By a News Reporter-Staff News Editor at Women's Health Weekly -- Fresh data on Women's Health are presented in a new report. According to news reporting originating from Detroit, Michigan, by NewsRx correspondents, research stated, "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."
Our news editors obtained a quote from the research from Detroit Medical Center, "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). Online retrospective review. Online reports of patients who underwent Essure tubal sterilization. Essure tubal sterilization. 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. 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."
According to the news editors, the research concluded: "Additionally, 44 women underwent hysterectomy after an adverse event reported to be associated with the use of the device."
For more information on this research see: Analysis of Adverse Events With Essure Hysteroscopic Sterilization Reported to the Manufacturer and User Facility Device Experience Database. Journal of Minimally Invasive Gynecology, 2013;20(6):825-829. Journal of Minimally Invasive Gynecology can be contacted at: Elsevier Science Inc, 360 Park Ave South, New York, NY 10010-1710, USA. (Elsevier - www.elsevier.com; Journal of Minimally Invasive Gynecology - www.elsevier.com/wps/product/cws_home/704371)
The news editors report that additional information may be obtained by contacting Z.A. Al-Safi, Detroit Med Center, Detroit, MI, United States. Additional authors for this research include V.I. Shavell, D.T.G. Hobson, J.M. Berman and M.P. Diamond (see also Women's Health).
Keywords for this news article include: Detroit, Surgery, Therapy, Michigan, Endoscopy, Hysteroscopy, United States, Women's Health, Tubal Sterilization, Adverse Drug Reaction, North and Central America, Reproductive Sterilization, Obstetric Surgical Procedures, Gynecologic Surgical Procedures
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