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

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 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.

Minimum evidence-based care in intrauterine growth-restricted fetuses and neonatal prognosis.

BACKGROUND: Introduction: There is clear evidence that fetuses with intrauterine growth restriction (IUGR) do not receive the minimum evidence-based care during their antenatal management. OBJECTIVE: Considering that optimal management of IUGR may reduce neonatal morbi-mortality in IUGR, the objective of the present study was to evaluate the impact of antenatal management of IUGR according to the recommendations of the French college of gynecologists and obstetricians (CNGOF) on the neonatal prognosis of IUGR fetuses. STUDY DESIGN: From a historical cohort of 31,052 children, born at the Femme Mère Enfant hospital (Lyon, France) between January 1, 2011 and December 31, 2017, we selected the population of IUGR fetuses. The minimum evidence-based care (MEC) in the antenatal management of fetuses with IUGR was defined according to the CNGOF recommendations and neonatal prognosis of early and late IUGR fetuses were assessed based on the whether or not they received MEC. The neonatal prognosis was defined according to a composite criterion that included neonatal morbidity and mortality. RESULTS: A total of 1020 fetuses with IUGR were studied. The application of MEC showed an improvement in the neonatal prognosis of early-onset IUGR (p = 0.003), and an improvement in the neonatal prognosis of IUGR born before 32 weeks (p = 0.030). Multivariate analysis confirmed the results showing an increase in neonatal morbi-mortality in early-onset IUGR in the absence of MEC with OR 1.79 (95% CI 1.01-3.19). CONCLUSION: Diagnosed IUGR with MEC had a better neonatal prognosis when born before 32 weeks. Regardless of the birth term, MEC improved the neonatal prognosis of fetuses with early IUGR. Improvement in the rate of MEC during antenatal management has a significant impact on neonatal prognosis.

Opportunistic salpingectomy during vaginal hysterectomy for a benign pathological condition.

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate the surgical feasibility of opportunistic salpingectomy or salpingo-oophorectomy during benign vaginal hysterectomy (HV) and the prevalence of occult tubal lesions. METHODS: In this prospective study from 1 September 2013 to 1 November 2015, the prevalence of bilateral salpingectomy with or without ovariectomy and the prevalence of histopathological and immunohistochemical tubal abnormalities were assessed. RESULTS: A total 115 patients were included. Bilateral salpingectomy was performed in 85 patients (73.92%; group A) and was technically impossible in 30 patients (26.08%; group B). Older patients (62.9 vs 57.5 years, p = 0.009), menopausal status (83.33% vs 62.35%, p = 0.03) and elevated BMI (27.58 vs 25.05 p = 0.03) were statistically associated with failure of salpingectomy. There was only one case of postoperative hemorrhage in group A. There was no difference with regard to intra- or postoperative complications, blood loss, and operating time between the two groups. Among the 67 fallopian tubes analyzed with a validated histopathological protocol, there were 8 (11.94%) immunohistochemical abnormalities with a "p53 signature." CONCLUSIONS: With the recent demonstration of a tubal origin of most ovarian cancer, opportunistic salpingectomy could be a theoretically relevant prevention strategy. Bilateral salpingectomy could be performed during benign vaginal hysterectomy by experienced surgeons. The advantages and disadvantages of exclusive salpingectomy during pelvic floor surgery should be discussed with the patients.

A retrospective comparison of two vaginal mesh kits in the management of anterior and apical vaginal prolapse: long-term results for apical fixation and quality of life.

