Complications after opportunistic salpingectomy compared with tubal ligation at cesarean section: a retrospective cohort study.

OBJECTIVE: To compare perioperative and postoperative complications in patients who underwent opportunistic salpingectomy (OS) (removal of the fallopian tubes for ovarian cancer risk reduction during another surgery) at the time of cesarean section (C-section) with those in patients who underwent tubal ligation. DESIGN: A population-based, retrospective cohort study. SETTING: British Columbia, Canada. PATIENT(S): A total of 18,184 patients were included in this study, of whom 8,440 and 9,744 underwent OS and tubal ligation, respectively. INTERVENTION(S): Patients who underwent OS during a C-section were compared with those who underwent tubal ligation during a C-section. MAIN OUTCOME MEASURE(S): We examined the perioperative outcomes, including operating room time, length of hospital stay, surgical complications such as infections, anemia, incision complications, injury to a pelvic organ, or operating room return; postoperative complications, including physician visits for a postoperative infection or visits that resulted in ultrasound or laboratory examinations and hospital readmissions in the 6 weeks after discharge; and likelihood to fill a prescription for antibiotics or analgesics. RESULT(S): The OS group had decreased odds of perioperative complications compared with the tubal ligation group (adjusted odds ratio [aOR], 0.77; 95% confidence interval [CI], 0.61-0.99). Patients who underwent OS did not have increased risks of physician visits for surgical complications, such as infection, or hospital readmissions in the 6 weeks after hospital discharge. In addition, these patients had 18% and 23% increased odds of filling prescriptions for nonsteroidal anti-inflammatory drugs (aOR, 1.18; 95% CI, 1.07-1.28) and opioids (aOR, 1.23%; 95% CI, 1.12-1.35), respectively. CONCLUSION(S): In this population-based, real-world study of OS at C-section, we report decreased perioperative complications and no difference in postoperative complications between patients who underwent OS and those who underwent tubal ligation. Patients who underwent OS had an increased likelihood of filling a prescription for nonsteroidal anti-inflammatory drugs and opioids in the 6 weeks after hospital discharge. This result should be interpreted with caution because we did not have data on over-the-counter medication use and, thus, not all prescription analgesics were captured in our data. Our data suggest that OS after C-section is a safe way to provide effective contraception and ovarian cancer risk reduction.

Primary Ovarian Pregnancy after Bilateral Tubal Sterilization.

Tubal sterilization is considered a permanent method of contraception because it is highly effective. However, pregnancy can still occur following a successful procedure and such pregnancies are likely to be ectopic. Primary ovarian pregnancy is one of the rarest forms of ectopic pregnancy having incidence of 1/7000-1/40,000 in live births and 0.5-3% of all ectopic gestations. In this paper, we report a rare case of ovarian pregnancy after tubal sterilization. All women who are offered this procedure should always be educated about its failure rate. And in women presenting with acute abdomen, a prior history of tubal sterilization doesn't preclude the possibility of ectopic pregnancy. Keywords: Contraception; ovarian pregnancy; tubal sterilization.

Risk of ovarian cancer after salpingectomy and tubal ligation: Prospects on histology and time since the procedure.

OBJECTIVE: Recent theories propose that most epithelial ovarian cancer (EOC), depending on histological type, originate from other gynecological tissues and involve the ovary secondarily. According to these theories, any protective effect of salpingectomy and tubal ligation may vary by histological type. The study aim was to examine the association between salpingectomy and tubal ligation, respectively, and risk of EOC, with a focus on associations specific for histological types. METHODS: We identified EOC cases and matching controls in national registries and gathered information on surgical procedures and potential confounders. Conditional logistic regression was used to estimate odds ratio (OR) with 95% confidence interval (CI) of EOC related to salpingectomy and tubal ligation, respectively, overall and stratified by histological type. Furthermore, we investigated the association according to timing of the procedures. RESULTS: Our study comprised 16,822 EOC cases. Each case was matched with 40 controls. There was an overall EOC risk reduction after unilateral (OR = 0.73; 95% CI: 0.60-0.87) and bilateral salpingectomy (OR = 0.46; 95% CI: 0.31-0.67). A slight risk reduction was seen among women with previous tubal ligation (OR = 0.91; 95% CI: 0.83-0.99). For salpingectomy, the risk reduction increased with increasing time since the surgical procedure and was only present among women younger than 50 years at salpingectomy. Unilateral and bilateral salpingectomy was associated with a risk reduction for most histological types. CONCLUSION: The association between previous salpingectomy and reduced risk of several histological subtypes of EOC supports the suggested theories about the site of origin of EOC and may be of clinical importance.

