The impact of opportunistic salpingectomy on ovarian cancer mortality and healthcare costs: a call for universal insurance coverage.

BACKGROUND: Opportunistic salpingectomy at the time of hysterectomy or as an alternative to bilateral tubal ligation may reduce the incidence of ovarian cancer, because it has been demonstrated that most serous ovarian cancers begin in the fallopian tubes. However, salpingectomy at the time of sterilization is not always financially covered by third-party payers, and this represents a barrier to adoption. Routine salpingectomy has become more common but is not always practiced at the time of hysterectomy. OBJECTIVE: This study aimed to determine the impact of opportunistic salpingectomy as an alternative tubal ligation and routine salpingectomy at the time of hysterectomy on ovarian cancer mortality and overall cost. STUDY DESIGN: An 8-state Markov state transition model was constructed, including hysterectomy, tubal ligation, and ovarian cancer. Transition probabilities were informed by previously reported population data and include age-adjusted rates of elective sterilization and hysterectomy. This model was used to predict ovarian cancer incidence and the cost effectiveness of opportunistic salpingectomy. Testing of this model suggested that it accurately predicted overall life expectancy and closely predicted the rate of hysterectomy in the population. The model may underestimate the rate of tubal sterilization, making it conservative with respect to the benefits of salpingectomy. RESULTS: The recursive Markov model was run from ages 20 to 85 years in 1-year intervals with a half step correction and included age-adjusted rates of tubal ligation, hysterectomy (with and without oophorectomy), and ovarian cancer. The model predicts that opportunistic salpingectomy at the time of tubal ligation will reduce ovarian cancer mortality by 8.13%. Opportunistic salpingectomy at the time of hysterectomy will reduce ovarian cancer mortality by 6.34% for a combined decrease of 14.5%. Both strategies are cost effective when considering only the cost of the opportunistic salpingectomy. The excess cost of opportunistic salpingectomy at the time of tubal ligation was $433.91 with an incremental cost-effective ratio of $6401 per life-year and $5469 per quality-adjusted life year gained when adjusting for ovarian cancer with a utility of 0.64. The incremental cost-effective ratio for opportunistic salpingectomy during hysterectomy at a cost of $124.70 was $2006 per life-year and $1667 per quality-adjusted life year. When considering the impact of ovarian cancer prevention with respect to the cost of ovarian cancer treatment, opportunistic salpingectomy may produce a substantial healthcare savings. Utilizing a 3% discount rate, it is estimated that the total savings for universal salpingectomy could be as high as $445 million annually in the United States. A sensitivity analysis around the benefit of opportunistic salpingectomy suggests that this procedure will be cost effective even if salpingectomy provides only a modest reduction in the risk of ovarian cancer. CONCLUSION: It is estimated that universal opportunistic salpingectomy may prevent 1854 deaths per year from ovarian cancer and may reduce healthcare costs. Given these data, universal opportunistic salpingectomy should be considered at the time of tubal ligation and hysterectomy and covered by third-party payers.

Cost-effectiveness of opportunistic salpingectomy vs tubal ligation at the time of cesarean delivery.

