Hysteroscopic Sterilization Research Articles

98: Hysteroscopic Sterilization: Long-Term Safety and Efficacy

98: Hysteroscopic Sterilization: Long-Term Safety and Efficacy

Mise au point sur la contraception

Since the introduction of hormonal contraceptives in the 1960s, great advances have been achieved in contraception. Biological effects of sexual steroids as well as risks and benefits of oral contraception are better estimated. After the development of a new hormone-containing intra-uterine system, new hormone delivery systems offer women safe and effective contraceptive options. These new options that combine high efficacy and ease of use should allow better acceptance and compliance than daily pill ingestion and should then reduce the high rate of unintended pregnancies terminated by elective abortion. Transdermal contraceptive system and vaginal ring offer a promising innovative approach in pregnancy prevention. Subdermal implants give women the choice of a highly effective contraceptive system in spite of significant side effects. New hormonal delivery systems such as injectables are under development. Hysteroscopic tubal sterilization is now also available and is a very effective procedure. This wide variety of new contraceptive methods offers a marked improvement from previous medications for users by providing better efficacy and tolerability.

97: Office Hysteroscopic Sterilization Compared to Laparoscopic Sterilization: A Critical Cost Analysis

To evaluate the actual cost difference in performing an Essure hysteroscopic sterilization in the office compared to an ambulatory surgery using laparoscopic sterilization in the operating room. Cost-comparison analysis. University hospital and affiliated out-patient office. This is a cost-comparison of the typical costs to the healthcare economy at our institute, and does not involve individual patient data. Hysteroscopic placement of Essure device in an office setting and laparoscopic tubal ligation for permanent sterilization. The various costs associated with the two procedures at our institution were compiled, and a direct cost comparison was made. We utilized actual institutional costs of the procedures, not billing or reimbursement. We found laparoscopic tubal ligations to cost $3405 compared to hysteroscopic placement of the Essure device that costs $1374 yielding a $2031 difference between the procedures. In our institution and in our experience, office-hysteroscopic placement of the Essure device is a more cost effective method than laparoscopic tubal ligation.

67: Pregnancies in Women Who Have Undergone the Essure Hysteroscopic Sterilization Procedure: A Summary of 37 Cases

A clinical analysis of pregnancies in women that have undergone the Essure hysteroscopic sterilization procedure (Conceptus Inc., San Carlos, CA). All pregnancies reported to the device manufacturer from 1997 to December, 2004 were analyzed. Clinical surgical procedure and office settings. The clinical events associated with the 37 pregnancies were analyzed. All pregnancies occurred in women who had undergone the Essure permanent sterilization procedure reported from worldwide commercial and clinical sites. Of the 37 reported pregnancies following and estimated 29,736 procedures, 6 women (16%) were pregnant prior to placement of the micro-inserts, 21 cases (57%) were associated with a failure of adequate post-procedure follow-up, 7 cases (19%) were attributed to misinterpreted hysterosalpingograms (HSGs) or X-rays followed by an incorrect decision to rely on the method, 1 case (3%) followed expulsion of a prior device design, and 2 cases (5%) are pending further investigation. The data indicate that most pregnancies are avoidable and can be potentially overcome by (1) ensuring the women are using a reliable form of contraception prior to the procedure (2) performing the procedure prior to ovulation and thus avoiding the risk of luteal phase pregnancy (3) improving the quality and accuracy of HSG/X-ray film reporting and encouraging radiologists and clinicians to communicate on film interpretation, and (4) to educate clinicians and patients about the necessity of the 3-month follow-up to confirm both tubal occlusion and correct position of the micro-inserts. The avoidable nature of these failures indicates that with improved care, these failures can be reduced.

