Eficacia del retiro quirúrgico de Essure para el alivio del dolor pélvico: serie de casos / Surgical removal of the Essure device as a response to pelvic pain: case series

Resumen OBJETIVO: Evaluar la eficacia del retiro quirúrgico del Essure como medida para aliviar el dolor pélvico ocasionado, presuntamente, por este dispositivo. MATERIALES Y MÉTODOS: Estudio descriptivo y retrospectivo de una serie de casos. Se revisaron las historias clínicas de las pacientes atendidas entre el 1 de enero de 2016 y el 15 de agosto de 2018 en el Complexo Hospitalario Universitario de Ourense para la extracción quirúrgica del dispositivo Essure. Parámetros de estudio: datos demográficos, historial médico, información de la inserción, características del dolor, tipo de intervención, hallazgos durante la intervención y posoperatorios. Los datos se analizaron con el programa SPSS, versión 24 para Windows. RESULTADOS: Se intervinieron 11 pacientes y 7 de ellas tuvieron dolor abdominal después de la colocación del dispositivo, con una tardanza media de aparición de 3.75 años. La técnica quirúrgica más practicada fue la salpingectomía bilateral (7 de 11 pacientes). 7 de las 11 pacientes continuaron con dolor luego de la extracción del dispositivo; de ellas, 2 tenían diagnóstico previo de dolor crónico y 3 antecedente de cirugía abdominal. CONCLUSIONES: En esta muestra de pacientes a quienes se extrajo el Essure, el retiro no resultó eficaz para aliviar el dolor en casi dos tercios de ellas. Esto pone de relieve que la extracción no garantiza la eliminación del dolor. Las investigaciones futuras deberán dirimir porqué en algunos casos la cirugía de extracción no resulta efectiva.

Abstract OBJECTIVE: To evaluate the efficacy of the surgical removal of Essure in the elimination of pelvic pain caused, presumably, by this device. MATERIALS AND METHODS: A descriptive study of case series was conducted retrospectively. A review was performed of the medical histories of all the patients (11 in total) who underwent surgical removal of Essure devices at the University Hospital of Ourense (Spain) in the period between 1 January 2016 and 15 August 2018. The following items were collected: demographic data, medical history, data related to the insertion, characteristics of the pain, type of intervention, findings during the intervention and postoperative findings. The total number of patients intervened during that period was 11. The data was analyzed with the statistical software SPSS version 24 for Windows. RESULTS: Eleven patients were operated and 7 of them had abdominal pain after placement of the device, with an average delay of appearance of 3.75 years. The most practiced surgical technique was bilateral salpingectomy (7 of 11 patients). 7 of the 11 patients continued with pain after removal of the device; of them, 2 had previous diagnosis of chronic pain and 3 antecedents of abdominal surgery. CONCLUSIONS: It is evident that surgical removal of the Essure insert was not effective in almost two-thirds of the patients under study, which highlights that its removal does not guarantee the elimination of pain. Future research should determine why in some cases surgical removal is not effective.

Definitive Contraception: Trends in a Ten-year Interval / Contracepção definitiva: tendências em um intervalo de dez anos

