the North Koreans
to try to settle the problem. You couldn't do it because it was from
such different perceptions" (Swankin, 2016).
Rome had a dynamic personality, and was not shy about getting her
larger points across. Swankin recalled that at one of the first
meetings, "Esther, comes in in a white dress…She was nursing her baby,
and she was nursing [him] at the meeting. It was not enough to cover
her breast; we're doing natural things here. You should have seen these
guys [lawyers in the three-piece suits]. They were gulping, gulping,
gulping," their discomfort palpable about the perceived impropriety.
Swankin continued with his recollection of the scene, with Rome saying,
"[you] know. We don't have to actually do anything. We can bleed all over
our dresses; they do in many, many places. I don't know if you
appreciate that, but it wouldn't bother me if we couldn't do something
here. Maybe that's the alternative." Here, a veiled threat of
abandoning tampons for an "alternative" approach reminded the corporate
representatives of the collective influence millions of tampon wearers
had on their future profits.
Rome, in a way, was living evidence of the political power of
reproductive processes. With her behavior Rome challenged multiple
norms: do not bring a baby to a business meeting, do not expose a
breast in public, do not breastfeed in public, do not "free bleed" on a
white dress. With her very body she offered evidence that had been
excluded from the realm of common knowledge amongst these male
corporate representatives and she demanded that they understand women's
bodies differently. She also requested that payment for a babysitter of
her choice be included in her travel expenses, although it was not
deemed a legitimate cost of the trip to Philadelphia for the meetings.
Her ability to push these boundaries was crucial because corporate
representatives had not been confronted by menstrual realities in this
visceral way. Though they had significant familiarity with their
companies, marketing strategies, and the tampon as an object of
manufacturing, they had little grasp of consumer expectations,
preferences, and actual experience using tampons, and no embodied
understanding of how well the tampons functioned (or not). This was
exactly why Becky LeBuhn knew that women needed to be the major voice
on the Tampon Task Force. Simply by inhabiting their gendered male
bodies, the corporate representatives did not have to participate in
the social norms required to hide menstrual fluid. They were exonerated
from the disproportionate cost of possible illness and death borne upon
their bodies due to tampon-associated TSS.
Swankin recalled that the manufacturers really did not understand—or
chose not to understand—the feminist advocates and consumer
stakeholders, and their usual mode of business thinking did not help.
The corporate representatives fell into de facto salesmanship, which
pandered to the women rather than engaging their legitimate concerns.
As Swankin put it:
[o]ne time they brought in Stephan–wife
[Stepford-wife] types to the meeting, and the discussion that time was
deodorants [in tampons]…The women that they brought were all dressed
up, absolute straight out of New York ad agencies, and they had
prepared expensive sample kits to pass out, of all the different
things, and everybody threw in what they wanted to give them, in this
little goody basket (Swankin, 2016).
The "freebie" baskets were
ironically filled with the very deodorant tampons and products for
which the women sought safety regulations and also had no intention of
ever using. LeBuhn, who continued to serve as the convener and
secretariat for the advocacy groups, felt that it was very
condescending, as if the companies were trying to influence the
consumer representatives with token gifts (LeBuhn, 2017). Swankin
concurred, noting that the advocates "refused to take them. But that's
another example, of obviously, they [the corporate reps] thought that
by…taking a Madison Avenue approach that they [the consumer groups]
were going to say 'Ah, I see what you are trying to do.'" And that was
to get them to agree with the manufacturers that the products were
perfectly fine as they were. Swankin concluded that the corporate
representatives "just had zero connection in their minds to what people
wrote [Our Bodies, Ourselves]
and their allies," as he put it, which included not only all the
consumer advocates at the meeting but the strong grass-roots network
that each organization cultivated.
It took awhile for the manufacturers to realize that the feminist
health advocates and consumer groups would not easily be swayed and
that they had multiple concerns. There were other tampon-related
problems besides just a lack of absorbency standards: tensil strength
of string so it would not break, particulates sloughing and fraying
from the tampon's "pledget" wadding, applicators that cut vaginal skin,
allergic reactions to embedded perfumes and deodorants, undisclosed
leachable chemicals, and overall general "biocompatibility" (Kobren,
1981). Since none of this was tested for or regulated, it was an
opportunity for sweeping policy recommendations. In this regard, a
significant point of contention for the health advocates was the lack
of available scientific data about any of these issues. The consumer
groups had the burden of proof on their side since CDC scientists as
well state epidemiologists had reported a significant association with
superabsorbent tampons and an increased risk of TSS (Osterholm, 1982).