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.

Hysterectomy With and Without Oophorectomy, Tubal Ligation, and Risk of Cardiovascular Disease in the Nurses' Health Study II.

Background: Hysterectomy, oophorectomy, and tubal ligation are common surgical procedures. The literature regarding cardiovascular disease (CVD) risk after these surgeries has focused on oophorectomy with limited research on hysterectomy or tubal ligation. Materials and Methods: Participants in the Nurses' Health Study II (n = 116,429) were followed from 1989 to 2017. Self-reported gynecologic surgery was categorized as follows: no surgery, hysterectomy alone, hysterectomy with unilateral oophorectomy, and hysterectomy with bilateral oophorectomy. We separately investigated tubal ligation alone. The primary outcome was CVD based on medical-record confirmed fatal and nonfatal myocardial infarction, fatal coronary heart disease, or fatal and nonfatal stroke. Our secondary outcome expanded CVD to include coronary revascularization (coronary artery bypass graft surgery, angioplasty, stent placement). Cox proportional hazard models were used to calculate hazard ratios (HR) and 95% confidence intervals (CIs) and were adjusted a priori for confounding factors. We investigated differences by age at surgery (≤50, >50) and menopausal hormone therapy usage. Results: At baseline, participants were on average, 34 years old. During 2,899,787 person-years, we observed 1,864 cases of CVD. Hysterectomy in combination with any oophorectomy was associated with a greater risk of CVD in multivariable-adjusted models (HR hysterectomy with unilateral oophorectomy:1.40 [95% CI: 1.08-1.82]; HR hysterectomy with bilateral oophorectomy:1.27 [1.07-1.51]). Hysterectomy alone, hysterectomy with oophorectomy, and tubal ligation were also associated with an increased risk of combined CVD and coronary revascularization (HR hysterectomy alone: 1.19 [95% CI: 1.02-1.39]; HR hysterectomy with unilateral oophorectomy: 1.29 [1.01-1.64]; HR hysterectomy with bilateral oophorectomy: 1.22 [1.04-1.43]; HR tubal ligation: 1.16 [1.06-1.28]). The association between hysterectomy/oophorectomy and CVD and coronary revascularization risk varied by age at gynecologic surgery, with the strongest association among women who had surgery before age 50 years. Conclusion: Our findings suggest that hysterectomy, alone or in combination with oophorectomy, as well as tubal ligation, may be associated with an increased risk of CVD and coronary revascularization. These findings extend previous research finding that oophorectomy is associated with CVD.

A systematic review of long-term complications of mechanical tubal occlusion.

OBJECTIVES: To collate the available evidence of the rare but identified late complications of mechanical tubal occlusion. The primary objective is to describe the nature of these longer-term acute presentations. Secondary objectives are: 1) to delineate their aetiology, 2) characterise imaging findings and 3) identify successful management options. STUDY DESIGN: Literature search using National Institute of Clinical Excellence Healthcare Databases Advanced Search and terms (complicat* OR torsion OR infect* OR migrat* OR extru*) AND (tubal occlusion OR sterili*). Results reviewed by CM and JH for eligibility. RESULTS: 33 published case reports of long-term complications of mechanical tubal occlusion. 30 demonstrated migration of the device. 16 had infective pathology. Multiple modalities of imaging used with no clear evidence that one was superior. Medical and surgical management was used with removal of device proving definitive treatment. CONCLUSIONS: Long-term complications of mechanical tubal occlusion are rare and show a varied clinical course. Clinicians should be mindful of this when evaluating patients in the acute setting, as there is no identified timeline as to when complications may occur. Imaging is almost always essential for diagnosis and the modality should be directed by the clinical presentation. Definitive management is by removal of the occlusive device, but this carries its own risks.

Analysis of clinical data associated with Essure® sterilization devices: An expanded case series.

