Nonpalpable implant removals at centre of experience in France: a cohort study.

OBJECTIVE(S): Management and localisation strategies to remove nonpalpable contraceptive implants may be difficult. We aimed to evaluate our imaging modalities to identify deep implant and patient outcomes related to removal. STUDY DESIGN: In this retrospective study, we reviewed all cases referred to our specialised centre for nonpalpable contraceptive implants from January 2018 to August 2022. RESULTS: Out of the cohort studied, 47 female subjects exhibited nonpalpable implants. The implant was nonpalpable for thirty-six patients (76,6%) immediately after the insertion whereas it was not palpable several months after the insertion for eleven patients (23.4%). Twelve patients (25.5%) had one or more failed removal attempts before referral.All 47 implants were successfully visualised via ultrasound in the upper arm: 40 implants (85.1%) were located in the subdermal tissue, 4 (8.5%) were intrafascial and 3 (6.4%) were intramuscular. Depth of the implant was 4.0 mm [1.7 - 12.0]. No clinical factors were statistically associated with differences in depth or location (subdermal vs subfascial). Removal procedures were mainly under local anaesthesia in 74.5% of cases in an outpatient setting. There were two Clavien-Dindo grade 1 complications (one case of cutaneous scar dehiscence and one transient postoperative neuropathic complaint in the upper arm resolved within 3 months under analgetics). CONCLUSIONS: Identification of deep implants requires following the ultrasound modality protocol. Ultrasound detection makes easy and safe implant removal. Training programs for the insertion as well as for the removal of correct and incorrect inserted implants should be continued and developed all around the world.

Clinical improvement after Essure® devices removal: a systematic review.

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. MATERIALS AND METHODS: A review of literature in electronic search in Medline and Embase databases from January 2002 to January 2022 using the following keywords: Essure; Essure removal; quality of life; symptomatology improvement. RESULTS: Out of 764 articles in the initial database, 18 clinical studies were eligible for inclusion in our literature review. Overall clinical improvement rates after removal ranged from 21% to 98%. All symptoms were less frequent after Essure® removal, although with large discrepancies between studies. Lack of improvement was reported between 1% to 15% of patients. Rate of patients with improvement of QoL after removal ranged from 58 to 98%. The pain was reported as significantly reduced after the surgery. CONCLUSIONS: In the available literature, Essure® removal in symptomatic patients may improve symptoms and quality of life. This should be discussed in the benefits and risks ratio before deciding on the best option of management.

Essure® removal in symptomatic patients may improve symptoms and quality of life.

Clinical and histopathological correlations in symptomatic patients with salpingectomy for Essure® implant removal: a cross-sectional study.

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. Histopathological and clinical correlations were also investigated. RESULTS: In the STTE from 47 cases, acute inflammation was observed in 3/47 (6.4%) cases. Chronic inflammation with lymphocytes (42.5%, 20/47) was associated with a significant higher pre-operative pain score (p = .03). Fibrosis was noted in 43/47 (91.5%) cases. Fibrosis without lymphocytes (51.1%, 24/47) was statistically associated with significant reduced pain (p = .04). At distance from the Essure® implant, only chronic inflammation with lymphocytes was present in 10/47 (21.7%) cases. CONCLUSIONS: Inflammation response do not seem to be enough to explain all the Essure-related adverse outcomes, suggesting the involvement of other biological mechanisms. CLINICALTRIALS.GOV IDENTIFIER: NCT03281564.

Inflammation and fibrosis are found in the surrounding tubal tissue around the Essure^®. Inflammation process alone doesn't seem to be enough to explain symptomatology.

The minimally invasive sacrospinous fixation under visual guidance: An anatomical study.

OBJECTIVE: Sacrospinous fixation is the gold standard procedure for management of apical pelvic organ prolapse by the vaginal route. However, there may be a relevant risk of neurovascular injury due to the proximity of neurovascular structures. We propose an anatomical study concerning the sacrospinous ligament with a new innovative minimally invasive technology using both a suture capturing device and a chip-on-the-tip endoscope to perform sacropinous fixation. STUDY DESIGN: Bilateral sacrospinous fixation was performed in three female cadavers, in the course of the anatomical study conducted with a specific device (the Suture Capturing I Stitch™ Device) under real time visual guidance with a chip-on -the-tip endoscope, the NanoScope™ system. RESULTS: Identification of ischial spine and sacrospinous ligament as well as feasibility of sacrospinous fixation under NanoScope™ control were always possible on both sides. CONCLUSIONS: This new innovative minimally invasive technology using both a suture capturing device and a chip-on-the-tip endoscope is relevant and could be an advantage in terms of safety and better placement of the suture on the sacrospinous ligament.

