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Unexpected Consequences

A tampon is a thing. A bacterium is a life form. These assertions, however, are shortsighted. As it turns out, and as toxic shock syndrome (TSS) came to attest, both are quite more dynamic together than anyone ever imagined. This was difficult to envision because of the overwhelming assumption that tampons were inert, disposable objects. They sometimes caused irritation, an allergic reaction from embedded perfumes, or lacerations from an applicator, but they were not conceptualized as dynamic. That a bacterium typically associated with food poisoning or boils might possibly develop into a strain that could produce septic shock seemed like a stretch, but it became accepted knowledge. Agreeing on a new ailment of TSS and further specifying it as tampon-related TSS became part of a repertoire of illnesses predominantly affecting women.

What is not well conceptualized, and an idea that I propose here, is that during this process a bacterium became the overlooked and unintended user of tampons, thus changing the relationship of user/technology. The bacterium advantageously capitalized on the technological innovation to reproduce and multiply. Though tampons were intended for menstruating women to be the dominant users of the technology, it is constructive to think of bacteria as users, too. This changes subject/object orientation, thus shifting the conditions of agency. It is here that the relational activity of technology and bacterium must be far better conceptualized and understood as co-agents of unintended illness.

This chapter focuses on this relational activity. There are many conceptual underpinnings that need to be addressed to better understand this techno-bacteriological relationship. First, tampons are a technology, with a history of design and development during the twentieth century. Second, they share in common the ability to cause gendered injury, like many other technologies used to manage and regulate women’s reproductive bodies. As such, and third, they fall into a loosely woven safety net of the Medical Device Amendments (MDA), which in theory provide a process by which therapeutic technology undergoes testing to assess its compatibility with the human body and its proclivity to do harm. Fourth, what these tests do not predict is how other organisms in and of the human body will interact with medical devices, because technology is not neutral or inert. This has a direct effect on the next important concept: that bacteria possess the ability to become technological users, and, as users, create unintended consequences for humans with which they share an ecological space. Finally, this techno-bacteriological interface has been poorly anticipated in terms of design and risk, so that resultant injury appears unexpectedly, as a surprise. The indecorous subject of tampons and menstruation made it difficult for many to willingly concede the game-changing scope of this technobiological illness.1

Tampons as Technologies

Tampons were neither regulated nor particularly trusted technologies when they first commercially appeared in the form of Tampax in 1936. They required a good degree of domestication as emergent technologies, accompanied by educational advertising teaching women about the benefits of the technology.2 Because tampons were phallic-like in shape and a perceived threat to the virginal hymen, some educators, nurses, and parents felt convinced to leave well enough alone. They promoted the use of disposable sanitary napkins instead for adolescent girls.3 Yet, by the 1940s, many young women were early adopters, because they recognized how tampons relieved them of the physical encumbrance of elastic belts, long tabs, and uncomfortably thick pads worn between the thighs.4 Advertising, menstrual hygiene education films, and word of mouth shifted many women’s opinions about tampons from dubious to acceptable; under certain circumstances such as dancing, swimming, or working long shifts, many embraced them as a useful tool of physical liberation.5 Still, there was much cloaking, double entendre, and indirect language about how and when to use a tampon. To the uninitiated, the cryptic language of advertising made tampons seem like magic in a box; I have anecdotally heard more than once that a thoughtful but unknowing young boy would gift a girl in first or second grade this special box because she could do all kinds of amazing things with it, like ride horses or bikes, and do gymnastics.

By the 1960s, through skillful advertising campaigns, companies successfully associated bodily freedom and women’s liberation with the use of tampon technologies.6 Once women accepted tampons, they entered into a tacit agreement with the corporation, assuming that this commodity was safe. There were some complaints of abrasions, strings breaking, products leaking, and contact dermatitis related to deodorants and perfumes embedded in tampon materials. Other complaints regarded problems of disposal and clogged plumbing when they were flushed down the toilet. Yet, overall, cotton tampons enjoyed a solid reputation. They may not have worked well for all women, but they could be viewed similar to a bandage: a medical dressing to absorb blood.

Though we often think of tampons as static objects, designers, chemists, and inventors, working on behalf of large corporations, filed many patents to transform the plain old cotton tampon into something they thought would be significantly better and thus gain a larger share of the market. Though Tampax may have been the first cotton tampon to be successfully commercialized in 1936, others with different designs soon followed. Wix, a competitor of Tampax in the 1930s, incorporated a cellophane sheath, which, according to the inventor Frederick Richardson, was “to hold the body of the absorbent material in its proper desired shape, and in part, to enable the plug to be easily inserted into working position.”7 He suggested that deodorants such as phenol, peppermint, or wintergreen could be added easily to the cotton. At the Personal Products Corporation—a Johnson & Johnson subsidiary—George C. Graham developed a patent for a flexible tampon composed of “cotton, rayon, paper, hemp or wool” in 1957.8 Simultaneously, he applied for a patent for a tampon composed of absorptive salts, including sodium carboxyethylcellulose or sodium carboxymethylcellulose.9 He also received a patent in 1960 for a “tow tampon.” This tampon would have longer rather than shorter filaments for better absorption of fluids by creating capillaries. This patent made claim on a particular manufacturing process and design, but imagined a variety of materials to satisfy the end product of a tampon.

Patenting as broadly as possible was common practice, and materials included “Dacron” polymeric polyester, nylon, viscose rayon, vinyl fibers, acrylic fibers, “saran” polymeric vinyl chloride, polyethylene, glass fibers, protein fibers, and silk.10 Polyester emerged as a synthetic fiber in the 1950s, and the reference in the patent to Dacron reflected the proprietary name given to it by DuPont. Also by 1960, scientists at Kimberly-Clark Corporation, the maker of Kotex sanitary napkins, had received patents for tampons composed of 60 percent cotton and 40 percent “crimped viscose rayon staple fibers.”11 The variety of materials indicated that inventors were thinking beyond cotton grown on the farm, to fibers and substances easily created in the lab.

