Arielle N Valdez-Sinon, Anja S Frost, Anita M Madison, Rand El Sharaiha, Kristin E Patzkowsky, Megan E Gornet
{"title":"Food and Drug Administration Database Secondary Analysis: Difference in Operative Hysteroscopy Device Adverse Event Reporting.","authors":"Arielle N Valdez-Sinon, Anja S Frost, Anita M Madison, Rand El Sharaiha, Kristin E Patzkowsky, Megan E Gornet","doi":"10.1016/j.jmig.2025.04.009","DOIUrl":"10.1016/j.jmig.2025.04.009","url":null,"abstract":"<p><strong>Study objective: </strong>To investigate, describe, and compare adverse event reports (AERs) and their patterns amongst commonly used operative hysteroscopy devices.</p><p><strong>Design: </strong>A secondary analysis of the Manufacturer and User Facility Device Experience (MAUDE) published by the Food and Drug Administration.</p><p><strong>Setting: </strong>N/A.</p><p><strong>Patients or participants: </strong>Women who underwent hysteroscopic surgery, with adverse events reported to MAUDE.</p><p><strong>Interventions: </strong>Search terms within the MAUDE database included \"resectoscope,\" \"hysteroscopic reciprocating morcellator,\" \"MyoSure,\" and \"TruClear.\" Reports were categorized by device type, patient complications, and required interventions. Statistical analysis utilized Fisher's exact tests.</p><p><strong>Measurements and main results: </strong>Between January 2014 and April 2024, 1872 AERs were identified for hysteroscopes: 664 for resectoscopes and 1208 for morcellation devices (MyoSure, N = 645 and TruClear, N = 563). While absolute complication rates are not able to calculated from MAUDE, there were significant differences in the reporting of patient complications: resectoscope devices had higher frequency of infection (p < .01) while morcellation devices had higher frequency reporting of hemorrhage (p < .001), uterine perforation (p < .001), and bowel perforation (p < .001). Morcellation device AERs more often reported operative intervention (1.1% vs 12.4%, p < .001). Subgroup analysis comparing AERs of morcellation devices showed the majority (73.2%) of TruClear AERs registered no patient impact or harm, while only 21.2% of MyoSure AERs reported no patient impact. MyoSure device AERs had higher frequency of hemorrhage (p < .001), infections (p < .001), uterine perforations (p < .001), and bowel perforations (p < .001). Additionally, MyoSure AERs reported more surgical intervention compared to TruClear AEs (19.5% vs 4.3%, p < .001).</p><p><strong>Conclusion: </strong>While conclusions within the MAUDE database are limited, especially given the lack of data concerning the volume of surgeries done with each device and the voluntary reporting mechanism, there are significant differences in the types of adverse events reported among operative hysteroscopy instruments. Morcellation AERs had a significantly higher frequency of patient complications and described more surgical interventions compared to AERs for resectoscopes. When comparing MyoSure and TruClear, MyoSure AERs described a significantly greater proportion of serious patient complications compared to TruClear device AERs. Devices with similar functions may differ in how stakeholders report complications.</p>","PeriodicalId":16397,"journal":{"name":"Journal of minimally invasive gynecology","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143988718","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Author's Reply Regarding \"Postoperative Urinary Complications in Minimally Invasive vs Abdominal Radical Hysterectomy: A Meta-Analysis with a Focus on Ureterovaginal Fistula\".","authors":"Jong Ha Hwang, Bitnarae Kim","doi":"10.1016/j.jmig.2025.04.019","DOIUrl":"10.1016/j.jmig.2025.04.019","url":null,"abstract":"","PeriodicalId":16397,"journal":{"name":"Journal of minimally invasive gynecology","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144007156","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Caring for the LGBTQIA+ Patient: A Best-Practices Primer on Language, Sexual Function Considerations, and Health Disparities in Gynecologic Care.","authors":"Molly K Irvin, Madison Ellis, Tierney K Lorenz","doi":"10.1016/j.jmig.2025.04.013","DOIUrl":"10.1016/j.jmig.2025.04.013","url":null,"abstract":"<p><p>Despite representing a growing percentage of the global population, queer patients (i.e., lesbian, gay, bisexual, transgender, intersex, and/or