OBJECTIVES: To evaluate clinical data in women who underwent Essure® hysteroscopic sterilization and to determine whether this sterilization technique plays a role in developing new-onset symptoms. STUDY DESIGN: An observational, retrospective, single-center study. It was conducted in a secondary level hospital. It included 804 women who had Essure® hysteroscopic sterilization from 2009 to 2017. Charts from these women were reviewed from June 2009 to November 2019, searching for the development of gynecological symptoms (pelvic pain and bleeding disorders) and non-gynecological symptoms (bloating, joint pain, fatigue, headache, alopecia, allergy and depression). The sample was divided into two groups depending on whether they had developed gynecological symptoms (symptomatic group) or not (asymptomatic group), and a descriptive and comparative analysis was made between them. The impact of the global social alarm in 2015 regarding adverse events attributed to the devices, the development of non-gynecological symptoms, and the treatments required, including conservative and surgical options, were also described. RESULTS: Out of 804 women who had Essure® devices placed, 541(67.29%) remained asymptomatic, 263(32.71%) developed gynecological symptoms, and 41 of these (15.5% of the total sample) requested Essure® surgical removal. Pelvic pain was the most frequent symptom and the main reason for surgical removal. Bleeding alterations were the second most frequent symptom. Up to 55.89% described the symptoms after the social alarm. Non-gynecological symptoms were statistically significantly more frequent in the symptomatic group. CONCLUSIONS: More than a half of the women who underwent Essure® sterilization remained asymptomatic. The new-onset symptoms attributed to the devices are the minority and causality is difficult to establish. IMPLICATIONS STATEMENT: Our research provides new follow-up data about Essure® hysteroscopic sterilization. Association between gynecological symptoms and Essure® devices is difficult to demonstrate and some confounding factors may be implicated. The results we described, may guide and counsel medical-patient decisions for the treatment of symptoms related to the devices, including surgical removal.

A systematic review and meta-analysis on tubal ligation and breast cancer risk.

BACKGROUND: Based on previous studies, it has been hypothesized that tube sterilization may be associated with a lower risk of breast cancer. This study aims to investigate the relationship between tubal ligation and the risk of breast cancer through a systematic review and meta-analysis. METHODS: In this systematic review and meta-analysis, PubMed/Medline, Web of Science, Scopus, and Google Scholar were searched for relevant non randomized studies published up to November 2020. Then, we screened the papers to include the eligible papers in the meta-analysis. Finally, we pooled the extracted results of individual studies to estimate the summary effect size. All analyses were done using Stata software version 13 (Stata Corp, College Station, TX). RESULTS: Four hundred sixty-four papers were retrieved from PubMed/Medline (160), Scopus (165), and Web of Science (139), and 21 papers from Google Scholar and manual search of references in selected full texts. After the removal of duplicates and screening of the papers, 11 articles (6 cohort and 5 case-control study) were included in the final analysis. The results of cohort (RR = 0.99, 95% CI = 0.97-1.0, I2 = 21.1%) and case control studies (OR = 0.87, 95% CI = 0.62-1.12, I2 = 88.9%) revealed that tubal ligation was not significantly associated with breast cancer risk. CONCLUSION: According to our findings, tubal ligation cannot be considered as a risk factor associated with breast cancer risk.

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.

FSFI score and timing of tubal ligation in patients: preliminary results of an online survey.

INTRODUCTION: Tubal ligation is the most common contraceptive method worldwide. Apart from a very low pearl index and anxiety relief, other benefits are not commonly recognised. In young patients, there is the post-operative risk of regretting the decision with the need for In-Vitro-Fertilisation or refertilising surgery. Positive side effects have not been widely published. In our study we investigated the change in the female sexual function index score after tubal ligation. MATERIAL AND METHOD: In this survey the FSFI score of participants around the time of the tubal ligation was compared with the FSFI score of intermediate and long-term time distance to the ligation. RESULTS: The data indicate an increase in younger women seeking information on permanent contraception and whilst the FSFI score of the early group indicates a risk of female sexual dysfunction, the intermediate and long-term FSFI scores are comparable to published control groups. DISCUSSION: Besides the obvious benefit of a low pearl index, tubal ligation may contribute to reduce the risk of female sexual dysfunction in the mid and long term. Informed consent is essential for the surgeon and patient to weigh up the risks and benefits individually including possible future perspectives on family planning.

