Safety reporting of Essure medical device: a qualitative and quantitative assessment on the FDA manufacturer and user facility device experience database in 2018
BackgroundThere 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).MethodsA retrospective analysis e...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-07-01
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| Series: | Frontiers in Reproductive Health |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/frph.2023.1172927/full |
| _version_ | 1797780643407462400 |
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| author | Chenyu Zou Brandy Davis Patricia R. Wigle Ana L. Hincapie Jeff Jianfei Guo |
| author_facet | Chenyu Zou Brandy Davis Patricia R. Wigle Ana L. Hincapie Jeff Jianfei Guo |
| author_sort | Chenyu Zou |
| collection | DOAJ |
| description | BackgroundThere 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).MethodsA 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.ResultsA 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.ConclusionThese 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 |
| first_indexed | 2024-03-12T23:46:57Z |
| format | Article |
| id | doaj.art-f40a6e06570f48589ae6becb595e5e47 |
| institution | Directory Open Access Journal |
| issn | 2673-3153 |
| language | English |
| last_indexed | 2024-03-12T23:46:57Z |
| publishDate | 2023-07-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Reproductive Health |
| spelling | doaj.art-f40a6e06570f48589ae6becb595e5e472023-07-14T05:50:01ZengFrontiers Media S.A.Frontiers in Reproductive Health2673-31532023-07-01510.3389/frph.2023.11729271172927Safety reporting of Essure medical device: a qualitative and quantitative assessment on the FDA manufacturer and user facility device experience database in 2018Chenyu Zou0Brandy Davis1Patricia R. Wigle2Ana L. Hincapie3Jeff Jianfei Guo4Department of Health Outcomes Research and Policy, Harrison College of Pharmacy, Auburn University, Auburn, AL, United StatesDepartment of Health Outcomes Research and Policy, Harrison College of Pharmacy, Auburn University, Auburn, AL, United StatesDivision of Pharmacy Practice & Administrative Sciences, The James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH, United StatesDivision of Pharmacy Practice & Administrative Sciences, The James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH, United StatesDivision of Pharmacy Practice & Administrative Sciences, The James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH, United StatesBackgroundThere 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).MethodsA 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.ResultsA 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.ConclusionThese 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 actionshttps://www.frontiersin.org/articles/10.3389/frph.2023.1172927/fulladverse event reportingdevice safetyEssuremaudesurveillance |
| spellingShingle | Chenyu Zou Brandy Davis Patricia R. Wigle Ana L. Hincapie Jeff Jianfei Guo Safety reporting of Essure medical device: a qualitative and quantitative assessment on the FDA manufacturer and user facility device experience database in 2018 Frontiers in Reproductive Health adverse event reporting device safety Essure maude surveillance |
| title | Safety reporting of Essure medical device: a qualitative and quantitative assessment on the FDA manufacturer and user facility device experience database in 2018 |
| title_full | Safety reporting of Essure medical device: a qualitative and quantitative assessment on the FDA manufacturer and user facility device experience database in 2018 |
| title_fullStr | Safety reporting of Essure medical device: a qualitative and quantitative assessment on the FDA manufacturer and user facility device experience database in 2018 |
| title_full_unstemmed | Safety reporting of Essure medical device: a qualitative and quantitative assessment on the FDA manufacturer and user facility device experience database in 2018 |
| title_short | Safety reporting of Essure medical device: a qualitative and quantitative assessment on the FDA manufacturer and user facility device experience database in 2018 |
| title_sort | safety reporting of essure medical device a qualitative and quantitative assessment on the fda manufacturer and user facility device experience database in 2018 |
| topic | adverse event reporting device safety Essure maude surveillance |
| url | https://www.frontiersin.org/articles/10.3389/frph.2023.1172927/full |
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