asexual; LGBTQIA+) continue to experience significant disparities in gynecologic healthcare. Common barriers to inclusive care include discriminatory healthcare experiences, difficulty finding identity-affirming providers, and systemic lack of competency in addressing queer-specific medical needs. Such barriers arise out of heteronormative assumptions, limited provider training, and insufficient understanding of diverse sexual and gender identities. This narrative review examines gynecologic care considerations for lesbian, gay, bisexual/pansexual, asexual, intersex, and transgender patients. We review research documenting how queer patients delay or avoid healthcare due to fear of judgment, discrimination, and inadequate provider understanding. Our review highlights unique healthcare needs across different queer identities, including inclusive and culturally-sensitive sexual health screening that includes (but is not centered solely on) queer-specific sexual practices; considerations for transgender patients undergoing gender-affirming care; and incorporating intersectionality into assessment, treatment planning, and delivery. Finally, we make direct recommendations for caring for queer patients, including developing inclusive intake processes; training healthcare teams in affirming, non-discriminatory practices; using gender-neutral language; recognizing the diversity of sexual and gender identities; and addressing minority stress and its impacts on health.</p>","PeriodicalId":16397,"journal":{"name":"Journal of minimally invasive gynecology","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143976513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Regarding \"Postoperative Urinary Complications in Minimally Invasive vs Abdominal Radical Hysterectomy: A Meta-Analysis with a Focus on Ureterovaginal Fistula\".","authors":"Haiying Yang, Siwei Dong","doi":"10.1016/j.jmig.2025.04.018","DOIUrl":"https://doi.org/10.1016/j.jmig.2025.04.018","url":null,"abstract":"","PeriodicalId":16397,"journal":{"name":"Journal of minimally invasive gynecology","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143997535","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Regarding \"Quadratus Lumborum Block for Total Laparoscopic Hysterectomy: A Systematic Review and Meta-Analysis\".","authors":"Xumei Xin","doi":"10.1016/j.jmig.2025.04.017","DOIUrl":"10.1016/j.jmig.2025.04.017","url":null,"abstract":"","PeriodicalId":16397,"journal":{"name":"Journal of minimally invasive gynecology","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143986957","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pierre-Emmanuel Bouet, Roland Antaki, Constance Rio, Caroline Boileau-Savary, Magalie Boguenet, Bruno Vielle, Guillaume Legendre, Philippe Descamps, Pascale May-Panloup, Hady El Hachem, Louise Lapensée
{"title":"High Prevalence of Chronic Endometritis in Women Diagnosed With Hydrosalpinx Before In Vitro Fertilization Treatment.","authors":"Pierre-Emmanuel Bouet, Roland Antaki, Constance Rio, Caroline Boileau-Savary, Magalie Boguenet, Bruno Vielle, Guillaume Legendre, Philippe Descamps, Pascale May-Panloup, Hady El Hachem, Louise Lapensée","doi":"10.1016/j.jmig.2025.04.016","DOIUrl":"10.1016/j.jmig.2025.04.016","url":null,"abstract":"<p><strong>Objective: </strong>To compare the prevalence of chronic endometritis (CE) in women with hydrosalpinx undergoing in vitro fertilization (IVF), to a control group without hydrosalpinx.</p><p><strong>Design: </strong>A bicentric historical prospective case-control study, between June 2017 and December 2021.</p><p><strong>Setting: </strong>Angers and Montreal university hospitals.</p><p><strong>Patient(s): </strong>In the Hydrosalpinx (H) group, we included all women undergoing IVF for various indications, and who were diagnosed with a hydrosalpinx before or during the cycle. In the control (C) group, we included women without hydrosalpinx, undergoing IVF for male factor infertility, or following bilateral tubal ligation.</p><p><strong>Intervention(s): </strong>A laparoscopy was scheduled for the removal of the hydrosalpinx, and an endometrial biopsy was performed concomitantly to rule out CE. In the C group, an endometrial biopsy was performed in the clinic. CE diagnosis was confirmed using immunohistochemistry.