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Background
The Essure Miro-Insert System is an FDA-approved hysteroscopic approach to tubal sterilization. The primary advantages of the Essure System over other techniques of female sterilization are that the Essure System is non-incisional and sterilization can be performed without general anesthesia. Using a hysteroscopic approach, one Essure micro-insert is placed in the proximal section of each fallopian tube lumen. The micro-insert expands upon release, acutely anchoring itself in the fallopian tube. The micro-insert subsequently elicits a benign tissue response. Tissue in-growth into the micro-insert anchors the device and occludes the fallopian tube, resulting in sterilization. FDA approval of the Essure System was based on the results of a Phase III clinical trial involving 518 sexually active reproductive-age women who underwent a placement procedure. The Essure System was reported to be 98 percent effective in preventing pregnancy after two years follow up. The primary endpoints of the Phase III study of Essure were pregnancy prevention, safety of the placement procedure, and safety of long-term use. Secondary endpoints included patient satisfaction and bilateral placement rate. Bilateral placement rate was 86% on 1st attempt and 90% on 2nd attempt. Average hysteroscopy time was 13 minutes, and average procedure time was 35 minutes. Nichols et al (2006) compared hysteroscopic female sterilization with the Essure system performed in-office versus a hospital operating room (OR) among newly trained physicians. Procedure time (scope in/scope out time), device placement rates, and incidence of complications and adverse events were compared. There was no significant difference in scope time between the 2 settings. There was no significant difference in placement rates, although the placement rate was somewhat higher in-office (91 % versus 88 %). There were no complications among any of the procedures, and the incidence of minor adverse events was extremely low in both settings (OR = 2 %, in-office = 1 %). The authors concluded that thereis no clear advantage to performing hysteroscopic sterilization with the Essure system in a hospital operating room. Hysteroscopic sterilization can be performed safely and efficiently in an office setting. In an observational, multi-center, 6-month study, Panel and Grosdemouge (2008) evaluated a new hysteroscopic method of tubal sterilization; specifically, to examine the factors associated with placement failure of Essure implants. A total of 7 gynecology clinics, including 5 public hospitals and 2 private clinics; and a total of 495 women who provided informed consent were included in this study. All procedures were done by a vaginoscopic approach with a 5-mm operating hysteroscope. Data collected were age, parity, type of anesthesia, pre-medication, endometrial aspect, ostia visualization, duration of the procedure, pain during the procedure, and associated procedures. Unilateral and bilateral placement rates were assessed. Adverse events at 3 months (e.g., expulsion, migration, perforation) were also recorded. Mean parity was 2.45; 20 women were nulliparous. In 56.3 % of cases (n = 277), none or local anesthesia was used for the placement procedure. Overall, 86 % of the women (n = 423) had non-steroidal anti-inflammatory drug (NSAID) pre-medication, and 8.1 % (n = 40) had another intra-uterine surgical procedure performed at the same time. In 24 cases, at least one of the tubal ostia could not be visualized well during hysteroscopy. The authors concluded that the failure rate for Essure micro-insert placement was 6 % at first attempt and 3.3 % after two attempts. Success rate was not significantly associated with parity, mode of analgesia, NSAID pre-medication, or combination with another procedure. The only factor significantly associated with the failure rate was poor visualization of the tubal ostia. An assessment by the National Institute for Health and Clinical Excellence (NICE, 2009) concluded that current evidence on the safety and efficacy of hysteroscopic sterilization by tubal cannulation and placement of intrafallopian implants is adequate to support the use of this procedure. Vancaillie and colleagues (2008) evaluated placement efficacy and reliability of a an intra-tubal occlusion device, the Adiana System for Transcervical Sterilization, for permanent contraception and assessed tolerability and overall satisfaction. A total of 770 women with known parity were recruited to participate in a prospective, multi-center study. Bipolar, low-level radiofrequency energy delivery and porous silicon inserts were used. Inserts were placed bilaterally in the fallopian tube lumen. Subsequent bilateral occlusion was assessed with hysterosalpingography. Overall, bilateral placement success was achieved in 611 of 645 women (95 %). Bilateral occlusion was confirmed in 570 of 645 (88.4 %). The 1-year pregnancy prevention rate as derived with life-table methods was 98.9 %. The authors concluded that this transcervical sterilization system offers an effective contraceptive method, which was well-tolerated and had a high satisfaction rate. Palmer and Greenberg (2009) compared the available data on transcervical sterilization procedures (Essure and Adiana) to study the strengths and weakness of each system. The authors reported that the Essure implants have been offered to women in the U.S. for 7 years and have proved to be safe, effective, and well-tolerated. On the other hand, the experience with the Adiana system is limited (with only 12-month data). However, results from the pivotal study provided important clinical information. As with the Essure implants, the Adiana system appears to be well-tolerated with low rates of side effects, although more data are clearly needed. The overall bilateral placement rates for both systems are similar (94 % to 95 %), and the rates of tubal occlusion following hysterosalpingography are comparable. There have been no reported pregnancies after Essure implantation from the phase II and pivotal clinical trials. Results from the Evaluation of the Adiana System for Transcervical Sterilization study (Vancaillie et al, 2008) indicated that the cumulative failure rate of the Adiana system using life-table methods was 1.07 % at the primary endpoint of 1 year, which falls within the range of other sterilization methods (0 to 2.4 %). On July 6, 2009, the FDA approved the Adiana Permanent Contraception System for women who desire permanent birth control by occlusion of the fallopian tubes. Appendix Hysteroscopic tubal sterilization is contraindicated in any woman who: Is uncertain about her desire to end fertility; or Can have only occlusion device placed (including members with apparent contralateral proximal tubal occlusion and members with a suspected unicornuate uterus); or Has previously undergone a tubal ligation.
Hysteroscopic tubal sterilization is also contraindicated for women with any of the following conditions: Pregnancy or suspected pregnancy; or Delivery or termination of a pregnancy less than 6 weeks before occlusion device placement; or Active or recent upper or lower pelvic infection; or Known allergy to contrast media or known hypersensitivity to nickel confirmed by skin test.
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