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Essure

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https://www.readbyqxmd.com/read/28390945/intraoperative-factors-that-predict-the-successful-placement-of-essure-microinserts
#1
Chloé J Arthuis, Emmanuel G Simon, Thomas Hébert, Henri Marret
OBJECTIVE: To determine whether the number of coils visualized in the uterotubal junction at the end of hysteroscopic microinsert placement predicts successful tubal occlusion. DESIGN: Cohort retrospective study (Canadian Task Force classification II-2). SETTING: Department of obstetrics and gynecology in a teaching hospital. PATIENTS: One hundred and fifty-three women underwent tubal microinsert placement for permanent birth control from 2010 through 2014...
April 5, 2017: Journal of Minimally Invasive Gynecology
https://www.readbyqxmd.com/read/28385588/outcomes-of-elective-outpatient-hysteroscopic-sterilization-in-undocumented-women-a-retrospective-analysis
#2
Patsy J McGuire, Jennifer Butler, Christina Gavito, Jeanelle Sheeder, Kristina Tocce
OBJECTIVE: To determine the feasibility of hysteroscopic sterilization in low-income and unauthorized immigrant women when financial barriers to care are removed. METHODS: Outpatient hysteroscopic sterilization for low-income women at an urban clinic was made possible by grant funding. All procedures were performed by obstetrician/gynecologist attending physicians or supervised trainees. Electronic records were reviewed for cases performed from June 2010 to December 11, 2013...
April 3, 2017: Women's Health Issues: Official Publication of the Jacobs Institute of Women's Health
https://www.readbyqxmd.com/read/28333802/hysteroscopic-sterilization-with-essure-summary-of-the-u-s-food-and-drug-administration-actions-and-policy-implications-for-postmarketing-surveillance
#3
Rachel Steward
No abstract text is available yet for this article.
April 2017: Obstetrics and Gynecology
https://www.readbyqxmd.com/read/28259704/-can-we-still-afford-to-put-essure-%C3%A2
#4
EDITORIAL
P Panel, P Baissas
No abstract text is available yet for this article.
March 2017: Gynecologie, Obstetrique, Fertilite & Senologie
https://www.readbyqxmd.com/read/28254503/medicolegal-review-essure-lawsuits-and-legal-strategies-adverse-to-gynecologists
#5
REVIEW
Amber M Klimczak, Russell R Snyder, Mostafa A Borahay, John Y Phelps
The minimally invasive Essure procedure for hysteroscopic sterilization is an ongoing target for litigation. Although efficacious, this device has been scrutinized by the US Food and Drug Administration (FDA) owing to alleged complications. Patients affected by these potential complications are filing lawsuits against Bayer, the manufacturer of Essure. Many of these lawsuits have been barred by preemption, a legal doctrine that limits what can be required of a product by state lawsuits once the FDA approves it; however, in the lawsuits that have been allowed to proceed, the manufacturer has used a legal strategy termed the "learned intermediary doctrine" in an effort to shift blame to the gynecologist to absolve itself of liability...
February 27, 2017: Journal of Minimally Invasive Gynecology
https://www.readbyqxmd.com/read/28178577/operative-and-diagnostic-hysteroscopy-a-novel-learning-model-combining-new-animal-models-and-virtual-reality-simulation
#6
Alfred Bassil, Chrystèle Rubod, Yves Borghesi, Yohan Kerbage, Elie Servan Schreiber, Henri Azaïs, Charles Garabedian
CONTEXT: Hysteroscopy is one of the most common gynaecological procedure. Training for diagnostic and operative hysteroscopy can be achieved through numerous previously described models like animal models or virtual reality simulation. We present our novel combined model associating virtual reality and bovine uteruses and bladders. STUDY DESIGN: End year residents in obstetrics and gynaecology attended a full day workshop. The workshop was divided in theoretical courses from senior surgeons and hands-on training in operative hysteroscopy and virtual reality Essure(®) procedures using the EssureSim™ and Pelvicsim™ simulators with multiple scenarios...