Additionally, manufacturers still could not prove definitively that
tampons were uninvolved. Manufacturers were not forthcoming with all
their data, calling it "proprietary," though Swankin felt results could
have been easily squelched if they did not serve corporate needs.
Furthermore, corporate lawyers were well aware of product liability
lawsuits filed against all the manufacturers related to both bodily
harm and deaths resulting from tampon-related TSS, the most well
publicized and successful being Kehm v. Procter & Gamble (1982), concerning Patricia Kehm's death resulting from the use of Rely tampons (Riley, 1986).
The issue of data sharing and the integrity of the corporate-sponsored
research was a serious concern. At the outset, the consumer advocates
were at a disadvantage without their own scientific research lab to
double-check data and results. The manufacturers possessed a depth of
scientific know-how with engineers, biologists, animal labs, and money
to run any number of tests. The consumer groups had no such resources
or facilities. Furthermore, Swankin reflected, "[t]he manufacturers,
nobody believed them…it was going to be bought research." He added,
"[t]here were all these allegations [about proprietary studies], that
the study was legitimate, and it came out and it didn't say what they
wanted it to hear they'd kill it, so we'd never see it anyway." Due to
the lack of open sharing, and fears of proprietary secrets being
revealed not only to corporate rivals but the broader public, the data
collected was not made available to the advocates to examine.
Furthermore, ASTM would not pay for tests at the behest of the consumer
groups. Within the negotiating structure, they were at the mercy of
manufacturers and data produced by in-house scientists who chose
whether or not to share. The consumer groups had no way to evaluate the
validity of scientific presentations without their own lab to
corroborate or challenge the methods and data. This was about to change.
Fighting Fire with Fire
If absorbency was the key factor to convey in warning labels, it was
important to have data on it. The Tampon Task force was charged with
creating a standard for measuring absorbency and a standard for
intra-laboratory results. The consumer groups and health advocates
wanted one that was not solely in service of the manufacturers, and at
the same time through their presence they did not want to give tacit
approval for a hollow standard (Memo, 1983). The consumer groups
recognized that they needed a sympathetic scientist with access to a
lab to help them translate their feminist intents through the language
of science to the other manufacturers at the negotiating table. They
found this in Nancy Reame.
Reame met Rome in the late 1970s at a small conference sponsored by the
Society for Menstrual Cycle Research (SMCR). She held a Master of
Science in Nursing and was just finishing her PhD in Physiology,
focusing on reproductive sciences. She had always been interested in
women's reproductive health, including the endocrinology of
menstruation, and was headed toward a tenure-track position in the
School of Nursing at the University of Michigan. Later in her career,
Reame was named to the Institute of Medicine and became a fellow with
the American Association for the Advancement of Science. Her work on
endocrinology and menstrual health brought her to the SMCR meeting.
There, Reame learned about the problematic politics of tampons.
First, she got a crash course in tampon testing from a newly hired
researcher at Kimberly-Clark Corporation, the manufacturer of Kotex
sanitary napkins and tampons, whom she met at the conference. This
researcher, referred to here as "Karen," confided in Reame about the
overall lack of understanding the corporate scientists had about all
things vaginal and menstrual. Reame summarized the essence of their
said "[y]ou would be amazed how tampons are tested
by the industry…They hired me because I'm the first reproductive
physiologist they have in the feminine care division. It's all paper
chemists. It's all men. They don't use menstrual fluid. They don't use
blood of any kind. They use blue dyed saline water. It's pretty clear
it's repugnant to talk about menstrual blood much less work with it in
the lab." And she [Karen] said, "[w]hat's worse, they don't even
understand the functioning of the female human vagina." And she said
"[t]hey hired me, [and] as part of the interview when I sat down, they
said could I please draw a human vagina, just the anatomy?"
