Accuracy of Ultrasonography in the Evaluation of Tubal Sterilization Microinsert Positioning: Systematic Review and Meta-analysis.

The current reference standard to check the position of a tubal sterilization microinsert device after its insertion is hysterosalpingography. The objective of this study was to evaluate the accuracy of 2-dimensional (2D) and 3-dimensional (3D) ultrasonography (US) in the positioning of the tubal sterilization microinsert for definitive contraception. We searched MEDLINE, Embase, Cochrane, and Scopus databases through October 2017. Selection criteria included studies that analyzed the accuracy of 2D or 3D US, or both, with respect to the positioning of the microinsert. Data were displayed as forest plots and a summary receiver operating characteristic curves. Values for sensitivity, specificity, and positive and negative likelihood ratios (LRs) were calculated. The pooled analysis produced sensitivity and specificity values for 2D US in the positioning of the microinsert of 0.88 (95% confidence interval [CI], 0.47-1.0) and 0.92 (95% CI, 0.88-0.95), respectively, with positive and negative LRs of 8.68 (95% CI, 1.63-46.1) and 0.35 (95% CI, 0.11-1.11), respectively. Three studies analyzed the performance of 3D US, showing sensitivity, specificity, and positive and negative LRs of 0.75 (95% CI, 0.35-0.97), 0.82 (95% CI, 0.77-0.87), 3.65 (95% CI, 2.31-5.75), and 0.46 (95% CI, 0.2-1.09). In conclusion, 2D and 3D US are methods that show good accuracy in tubal sterilization microinsert positioning.

Esterilização tubária histeroscópica: uma atualização sobre o dispositivo Essure® / Hysteroscopic tubal sterilization: update on the Essure® device

No intuito de oferecer para a laqueadura tubária uma alternativa menos invasiva e com menos complicações, foi desenvolvido o dispositivo Essure®, aplicado ao método da esterilização histeroscópica, além de ter utilidade nos quadros de hidrossalpinge com indicação de fertilização in vitro (FIV). Este artigo, por meio de uma revisão de literatura, teve como objetivo reunir dados acerca do uso do Essure®, incluindo resultados obtidos com o dispositivo, bem como comparações em diversos aspectos com outras metodologias de esterilização. Foram utilizados os bancos de dados PubMed, Lilacs e Scielo, no período entre 1970 e 2016. Foram pesquisados os termos "hysteroscopic contraception"; "Essure"; "definitive tubal sterilization; "sterilization"; "contraception". A literatura demonstrou se tratar de um dispositivo de fácil e rápida inserção, e com bons resultados para anticoncepção. Porém, devido a complicações como perfuração tubária, implante peritoneal e aborto, bem como para avaliar seu custo financeiro ao sistema de Saúde, mais estudos prospectivos são necessários.(AU)

In order to provide a less invasive and harmful technique compared to the tubal ligation, the Essure® device was developed, applied to the hysteroscopic sterilization method. It is also used in cases of hydrosalpinus and indication of in vitro fertilization (IVF). This article, through a literature review, aimed to gather data about the use of Essure®, including results obtained with the device, comparing different aspects with other methods of sterilization. For this purpose, PubMed, Lilacs and Scielo databases were used, with results from 1970 to 2016. The keywords searched were "hysteroscopic contraception", "Essure", "definitive tubal sterilization". The literature has shown that it is a quickly and easily inserted device with good results for contraception. However, due to complications such as tubal perforation, peritoneal implantation and abortion, as well as to evaluate its financial cost to the health system, more prospective studies are needed.(AU)

High miscarriage rate in women treated with Essure® for hydrosalpinx before embryo transfer: a systematic review and meta-analysis.

