Analysis of adverse events with essure hysteroscopic sterilization reported to the manufacturer and user facility device experience database

Zain A. Al-Safi, Valerie I. Shavell, Deslyn T.G. Hobson, Jay M. Berman, Michael P. Diamond

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

Study Objective: The Manufacturer and User Facility Device Experience database may be useful for clinicians using a Food and Drug Administration-approved medical device to identify the occurrence of adverse events and complications. We sought to analyze and investigate reports associated with the Essure hysteroscopic sterilization system (Conceptus Inc., Mountain View, CA) using this database. Design: Retrospective review of the Manufacturer and User Facility Device Experience database for events related to Essure hysteroscopic sterilization from November 2002 to February 2012 (Canadian Task Force Classification III). Setting: Online retrospective review. Patients: Online reports of patients who underwent Essure tubal sterilization. Intervention: Essure tubal sterilization. Measurements and Main Results: Four hundred fifty-seven adverse events were reported in the study period. Pain was the most frequently reported event (217 events [47.5%]) followed by delivery catheter malfunction (121 events [26.4%]). Poststerilization pregnancy was reported in 61 events (13.3%), of which 29 were ectopic pregnancies. Other reported events included perforation (90 events [19.7%]), abnormal bleeding (44 events [9.6%]), and microinsert malposition (33 events [7.2%]). The evaluation and management of these events resulted in an additional surgical procedure in 270 cases (59.1%), of which 44 were hysterectomies. Conclusion: Sixty-one unintended poststerilization pregnancies were reported in the study period, of which 29 (47.5%) were ectopic gestations. Thus, ectopic pregnancy must be considered if a woman becomes pregnant after Essure hysteroscopic sterilization. Additionally, 44 women underwent hysterectomy after an adverse event reported to be associated with the use of the device.

Original languageEnglish (US)
Pages (from-to)825-829
Number of pages5
JournalJournal of Minimally Invasive Gynecology
Volume20
Issue number6
DOIs
StatePublished - Nov 7 2013

Fingerprint

Databases
Tubal Sterilization
Equipment and Supplies
Ectopic Pregnancy
Hysterectomy
Pregnancy
Advisory Committees
United States Food and Drug Administration
Pregnant Women
Catheters
Hemorrhage
Pain

Keywords

  • Essure
  • Manufacturer and User Facility Device Experience
  • Microinsert
  • Sterilization

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Analysis of adverse events with essure hysteroscopic sterilization reported to the manufacturer and user facility device experience database. / Al-Safi, Zain A.; Shavell, Valerie I.; Hobson, Deslyn T.G.; Berman, Jay M.; Diamond, Michael P.

In: Journal of Minimally Invasive Gynecology, Vol. 20, No. 6, 07.11.2013, p. 825-829.

Research output: Contribution to journalArticle

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abstract = "Study Objective: The Manufacturer and User Facility Device Experience database may be useful for clinicians using a Food and Drug Administration-approved medical device to identify the occurrence of adverse events and complications. We sought to analyze and investigate reports associated with the Essure hysteroscopic sterilization system (Conceptus Inc., Mountain View, CA) using this database. Design: Retrospective review of the Manufacturer and User Facility Device Experience database for events related to Essure hysteroscopic sterilization from November 2002 to February 2012 (Canadian Task Force Classification III). Setting: Online retrospective review. Patients: Online reports of patients who underwent Essure tubal sterilization. Intervention: Essure tubal sterilization. Measurements and Main Results: Four hundred fifty-seven adverse events were reported in the study period. Pain was the most frequently reported event (217 events [47.5{\%}]) followed by delivery catheter malfunction (121 events [26.4{\%}]). Poststerilization pregnancy was reported in 61 events (13.3{\%}), of which 29 were ectopic pregnancies. Other reported events included perforation (90 events [19.7{\%}]), abnormal bleeding (44 events [9.6{\%}]), and microinsert malposition (33 events [7.2{\%}]). The evaluation and management of these events resulted in an additional surgical procedure in 270 cases (59.1{\%}), of which 44 were hysterectomies. Conclusion: Sixty-one unintended poststerilization pregnancies were reported in the study period, of which 29 (47.5{\%}) were ectopic gestations. Thus, ectopic pregnancy must be considered if a woman becomes pregnant after Essure hysteroscopic sterilization. Additionally, 44 women underwent hysterectomy after an adverse event reported to be associated with the use of the device.",
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