Hysteroscopic Sterilization Research Articles

Unilateral Placement of the Adiana Device after Failed Bilateral Placement of the Essure Device for Hysteroscopic Sterilization

This case report outlines the successful completion of hysteroscopic sterilization using the Adiana Permanent Contraception device (Hologic, Inc., Bedford, MA) after failure of multiple attempts to bilaterally place the Essure Permanent Birth Control system (Conceptus Inc., Mountain View, CA). The patient desired hysteroscopic sterilization using the Essure system. Although the first coil was easily placed in the right ostium, the second coil could not be passed beyond 2.4 cm into the left ostium. Inasmuch as the Adiana system needs to be passed only 1.4 cm into the ostium, this was found to be adequate for appropriate placement of the implant. Adiana may be an effective alternative to Essure, especially in patients in whom tubal stricture or spasm prevents Essure placement.

Hysteroscopic sterilization with Essure® device in situ: a challenge?

Hysteroscopic sterilization through the Essure® method is preferably performed in the outpatient department without any form of anesthesia. This approach requires the hysteroscopic skills of the gynecologist to use the vaginoscopic route. Initially, the manufacturer advised to remove any type of intrauterine device (IUD), 1 month before the procedure, to prevent difficult procedures and also to increase the success rate of placement. This observational prospective study analyzed the outcome in women in where the IUD was left in the uterus during the sterilization. During a period of 2 years, all women have been included consecutively in seven public hospitals located in France and the Netherlands. During this procedure, 32 out of 239 IUDs had to be removed to finish the sterilization successfully. The placement success rate was 97%. Placement failures were not related to the IUD being present at the time of the procedure. At confirmation tests 3 months after insertion of the Essure®, only five tubes were still patent. No complications were registered. Pain was recorded, and women responded well on oral nonsteroidal anti-inflammatory drug medication. The IUD did not need to be removed before the start of the hysteroscopic sterilization; only in case the procedure could not be completed, the IUD had to be removed during the sterilization itself. Placement rate was 97.1%.

Cost analysis of hysteroscopic sterilization versus the intrauterine device as long-term contraception

The intrauterine device (IUD) is effective as laparoscopic tubal sterilization (LS), reversible and more cost effective in a 5 year model. Hysteroscopic sterilization (HS) is less invasive, as or more effective than LS. Published HS cost data addresses short term costs rather than the long term societal perspective. We compared the cost of HS with IUD for long-term contraception using decision analysis modeling incorporating clinical outcomes

Committee Opinion No. 458: Hysterosalpingography After Tubal Sterilization

The U.S. Food and Drug Administration has approved two devices for hysteroscopic tubal sterilization. To minimize the failure rates of these effective methods, it is important for health care providers to understand the important role hysterosalpingography (HSG) plays in any hysteroscopic tubal sterilization procedure. The purpose of this Committee Opinion is to emphasize the necessity of performing HSG 3 months after hysteroscopic tubal sterilization and to identify factors that may interfere with performance of an adequate HSG assessment.

Assessment of three-dimensional ultrasound examination classification to check the position of the tubal sterilization microinsert

To assess the accuracy of three-dimensional (3D) ultrasound to determine the position of Essure microinserts. Prospective observational study. Gynecology department in a teaching hospital. Forty women who underwent hysteroscopic sterilization from March through October 2008. Both 3D ultrasound and hysterosalpingography (HSG) were performed 3 months after the procedure to verify device position. Positions seen on 3D ultrasound were classified in four categories: a perfect position (1 + 2 + 3), a proximal position (1 + 2), a distal position (2 + 3), and a very distal position (3-only). MAIN OUTCOME AND MEASURE(S): Microinsert position on 3D ultrasound and correlation with HSG. Overall, 93% of the devices for 40 patients were found to have been placed successfully. The final sample comprised 64 Essure devices. HSG showed tubal patency for only three devices, all classified as 3-only. No tubal permeability was noted for the other 61 positions. This 3-only location on 3D ultrasound was statistically associated with a failure of sterilization in comparison with the other locations (3/16 [18%] vs. 0/48 [0%]). 3D ultrasound is a simple and reproducible technique to assess the position of the Essure microinsert and appears to protect most patients from the negative aspects of pelvic radiography and of HSG. Using the 3D ultrasound classification presented in this study appears to make it possible to use HSG for backup confirmation only when Essure is found to be in the 3-only position on 3D ultrasound.

