Chronic Pelvic Pain in Women with a History of Essure Placement: A Systematic Review of Differential Diagnosis and Management Options

Abstract

Study Objective The purpose of this article is to provide an evidence based review of management options for patients with pelvic pain and an in situ Essure device. Design Literature review and qualitative analysis. Setting N/A Patients or Participants N/A Interventions N/A Measurements and Main Results The Essure device was voluntarily withdrawn from the market in 2018 by the manufacturer due in part to concerns about post placement adverse events and an FDA black box warning about uterine and fallopian tube perforation, suspected allergic or hypersensitivity reaction, and need for surgical removal for adverse events which were mostly related to pain. We performed a PubMed keyword literature search, as well as directed searches of Obstetrics & Gynecology, American Journal of Obstetrics and Gynecology, and Journal of Minimally Invasive Gynecology. A total of 43 publications were included, and consisted of 7 prospective studies, 15 retrospective studies, 18 case series, 2 review articles, and one summary article by the FDA. Conclusion A brief summary of recommendations and conclusions from this review: - Initial work up of pain in a patient with Essure devices should begin with placement confirmation via either transvaginal ultrasound or hysterosalpingogram/Xray. - In the event Essure microinserts are malpositioned, device removal is recommended. - In patients with a history and physical exam suggestive of possible endometriosis or adenomyosis, consider an attempt at hormonal management prior to surgical excision of the Essure device. - We recommend a laparoscopic resection of the fallopian tubes with or without partial coronuectomy for the management of pelvic pain of and no other identifiable source, even if Essure device is positioned appropriately. - We recommend an imaging modality be available in the OR during device removal to confirm an intact device and/or complete resection. - If hysterectomy is planned for in patients with the Essure device for indications other than pelvic pain, we recommend en block resection of the fallopian tubes and cornua.