Viscose rayon emerged as a popular addition to tampons, proving to be both absorbent and cheap to procure. Derived from wood cellulose, it is processed with other chemicals, dried, and spun to form fibers. Unlike cotton or silk, which retain their properties and characteristics, chemical processes transform cellulose into a semi-synthetic fiber. Most of the popular brands of tampons—Tampax, Playtex, o.b., Kotex—have incorporated rayon, but because the labeling of ingredients is not mandated, that information is not readily available.12 By 1996, researchers felt that there were only two all-cotton tampons available to test; all the rest contained rayon.13 In part, Tambrands introduced “Tampax Naturals” that same year, calling the product line “the first U.S.-made all-cotton tampon”—despite that same composition of the original Tampax—in response to some women’s desires for a natural tampon. However, rayon continues to be used as a core component of tampons. Even the employees of the Good Shepherd Food-Bank in Maine, on a goodwill tour of the neighboring Tambrands manufacturing plant in 2012, waxed eloquent about the machinery as it produced Tampax Pearl tampons, made out of both cotton and rayon, the fibers “spun into a solid mat.”14

Inventors continued to develop new fibers and materials during the 1960s and 1970s. The scientists Billy Harper, Robert Bashaw, and Bobby Atkins developed sodium polyacrylate for Dow Chemical Company, filing a patent for the chemical in 1966.15 Due to its polymer structure containing sodium ions, sodium polyacrylate absorbs anywhere from 200 to 1,000 times its own weight in water. The material forms into a gel, which in essence holds fluids. In 1978, Russell L. Johnson for the Kimberly-Clark Corporation devised a digital tampon meant to be inserted with a finger. It used a cotton-rayon fiber base, and capitalized on the newly developed “super absorbent fibers,” including polyacrylate, cross-linked polyurethane, or polyester foam.16 Currently, sodium polyacrylate is a common absorbent in disposable baby diapers.17 Of course, bodily fluids from urine to menstrual fluid are not pure water, thus the polyacrylate is not as effective with salts and proteins, so it must be paired with other materials to produce an absorbent tampon or diaper less likely to leak.

By the mid-1970s, the leading tampon manufacturers landed patents for tampons that included some derivative of carboxymethylcellulose (CMC) as one of its absorbent components. CMC, derived from the more familiar plant material of cellulose, when synthesized by a reaction with chloroacetic acid, becomes a viscose thickening agent, shifting from powder to gel when introduced to liquids. It is used as a food additive to stabilize emulsions, such as ice cream, but also to help with gelling texture in toothpaste, detergents, or paints. It is considered nontoxic and hypoallergenic, and by all appearances, it is a dream material with which to work due to its relative stability. International Playtex, Inc., filed a patent for “preparation of water-insoluble carboxymethyl cellulose absorbents” in 1978, the purpose of which was for absorbency in a tampon.18 Kimberly-Clark filed a patent in 1976 for a compressed tampon composed of absorbent fibers, including carboxymethylcellulose.19

By 1974 Procter & Gamble (P&G) already test-marketed its synthetic Rely, composed of a polyester sheath, compressed polyurethane (and later polyester) foam cubes, and carboxymethylcellulose, but continued to hone its own version of a CMC tampon, as evidenced by its patent encompassing many “absorbent devices” filed in 1981.20 Incorporating CLD-2—the trade name for cross-linked CMC manufactured by Buckeye Cellulose Corporation, a subsidiary of P&G—this iteration of the tampon also included Pluronic L-92, a nonionic surfactant manufactured by BASF, helping the fibers to be more hydrophilic, and referred to as “mensesphilic” in the patent.21 The significance of this surfactant would not be discovered until the early 1990s, when researchers found that Pluronic L-92 increased production of the TSST-1 toxin.22 It is unfair to characterize this lack of oversight as purposeful, yet the zeal for superabsorbents overrode their downside.

Figure 1.1. Patent for Rely Tampons, 1974. This patent displays Rely’s novel features, including the shape, sheath, inserter, and polyurethane cells, later replaced with polyester foam. Source: Jean Schaefer, inventor; Procter & Gamble Company, assignee. Catamenial Aggregate Absorbent Body, US Patent 3,815,601, filed May 9, 1973 and assigned June 11, 1974.

Figure 1.2. Rely Tampon and applicator (side view). The plastic applicator houses and inserts the tampon. The unique composition of the tampon is quite light and airy compared to a compressed cotton tampon. Photo by Sharra Vostral.

Figure 1.3. Rely Tampon and applicator (front view). The polyester casing is visible here, showing the cuplike shape as it expands, referred to as a “rosette.” Within the case are small polyester foam cubes and the thickening agent carboxymethylcellulose. This tampon came from an unused sample box. Photo by Sharra Vostral.

In effect, the chemistry of absorbent materials had so flourished that the term “superabsorbents” defined this new category. A 1979 article title in Chemical Week proclaimed “Superabsorbents Seek Markets That Are Super,” indicating the turn from plain old cotton or rayon to highly processed and synthesized components in search of applications for customer purchase.23 The writer noted that personal care products and diapers were prime areas for applying these new polymers, since superabsorbents could soak up 50 to 1,500 times their weight in water. Yet the weekly urged that “consumer education must be undertaken to promote other uses for the materials and to dispel the notion that absorbent means bulky.” Because traditional materials required more volume rather than less to absorb an equivalent amount, this common wisdom needed to be dispelled to show that “new-and-improved” translated into a sleeker, smaller product.

Problematic Female-Specific Technologies

That tampons should be artifacts worth “modernizing” fits into the ideological scope of progressive science and technological determinism offered during the 1960s and 1970s. NASA experienced great success with the space program, inspiring a new generation of scientists to dream big in spite of the risks. Faster, nonhuman mainframe computers crunched mathematical formulas at blistering speeds. Insecticides and herbicides applied to crops yielded greater harvests, with abundance to share. And petrochemicals and plastics could be manufactured more efficiently and more cheaply than just about any material that they replaced. Scientists, it seemed, held the keys to nature itself and could not only solve the world’s problems but also do it better than ever imagined. Though we now recognize there are costs for all this “progress” that were oftentimes conveniently ignored, nonetheless these huge scientific and technological gains created the impression that no problem was beyond the scope of technoscientific solutions.