How to be sure of a complete removal of Essure® implant? A radiological study of Essure® microinserts.

PURPOSE: Laparoscopic cornuectomy, one of the most performed surgical techniques to remove Essure® implants, is associated with a risk of fragmentation of the device. We aimed to assess the diagnostic accuracy of the intraoperative radiograph of the removed Essure® microinserts compared with intraoperative inspection of the device. STUDY DESIGN: In this French retrospective cohort study including 66 patients, two experienced gynecologists and two residents evaluated the intraoperative radiograph in a blind manner. Diagnostic accuracy was calculated for each observer. RESULTS: The global sensitivity and specificity for intraoperative radiograph to detect a residual fragment for both senior gynecologists and residents were, respectively 87.5 % (±3.3) and 80.0 % (+/12.2). Pooled positive (PPV) and negative predictive values (NPV) for intraoperative radiograph were respectively 99.2 % (±0.5) and 21.6 % (±6.4). There was a statistically significant difference in intraoperative radiograph analysis between senior gynecologists and residents (sensitivity: 91.4 %±0.8 vs 79.6 %±1.5, p = 0.02; specificity: 100% vs 50.0 %, p < 0.0001; PPV: 100 % vs 98.0 % ±0.1, p = 0.0007; NPV: 26.8 % ±1.8 vs 7.2 % ±0.5, p = 0.009). Sensitivity and specificity of the intraoperative inspection of the removal specimen was respectively 95.3 % and 100 % (PPV and NPV were, respectively 100 and 40 %). There were no statistically significant differences in diagnostic accuracy between intraoperative radiographs analysis and intraoperative inspection of the device for the senior gynecologists. CONCLUSIONS: Intraoperative radiograph of the removed Essure® implants analysis is a difficult skill needing specific training. Postoperative pelvic X-ray is still recommended in clinical practice after laparoscopic cornuectomy.

Plasma and peritoneal fluid cytokine profiles in patient with Essure® implant: Towards a molecular signature?

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. RESULTS: There were 60 symptomatic patients with Essure® device, 30 patients with endometriosis and a control group of 30 patients. The PF levels of Interleukin-10 (IL-10), Interleukin-6 (IL-6), and Monocyte chemoattractant protein-1 (MCP-1) were statistically higher in endometriosis group than in Essure® group and control group. The plasma level of MCP-1 was higher in Essure® group than in endometriosis group and control group. The plasma level of TNF-α was higher in Essure® group than in control group. CONCLUSIONS: The chemokine MCP-1 as well as the pro-inflammatory TNF-α, are known to be increased in patients with fibromyalgia and chronic fatigue syndrome. Since patients with Essure® may exhibit symptoms similar to fibromyalgia, MCP-1 and TNF-α may be relevant markers in symptomatic patients with Essure®. Because of the lack of longitudinal data (no evaluation of postoperative cytokine profile and no assessment of the level of clinical improvement), other studies are needed to confirm these preliminary results.

Mid-Term Results of a New Transobturator Cystocele Repair by Vaginal Patch Plastron without Mesh.

Cystoceles are the most common prolapses. Limitation of the use of synthetic mesh has led to the comeback of native tissue repair procedures. We have developed a new transobturator technique with native tissue based on a mix of a vaginal plastron technique and the transobturator procedure. We present the functional and anatomical mid-term results. In this retrospective study, the vaginal plastron technique and the transobturator procedure were performed in 32 patients. Functional assessment with several validated quality-of-life questionnaires (SF-12, PFIQ-7, PFDI-20, PISQ12) and anatomical evaluation with pelvic examination were performed at 1, 6, and 12 months after surgery. The anatomical success rate was 94.4% at 12 months. There was one Clavien-Dindo grade 2 postoperative complication (one urinary tract infection). All of the quality-of-life scores were statistically significantly improved at one year follow-up. The transobturator technique combined with the vaginal plastron seems to be a promising, effective, innovative, and relevant technique for the repair of high-stage cystoceles.

Long-Term Results after Bilateral Sacrospinous Colposuspension: A Prospective Study.