Abstract Objective To evaluate the trends in definitive contraception in a ten-year interval comprising the years 2002 and 2012. Method Retrospective analysis of the tubal sterilization performed in our service in 2002 and2012,analyzingthedemographiccharacteristics,personalhistory,previouscontraceptive method, definite contraception technique, effectiveness and complications. Results Definitive contraception was performed in 112 women in 2002 (group 1) and in 60 women in 2012 (group 2). The groups were homogeneous regarding age, parity, educational level and personal history. The number of women older than 40 years choosing a definitive method was more frequent in group 1, 49.1% (n = 55); for group 2, the rate was 34.8% (n = 23) (p = 0.04). The time between the last delivery and the procedure was 11.6±6.2 and 7.9±6.4 years (p = 0.014) in 2002 against 2012 respectively. In 2002, all patients performed tubal ligation by laparoscopic inpatient regime. In 2012, the bilateral placement of the Essure (Bayer Corporation, Whippany, NJ, US) device was suggested to 56.1% (n = 37) of the patients, while laparoscopy was suggested to 43.9% (n = 29) of them. All women who underwent laparoscopic sterilization had the procedure successfully completed using silastic rings. The overall bilateral device placement rate for the Essure was 91.6%, with only one complication reported. All Essure procedures were performed in an outpatient setting; for the laparoscopy, this rate was 79% (n = 15). No intentional pregnancies occurred until this date. Conclusions There is a trend in the decrease in definitive contraception over the years in our institution, maybe as a result of the development of long-acting reversible contraceptives. The hysteroscopic procedure has become a frequent option, as it is performed in an office setting without anesthesia, being a well-tolerated, minimal invasive method.

Resumo Objetivo Avaliar as tendências da contracepção definitiva feminina num intervalo de 10 anos, 2002 e 2012. Métodos Análise retrospectiva das mulheres submetidas a esterilização em 2002 e 2012 no Serviço de Ginecologia de um hospital em Portugal, atendendo às caraterísticas demográficas, antecedentes pessoais, método contraceptivo prévio, técnica de contracepção efetuada, eficácia e complicações ocorridas. Resultados Foram submetidas a contracepção definitiva 112 mulheres em 2002 (grupo 1), e 66 em 2012 (grupo 2). Os grupos eram semelhantes na idade, paridade, nível educacional e antecedentes pessoais. O número de mulheres com mais de 40 anos que optou por um método definitivo foi superior no grupo 1, 49,1% (n = 55), versus 34,8% (n = 23) no grupo 2 (p = 0,04). O tempo decorrido entre o último parto e o procedimento foi de 11.6±6.2 anos e 7.9±6.4 anos (p = 0.014) em 2002 versus 2012, respetivamente. Em 2002, todas as mulheres foram submetidas a laqueação tubária em regime de internamento. Em 2012, a colocação bilateral do Essure (Bayer Corporation, Whippany, NJ, EUA) foi proposta para 56,1% (n = 37) das pacientes, enquanto a laparoscopia foi proposta para 43,9% (n = 29) delas. A laqueação por laparoscopia foi realizada com sucesso em todos os casos com anéis de silastic. A taxa de colocação bilateral do Essure foi de 91,6%, tendo sido registrada uma complicação. Todos os procedimentos com Essure foram realizados em regime de ambulatório, enquanto que tal se verificou em 79% (n = 15) daquelas pacientes submetidas a laparoscopia. Não ocorreram gravidezes não intencionais. Conclusão Parece haver uma tendência para a diminuição da esterilização como opção contraceptiva, provavelmente devido à disponibilidade de diversos métodos contraceptivos de longa duração aliada aos benefícios não contraceptivos. A opção pelo dispositivo Essure, mais recentemente, é justificada pela sua realização em contexto de consultório, sem anestesia, sendo um método minimamente invasivo e bem tolerado.

Analysis of surgeries performed after hysteroscopic sterilization as tabulated from 3,803 Essure patient experiences