The science of medicine developed further as well, with women’s bodies and health needs receiving renewed attention. With the wild success of the birth control pill, corporations could no longer ignore women’s desires to manage their own fertility and experience better pregnancies. Thus, progressive science and scientific medicine heeded the cultural message and began delivering more options to women, ranging from disposable baby bottles, to New Freedom sanitary pads, and, more ominously, products that caused injury as well.

One such pharmaceutical was thalidomide, a sedative prescribed to pregnant women to treat morning sickness and nausea. Widely available throughout Europe, Australia, and Canada during the 1950s and 1960s, thousands of women took the medication, unknowingly exposing their fetuses to toxins that caused birth defects, most notably the absence of limbs. Interestingly, it was a female physician hired in 1960 by the Food and Drug Administration (FDA) who stalled the drug’s application in the United States, ultimately refusing its approval. Frances Kelsey, a pharmacologist who worked on a treatment for malaria among other projects, upended the erroneously held assumption that the placenta was impervious to chemicals by recognizing that its porous composition allowed pharmaceuticals to pass through it. Furthermore, pharmaceuticals affected adults, children, and fetuses quite differently. Her readings of British studies on thalidomide pointed to enough concerns that she requested further scientific testing rather than relying on more testimonials from the Richardson-Merrell pharmaceutical company. Kelsey held firm, despite pressure and bullying for the drug’s approval, and demanded more proof of safety. By late 1961, German health authorities had linked thalidomide to birth defects, and they recalled the drug, which was available there over the counter. The March of Dimes estimated that more than 10,000 children were born with defects due to thalidomide, though only seventeen were connected to it in the United States, in no small part due to Kelsey.24 It took until 2012 for the manufacturer Gruenenthal Group and its chief executive to apologize for the tragedy unleashed by the drug.

In a similar example, the Dalkon Shield, an intrauterine device (IUD) intended to prevent pregnancy, by all accounts seemed to be a promising method of birth control yet it also delivered unintended injuries. Though IUDs were not new, the design of the Dalkon Shield was unique—a plastic horseshoe crablike insert with fins, that when installed in the uterus encouraged white blood cell activity that in turn attacked sperm when present. With national marketing beginning in January 1971, over 2.5 million women used the Dalkon Shield, manufactured by A. H. Robins Company, until it was voluntarily withdrawn from the market in 1974.25 At that time, the FDA did not require stringent testing of medical devices, and the agency’s only recourse was to issue a recall after a sufficient number of physicians and patients reported problems.26

The undoing of the Dalkon Shield was its multifilament tail string covered in a nylon sheath that remained attached to the device after insertion so that it could be removed at a later date. It turned out that this string was prone to knotting and perforating, thus creating a perfect wicking agent, drawing bacteria from the vagina into the usually sterile uterus. For many women, pelvic inflammatory disease resulted, including infection, scarring of the fallopian tubes, and, in the worst cases, damage leading to a hysterectomy. For some women, the plastic fins on the device embedded into the uterus. For others, the device did not prevent conception and instead led to “septic spontaneous abortion” in which bacteria that wicked from the IUD infected the placenta and then the woman; this resulted in not only unwanted pregnancies and illness, but also eighteen deaths.27 Compounding the grief brought on by a birth control device that caused permanent infertility was the revelation that A. H. Robins had previous knowledge of its defects. When A. H. Robins purchased the IUD from Dalkon Corporation, confidential memoranda noted the device’s proclivity to wick.28 More than 300,000 parties sued A. H. Robins in product liability cases, which continued well into the 1980s and ultimately led to the downfall of the company.

Medicines and devices related to women’s reproductive health that caused far worse problems than the ones they promised to solve understandably created fear and anger. It was unwelcomed and unwanted news that novel solutions to maternal health and birth control led to damaging consequences in this era of “progressive” technoscience. There was also something particularly troubling about the damage caused to women’s reproductive health when some scientists, physicians, and business representatives chose to ignore problems and instead narrow the frame of vision to exclude glaring errors. It is not a large leap to apply Langdon Winner’s provocative thesis that politics are embedded into objects and technological artifacts to understand how these devices embodied societal ignorance and sexism.29

Yet, in the same era, women’s liberation gained traction and feminism provided tools to critique medical “progress” and generate dissent.30 In part, the women’s health movement, begun in the late 1960s, called for woman-friendly, woman-centered approaches to women’s life-course health needs, epitomized by information distributed in Our Bodies, Ourselves, edited by the Boston Women’s Health Book Collective.31 When the universal male stood in for all things human, and an androcentric approach devalued women’s health concerns, the women’s health movement insisted on the normalcy of women’s reproductive life cycles, as well as the need for woman-friendly health advice. The force of women’s health advocates was abundantly clear at the congressional hearing on the pill in 1970, with protesters bringing a halt to the all-male proceedings. Feminist health advocates could now mark side effects and ill health associated with medical “progress” as a significant cost rather than mere inconveniences to be endured.32 They pressured public health officials and regulators to be accountable, and this marked an important shift in medicine to recognize patients’ rights.33

Medical Device Amendments of 1976

The way that medical devices were viewed changed as well in the 1970s as a result of new regulatory policies brought forth by the 1976 Medical Device Amendments (MDA) to the Federal Food, Drug and Cosmetic Act (FFDCA). The FFDCA currently provides definitions for food (including chewing gum), food additives such as food coloring, dietary supplements, and even tobacco. In 1938, the FFDCA gave the FDA authority to oversee not only food and drugs, but cosmetics as well, in part to quell the cases of misleading labeling, egregious health claims, and outright dangerous additives to comestibles and medicines. However, there was no formalized review process specifically for devices, ranging from instruments to diagnose diseases to apparatuses worn on or implanted into the body, and the products required no official approval. Items such as sanitary pads and tampons, however, were classified as cosmetics (an odd fit rationalized because they touched the skin) and received minimal regulatory attention.