The conversation left an
impression upon Reame about the systematic misunderstanding of women's
bodies in relation to menstruation and tampon development. Following
this meeting, Karen invited Reame to Neenah, Wisconsin and the
headquarters of Kimberly-Clark Corporation to present her dissertation
work on the biology of menstruation. The seminar resulted in a
one-year, $25,000 contract to conduct viscosity studies of menstrual
fluid. This late-1970s interaction was the last of Reame's connection
to the company.
that was pretty much the extent of her
interview…They knew enough to go after a physiologist, but two other
male candidates were vying for the job: one a primate specialist, one a
guinea pig physiologist, and she herself was a basic scientist in
reproductive physiology. [Karen] said, "I was working with guinea pigs,
but I have a vagina, and I knew enough about basic anatomy that I drew
the right relationship of the vagina and uterus from my anatomy class,"
and she said, "and I got the job." And she said "[t]hat just shows the
level of ignorance in the feminine care industry; no wonder something
serious was going to happen" (Reame, 2016).
The second important result of attending the SMCR conference was that
Reame met Esther Rome. Rome had not forgotten her. After the first two
meetings of the Tampon Task Force, it was clear that the health
advocates needed scientific help, and Rome reached out to Reame. Reame
remembered Rome, saying to her "you're not going to believe this! They
expect us to just buy into their data! We aren't going to do that. We
need somebody who can do this!" (Reame, 2016). Rome further explained
to Reame why it was so important to get her on board. Reame recalled
'[y]ou are the only person in the country that's ever worked
with menstrual blood! We don't want an epidemiologist, we don't want
someone who can crunch the numbers, we want someone who's actually done
some clinical research.' I said of course! I love it! This sounds like
such an adventure! (Reame, 2016).
Reame joined forces (receiving
$2,500 for the lab studies) and attended the meetings alongside Rome,
Swankin, and the others, thus legitimizing their position. Swankin
explained, "Nancy was the connection to the science; she could explain
deep science" and had a fluid way of doing so, and she "played that
role of connecting science to activists." In addition, Reame had "a
very important function; they [the corporate representatives and
lawyers] respected her, you couldn't laugh at her, you couldn't make
believe she wasn't there" (Swankin, 2016). With Reame on board, the
consumer groups and feminist advocates could participate in a more
robust manner, matching science with science.
Setting a Test Method: The Syngyna
The syngyna—a synthetic-vagina test apparatus—was a device designed to
measure tampon absorbency. It was developed in 1958 by G. W. Rapp, a
professor of biochemistry and physiology at Loyola University Chicago
for the Campana Corporation, which manufactured Pursettes tampons
(Rapp, n.d). As his lab report explains, Rapp first devised some basic
methods to measure absorbency, such as dripping a measured amount of
fluid on a tampon or dunking a tampon in a flask filled with fluid
until it reached full capacity, but neither seemed to replicate body
temperature, muscular pressure, or angle and positioning of a
vaginally-worn tampon. He tried developing an "in vivo" test using
women as test subjects but rejected this approach because they
presented too many uncontrollable variables. As a result, he devised a
glass vacuum tube with a hydrostatic head, and inside the tube a condom
pulled taunt served as the vaginal orifice. It was surrounded by a warm
water bath to simulate body temperature (Figure 1 and Figure 2). The
hydrostatic head controlled the flow rate of the liquid entering the
syngyna chamber. (To see a modern version in use go to "Tampons—Syngyna
Test by SGS" on You Tube, https://youtu.be/KYXUQDzSg4o.)