BACKGROUND: Removal of the fallopian tubes at the time of hysterectomy or interval sterilization has become routine practice to prevent ovarian cancer. While emerging as a strategy, uptake of this procedure at the time of cesarean delivery for pregnant women seeking permanent sterilization has not been widely adopted due to perceptions of increased morbidity and operative difficulty with a lack of available data in this setting. OBJECTIVE: We sought to conduct a cost-effectiveness analysis comparing strategies for long-term sterilization and ovarian cancer risk reduction at the time of cesarean delivery, including bilateral tubal ligation, opportunistic salpingectomy, and long-acting reversible contraception. STUDY DESIGN: A decision-analytic and cost-effectiveness model was constructed for pregnant women undergoing cesarean delivery who desired permanent sterilization in the US population, comparing 3 strategies: (1) bilateral tubal ligation, (2) bilateral opportunistic salpingectomy, and (3) postpartum long-acting reversible contraception. This theoretic cohort consisted of 110,000 pregnant women desiring permanent sterilization at the time of cesarean delivery and ovarian cancer prevention at an average of 35 years who were monitored for an additional 40 years based on an average US female life expectancy of 75 years. The primary outcome measure was the incremental cost-effectiveness ratio. Effectiveness was measured as quality-adjusted life years. Secondary outcomes included: the number of ovarian cancer cases and deaths, procedure-related complications, and unintended and ectopic pregnancies. The 1-, 2-, and 3-way and Monte Carlo probabilistic sensitivity analyses were performed. The willingness-to-pay threshold was set at $100,000. RESULTS: Both bilateral tubal ligation and bilateral opportunistic salpingectomy with cesarean delivery have favorable cost-effectiveness ratios. In the base case analysis, salpingectomy was more cost-effective with an incremental cost-effectiveness ratio of $23,189 per quality-adjusted life year compared to tubal ligation. Long-acting reversible contraception after cesarean was not cost-effective (ie, dominated). Although salpingectomy and tubal ligation were both cost-effective over a wide range of cost and risk estimates, the incremental cost-effectiveness ratio analysis was highly sensitive to the uncertainty around the estimates of salpingectomy cancer risk reduction, risk of perioperative complications, and cost. Monte Carlo probabilistic sensitivity analysis estimated that tubal ligation had a 49% chance of being the preferred strategy over salpingectomy. If the true salpingectomy risk of perioperative complications is >2% higher than tubal ligation or if the cancer risk reduction of salpingectomy is <52%, then tubal ligation is the preferred, more cost-effective strategy. CONCLUSION: Bilateral tubal ligation and bilateral opportunistic salpingectomy with cesarean delivery are both cost-effective strategies for permanent sterilization and ovarian cancer risk reduction. Although salpingectomy and tubal ligation are both reasonable strategies for cesarean patients seeking permanent sterilization and cancer risk reduction, threshold analyses indicate that the risks and benefits of salpingectomy with cesarean delivery need to be better defined before a preferred strategy can be determined.

Esterilização tubária histeroscópica: uma atualização sobre o dispositivo Essure® / Hysteroscopic tubal sterilization: update on the Essure® device

No intuito de oferecer para a laqueadura tubária uma alternativa menos invasiva e com menos complicações, foi desenvolvido o dispositivo Essure®, aplicado ao método da esterilização histeroscópica, além de ter utilidade nos quadros de hidrossalpinge com indicação de fertilização in vitro (FIV). Este artigo, por meio de uma revisão de literatura, teve como objetivo reunir dados acerca do uso do Essure®, incluindo resultados obtidos com o dispositivo, bem como comparações em diversos aspectos com outras metodologias de esterilização. Foram utilizados os bancos de dados PubMed, Lilacs e Scielo, no período entre 1970 e 2016. Foram pesquisados os termos "hysteroscopic contraception"; "Essure"; "definitive tubal sterilization; "sterilization"; "contraception". A literatura demonstrou se tratar de um dispositivo de fácil e rápida inserção, e com bons resultados para anticoncepção. Porém, devido a complicações como perfuração tubária, implante peritoneal e aborto, bem como para avaliar seu custo financeiro ao sistema de Saúde, mais estudos prospectivos são necessários.(AU)

In order to provide a less invasive and harmful technique compared to the tubal ligation, the Essure® device was developed, applied to the hysteroscopic sterilization method. It is also used in cases of hydrosalpinus and indication of in vitro fertilization (IVF). This article, through a literature review, aimed to gather data about the use of Essure®, including results obtained with the device, comparing different aspects with other methods of sterilization. For this purpose, PubMed, Lilacs and Scielo databases were used, with results from 1970 to 2016. The keywords searched were "hysteroscopic contraception", "Essure", "definitive tubal sterilization". The literature has shown that it is a quickly and easily inserted device with good results for contraception. However, due to complications such as tubal perforation, peritoneal implantation and abortion, as well as to evaluate its financial cost to the health system, more prospective studies are needed.(AU)

Use of Hysterosalpingo-Foam Sonography for Assessment of the Efficacy of Essure Hysteroscopic Sterilization.

OBJECTIVES: Hysterosalpingo-foam sonography (HyFoSy) has been suggested to be a possible less invasive alternative to hysterosalpingography (HSG), which is the reference standard for confirmation of tubal occlusion after Essure (Bayer AG, Leverkusen, Germany) hysteroscopic sterilization. The purpose of our study was to evaluate the accuracy of HyFoSy compared to HSG for confirmation of tubal occlusion after Essure hysteroscopic sterilization. METHODS: A prospective study included 90 patients who underwent Essure hysteroscopic sterilization. Twelve weeks after the sterilization, 2-dimensional transvaginal ultrasonography was performed to assess the microinsert position and was followed by HyFoSy and HSG for evaluation of tubal occlusion. Patients with patent fallopian tubes on HSG were scheduled for additional HSG procedures at 3-month intervals until tubal occlusion was documented. RESULTS: Of 90 enrolled patients, 86 patients with 170 fallopian tubes underwent the complete imaging protocol. Tubal occlusion was evaluated by HyFoSy as an index test and HSG as a reference standard. The accuracy of HyFoSy was 97.1% (95% confidence interval [CI], 93%-99%). The sensitivity and specificity were 100% (95% CI, 97%-100%) and 54.6% (95% CI, 23%-83%), whereas the positive and negative predictive values were 97.0% (95% CI, 93%-99%) and 100% (95% CI, 42%-100%), respectively. No long-term complications were reported for HyFoSy or HSG. CONCLUSIONS: Given that the concordance rate for tubal occlusion between HyFoSy and HSG was not 100%, an occluded fallopian tube on HyFoSy should be confirmed by HSG, which remains the reference standard for confirmation of tubal occlusion after Essure hysteroscopic sterilization.

