Enabling Technologies for Gynecologic Vaginal Surgery: A Systematic Review.

OBJECTIVE: To systematically review the literature to evaluate clinical and surgical outcomes for technologies that facilitate vaginal surgical procedures. DATA SOURCES: We systematically searched MEDLINE, EMBASE, and ClinicalTrials.gov from January 1990 to May 2022. METHODS OF STUDY SELECTION: Comparative and single-arm studies with data on contemporary tools or technologies facilitating intraoperative performance of vaginal gynecologic surgical procedures for benign indications were included. Citations were independently double screened, and eligible full-text articles were extracted by two reviewers. Data collected included study characteristics, technology, patient demographics, and intraoperative and postoperative outcomes. Risk of bias for comparative studies was assessed using established methods, and restricted maximum likelihood model meta-analyses were conducted as indicated. TABULATION, INTEGRATION, AND RESULTS: The search yielded 8,658 abstracts, with 116 eligible studies that evaluated pedicle sealing devices (n=32), nonrobotic and robotic vaginal natural orifice transluminal endoscopic surgery (n=64), suture capture devices (n=17), loop ligatures (n=2), and table-mounted telescopic cameras (n=1). Based on 19 comparative studies, pedicle sealing devices lowered vaginal hysterectomy operative time by 15.9 minutes (95% CI, -23.3 to -85), blood loss by 36.9 mL (95% CI, -56.9 to -17.0), hospital stay by 0.2 days (95% CI, -0.4 to -0.1), and visual analog scale pain scores by 1.4 points on a subjective 10-point scale (95% CI, -1.7 to -1.1). Three nonrandomized comparative studies and 53 single-arm studies supported the feasibility of nonrobotic vaginal natural orifice transluminal endoscopic surgery for hysterectomy, adnexal surgery, pelvic reconstruction, and myomectomy. Data were limited for robotic vaginal natural orifice transluminal endoscopic surgery, suture capture devices, loop ligatures, and table-mounted cameras due to few studies or study heterogeneity. CONCLUSION: Pedicle sealing devices lower operative time and blood loss for vaginal hysterectomy, with modest reductions in hospital stay and pain scores. Although other technologies identified in the literature may have potential to facilitate vaginal surgical procedures and improve outcomes, additional comparative effectiveness research is needed. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42022327490.

Health Care Disparities in Patients Undergoing Hysterectomy for Benign Indications: A Systematic Review.

OBJECTIVE: To explore how markers of health care disparity are associated with access to care and outcomes among patients seeking and undergoing hysterectomy for benign indications. DATA SOURCES: PubMed, EMBASE, and ClinicalTrials.gov were searched through January 23, 2022. METHODS OF STUDY SELECTION: The population of interest included patients in the United States who sought or underwent hysterectomy by any approach for benign indications. Health care disparity markers included race, ethnicity, geographic location, insurance status, and others. Outcomes included access to surgery, patient level outcomes, and surgical outcomes. Eligible studies reported multivariable regression analyses that described the independent association between at least one health care disparity risk marker and an outcome. We evaluated direction and strengths of association within studies and consistency across studies. TABULATION, INTEGRATION, AND RESULTS: Of 6,499 abstracts screened, 39 studies with a total of 46 multivariable analyses were included. Having a Black racial identity was consistently associated with decreased access to minimally invasive, laparoscopic, robotic, and vaginal hysterectomy. Being of Hispanic ethnicity and having Asian or Pacific Islander racial identities were associated with decreased access to laparoscopic and vaginal hysterectomy. Black patients were the only racial or ethnic group with an increased association with hysterectomy complications. Medicare insurance was associated with decreased access to laparoscopic hysterectomy, and both Medicaid and Medicare insurance were associated with increased likelihood of hysterectomy complications. Living in the South or Midwest or having less than a college degree education was associated with likelihood of prior hysterectomy. CONCLUSION: Studies suggest that various health care disparity markers are associated with poorer access to less invasive hysterectomy procedures and with poorer outcomes for patients who are undergoing hysterectomy for benign indications. Further research is needed to understand and identify the causes of these disparities, and immediate changes to our health care system are needed to improve access and opportunities for patients facing health care disparities. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42021234511.

