Laparoscopic Essure Research Articles

7455 Long Term Outcomes after a Uterine-Sparing Approach to Essure Contraceptive Device Removal: A Case Series and Follow up Survey

<h3>Study Objective</h3> To analyze long-term effectiveness of a conservative, uterine-sparing approach to laparoscopic Essure contraceptive device removal. Specific outcomes of interest include patient satisfaction, symptom resolution and need for subsequent surgical intervention. <h3>Design</h3> Retrospective case series and follow up survey. <h3>Setting</h3> Large academic medical center. <h3>Patients or Participants</h3> Patients who underwent laparoscopic Essure removal without concomitant hysterectomy between January 2016 and December 2019. <h3>Interventions</h3> Patient underwent surgical removal of Essure device by laparoscopic salpingectomy or salpingostomy. Greater than 18 months after removal participants completed a survey assessing outcomes. <h3>Measurements and Main Results</h3> Twenty-nine patients underwent conservative Essure removal and there were 19 survey respondents, for a response rate of 65.5%. Among survey respondents, the mean length of time from Essure placement to removal was 56.7 months (range 5-117), and the mean length of time from removal to survey administration was 49.7 months (range 23-86). The most frequently reported symptom was pain (100%), followed by bleeding (52.6%), headache (42.1%), and dyspareunia (42.1%). The majority of patients underwent laparoscopic salpingectomy (79.3%); 3 patients (13.8%) underwent a combined hysteroscopic and laparoscopic approach, and 2 (6.9%) underwent laparoscopic cornuectomy. In reporting symptom improvement after Essure removal, 47.4% of patients reported total improvement, 36.8% reported almost total improvement, 5.3% reported some improvement, and 10.5% reported no improvement. The majority of patients (89.5%) reported satisfaction with their surgical results, and only 2 patients required subsequent surgical intervention for symptom management. <h3>Conclusion</h3> The majority of patients in our cohort reported almost total or total improvement in symptoms almost two years after Essure removal, with low rates of reintervention. A uterine-sparing approach to Essure removal, using laparoscopic and hysteroscopic modalities, may be a feasible and effective approach to addressing Essure-attributed symptoms.

8250 Two Approaches to Laparoscopic Removal of Essure® Coils: Salpingectomy and Cornuectomy

<h3>Study Objective</h3> To describe two uterine-sparing methods for laparoscopic Essure® coil removal. <h3>Design</h3> Demonstration of surgical steps involved in laparoscopic removal of Essure® coils. <h3>Setting</h3> University academic hospital. <h3>Patients or Participants</h3> The patient is a 39-year-old G1P1 with history of Essure® system sterilization presenting with chronic pelvic pain. <h3>Interventions</h3> Laparoscopic bilateral Essure® coil removal via bilateral salpingectomy and en bloc cornuectomy. <h3>Measurements and Main Results</h3> N/A. <h3>Conclusion</h3> Laparoscopic Essure® coil removal is a practical uterine-sparing option with no difference in perioperative outcomes between cornuectomy and salpingectomy alone.

Release of metal elements from the Essure implant: A prospective cohort study

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 designNi, 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. Correlation between metal elements concentrations and reported pre-operative symptoms was also investigated. ResultsThere were 131 patients in group A vs 92 control patients in group B. The concentrations of Cr and Ni in PF between both groups were significantly different (p < 0.0001) while there was no statistical difference for Sn (p = 0.58). There was also a significantly higher concentration in the FT for the 3 metal elements in group A than in group B (p < 0.0001). There were differential dynamics of the levels of metal elements based on the length of time between the placement and removal of Essure®. ConclusionsThere was a chronic exposure to metal elements in symptomatic patients with Essure® raising the question of the relationship between adverse effects and these potential toxic metals.

Could the anatomic location of Essure® device explain the impairment of quality of life?

Since health-related quality of life (HRQL) could improve after removal of Essure® (Bayer, Leverkusen, Germany) inserts in symptomatic patients, we aimed to assess whether such postoperative enhancement was linked to the anatomic placement of the device. Correct and incorrect placed Essure® (Bayer) were identified in the electronic database of the French cohort Ablimco (cohort of consenting patients with laparoscopic Essure® [Bayer] removal). HRQL, pain and heavy menstrual bleeding were evaluated after Essure® (Bayer) removal with validated quality of life questionnaires (Short Form12 Questionnaire, Visual Analogue Scale, French version of the McGill Pain Questionnaire and the pictorial blood assessment chart PBAC). Sixty-five patients were included in the study divided in two groups (group A with correct placement: 45 patients and group B with incorrect placement: 20 patients). HRQL and Pain Index were improved in both groups at 6 months post-surgery. There was not any statistically significant difference between group A and B. The PBAC score increased at 6 months postoperatively in group A and B without any statistically significant difference between them. Postoperative improvement of quality of life and pain index was similar whatever the position of the implant. This suggests that symptomatology and quality of life are not related to the anatomic location of the Essure® (Bayer) implants.