INTRODUCTION AND HYPOTHESIS: To compare apical correction in stage ≥3 cystocele between two mesh kits. METHODS: This was a retrospective, nonrandomized study that compared two groups matched on anterior/apical POP-Q stage: 84 received Elevate Ant™ single-incision mesh (Elevate Ant group) and 42 Perigee™ transvaginal mesh (Perigee group). Follow-up at 1 and 2 years comprised objective (POP-Q) and subjective (PFDI-20, PFIQ-7, PISQ-12) assessments. The primary endpoint was objective success: 2-year apical POP-Q stage ≤1. Secondary endpoints were anterior POP-Q stage, subjective results and complications. RESULTS: Groups were comparable in terms of age (66.6 and 64.7 years, respectively; p = 0.19), BMI (both 25.4 kg/m2; p = 0.93), and history of hysterectomy (7.2 % and 14.3 %; p = 0.21) or prolapse surgery (12 % and 14.3 %; p = 0.72). Operative time was shorter in the Elevate Ant group (54.1 vs. 62.5 min; p = 0.048), and the 2-year objective apical success rate was higher (92.9 % vs. 66.7 %; p < 0.0001), with better point C correction (-5 vs. -3.8; p = 0.006). Function improved in both groups, with significantly better PFIQ-7 (p = 0.03) and PFDI-20 (p = 0.02) scores in the Elevate Ant group at 2 years. Vaginal exposure was not seen in the Elevate Ant group but occurred in two patients in the Perigee group (p = 0.33). Factors associated with success were age >65 years (OR 7.16, 95 % CI 1.83 - 27.97) and treatment with Elevate Ant mesh (OR 10.16, 95 % CI 2.78 - 37.14). Postoperative stress urinary incontinence rate was greater with the Elevate Ant group (29.8 % and 16.7 %; p = 0.11). CONCLUSIONS: The use of the Elevate Ant mesh was associated with significantly better apical correction at 2 years. Function improved in both groups, but with a significantly better PFDI-20 score in the Elevate Ant group at 1 and 2 years. The postoperative stress urinary incontinence rate, however, tended to be greater in the Elevate Ant group. The results need confirming with longer follow-up of these cohorts and in randomized studies.

Long-term outcome after overlapping anterior anal sphincter repair for fecal incontinence.

PURPOSE: The aim was to assess long-term results and quality of life following anterior anal sphincter repair for anal incontinence. PATIENTS AND METHODS: Twenty-three female patients underwent anterior anal sphincteroplasty over a 10-year period between January 1999 and January 2009 in a gynecological surgery department. Patients were asked to complete pre- and postoperative questionnaires comprising the Jorge and Wexner incontinence score. The secondary objective was to assess pre- and post-sphincteroplasty symptom severity and sexual quality of life. Mean follow-up was 87 months (median, 91.5 months). Kaplan-Meier time-to-event analysis was applied. RESULTS: Mean age was 52 years (±15.2), and mean postoperative Jorge and Wexner score, 7.5/20 (±4.1). Seventeen patients (85 %) declared themselves satisfied by the repair; 12 (60 %) showed good fecal continence. Fecal incontinence had a negative impact on quality of life for 15 % and on sexuality for 50 % of patients. Kaplan-Meier analysis showed 85 % conservation of anal continence correction at 1 year, 74 % at 48 months, 67 % at 60 months, and 48 % at 84 months. CONCLUSIONS: Overlapping anterior anal sphincter repair provided lasting improvement in fecal incontinence, with satisfactory long-term functional results. At 84 months' follow-up, 48 % of patients maintained good fecal continence, with a satisfaction rate of 85 %. Anal sphincteroplasty may be a first-line attitude in young female fecal incontinence patients with a recent sphincter defect following initially undiagnosed obstetric trauma and also restores perineal comfort.

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.

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.

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.

Fetal growth restriction: underdiagnosed condition with non-optimal screening.