Nonestrogen Therapies for Treatment of Genitourinary Syndrome of Menopause: A Systematic Review.

OBJECTIVE: To systematically review the literature and provide clinical practice guidelines regarding various nonestrogen therapies for treatment of genitourinary syndrome of menopause (GSM). DATA SOURCES: MEDLINE, EMBASE, ClinicalTrials.gov , and Cochrane databases were searched from inception to July 2021. We included comparative and noncomparative studies. Interventions and comparators were limited to seven products that are commercially available and currently in use (vaginal dehydroepiandrosterone [DHEA], ospemifene, laser or energy-based therapies, polycarbophil-based vaginal moisturizer, Tibolone, vaginal hyaluronic acid, testosterone). Topical estrogen, placebo, other nonestrogen products, as well as no treatment were considered as comparators. METHODS OF STUDY SELECTION: We double-screened 9,131 abstracts and identified 136 studies that met our criteria. Studies were assessed for quality and strength of evidence by the systematic review group. TABULATION, INTEGRATION, AND RESULTS: Information regarding the participants, details on the intervention and comparator and outcomes were extracted from the eligible studies. Alternative therapies were similar or superior to estrogen or placebo with minimal increase in adverse events. Dose response was noted with vaginal DHEA and testosterone. Vaginal DHEA, ospemifene, erbium and fractional carbon dioxide (CO 2 ) laser, polycarbophil-based vaginal moisturizer, tibolone, hyaluronic acid, and testosterone all improved subjective and objective signs of atrophy. Vaginal DHEA, ospemifene, tibolone, fractional CO 2 laser, polycarbophil-based vaginal moisturizer, and testosterone improved sexual function. CONCLUSION: Most nonestrogen therapies are effective treatments for the various symptoms of GSM. There are insufficient data to compare nonestrogen options to each other.

Comparative analyses of attitude, knowledge, and recollection of preoperative counseling regarding pelvic mesh among women with or without a mesh-related complication.

PURPOSE: Our objective was to compare the recollection of preoperative counseling regarding mesh for pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI) among women with or without a mesh-related complication (MRC). We hypothesized that the patients who had MRC would better recollect counseling regarding complications associated with mesh. METHODS: We conducted a retrospective cohort study among women who had prior implantation of synthetic, non-absorbable mesh for POP and/or SUI at least 3 months prior who presented with or without a MRC. The primary outcome was the proportion of women who recalled being counseled preoperatively about the risk of mesh exposure. RESULTS: Ninety-six women were included in the final analysis (50 MRC; 46 no MRC). MRC women presented further in time from the index surgery [median 69 months [IQR 26-115] vs 12 months (IQR 6-64), p < 0.01]. After adjustment for time since surgery and age, MRC women were significantly less likely to recall being counseled about the possibility of any MRC [19/50 (38%) vs 32/44 (73%), aOR 0.29, 95% CI 0.11-0.79, p = 0.01]. They were also less likely to report they would undergo the same surgery again 5-point Likert scale [median 3 (IQR 1-4) vs 5 (IQR 3-5), 5-point Likert scale, p < 0.01], less satisfied with their mesh surgery [median 1 (IQR 1-3) vs 5 (IQR 3-5), 5-point Likert scale, p < 0.01] and recommended improved preoperative counseling [27/50 (54%) vs 6/46 (13%), p < 0.01]. CONCLUSION: Women who experienced MRC were less likely to recall being counseled about the possibility of MRC and report more unmet needs regarding perioperative counseling than women without MRC.

