E-sisters and the case of the Essure coil: power, representation, and voice in women’s public docket accounts to the FDA of medical device adverse events

ABSTRACT

One in ten U.S. patients has an internally implanted medical device. Yet, lax regulation by the U.S. Food and Drug Administration (FDA) has resulted in the approval of medical devices disproportionately harming women, including Bayer Pharmaceutical’s Essure, a permanent female sterilization device. Victims of Essure often suffer adverse events, including serious injuries, device malfunctions, and death. Guided by critical feminist theorizing, this case study examines 500 public docket comments written to the FDA by female patients recounting their experiences of adverse events with Essure. Reflexive thematic analysis revealed how women: (a) voiced their experiences to contest meanings of ‘safety,’ expressed identification with their ‘E-Sisters,’ and protected future women from harm; (b) identified forces of greed, deception, and gender bias as creating the conditions for harm to befall them; and (c) enacted resistance and called for a change in the status quo by the FDA and Bayer. Theoretical and practical implications for health communication researchers, medical practitioners and educators, and regulatory agencies are offered.

KEYWORDS:

• Health communication
• medical device regulation
• critical feminist theorizing
• women’s health
• pharmaceutical marketing

Disclosure statement

No potential conflict of interest was reported by the authors.