Essure® Transcervical Sterilization Combined with the Hydro Thermablator® System for Endometrial Ablation: A Perihysterectomy Safety Study

Garza-Leal, J.; Castillo, L.; Hernandez, I.; Livengood, Ryan H.; Price, P.C.; Coad, James E.

doi:10.1016/j.jmig.2008.09.002

Cited by 3 publications

(6 citation statements)

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“…In a perihysterectomy safety study, GEA after Essure® sterilization was found to cause no thermal serosal injury. The rise in serosal temperature during GEA was similar in the tubes with and without an Essure micro-insert [20].…”

Section: Correct Localization (N = 24)mentioning

confidence: 78%

Combining NovaSure® endometrial ablation and Essure® hysteroscopic sterilization: a feasibility study to evaluate the confirmation tests

2010

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Since NovaSure® endometrial ablation (GEA) is not reliable as contraception, a reliable permanent contraceptive method which can be offered during the same operative session is often preferred by patients. We present a series of 24 patients treated by NovaSure® GEA followed by Essure® hysteroscopic sterilization at the same session. Bilateral placement of the micro-inserts after GEA was successful in all 24 patients. Confirmation by ultrasound and plain X-ray of the pelvis indicated a correct position in all 48 tubes. Routine follow-up by hysterosalpingography (HSG) to document bilateral tubal occlusion was only possible in 17/23 (74%) patients; these 34 tubes were blocked. In 6/23 (26%) patients, tubal occlusion could not be determined by HSG because of minimal filling of the uterine cavity with contrast medium. The latter was caused by severe uterine synechiae. All patients were satisfied with the result of GEA at 3 months; 19 women (83%) reported amenorrhea and the others, a strong reduction in menstrual blood loss. The combination of Essure® hysteroscopic sterilization and NovaSure® GEA is feasible and safe. However, after this combined approach the HSG as confirmation test is not always useful because of severe synechiae.

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Section: Correct Localization (N = 24)mentioning

confidence: 78%

Combining NovaSure® endometrial ablation and Essure® hysteroscopic sterilization: a feasibility study to evaluate the confirmation tests

2010

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“…1 They found that serosal temperatures remained < 45°C during the Thermachoice and HTA procedures, and that no thermal injury was observed in fallopian tubes implanted with Essure micro inserts. 8,10 The thermal distribution and heat injury down the fallopian tube with an Essure micro-insert in situ appear to be similar among the Thermachoice, HTA, and NovaSure procedures and between implanted and non-implanted tubes.…”

Section: Discussionmentioning

confidence: 92%

“…[7][8][9] Garza et al presented data regarding the use of NovaSure ablation after placement of Essure micro-inserts at the 2008 American Association of Gynecologic Laparoscopists (AAGL) meeting. 9 In this report, 13 women scheduled to undergo total abdominal hysterectomy had insertion of the Essure micro-insert in one fallopian tube using the contralateral tube as a control.…”

Section: Discussionmentioning

confidence: 99%

“…The micro-inserts were also found not to alter the primary NovaSure ablation to the intrauterine cavity. Interestingly, Garza et al and Valle et al evaluated both Thermachoice and HTA in a similar fashion, 8,10 technologies currently approved by the FDA for use after placement of the Essure micro-inserts and satisfactory confirmation HSG. 1 They found that serosal temperatures remained < 45°C during the Thermachoice and HTA procedures, and that no thermal injury was observed in fallopian tubes implanted with Essure micro inserts.…”

Section: Discussionmentioning

confidence: 99%

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Safety and Effectiveness of NovaSure^® Endometrial Ablation After Placement of Essure^® Micro-Inserts

Basinski¹,

Price²,

Burkhart³

et al. 2012

Journal of Gynecologic Surgery

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Objective: In-office NovaSure Ò after Essure Ò is a clinical paradigm for which physicians are seeking information. A PubMed search ( July 2011) revealed no peer-reviewed articles describing this treatment sequence. To address the paucity of data on this topic, patients who had undergone Essure followed by NovaSure in a private practice office between July 1, 2008 and December 31, 2009 were evaluated. The objective was to evaluate safety and feasibility of in-office NovaSure after Essure, and to determine if the effectiveness of either procedure was altered by this treatment sequence. Design: This was a retrospective cohort study of 117 women (ages 24-52). Methods: Patients underwent Essure followed by NovaSure in two in-office sessions, separated by a median of 14 days. All patients had menorrhagia and desired permanent sterilization. A postprocedure patient questionnaire was administered to assess satisfaction and perceived effectiveness. Results: Among patients who underwent Essure followed by NovaSure, 83/117 (71%) returned for a 3-month hysterosalpingogram (HSG). Satisfactory placement and tubal occlusion were noted in 79/83 (95%) of these patients. Amenorrhea or spotting was observed in 72/97 (74%) of patients, 22/97 (23%) reported a satisfactory decrease in menstrual flow, and 3/97 (3%) reported ablation failure. Essure followed by NovaSure did not decrease the effectiveness of either procedure, and no adverse events were attributed to the combination of the two procedures. Patients reported high levels of satisfaction with both procedures. Conclusions: In women seeking permanent birth control and menorrhagia reduction, in-office Essure followed by NovaSure appeared to be safe, effective, and associated with high patient satisfaction. (J GYNECOL SURG 28:83)

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“…The concern about its safety lies in the theoretical risk of transmission of heat energy via the micro‐insert into the serosal layer and further to the intra‐abdominal structures. The mean temperature has been studied and noted to be below 45°C at the serosal layer . No thermal damage into the abdominal structures has ever been reported.…”

Section: Methods Of Hysteroscopic Sterilisationmentioning

confidence: 99%

Update on hysteroscopic sterilisation

Murthy

Edwards

Pathak

2017

The Obstetric & Gynaecologis

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Essure® Transcervical Sterilization Combined with the Hydro Thermablator® System for Endometrial Ablation: A Perihysterectomy Safety Study

Cited by 3 publications

References 0 publications

Combining NovaSure® endometrial ablation and Essure® hysteroscopic sterilization: a feasibility study to evaluate the confirmation tests

Combining NovaSure® endometrial ablation and Essure® hysteroscopic sterilization: a feasibility study to evaluate the confirmation tests

Safety and Effectiveness of NovaSure^® Endometrial Ablation After Placement of Essure^® Micro-Inserts

Update on hysteroscopic sterilisation

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Essure® Transcervical Sterilization Combined with the Hydro Thermablator® System for Endometrial Ablation: A Perihysterectomy Safety Study

Cited by 3 publications

References 0 publications

Combining NovaSure® endometrial ablation and Essure® hysteroscopic sterilization: a feasibility study to evaluate the confirmation tests

Combining NovaSure® endometrial ablation and Essure® hysteroscopic sterilization: a feasibility study to evaluate the confirmation tests

Safety and Effectiveness of NovaSure® Endometrial Ablation After Placement of Essure® Micro-Inserts

Update on hysteroscopic sterilisation

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Product

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Safety and Effectiveness of NovaSure^® Endometrial Ablation After Placement of Essure^® Micro-Inserts