Learner Satisfaction and Experience With a High-definition Telescopic Camera During Vaginal Procedures: A Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to compare learner satisfaction and experience with a table-mounted, projecting, high-definition telescopic camera system (VITOM) versus traditional learner observation during vaginal surgery. METHODS: Medical student and resident learners were randomized to vaginal surgery observation with or without the use of VITOM. We collected data on learner characteristics and their experience with vaginal surgery. After the surgery, learners completed the faculty/preceptor and working environment domains of the Veterans Affairs Learner's Perceptions Survey (VA LPS). The primary outcome was learners who were "very satisfied" on the VA LPS faculty/preceptor domain. We queried their ability to observe the surgery and satisfaction with learning in the operating room using a 100-mm visual analog scale. RESULTS: Ninety-two learners completed the study (n = 44 VITOM, n = 48 no VITOM). There was no significant difference between groups in the proportion of learners "very satisfied" on the VA LPS faculty/preceptor domain (93.2% VITOM vs 91.5% no VITOM; odds ratio, 1.27; 95% confidence interval, 0.20-9.19; P = 0.99). Learners in the VITOM group were more likely to report ability to see what the main surgeon was doing (93.2% VITOM vs 62.5% no VITOM; odds ratio, 8.02; 95% confidence interval, 2.07-46.32; P < 0.01). Using the visual analog scale, learners in the VITOM group reported higher satisfaction with learning in the operating room (median, 96 [interquartile range, 89-100] VITOM vs median, 80 [interquartile range, 57-98] no VITOM; P < 0.01). CONCLUSION: The use of a table-mounted, projecting, telescopic camera system during vaginal surgery showed no difference in learner satisfaction on validated questionnaires but resulted in improved experience and visualization.

"Landmark" Articles in Female Pelvic Medicine and Reconstructive Surgery: Do We Read What We Cite?

OBJECTIVE: The aim of the study was to describe the provision of a "landmark" article reading list to trainees by their Female Pelvic Medicine & Reconstructive Surgery (FPMRS) fellowship programs. METHODS: In this cross-sectional study, a web-based survey was sent to program coordinators of accredited FPMRS programs. Available reading lists were collected, and a master list compiled. Nonparametric tests were used to investigate the association between the number of faculty members and presence of a reading list. RESULTS: We received a response from 46 (92%) of the 50 Accreditation Council for Graduate Medical Education programs contacted. Half the programs (23/46, 50%) reported that they do not offer a recommended reading list, 5 programs were unsure and over more than 60% with a list (12/18, 67%) shared their list with the investigators. Programs had between 2 and 14 core faculty members with a median (interquartile range) of 4 (3-6). Programs with a reading list had significantly fewer faculty members (3.5, 3-5 vs 5, 3-6, P = 0.03). There were 323 unique articles across the 12 lists, with a median of 25 articles per list. Thirty-four articles were on 4 or more lists; 9 of these (9/34, 26%) have previously been identified as citation classics. CONCLUSIONS: At least 50% of the Accreditation Council for Graduate Medical Education accredited programs do not provide their fellows with a recommended reading list, and fewer core faculty members are associated with the presence of such a list. Although some commonalities are found between reading lists, a universal reading list of "landmark" articles could improve the consistency of FPMRS fellowship education.

The Impact of Fluoroscopy During Percutaneous Nerve Evaluation on Subsequent Implantation of a Sacral Neuromodulator Among Women With Pelvic Floor Disorders: A Randomized, Noninferiority Trial.

OBJECTIVES: To evaluate whether percutaneous nerve evaluation (PNE) without fluoroscopy is inferior to fluoroscopy use in women undergoing trials of sacral neuromodulation (SNM) for pelvic floor disorders (PFDs). MATERIALS AND METHODS: In an unblinded noninferiority trial, women undergoing PNE were randomized to fluoroscopy or no fluoroscopy. The primary outcome was "success" and defined as implantation of the permanent SNM device within three months of PNE. At an expected 40% success and a 30% noninferiority threshold, 33 participants in each group were needed for 80% power (α = 0.05). Univariate analyses and a logistic regression model adjusting for univariate variables associated with the primary outcome were performed. RESULTS: From April 2016 to December 2018, 74 participants underwent PNE of which 36 underwent PNE with fluoroscopy and 38 without. The fluoroscopy group had less baseline mean daily voids compared to the no fluoroscopy group (10.79 ± 6.48 vs. 16.21 ± 10.05, p = 0.01). PNE performed without fluoroscopy had similar success (18/38, 47.4%) compared to fluoroscopy (21/36, 58.3%), meeting our noninferiority definition (difference 10.9%, 90% CI -8% to 30%, p = 0.049). In a logistic regression model adjusting for age, Charlson comorbidity index, stage of prolapse, and number of baseline voids per day, trial success was still similar between the two groups (adjOR 1.82, 95% CI 0.52 to 6.94, p = 0.36). CONCLUSIONS: PNE performed without fluoroscopy is noninferior to PNE with fluoroscopy use for the outcome of SNM device implantation within three months among women undergoing therapy for PFDs.