68: Global Endometrial Ablation Using the Novasure Radiofrequency Device Followed by Essure Hysteroscopic Sterilization

68: Global Endometrial Ablation Using the Novasure Radiofrequency Device Followed by Essure Hysteroscopic Sterilization

Female sterilisation: a cohort controlled comparative study of ESSURE versus laparoscopic sterilisation

To compare patient satisfaction, discomfort, procedure time, success rate and adverse events of hysteroscopic (ESSURE, Conceptus Inc, San Carlos, USA) versus laparoscopic sterilisation. Cohort controlled comparative study. The day surgery and outpatient unit of three large UK hospitals. Eighty-nine women requesting sterilisation were enrolled into the study. A 2:1 ratio of ESSURE placement to laparoscopic sterilisation was undertaken. Laparoscopic sterilisation was carried out under general anaesthesia in the day surgery unit whereas all ESSURE procedures were carried out in a dedicated outpatient facility. All patients completed a self-assessment diary on days 7 and 90 post-operatively. Patient satisfaction, tolerance and discomfort were measured using an ordinal Likert style scale. Data were analysed using the chi(2) test for statistical significance. The primary outcome measure is patient satisfaction with ESSURE versus laparoscopic sterilisation. This included satisfaction with the decision to proceed with the relevant sterilisation method, recovery from the procedure and overall satisfaction following either ESSURE or laparoscopic sterilisation. Secondary outcome measures include successful completion of procedure, procedure time, tolerance, patient discomfort and post-operative adverse events. All women who underwent laparoscopic sterilisation had the procedure successfully completed whereas the overall bilateral device placement rate for ESSURE was 81%. Patient satisfaction with their decision to undergo either ESSURE or laparoscopic sterilisation was high with 94% of the ESSURE group being 'very' or 'somewhat' satisfied at 90 days post-procedure versus 80% in the laparoscopic sterilisation group. At 90 days post-procedure 100% of women in the ESSURE group were 'very satisfied' with their speed of recovery versus 80% in the laparoscopic sterilisation group. The procedure time (defined from the time of insertion of the hysteroscope or laparoscope to its removal) took significantly longer for ESSURE than laparoscopic sterilisation (mean = 13.2 vs 9.7 minutes, P= 0.045). However, the time required for insertion of a Verres needle and insufflation of the abdominal cavity is a necessary part of the laparoscopic sterilisation and had it been included would bring the procedures times more in line with each other. The mean time spent in hospital was significantly shorter for the ESSURE group than the laparoscopic group (188.7 vs 396.1 minutes, P < 0.005). Eighty-two percent of women in the ESSURE group described their tolerance of the procedure between 'good and excellent' compared with only 41% of the laparoscopic sterilisation group (P= 0.0002). Only 31% of the ESSURE group reported moderate or severe pain following the procedure compared with 63% of the laparoscopic sterilisation group (P= 0.08). Only 11% of patients had problems immediately post-operatively in the ESSURE group compared with 27% in the laparoscopy group. Finally, in the more medium term (three months post-operatively), patients still had an advantage in terms of post-procedure adverse events in the ESSURE group (21%vs 50%). This study provides evidence that ESSURE can be performed in the majority of women and, when successful, is associated with a greater overall patient satisfaction rate than laparoscopic sterilisation. Women also spend less time in hospital, have better tolerance of the procedure and describe less severe post-operative pain. However, the devices cannot be bilaterally placed in all cases and some women do not tolerate the procedure awake.

Currently available devices for female sterilization

Sterilization is now the method of family planning most commonly used in the world. Over the last 150 years, research has evolved in the search for the ideal method of female sterilization. The procedure should ideally have high efficacy, be readily accessible and be personally and culturally acceptable. The method should be simple, quick, easily learned and be able to be performed in an outpatient setting without general anesthesia. The most common and effective method for sterilization has, thus far, been via the laparoscopic route. Hysteroscopic sterilization, however, potentially fulfills many of these ideal criteria, but until recently has remained more of a concept than a reality.