Interstitial Ectopic Pregnancy in a 34-Year-Old Woman After Removal of Essure Microinserts and Reversal of Hysteroscopic Sterilization.

BACKGROUND Interstitial ectopic pregnancy, a pregnancy occurring in the part of the fallopian tube that is within the body of the uterus, poses a significant risk to patients, with a mortality rate of up to 2.5%, which is 7 times higher than for tubal ectopic pregnancies. Hysteroscopic sterilization reversal carries a potential risk of interstitial ectopic pregnancy; therefore, it is important to counsel patients appropriate and review the alternative option for in vitro fertilization. In vitro fertilization has been shown to have a superior pregnancy and live birth rate in comparison to sterilization reversal. Women who have undergone sterilization via hysteroscopic placement of the Essure device may complete in vitro fertilization with sterilization devices left in situ without significantly reducing the pregnancy rate. CASE REPORT A 34-year-old woman, G6P3023, presented to the Emergency Department after incidental detection of left interstitial ectopic pregnancy measuring 9 weeks of gestation. She had previously undergone a right salpingectomy for ectopic pregnancy soon after reversal of Essure sterilization via bilateral tubouterine reimplantation; this is a procedure that is infrequently performed due to limited evidence to suggest that this is a safe and efficacious method to achieve future pregnancies. This patient underwent an uncomplicated left cornuostomy and salpingectomy, rendering the need for in vitro fertilization to conceive in the future. CONCLUSIONS Patients seeking fertility treatment after hysteroscopic sterilization should be counseled that tubouterine reimplantation poses significant morbidity risk based on the nature of the surgery. Instead, patients who have undergone hysteroscopic sterilization who desire future pregnancy should be advised that in vitro fertilization, with or without salpingectomy, may be a safer and more efficacious option to achieve live birth.

Comparative Effectiveness and Safety of Intrauterine Contraception and Tubal Ligation.

BACKGROUND: Tubal ligation remains common in the USA, especially among low-income patients. OBJECTIVE: To compare the effectiveness and safety of intrauterine contraceptives (IUC) to laparoscopic tubal ligation for Medicaid clients. DESIGN: We partnered with patient and clinician stakeholders to conduct a retrospective cohort study using California Medicaid claims for patients who had an IUC placed or laparoscopic tubal ligation performed in 2008-2014, excluding procedures performed within 42 days of a birth. We applied log-linear (Poisson) event-history regression models for clustered person-period data to adjust for sociodemographic variables and pre-procedure health status when examining associations between these contraceptive procedures and claims related to contraceptive failure, complications, and pain in the first year post-procedure. KEY RESULTS: We identified 35,705 patients who had a levonorgestrel IUC placed, 23,628 patients who had a copper IUC placed, and 23,965 patients who underwent laparoscopic tubal ligation. In unadjusted analyses, rates of pregnancy within 1 year were similar following levonorgestrel IUC (2.40%) or copper IUC placement (2.99%) or tubal ligation (2.64%). In adjusted analyses, compared to tubal ligation, pregnancy was less common following placement of a levonorgestrel IUC (adj IRR 0.72, 95% CI 0.64-0.82) and similar with placement of a copper IUC (adj IRR 0.92, 95% CI 0.82-1.05). Procedural complications such as infection (0.35% vs. 2.91%) were significantly less common with IUC placement than tubal ligation. Claims for pelvic and abdominal pain decreased in frequency with time since all procedures; 6 to 12 months post-procedure, pelvic pain claims were less common after levonorgestrel IUC (adj IRR 0.69, 95% CI 0.65-0.73) or copper IUC placement (adj IRR 0.70, 95% CI 0.66-0.75) than tubal ligation. CONCLUSIONS: IUC appears at least as effective as laparoscopic tubal ligation at 1-year post-procedure with lower rates of infection and pelvic pain 6 to 12 months post-procedure. CLINICAL TRIAL REGISTRATION: NCT03438682.

Gestational diabetes and intraoperative tubal sterilization are risk factors for high incidence of pain after cesarean delivery: a prospective observational study.