Can Baseline Electromyography Predict Response to Biofeedback for Anorectal Disorder? A Long-Term Follow-Up Study.

BACKGROUND: Biofeedback has been recommended for the treatment of anorectal disorders, especially constipation and fecal incontinence (FI). The objective of this study was to assess the long-term efficacy of biofeedback and evaluate baseline electromyography (EMG) as a predictor for maintenance of long-term improvement. METHODS: A retrospective chart review was performed on randomly selected patients who underwent biofeedback between the years 1990 and 2000. Clinical characteristics, including EMG values at baseline (resting and contraction) as well as EMG after exercises, were collected. Patients were contacted and were classified as "improved" if they had self-reported symptomatic improvement and "not-improved" if their symptoms were unchanged or worsened. RESULTS: A total of 41 subjects were included. Majority (85.4%) were female, the mean age was 48.95 ± 15.46 (range 22 - 77 years) and the median follow-up was 4 years (range 4 - 5 years). Constipation was the primary indication for biofeedback in 27/41 (65.9%), FI in 9/41 (22%) and "other" in 5/41 (12.1%). Within constipation, 55.6% reported long-term improvement as compared to 66.7% of FI and 80% of the other patients. There was borderline difference in the baseline EMG (3.11 ± 1.85 µV, improved, and 7.41 ± 11.01 µV, not improved, P = 0.06) but no significant difference in post-exercise resting (3.13 ± 3.21 µV, improved, and 4.28 ± 3.63 µV, not improved, P = 0.33) and contraction EMG between the two groups. CONCLUSIONS: Biofeedback is an important treatment tool in anorectal disorders. Over 50% of our subjects maintained their improvement 4 - 5 years after completing biofeedback therapy. A lower resting baseline EMG showed a trend of association with improvement in the long term.

The Vaginal and Urinary Microbiomes in Premenopausal Women With Interstitial Cystitis/Bladder Pain Syndrome as Compared to Unaffected Controls: A Pilot Cross-Sectional Study.

Interstitial cystitis/bladder pain syndrome (ICBPS) may be related to an altered genitourinary microbiome. Our aim was to compare the vaginal and urinary microbiomes between premenopausal women with ICBPS and unaffected controls. This cross-sectional study screened premenopausal women with an O'Leary-Sant questionnaire (ICBPS if score ≥6 on either index; controls <6 on both). Women completed questionnaires on health characteristics, pelvic floor symptoms (OABq, PFDI-20), body image (mBIS), and sexual function (PISQ-IR). Bacterial genomic DNA was isolated from vaginal and clean-catch urinary specimens; the bacterial 16 rRNA gene was sequenced and analyzed using the QIIME pipeline. We performed UniFrac analysis (ß-diversity) and generated Chao1 estimator (richness) and Simpson index (richness and evenness) values. We analyzed 23 ICBPS and 18 non-ICBPS patients. ICBPS patients had increased vaginal deliveries, BMI, and public insurance as well as worsened OAB-q, PFDI-20, mBIS, and PISQ-IR domain scores. Lactobacilli was the most abundant genus in both cohorts, and anaerobic or fastidious predominance was similar between groups (p = 0.99). For both the urine and vagina specimens, Chao1 and Simpson indices were similar between ICBPS and unaffected women. Weighted and unweighted UniFrac analyses showed no differences between groups. A significant correlation existed between the urinary and vaginal Simpson indices in ICBPS women, but not in unaffected women. Premenopausal women with ICBPS, despite worsened socioeconomic indicators and pelvic floor function, were not found to have significantly different urinary and vaginal microbiomes compared to women without ICBPS.

