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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
#1
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...
December 2, 2016: Obstetrics and Gynecology
https://www.readbyqxmd.com/read/27867049/improving-rates-of-post-essure-hysterosalpingography-in-an-urban-population-using-electronic-tracking-reminders
#2
Yu-Han Virginia Hu, Kavita Shah Arora
STUDY OBJECTIVE: To demonstrate the efficacy of electronic reminders for follow up hysterosalpingography after Essure hysteroscopic sterilization in an urban, tertiary-care hospital obstetrics and gynecology practice DESIGN: Retrospective cohort SETTING: University-affiliated, urban, tertiary-care teaching hospital obstetrics and gynecology practice. PATIENTS: Two hundred and fifty patients underwent Essure hysteroscopic sterilization between June 2011 and July 2014...
November 17, 2016: 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
#3
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
#4
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
#5
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...
October 6, 2016: Gynecologic and Obstetric Investigation
https://www.readbyqxmd.com/read/27679288/complications-and-compliance-of-hysteroscopic-sterilization-with-essure-in-an-inner-city-hospital
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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...
September 13, 2016: 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
#12
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
#13
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...
2016: BMJ Case Reports
https://www.readbyqxmd.com/read/27462885/initial-experience-with-hysteroscopic-tubal-occlusion-essure%C3%A2
#14
Daniella De Batista Depes, Ana Maria Gomes Pereira, Umberto Gazi Lippi, João Alfredo Martins, Reginaldo Guedes Coelho Lopes
OBJECTIVE: To evaluate results of early tubal occlusions performed by hysteroscopy (Essure®). METHODS: This prospective study included 38 patients, 73.7% of them were white, mean age 34.5 years, they have had on average 3 pregnancies and 2.7 of deliveries. A total of 86.8% of patients previously prepared the endometrium. All procedures were carried out at outpatient unit without anesthesia. RESULTS: Insertion rate of the device was 100% at a mean time of 4 minutes and 50 seconds...
April 2016: Einstein
https://www.readbyqxmd.com/read/27462605/combined-hysteroscopy-laparoscopy-approach-for-excision-of-pelvic-nitinol-fragment-from-essure-contraceptive-device-role-of-intraoperative-fluoroscopy-for-uterine-conservation
#15
E Scott Sills, Gianpiero D Palermo
We describe the successful removal of a pelvic contraceptive coil in a symptomatic 46-year-old patient who had Essure devices for four years, using a combined hysteroscopy-laparoscopy-fluoroscopy approach. Following normal hysteroscopy, at laparoscopy the right Essure implant was disrupted and its outer nitinol coil had perforated the fallopian tube. However, the inner rod (containing polyethylene terephthalate) had migrated to an extrapelvic location, near the proximal colon. In contrast, the left implant was situated within the corresponding tube...
July 2016: Obstetrics & Gynecology Science
https://www.readbyqxmd.com/read/27422719/laparoscopic-cornuectomy-as-a-technique-for-removal-of-essure-microinserts
#16
Luke Thiel, Darrien Rattray, John Thiel
STUDY OBJECTIVE: Present a laparoscopic technique for complete removal of Essure™ microinserts (including nitinol coil and PET fibers). DESIGN: Step-wise instruction using video. The study was granted a Research Ethics Board exemption as the Regina Qu'Appelle Health Region Research Ethics Board does not ethics board approval for single case submissions. SETTING: Recent concern regarding adverse outcomes (persistent pelvic pain, device malposition, nickel allergy) following Essure™ placement has led to a small percentage of women requesting removal of the coils(1)...
July 12, 2016: Journal of Minimally Invasive Gynecology
https://www.readbyqxmd.com/read/27333666/is-essure-warning-a-game-changer
#17
Sabriya Rice
No abstract text is available yet for this article.
March 7, 2016: Modern Healthcare
https://www.readbyqxmd.com/read/27318772/-what-signs-should-you-look-for-ultrasound-2d-3d-to-affirm-the-good-location-of-tubal-implants-about-a-retrospective-study-of-92%C3%A2-cases
#18
M Simorre, P Lopes, C Le Vaillant
OBJECTIVE: The aim of this study is to propose an analysis of the route and the curvature of the Essure(®) system in 3D ultrasound to determine their correct location so as not to miss a tubal perforation. METHODS: This is a retrospective single center study during 2 years analyzing 92 3D ultrasound performed by a single sonographer. Implant placement was performed by different operators. One prescribed 3D ultrasound control in case of difficulties with the installation; other indications where systematics...
June 16, 2016: Gynécologie, Obstétrique & Fertilité
https://www.readbyqxmd.com/read/27257083/confirmation-testing-of-essure-microinserts-in-unintended-pregnancies-using-a-10-year-retrospective-database
#19
Darrien Rattray, Peter Thiel, Ian Suchet, John Thiel
STUDY OBJECTIVES: To examine the imaging modality used in cases of Essure failures and determine the cause of the unintended pregnancies (noncompliance to follow-up recommendations, misinterpretation of the imaging test, or device failure). DESIGN: Retrospective, single-center interventional cohort (Canadian Task Force classification II-2). SETTING: Tertiary level hospital. PATIENTS: Women who have had Essure placement and subsequent pregnancy...
September 2016: Journal of Minimally Invasive Gynecology
https://www.readbyqxmd.com/read/27257082/in%C3%A2-vitro-fertilization-outcomes-after-placement-of-essure-microinserts-in-patients-with-hydrosalpinges-who-previously-failed-in%C3%A2-vitro-fertilization-treatment-a-multicenter-study
#20
Shlomo B Cohen, Jerome Bouaziz, Eyal Schiff, Alexander Simon, Michel Nadjary, Mordechai Goldenberg, Raoul Orvieto, Ariel Revel
STUDY OBJECTIVE: To investigate whether hysteroscopic proximal tubal occlusion with Essure microinserts (Conceptus Inc.; Bayer, AG, North Rhine-Westphalia, Germany) can improve pregnancy rates in patients with hydrosalpinges who had failed in vitro fertilization (IVF) treatment. DESIGN: A prospective cohort study. SETTING: University-affiliated tertiary centers. PATIENTS: Twenty-four consecutive women with hydrosalpinges who had failed IVF treatment were included...
September 2016: Journal of Minimally Invasive Gynecology
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