Microinsert nonincisional hysteroscopic sterilization

University of Adelaide, Tarndarnya, South Australia, Australia
Obstetrics and Gynecology (Impact Factor: 5.18). 08/2003; 102(1):59-67. DOI: 10.1016/S0029-7844(03)00373-9
Source: PubMed


To assess the safety, effectiveness, and reliability of a tubal occlusion microinsert for permanent contraception, as well as to document patient recovery from the placement procedure and overall patient satisfaction.
A cohort of 518 previously fertile women seeking sterilization participated in this prospective, phase III, international, multicenter trial. Microinsert placement was attempted in 507 women. Microinserts were placed bilaterally into the proximal fallopian tube lumens under hysteroscopic visualization in outpatient procedures.
Bilateral placement of the microinsert was achieved in 464 (92%) of 507 women. The most common reasons for failure to achieve satisfactory placement were tubal obstruction and stenosis or difficult access to the proximal tubal lumen. More than half of the women rated the average pain during the procedure as either mild or none, and 88% rated tolerance of device placement procedure as good to excellent. Average time to discharge was 80 minutes. Sixty percent of women returned to normal function within 1 day or less, and 92% missed 1 day or less of work. Three months after placement, correct microinsert placement and tubal occlusion were confirmed in 96% and 92% of cases, respectively. Comfort was rated as good to excellent by 99% of women at all follow-up visits. Ultimately, 449 of 518 women (87%) could rely on the microinsert for permanent contraception. After 9620 woman-months of exposure to intercourse, no pregnancies have been recorded.
This study demonstrates that hysteroscopic interval tubal sterilization with microinserts is well tolerated and results in rapid recovery, high patient satisfaction, and effective permanent contraception.

32 Reads
  • Source
    • "It is inserted in the oice, does not require general anesthesia, and has been shown to be more cost efective than laparoscopic sterilization[11]. It also does not require an incision and has a lower incidence of postoperative pain compared to surgical sterilization techniques[12,13]. he average time for the procedure is under ten minutes[1]. he procedure consists of placing the small, lexible Essure microinserts into the fallopian tubes via a catheter through the vagina and cervix. he inserts are made of polyethylene terephthalate (PET) ibers that cause an inlammatory reaction resulting in ibrosis, which occludes the fallopian tubes. "
    [Show abstract] [Hide abstract]
    ABSTRACT: . Hysteroscopic tubal sterilization (Essure) is a minimally invasive option for permanent contraception with high reported rates of patient satisfaction. A small percentage of these women subsequently choose to have the tubal inserts removed due to regret or perceived side effects such as late-onset pelvic pain secondary to placement of the Essure device. Case . A twenty-nine-year-old woman G4P4014 presented with a two-year complaint of chronic pelvic pain and dyspareunia after the hysteroscopic placement of an Essure device for sterilization. On reviewing the images of the HSG, it was noted that although tubal occlusion was confirmed, the left Essure coil appeared curved on itself in an elliptical fashion and did not seem to follow the expected anatomic trajectory of the fallopian tube. The patient reported resolution of chronic pelvic pain following laparoscopic removal of Essure device. Conclusion . A misplaced Essure device should be considered in the differential diagnosis of chronic pelvic pain in women who had difficult placement of the device. In addition to demonstrating tubal occlusion, careful examination of the configuration of the Essure microinserts on HSG examination provides valuable information in patients with pelvic pain after Essure placement.
    Full-text · Article · Jan 2016
  • Source
    • "Factors impeding bilateral placement from being possible include uterine anomalies and proximal tubal occlusion, tortuosity, spasm, or stenosis.3,4,15 In the Cooper et al study of 518 patients, placement of the Essure™ was not attempted in 2% because of uterine, cervical, or fallopian tube pathology preventing exposure of the tubal ostia.4 Anatomic factors, such as lateral tubes, endometrial polyps, uterine adhesions, stenotic tubes, obesity, and no visible tubal ostium, accounted for 77% of cases of failed bilateral placement in this 2003 study. "
    [Show abstract] [Hide abstract]
    ABSTRACT: The Essure™ system for permanent contraception was developed as a less invasive method of female sterilization. Placement of the Essure™ coil involves a hysteroscopic transcervical technique. This procedure can be done in a variety of settings and with a range of anesthetic options. More than eight years have passed since the US Food and Drug Administration approval of Essure™. Much research has been done to evaluate placement success, adverse outcomes, satisfaction, pain, and the contraceptive efficacy of the Essure™. The purpose of this review is to summarize the available literature regarding the efficacy, safety, and patient satisfaction with this new sterilization technique.
    Full-text · Article · Apr 2011 · Patient Preference and Adherence
  • Source
    • "After 11.5 months of follow-up, none of the women was pregnant, which is in accordance with other studies (Cooper et al., 2003; Litta et al., 2003; Teoh et al., 2003; Kerin et al., 2004; Menez and Lopes, 2004; Rosen, 2004; Shankar et al., 2004; Ubeda et al., 2004), although long-term follow-up is needed. Although there were no complications in the present study, which may be due to the small sample size, it should be stressed that several authors have reported a risk of malpositioning and expulsion of the devices, with an incidence ranging from 1.3% (Kerin et al., 2003) to 3.6%, and a risk of uterine perforation ranging from 0.9% to 2.6% (Cooper et al., 2003; Kerin et al., 2004). Kerin et al. (2004) described a perforation rate of 1%. "
    [Show abstract] [Hide abstract]
    ABSTRACT: 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.
    Full-text · Article · Jan 2006 · Human Reproduction
Show more