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
