Signs and symptoms: Adverse events associated with a sterilization device

Area of Science:

• Medical Device Safety
• Reproductive Health
• Patient-Reported Outcomes

Background:

• Female sterilization is a common contraceptive method in the U.S.
• Sterilization devices have contributed to the rise in contraceptive procedures.
• Essure is a widely used permanent birth control device.

Purpose of the Study:

• To examine adverse event reports for the Essure sterilization device.
• To analyze patient-reported symptoms and their impact on daily life.
• To investigate healthcare experiences and physician interactions related to Essure.

Main Methods:

• Mixed methods study analyzing 2500 U.S. Food and Drug Administration (FDA) adverse event reports (2006-2017).
• Quantitative coding for patient problems (pain, bleeding).
• Qualitative coding for symptom impact on life and healthcare experiences.

Main Results:

• Pain and bleeding were the most frequently reported patient problems.
• Patients faced challenges when subjective symptoms lacked objective clinical signs.
• Physicians often dismissed or deflected patient concerns, impacting care.

Conclusions:

• Patient-reported symptoms associated with Essure require thorough investigation.
• Diagnosis of device-related issues can be complicated by the lack of objective findings.
• The study raises critical questions about medical device regulation and patient advocacy.