Toxic Shock. Sharra L. Vostral

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