Hysteroscopic sterilization: long-term safety and efficacy

Introduction: The goal of the study was to assess the long-term safety and efficacy of hysteroscopic sterilization.Materials and Methods: The Essure micro-insert (Conceptus Inc., San Carlos, CA) was placed into the proximal segment of at least one fallopian tube lumen of 682 women in the prospective, multicenter, international Phase II and Pivotal clinical trials. Successful bilateral device placement was achieved in 643 (94%) women. After confirmation of tubal occlusion by hysterosalpingogram, they began relying on the micro-inserts for contraception. These women continue to be assessed at 1-, 2-, 3-, 4- and 5-year intervals.Results: As of December 16, 2004, 643 women contributed effectiveness time, 194 in the Phase II study and 449 in the Pivotal trial. In total, the 643 trial participants contributed 29357 months of follow-up time without pregnancy. The average duration of reliance on this method for permanent contraception was 52.9 months for Phase II subjects and 42.5 months for women in the Pivotal trial. To date, there have been no long-term adverse events found by the investigators to be directly related to the micro-insert or placement procedure.Conclusion: These findings indicate that this nonincisional method of hysteroscopic sterilization can be performed without general anesthesia and has acceptable long-term safety and contraceptive efficacy. Introduction: The goal of the study was to assess the long-term safety and efficacy of hysteroscopic sterilization. Materials and Methods: The Essure micro-insert (Conceptus Inc., San Carlos, CA) was placed into the proximal segment of at least one fallopian tube lumen of 682 women in the prospective, multicenter, international Phase II and Pivotal clinical trials. Successful bilateral device placement was achieved in 643 (94%) women. After confirmation of tubal occlusion by hysterosalpingogram, they began relying on the micro-inserts for contraception. These women continue to be assessed at 1-, 2-, 3-, 4- and 5-year intervals. Results: As of December 16, 2004, 643 women contributed effectiveness time, 194 in the Phase II study and 449 in the Pivotal trial. In total, the 643 trial participants contributed 29357 months of follow-up time without pregnancy. The average duration of reliance on this method for permanent contraception was 52.9 months for Phase II subjects and 42.5 months for women in the Pivotal trial. To date, there have been no long-term adverse events found by the investigators to be directly related to the micro-insert or placement procedure. Conclusion: These findings indicate that this nonincisional method of hysteroscopic sterilization can be performed without general anesthesia and has acceptable long-term safety and contraceptive efficacy.

Hysteroscopic permanent tubal sterilization using a nitinol-dacron intratubal device without anaesthesia in the outpatient setting: procedure feasibility and effectiveness

Hysteroscopic permanent tubal sterilization has recently been introduced, resulting in a non-invasive, safe and effective technique. The aim of this study was to assess the feasibility of outpatient hysteroscopic tubal sterilization using a nitinol-dacron intratubal device without anaesthesia and to assess patient procedure compliance. We untertook a prospective study of 36 consecutive cases of outpatient hysteroscopic tubal sterilization using a nitinol-dacron intratubal device without anaesthesia. Tubal sterilization was performed by placing the device with the aid of a 5.2-mm continuous-flow operative hysteroscope. At the end of the procedure women were asked to rate the pain experienced on a visual analogue scale (VAS) (0, no discomfort to 100, severe discomfort). Successful device placement was assessed after 3 months by hysterosalpingography and diagnostic hysteroscopy. Successful bilateral placement was obtained in 32 patients (88.9%); in one (2.8%) the placement was monolateral; and in three (8.3%) the procedure failed. Mean operating time was 8.6 +/- 5.3 min. A mean VAS of 36.1 +/- 23.9 was recorded. The nitinol-dacron intratubal device is safe, appears to be effective long-term, is non-invasive and can be used in the outpatient setting without anaesthesia. Low-level discomfort was experienced by the patients. Limitations of its use include that it is not effective immediately, it is irreversible, it requires special equipment and training, and it is difficult to use in cases of uterine anomalies. We conclude that this method may be offered to all woman asking for permanent tubal sterilization, particularly those who refuse or have contraindications for anaesthesia.

Confirmation of Essure ® microinsert tubal coil placement with conventional and volume-contrast imaging three-dimensional ultrasound

To determine the accuracy of ultrasound in the assessment of proximal fallopian tube positioning of the Essure microinsert coil 3 months after postprocedure. Prospective cohort study (Canadian Task Force classification II-2). Reproductive-age women in a tertiary care hospital. Reproductive-age women presenting with a request for permanent contraception. Hysteroscopic sterilization with the Essure microinsert coil and conventional or volume-contrast three-dimensional (3D) ultrasound imaging 3 months after the procedure. Coil position on ultrasound. Forty-eight of the 50 patients had successful placement of the Essure coils, and three patients required a second attempt on one tube. Conventional or volume-contrast (3D) ultrasound showed proper positioning of the coils within the proximal fallopian tube in 42 women (84%); five women (10%) required hysterosalpingogram to show appropriate positioning. Two patients (4%) required laparoscopic tubal sterilization, and one patient (2%) was lost to follow-up. Transvaginal ultrasound is an acceptable method of confirming proper placement of the Essure microinsert coil within the proximal fallopian tube 3 months after the procedure.