Camera trocar lifting in office gasless laparoscopic sterilization under local anesthesia

We evaluated 35 cases of a mechanical approach to abdominal wall lifting, used in office-based gasless laparoscopic sterilization under local anesthesia. Lifting of the abdominal wall, using the camera trocar as an anchoring device and complemented by suprapubic lifting by means of a towel clamp, led to passive intra-abdominal air filling, giving sufficient space to identify, anesthetize, coagulate and cut the Fallopian tubes. Only mild sedation was necessary. All women walked to and from the operating room. All had successful tubal ligation. The overall satisfaction rate was 97%. The mechanical lifting moment was not painful. With the exception of one woman with failed tubal anesthesia, all women had a low mean pain score of 2.6 (VAS 0–10). No complications occurred except one wound infection. The costs were < ¼ of those of traditional laparoscopic sterilization and office hysteroscopic sterilization. This approach is effective for office-based laparoscopic sterilization. Room air, two strings and a needle replace active gas insufflation and narcosis.

Hysteroscopic Sterilization in Patients with a Mirena Intrauterine Device: Transition from Extended Interval to Permanent Contraception

Objective To estimate the feasibility and elucidate the benefits of performing hysteroscopic sterilization in patients who have a Mirena intrauterine device (IUD) in place. Design Retrospective case-controlled study with 3:1 ratio (Canadian Task Force Classification II-2). Setting Procedures were performed in an outpatient or office setting affiliated with an academic medical center. Hysterosalpingograms were obtained and interpreted jointly by an investigator and a radiologist using standard protocol. Patients Subjects included all patients undergoing hysteroscopic sterilization July 2007 thru December 2008 with a Mirena IUD in place. Patients without an IUD served as a comparison group. Interventions All procedures were performed with a 4.2-mm Bettocchi continuous-flow hysteroscope with saline solution insufflation. Delivery catheters were passed through a 5F operative channel. Essure implants were positioned and released per standard protocol. IUD devices were removed after confirmation of bilateral tubal occlusion. Measurements & Main Results There were 12 patients currently using a Mirena IUD for contraception who elected to undergo hysteroscopic sterilization. Procedures were performed in the usual manner. Chart review identified the most recently treated patients without an IUD in place matched for age and body mass index to study patients. Recorded details included age, body mass index, parity, procedure time, placement success, and tubal occlusion. There were no significant differences between the groups with respect to any metric except completion of the 3- month hysterosalpingogram. Conclusion Hysteroscopic sterilization can be performed successfully with a Mirena IUD in place. Advantages include flexibility in timing of the procedure, assurance of contraception until confirmation of tubal occlusion, and increased likelihood of appropriate follow-up.

Transcervical Sterilization

Sterilization is frequently chosen as a method of permanent contraception. Traditional approaches involve surgery under anesthesia in an operating room and are associated with a recovery period and scars. Transcervical sterilization is an incision-free, minimally invasive approach to sterilization. When compared with laparoscopic surgery, transcervical hysteroscopic sterilization does not need to be performed in an operating room, requires less anesthesia, has a shorter recovery period, and is more cost effective. The Essure Permanent Birth Control System (Conceptus, Inc., Mountain View, CA) and Adiana Permanent Contraception System (Hologic, Inc., Bedford, MA) are two available hysteroscopic sterilization techniques. They cause fibrosis and tubal occlusion over a 3-month period so women must use an alternative form of contraception during the first 3 months. A 3-month hysterosalpingogram confirms successful placement and tubal occlusion. Transcervical sterilization is similarly effective to other sterilization methods and is satisfactory to women.

Paracervical Block Efficacy in Office Hysteroscopic Sterilization

To estimate the efficacy of paracervical block compared with saline for pain relief during office hysteroscopic sterilization. This study was a randomized, placebo-controlled study of women desiring hysteroscopic sterilization. A paracervical block of 1% lidocaine or normal saline was administered before office hysteroscopic sterilization. Patients and investigators were blinded to assignments. A pre hoc power analysis determined that 40 women would be required per arm to detect a difference of 0.9 cm on a visual analog scale. Pain was recorded on a visual analog scale at multiple procedure time points. Individualized standardized pain scores were constructed by weighted reporting of objective and subjective sensation. A total of 103 consecutive women were eligible, and 80 women were randomized, with 40 per group. Thirty-seven (93%) in each group had successful placement. The lidocaine group showed significantly lower pain scores for tenaculum placement (mean+/-standard deviation: 0.97+/-1.28 compared with 3.00+/-2.41, P<.001) traversing the external cervical os (1.46+/-1.71 compared with 3.77+/-2.68, P<.001) and internal os (1.79+/-2.11 compared with 4.10+/-2.77, P<.001). There was no significant observed difference with device placement in tubal ostium (3.15+/-2.69 compared with 3.74+/-2.73, P=.33). Multivariable linear regression analysis demonstrated a relationship of pain to procedural time (P=.047) and to group assignment (P<.01). Paracervical block with 1% lidocaine provides effective pain relief for cervical manipulations during office hysteroscopic sterilization, but does not reduce the pain associated with upper uterine/tubal manipulation when placing the devices. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00811187. I.