OBJECTIVE: Although previous research has suggested that risk for reoperation among hysteroscopic sterilization (HS) patients is more than ten times higher than for patients undergoing standard laparoscopic tubal ligation, little has been reported about these subsequent procedures. METHODS: This descriptive cohort study used a confidential online questionnaire to gather data from women (n=3,803) who volunteered information on HS followed by device removal surgery performed due to new symptoms developing after Essure placement. RESULTS: In this sample, mean age was 35.6 years and women undergoing hysterectomy after HS comprised 64.9% (n=2,468). Median interval between HS and hysterectomy was 3.7 (interquartile range, 3.9) years and mean age at hysterectomy was 36.3 years. Some patients (n=1,035) sought removal of HS devices and fallopian tubes only, while other miscellaneous gynecological procedures were also occasionally performed for Essure-associated symptoms. When data from all patients who had any post-Essure surgery besides hysterectomy were aggregated (e.g., device removal +“other” cases, n=1,335) and compared to those cases undergoing hysterectomy, mean age was significantly lower than for the hysterectomy group (34.4 vs. 36.3 years, respectively; P<0.01); uterus-conserving surgeries were also typically performed significantly earlier than hysterectomy (P<0.01). CONCLUSION: This investigation is the first to characterize specific gynecological operations after Essure, and suggests that the predominant surgical answer to HS complaints is hysterectomy for many women. Dissatisfaction with HS may represent an important indication for hysterectomy and additional study is needed to quantify this phenomenon.

Combined hysteroscopy-laparoscopy approach for excision of pelvic nitinol fragment from Essure contraceptive device: Role of intraoperative fluoroscopy for uterine conservation

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. Intraoperative fluoroscopy was used to confirm complete removal of the device, which was further verified by postoperative computed tomography. The patient's condition improved after surgery and she continues to do well. This is the first report to describe this technique in managing Essure complications remote from time of insertion. Our case highlights the value and limitations of preoperative and intraoperative imaging to map Essure fragment location before surgery.

Endometrial fluid associated with Essure implants placed before in vitro fertilization: Considerations for patient counseling and surgical management / 대한생식의학회지

Essure (Bayer) received approval from the U.S. Food and Drugs Administration as a permanent non-hormonal contraceptive implant in November 2002. While the use of Essure in the management of hydrosalpinx prior to in vitro fertilization (IVF) remains off-label, it has been used specifically for this purpose since at least 2007. Although most published reports on Essure placement before IVF have been reassuring, clinical experience remains limited, and no randomized studies have demonstrated the safety or efficacy of Essure in this context. In fact, no published guidelines deal with patient selection or counseling regarding the Essure procedure specifically in the context of IVF. Although Essure is an irreversible birth control option, some patients request the surgical removal of the implants for various reasons. While these patients could eventually undergo hysterectomy, at present no standardized technique exists for simple Essure removal with conservation of the uterus. This article emphasizes new aspects of the Essure procedure, as we describe the first known association between the placement of Essure implants and the subsequent development of fluid within the uterine cavity, which resolved after the surgical removal of both devices.

Contraceptive failure after hysteroscopic sterilization: Analysis of clinical and demographic data from 103 unplanned pregnancies

OBJECTIVE: This investigation examined data on unplanned pregnancies following hysteroscopic sterilization (HS). METHODS: A confidential questionnaire was used to collect data from women with medically confirmed pregnancy (n=103) registered after undergoing HS. RESULTS: Mean (+/-SD) patient age and body mass index (BMI) were 29.5+/-4.6 years and 27.7+/-6.1 kg/m2, respectively. Peak pregnancy incidence was reported at 10 months after HS, although or =30 years and BMI <25 reported conception after HS somewhat sooner than younger patients, although the differences in time to pregnancy were not significant (P=0.24 and 0.09, respectively). The recommended post-HS hysterosalpingogram (to confirm proper placement and bilateral tubal occlusion) was obtained by 66% (68/103) of respondents. CONCLUSION: This report is the first to provide patient-derived data on contraceptive failures after HS. While adherence to backup contraception 3 months after HS can be poor, many unintended pregnancies with HS occur long after the interval when alternate contraceptive is required. Many patients who obtain HS appear to ignore the manufacturer's guidance regarding the post-procedure hysterosalpingogram to confirm proper device placement, although limited insurance coverage likely contributes to this problem. The greatest number of unplanned pregnancies occurred 10 months after HS, but some unplanned pregnancies were reported up to 7 years later. Age, BMI, or surgical history are unlikely to predict contraceptive failure with HS. Further follow-up studies are planned to capture additional data on this issue.