February 1, 2017: European Journal of Obstetrics, Gynecology, and Reproductive Biology
https://www.readbyqxmd.com/read/28067009/one-step-3d-tv-hysterosalpingo-foam-sonography-3d-tv-hyfosy-confirmation-test-for-essure%C3%A2-follow-up-a-multicenter-study
#7
Brunella Zizolfi, Lucia Lazzeri, Mario Franchini, Attilio Di Spiezio Sardo, Carmine Nappi, Emilio Piccione, Caterina Exacoustos
OBJECTIVE: To evaluate the feasibility and accuracy of a three-dimensional-transvaginal-hysterosalpingo-contrast-sonography using the new dedicated contrast-enhanced gel foam (3D-TV-HyFoSy) to assess the position of the tubal sterilization Essure® devices and consequent tubal occlusion in patients who underwent Essure® hysteroscopic tubal sterilization. METHODS: This multicenter study was prospectively conducted from June 2012 to July 2014 in four italian centers and included 50 women who underwent hysteroscopic Essure® microinsert placement, for a total of 95 tubes...
January 9, 2017: Ultrasound in Obstetrics & Gynecology
https://www.readbyqxmd.com/read/27926652/hysteroscopic-sterilization-with-essure-summary-of-the-u-s-food-and-drug-administration-actions-and-policy-implications-for-postmarketing-surveillance
#8
Jessica R Walter, Comeron W Ghobadi, Emily Hayman, Shuai Xu
In September 2015, the U.S. Food and Drug Administration (FDA) convened a meeting of the Obstetrics and Gynecology Advisory Board Committee to address the sudden increase of patient-reported adverse events surrounding Essure, a Class III device offering a less invasive method for permanent female sterilization. After a review of the premarketing and postmarketing data and existing scientific literature, the FDA concluded there was insufficient evidence to remove the device from the market. However, the FDA did release a new guidance document requiring a black box warning for the device and ordered a new postmarketing study comparing Essure's safety and efficacy with laparoscopic tubal sterilization...
January 2017: Obstetrics and Gynecology
https://www.readbyqxmd.com/read/27867049/improving-rates-of-post-essure-hysterosalpingography-in-an-urban-population-using-electronic-tracking-reminders
#9
Yu-Han Virginia Hu, Kavita Shah Arora
STUDY OBJECTIVE: To demonstrate the efficacy of electronic reminders for follow-up hysterosalpingography (HSG) after Essure hysteroscopic sterilization in an urban tertiary care hospital obstetrics and gynecology practice. DESIGN: Retrospective cohort study (Canadian Task Force classification II-3). SETTING: Obstetrics and gynecology practice at a university-affiliated urban tertiary care teaching hospital. PATIENTS: Two hundred and fifty patients who underwent Essure hysteroscopic sterilization between June 2011 and July 2014...
February 2017: Journal of Minimally Invasive Gynecology
https://www.readbyqxmd.com/read/27854386/high-miscarriage-rate-in-women-treated-with-essure%C3%A2-for-hydrosalpinx-before-embryo-transfer-a-systematic-review-and-meta-analysis
#10
REVIEW
M W Barbosa, A Sotiriadis, S I Papatheodorou, V Mijatovic, C O Nastri, W P Martins
OBJECTIVES: Essure® has been tested as an alternative treatment for hydrosalpinx before embryo transfer (ET) in women undergoing assisted reproduction techniques. However, the persistence of a foreign body inside the uterine cavity might have a negative impact on the outcome of pregnancy. The present systematic review aimed at identifying, appraising and summarizing the available evidence regarding the effectiveness and safety of using Essure prior to ET for women with hydrosalpinx. METHODS: We searched for studies in PubMed, Scopus, CENTRAL, Web of Science and ClinicalTrials...
November 2016: Ultrasound in Obstetrics & Gynecology
https://www.readbyqxmd.com/read/27822350/surgical-excision-of-essure%C3%A2-devices-with-eshre-class-iib-uterine-malformation-sequential-hysteroscopic-laparoscopic-approach-to-the-septate-uterus
#11
E S Sills, G D Palermo
OBJECTIVE: While contraindications to Essure® placement have been provided by the manufacturer, there is no consensus on how best to remove these contraceptive devices. Here, we describe a non-hysterectomy removal of Essure® for a patient with a septate uterus (ESHRE Class IIb uterine malformation). CLINICAL CASE: A 35yr old G4 P2 presented for removal of Essure® implants after three years of gradually increasing pelvic pain, weight gain, headache, dizziness, lower extremity paresthesia, and fatigue which followed hysteroscopic sterilization (HS)...