BACKGROUND: Fetal Growth restriction (FGR) is the pathological failure of a fetus to reach its biologically determined growth potential. Detection of FGR fetuses is a universally agreed key objective of antenatal care. Antenatal detection of FGR has undeniable benefits, juggling between intensive fetal surveillance and optimized timing of delivery; it reduces adverse perinatal outcomes by up to four-fold. However, FGR is still widely underdiagnosed. We aimed to identify the prevalence of FGR diagnosis in our wards and study the impact of the 2013 published French guidelines on the detection rate of FGR. The secondary objective aimed to highlight the factors of suboptimal screening in the population of non-diagnosed FGR fetuses and emphasize the screening method that led to antenatal diagnosis of FGR. MATERIALS AND METHODS: We conducted a retrospective study at a single tertiary maternity center in Lyon-France, the Femme Mère Enfant Hospital, including the exhaustive population of FGR born after 24 + 0 weeks of gestation from 1 January 2011 to 31 December 2017. FGR was defined combining the neonatal and antenatal consensus-based definitions for early and late FGR in absence of congenital anomalies, excluding small for gestational age fetuses. For all FGR fetuses, we compared the antenatal detection rate of FGR during 2011-2013 to 2015-2017, since the French guidelines were published in December 2013. When FGR fetuses underwent an antenatal diagnosis of FGR, we retrospectively collected the characteristics that led to the diagnosis. When fetuses were not diagnosed as FGR, we retrospectively reviewed the implementation of the recommended screening method, enabling to evaluate whether screening was optimal or not. Statistical analysis was performed in July 2018, and statistical significance was regarded as a p-value <.05. RESULTS: Over the seven-year period, and among 31,052 newborns, 1020 (3.3%) infants were identified as FGR and met the inclusion criteria. The detection rate of FGR was similar before and after publication of the French Guidelines related to FGR in 2013. Indeed, 50.8% (201/395) FGR were diagnosed between 2011 and 2013 versus 52.6% (245/465) between 2015 and 2017 (p = .59). In the population of non-diagnosed FGR infants, screening was suboptimal in 80%. Symphysis-fundal height (SFH) was not measured in 10.7%, with no difference before and after 2014 (7.3 versus 11.8% p = .11). Ultrasound examination for fetal biometry had not been prescribed in spite of abnormal SFH in 47.7% of undiagnosed FGR infants. Diagnosis has been missed in 11.5% of infants because of misinterpretation of the estimated fetal weight's centile. CONCLUSION: FGR is widely underdiagnosed. However, the limited performances can partially be explained by the regular misuse of screening method in clinical practice. Despite the systematic third trimester ultrasound screening, the detection rate of FGR was similar to the one reported in the medical literature. The timing of routine third trimester ultrasound in low-risk women may be rethought.

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.

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.

Standardized healthcare pathway in intrauterine growth restriction and minimum evidence-based care.

INTRODUCTION: Fetal growth restricted fetuses are less likely to receive evidence-based care; a previous work demonstrated an improvement in neonatal prognosis when fetuses with intrauterine growth restriction (IUGR) received minimum evidence based-care. OBJECTIVE: The objective of the study was to evaluate the impact of a standardized healthcare pathway on the implementation of the recommended clinical practice in the antenatal management of IUGR fetuses, in comparison to a traditional pathway. The quality of the implementation of practice has been defined whether or not minimum evidence-based care (MEC), defined according to the recommendations of the French college of gynecologists and obstetricians (CNGOF), has been implemented. STUDY DESIGN: From a historical cohort of 31,052 children, born at the Femme Mère Enfant Hospital (Lyon, France) between January 1st, 2011 and December 31st, 2017, we selected the population of IUGR fetuses. We compared the rate of MEC between the IUGR fetuses followed-up in the traditional healthcare pathway versus the IUGR fetuses followed-up in a standardized healthcare pathway between 2015 and 2017. RESULTS: A total of 245 IUGR were tracked between 2015 and 2017. Over this period, 120 fetuses were followed within the traditional pathway and 125 within the IUGR pathway. The standardized pathway resulted in a higher rate of MEC (86,4%) when compared to IUGR fetuses followed-up in the traditional pathway (27,5% (OR* 20 (95 % CI 10.0-39.7). Among early-onset IUGR: 31 % received MEC in the traditional pathway versus 83 % in the standardized pathway (p<0.001). Among late-onset IUGR: 22 % received MEC in the traditional pathway versus 92 % in the standardized pathway (p<0.001). The provided care in the standardized pathway resulted in an increase of complete antenatal corticosteroid therapy (92,8 %) when compared to the traditional pathway (50.0 %; p<0.001) and a reduction of the rate of caesarean sections before labor for non-reassuring fetal heart rate (15 %) when compared to the traditional pathway (41.3 % p=0.007). CONCLUSION: The standardized pathway improves the implementation of the local recommendations in the management of early- and late-onset IUGR. This study is the first to suggest a standardized care pathway in prenatal medicine. A medico-economic study could estimate the health care savings that such a pathway would provide by allowing a medical management in accordance with the recommendations.

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.

Outpatient vaginal surgery for pelvic organ prolapse: a prospective feasibility study.