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.gov and the reference lists of eligible studies. All studies including at least 10 women with hydrosalpinx who received Essure, any other intervention or no treatment prior to ET were considered eligible. Study selection, data extraction and evaluation of the risk of bias were performed independently by two authors. Study outcomes were miscarriage per clinical pregnancy, singleton preterm birth per singleton live birth and live birth/ongoing pregnancy and clinical pregnancy per ET. The pooled results for each outcome and intervention were summarized as proportions with their respective 95% CIs, using a random-effects model. RESULTS: Our electronic search of databases was performed on 7 November 2015, and 26 studies with 43 study arms were considered eligible: eight study arms evaluating Essure; seven assessing tubal aspiration; seven appraising effects of no treatment; 12 evaluating salpingectomy; two assessing tubal division; and seven evaluating tubal occlusion. When compared with women who had no intervention, women with Essure had a higher clinical pregnancy rate per ET (36% (95% CI, 0-43%) vs 13% (95% CI, 9-17%)). When compared with women who had other interventions, women with Essure had a higher miscarriage rate per clinical pregnancy (38% (95% CI, 27-49%) vs 15% (95% CI, 10-19%)). CONCLUSIONS: The available evidence suggests that, although Essure prior to ET in women with hydrosalpinx improves the chance of achieving a clinical pregnancy compared with no intervention, it is associated with a higher rate of miscarriage when compared with the other interventions. Although this evidence is based on observational studies, we believe that salpingectomy should be the first option for women who are eligible for videolaparoscopy. However, it is still premature to make recommendations for women who are not eligible for surgery, and randomized controlled trials are needed to clarify which is the best treatment alternative in such a scenario. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.

Initial experience with hysteroscopic tubal occlusion (Essure®).

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. Based on the analogical visual scale, average pain reported was three, and 55.3% of women did not report pain after the procedure. After 3 months, 89.5% of patients were very satisfied with the method. Simple radiographs of the pelvis showed 92.1% of topical devices, and one case of unilateral expulsion had occurred. A four years follow-up did not show failure in the method. CONCLUSIONS: Tubal occlusion through hysteroscopy at outpatient unit and without anesthesia was a quickly and well-tolerated procedure. No serious complications were seen, the success rate was high, and patients were satisfied. OBJETIVO: Avaliar os resultados das primeiras oclusões tubárias realizadas pela via histeroscópica (Essure®). MÉTODOS: Estudo prospectivo com 38 pacientes, sendo 73,7% caucasianas, com média de idade de 34,5 anos, e com 3 gestações e 2,7 partos em média. Do total, 86,8% das pacientes fizeram preparo prévio do endométrio. Todos os procedimentos foram ambulatoriais e sem anestesia. RESULTADOS: A taxa de inserção do dispositivo foi de 100%, com tempo médio de 4 minutos e 50 segundos. Segundo a Escala Visual Analógica, a dor média obtida foi de três, e 55,3% das mulheres não referiram qualquer dor após o método. Ocorreu um caso de reflexo vagal e 89,5% das pacientes retornaram às atividades normais no mesmo dia. Após 3 meses, 89,5% das pacientes encontravam-se muito satisfeitas com o método. A radiografia simples da pelve evidenciou 92,1% de dispositivos tópicos, ocorrendo um caso de expulsão unilateral. Após 4 anos de seguimento, não houve falha do método. CONCLUSÃO: A oclusão tubária por via histeroscópica em regime ambulatorial e sem anestesia foi um procedimento rápido, bem tolerado, isento de complicações graves e com alta taxa de sucesso e satisfação das pacientes.

Initial experience with hysteroscopic tubal occlusion (Essure®) / Experiência inicial com a oclusão tubária por via histeroscópica (Essure®)

ABSTRACT 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. Based on the analogical visual scale, average pain reported was three, and 55.3% of women did not report pain after the procedure. After 3 months, 89.5% of patients were very satisfied with the method. Simple radiographs of the pelvis showed 92.1% of topical devices, and one case of unilateral expulsion had occurred. A four years follow-up did not show failure in the method. Conclusions Tubal occlusion through hysteroscopy at outpatient unit and without anesthesia was a quickly and well-tolerated procedure. No serious complications were seen, the success rate was high, and patients were satisfied.

