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

Abstract

ObjectiveAlthough 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.MethodsThis 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.ResultsIn 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).ConclusionThis 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.

Challenges in Removing the Essure® Device

“…A total of 3803 patients responded to the questionnaire and 2468 (64.9%) had undergone a hysterectomy. [ 14 ] Patients have chosen this surgery to prevent retained fragments of the device, despite the known higher cost, increased morbidity, prolonged recovery time, increased overall complication rate, and the risk of more blood loss during surgery associated with hysterectomy. However, also bilateral salpingectomy is a common approach for Essure ® removal.…”

Complicaciones asociadas con la histeroscopia

“…En el proceso de búsqueda se seleccionaron cinco estudios descriptivos alusivos a las complicaciones inherentes a la histeroscopia, y cinco referentes a investigaciones comparativas frente a complicaciones asociadas con histeroscopia con energía monopolar y bipolar. Entre los cinco primeros dos correspondían a histeroscopia oficinal indicado por infertilidad 14 , con varias indicaciones respecto a hemorragia uterina anormal y técnicas de reproducción asistida 15 , y tres se trataban de histeroscopia quirúrgica indicada por hemorragia uterina anormal 16,17 y esterilización 18 (figura 1). Para la histeroscopia oficinal la complicación más prevalente fue el dolor determinado por la dilatación cervical sin anestesia; Zayed y col. (2014) la reportan como la principal que finalizó con la interrupción del procedimiento en 2.3% por dolor insoportable 15 , por otro lado Díaz y col. (2017) informaron como evento adicional al dolor la presencia de efecto vasovagal en 3%.…”

“…17 Sills y col.(2017) determinaron las complicaciones tras la esterilización por técnica essure a través de histeroscopia, reportando urticaria, erupción, hinchazón, comezón y dolor como las principales relacionados directamente con la medida anticonceptiva y no con la técnica quirúrgica, que de acuerdo con la gravedad terminaron en histerectomía. 18 En cuanto a las investigaciones comparativas frente a la histeroscopia con energía monopolar y bipolar, los cinco estudios encontrados fueron concluyentes frente a las complicaciones más frecuentes [19][20][21][22][23] (tabla 1). En todos las poblaciones fueron asignadas aleatoriamente de acuerdo con el tipo de energía usada, logrando en su mayoría una distribución equitativa.…”

“…REPERT MED CIR. 2019; 28(1): [12][13][14][15][16][17][18] La histeroscopia es el proceso de visualización y operación de la cavidad endometrial desde un enfoque transcervical, realizado a través de un histeroscopio básico. Es una intervención mínimamente invasiva de uso diagnóstico y terapéutico para el abordaje de diversas patologías intrauterinas y endocervicales.…”