The Cost-Effectiveness of Salpingectomies for Family Planning in the Prevention of Ovarian Cancer.

OBJECTIVE: Ovarian cancer is the most lethal gynaecologic cancer. Disease prevention may be the only method to reduce the incidence of ovarian cancer. The Society of Gynecologic Oncology advised that salpingectomies may be an appropriate and feasible strategy for ovarian cancer risk reduction. This study conducted an economic evaluation from a societal perspective of bilateral salpingectomies versus conventional sterilization techniques in the prevention of ovarian cancer. STUDY DESIGN: We performed a micro-cost analysis comparing laparoscopic tubal coagulation, tubal clips and bilateral salpingectomies at the Michael Garron Hospital, formerly the Toronto East General Hospital, from 2015 to 2016. A Markov model was used in the cost-effectiveness and cost-utility analyses on these surgical procedures in ovarian cancer prevention. Costs were derived for the number ovarian cancer cases observed per sterilization method, cancer treatment, and associated procedural costs over each cancer patient's lifetime. The number of bilateral salpingectomies required to prevent an additional ovarian cancer case with the recommended treatment was also estimated. RESULTS: Bilateral salpingectomies performed at the Michael Garron Hospital generated savings of $7823 per life-year gained (95% CI $3248-$10 190; incremental cost [ΔC] -$907, incremental effect [ΔE] 0.11 life-years gained) compared with tubal clips and savings of $6315 per life-year gained (95% CI -$6360 to $9342; ΔC -$755, ΔE 0.11 life-years gained) compared with tubal coagulation. Most importantly, for every 150 bilateral salpingectomies performed, one case of ovarian cancer may be prevented. CONCLUSION: Laparoscopic bilateral salpingectomy is the dominant, cost-effective surgical strategy when compared to tubal clips and tubal coagulation to prevent ovarian cancer. Laparoscopic bilateral salpingectomies reduce costs and enhance quality-adjusted life-years relative to the two alternative treatments.

Cost-effectiveness of opportunistic salpingectomy for ovarian cancer prevention.

OBJECTIVES: Data suggesting a link between the fallopian tube and ovarian cancer have led to an increase in rates of salpingectomy at the time of pelvic surgery, a practice known as opportunistic salpingectomy (OS). However, the potential benefits, risks and costs for this new practice are not well established. Our objective was to assess the cost-effectiveness of opportunistic salpingectomy at the time of laparoscopic permanent contraception or hysterectomy for benign indications. METHODS: We created two models to compare the cost-effectiveness of salpingectomy versus usual care. The hypothetical study population is 50,000 women aged 45 undergoing laparoscopic hysterectomy with ovarian preservation for benign indications, and 300,000 women aged 35 undergoing laparoscopic permanent contraception. SEER data were used for probabilities of ovarian cancer cases and deaths. The ovarian cancer risk reduction, complication rates, utilities and associated costs were obtained from published literature. Sensitivity analyses and Monte Carlo simulation were performed, and incremental cost-effectiveness ratios (ICERs) were calculated to determine the cost per quality adjusted life year (QALY) gained. RESULTS: In the laparoscopic hysterectomy cohort, OS is cost saving and would yield $23.9 million in health care dollars saved. In the laparoscopic permanent contraception cohort, OS is cost-effective with an ICER of $31,432/QALY compared to tubal ligation, and remains cost-effective as long as it reduces ovarian cancer risk by 54%. Monte Carlo simulation demonstrated cost-effectiveness with hysterectomy and permanent contraception in 62.3% and 55% of trials, respectively. CONCLUSIONS: Opportunistic salpingectomy for low-risk women undergoing pelvic surgery may be a cost-effective strategy for decreasing ovarian cancer risk at time of hysterectomy or permanent contraception. In our model, salpingectomy was cost-effective with both procedures, but the advantage greater at time of hysterectomy.