Office hysteroscopic sterilization compared with laparoscopic sterilization: A critical cost analysis

Study objective To evaluate the actual cost difference in performing Essure hysteroscopic sterilization in the office compared with ambulatory surgery using laparoscopic sterilization in the operating room. Design Cost-comparison analysis (Canadian Task Force classification III). Setting University hospital and affiliated outpatient office. Interventions Hysteroscopic placement of Essure device in an office setting and laparoscopic tubal ligation for permanent sterilization. Measurements and main results The various costs associated with the two procedures at our institution were compiled, and a direct cost comparison was made. We used actual institutional costs of the procedures, not billing or reimbursement. We found laparoscopic tubal ligations to cost $3449 compared with hysteroscopic placement of the Essure device that costs $1374 yielding a $2075 difference between the procedures. Conclusion In our institution and in our experience, office-hysteroscopic placement of the Essure device is a more cost-effective method than laparoscopic tubal ligation.

Hysteroscopic sterilisation in the outpatient department without anaesthesia

Background: Compared to laparoscopic sterilisation, the hysteroscopic approach obviates admission, general anaesthesia, surgical incisions and a complication rate of 5 per 1,000 procedures. The use of the new hysteroscopic sterilisation device Essure (Conceptus) for the first consecutive 175 patients, without the use of local or intravenous anaesthesia or any sedation, has been evaluated in the outpatient department (OPD). Results: Successful bilateral placement was achieved in 95% of all women. Pain during the procedure was assessed by a visual analogue score and appeared to be 2.5 on average. All women could be discharged within 1 h; only two women encountered a vasovagal collapse; no adverse events occurred. All women were satisfied with this method. After 1,200 woman-months, no pregnancy was found. Conclusion: Hysteroscopic sterilisation with Essure can be done safely in the OPD without anaesthesia.

Hysteroscopic sterilization: away with the laparoscope?

In a review of the literature the history, present state of the art and possible future developments of hysteroscopic sterilization is given. In the Netherlands two systems are now available: Ovabloc® and Essure®. Although not yet as extensively evaluated as laparoscopic sterilization the pregnancy rate does not seem to be higher and the (major) complication rate appears to be significantly lower. According to this review hysteroscopic sterilization is an attractive alternative method of sterilization and is probably clearly indicated in cases of (relative) contra-indications to laparoscopy: obesity, intra-abdominal adhesions, haemorrhagic diathesis and cardiopulmonary disease. As long as X-rays are still advised in hysteroscopic sterilization techniques, this requirement remains the main disadvantage when compared with the laparoscopic approach, but otherwise one could indeed conclude: away with the laparoscope in sterilization!

Initial Asian experience in hysteroscopic sterilisation using the Essure permanent birth control device

To present our initial experience in the use of the Essure permanent birth control device in a predominately Asian population. A retrospective study. Minimally Invasive Surgery Unit, KK Women's and Children's Hospital, Singapore. Eighty women seeking permanent birth control. From 22 June 2001, women who sought sterilisation were counselled with regards to the various options of permanent birth control. Informed consent for hysteroscopic sterilisation was obtained only after the woman met the criteria for Essure permanent birth control. The sterilisation procedure was carried out without the need for general anaesthesia in a day surgery centre using the Essure permanent birth control device. The surgical details and post procedure follow up were analysed. Feasibility and safety of the Essure permanent birth control device in Asians and its non-placement rate. No serious adverse events or complications were encountered in using the Essure device. No pregnancies have been reported in our series to date. A significant reduction in the Essure device non-placement rate (20.0%vs 4.0%, P= 0.021) and mean operation time (27.3 vs 19.6 minutes, P= 0.006) were seen when patients were pre-medicated with spasmolytic agent and analgesia. The Essure permanent birth control device is safe and suitable for Asians. Its non-placement rate may be improved with pre-medication of spasmolytic agent and analgesia.

