Essure

OBJECTIVE: To determine whether adenomyosis is present in the cornual portion of hysterectomies of symptomatic sterilization device users and in patients hysterectomized for different benign causes and who presented with pelvic pain and/or menstrual alterations. METHODS: An observational, analytical, cross-sectional, single-center, retrospective cohort study was conducted in a secondary level hospital. Cohort 1 consisted of women who had Essure® hysteroscopic sterilization devices inserted between 2009 and 2017, who developed gynecologic symptoms (pelvic pain, heavy menstrual bleeding, and/or abnormal uterine bleeding) and who underwent a hysterectomy for explantation of the devices...

OBJECTIVE(S): Many patients with Essure® implant may experience adverse events related to the device. Although local inflammation does not appear to be the pathophysiological mechanism underlying the symptoms, systemic inflammation could play a role. In the present study, as cytokines are involved in the inflammatory process, we proposed to investigate the profile of circulating and peritoneal cytokines. STUDY DESIGN: In this retrospective study, we evaluated the levels of cytokines in peritoneal fluid (PF) as well as in plasma sample from three different groups: Essure® group, endometriosis group (known to be associated with immune dysregulation), and control group...

OBJECTIVE: To review the FDA premarket regulatory and postmarket surveillance processes for two minimally invasive gynecologic surgery (MIGS) case studies- the laparoscopic power morcellator (LPM) and the Essure® permanent birth control device- and to introduce the IDEAL framework for safely introducing and monitoring MIGS devices. DATA SOURCES: News media publications, Agency websites, Legal articles, Scientific papers METHODS OF STUDY SELECTION: Articles and papers were selected that described events leading to FDA approval of these devices and subsequent complications...

No abstract text is available yet for this article.

OBJECTIVE: To test agreement and interchangeability between distal (dRA) and forearm radial arterial (RA) pressures (AP) during general anesthesia (GA) for prone spinal surgery. METHODS: This prospective observational study involved 40 patients scheduled for GA spinal surgery. The right dRA and left forearm RA were cannulated in all patients to continuously measure invasive blood pressures (IBP). We compared the agreement and trending ability of systolic AP (SAP), diastolic AP (DAP), and mean AP (MAP) at each site 15 minutes after tracheal intubation, start of surgery, 30 and 60 minutes after the start of surgery, and after skin suturing...

BACKGROUND: Social support groups are an important resource for people to cope with problems. Previous studies have reported the different types of support in these groups, but little is known about the type of reactions that sharing of personal experiences induce among members. It is important to know how and to what extent members of support groups influence each other regarding the consumption of medical care. We researched this in a web-based Facebook group of women sterilized with Essure...

BACKGROUND: There have been numerous cases of adverse events since the introduction of Essure medical devices for sterilization in 2002. This study analyzed the safety event reports of the Essure reported in the Manufacturer and User Facility Device Experience (MAUDE). METHODS: A retrospective analysis examined the MAUDE reports between Jan-1, 2018, and Oct-31, 2018 and focused on safety reports related to the Essure device. Safety reports were categorized and analyzed by their event type, device problem, patients' symptoms and the level of harm...

PURPOSE: Essure® implant is a permanently implanted minimally invasive birth control device for women (female sterilisation) widely used between 2002 and 2018. Many adverse events were reported by patients. Increasingly removal procedures have been performed in symptomatic patients. However, there is a lack of in-depth studies on clinical improvement after Essure® removal. We aimed to review all clinical studies about symptoms and quality of life (QoL) after removal procedures...

PURPOSE: Many concerns have been raised about adverse effects related to Essure® device. Several pathophysiological hypotheses have been proposed including allergic reactions, Autoimmune/Autoinflammatory Syndrome Induced by Adjuvants, galvanic corrosion with release of heavy metals and inflammation. In the present study, we aimed to focus on inflammation process by performing a histopathological evaluation of Fallopian tubes in symptomatic patients with Essure® removal. MATERIALS AND METHODS: A cross-sectional study with identification of the type of inflammatory response and characterisation of inflammatory cells in the surrounding tubal tissue around the Essure® (STTE) and at distance from the implant...

OBJECTIVE: The objective of this study was twofold. (1) To investigate the predictive characteristics of transvaginal ultrasonography for hysteroscopy necessity in Essure removal surgery. (2) To investigate the additional predictive value of a preoperative pelvic radiograph to transvaginal ultrasonography for hysteroscopy necessity. STUDY DESIGN: Retrospective cohort study, performed in an academic and a non-academic teaching hospital in the Netherlands. 71 women who underwent Essure removal surgery with a perioperative hysteroscopy and who had a preoperative pelvic X-ray and transvaginal ultrasound were included...