Paracervical Block Efficacy in Office Hysteroscopic Sterilization: A Randomized Controlled Trial

Paracervical Block Efficacy in Office Hysteroscopic Sterilization: A Randomized Controlled Trial

Frank Wright

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Hysteroscopic Sterilization in a Large Group Practice

To estimate device placement and tubal occlusion rates for hysteroscopic sterilization and evaluate risk factors for failure. Women undergoing hysteroscopic sterilization at Kaiser Permanente Northern California from January 2004 to December 2006 were identified. Risk factors assessed included age, parity, body mass index (BMI), operative location, and provider experience with the technique. Occlusion was determined by hysterosalpingogram. Univariable analyses were performed to identify factors predictive of successful placement and occlusion. The Cochrane-Armitage test was performed for trend analysis. Hysteroscopic sterilization was attempted in 884 women by 118 physicians at 30 Kaiser Permanente Northern California facilities. The initial placement attempt was successful in 850 patients (96.2%). Patient age, nulliparity, and BMI were not predictive of successful placement. Bilateral occlusion was demonstrated by hysterosalpingogram in 687 of 739 patients (93.0%). There were no significant differences in age, nulliparity, and BMI between those with and without occlusion. Loss to follow-up before a hysterosalpingogram was obtained was 13%. There was no significant increase in occlusion rate with experience (P for trend=.6). High placement and occlusion rates were noted from the first insertions, and success was not related to age, parity, BMI, or operator experience. III.

Transcervical hysteroscopic sterilization using cyanoacrylate: A long‐term experimental study on sheep

We investigated the transcervical hysteroscopy application of n-butyl-2-cyanoacrylate in the uterine tube lumen of a non-rodent animals (sheep) with fallopian tube dimensions similar those in humans. Standard hysteroscopic procedures were performed on female Texel sheep (n = 26). The right and left ostia were identified. For each ewe, a urethral catheter (5Fr) was used for the delivery of 0.5 mL of saline or an equal volume of n-butyl-2-cyanoacrylate into the uterine tube. Following the procedure, ewes were housed with males of proven fertility for 90 days (equivalent to 5.5 estrous cycles). Postmortem (dye and burst pressure) and in vivo (hysterosalpingogram) testing for tube patency were both performed 90 days and 180 days following the procedure. All animals receiving the saline treatment became pregnant. Gross inspection of uterine tubes following n-butyl-2-cyanoacrylate treatment revealed no visceral adhesions or fibrosis. However, postmortem testing revealed total obstruction within the fallopian tubes. This was confirmed by hysterosalpingogram, in that iodine contrast did not escape into the abdominal cavity. The cyanoacrylate promoted a reliable fallopian tube obstruction without fibrosis in an animal model exhibiting a similar tube diameter to that found in women. The technique can be evaluated for efficacy in vivo using hysterosalpingography.

Efficiency and Satisfaction of Hysteroscopic Tubal Sterilization with the Essure® System: A Four Years Retrospective Study

Study Objective: Hysteroscopic sterilization is a new approach to non-invasive sterilization for which there is currently little data in the literature. The purpose of this study was to assess the efficiency of this method based on proven tubal occlusion at post-operative hysterosalpingography and on the prevention of pregnancy. Secondary objectives were evaluation of patient tolerance, of patient satisfaction and reasons for no-show for post-operative hysterosalpingography follow-up.

Feasibility of Hysterosalpingography Following a Combined Radiofrequency Global Endometrial Ablation and Hysteroscopic Sterilization Procedure

Study Objective: To describe the feasibility of performing hysterosalpingography after patients undergo a combined radiofrequency global endometrial ablation and hysteroscopic sterilization procedure. Design: Descriptive feasibility study. Setting: Midwestern United States, academic medical center. Patients: Sixty-six women (ages 20–50) underwent radiofrequency global endometrial ablation followed by hysteroscopic sterilization during a single procedure for menorrhagia and permanent sterilization. Intervention: Evaluation of the rate and efficacy of hysterosalpingograms following the procedure. Measurements and Main Results: Sixty-six women underwent the combined procedure between January 2004 and January 2009. The inserts were successfully placed bilaterally in 65 of the 66 women. Of the 65 women, 50 (77%) women returned for the recommended hysterosalpingogram (HSG) at 3 months. Two of the 50 were unable to proceed with the test secondary to cervical stenosis. In all 48 of the women who where able to undergo HSG, the study was adequate to assess device placement and tubal occlusion. Three (3/48, 6.2%) women had unilateral tubal patency at three months. All of these women returned at 6 months with documentation of total occlusion of both ostia. Conclusion: Hysterosalpingography is a practical method to document tubal occlusion in women who undergo a combined radiofrequency global endometrial ablation and hysteroscopic sterilization procedure. Cervical stenosis is a rare complication that may preclude the use of HSG.