Passage of the MDA of 1976 gained traction in Congress, with Senator Edward Kennedy its prime advocate. Serious, undisclosed defects in technologies such as pacemakers, IUDs, and intraocular lenses caused harm and injury to patients, leaving a trail of product liability lawsuits in their wake. To address this regulatory deficiency, the amendment also created the Bureau of Medical Devices within the FDA specifically to monitor applications for approval.34 According to the amendments, a medical device covers a broad range of instruments, diagnostic tools, and mechanical interventions to mitigate human health; it does not cover “chemical action,” which is generally under the purview of drugs in the FDA.35 The amendment also set parameters for three classes of medical devices according to their perceived risk. Class I requires the least regulatory control, including items such as dental floss, bed pans, or examination gloves. Class II calls for further assurances of safety, labeling, and monitoring to assess harm and prevent injury to patients. Powered wheelchairs, hearing aids, and tampons fall into this category. Class III represents those technologies, such as artificial hearts, that are novel and sustain human life but may cause harm due to their experimental nature.

Complicating the 1976 classification system was the treatment of devices considered to have a long-standing record of safety. According to David Kessler, who would later become the commissioner of the FDA in 1990,

Pre-amendment devices are assigned to the least-regulated class that is sufficient to provide reasonable assurance of safety and effectiveness. Post-amendment devices that are deemed “substantially equivalent” to pre-amendment devices are assigned to the same class as their comparable pre-amendment devices and may be marketed after the manufacturer provides the FDA with premarketing notification.36

Thus, “if a manufacturer can establish substantial equivalence,” it need only provide the FDA with a premarket notification. If not, the device must go through premarket approval. And, according to Kessler, since the “substantial equivalence” clause encompasses far less testing, cost, and time, it benefits a company to have its device ushered through the regulatory process with premarket notification.

In general, most tampons on the market before 1976 were “grandfathered” in to the new classification system, whereby manufacturers established “substantial equivalence.”37 Furthermore, tampons were categorized as Class II medical devices, a significant definitional shift from cosmetics. Despite the intentions to protect users, the system missed many new technological changes due to the language of “substantial equivalence.” Thus, tampons marketed before 1976 fell into the least regulated class. This is significant to the TSS story and Rely tampons. Rely was first test-marketed in Fort Wayne, Indiana, in 1974 and P&G was not bound by federal law to produce new evidence of safety because it was technically a “pre-amendment device.”38 Thus, even though Rely tampons were relatively new in terms of composition, they were a Class II medical device previously distributed and did not require extra testing or scrutiny.

One of the shortcomings of the MDA is the way it renders medical technologies inert. Artifacts such as joint replacements, cochlear implants, and even wound dressings are technologies that affect biological systems, and they are increasingly intended for internal bodily use. Nelly Oudshoorn, who studies technology dynamics and healthcare, suggests that there are different harms associated with invisible technologies of the body, or those technologies not “seen” but found internally. She asks, “What forms of vulnerability emerge when technology moves under the skin?” Her research examines implantable cardioverter defibrillators (ICDs), more generally referred to as pacemakers. These ICDs regularize the beats of a heart but also tend to send out rogue shocks that come on without warning and are uncomfortable to endure. She argues that “vulnerabilities faced by … ICD users introduce other ways of coping with harm than the vulnerabilities caused by technologies external to bodies.” Some of these coping mechanisms include keeping large magnets nearby to neutralize the shock, or alternatively feeling despondent about not only heart disease but also the painful treatment.39 Because the technologies cannot be removed, and managing the underlying medical condition holds prominence over all other concerns, there is no respite from the detrimental “side effects” of the therapeutic technology with which the patient must comply.

Bacterium and Agential Power

These kinds of medical harms are not a surprise when viewed through Bruno Latour’s provocative notion of technological agency, which offers a means to include objects, as nonhuman actors, on par with humans in considering relationships, outcomes, and events.40 Latour’s actor-network theory has been well discussed, and it is not my aim to enter into that debate. However, it, along with Stephen J. Collier and Aihwa Ong’s development of “global assemblages,” brings to bear the “new material, collective, and discursive relationships” of objects and things.41 The political theorist Jane Bennett in Vibrant Matter expounds on this notion of material agency and the recalcitrance of things. She explores the vitality and capacity of things “not only to impede or block the will and designs of humans but also to act as quasi agents or forces with trajectories, propensities, or tendencies of their own.”42 This approach challenges the knee-jerk reaction to dismiss things, nonhumans, and technologies as just “stuff” and instead encounter them on their own accord and on their own terms. It is exactly this lack, and the correlating construction of tampons as inert, that fails to imagine them as energetic things with capacity to enact change.

If I replace the word “objects” with “bacteria” in the previous paragraph, this also changes the perspective about their agency in relation to humans. This should not be unforeseen, given the growing recognition of the deep relationship of bacteria to human life. The Human Microbiome Project sponsored by the National Institutes of Health (NIH) has revealed only a small fraction of the ways in which human bodies are intertwined with microbial entities.43 According to Lita Procter of the NIH, who leads the Human Microbiome Project, “The definition of a human microbiome is all the microbial microbes [sic] that live in and on our bodies but also all the genes—all the metabolic capabilities they bring to supporting human health.” Approximately only one in ten cells are “human,” and the rest belong to everything else.44 Furthermore, the mycobiome more specifically focuses on viruses and fungi, and this must also be incorporated to help counter the predominant attention given to bacteria in the microbiome.45

Despite the Western belief in rationality and individualism, we can hardly make the claim of personal sovereignty once we account for the flora and fauna that each of us supports, as well as support us, in our own ecosystems. The microbiome project, for my purposes here, helps to challenge the primacy of the human as the sole life force of the body. From this perspective, it makes sense that bacteria should be considered as agents, with the ability to act and influence outcomes. As Karen Barad, a feminist theorist, explains, “Agency is not held, it is not a property of persons or things; rather, agency is an enactment, a matter of possibilities for reconfiguring entanglements.” Furthermore, if agency is enactment, which is not necessarily human centered, it helps take into account “entanglements of intra-acting human and non-human practices.”46 Thus, Staphylococcus aureus and tampons configured a new illness entanglement that crested in the early 1980s.