STUDY OBJECTIVE: To describe a uterine-sparing minimally invasive surgical technique for laparoscopic resection of tubal occlusion devices using bilateral cornuectomy. DESIGN: This video reviews the background of the tubal occlusion device known as Essure and the indications and methods for surgical removal with a stepwise demonstration of a minimally invasive technique with narrated video footage. SETTING: The most cited reason for patients' desire for removal of the Essure device is pelvic pain...

The Essure® Device is a female sterilization implant comprised of four alloys (Ni-Ti, 316L SS, Pt-Ir and Sn-Ag) and Dacron fibers. As part of the mandated 522 post-market surveillance study, implant retrieval and metal-ion analysis methods were developed separate from patient clinical data, to quantify trace metal ions found in tissue and to assess implant degradation present. Three segments of tissue (proximal implant, distal implant, and tissue distal from the implant) stored in neutral buffered formalin, were retrieved...

OBJECTIVE: To evaluate perioperative outcomes and symptom resolution in women undergoing Essure removal. METHODS: Single centre cohort study at a large University Teaching Hospital in the UK. Symptoms and Quality of life (QoL) were assessed using a standardised questionnaire administered at 6-months and up to 10-years following removal of Essure® devices. RESULTS: 61 women underwent surgical removal of Essure® devices representing 61/1087 (5...

BACKGROUND AND OBJECTIVE: To analyze long-term effectiveness of a conservative, uterine-sparing approach to laparoscopic Essure removal. Specific outcomes of interest include patient satisfaction, symptom resolution, and subsequent surgical intervention. METHODS: A retrospective case series and follow-up survey. Patients who underwent laparoscopic Essure removal without concomitant hysterectomy between January 1, 2016 and December 31, 2019 were identified. Greater than 18 months after removal participants completed a survey assessing outcomes...

OBJECTIVE: To analyze quality of life(QoL) and symptom resolution after surgical removal of Essure devices. METHODS: Single-center cohort study which included patients with Essure removal between February 2017 and March 2018. Surgery was performed in 65 patients by laparoscopy (Salpingectomy only or Hysterectomy). Questionnaires were used to assess QoL(SF-36), emotional disorders(HAD) and symptoms preoperatively, at 3 months and 4 years postoperatively...

OBJECTIVES: To evaluate clinical data in women who underwent Essure® hysteroscopic sterilization and to determine whether this sterilization technique plays a role in developing new-onset symptoms. STUDY DESIGN: An observational, retrospective, single-center study. It was conducted in a secondary level hospital. It included 804 women who had Essure® hysteroscopic sterilization from 2009 to 2017. Charts from these women were reviewed from June 2009 to November 2019, searching for the development of gynecological symptoms (pelvic pain and bleeding disorders) and non-gynecological symptoms (bloating, joint pain, fatigue, headache, alopecia, allergy and depression)...

BACKGROUND: The objective of our study was to assess the rate and causes for Essure® micro-insert system removal and patients' long term satisfaction rate with the procedure. METHODS: All patients who underwent Essure® hysteroscopic sterilization at our tertiary centre between years 2007 and 2018 were included in this follow-up study. A questionnaire was sent to all patients per standard mail. Patients who did not respond to questionnaires per mail, were called by phone...

The Essure® permanent contraceptive implant, comprised of four alloys (nickel-titanium, 316L stainless steel, platinum-iridium, and tin-silver solder) and Dacron (PET) fibers, has been approved for use in the US for about two decades. However, little has been published on this implant's biomaterials performance, and as this implant gains interest in terms of in vivo performance, methods of implant post-retrieval storage also need to be assessed. This study investigated the electrochemical properties and ion release profile of Essure® during storage in phosphate buffered saline (PBS), 10 mM H2 O2 /PBS, a simulated inflammatory solution, and 10% neutral buffered formalin (NBF) to investigate the corrosion behavior and metal ion release...

No abstract text is available yet for this article.

OBJECTIVE(S): The causal mechanistic relationships between Essure® and adverse effects are unclear, but corrosion in the in-vivo environment with release of metal ions may be suspected. Here we evaluated the concentrations of nickel (Ni), chromium (Cr) and tin (Sn) in the peritoneal fluid (PF) and in the fallopian tube (FT) during laparoscopic Essure® removal compared to a control group. STUDY DESIGN: Ni, Cr and Sn concentrations were determined in the PF and FT from two groups(group A: symptomatic patients with Essure®) vs group B (control group without Essure®) by Inductively Coupled Plasma Mass Spectrometry analysis...