Quality of life and symptoms following laparoscopic essure removal: a prospective multicenter study

The objective of this study was to compare quality of life and symptoms before and after Essure removal. This multicenter, prospective study evaluated patient-reported quality of life and symptoms before and 4 months after laparoscopic Essure removal for device-attributed symptoms. Quality of life was measured using the validated Short Form-8 questionnaire for health-related quality of life. Symptoms were measured using a study-specific questionnaire. Essure removal was performed on 80 patients with device-attributed symptoms at 4 institutions between 2018 and 2020. The majority (n=53, 66.3%) underwent a laparoscopic hysterectomy and bilateral salpingectomy, and the remainder (n=27, 33.8%) underwent a laparoscopic bilateral salpingectomy alone. Indications for device removal were pain (n=73, 91.3%) and abnormal bleeding (n=42, 52.5%), in addition to several other patient-reported symptoms. 51 (63.8%) patients completed the postoperative questionnaire. Quality of life was significantly improved following Essure removal as measured by the physical and mental component summary scores (Table 1). Almost all symptoms were less commonly reported after Essure removal (Table 1). Subgroup analyses of patients who underwent a hysterectomy or a salpingectomy alone also demonstrated a significantly improved quality of life after the procedure. Symptoms were more likely to resolve following hysterectomy and salpingectomy compared to salpingectomy alone. Most patients (n=47/51, 92.2%) were satisfied with the results of their surgery. Patients undergoing laparoscopic Essure removal for device-attributed symptoms report improved quality of life and symptoms following the procedure. While the relationship between the Essure device and adverse symptoms remains unclear, Essure removal may benefit those experiencing adverse symptoms and is associated with high patient satisfaction.

Essure® removal in 10 steps

Many women request Essure® removal because of possible side effects related to the device itself. Laparoscopic Essure® removal in symptomatic women may be associated with improvement in quality of life. We aim to describe the surgical technique in ten steps in the accompanying video as the standardization of the laparoscopic Essure® removal procedure could help to diminish the risk of fractures of the device with this easy and safe 10-step procedure.

Robotic-assisted laparoscopic Essure removal: a novel surgical approach.

Primary objective was to evaluate safety and feasibility of robotic-assisted Essure removal while describing the procedure. Secondary objective was to assess improvement of symptoms post-operatively. The design was retrospective cohort study. Patients included were thosewho underwent robotic-assisted Essure removal between June, 2015 and December, 2020 for symptomatic relief. Interventions are robotic-assisted laparoscopic removal of Essure devices. A retrospective chart review was conducted. Phone survey of pain scores and quality-of-life ratings were performed. Twenty-one women underwent robotic-assisted removal of Essure devices. Two cases were excluded from analysis due to concomitant procedures. All devices were removed intact (19/19). The mean time from placement to removal was 5.3years. Safety and feasibility were demonstrated, mean operating time was 43.1 ± 12min, mean length of stay (LOS) was 11h, and no complications occurred. Mean pain scores (0-10) improved from 8.5 before surgery to 0.75 at 1 month after surgery (p < 0.005). Mean Quality-of-Life (QOL) scores (0-7) improved from 5.9 prior to surgery to 1.5 at 1 month after surgery (p < 0.005). To our knowledge, this is the first report of the use of robotic assistance for Essure removal. Robotic-assisted laparoscopic Essure removal appears safe, feasible, and potentially superior to other surgical approaches. Despite discontinuation of the device in 2018, Essure removal is likely to remain needed. Robotic-assisted laparoscopic Essure removal appears effective in treating pain and various other symptoms attributed to Essure devices.

Resolution of Dermatitis After Laparoscopic Essure Coil Removal [7R

INTRODUCTION: Systemic contact dermatitis due to nickel component of Essure is a rare complication. METHODS: We present a case of a 31 year old who developed a rash after Essure placement that resolved with complete removal of the coils. The patient had a history significant for Crohn's disease and multiple abdominal surgeries. To avoid another surgery, she elected for surgical sterilization with Essure. Approximately two months after placement of Essure, she developed diffuse itching and blistering with scarring. Over the course of two years, she was seen by numerous subspecialists for evaluation of the rash. Allergen testing by dermatology revealed a nickel allergy. The patient was then referred to gynecologic surgeons to discuss management. On exam, she was found to have ill-defined, erythematous patches, studded with red/brown crusted papules and superficial excoriation. The patient was counseled on her options and she preferred Essure removal. She underwent a hysteroscopy and laparoscopic bilateral salpingectomy with complete removal of the Essure coils. Complete removal was confirmed by identifying the gold tag at the proximal end of the coil after removal. Her skin lesions and itching began to improve immediately, and the lesions had almost completely resolved six weeks after surgery. CONCLUSION: Allergic contact dermatitis that resolves with Essure removal has been reported. This is the fifth case report of such a reaction. With allergic reactions like this, complete removal of the coils is essential, as leaving even a small piece of the coil could result in persistent symptoms.

