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.
"The Essure™ system is a minimally invasive alternative for permanent female sterilization.4–6 Essure™ utilizes a transcervical hysteroscopic approach to place permanent microinserts into the fallopian tube ostia bilaterally. "
[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.
"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.
Human Reproduction 01/2006; 20(12):3419-22. DOI:10.1093/humrep/dei232 · 4.57 Impact Factor
"A. Magos, L. Chapman / Obstet Gynecol Clin N Am 31 (2004) 705–719 715 There has been a three-phased international multicentered study that looked at different aspects of the microinsert device . The most recently published was between May 2000 and February 2001 enrolling 518 previously fertile women of childbearing age seeking permanent birth control. "
[Show abstract][Hide abstract] ABSTRACT: This article provides an overview of the history of hysteroscopic sterilization including the current state of the art and future ideals. Unlike laparoscopic techniques, sterilization by hysteroscopy can be performed in an outpatient setting without general anesthesia. Many attempts have been made to develop a safe and effective method, but until recently, without success. The Essure system is the first one that seems to be a realistic alternative to laparoscopic sterilization, but is irreversible. The search is still on for the optimum method of hysteroscopic sterilization.
Obstetrics and Gynecology Clinics of North America 10/2004; 31(3):705-19, xii. DOI:10.1016/j.ogc.2004.06.007 · 1.38 Impact Factor
Data provided are for informational purposes only. Although carefully collected, accuracy cannot be guaranteed. The impact factor represents a rough estimation of the journal's impact factor and does not reflect the actual current impact factor. Publisher conditions are provided by RoMEO. Differing provisions from the publisher's actual policy or licence agreement may be applicable.