Hysteroscopic sterilisation: a study of women's attitudes to a novel procedure

Laparoscopy is the most common mode of surgery for female tubal sterilisation. Hysteroscopic sterilisation is a new method which can be performed in the outpatient setting under local anaesthetic. We carried out a prospective cohort trial to determine whether women would actually favour hysteroscopic sterilisation over laparoscopic sterilisation. Data analysis in a cohort of 96 women showed that 77% would prefer laparoscopic sterilisation over the hysteroscopic procedure (23%), despite the advantages of an outpatient setting. Age, obstetric history, employment and marital status, access to transport and previous anaesthetic did not significantly influence the choice made.

Ultrasound: An effective method for localization of the echogenic Essure sterilization micro-insert: Correlation with radiologic evaluations

To examine the reliability and practicality of performing office-based transvaginal ultrasound for determining the ease of locating the Essure hysteroscopic sterilization micro-insert and compare its usefulness against established radiologic evaluations. Prospective single-center, single-arm, clinical study (Canadian Task Force classification xx). Hospital-based clinical research center. One hundred forty-five women of reproductive age and proven fertility. Thirty-seven women who underwent the Essure hysteroscopic method of sterilization had routine radiologic and transvaginal ultrasound assessments for determining the retention of these micro-inserts from 3 months to 2 years after placement. An additional 108 women had ultrasound assessment as the only means of micro-insert localization 3 months after placement. The 145 women (100%) who underwent an ultrasound assessment at a 3-month, posthysteroscopic-sterilization office visit had their micro-inserts readily identified and localized to the uterotubal area due to the micro-inserts' dense echogenic properties. For the 37 women who had both assessments, the ultrasound findings correlated with pelvic radiograph and hysterosalpingogram assessments of micro-insert location in all instances. In addition, the ultrasound evaluations provided additional information about the micro-inserts relative position to the surrounding, less-echogenic soft tissue structures of the upper uterotubal area. In the 37 women who had serial ultrasound and radiologic evaluations performed for up to 2 years after micro-insert placement, ultrasound was found to be equally effective in identifying the location of the micro-inserts and indicted that their position remained identifiable and stable over time. A single transvaginal ultrasound in-office examination, performed 3 months after hysteroscopic micro-insert placement, was found to be a simple, reliable, and convenient method of assessing micro-insert location, when compared with radiologic assessments.

Concomitant use of balloon endometrial ablation and hysteroscopic sterilization in a septate uterus

Concomitant use of balloon endometrial ablation and hysteroscopic sterilization in a septate uterus

Essure Hysteroscopic Sterilization: Results Based on Utilizing a New Coil Catheter Delivery System

Study Objective To assess the safety and placement effectiveness of a new delivery catheter for the Essure micro-insert hysteroscopic sterilization system. Design Prospective, multicenter, single-arm clinical study. (Canadian Task Force classification II-3). Setting Hospital-based clinical research centers. Patients One hundred two women of reproductive age and proven fertility. Intervention A new coil catheter delivery system was used for micro-insert placement. Measurements and Main Results The bilateral placement of micro-inserts using the coil catheter delivery system occurred in 100 women out of 102 attempts (98%). The two women who did not have successful micro-insert placement were subsequently shown to have proximal tubal stenotic disease. Conclusion These findings indicate that the introduction of the coil catheter delivery system for Essure hysteroscopic sterilization improves the micro-insert bilateral placement rate when compared with previous studies. It is hypothesized that the coil catheter has superior navigational properties, particularly within tortuous or narrowed tubal lumens.

Hysteroscopic tubal sterilization in the unusual situation

Hysteroscopic tubal sterilization in the unusual situation

Adiana hysteroscopic sterilization: Interim results of the EASE clinical trial

Adiana hysteroscopic sterilization: Interim results of the EASE clinical trial