</p><p><strong>Measurements and main results: </strong>Our primary endpoint was the rate of positive biopsies for CE. Ninety-four patients were included, 62 in the H group and 32 in the C group. Mean age was 32.1 ± 5.1 years. The prevalence of CE was significantly higher in the H group compared to the C group (41.9% (26/62) vs 15.6% (5/32) (p = .01)). Multivariate analysis showed that the presence of hydrosalpinx was an independent risk factor of CE (aOR = 3.93 (1.31-11.81)), whether the hydrosalpinx was unilateral (aOR = 4.39 (1.32-14.61)) or bilateral (aOR = 3.52 (1.01-11.99)).</p><p><strong>Conclusions: </strong>There is a significant increase in the prevalence of CE in women with hydrosalpinx undergoing IVF, whether the hydrosalpinx was unilateral or bilateral.</p>","PeriodicalId":16397,"journal":{"name":"Journal of minimally invasive gynecology","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144008792","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dr Shinjini Pande, Dr Vivek Salunke, Dr Ria Katwala
{"title":"Isthmocele Endometrioma: A Collapsible Conundrum.","authors":"Dr Shinjini Pande, Dr Vivek Salunke, Dr Ria Katwala","doi":"10.1016/j.jmig.2025.04.014","DOIUrl":"https://doi.org/10.1016/j.jmig.2025.04.014","url":null,"abstract":"","PeriodicalId":16397,"journal":{"name":"Journal of minimally invasive gynecology","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143996770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Trends in Volume of Benign Hysterectomies Performed by Gynecologic Oncologists, 2015-2021: A National Surgical Quality Improvement Project Analysis.","authors":"Annalyn M Welp, Linda R Duska, Laura N Homewood","doi":"10.1016/j.jmig.2025.04.012","DOIUrl":"10.1016/j.jmig.2025.04.012","url":null,"abstract":"<p><strong>Study objective: </strong>To evaluate national trends in the surgical volume of benign hysterectomies and trends in the percentage of benign hysterectomies performed by gynecologic oncologists (GOs) in the United States through analysis of the National Surgical Quality Improvement Program (NSQIP) database. The study secondarily sought to evaluate if any clinical patient factors accounted for differences in type of surgeon subspecialization. The study hypothesized that in alignment with self-reported GO surveys, GOs were performing an increasing volume of benign hysterectomies annually.</p><p><strong>Design: </strong>Observational retrospective analysis.</p><p><strong>Setting: </strong>National.</p><p><strong>Participants: </strong>NSQIP participants.</p><p><strong>Interventions: </strong>This observational study queried the NSQIP database for the total number of hysterectomies performed from 2015 to 2021 in the United States, with attention to surgeon subspecialization, the pathology-proven presence of malignancy, and factors that may influence the surgical complexity of the case, including a history of abdominal/pelvic surgeries, the presence of intraoperative endometriosis, and uterine weight in grams. Statistical analysis was performed using SAS 9.4 (SAS Institute, Cary, NC) and SPSS (29.0.2.0[20]).</p><p><strong>Measures and main results: </strong>The volume of all hysterectomies in the United States increased from 2015 to 2021 in this sample. The overall increase in benign hysterectomies was statistically significant, with an annual percentage multiplier (APM) of 1.003% (95% CI 1.001-1.006) per year. GOs performed an increasing share of the total number of benign hysterectomies with an APM of 1.026% per year (95% CI 1.02-1.03). GOs were more likely to perform benign hysterectomies in patients with a history of prior abdominal surgery (p <.001) and in uterine weights >500 g (p <.001). No difference was observed in surgeon subspecialization in patients with a prior history of pelvic surgery (p = .10) or presence of intraoperative endometriosis (p = .10).</p><p><strong>Conclusions: </strong>The overall volume of benign hysterectomies in the United States is increasing, based on NSQIP data between 2015 and 2021. This analysis shows that GOs are performing significantly increasing volumes and proportions of benign hysterectomies compared to the overall national increase in cases within this cohort.</p>","PeriodicalId":16397,"journal":{"name":"Journal of minimally invasive gynecology","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144040822","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}