Essure® Tubal Sterilization Combined with Subsequent NovaSure® Endometrial Ablation: A Retrospective Analysis

Study Objective: To evaluate the safety and outcome of combining the Essure® tubal sterilization system followed by NovaSure® Endometrial Ablation prior to the 3-month Essure Confirmation Test(CoT) .Design: Retrospective cohort study of women who underwent Essure hysteroscopic sterilization followed by NovaSure EA between July 1, 2008 and April 15, 2009. All participants had menorrhagia and desired permanent sterilization. Demographic information, anesthesia type, bilateral placement rate, ablation treatment time, intra-operative and post-procedure complications, Essure confirmation results, and follow-up data were collected and reviewed.Setting: Private gynecologic practice in Indiana.Patients: 59 patients (ages 25-50) were identified who underwent Essure hysteroscopic sterilization followed by NovaSure EA in two in-office sessions separated by an average of 25 days.Intervention: All patients underwent Essure micro-insert placement followed by Novasure EA and had/are scheduled to have a(CoT).Measurements and Main Results: 25/59 patients completed the 3-month CoT. 24/25 patients underwent successful 3-month CoTs. At the 3-month CoT, 22 patients were noted to have bilateral occlusion, 2 patients had unilateral occlusion, and one patient could not tolerate the test. 34 patients are still in the 3-month waiting period prior to CoT. No adverse events have been reported in this cohort. Patients will be followed for the next 12 months for contraceptive and EA effectiveness.Conclusion: To date, in this retrospective medical chart review, Essure hysteroscopic sterilization followed by NovaSure EA, in women who desire permanent birth control and reduction of menorrhagia, appears to be safe and effective. In addition, the present data supports that a majority of 3-month CoTs can be obtained and evaluated post-NovaSure EA. Study Objective: To evaluate the safety and outcome of combining the Essure® tubal sterilization system followed by NovaSure® Endometrial Ablation prior to the 3-month Essure Confirmation Test(CoT) . Design: Retrospective cohort study of women who underwent Essure hysteroscopic sterilization followed by NovaSure EA between July 1, 2008 and April 15, 2009. All participants had menorrhagia and desired permanent sterilization. Demographic information, anesthesia type, bilateral placement rate, ablation treatment time, intra-operative and post-procedure complications, Essure confirmation results, and follow-up data were collected and reviewed. Setting: Private gynecologic practice in Indiana. Patients: 59 patients (ages 25-50) were identified who underwent Essure hysteroscopic sterilization followed by NovaSure EA in two in-office sessions separated by an average of 25 days. Intervention: All patients underwent Essure micro-insert placement followed by Novasure EA and had/are scheduled to have a(CoT). Measurements and Main Results: 25/59 patients completed the 3-month CoT. 24/25 patients underwent successful 3-month CoTs. At the 3-month CoT, 22 patients were noted to have bilateral occlusion, 2 patients had unilateral occlusion, and one patient could not tolerate the test. 34 patients are still in the 3-month waiting period prior to CoT. No adverse events have been reported in this cohort. Patients will be followed for the next 12 months for contraceptive and EA effectiveness. Conclusion: To date, in this retrospective medical chart review, Essure hysteroscopic sterilization followed by NovaSure EA, in women who desire permanent birth control and reduction of menorrhagia, appears to be safe and effective. In addition, the present data supports that a majority of 3-month CoTs can be obtained and evaluated post-NovaSure EA.

Feasibility of Hysterosalpingography To Evaluate Tubal Occlusion Following Concomitant Adiana® Transcervical Sterilization and NovaSure® Endometrial Ablation

Study Objective: To evaluate whether concomitant Adiana hysteroscopic sterilization with NovaSure endometrial ablation can limit the ability to perform a three month post-operative hysterosalpingogram (HSG) with pathology tissue correlation.

Evaluating the Learning Curve for a Novel Hysteroscopic Sterilization Technique

Evaluating the Learning Curve for a Novel Hysteroscopic Sterilization Technique

Confirmation Test after Essure: “Look for the Fourth Marker”

Study Objective: To instruct gynaecologists and radiologists about the importance to look for the fourth marker at HSG and plain X ray used as a confirmation test for hysteroscopic sterilization with Essure.

Factors Affecting Acceptability of Hysteroscopic Sterilization to Providing Physicians

Factors Affecting Acceptability of Hysteroscopic Sterilization to Providing Physicians