Comparison of Healthcare Costs Among Commercially Insured Women in the United States Who Underwent Hysteroscopic Sterilization Versus Laparoscopic Bilateral Tubal Ligation Sterilization.

BACKGROUND: This study evaluated healthcare costs of index procedures and during a 6-month follow-up of women who had hysteroscopic sterilization (HS) versus laparoscopic bilateral tubal ligation (LBTL). MATERIALS AND METHODS: Women (18-49 years) with claims for HS and LBTL procedures were identified from the MarketScan commercial claims database (January 1, 2010, to December 31, 2012) and placed into separate cohorts. Demographics, characteristics, index procedure costs, and 6-month total healthcare costs and sterilization procedure-related costs were compared. Multivariable regression analyses were used to examine the impact of HS versus LBTL on costs. RESULTS: Among the study population, 12,031 had HS (mean age: 37.0 years) and 7286 had LBTL (mean age: 35.8 years). The majority (80.9%) who had HS underwent the procedure in a physician's office setting. Fewer women who had HS versus LBTL received the procedure in an inpatient setting (0.5% vs. 2.1%), an ambulatory surgical center setting (5.0% vs. 23.8%), or a hospital outpatient setting (13.4% vs. 71.9%). Mean total cost for the index sterilization procedure was lower for HS than for LBTL ($3964 vs. $5163, p < 0.0001). During the 6-month follow-up, total medical and prescription costs for all causes ($7093 vs. $7568, p < 0.0001) and sterilization procedure-related costs ($4971 vs. $5407, p < 0.0001) were lower for women who had HS versus LBTL. Multivariable regression results confirmed that costs were lower for women who had HS versus LBTL. CONCLUSIONS: Among commercially insured women in the United States, HS versus LBTL is associated with lower average costs for the index procedure and lower total healthcare and procedure-related costs during 6 months after the sterilization procedure.

Permanent Contraception for Women.

Permanent contraception is a highly desired and commonly used contraceptive option for women around the world who desire never to become pregnant. Current methods of female permanent contraception require surgery. Postpartum tubal ligation and interval surgical tubal ligation are safe and effective, do not interfere with menstrual cycles, and require no ongoing cost or medical checkups. Hysteroscopic tubal occlusion offers a less invasive surgical approach, but requires an imaging study for verification of correct placement. However, not all women have access to a surgeon trained to provide permanent contraception, or they may face other prohibitive logistic or financial burdens. The development of novel permanent contraception methods that are immediately effective and/or nonsurgical could help improve access to and acceptability of permanent contraception. The expansion of permanent contraception options could help women achieve their family planning goals and reduce unintended pregnancies.

Update on permanent contraception options for women.

PURPOSE OF REVIEW: Permanent methods are the most commonly used contraceptive options worldwide. Even with the increase in popularity and accessibility of long-acting reversible methods, there remains high demand for permanent options, especially among women in developing countries. RECENT FINDINGS: Traditional methods of permanent contraception, such as postpartum tubal ligation and interval surgical tubal occlusion or electrocautery by mini-laparotomy or laparoscopy are well tolerated and highly effective. Bilateral total salpingectomy for ovarian cancer risk reduction is currently being investigated. Hysteroscopic tubal occlusion reduces or eliminates the need for anesthesia, but requires surgical training and specialized equipment. Alternative permanent contraception methods are being explored including immediately effective hysteroscopic methods, and nonsurgical permanent contraception methods that have the potential to improve access and reduce cost. SUMMARY: Permanent contraception methods are an important part of the contraceptive methods mix designed to meet the needs of women who have completed desired family size or wish never to become pregnant. Current surgical approaches to permanent contraception are well tolerated and highly effective. The development of a highly effective nonsurgical approach could simplify the provision of permanent contraception.

Ultrasound assessment of the Essure contraceptive devices: is three-dimensional ultrasound really needed?