The absorption testing methodology called for either a saline solution
or a viscous material called "blue goo"—composed of cellulose gum,
glycerol, sodium chloride, sodium bicarbonate and water—to be used as
the control (Rapp, n.d.). To make this a "known" in an experiment, it
made sense to produce a fluid with consistent elements that any decent
lab technician could create. This helped to eliminate variables and
focus upon the unknown properties of the tampons, each with their
various sizes, shapes, and absorbencies. The syngyna apparatus and test
method circulated throughout the industry as a means of determining
tampon absorbencies, but it had not been scrutinized in terms of its
efficacy to set a federal standard. This was one of the goals of the
Tampon Task Force. Thus, the Bureau of Medical Devices, a division of
the FDA, and the manufacturers began using the syngyna test to assess
its accuracy across brands, but the consumer groups and feminist health
advocates were left out until Nancy Reame joined them. The task force
accepted Reame as a peer scientist, and one of the manufacturers sent
her the specialized syngyna lab apparatus to begin. She said that when
it arrived, there were plenty of jokes about it in her all-female lab,
including speculations about "vagina envy." They named theirs Sally
The very basis of the standardizing process was questionable to Reame
and the health advocates. The syngyna was a poor representation of the
dynamic vagina, and its methodology excluded real menstrual fluid. The
feminists questioned whether or not the saline was a sufficient
stand-in for menses, which was complex during any given menstrual
cycle, containing proteins, mucus, and cellular debris as well as
blood. This lab-made representation of menstrual blood was decidedly
synthetic, and not in any way a natural product of a woman's body. What
kind of effect would a simulated product rather than menstrual fluid
have upon absorbency? The consumer advocates did not know, and even if
the industry scientists had any inkling, they certainly were not going
to say, for fear of revealing anything they perceived as proprietary or
The convenient de-gendered and dehumanized syngyna erased all forms of
difference, from the size of the vaginal canal, with its shape, angle,
elasticity, length, and circumference, to the fluids coming from it,
eliminating vagaries of menstrual fluid from watery to clotted and its
rates as well as volume, which women would never conceptualize and
measure in grams anyhow. Perturbed, Reame recalled that even the canal
itself was represented by a condom, "Sheik" unlubricated #9, loaded
with racialized and ethnic overtones (Reame, 2017).
The reduction of vaginal canals to one form and shape had a long
history with tampon developers. Earle Cleveland Haas, a doctor of
osteopathy and the inventor of the Tampax tampon in the 1930s, held a
similarly dismissive attitude. When asked if he measured any part of
the vagina or cervix during the development of Tampax, Haas remarked,
"I have seen so damn many of them I had an idea. Some are short and
some are longer, of course, but that didn't make any difference" (Kehm v. Procter & Gamble,
p. 1179). Reame wondered aloud what kind of testing device women might
devise, for surely it would not involve a condom. Reame challenged this
entrenched legacy of reducing menstruation to a simplistic mechanical
process disconnected from the materiality of bodies and launched a
research program to alter the science.
By 1983, Reame's lab at the University of Michigan became one of the
eight (she estimates) to test the differences in absorbency amongst the
pooled tampon samples across a range of categories (Regular, Super, and
Super-Plus) provided to her by the other manufacturers. Her lab was on
par with the industry labs, which was critical in terms of legitimacy,
especially since she was the sole investigator to test tampon
absorption of blood. In her prior studies for Kimberly-Clark, she
tapped into her OB/GYN nursing network and asked the labor and delivery
nurses to collect their own menstrual fluid in a menstrual cup called a
Tassaway. For the syngyna experiments, she dropped by the hospital
blood bank to gather outdated donated blood, which the technicians were
more than happy to offload. (These were the days before HIV and there
were no IRB protocols, so this grassroots approach was a creative and
pragmatic solution.) Early on in planning the design of the studies,
Reame had proposed to the task force using heparinized blood as a
comparative test fluid against saliva at all eight study sites, but was
told by several industry scientists that such an approach would simply
not be realistic under laboratory conditions (although no data were
ever presented she pointed out). Deciding to proceed anyway with
testing both saline and blood, she was pleasantly surprised when the
donated blood performed as well as a reproducible test fluid (Reame, 2016).
Reame reflected on the results and commented, "the overall findings
were pretty close to what I showed in my lab, which makes me think they
were all pretty on target," but "I couldn't get a handle of how similar
my data were with everybody else's, although they all…had to contribute
and show data, but nobody wanted to say [what they had]. That just made
me mad. That's just not the way [we do things]. We're used to sharing."
Here, her understanding of both good science and feminist science came
to the fore. There was not an open practice of sharing data, and
Swankin felt that the industry folks were always hedging for the next
lawsuit, worrying about every possible implication of the data in terms
of liability. This was not entirely unwarranted since Procter &
Gamble had been successfully sued for product liability due to injuries
and deaths related to Rely tampons, and there were at least one
thousand cases in the works against them alone (Gruber, 1989; Vostral,
2011). Swankin also recalled that the litigation lawyers were a
different crew than the task force lawyers, indicating an extensive
legal department to look out for each of the manufacturers interests,
yet another challenge for the resource-deprived consumer groups.
