OBJECTIVES : Since the introduction of the implantable medical device Essure for sterilization in 2002, more than 30,000 women worldwide have suffered from severe side effects from the device, including pelvic pain, allergic reaction, and bleeding. Essure was withdrawn from the marketplace in December 2018. This research analyzed the post-marketing Essure safety event reports, and assessed the surveillance policies of both the pharmaceutical company and the FDA.

METHODS : The primary data source was the FDA MAUDE (Manufacturer and User Facility Device Experience) database. This study included all Essure reports to FDA MAUDE from January to October 2018. Using the NVivo® software, a qualitative data analysis program, Essure safety reports from the United States were examined and analyzed. Safety reports were categorized and analyzed by their event type, device problem, patients' symptoms, and the level of harm. Of those, 10% were randomly selected and analyzed in further detail.

RESULTS : A total of 4982 available reports were analyzed. The main themes of safety reports were bleeding, pain, surgery, and infection. Quantitative analysis of a random sample of 500 reports showed that operation and pain were both contained in greater than 80% of the reports. Hemorrhage, hysterectomy, and menorrhagia were each mentioned in great than 30% of the reports. There were seven reported deaths, including two infant deaths.

CONCLUSIONS : Essure had significant safety issues. More safety report processes should be utilized to notify consumers of potential side effects. In light of this severely problematic issue in medical device safety reporting and regulation, this study suggests that health care providers, the medical device industry, and the FDA need to work together and implement stricter control of medical device post-marketing surveillance to better protect patient safety.