Sentiment Analysis of Web Sites Related to Vaginal Mesh Use in Pelvic Reconstructive Surgery.

OBJECTIVES: The purpose of this study was to utilize sentiment analysis to describe online opinions toward vaginal mesh. We hypothesized that sentiment in legal Web sites would be more negative than that in medical and reference Web sites. METHODS: We generated a list of relevant key words related to vaginal mesh and searched Web sites using the Google search engine. Each unique uniform resource locator (URL) was sorted into 1 of 6 categories: "medical", "legal", "news/media", "patient generated", "reference", or "unrelated". Sentiment of relevant Web sites, the primary outcome, was scored on a scale of -1 to +1, and mean sentiment was compared across all categories using 1-way analysis of variance. Tukey test evaluated differences between category pairs. RESULT: Google searches of 464 unique key words resulted in 11,405 URLs. Sentiment analysis was performed on 8029 relevant URLs (3472 legal, 1625 "medical", 1774 "reference", 666 "news media", 492 "patient generated"). The mean sentiment for all relevant Web sites was +0.01 ± 0.16; analysis of variance revealed significant differences between categories (P < 0.001). Web sites categorized as "legal" and "news/media" had a slightly negative mean sentiment, whereas those categorized as "medical," "reference," and "patient generated" had slightly positive mean sentiments. Tukey test showed differences between all category pairs except the "medical" versus "reference" in comparison with the largest mean difference (-0.13) seen in the "legal" versus "reference" comparison. CONCLUSIONS: Web sites related to vaginal mesh have an overall mean neutral sentiment, and Web sites categorized as "medical," "reference," and "patient generated" have significantly higher sentiment scores than related Web sites in "legal" and "news/media" categories.

Analyzing the Readability of Online Urogynecologic Patient Information.

OBJECTIVE: We sought to describe the readability of Web sites arising from the most common Google search terms related to pelvic organ prolapse, bladder control, and bowel control. METHODS: Google was queried to capture the top 100 search results for the keywords in each disease group. For the top 20 results of each keyword, we analyzed the text for readability using 4 readability formulas: Dale-Chall, Gunning-Fog, Simple Measure of Gobbledygook (SMOG), and Flesch-Kincaid Grade Level.Readability scores were compared using 1-way analysis of variance (α = 0.05), and the Tukey test was performed to characterize any significant differences. The χ tests were used to compare results above and below the eighth grade reading level. Spearman correlations were used to compare the reliability of the different readability formulas. RESULTS: We evaluated 2731 unique Web sites for readability, of which 2334 (85%) had a SMOG score at or above an eighth grade reading level. The mean SMOG score was 9.7 ± 2.1. Web sites in the bladder control keyword group had statistically higher SMOG scores than those in the bowel control and pelvic organ prolapse groups, with means of 9.9 ± 2.0, 9.4 ± 2.1, and 9.6 ± 2.0, respectively. The SMOG was found to be the most reliable. CONCLUSIONS: The vast majority of urogynecologic information available to patients on the Internet is written at or above an eighth grade reading level despite longstanding recommendations to the contrary. Clinicians should advise patients that the information they find online may be difficult to understand.

Changes in the Vaginal Microenvironment as Related to Frequency of Pessary Removal.