The report that Reame submitted to the Tampon Task Force titled
"Comparison of Syngyna Fluid and Venous Blood Using the Syngyna
Absorbancy (sic) Test" drew attention to some important differences in
findings between saline and heparinized blood (Reame, 1983). Esther
Rome and Jill Wolhandler also chimed in with Reame in the "Letters"
section of JAMA, the Journal of the American Medical Association,
bringing feminist science to established and mainstream medicine. As
they saw it, there were "questions about the statistical validity of
the analysis of test data presented to the task force" in which the
results using saline and heparinized blood were different. "Although
the relative ranking of the product does not change," they stated, "the
differences in absolute absorbency seem significantly different at the
higher absorbencies, with much more blood being absorbed" (Rome,
Wolhandler, & Reame, 1988, p. 686). This raised the concern that
some tampons might be miscategorized as less absorbent than they
actually were; when presented with menstrual fluid they would absorb
more than they did with saline. This had potential health ramifications
if women thought that they were using a less-absorbing tampon due to
the way it was potentially mislabeled. Here, the very basis of the
standard could be inherently flawed due to the use of a less-than-ideal
synthetic fluid in the lab protocol.
For the consumer groups and feminist advocates, the goals of the study
were to establish absorbency ranges measured in grams of fluid, which
then correlated with an agreed-upon nomenclature such as Regular,
Super, and Super-Plus. The manufacturers argued on both fronts. They
wanted decent margins within a category due to the fact that not every
tampon, even from the same lot number, is exactly the same. For
example, a box of Regulars could contain tampons that absorbed more or
less, and the manufacturers wanted these allowances likely because the
machinery was not calibrated for this kind of precision (Swankin,
2016). The other hurdle was nomenclature, since the
terms used were generated by marketing departments. Both Tampax and Playtex
produced Super tampons, but Playtex absorbed far more. Regularizing the
Super designation would force material changes for one or both. As
these companies were fierce business competitors, the stakes were high
concerning the implications of the standards for market share and costs.
The naming of the sizes remained a problem. Several ideas were floated.
One was to do nothing and just list the grams of absorption. This
allowed advertisers to use any words they wanted to describe the
product, which would prolong the misunderstandings. Another was to
create a scale similar to sunscreen, with higher numbers correlating
with higher absorption, also conveyed numerically in grams. This, Rome
insisted, was equally confusing and misleading (Rome & Wolhandler,
1985). Steve Fellman, the lawyer representing Tambrands, Inc.,
described how manufacturers suggested offering "small, medium, large,
and extra large" as possible terminology, but this was not well
received (Fellman, 2016). The implication was that this system
correlated to vaginal size rather than tampon absorbency, which had no
relationship to one another.
The task force as a whole, however, never came to any agreements and
disbanded by 1985. Rome and Wolhandler wrote a letter to the Living
Section of The New York Times
indicating "[o]ne thing we learned from the Tampon Task Force is that
the materials used in tampons have not been tested adequately. Most
have never been studied in the vaginal environment" (Rome &
Wolhandler, 1985). Furthermore, Rome wrote that the manufacturers
ultimately agreed "on an industry standard for the Syngyna test that is
similar to the test proposed by the American Society of Testing and
Materials and that continues to have the same flaws" (Rome, Wolhandler,
& Reame, 1988). Fellman may have had influence behind the scenes
with manufacturers, however, breaking the stalemate amongst them.
Whether it was his personality, the fact that Tambrands had not
succumbed to the "absorbency wars" (as they were referred to in-house),
or that the company simply had less to lose, he likely helped convince
some manufacturers to agree to absorbency ranges and terminology. But
this still included the flaw mentioned by Rome: the use of saline
rather than blood or menstrual fluid in the syngyna test.
Even though the Tampon Task Force did not achieve its goals,
letter-writing campaigns to the FDA spearheaded by BWHBC and a lawsuit
brought against the FDA by the Public Citizen Health Research Group
pressured the agency to act on the issue of labeling, which was still
unresolved (Public Citizen, 1988). The judge ruled in the consumers'
favor that the FDA must publish a final regulation by October 31, 1989.