The loss of apical support is usually present in patients with pelvic organ prolapse. An effective correction for the vaginal apex may be an essential part of a durable repair for these women. Apical suspension of the sacrospinous ligament is likely one of the best treatments by the vaginal route. We proposed the evaluation of the functional and anatomical long-term results of an ultralight and macroporous sling. In this prospective study, bilateral sacrospinous colposuspension was performed in 32 patients with a specific mesh. Functional assessment with several validated quality of life questionnaires and pelvic examination was performed at 1, 6, 12, and 24 months after surgery. Pelvic examination using the POP-Q classification showed a very good efficacy of the BSC mesh with only three prolapse recurrences at 24 months after surgery. All the following QoL scores were significantly improved by two years: PFIQ-7 (p < 0.0001), PFDI-20 (p < 0.0001), and SF-12 (p < 0.0001). No improvement was achieved by the PISQ12 questionnaire. This vaginal minimally invasive procedure is effective, quick, reproducible, and easy. It may be a relevant option for a vaginal vault or cervical or uterine prolapse.

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

BACKGROUND: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.

Psychological impact on healthcare workers in obstetrics and gynecology in France in 18 French University Hospitals during the first Covid-19 lockdown: a prospective observational study.

PURPOSE: To assess the level of stress and anxiety in healthcare workers in the departments of obstetrics and gynecology in France during and after the first Covid-19 lockdown. METHODS: Two web-based cross-sectional surveys using several validated questionnaires (the HAD scale, the PSS-10 questionnaire and the Short Form 12 Questionnaire [SF-12]) were proposed to all staff of obstetrics and gynecologic departments in 18 French university hospitals. RESULTS: A total of 1565 respondents answered the first questionnaire and 1109 completed the second survey. Respondents reported greater levels of stress and impaired mental quality of life during the lockdown, followed by a significant improvement after the end of lockdown (respectively p < .0001 and p = .01). Anxiety was significantly higher among the older participants during the lockdown (p = .008). The potential putative factors related to impaired mental health status were personal protective equipment (PPE) deficit (<.0001), the fear of contracting the virus from the workplace and transmitting to their families (<.0001) and concerns about information given by media and hospitals (<.0001). CONCLUSIONS: Understanding the heavy mental repercussions of the Covid-19 pandemic on healthcare workers could lead to the identification of high-risk in medical and non-medical staff and the implementation of targeted psychological monitoring program.

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 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. Correlation between metal elements concentrations and reported pre-operative symptoms was also investigated. RESULTS: There 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®. CONCLUSIONS: There 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.

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.

Inbag Morcellation Applied to the Laparoscopic Surgery of Leiomyoma: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the efficacy and safety of an endoscopic bag during laparoscopic morcellation of leiomyoma or myomatous uterus. MATERIALS AND METHODS: A total of 48 patients with symptomatic leiomyoma were randomized for laparoscopic morcellation in two groups: group A with a specific endoscopic bag or group B without any bag. The primary outcome measure was the detection of smooth muscle cells from washing after power morcellation determined by peritoneal cytology and immunohistochemistry (IHC). RESULTS: Cytology and IHC from group A did not revealed any smooth muscle cells, while 29% of cases (7/24) from group B were positive (p = .009). The duration of the surgical procedure was the same in both groups. The duration of positioning the bag did not change significantly during the study. Only in one case the use of the bag was difficult due to a low pneumoperitoneum. CONCLUSIONS: The use of a morcellation bag is efficient to prevent the spread of smooth muscle cells during the morcellation of leiomyoma or myomatous uterus. This study confirms the feasibility and the safety of the laparoscopic inbag morcellation versus open morcellation.

How can we minimize the potential risk of viral contamination during laparoscopic procedures for suspected or infected COVID-19 patients?

Several societies have raised the risk of viral transmission of SARS-Cov-2 due to surgical smoke during laparoscopic procedures in infected patients. We propose to discuss this issue and to describe specific measures during laparoscopic procedures and a new homemade closed filtration system for smoke evacuation. Since the outbreak of COVID-19, performing a laparoscopy should meet multi-modal requirements. Surgical smoke evacuation device may be an effective tool in reducing exposure to surgical smoke and aerosols.

Potential release of toxic metal elements from Essure® device in symptomatic patients: First results of the French Ablimco cohort.