OBJECTIVE: The aim of the study was to describe the effect of frequency of pessary removal on the vaginal microenvironment. METHODS: We performed a secondary analysis of a multicenter randomized trial of hydroxyquinoline gel in women presenting for pessary fitting. Patients had vaginal secretions analyzed at baseline, 2 weeks, and 3 months. Patients were stratified by frequency of pessary removal at least once daily, at least once weekly, and less often than once weekly. These groups were compared for prevalence of Lactobacillus predominance (primary outcome), anaerobic predominance, Mobiluncus prominence, vaginal symptoms, and bacterial vaginosis by Nugent criteria, and correction for confounding variables was performed. RESULTS: One hundred thirty-seven women were included in this analysis: 34 (25%) removed the pessary daily, 54 (39%) at least weekly, and 49 (36%) less often than once weekly. Women who removed the pessary less often than weekly were older (P < 0.01), using more hormone therapy (P = 0.03), and more likely to have bacterial vaginosis at baseline (P < 0.01). At 2 weeks, the predominance of Lactobacillus in the group removing pessary daily was higher (41% daily vs 24% weekly vs 9% longer, P = 0.03) and this persisted after confounder correction (P < 0.01). Women who removed their pessary less than weekly were more likely to have anaerobic predominance at 3 months (P = 0.04). CONCLUSIONS: Women who remove their pessaries less often than once weekly have an increased prevalence of anaerobes at 3 months, but no difference in vaginal symptoms or pessary satisfaction.

Current practice patterns and knowledge among gynecologic surgeons of InterStim® programming after implantation.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to describe surgeons' current practices in InterStim® programming after initial implantation and their knowledge of programming parameters. We hypothesized that surgeons performing their own reprogramming would have increased knowledge. METHODS: We administered a written survey to attendees at the Society of Gynecologic Surgeons Scientific Meeting and analyzed those on which surgeons indicated they offer InterStim® care. The survey queried surgeon characteristics, experience with InterStim® implantation and programming, and clinical opinions regarding reprogramming and tested six knowledge-based questions about programming parameters. Correct response to all six questions was the primary outcome. RESULTS: One hundred and thirty-five of 407 (33%) attendees returned the survey, of which 99 met inclusion criteria. Most respondents (88 of 99; 89%) were between 36 and 60 years, 27 (73%) were women, 76 (77%) practiced in a university setting, and 76 (77%) were trained in Female Pelvic Medicine and Reconstructive Surgery (FPMRS). Surgeons who had InterStim® programming training were more likely to perform their own programming [15/46 (32%) vs 6/47 (13%), p = 0.03]. Most answered all knowledge-based questions correctly (62/90, 69%); no surgeon characteristics were significantly associated with this outcome. Most surgeons cited patient comfort (71/80, 89%) and symptom relief (64/80, 80%) as important factors when reprogramming, but no prevalent themes emerged on how and why surgeons change certain programming parameters. CONCLUSIONS: Surgeons who had formal InterStim® programming training are more likely to perform programming themselves. No surgeon characteristic was associated with improved programming knowledge. We found that surgeons prioritize patient comfort and symptoms when deciding to reprogram.

Use of an iPad™ application in preoperative counseling for pelvic reconstructive surgery: a randomized trial.

INTRODUCTION AND HYPOTHESIS: The goal of this study was to evaluate whether the addition of an iPad™ application to the informed consent process for pelvic organ prolapse (POP) surgery improves patient understanding and retention of information compared with standard verbal counseling (SVC) alone. METHODS: Patients scheduled for POP surgery were randomized to SVC alone or SVC augmented with an iPad™ application. Prior to counseling, immediately following counseling, and 6 weeks after surgery, patients completed a written quiz testing their understanding of POP and surgical repair (worst score 0; best score 20). Primary outcome was score change from pre- to immediately postcounseling. Secondary outcomes were patient satisfaction and score change from postcounseling to 6 weeks after surgery. Twenty-six patients per group were needed to detect a 2.8-point difference in score change between groups (80% power; α = 0.05). RESULTS: Sixty patients were randomized, and 57 patients (29 SVC; 28 iPad) were included in the final analysis. There was no significant difference in score change between groups immediately postcounseling. Six weeks after surgery, patients in the iPad group had more deterioration of score (iPad -4.0 ± 2.8 vs. SVC -0.6 ± 2.3 points; p = 0.02). Both groups reported similar satisfaction with counseling. CONCLUSIONS: The addition of a POP-based iPad™ application to the informed consent process for POP surgery did not improve patient comprehension immediately postcounseling and resulted in poorer retention of information 6 weeks after surgery compared with SVC alone.