53: Tips and tricks for effective laparoscopic removal of Essure device

The purpose of this video is to describe a simple, effective, and safe technique for laparoscopic removal of Essure implants. We focus on the steps of the procedure and also techniques to overcome possible complications. Essure implants can be associated with pelvic pain, which may warrant their removal. We present recordings from our laparoscopic Essure removal procedure. Our steps for safe and effective laparoscopic technique consist of: 1) injection of vasopressin through the abdominal wall into uterine cornua via spinal needle to decrease blood profusion to the operative site; 2) use of a vessel sealer device to coagulate and dissect the mesosalpinx to access the cornua and expose the implants; 3) use of gentle traction, open-and-spread, and twisting technique to remove the implants; and 4) completion of the salpingectomy only after the implants have been entirely removed. Additional tips and tricks for successful outcomes are highlighted. This technique for laparoscopic removal of Essure implants minimizes blood loss and allows for concomitant salpingectomy to achieve permanent sterilization. Our video presentation allows the viewer to easily learn this safe and effective technique.

373 - Operative Variables Associated with Postoperative Pain Resolution Following Laparoscopic Essure® Removal

373 - Operative Variables Associated with Postoperative Pain Resolution Following Laparoscopic Essure® Removal

Essure Removal for the Treatment of Device-Attributed Symptoms: An Expanded Case Series and Follow-up Survey

Study ObjectiveTo evaluate perioperative outcomes and symptom resolution in women undergoing removal of the Essure device for device-attributed symptoms. DesignRetrospective case series and follow-up patient survey (Canadian Task Force classification III). SettingLarge academic medical center. PatientsFifty-two women who underwent laparoscopic or hysteroscopic Essure removal between 2012 and 2016. InterventionsWomen underwent one of four procedures: laparoscopic hysterectomy (LH) and bilateral salpingectomy (BS), laparoscopic BS and cornuectomy, laparoscopic Essure removal and BS, or hysteroscopic Essure removal and laparoscopic BS. Measurements and Main ResultsFifty-two women who underwent Essure removal were asked to complete a survey regarding symptom resolution and quality of life following the procedure. Thirty-two women (61.5%) responded to the survey. Seventy-five percent (24/32) reported almost total or total improvement in quality of life, 56.3% (18/32) for sex life, 53.1% (17/32) for pelvic pain, and 65.6% (21/32) for daily activities. The majority of women reported some degree of improvement in all four domains queried (87.5%, 28/32). When asked about their symptoms in general, 31.3% (10/32) of women reported ongoing or worse symptoms after Essure removal. All procedures took approximately one hour (mean 65 min, SD 33 min), were associated with minimal blood loss (mean 31 mL, SD 17), and had no perioperative complications. ConclusionEssure removal is a procedure that may be effective for treating most women with symptoms attributed to the device. Patients should be counseled that some symptoms may persist or even worsen following surgery.

Laparoscopic Essure Removal

Essure contraceptive device is an FDA approved tubal occlusive sterilization method that has been available for over a decade. There has been a steady increase in the number of patients requesting Essure removal due to perceived relationship to pelvic pain and other symptoms. Patients presenting for consultation request complete removal of the device. They are counseled that their symptoms may persist despite Essure removal. This video presents three techniques of laparoscopic Essure removal. In the first technique, the fallopian tubes and the uterine cornua are removed. In the second technique, the distal fallopian tube is incised and the Essure device is extracted, followed by a salpingectomy while preserving the cornua. Some patients elect to undergo a total laparoscopic hysterectomy with bilateral salpingectomy. In 11 patients surveyed, 73% reported improvement in pelvic pain and quality of life.

Surgical aspects of removal of Essure microinsert

Essure is designed as a hysteroscopically placed permanent birth control. Removal of the Essure microinsert can be a technically challenging procedure. Requests for removal are uncommon but do occur. Although hysteroscopic and laparoscopic removal has been reported, there is limited information available describing appropriate surgical technique.There have been six patients requesting Essure removal at our institution (one approximately 2 years after placement). Based on this experience, we have developed specific counseling points and surgical principles for laparoscopic removal: avoid injection of a hemostatic solution into the fallopian tube; avoid excessive traction on the coils; avoid cauterization of the outer coil; follow the Essure coil into the interstitial end of the fallopian tube to ensure complete removal of the insert; perform a salpingectomy rather than a salpingostomy.By taking into account these principles, key preoperative counseling points can be discussed, and laparoscopic Essure removal years after placement can be accomplished in a safe and deliberate fashion.