The final categories for absorption by grams as well as nomenclature
came that year, with standardized labeling for tampons effective in
March of 1990 (CDC, 1990; Farley, 1991). The final standards were
defined in terms of ranges, while keeping the same language of the
marketers, though regularizing the meaning: 6 g or less (junior
absorbency), greater than 6 g up to and including 9 g (regular
absorbency), greater than 9 g up to and including 12 g (super
absorbency) or greater than 12 g up to and including 15 g (super plus
absorbency) (Federal Register). That information about absorptive
ranges and their correlating definition was finally encoded into
federal policy was a success. These ranges and descriptive terms were
non-negotiable elements for the consumer groups and health advocates
from the very beginning. Their influence upon the Tampon Task Force is
printed upon every box of tampons by its display of absorbency ranges,
so that women can have accurate information about their tampons in an
effort to best match their menstrual flow.
The Elusive Pursuit of Standards
Despite the success of labeling in terms of grams and nomenclature, the
feminist advocates felt shortchanged. They had far greater ambitions
for tampon safety and wanted to address chemical residue in deodorant
tampons and their perfumes, string breakage, plastic applicator
lacerations, and overall material safety. They wanted standards for
these things, but in the end they all got dropped. In part, early
conversations by the task force about these agenda items helped the
manufacturers delay discussions about the real issue of absorbency, and
detracted from the greater goal at hand. At a certain point, the
consumer groups and health advocates realized they needed to distill
their efforts to focus on one issue rather than diluting things with
lots of demands, though they were legitimate. They were unable to get
all the industry scientists on board to use any form of blood, which
ironically would seem to offer more accuracy in terms of replicating
real life conditions. It may also be that there was not a critical mass
of feminist scientists in the room to overcome the prevailing norm for
saline. Even Sydney Wolfe of the Public Citizen Health Research Group,
who supported labeling and helped to sue the FDA, sided against
feminist science in support of saline. He argued that because blood
came from different sources, it was simply impossible to reproduce lab
conditions and standardize tests, thus saline was the best test fluid
upon which to base absorbency standards (Wolfe, 1987).
The results for both saline and blood did yield the same rank order of
tampons, so using blood was not necessarily required, though the
protest about the higher absorbency of blood was never resolved and
tampon users remain in the dark about this important piece of
information. Yet, the very act of offering an alternative means of
envisioning the methodology and providing data challenged dominantly
held views about the insignificance of menstrual fluid. The women’s
health advocates, and especially the influence of Esther Rome, was felt
beyond the standard setting process. Some of the men were personally
affected by their involvement with the task force. Swankin acknowledged
he got "a real education" from the women on the task force, and he
appreciated the way Rome raised her points. Steven Fellman, the lawyer
who represented Tampax, Inc. took a copy of Our Bodies, Ourselves home to his wife due to meeting Rome, something he would not have done otherwise (Fellman, 2016).
The process to agree upon an absorbency standard suffered on multiple
fronts during the 1980s: President Ronald Reagan's administration was
unsupportive of new federal regulations, industries resisted changes to
tampon packaging and product design since they threatened
profitability, and there was no critical mass of feminist scientists on
board with the proposed methodology. Though the task force disbanded
without agreement in 1985, the process of bringing consumer groups,
health advocates, and corporate representatives together marked an
important precedent in standard setting. Furthermore, some of the goals
of the feminist health advocates were included in federal labeling
guidelines appearing five years after the last official meeting of the
Tampon Task Force.
The need for more precise labeling and testing remains. Categorized as
Class II medical devices, tampon contents are considered "trade
secrets" and not publicly disclosed, so there is still no way to know
what materials or chemicals they may contain, even when a new product
is introduced, or how they might relate to TSS. Carolyn Maloney (D-NY)
introduced the Tampon Safety and Research Act in 1997, renamed the
Robin Danielson Act regarding tampon safety, in recognition of
Danielson’s death due to TSS in 1998. For nearly twenty years Maloney
has pursued this legislation, to no avail. It would require independent
research upon tampons and sanitary napkins to gauge their health
impact, and content labeling similar to clothing or food (H.R. 1708,
2015). This basic information is long overdue, and the threat of a
House bill along with grassroots protests have compelled some
manufacturers such as Kimberly-Clark (Kotex) and Procter & Gamble
(Tampax, Always) to list ingredients (Kounang, 2015).