STUDY OBJECTIVE: To evaluate the feasibility of 3-dimensional ultrasound (3DUS) for sonographic localization of Essure microinserts, comparing it with 2-dimensional ultrasound (2DUS) insofar as time to visualize the inserts and accuracy in determining their localization. DESIGN: Prospective study (Canadian Task Force classification II-2). SETTING: University clinic. PATIENTS: Twenty-seven consecutive women undergoing hysteroscopic Essure device placement. INTERVENTIONS: Essure microinserts were inserted in the outpatient hysteroscopy clinic following the manufacturer's recommendations, leaving from 3 to 8 loops of the inserts in the uterine cavity. In all patients, 2DUS and 3DUS were performed 3 months after the procedure. 2DUS was performed first; the device(s) were located, and their position was recorded. Then 3DUS scans were acquired, trying when possible to have both devices at least at a 45-degree angle with the insonation beam for optimal rendering on 3DUS. The OmniView method with volume contrast imaging was used to show the relationships of the microinserts within the uterine cavity when possible. To define the position of the Essure device in relation to the uterus and the salpinges, we used the classification developed by Legendre and colleagues. After sonographic evaluation all women underwent hysterosalpingography to assess the success of sterilization. MEASUREMENTS AND MAIN RESULTS: Hysteroscopic insertion was successful in all patients, with 2 Essure devices placed in 25 patients and 1 device in 2 patients (due to previous salpingectomy performed because of ectopic pregnancy), for a total of 52 devices. One spontaneous late (within 3 months) expulsion of the device occurred; the device had migrated almost completely into the uterine cavity. At 3-month follow-up, all 51 correctly placed devices were easily observed at 2DUS (mean [SD] duration of the procedure, 2.25 [0.8] minutes). At 3DUS in 51 cases, the device was in perfect position (1+2+3) in 21 (41.2%), in position 2+3 in 14 (27.4%), and in position +3 in 16 (31.4%). Both microinserts were observed on 3DUS reconstructed images in 31 of 35 (88.6%) 1+2+3 and 2+3 cases. However, in the 16 cases in which the devices were in position +3 (salpinx only), a single 3D sweep failed to demonstrate both devices in 10 of 16 cases (62.5%), due to substantially different angles of orientation of the inserts. This was because if 1 of the 2 devices was placed at a <30-degree angle with the insonation beam, its identification along the uterine wall was questionable because of concurrent hyperechogenicity of the bowel loops and poor visualization. Time for performance of 3DUS was 14.4 [4.8] minutes. Hysterosalpingography was performed in all patients, and confirmed tubal occlusion in all but 1 case. CONCLUSIONS: On the basis of a limited number of patients, 2DUS is more time-efficient and equivalent to 3DUS in locating Essure contraceptive microinserts. These results should be considered when planning sonographic follow-up of patients with Essure devices.

Bringing men to the table: sterilization can be for him or for her.

Sterilization, male and female combined, is the most common use of contraception in the United States. Despite the lower risk, higher cost-efficacy, and high efficacy of vasectomy compared with female sterilization, more US women rely on female sterilization than male sterilization. Reasons for low use of vasectomy include lack of knowledge and misconceptions about the procedure, lack of access, provider bias, and patient preferences. This article will provide a basic overview of male and female sterilization, an exploration of vasectomy barriers, and ways obstetrician-gynecologists can increase vasectomy uptake including regular recommendation of vasectomy to patients in long-term committed relationships considering sterilization.

[Cost effects of laparoscopic and hysteroscopic female sterilization]. / Naisten laparoskooppisen ja hysteroskooppisen sterilisaation kustannusvaikutukset.

INTRODUCTION: The aim was to elucidate the costs and clinical results of sterilization. MATERIAL AND METHODS: A retrospective analysis was carried out on sterilizations conducted at the Hyvinkää hospital in 2006 to 2007 by tubal ligation with clips and by microimplants. RESULTS: Total costs obtained for microimplant sterilization per patient were 1,146 Euros and for clip sterilization 1,712 Euros. Postoperative pain was significantly less in the microimplant group, and adverse effects associated with the procedure were more common in the clip sterilization group. CONCLUSIONS: Microimplant sterilization performed on an outpatient basis is more cost-effective than laparoscopic clip sterilization.

Pre-hysterectomy assessment of immediate tubal occlusion with the third-generation ESSURE insert (ESS505).