Generally, it has not been understood that bacteria intra-act, entangle, or configure. These are neutral conceptualizations, without judgment of outcome. Instead, bacteria are usually categorized by relational characteristics that indicate their increasing capacity to do harm to humans. “Symbiotic” is the least threatening, with organisms living and interacting together.47 More specifically a relationship to bacteria may be mutual (benefiting both organisms), commensal (benefiting one but not harming the other), and parasitic (living at the expense of the other). Microbes on and in the human body are often described as “microbial inhabitants” or “microbial communities.”48 Some are even “residential microbial communities,” which offers the bacteria a degree of legitimacy, as if they live in an appropriate suburban setting. Though these terms gesture to greater relational structures, it still seems that the bacteria are a community unto themselves. Michael Wilson, a microbiologist, acknowledges the dependency that humans have on them, and he describes a “human-microbe symbiosis,” going so far as to refer to each of us as having a “microbial self.”49 Though this affords greater recognition of the work of bacteria, it still leaves the human self as the dominant life form.

As Linda Nash, a scholar of environmental history, points out, the modern conceptualization of the body relies on a bacteriological notion of disease as existing outside an otherwise healthful person, and this model applies to pollution, too. Although her concern is to highlight the deleterious effects of environmental toxins by reclaiming the ecological body—one more porous and situated within a landscape and polluted environment—this model is useful as one looking inward to the landscapes of the microbiome as well.50 The body as a dynamic ecological space, a metaphorical rain forest, helps to recognize it beyond that of the human sentient being. Stefan Helmreich, an anthropologist who studies science, suggests that a reconceptualized nomenclature for humans, Homo microbis, may better reflect the makeup of human beings and the “microscopic companion species” laced throughout our bodies that are intrinsic to who we think we are as humans. Heather Paxson, an anthropologist who studies food, offers “microbiopolitics” to frame the ways in which “microscopic biologic agents” configure not just our microbiome, but also politics in public health and food safety, and how humans arrange structures of power.51 Furthermore, Helmreich describes “symbiopolitics” as a term to refer to “the densely political relations among many entangled living things—not just microbial—at many scales.”52 I build on symbio- and microbiopolitics and argue that we must also engage these organisms as users with technologies in and of the body.

Instead of referring to bacteria as residents or inhabitants as they are also sometimes called, claiming bacteria as constituents acknowledges their greater agential power. For instance, constituents in political districts allow elected officials to represent their interests; the will of individuals is not always followed, but nonetheless inherent to the structure is the assumption that constituents should have a voice in larger political dynamics. Bacteria should not be afforded something akin to citizenship rights; however, keeping bacterial agency in the frame of larger health systems would serve humans well. By thinking about bacteria as constituents of the human body, a more robust, complex, and all-encompassing understanding of human-bacterial relationships emerges. Labeling bacteria as constituents avoids the problematic constructions of the “host” body in which a universal male bears the burden of feeding the greedy invaders. Never mind that the body is not a feminine hostess (also problematic in other ways), in which the body simply becomes the site for ungrateful and usually unwelcome guests. The more accurate description is that some bacteria are simply part and parcel of being human—Homo microbis—and considering them as constituents affords them a bit of recognition in the larger body politic.

Bacteria, and, for that matter, any unwanted organism that threatens to do harm, accumulate meanings of “the other” by the language used about them. For example, my father, an agronomist, often described a weed as a “plant out of place.” As a child, I was comforted that the weed was still a plant that might do well somewhere else, just not alongside a corn crop. My critical reading now recognizes the power of labeling a plant a “weed,” which disparages one plant while simultaneously naturalizing the legitimacy of another. This construction of a species “out of place” is prominent to descriptions of many ecosystems. Banu Subramanium, a scholar of race, gender, and science, discusses the political costs of describing these out-of-place organisms in racialized terms, and the prejudices laced into tropes such as “invasive species” versus “native species.” This proclivity of naming conveys information about systems and structures of power.53 How bacteria have been labeled and described in reference to colonization is a political description as well. Reading bacteria through postcolonial and indigenous studies changes the frame of reference. The colonizers (in this case human bodies) take on the assumption that they are the colonized and translate indigeneity onto themselves.54 The (formerly) indigenous bacteria assert their sovereignty, form colonies and rebel, taking on the pejorative role of an invader. In this model, the body is not a holistic ecosystem, but an empire that has claimed its primacy and indigeneity, and thereby exerts dominance, power, and control to eliminate its unwanted subjects. Even language to reduce MRSA in hospital intensive-care units refers to “universal decolonization strategies.”55 Language paints an antagonistic picture of bacteria, an enemy that science and medicine must thwart.

Moving away from this a bit, and assuming that microflora are contingent communities with agency, one way to rethink the relationship of bacteria and bodies is with a feminist analysis. Feminism provides a means to examine nontraditional communities and those excluded or devalued by dominant power structures, and it reveals biases that tend to privilege one group while simultaneously dismissing another. A feminist-studies reading of TSS focusing on S. aureus as a marginalized community of the body demonstrates not only how bacteria are overlooked, but also the detrimental consequences of doing so. This framework provides a more inclusive reading of the body, not only as a microbiome, but also as one with constituent communities that may be affected in different ways by technological interventions. As one commenter about the microbiome project on the NPR Shots health blog noted, “What if the microbes stage a revolution? Or go on strike? Would they vote Dem[ocratic] or Rep[ublican]? What effect do the TSA scanners have on them?”56 Though these comments are meant to be humorous, the writer captures the sentiment that we do not control our microbes, and we need to think more comprehensively about how technologies affect them and, in turn, how these interactions may affect us.

In fact, these technological encounters with the microbiome can have reactive and unexpected consequences. I contribute the term “biocatalytic technology” to better interpret, analyze, and understand technobiological interfaces. Biocatalytic technologies are those technologies that are not primarily dangerous to humans, but have the potential to catalyze microbial activity that may result in harm because of their use. For example, the microbial activity may precipitate an infection located at cellular interfaces and crevices of hip replacements, or it could produce toxins deadly to human organ systems. The dual analysis requires one of technological agency and microbiopolitics. This means looking at bacteria as constituents of the human body, with the potential to interact with technologies and become biocatalytic agents. The term “biocatalytic technology” offers a way to understand the actualization of reactive tampon technology with constituent bacteria. The term also provides language to interrogate those technologies that seem safe, yet still may precipitate other forms of harm because of their use.