This historical case study points to the significant implications of
consumer groups and feminist advocates using tactics learned while
writing Our Bodies, Ourselves
and deploying them in the federal regulation process by producing their
own scientific data. It also highlights the importance of feminist
ideas privileging women's understandings of their own bodies to shape
science during the 1980s, in the face of the unknowns related to Toxic
Shock Syndrome. Though the overall lab methods employed may seem
conventional, the testing of actual blood when it was purposely
excluded demonstrates resistance to status quo scientific practice.
Importantly it asserts the primacy of bodily experiences to
menstruation and Esther Rome's insistence upon flesh, vaginal orifices,
and menstrual blood being inseparable from the tampon as a
technology—women's bodies were the requisite context.
The syngyna summarily detached menstruation and tampons from women's
embodied experiences by instrumentalizing them for lab purposes. Women
and their bodies were invisiblized and simulated by technoscientific
apparatus, with differences erased and then standardized into glass,
tubing, and latex condoms (which, incidentally, come in various sizes
to accommodate differently shaped penises). All difference between
women was extricated; the resulting data from the syngyna test were
more "real" than could be gathered from a flesh-and-blood person. Yet,
the quality of the data drawn upon to set policy recommendations was
absolutely crucial to absorption standardization. Feminist science both
questioned assumed lab practices as well as devised new methods,
insisting upon the biological materiality of menstruating bodies in an
effort to accurately label tampon boxes and therefore stem the rates of
1. Image of the syngyna apparatus glass tubing with tampon. In Dixie
Farley (1990, February), Preventing TSS: New tampon labeling lets women
compare absorbencies, FDA Consumer 24 (1),8.
Figure 2. Line drawing of syngyna lab apparatus. In D. E.
Marlowe, R. M. Weigle and R. S. Stauffenberg, (1981, May), “Measurement
of Tampon Absorbency Test Method Evaluation,” FDA, Bureau of Medical Devices, Report 81-013, Schlesinger Library, BWHBC, box 29, folder 2.
1The term "women" is used in its historical sense in this essay, since that was the common parlance of the moment.
Bobel, C. (2010). New blood: Third-wave feminism and the politics of menstruation. New Brunswick, NJ: Rutgers University Press.
Boston Women’s Health Book Collective (1973). Preface. In Boston Women’s Health Book Collective, Our bodies, ourselves: A book by and for women. Accessed at http://www.ourbodiesourselves.org/history/preface-to-the-1973-edition-of-our-bodies-ourselves/
Centers for Disease Control (1990, June 29). Historical perspectives
reduced incidence of menstrual Toxic-Shock Syndrome—United States,
1980–1990. MMWR Weekly, 39(25), 421–423. Retrieved from http://www.cdc.gov/mmwr/preview/mmwrhtml/00001651.htm
Centers for Disease Control (1980, September 19). Follow-up on Toxic-Shock Syndrome. MMWR Weekly, 29(37), 441–445.
Ellis, W. (1982, January 22). Wayne Ellis to F. Alan Anderson. Schlesinger Library, BWHBC, box 29, folder 2.
Farley, D. (1990, February), Preventing TSS: New tampon labeling lets women compare absorbencies, FDA Consumer 24(1), 8.
Federal Register. (1989, October 26). Department of Health and Human Services. Section 801.430. 54(26), 43771.
Feinstein, A. (1988, December 2) Scientific standards in epidemiologic studies of the menace of daily life. Science, 242(4883), 1257–1263.
Fellman, S. (2016, July 12). Interview with author.
Friedenfelds, L. (2010). The modern period: Menstruation in
twentieth-century America. Baltimore, MD: Johns Hopkins University
Gruber, W. (1989, March 27). After 8 years, Procter still not free of the Rely controversy. Chicago Tribune.
H.R. 1708, Robin Danielson Feminine Hygiene Product Safety Act of 2015.