OBJECTIVE: Many patients with Essure® devices request the removal of these implants due to persistent adverse effects. The pathophysiology remains unknown, but a corrosion of the implants in the in-vivo environment leading to metal ion release may be suspected. The implants consist of polyester fibers, nickel-titanium alloy and other metals including chromium. The purpose of this study is to deliver the first results on the concentrations of nickel and chromium (two potential toxic metal elements) in peritoneal fluid and in the fallopian tube tissue during laparoscopic removal of Essure®. STUDY DESIGN: In this prospective observational study conducted in a French academic research hospital (University hospital of Lyon), nickel and chromium concentrations were determined in the fallopian tube tissue and peritoneal liquid from symptomatic patients with Essure® by Inductively Coupled Plasma Mass Spectrometry (ICP-MS) analysis in a PerkinElmer NexION 350. RESULTS: Significant metal element concentrations were showed in the peritoneal fluid. There was also a differential concentration in the fallopian tube tissue with higher concentration close to the implant then lower at a distance from this implant. There was a correlation between the concentrations of the two metals. CONCLUSION: The presence of nickel and chromium in the fallopian tube tissue and the peritoneal fluid raises the question of a possible relationship between the symptoms attributed to Essure® implants and the dissemination of potential toxic metals due to galvanic corrosion of the devices.

Technics to put on and remove personal protective equipment before surgical or obstetrical procedure in suspected or infected COVID-19 patients (with video).

Coronavirus pandemic is widely changing our professional daily practice and preventive measures must be taken and taught. Before any planned gynaecological or obstetric surgery, specific technics to put on and safely remove personal protective equipment should be implemented in order to avoid any contamination for both patients and healthcare workers.

Quality of life after laparoscopic removal of Essure® sterilization devices.

OBJECTIVES: To assess changes in quality of life after laparoscopic removal of Essure® sterilization devices (Bayer AG, Leverkusen, Germany). STUDY DESIGN: In this prospective observational study in an academic research hospital, 80 women with new or worsening symptoms since placement of Essure® sterilization devices undergoing subsequent surgical removal were included. Laparoscopic removal of Essure® devices and salpingectomy with or without cornual excision were performed. Concomitant uterine procedures could be associated where indicated for gynaecological complaints. Comparison using the T student test for coupled series was done in this before-and-after study. RESULTS: Health related quality of life (HRQL) was the primary outcome measured by the Short Form 12 (SF-12) questionnaire and a global 10 cm visual analogue scale (VAS). Secondary outcomes included assessment of pain, using continuous (VAS) and ordinal scales (Modified McGill Pain Questionnaire), menstrual bleeding (pictorial blood loss assessment chart (PBAC) score) and surgical feasibility and safety. There was a significant improvement in quality of life in both mental and physical health aspects of the SF-12 (34.02 (+/-1.19) vs. 49.61 (+/-1.42, P < .0001) and 36.55 (+/-0.99) vs. 43.32 (+/-1.18, P < .0001 respectively) as well as global VAS assessment (+2.91 (SD +/-0.27)) at the end of the first post-operative month. These improvements were maintained at three and six months. Mean pain decreased at one month following surgery compared to baseline (VAS 3.6 (+/-0.36) to 1.4 (+/-0.25), P < .0001 and McGill pain score 18.70 (+/-1.88) to 4.73 (+/-0.90), P < .0001). Improvements of a similar magnitude were observed when analysis was restricted to the 47 women without concomitant uterine surgery. No significant changes in bleeding were seen following of Essure® device removal. Planned procedures were all successfully completed. CONCLUSION: Laparoscopic removal of Essure® devices in symptomatic women is technically successful and associated with short and medium-term improvement in quality of life as well as reduction in pelvic pain.

Difficult diagnosis of hemoperitoneum in a patient with a pelvic mass of large size.

INTRODUCTION: Intraperitoneal hemorrhage caused by a uterine myoma is rare (Tajima et al., 2015). PRESENTATION OF CASE: A 47-year-old woman was admitted to the emergency room for worsening abdominal pain. Ultrasound revealed fluid filled almost the entire abdominal cavity as well as the presence of a mass of about 20cm near the uterus. It was not easy to understand the nature of the fluid by ultrasound. It appeared to be ascites with a tumoral pelvic neoformation. On TC there was extravasation of contrast material, but the bleeding site was not identifiable. An emergency operation was performed. Bleeding was from a subserosalmyoma on the anterior wall of the uterus; myoma measured approximately 20cm in maximum diameter. Pathological assessment of the resected specimen revealed bleeding from ruptured tortuous veins on a serosal-type uterine myoma. DISCUSSION: Spontaneous rupture of a vein or an artery overlying a myoma has been documented in English literature on the subject, although it is extremely rare (Tajima et al., 2015). CONCLUSION: The differential diagnosis between ascites and hemoperitoneum is sometimes not easy. Ultrasound is a helpful instrument in expert hands to make a diagnosis of hemoperitoneum. The aid of other diagnostic methods as TC help the clinician to arrive at the correct diagnosis quickly.