RESUMO Objetivo Avaliar os resultados das primeiras oclusões tubárias realizadas pela via histeroscópica (Essure®). Métodos Estudo prospectivo com 38 pacientes, sendo 73,7% caucasianas, com média de idade de 34,5 anos, e com 3 gestações e 2,7 partos em média. Do total, 86,8% das pacientes fizeram preparo prévio do endométrio. Todos os procedimentos foram ambulatoriais e sem anestesia. Resultados A taxa de inserção do dispositivo foi de 100%, com tempo médio de 4 minutos e 50 segundos. Segundo a Escala Visual Analógica, a dor média obtida foi de três, e 55,3% das mulheres não referiram qualquer dor após o método. Ocorreu um caso de reflexo vagal e 89,5% das pacientes retornaram às atividades normais no mesmo dia. Após 3 meses, 89,5% das pacientes encontravam-se muito satisfeitas com o método. A radiografia simples da pelve evidenciou 92,1% de dispositivos tópicos, ocorrendo um caso de expulsão unilateral. Após 4 anos de seguimento, não houve falha do método. Conclusão A oclusão tubária por via histeroscópica em regime ambulatorial e sem anestesia foi um procedimento rápido, bem tolerado, isento de complicações graves e com alta taxa de sucesso e satisfação das pacientes.

Hysteroscopic sterilization of patient with intrauterine device Mirena®.

Tubal sterilization is the definitive procedure most often used worldwide to control fecundity. Laparoscopic ligature is safe, but invasive and with possible surgical and anesthetic risks. The hysteroscopic approach enables tubal occlusion at outpatient's setting without the need of incisions or anesthesia. A microdevice (Essure®) is inserted directly into the tubes and its polyethelene fibers cause obstruction of tubes in about three months. During this period, it is recommended that patients continue the use of a temporary birth control method. Several women use the levonorgestrel-releasing intrauterine system, which is called in the market as Mirena®. This report evaluated the possibility of inserting Essure® without remove the intrauterine device; patient tolerance to the procedure was also assessed. The tubal device was successfully placed in the patient without the need to remove Mirena®. After three months the intrauterine device was removed with no intercurrent events.

Control de dispositivos intratubarios Essure mediante estudios de imágenes / Detection and control of Essure device by pelvic radiography and ultrasound

Objetivo: Comparar la efectividad en la detección y control del dispositivo intratubario (DIT) Essure por medio de la radiografía abdominopélvica y el ultrasonido. Método: Control de los primeros 5 casos de esterilización tubaria ambulatoria con Essure, después de 1 y 2 años de su inserción, mediante radiografía abdominopélvica y ecografía transvaginal. Resultados: Ambos exámenes de imágenes permitieron corroborar la presencia del dispositivo Essure en las 5 pacientes, al completar su primer y segundo año desde su inserción. Conclusión: Tanto la radiografía abdominopélvica como la ecografía transvaginal, permiten detectar y controlar la presencia del DIT Essure. El ultrasonido realizado por el ginecólogo en la consulta, puede reemplazar a la radiografía simple, como método de detección y control de los dispositivos intra-tubarios (Essure). Las ventajas comparativas permiten concluir que el ultrasonido, no irradia a la paciente y permite explorar el resto de la anatomía de los órganos sexuales internos durante el mismo procedimiento. Sin embargo, es de mayor costo que la radiografía.

Objective: To compare the effectiveness in the detection and control of Essure by pelvic radiography and ultrasound. Method: Control of the first 5 cases of ambulatory sterilization with Essure after 1 and 2 years. Detection and control by pelvic x-ray and transvaginal ultrasonography. Results: Both methods allowed corroborating the presence of the Essure device in the 5 patients, when completing their first and second year from the insertion. Conclusion: As much the pelvic x-ray as the transvaginal ultrasound allows to detect and check the presence of the Essure device. The transvaginal ultrasonography can replace the x-ray like method of detection and check of the Essure devices. The comparative advantages allow concluding that the ultrasound usually is available for the gynecologist, does not radiate the patient and allows exploring the internal sexual organs anatomy during the same act. Nevertheless, it is of greater cost than x-ray.