STUDY OBJECTIVE: To assess the ability of a new iteration of the ESSURE insert (ESS505) to achieve short-term fallopian tube occlusion. DESIGN: Prospective, single center, interventional cohort (Canadian Task Force classification II-1). SETTING: Tertiary care hospital. PATIENTS: Women scheduled to undergo hysterectomy. INTERVENTION: Patients underwent placement of the ESS505 in the right fallopian tube and ESS305 (the commercially approved previous version of the device) in the left fallopian tube at 30 (n = 10), 60 (n = 10), or 90 (n = 10) days before a planned hysterectomy. Tubal occlusion was assessed via hysterosalpingography (HSG) both at the time of placement and just before hysterectomy. Ultrasound was used to evaluate acute device placement. MEASUREMENTS AND MAIN RESULTS: Thirty-five women (mean age, 39.7 years) were enrolled from July 2012 to January 2013, and 30 underwent both ESSURE placement and scheduled hysterectomy. Mean (SD) placement time for the ESS305 and ESS505 devices was 1.4 (0.65) minutes and 1.3 (0.42) minutes, respectively (p = .36). At 1 hour after ESS505 placement, 29 of 30 tubes (97%) exhibited complete occlusion at HSG, compared with only 4 of 30 tubes (13%) after ESS305 placement (p < .001 for difference in occlusion rates). At hysterectomy, the tubal occlusion rate was high in both groups: 97% for ESS505 and 100% for ESS305 tubes. High occlusion rates were observed in each of the 3 duration groups (30, 60, and 90 days). Five women experienced only minor adverse effects. CONCLUSION: ESS505, a modification to the commercially available ESS305 designed to cause immediate tubal occlusion, demonstrated a high rate of both immediate-term and intermediate-term tubal occlusion. Early tubal occlusion may obviate the need for interim alternative contraceptive methods after ESSURE placement.

Probability of pregnancy after sterilization: a comparison of hysteroscopic versus laparoscopic sterilization.

OBJECTIVE: To compare the expected probability of pregnancy after hysteroscopic versus laparoscopic sterilization based on available data using decision analysis. STUDY DESIGN: We developed an evidence-based Markov model to estimate the probability of pregnancy over 10 years after three different female sterilization procedures: hysteroscopic, laparoscopic silicone rubber band application and laparoscopic bipolar coagulation. Parameter estimates for procedure success, probability of completing follow-up testing and risk of pregnancy after different sterilization procedures were obtained from published sources. RESULTS: In the base case analysis at all points in time after the sterilization procedure, the initial and cumulative risk of pregnancy after sterilization is higher in women opting for hysteroscopic than either laparoscopic band or bipolar sterilization. The expected pregnancy rates per 1000 women at 1 year are 57, 7 and 3 for hysteroscopic sterilization, laparoscopic silicone rubber band application and laparoscopic bipolar coagulation, respectively. At 10 years, the cumulative pregnancy rates per 1000 women are 96, 24 and 30, respectively. Sensitivity analyses suggest that the three procedures would have an equivalent pregnancy risk of approximately 80 per 1000 women at 10 years if the probability of successful laparoscopic (band or bipolar) sterilization drops below 90% and successful coil placement on first hysteroscopic attempt increases to 98% or if the probability of undergoing a hysterosalpingogram increases to 100%. CONCLUSION: Based on available data, the expected population risk of pregnancy is higher after hysteroscopic than laparoscopic sterilization. Consistent with existing contraceptive classification, future characterization of hysteroscopic sterilization should distinguish "perfect" and "typical" use failure rates. IMPLICATIONS: Pregnancy probability at 1 year and over 10 years is expected to be higher in women having hysteroscopic as compared to laparoscopic sterilization.

Hysteroscopic tubal sterilization: a health economic literature review.

BACKGROUND: Hysteroscopic sterilization is a minimally invasive alternative to laparoscopic tubal ligation for women who want permanent contraception. In contrast to the laparoscopic technique, a hysteroscope is used to pass permanent microinserts through the cervix and place them in the fallopian tubes. This procedure does not require local or general anesthesia and can be performed in an office setting. OBJECTIVES: The objective of this analysis was to determine, based on published literature, the cost-effectiveness of hysteroscopic tubal sterilization (HS) compared with laparoscopic tubal ligation (LS) for permanent female sterilization. DATA SOURCES: A systematic literature search was conducted for studies published between January 1, 2008, and December 11, 2012. REVIEW METHODS: Potentially relevant studies were identified based on the title and abstract. Cost-utility analyses (studies that report outcomes in terms of costs and quality-adjusted life-years) were prioritized for inclusion. When not available, cost-effectiveness, cost-benefit, and cost-consequence analyses were considered. Costing studies were considered in the absence of all other analyses. RESULTS: A total of 33 abstracts were identified. Three cost analyses were included. A retrospective chart review from Canada found that HS was $111 less costly than LS; a prospective activity-based cost management study from Italy reported that it was €337 less costly than LS; and the results of an American decision model showed that HS was $1,178 less costly than LS. LIMITATIONS: All studies had limited applicability to the Ontario health care system due to differences in setting, resource use, and costs. CONCLUSIONS: Three cost analyses found that, although the HS procedure was more expensive due to the cost of the microinserts, HS was less costly than LS overall due to the shorter recovery time required. PLAIN LANGUAGE SUMMARY: Hysteroscopic sterilization is a minimally invasive alternative to conventional tubal ligation for women who want a permanent method of contraception. Both approaches involve closing off the fallopian tubes, preventing the egg from moving down the tube and the sperm from reaching the egg. Tubal ligation is a surgical procedure to tie or seal the fallopian tubes, and it usually requires general anesthesia. In contrast, hysteroscopic tubal sterilization can be performed in 10 minutes in an office setting without general or even local anesthesia. A tiny device called a microinsert is inserted into each fallopian tube through the vagina, cervix, and uterus without surgery. An instrument called a hysteroscope allows the doctor to see inside the body for the procedure. Once the microinserts are in place, scar tissue forms around them and blocks the fallopian tubes. Health Quality Ontario commissioned a systematic review of published economic literature to determine whether hysteroscopic sterilization is cost-effective compared to tubal ligation. This review did not find any studies that reported results in terms of both costs and effectiveness or costs and quality-adjusted life-years. We did find 3 costing studies and included them in our review. All of these studies found that when hysteroscopic sterilization was performed as an outpatient procedure, it was less expensive than tubal ligation due to a shorter recovery time. However, none of the studies apply directly to Ontario because of differences in our health care system compared to those in the studies.