March 28, 2016: Facts, Views & Vision in ObGyn
https://www.readbyqxmd.com/read/27705973/utility-of-three-dimensional-ultrasonography-to-assess-the-position-of-essure-tubal-occlusion-device-and-its-complications
#12
Covadonga Alvarez-Lopez, Javier De Santiago, Antonio Piñera, Roberto Rodriguez, Beatriz Herrero, Maria Herrera, Jaime Pillado, Ignacio Zapardiel
BACKGROUND: To determine the utility of three-dimensional (3D) sonography to control the position of hysteroscopic sterilizing device compared to hysterosalpingography (HSG). METHODS: A prospective observational study was carried out on 139 patients who underwent hysteroscopic tubal occlusion method between February 2012 and May 2013. Patients underwent 3D ultrasound scan to control device positioning, and they also underwent HSG as an additional control method...
2017: Gynecologic and Obstetric Investigation
https://www.readbyqxmd.com/read/27679288/complications-and-compliance-of-hysteroscopic-sterilization-with-essure-in-an-inner-city-hospital
#13
C M Santiago, N Astill
No abstract text is available yet for this article.
November 2015: Journal of Minimally Invasive Gynecology
https://www.readbyqxmd.com/read/27679001/the-essure-hysteroscopic-sterilization-initial-experience-in-cardiff-uk-does-prior-contraception-influence-the-ease-of-device-placement
#14
A Nargund, R Penketh, C Thomas, L Groves, S Hill
No abstract text is available yet for this article.
November 2015: Journal of Minimally Invasive Gynecology
https://www.readbyqxmd.com/read/27678972/hysteroscopic-proximal-occlusion-of-hydrosalpinges-by-essure-%C3%A2-in-32-laparoscopic-contraindicated-patients-before-assisted-reproductive-technology-art
#15
M Berkkanoglu, K Coetzee, H Bulut, K Ozgur
No abstract text is available yet for this article.
November 2015: Journal of Minimally Invasive Gynecology
https://www.readbyqxmd.com/read/27678719/laparoscopic-removal-of-essure-microinserts
#16
M S Mahmoud
No abstract text is available yet for this article.
November 2015: Journal of Minimally Invasive Gynecology
https://www.readbyqxmd.com/read/27647572/ep32-07-intra-and-interrater-reliability-of-the-3d-ultrasound-control-of-essure-implants
#17
S Herve, P Panayotopoulos, P Descamps, G Legendre
No abstract text is available yet for this article.
September 2016: Ultrasound in Obstetrics & Gynecology
https://www.readbyqxmd.com/read/27621196/evaluation-of-nickel-allergic-reactions-to-the-essure-micro-insert-theoretical-risk-or-daily-practice
#18
Sara Siemons, Michel Vleugels, Hugo van Eijndhoven
STUDY OBJECTIVE: To evaluate whether de novo development of nickel sensitization is related to placement of the Essure device, and to evaluate whether the grade of reaction to nickel increased after device placement in patients with a confirmed nickel allergy. DESIGN: Prospective cohort study (Canadian Task Force classification II-2). SETTING: Two nonacademic training hospitals in The Netherlands. PATIENTS: Healthy women of childbearing age desiring permanent sterilization...
January 1, 2017: Journal of Minimally Invasive Gynecology
https://www.readbyqxmd.com/read/27569594/does-essure-cause-significant-de-novo-pain-a-retrospective-review-of-indications-for-second-surgeries-following-essure-placement
#19
Huse Kamencic, Luke Thiel, Erwin Karreman, John Thiel
STUDY OBJECTIVES: To examine the surgical indications and pathologic findings in patients undergoing a second surgery following placement of the Essure permanent birth control system to determine the role of Essure in developing new onset pelvic pain. DESIGN: Retrospective cohort (Canadian Task Force classification II-2). SETTING: Tertiary level hospital. PATIENTS: Women who have had Essure placement and subsequent second surgery...
August 25, 2016: Journal of Minimally Invasive Gynecology
https://www.readbyqxmd.com/read/27466315/discordant-relationship-between-essure-microinsert-position-and-tubal-occlusion
#20
Melody Y Hou
Hysteroscopic sterilisation with Essure requires confirmation of tubal occlusion by hysterosalpingogram or microinsert position by transvaginal sonography 3 months after placement before women can rely on the method for pregnancy prevention. A 39-year-old woman underwent hysteroscopic sterilisation via Essure, with successful bilateral tubal occlusion documented on hysterosalpingogram. She had a subsequent unintended pregnancy and termination, and presented with persistent pelvic pain and other non-specific symptoms...
July 27, 2016: BMJ Case Reports
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