Not only is it possible for technologies to catalyze change, but the bacteria can also interact with them as unanticipated technological users. This is an important conceptual departure because only humans are presumed to be technological users. There is much hand-wringing by engineers and designers about non-users, who tend to be characterized as stubborn and unwilling to accept progress or change. Sally Wyatt, who studies digital technologies, has argued for more robust understandings of non-use. She identifies four types of non-users: (1) resisters, who do not want to use a technology; (2) rejecters, who have voluntarily stopped using a technology; (3) the excluded, those for whom the technology was not initially intended; and (4) the expelled, who have stopped using the technology involuntarily.57 These categories are extremely helpful in understanding why technologies are not adopted, and they move beyond blaming the non-users for their misguided ways. The flip side is to imagine an unwanted or unintended user. For example, a whale as a “technological bystander” becomes an unintended nonhuman user of low-frequency sonar, which is harmful to its existence.58 In the case of TSS, the S. aureus bacterium became a nonhuman unintended user of tampons, able to exploit the technology. The superabsorbent tampons served its interests, and the bacterium capitalized on them to grow and flourish. As biocatalytic agents, bacteria become the reimagined users of technology.

It is important that scientists, engineers, and designers move beyond a mechanical understanding of the body to envision it as a robust ecosystem with bacterial constituents that have the potential to become users. Researchers must ask how medical and bodily technologies will interact with bacterial constituents. This approach challenges the current embrace of nanotechnology and its applications for human health and welfare. Tinier in size than one-celled bacteria, these technologies may become objects to them. This is not a moot point; there is a new menstrual pad in development that incorporates nanofibers.59 This new pad may be a wonderful innovation, but we are not asking about the nonhuman users and what they may do with the technology.

The technobiological illness of TSS engages the two nonhuman entities of tampon and bacterium as necessary and vital cofactors.60 Furthermore, the powerful biocatalytic relationship between technology and bacterium was not just overlooked (since this would imply willful disregard) but, worse, it was unimagined as a possibility because the tampon was presumed to be inert. In addition, menstruation was dismissed as an insignificant fluid of a leaky mechanical body fixed with a menstrual plug. Even James Todd, who first identified and published results about TSS in 1978, lamented that “it should have been obvious that the group of young women with ‘vaginitis’ were of menstruating age and, in fact, three of our original patients, in retrospect, were menstruating at the onset of their illness, but we missed completely the possibility of any connection with tampon use.”61 In some ways, it was refreshing that Todd did not immediately fall into the essentialist trap of linking menstruation to illness in girls. Yet the relationship of the vaginal flora to technology was overlooked and dismissed as inconsequential. The historical legacy of minimizing women’s health concerns came to bear, and scientists were unaccustomed to thinking about bacteria as acting independently of the menstruous human body in their interactions with seemingly inert technology.

Risk and Injury

Imagining technology to have biocatalytic potential will change and expand the scope of risk. Though stakeholders look to science as a means to provide measurable data about risk, managing risk turns out to be as much of an art as it is a science. What exactly is risk and who holds responsibility for it? The answer to this question has changed over the twentieth century in the United States, with culpability falling across the spectrum to the individual, government officials, and corporations and their scientists and engineers. In part, an ethic of paternalism and social engineering marked a shift in the early- to mid-twentieth century from blaming individuals who were simply accident-prone and apt to injury, to an ethos that incorporated safety precautions into the very design of factory equipment “to solve the problem of accidents.”62 While shouldering responsibility for better equipment and design, engineers also exposed themselves to blame when things went awry. Henry Petroski, a civil engineer, has enumerated technological disasters such as bridge failures that haunt many engineers, and he argues we must continue to learn from these mistakes in order to prevent their reoccurrence.63 Arwen Mohun, a historian of technology, argues that publics in the first part of the twentieth century were painfully aware of work-related risks inherent to dangerous jobs, yet they were unwilling to relinquish risk altogether. Thus, they demanded the safe, circumscribed risk in their consumer consumption of roller coasters, for example, that engineers accommodated in the design process.64

What is truly a risk, and what is perceived as a risk, means something different to many individuals, and there are a number of means to gauge this perception.65 Building a nuclear plant and driving cars both pose risk, but often it is the nuclear power plant and its imminent breach of radioactive materials that cause more fear than the possible car accident when driving to the grocery store. Alvin Weinberg, a nuclear physicist and a research director at Oak Ridge National Laboratory from 1955 to 1973, proposed the idea of “trans-science” in 1972 to think about risk. He argued that science has the ability to pose questions, but not always the means to answer them, noting “they transcend science.”66 Thus, scientists have difficulty providing “facts” about risk “when scientists can offer only trans-scientific answers to questions of public policy in situations in which laymen, politicians, civic leaders, etc., look to scientists to provide scientific answers.”67 Weinberg’s concept of trans-science suggests that policy makers will never have the data that they really need to make informed decisions because the science to produce the data does not exist. The most we can ask for is good judgment, which by definition, is not science.

Many disciplines have taken up the study of risk: cognitive psychology, sociology, communication, and others. How experts and laypeople view risk variables is a concept many have tried to assess. Others have examined how both men and women express concerns about risk through their gendered identities.68 Yet it is important to the story of tampon-related TSS that scientists’ perceptions about gender have influenced assessments of risk for women users. Most of these scientists were men, and though it is problematic to assume that an essentialized woman scientist would make better judgments, as the story unfolds it was clear that the women who made decisions at crucial junctures shaped the trajectory of policy concerning tampons and TSS in ways that were influenced by their experiences as mothers, friends to other women, and as community members with women. From protesters to epidemiologists to lawyers to health advocates, women’s understandings of menstruation and how it was managed through menstrual hygiene technologies mattered greatly. Their identities as women at that particular historical moment did influence views of the science and the risk posed by tampons.