Hysteroscopic tubal sterilization: an evidence-based analysis.

BACKGROUND: Hysteroscopic tubal sterilization is a minimally invasive alternative to laparoscopic tubal ligation for women who want permanent contraception. The procedures involves non-surgical placement of permanent microinserts into both fallopian tubes. Patients must use alternative contraception for at least 3 months postprocedure until tubal occlusion is confirmed. Compared to tubal ligation, potential advantages of the hysteroscopic procedure are that it can be performed in 10 minutes in an office setting without the use of general or even local anesthesia. OBJECTIVE: The objective of this analysis was to determine the effectiveness and safety of hysteroscopic tubal sterilization compared with tubal ligation for permanent female sterilization. DATA SOURCES: A standard systematic literature search was conducted for studies published from January 1, 2008, until December 11, 2012. REVIEW METHODS: Observational studies, randomized controlled trials (RCTs), systematic reviews and meta-analyses with 1 month or more of follow-up were examined. Outcomes included failure/pregnancy rates, adverse events, and patient satisfaction. RESULTS: No RCTs were identified. Two systematic reviews covered 22 observational studies of hysteroscopic sterilization. Only 1 (N = 93) of these 22 studies compared hysteroscopic sterilization to laparoscopic tubal ligation. Two other noncomparative case series not included in the systematic reviews were also identified. In the absence of comparative studies, data on tubal ligation were derived for this analysis from the CREST study, a large, multicentre, prospective, noncomparative observational study in the United States (GRADE low). Overall, hysteroscopic sterilization is associated with lower pregnancy rates and lower complication rates compared to tubal ligation. No deaths have been reported for hysteroscopic sterilization. LIMITATIONS: A lack of long-term follow-up for hysteroscopic sterilization and a paucity of studies that directly compare the two procedures limit this assessment. In addition, optimal placement of the microinsert at the time of hysteroscopy varied among studies. CONCLUSIONS: Hysteroscopic sterilization is associated with: lower pregnancy rates compared to tubal ligation (GRADE very low); lower complication rates compared to tubal ligation (GRADE very low); no significant improvement in patient satisfaction compared to tubal ligation (GRADE very low). PLAIN LANGUAGE SUMMARY: Hysteroscopic tubal sterilization is a minimally invasive alternative to conventional tubal ligation for women who want a permanent method of contraception. Both approaches involve closing off the fallopian tubes, preventing the egg from moving down the tube and the sperm from reaching the egg. Tubal ligation is a surgical procedure to tie or seal the fallopian tubes, and it usually requires general anesthesia. In contrast, hysteroscopic tubal sterilization can be performed in 10 minutes in an office setting without general or even local anesthesia. A tiny device called a microinsert is inserted into each fallopian tube through the vagina, cervix, and uterus without surgery. An instrument called a hysteroscope allows the doctor to see inside the body for the procedure. Once the microinserts are in place, scar tissue forms around them and blocks the fallopian tubes. Health Quality Ontario conducted a review of the effectiveness and safety of hysteroscopic tubal sterilization compared to tubal ligation. This review indicates that hysteroscopic tubal sterilization is associated with: lower pregnancy rates compared to tubal ligation; lower complication rates compared to tubal ligation; no significant improvement in patient satisfaction compared to tubal ligation. However, we found a number of limitations to the studies available on hysteroscopic tubal sterilization. Among other concerns, most studies did not include long-term follow-up and only 1 study directly compared hysteroscopic tubal sterilization to tubal ligation.

