RESUMEN
The aim of this study was to understand the potential complications of the Essure® device as well as the factors influencing its onset and patient satisfaction. We present a 9-year descriptive prospective study that included 1068 patients. The device was placed in 1056 of them (98.8%); 894 had no pain or mild pain during the insertion and only 12 patients experienced pain greater than menstrual pain. The proportion of patients without pain was greater in the group that took NSAIDs or NSAIDs and BZD and the unmedicated group had the highest rate of severe pain (p = .00). In all, 161 of the 1064 patients who had the Essure® inserted reported having an adverse effect during the 3-months post-insertion (pelvic pain or discomfort). The mean score out of 10 attributed to this method was 9.06 (S = 1.11). We concluded that the Essure® shows a low rate of complications and users showed a high degree of satisfaction. Impact statement What is already known on this subject: There are few international publications on Essure®. When we conducted a search in PubMed for the term 'Essure', we obtained 221 publications. When we added the terms 'Essure and complications', we obtained 20 publications, and when we increased the restriction including 'satisfaction', we obtained seven; thus, the uniqueness of our study. What the results of this study add: We present a 9-year descriptive prospective study that included 1068 patients. The aim of this study was to understand the potential complications of the Essure® device (Bayer, Whippany, NJ), as well as factors that can influence its onset and the patient satisfaction. The device was placed in 1056 of the patients (98.8%); 894 had no pain or mild pain during the insertion and only 12 patients experienced pain greater than menstrual pain. The proportion of patients without pain was greater in the group that took NSAIDs or NSAIDs and BZD and the unmedicated group had the highest rate of severe pain (p=.00). What the implications are of these findings for clinical practice and/or further research: Our study shows a low rate of complications with Essure®, mild and transient in most cases, as well as a high degree satisfaction. Nevertheless, given the few published studies on this device, we believe that long-term follow-up is needed.
Asunto(s)
Histeroscopía/métodos , Satisfacción del Paciente/estadística & datos numéricos , Esterilización Tubaria/métodos , Adulto , Femenino , Humanos , Dolor Pélvico , Estudios Prospectivos , Esterilización Tubaria/efectos adversos , Esterilización Tubaria/instrumentaciónRESUMEN
Las malformaciones uterinas congénitas presentan una baja prevalencia en la población general (0,5-6,7 por ciento), el útero septo es la más frecuente. Estas enfermedades pueden afectar a los resultados reproductivos de las pacientes, así como aumentar la incidencia de abortos de repetición, presentaciones fetales anómalas o partos pretérminos. De la misma forma, los miomas uterinos submucosos también pueden producir alteraciones de la fertilidad, aunque la sintomatología más relacionada con los mismos es el sangrado. Constituyen el tumor benigno más frecuente del aparato genital femenino. El diagnóstico de estas patologías puede realizarse mediante pruebas de imagen como la ecografía transvaginal y la resonancia magnética, aunque la visualización directa vía histeroscópica sigue siendo de elección. Esta técnica constituye, además, la primera opción terapéutica, ya que se puede realizar tanto la resección del septo uterino como la miomectomía, sin apenas complicaciones y mediante una técnica quirúrgica segura y poco invasiva. El tratamiento histeroscópico está especialmente indicado en pacientes sintomáticas, con esterilidad o abortos de repetición, incluso antes de iniciar terapias de reproducción asistida. En el siguiente trabajo exponemos el caso de una paciente que presentaba un septo uterino constituido en su mayor parte por un leiomioma submucoso tratado vía histeroscópica; siendo un caso muy raro, dada la infrecuente asociación entre ambas patologías(AU)
Congenital uterine malformations present low prevalence in the general population (0.5-6.7 percent), and uterus septum is the most frequent. These pathologies can affect the reproductive outcomes of patients, as well as increase the incidence of repeating abortions, abnormal fetal presentations or preterm deliveries. In the same way, submucosal uterine fibroids can also produce alterations in fertility, although the most related symptomatology is bleeding. They are the most frequent benign tumor of the female genital tract. Diagnosis can be carried out through imaging tests such as transvaginal ultrasound and magnetic resonance imaging, although direct visualization, via hysteroscopy, is still the preferred option. This technique is also the first therapeutic option, since both, resection of the uterine septum and myomectomy can be performed with few complications and a safe and minimally invasive surgical technique. Hysteroscopy is especially indicated in symptomatic patients, with sterility or repeated abortions, even before initiating assisted reproduction therapies. In the following paper, we present the case of a patient who presented a uterine septum formed mostly by a submucosal leiomyoma. She was treated by hysteroscopy. This case is very rare given the infrequent association between both pathologies(AU)