The significance of this is that the risks perceived to be low resulted in great harm to some women and was particularly gendered because of the manner in which injury occurred. Superabsorbent tampons such as Rely did not fit the mold for usual measures of product injury. They differed because they possessed the potential to precipitate a reactive consequence, but not necessarily direct injury from the object per se. The uneven injuries were difficult to track both medically and from a legal, compensatory model as well.

S. Lochlann Jain, an anthropologist who studies design and law, has theorized the social and economic consequences from manufactured goods wounding humans. She argues that injury is not merely an unfortunate accident but is integral and assumed within consumption, and therefore capitalism itself. She suggests “injury law demonstrates the recursive way in which design issues also materialize and naturalize sets of injuries as visible and compensable or invisible and non-compensable.”69 Jain looks at examples such as the Ford Pinto, cigarettes, and keyboards, to name a few. In these types of cases, the relationship of technology to injury can be interpreted as causal.

The likes of lead poisoning, asbestosis and mesothelioma, and other environmental pollutants are constant reminders of damage caused by human-created products.70 Gregg Mitman, a historian of the environment and ecology, in the introduction to Landscapes of Exposure writes, “The preponderance of toxic, over infectious, agents of illness … reflects a long-term ‘epidemiological transition.’”71 Usually, epidemiological transition refers to stages of improved health directly attributable to a higher-quality standard of living as well as access to medical care, with correlating improved longevity and decreasing birth rate. However, it may be that “a range of medico-environmental materials from those used in medical devices implanted in bodies to waste products discharged into the environment” are marking a new transition to degenerative health, and that transition is characterized by David Morris, a scholar of medical humanities, as both postmodern and biocultural.72

The resulting injury brought about by Rely was complicated to delineate because the causal model of disease or acute poisoning, for example, did not fully account for relational injury. In and of itself Rely was not defective. It was not composed of toxic materials producing direct harm or triggering cancerous growths. As a medical device it was presumed inert, and Rely did not directly cause TSS. The injury incurred was biocatalytic. Once lodged in a vaginal canal, Rely held the strong potential to interact with bacteria that may be present as constituent communities within some women’s bodies. Because makers considered tampons to be inert, the leap to the reactivity of the technology seemed far-fetched.

It is only recently that the idea of indirect harm has gained some traction, and this can be seen in new policies by the EPA to limit perchlorates in drinking water. According to Sanjay Gupta, a physician and CNN’s chief medical correspondent, “It’s the first time we’ve ever regulated a chemical not because of what it does directly to you, but because it has an impact on iodine uptake that might affect your child down the road.”73 Thus, the capabilities to cause indirect harm were not well appreciated in the case of TSS. Yet, despite the prevailing wisdom of direct harm and inert technology, the live bacterium and synthetic superabsorbent tampon energetically interacted and were cofactors in producing illness. As Jain points out, design flaws may materialize as visible, requiring compensation, or remain invisible, and go unrecognized.

What people “see” is crucial. Take, for example, “the invisible gorilla” perception studies conducted by Christopher Chabris and Daniel Simons, which find that when people are asked to focus on one specific thing on a video, they miss the big picture of the costumed gorilla sauntering across the screen. Another attention researcher, Trafton Drew, used this same idea to test a highly skilled and trained set of experts who read data on screens: radiologists. Presented with multiple X-rays, and then an image of the gorilla, 83 percent were so focused on their object of intent that they missed it. This “inattentional blindness” allows them to home in on important and specific data, but since they are not looking for a gorilla they do not see it.74 This indicates that the framing of a data set is highly important regarding what a researcher can “see.” Jennifer Croissant, who studies the sociology of science and technology, discusses a finer point of agnotology, that is, absences of knowledge, not just rejected knowledge or purposeful ignorance, but “absent knowledges as forms of non-knowledge.”75 As Kathy Ferguson, a political and feminist theorist, suggests, “The questions that we can ask about the world are enabled, and other questions disabled, by the frame that orders the questioning. When we are busy arguing about the questions that appear with a certain frame, the frame itself becomes invisible; we become enframed within it.”76 Thus, the shape of knowledge had to change to see tampon-related TSS and, moreover, to address the gendered technology and indirect injury manifesting in women’s bodies.

In addition, injury from bacterial activity does not fit a traditional model of liability with financial compensation rewarded to victims, because bacteria cannot be sued. Bacteria are not persons in the sense of an individual, legal entity, or even a corporation, from whom monetary remuneration may be sought. There is no money in blaming bacteria—perhaps in human error in regard to medically unsterile practices, or the spread of E. coli with unsanitary farming methods—but not for generalized infections or bacterial toxins, especially from constituent bacteria residing on a person that suddenly goes rogue. Yet still, the injury of TSS in this particular case had the cofactor of the tampon to precipitate bacterial growth in some women, and manufacturers are responsible for tampon design and production.

Trusting Consumer Goods

Though my interest is in exploring tampons as technological artifacts, they also have an identity in the marketplace as a commodity, premised on producers and manufacturers delivering goods that consumers purchase for a price. Though debating the nuances of capitalism is not central to this book, it is worth noting that American consumers have come to an implicit agreement with manufacturers about commodities that they purchase. In the case of the sale of goods in the United States during the twentieth century, consumers submitted their health and well-being, and—importantly—money to corporations, in exchange for goods of reasonable quality and no danger. How deeply this understanding of safe commodities is naturalized in contemporary U.S. society can be seen in the outrage leveled against corporations, such as the case in China of melamine added to milk in 2009, responsible for the deaths of at least four babies and illnesses in 53,000 others.77 Cloaked in nationalistic righteousness, some vowed to boycott all imported food from China, others lamented that industrialism was occurring at the expense of health, and still others complained that policies about pure food were not up to the standards set in the United States. Besides fueling fears about the interdependency of global economies, the “bad” milk revealed an important naturalized assumption: in the United States, it is simply common knowledge that “good” milk should be produced and sold, and we are dumbstruck when systems fail to guarantee a safe product, and incensed when it causes illness instead of health.