BACKGROUND: In the light of recent progress in pelvic organ prolapse surgery, the modalities of hospital admission need reconsidering. This work aims to assess success rate of outpatient (ambulatory) vaginal mesh surgery for genital prolapse. METHODS: A prospective observational study was conducted between January 2015 and July 2017, including all patients presenting with POP-Q stage ≥3 anterior and/or apical prolapse. RESULTS: Sixty-nine of the 89 eligible patients were treated on an ambulatory basis (group A); 20 required overnight admission (group B): i.e., ambulatory success rate, 77.5%. Mean operative time was 44.9±2.5 min in group A and 62±6.5 min in group B. Reasons for ineligibility for ambulatory management comprised organizational issues at home (10.5%) and excessive home-to-hospital distance (5.7%). The postoperative urinary retention rate was 4.5%. Rates for successful cystocele correction (POP-Q <2) at 2 months were similar in the two groups: 94.2% in group A and 94.4% in group B (P=ns). Mean satisfaction score was 8.6±0.3/10. CONCLUSIONS: Outpatient anterior vaginal mesh surgery for prolapse is safe and effective. The current medical-economic context favors ambulatory management. Patient selection, prior information and continuity of care seem primordial.

Virtual reality simulation to enhance laparoscopic salpingectomy skills.

BACKGROUND: To assess skill enhancement and maintenance by virtual-reality simulation of laparoscopic salpingectomy in gynecologic surgery fellows. Skill acquisition by virtual-reality surgical simulation is an active field of research and technological development. Salpingectomy is one of the first gynecologic surgery techniques taught to fellows that requires accompanied learning. METHODS: A single-center prospective study was performed in the University of Lyon, France, including 26 junior fellows (≤ 3 semesters' internship) performing laparoscopic salpingectomy exercises on a LapSim® virtual reality simulator. Salpingectomy was performed and timed on 3 trials in session 1 and 3 trials in session 2, at a 3-month interval. Analysis was based on students' subjective assessments and a senior surgeon's objective assessment of skill. Progress between the 2 sessions was assessed on McNemar test and Wilcoxon test for matched series. RESULTS: 26 junior specialist trainees performed all trials. Most performed anterograde salpingectomy, both in session 1 (69 %) and session 2 (86 %). Mean procedure time was significantly shorter in session 2: 6.10min versus 7.82min (p=0.0003). There was a significant decrease in blood loss between the first trial in session 1 and the last trial in session 2: 167ml versus 70.3ml (p=0.02). Subjective assessment showed a significant decrease in anxiety and significant increase in perceived efficacy, eye-hand coordination and ergonomics. Efficacy, performance quality and speed of execution as assessed by the senior surgeon all improved significantly from trial to trial, while hesitation significantly decreased. CONCLUSIONS: The study showed that junior trainees improved their surgical skills on a short laparoscopic exercise using a virtual reality simulator. Virtual reality simulation is useful in the early learning curve, accelerating the acquisition of reflexes. Maintaining skill requires simulation sessions at shorter intervals.

Identification of risk factors for postpartum urinary retention following vaginal deliveries: A retrospective case-control study.

OBJECTIVE: Postpartum urinary retention (PUR) is an uncommon complication of vaginal delivery, defined as a failure to void spontaneously in the six hours following vaginal birth. The objective of this study was to identify risk factors for PUR in order to provide prompt management. STUDY DESIGN: A retrospective, comparative, case-control study, including two groups of 96 patients who delivered vaginally, was conducted at the Women and Children's University Hospital in Lyon, France. Patients were selected based on data extraction from the medical records of the obstetrics and gynecology department. The first group included patients with postpartum urinary retention and the second group, without PUR, was selected randomly, respecting 1:1 matching criteria, paired according to the year of delivery and patient's age at delivery. RESULTS: Logistic regression analysis found that instrumental delivery (OR 13.42, 95%CI [3.34;53.86], p = 0.0002), absence of spontaneous voiding before leaving the delivery room (OR 6.14, 95%CI [2.56;14.73], p < 0.0001), no intact perineum (OR 3.29, 95%CI [1.10;9.90], p = 0.03) and vulvar edema or perineal hematoma (OR 8.05, 95%CI [1.59;40.67], p = 0.01) were independent risk factors associated with PUR. CONCLUSION: The present study identified risk factors for PUR that should be taken into consideration as soon as delivery is over in order to implement appropriate management. Future studies are needed to assess the contribution of early systematic bladder scanning in patients with risk factors for early diagnosis of PUR.