Hajjeh R.A., Reingold A., Weil, A., Shutt, K., Schuchat, A., &
Perkins, B.A. (1999, November–December). Toxic Shock Syndrome in the
United States: Surveillance update, 1979–1996. Emerging Infectious Disease, 5(6), 807–810.
Kline, W. (2010). Bodies of knowledge: Sexuality, reproduction, and women's health in the second wave. Chicago, IL: University of Chicago Press.
Kobren, L. (1981, September 24). Standard for performance
characteristics of menstrual tampons. Schlesinger Library, BWHBC box
29, folder 2.
Kounang, N. (2015, November 13). What’s in your pad or tampon? CNN Health. Retrieved from http://www.cnn.com/2015/11/13/health/whats-in-your-pad-or-tampon/index.html
LeBuhn, B. (2017, February 5). Correspondence with author.
LeBuhn, B. (2017, March 7). Interview with author.
Martin, E. (1987). The Woman in the body: A cultural analysis of reproduction. Boston, MA: Beacon Press.
Memo (1983, October 1). Consumer members of Tampon Task Force. Schlesinger Library, BWHBC, box 29, folder 2.
Michael L. Kehm v. Procter & Gamble. United States Courthouse, Cedar Rapids, Iowa. April 5, 1982.
Osterholm, M., Davis, J. P., Gibson, R. W., Mandel J. S., Wintermeyer,
L. A., Helms, C. M., Forfang, J. C., Rondeau J., Vergeront, J. M.,
& the Investigative Team (1982). Tri-Sate Toxic-Shock Syndrome
study. I. Epidemiologic findings. Journal of Infectious Diseases, 145(4), 431–440.
Public Citizen (1988, June 1). Press release: FDA sued for failing to
require tampon absorbency labels. Schlesinger Library, BWHBC box 33,
Rapp, G.W. (n.d.). A comparison of the absorptive efficiency of
commercial catamenial tampons. Schlesinger Library, BWHBC box 29,
Reame, N. (2017, January 30 & February 10). Correspondence with author.
Reame, N. (2016, April 6). Interview with the author.
Reame, N. to Swankin, D., with attached report (1983, May 23). Schlesinger Library, BWHBC folder 34, box 1.
Riley, T. (1986). The price of a life: One woman's death from Toxic Shock. Bethseda, MD: Adler & Adler.
Rome, E., & Wolhandler, J. (1985, August 18). Toxic Shock Syndrome. The New York Times. Retrived from http://www.nytimes.com/1985/08/28/garden/l-toxic-shock-syndrome-224765.html.
Rome E., Wolhandler, J., & Reame, N. (1988). The absorbency of tampons. JAMA, 259(5), 685–686.
Schlievert, P.M., Shands, K. N., Dan, B. B., Schmid G. P., &
Nishimura, R. D. (1981). Identification and characterization of an
exotoxin from Staphylococcus aureus associated with toxic-shock syndrome. Journal of Infectious Diseases, 143(4), 509–516.
Swankin, D. (2016, February 24). Interview with author.
Tierno, P. (2001). The secret life of germs: What they are, why we need them, and how we can protect ourselves against them. New York, NY: Atria Books.
Todd, J., Fishaut, M., Kapral, F., & Welch, T. (1978). Toxic-Shock Syndrome associated with Phage-Group-I Staphylococci. Lancet, 2(8100),1116–1118.
“Toxic Shock Syndrome—United States, 1970-1980.” (1981, January 30) MMWR 30(3), 25–26.
“Update: Toxic Shock Syndrome–United States.” (1983, August 5). MMWR, 32(30), 398–400. Retrieved from http://www.cdc.gov/mmwr/preview/mmwrhtml/00000119.htm
Vostral, S. (2008). Under wraps: A history of menstrual hygiene technology. Lanham, MD: Lexington.
Vostral, S. (2011). Rely and Toxic Shock Syndrome: A technological health crisis. Yale Journal of Biology and Medicine, 84(4), 447–459.
Wolfe, S. (1987). Dangerous delays in tampon absorbency warnings. JAMA, 258(7), 949–951.
Sharra L. Vostral is an
Associate Professor of History in the College of Liberal Arts, and
affiliated with programs in Women's, Gender & Sexuality Studies, and
American Studies at Purdue University.