Safety reporting of Essure medical device: a qualitative and quantitative assessment on the FDA manufacturer and user facility device experience database in 2018.

Autor:	Zou C; Department of Health Outcomes Research and Policy, Harrison College of Pharmacy, Auburn University, Auburn, AL, United States., Davis B; Department of Health Outcomes Research and Policy, Harrison College of Pharmacy, Auburn University, Auburn, AL, United States., Wigle PR; Division of Pharmacy Practice & Administrative Sciences, The James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH, United States., Hincapie AL; Division of Pharmacy Practice & Administrative Sciences, The James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH, United States., Guo JJ; Division of Pharmacy Practice & Administrative Sciences, The James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH, United States.
Jazyk:	angličtina
Zdroj:	Frontiers in reproductive health [Front Reprod Health] 2023 Jul 13; Vol. 5, pp. 1172927. Date of Electronic Publication: 2023 Jul 13 (Print Publication: 2023).
DOI:	10.3389/frph.2023.1172927
Abstrakt:	Background: There have been numerous cases of adverse events since the introduction of Essure medical devices for sterilization in 2002. This study analyzed the safety event reports of the Essure reported in the Manufacturer and User Facility Device Experience (MAUDE). Methods: A retrospective analysis examined the MAUDE reports between Jan-1, 2018, and Oct-31, 2018 and focused on safety reports related to the Essure device. Safety reports were categorized and analyzed by their event type, device problem, patients' symptoms and the level of harm. Of this study cohort, 10% of samples were randomly selected for quantitative analyses. Thematic analysis was conducted for reports included death cases. Results: A total of 4,994 eligible reports were analyzed. There were ten reports associated with individuals' deaths, and the main themes of safety reports from qualitative analysis were pains, bleeding, surgery, migraine, and infection. Quantitative analysis of 500 randomly selected samples showed that 98% of adverse event reports were associated with different injuries such as surgery, pain, bleeding, hysterectomy, and menorrhagia. Additionally, more than 90% of reports were submitted by the manufacturer. Conclusion: These findings indicated several safety issues of Essure. More meaningful pre- and post-marketing surveillance and regulation are warranted in the medical device market to ensure safety and effectiveness, including investigating complaints, promptly sharing relevant information with regulators and users, and implementing corrective actions. Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (© 2023 Zou, Davis, Wigle, Hincapie and Guo.)
Databáze:	MEDLINE
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