Retroperitoneal Hemorrhage After Sacral Neurostimulator Placement for Urgency Urinary Incontinence.

Sacral neuromodulation (SNM) is an effective therapy for patients who experience urinary incontinence, idiopathic urinary retention, and fecal incontinence. Although typically a low-risk procedure, rarely, it can be associated with significant hemorrhage. A 61-year-old woman on chronic anticoagulation underwent uncomplicated implantation of SNM for refractory urgency urinary incontinence. Anticoagulation was held on the day of surgery and resumed on postoperative day 1. On postoperative day 2, the patient developed an extensive retroperitoneal hemorrhage. This was successfully treated by angioembolization of the left lateral sacral artery with the InterStim device left in situ. At 6-month follow-up, the device was functioning properly, and the patient's urinary symptoms were well controlled. Retroperitoneal hemorrhage is a rare complication after SNM placement. Conservative management with angioembolization should be considered as a first-line approach.

Analysis of adverse events with Essure hysteroscopic sterilization reported to the Manufacturer and User Facility Device Experience database.

STUDY OBJECTIVE: The Manufacturer and User Facility Device Experience database may be useful for clinicians using a Food and Drug Administration-approved medical device to identify the occurrence of adverse events and complications. We sought to analyze and investigate reports associated with the Essure hysteroscopic sterilization system (Conceptus Inc., Mountain View, CA) using this database. DESIGN: Retrospective review of the Manufacturer and User Facility Device Experience database for events related to Essure hysteroscopic sterilization from November 2002 to February 2012 (Canadian Task Force Classification III). SETTING: Online retrospective review. PATIENTS: Online reports of patients who underwent Essure tubal sterilization. INTERVENTION: Essure tubal sterilization. MEASUREMENTS AND MAIN RESULTS: Four hundred fifty-seven adverse events were reported in the study period. Pain was the most frequently reported event (217 events [47.5%]) followed by delivery catheter malfunction (121 events [26.4%]). Poststerilization pregnancy was reported in 61 events (13.3%), of which 29 were ectopic pregnancies. Other reported events included perforation (90 events [19.7%]), abnormal bleeding (44 events [9.6%]), and microinsert malposition (33 events [7.2%]). The evaluation and management of these events resulted in an additional surgical procedure in 270 cases (59.1%), of which 44 were hysterectomies. CONCLUSION: Sixty-one unintended poststerilization pregnancies were reported in the study period, of which 29 (47.5%) were ectopic gestations. Thus, ectopic pregnancy must be considered if a woman becomes pregnant after Essure hysteroscopic sterilization. Additionally, 44 women underwent hysterectomy after an adverse event reported to be associated with the use of the device.

Comparative analysis of different laparoscopic hysterectomy procedures.

PURPOSE: To compare the antecedent gynecological characteristics, indications for, and complications associated with, the different laparoscopic approaches to hysterectomy, in women with benign gynecological conditions. METHODS: A retrospective cohort study of 957 patients who underwent laparoscopic supracervical (LSH), total (TLH), and assisted vaginal (LAVH) hysterectomies between January 2003 and December 2009. RESULTS: Among 957 LH, 799 (83.5%) were LSH, 62 (6.4%) TLH, and 96 (10.1%) LAVH. Demographic characteristics were not different among the groups. Antecedent gynecologic conditions that were associated with the type of laparoscopic hysterectomy (LH) performed were: postmenopausal bleeding [LAVH vs. LSH, odds ratio (OR) 2.20; 95% confidence interval (CI) 1.04-4.65], previous pelvic surgery (TLH vs. LSH, OR 1.92; CI 1.05-3.52), previous cesarean delivery (LAVH vs. LSH, OR 0.39; CI 0.21-0.76), and prior hysteroscopy (LAVH vs. LSH, OR 0.29; CI 0.16-0.50). Preoperative diagnoses that were associated with the choice of LH were: menometrorrhagia (LAVH vs. LSH, OR 0.23; CI 0.14-0.38; TLH vs. LSH, OR 0.50; CI 0.26-0.98), uterine fibroids (LAVH vs. LSH, OR 0.25; CI 0.15-0.41), endometrial hyperplasia (TLH vs. LSH, OR 5.5; CI 2.04-14.84), and cervical dysplasia (TLH vs. LSH, OR 17.1; CI 6.83-42.79; LAVH vs. LSH, OR 8.05; CI 3.05-22.06). Estimated blood loss, operating time, and length of hospital stay were significantly reduced with LSH. CONCLUSION: Antecedent gynecological history and the indications for surgery were associated with the type of LH performed in our institution. LSH was the most common approach and was associated with significantly less morbidity.

