Signs and symptoms: Adverse events associated with a sterilization device.

Sterilization is now the most common contraceptive method used by women of in the U.S., and sterilization devices have played an important role in its increased popularity. This mixed methods study examines a random sample of 2500 U.S. Food and Drug Administration (FDA) adverse event reports made between 2006 and 2017 about Essure, a sterilization device. Quantitative coding was used to examine patient problems; pain and bleeding were reported most frequently. Qualitative coding analyzed impacts of symptoms on patients' everyday lives and patients' healthcare experiences, including intimate relationships, mothering, and paid employment. Findings suggest that some patients struggled when their reported "subjective" symptoms didn't result in "objective" clinical signs of problems, and when physicians dismissed or deflected their concerns in diagnostic encounters. This paper raises important issues regarding the symptoms patients associated with Essure, the diagnosis of device-driven disease and injury, and the FDA's regulation of medical devices.

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