Resolución Nº 0874: Procedimiento para la atención profesional frente a solicitudes de ligadura tubaria

Resolución que sin tener alcance general, describe el procedimiento médico de ligadura tubaria en pacientes que se atienden en los efectores del sistema de salud de la Ciudad. Fue creada luego del Consenso de Expertos realizado durante el año 2000, e impulsada por la Defensoría del Pueblo del Gobierno de la Ciudad de Buenos Aires

Resolución Nº 0874: Procedimiento para la atención profesional frente a solicitudes de ligadura tubaria

Resolución que sin tener alcance general, describe el procedimiento médico de ligadura tubaria en pacientes que se atienden en los efectores del sistema de salud de la Ciudad. Fue creada luego del Consenso de Expertos realizado durante el año 2000, e impulsada por la Defensoría del Pueblo del Gobierno de la Ciudad de Buenos Aires

Esterilización tubárica: una técnica quirúrgica original / Tubal sterilization: an original surgical procedure

RESUMEN. Procedimiento de contracepción quirurgica, que facilitará la reversibilidad de la permeabilidad tubárica dejando ambos extremos casi de igual calibre. Total 90 casos en 18 años, hasta 1993; sin complicaciones ni fracasos.

Timing of postpartum tubal sterilization using the Filshie clips: an analysis of data from two developing-country centers.

Two-hundred-ninety-seven women at a Panamanian center and 148 women at a Philippine center had their tubal sterilization performed during their postpartum hospital stay after an uncomplicated vaginal delivery of a live birth. The sterilizations were all performed with the use of the Filshie clip via minilaparotomy. The timing of the sterilization varied from two hours to six days after delivery. At each of the two centers, women sterilized within 48 hours after delivery were compared with those sterilized at 49 or more hours with respect to surgical difficulties, tubal injuries, complications/complaints, technical failures and lengths of hospitalization after sterilization and before discharge. The one-year gross cumulative pregnancy rates were also compared. No significant differences were detected in any of the above outcome variables between the two timing groups at each center. While the data suggest that tubal sterilizations by the Filshie clip performed two to six days following childbirth are as safe and effective as those performed within 48 hours of delivery, further studies are urged.

PIP: 297 women at a Panamanian center and 148 women at a Philippine center had their tubal sterilizations performed during their postpartum hospital stays after uncomplicated vaginal deliveries of livebirths. The sterilizations were all performed with the use of the Filshie clip via minilaparotomy. The timing of the sterilizations varied from 2 hours-6 days after delivery. At each of the 2 centers, women sterilized within 48 hours after delivery were compared with those sterilized at 49 or more hours with respect to surgical difficulties, tubal injuries, complications/complaints, technical failures, and lengths of hospitalization after sterilizations and prior to discharge. The 1 year grossed cumulative pregnancy rates were also compared. No significant differences were detected in any of the above outcome variables between the 2 timing groups at each center. While the data suggest that tubal sterilizations by Filshie clip performed between 2-6 days postpartum are as safe and effective as those performed within 48 hours of delivery, further studies are necessary.

Experiencia de exterilización por laparoscopia con anillo de Yoon en el Hospital Universitario "Dr. Angel Larralde" durante el período octubre 1985 a junio de 1987 / Sterilization experience by laparoscopy with Yoon ring at the Hospital Universitario \"Dr. Angel Larralde\" during octuber 1985 to june 1987

En este estudio de 59 pacientes que solicitaron ser esterilizadas por laparoscopia con la aplicación del anillo de Yoon, sólo 44 pacientes se les pudo practicar la técnica; el resto no se le práctico por varias causas de origen patológico, entre ellas: hidrosalping y slpingitis como las principales. El método permitió hacer el diagnóstico de dichos cuadros clínicos. Se demostró con el presente trabajo que la experiencia de esterilización por laparoscopia utilizando el anillo de Yoon, presenta el menor riesgo para la paciente, tanto quirúrgicamente, como para prevenir con mayor efectividad los embarazos no deseados

Obstrucción tubaria bilateral, fracaso del método / Bilateral tubal obstruction, the failure of the method

De 1,135 pacientes sometidas a obstrucción tubaria bilateral; en 1,129 pacientes el procedimiento fue eficaz; de estas pacientes, 1,111 (98%) fueron sometidas a obstrucción tubaria bilateral con el método de Pomeroy. Y en 19 pacientes (2%) se utilizaron anillos de Yoom con buenos resultados