BACKGROUND: Postcesarean delivery pain leads to several adverse maternal outcomes. The primary objective of this study was to determine the incidence of moderate-to-severe pain after the use of spinal morphine for cesarean delivery. The secondary aim was to identify factors influencing moderate-to-severe pain. METHODS: This was a prospective observational study. The inclusion criteria were a patient age of ≥18 years, and undergoing elective cesarean delivery under spinal anesthesia with intrathecal morphine (200 mcg). Moderate-to-severe pain was defined as a numerical rating scale score of more than 3. Preoperative and intraoperative data were collected including parity, history of cesarean delivery, pregnancy-associated problem, anesthesia blockade level, level of surgeon experience, incision type, tubal sterilization or appendectomy, and peritoneum suture. Chi-squared or Fisher's exact tests were used to examine risk factors. Multiple logistic regression was used to analyze independent factors associated with moderate to severe pain. RESULTS: In all, 660 patients were enrolled. As 16 were subsequently removed because they met the study withdrawal criteria, data relating to 644 patients were analyzed. The incidence of moderate-to-severe pain during the first postoperative day was 451/644 patients [70.03%; 95% confidence interval (CI): 66.38-73.44%]. The median pain score [interquartile range (IQR)] was 5 (3-6), with 176/644 (27.33%) patients needing rescue analgesics. A multivariate analysis revealed that two factors were associated with moderate-to-severe pain on the first postoperative day: gestational diabetes [adjusted OR (AOR), 1.849; 95% CI: 1.068-3.203; P=0.028] and intraoperative tubal sterilization (AOR, 1.533; 95% CI: 1.060-2.218; P=0.023). A significantly higher number of patients experienced moderate-to-severe pain on postoperative Day 1 [451/644 (70.03%)] than on Day 2 [349/644 (54.19%); P<0.001]. The median pain score [IQR] on postoperative Day 2 was 4 [3-5], which was less than on Day 1 (P<0.001). CONCLUSIONS: A high incidence of moderate-to-severe postoperative pain was found after a single dose of spinal morphine for cesarean delivery. Adequate pain control is required in women at risk of postcesarean delivery pain. More studies are needed on the analgesic requirements of diabetic patients or patients who receive intraoperative tubal sterilization.

Assessing adverse event reports of hysteroscopic sterilization device removal using natural language processing.

OBJECTIVE: To develop an annotation model to apply natural language processing (NLP) to device adverse event reports and implement the model to evaluate the most frequently experienced events among women reporting a sterilization device removal. METHODS: We included adverse event reports from the Manufacturer and User Facility Device Experience database from January 2005 to June 2018 related to device removal following hysteroscopic sterilization. We used an iterative process to develop an annotation model that extracts six categories of desired information and applied the annotation model to train an NLP algorithm. We assessed the model performance using positive predictive value (PPV, also known as precision), sensitivity (also known as recall), and F1 score (a combined measure of PPV and sensitivity). Using extracted variables, we summarized the reporting source, the presence of prespecified and other patient and device events, additional sterilizations and other procedures performed, and time from implantation to removal. RESULTS: The overall F1 score was 91.5% for labeled items and 93.9% for distinct events after excluding duplicates. A total of 16 535 reports of device removal were analyzed. The most frequently reported patient and device events were abdominal/pelvic/genital pain (N = 13 166, 79.6%) and device dislocation/migration (N = 3180, 19.2%), respectively. Of those reporting an additional sterilization procedure, the majority had a hysterectomy or salpingectomy (N = 7932). One-fifth of the cases that had device removal timing specified reported a removal after 7 years following implantation (N = 2444/11 293). CONCLUSIONS: We present a roadmap to develop an annotation model for NLP to analyze device adverse event reports. The extracted information is informative and complements findings from previous research using administrative data.

Post-ablation tubal sterilization syndrome: Does route of sterilization matter?