Hysteroscopic sterilization in the office setting.

Hysteroscopic sterilization is growing in popularity. Nearly 500,000 women have been sterilized using this method, and an increasing number of physicians are now performing this procedure in the office setting. The office setting can provide a cost-effective, convenient, and safe environment for hysteroscopic sterilization. Patients may benefit from avoiding hospital preoperative visits, excessive laboratory evaluation, operating room wait times, and expense associated with hospital care. Physicians may improve productivity through remaining in their office or avoiding operating room delays. This article reviews office-hysteroscopic sterilization with the Essure microinsert system.

Hysteroscopic sterilization using a virtual reality simulator: assessment of learning curve.

STUDY OBJECTIVE: To assess the learning curve using a virtual reality simulator for hysteroscopic sterilization with the Essure method. DESIGN: Prospective multicenter study (Canadian Task Force classification II-2). SETTING: University and teaching hospital in the Netherlands. PARTICIPANTS: Thirty novices (medical students) and five experts (gynecologists who had performed >150 Essure sterilization procedures). INTERVENTIONS: All participants performed nine repetitions of bilateral Essure placement on the simulator. Novices returned after 2 weeks and performed a second series of five repetitions to assess retention of skills. Structured observations on performance using the Global Rating Scale and parameters derived from the simulator provided measurements for analysis. MEASUREMENTS AND MAIN RESULTS: The learning curve is represented by improvement per procedure. Two-way repeated-measures analysis of variance was used to analyze learning curves. Effect size (ES) was calculated to express the practical significance of the results (ES ≥ 0.50 indicates a large learning effect). For all parameters, significant improvements were found in novice performance within nine repetitions. Large learning effects were established for six of eight parameters (p < .001; ES, 0.50-0.96). Novices approached expert level within 9 to 14 repetitions. CONCLUSION: The learning curve established in this study endorses future implementation of the simulator in curricula on hysteroscopic skill acquisition for clinicians who are interested in learning this sterilization technique.

Barriers to completion of desired postpartum sterilization.

Tubal sterilization is a highly effective, permanent, and safe method of contraception. Many women who desire postpartum sterilization do not obtain the procedure due to barriers. We performed a retrospective cohort study examining patients from a single obstetrics practice who delivered between 1/1/07 and 6/30/07 at Women and Infants Hospital in Providence, RI. During the study period, 626 women in the practice delivered. Of these subjects, 87 (14%) desired postpartum sterilization. Of these 87, 45 (51.7%) underwent sterilization as planned. In multivariable analysis controlling for age, BMI, delivery mode and marital status, older age (OR 2.15, 95% CI 1.12, 4.12, p=0.02) and cesarean delivery (OR 19.65, 95% CI 3.75, 103.1, p < 0.001) were associated with completion of postpartum sterilization and being married (OR 0.10, 95% CI 0.02, 0.56, p=0.009) and having a higher BMI (OR 0.60, 95% CI 0.39, 0.91, p=0.02) were associated with incompletion. Only half of women who request postpartum sterilization antenatally end up obtaining the procedure.

Laparoscopic tubal reanastomosis versus in vitro fertilization: cost-based decision analysis.

OBJECTIVE: Regret after tubal ligation continues to be a problem. After tubal ligation, couples have the option of tubal surgery or in vitro fertilization (IVF). STUDY DESIGN: Using decision analysis techniques, we compared cost-effectiveness of tubal reanastomosis by tubal type vs tubal surgery or in vitro fertilization (IVF) for 3 separate age groups of women: <35 years of age, 35 to 40 years of age and >40 years of age. Tubal techniques was divided into type A, those with more favorable prognosis because of the likelihood of having a more significant length tube at time of reanastomosis and type B, those with a worse prognosis of success. We incorporated delivery costs to address the impact of high order multiples in IVF. Data were extracted by studies available in the literature. All costs were adjusted to 2012 US dollars. One-way and 2-way sensitivity analyses were performed. RESULTS: The laparoscopic reanastomosis of type A dominated the other groups, because it was more effective and less costly then type B and IVF. However, when women were >40 years old with a history of type B, IVF was favored when its costs were at the lower limit. CONCLUSION: The most cost-effective choice for a woman desiring pregnancy after tubal ligation is laparoscopic reanastomosis after a prior clip or ring tubal ligation for women ≤40 years old. It is also the most cost-effective for the oldest cohort, assuming IVF costs are greater than $4500.