New onset delayed postpartum preeclampsia: different disorders?

OBJECTIVE: Delayed postpartum preeclampsia is a poorly studied disorder. We compared new onset delayed postpartum preeclampsia (NOPP) to recurrent/persistent, delayed onset postpartum preeclampsia (RPP) to see whether these were different disorders. METHODS: Delayed onset preeclampsia was defined as readmission >2 days to ≤ 6 weeks postpartum for preeclampsia. The NOPP group had no antecedent diagnosis of hypertensive disorders in the current pregnancy, and was compared to the RPP defined as a prior hypertensive disorder in the current pregnancy in terms of maternal demographics, obstetric and medical history, intrapartum and early postpartum course and clinical signs and symptoms and outcomes on postpartum readmission. RESULTS: There were a total of 56 (36.8%) patients in the RPP and 96 (63.2%) patients in the NOPP groups. NOPP cases delivered significantly later 39.0 ± 2 weeks vs. 37 ± 3.0 weeks p < 0.001, and had significantly lower blood pressure during the antepartum, early postpartum and readmission periods. In addition the NOPP group had significantly higher average number of symptoms 2 vs. 1.5 p = 0.013 on postpartum readmission. There were no statistically significant differences in the rates of major complications. CONCLUSIONS: In this comprehensive study of delayed postpartum preeclampsia, there were few significant differences in the clinical course and no differences in complications in the NOPP subgroup compared to cases with preeclampsia recurring in the late postpartum period.

Delayed postpartum preeclampsia and eclampsia: demographics, clinical course, and complications.

OBJECTIVE: To estimate and evaluate the demographics, clinical course, and complications of delayed postpartum preeclampsia in patients with and without eclampsia. METHODS: We conducted a retrospective cohort study of patients who were discharged and later readmitted with the diagnosis of delayed postpartum preeclampsia more than 2 days to 6 weeks or less after delivery between January 2003 and August 2009. RESULTS: One hundred fifty-two patients met criteria for the diagnosis of delayed postpartum preeclampsia. Of these, 96 (63.2%) patients had no antecedent diagnosis of hypertensive disease in the current pregnancy, whereas seven (4.6%), 14 (9.2%), 28 (18.4%), and seven (4.6%) patients had gestational hypertension, chronic hypertension, preeclampsia, and preeclampsia superimposed on chronic hypertension, respectively, during the peripartum period. Twenty-two patients (14.5%) developed postpartum eclampsia, and more than 90% of these patients presented within 7 days after discharge from the hospital. The most common presenting symptom was headache in 105 (69.1%) patients. Patients who developed eclampsia were significantly younger than those who did not (mean ± standard deviation, 23.2 ± 6.2 compared with 28.3 ± 6.7 years; adjusted odds ratio [OR] 1.13, 95% confidence interval [CI] 1.02-1.26, P=.03), and other demographic variables were no different. A lower readmission hemoglobin was associated with a lower odds of progression to eclampsia (10.7 ± 1.7 compared with 11.6 ± 2.2 g/dL, adjusted OR 0.75, 95% CI 0.57-0.98, P=.04). CONCLUSION: One week after discharge appears to be a critical period for the development of postpartum eclampsia. Education about the possibility of delayed postpartum preeclampsia and eclampsia should occur after delivery, whether or not patients develop hypertensive disease before discharge from the hospital.