OBJECTIVE: To compare the prevalence of clinical post-ablation tubal sterilization syndrome among women who underwent abdominal (i.e., peripartum or laparoscopic) vs hysteroscopic permanent contraception in addition to endometrial ablation. STUDY DESIGN: This study was a retrospective cohort study conducted at an academic medical center. We included women (N = 188) who successfully underwent both endometrial ablation and permanent contraception between 2005 and 2017. Forty-one women underwent hysteroscopic permanent contraception and 147 underwent abdominal (i.e., peripartum or laparoscopic) permanent contraception. The primary outcome was the prevalence of clinical post-ablation tubal sterilization syndrome, as defined by new or worsening cyclic pelvic pain after completion of both procedures. RESULTS: The overall prevalence of the syndrome was 19.1% (34 of 178 women who followed up), with no detected difference between those who underwent hysteroscopic (6 of 38, 15.8%) vs abdominal permanent contraception (28 of 140, 20.0%, p = 0.55). In multivariate regression modeling, when adjusted for race, parity, gynecologic pathologies, hormonal medication use, and the presence of baseline pain (both pelvic and non-pelvic) only younger patient age was marginally associated with increased odds of the syndrome (aOR 1.85, 95% CI 1.01- 3.45, p = 0.05), while abdominal as compared to hysteroscopic permanent contraception was not (aOR 1.29, 95% CI 0.59-2.84, p = 0.53). Of the 28 patients with clinical post-ablation tubal sterilization syndrome who underwent hysterectomy and/or salpingectomy as treatment for their pain, none showed signs of hematosalpinx or hematometra at the time of surgery or on final pathology. CONCLUSION: We did not find evidence that route of permanent contraception affects the risk of post-ablation tubal sterilization syndrome development. Younger patients may be at higher risk of this syndrome.

ASIA (Shoenfeld's syndrome) due to hysteroscopic Essure sterilization.

Essure (TM, Bayer; Leverkusen, Germany) may act as a potential cause of autoimmune/inflammatory syndrome by adjuvants (ASIA). Essure is a device hysteroscopically inserted into the fallopian tubes to elicit a local inflammatory response for permanent sterilization. Patients with ASIA present with a constellation of symptoms including fatigue, cognitive impairment, and arthralgias. It is well known that ASIA is triggered by implantation of foreign material such as breast implants and mesh for hernia repair. In the current study, we present a retrospective cohort of 33 patients electing to remove Essure due to pelvic pain and systemic symptoms consistent with an ASIA diagnosis, and detail a case report of an Essure patient. Furthermore, we reviewed the existing literature on adverse events associated with Essure and studies assessing outcomes following explantation. The concept that Essure may trigger ASIA is further supported by both in vivo and in vitro studies demonstrating immunostimulatory effects of the material components of the device. We conclude that the existing evidence is sufficient to recommend screening of Essure recipients for ASIA symptoms, and where indicated, discussion of the risks and potential benefits of surgical removal.

Tubal interruption and subsequent surgery for pain after endometrial ablation: A retrospective cohort study.

BACKGROUND: Endometrial ablation (EA) is an alternative to hysterectomy for abnormal uterine bleeding (AUB), with reduced recovery time and fewer operative risks. However, post-ablation pain may be associated with subsequent surgery, including hysterectomy. It is uncertain what factors affect surgery rates for post-ablation pain, particularly with respect to timing and technique of tubal interruption. AIM: To evaluate the relationship between tubal interruption and post-ablation pain and subsequent surgery. MATERIALS AND METHODS: We conducted a retrospective cohort study involving 324 patients at a Melbourne tertiary hospital from 2009 to 2020. The primary outcome was subsequent pelvic surgery for pain following EA. RESULTS: Pain following EA was reported by 29.7% of patients, with 10.5% of patients undergoing subsequent surgery for pain. Patients with tubal interruption were more likely to undergo subsequent surgery for pain than those with no tubal interruption (odds ratio (OR): 3.49, 95% CI: 1.59-7.66; P = 0.002). Tubal ligation was strongly associated with subsequent surgery for pain (OR: 3.12, 95% CI: 1.48-6.57; P = 0.003). In contrast, those with salpingectomy did not have an increased risk of subsequent surgery for pain, compared to those with no tubal interruption (OR: 1.5; 95% CI 0.32-7.13). Pre-ablation pain (adjusted OR: 2.98, 95% CI: 1.37-6.48; P = 0.006) and previous caesarean section (OR: 2.66; 95% CI: 1.13-6.25; P = 0.025) were also associated with subsequent surgery for pain. CONCLUSION: Our results suggest that tubal interruption, pre-ablation pain and previous caesarean section are associated with subsequent surgery for pain. These results can better inform preoperative counselling regarding the risk of subsequent surgery after EA.