This confidence in milk in the United States is also narrowly defined. In his lecture “The Cow Tipping Point,” David Ehrenfeld, a biologist, looks at the ways recombinant bovine growth hormone (rBGH) as a biotechnology is not well understood, sometimes purposefully, in terms of both direct and indirect injury and harm.78 For lactating cows treated with rBGH, the injury is often similar to other regularly lactating cows, such as mastitis and sore knees, though rBGH-treated cows suffer more and more often. Peer-reviewed papers by both industry and independent scientists often contradict one another, muddying the differences between naturally occurring BGH and rBGH. Despite animal suffering and the economic impact on producers to replace milk cows that die prematurely, these costs are not part of the “science” of whether or not to use the growth hormone. Questions for human health that are not obvious in terms of direct injury include the cross-species genetic exchanges in bacteria that weaken antibiotics, and rBGH’s role in that. Ehrenfeld concludes that, due to our faith in science, “we forget that technology is unable, both in theory and in practice, to resolve most of the practical problems that it itself creates.”79 Furthermore, technical or scientific facts will not produce a moral resolution, because their scope simply is too narrow.

This viewpoint paints a discouraging picture for the ability of regulating bodies to provide intervention concerning risk and injury, especially in relation to indirect harm. Government intervention, testing, and regulation have also been tempered through politics and legislation over the course of the twentieth century, with many arguing that neoliberalism has put us all at risk by reducing oversight and asking corporations to regulate themselves.80 Risk, limited safety, and tolerance for injury continue to be built into consumer goods, and tampons are caught in the crosshairs of these assumptions and ideologies. The complexity of tampon-related TSS is that the tampon causes indirect harm to some and not all menstruators, and the science supporting these claims has been very difficult to unpack because it is produced by both corporate-sponsored and independent scientists.

Technology’s Double Edge

DuPont’s now-famous slogan, “Better Things for Better Living … through Chemistry,” evokes the ethos of progressive technoscience in twentieth-century United States culture. Consumers have been well trained to expect more from their purchasing power and for corporations to deliver scientifically managed products, including food. In her book Empty Pleasures: The Story of Artificial Sweeteners from Saccharin to Splenda (2010), Carolyn Thomas, an American studies scholar, notes that many women in particular came to rely on saccharin as a low-calorie sugar substitute, and in light of health warnings and recommendations to possibly discontinue it, women rallied to the support of saccharin, despite its risks. The links to cancer were insignificant to people following reduced-sugar diets, to people with diabetes, and to others who simply liked the pleasure of being able to eat sweet treats. Women flooded the FDA with handwritten letters and notes, begging for saccharin to remain on the market as a sugar substitute. Modern chemistry had delivered a miracle sweetener, and many chose to trust their taste buds rather than scientists’ data pointing to saccharin’s danger. In fact, the New York Times reporting on the recall of Rely in 1980 referred to the similarities between the two. An unnamed advertising executive noted to a reporter that “the reaction could be like saccharin. There’s such a strong preference for tampons that it might outweigh the degree of risk.”81 There was some truth in this since the risk was low for most women. This attitude, however, pushed the burden of the illness onto women, citing their “preference” and choice to use tampons knowing that they were dangerous, rather than holding the companies responsible for the manufacture, design, and distribution of synthetic superabsorbent tampons.

There were plenty of mixed feelings and mixed messages about tampons. Before the recall during the 1970s, tampons, including Rely, enjoyed widespread support. For many women tampons were their only choice, and there was no going back to sanitary pads with cellulose wadding and elastic belts. For most young women who suffered through pads chafing the inner thighs, the discomfort of a bulky pad worn between their legs, and the awkward gait of walking around a pad, wearing a tampon, whatever its composition, eliminated these problems. In light of the superabsorbents that were readily available to manufacturers, and consumers’ willingness to try more technologically sophisticated products, it is no wonder that more and more tampons incorporated synthetics and that women would like them.

In addition, tampon technology was particularly linked with women’s liberation. Advertisers equated bodily freedom to political freedom, a claim that was hard to contradict and was reinforced in advertisements with women in white outfits undertaking all sorts of desirable activities. After using tampons, most women had no intention of returning to pads. Many women incorporated tampon technology into their daily lives, and this object became an important item in what I refer to as the “feminist toolbox.” Like other tools such as birth control, trousers, and the right to enter a contract, tampons offered a unique vehicle to support personal independence and agency, and to absorb bodily fluid while remaining unencumbered. Because of this very personal and intimate relationship of the tampon to women’s sense of freedom and well-being, the emergence of TSS seemed both impossible and particularly destabilizing. How could this object, so normalized and domesticated, suddenly become deadly? Some women, like the saccharin users, refused to believe that products might cause harm and continued on as before, their faith in Rely clouding facts and adding to denial. Others acquiesced to warnings and limited their tampon usage or switched back to pads. Others got angry and boycotted, and some sued manufacturers for product liability.

Many scientists continue to be divided about what exactly triggered the outbreak; with a strong history of scientific method and inconclusive results, it was and continues to be difficult to make scientifically informed recommendations in the face of contradictory evidence. Even in 2012, researchers publishing in the Australasian Journal of Dermatology asked as part of their article title “Is Menstrual Toxic Shock Syndrome Really Caused by Tampons?,” raising the same decades-old and misleading question that researchers in the early 1980s did.82 The title indicates doubt about the role of tampons due to the assumption that they are inert. If, as Langdon Winner argues, artifacts have politics, and if, as Bruno Latour and Jane Bennett suggest, things exert agency, then it is high time to recognize the social and political meanings of menstrual hygiene technologies as well as the multiple outcomes related to their technological use. Because tampon technology has historically been disparaged, is hidden from sight, is worn internally within the body, and is primarily used by women, this changes the scope of injury compared to a faulty automobile airbag or a dresser drawer that tips over onto a person. No contemporary woman in the United States has benefited from unearned privileges derived from purposely or accidentally exposing menstrual fluid for others to see. Tampons powerfully conceal a disparaged bodily fluid, and thus the social disregard for menstruation casts a shadow on related illnesses such as TSS. Because of these social roadblocks, the imagination must be stretched to consider bacterium that reside on bodies and in vaginal spaces as technological users of tampons, even though they were not the primary target audience. By examining TSS as the result of a biocatalytic technology, we can gain a better understanding of how we need to think very carefully and deeply about technologies for biological use, not just for humans but for nonhumans as well.