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2007
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Essure® sterilization associated
with endometrial ablation.
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Int J Gynaecol Obstet. 2007 Mar 20; [Epub ahead of print]
Donnadieu AC, Deffieux X, Gervaise A, Faivre E, Frydman R, Fernandez H.
Univ Paris-Sud, Clamart, France; Service de Gynecologie-Obstetrique et Medecine de la Reproduction, Hopital Antoine Beclere, Assistance Publique-Hopitaux de Paris (AP-HP), Clamart, France.
OBJECTIVE: To evaluate the feasibility and the outcome of Essure® sterilization associated with different techniques of endometrial ablation. METHOD: Retrospective study conducted among 23 women with confirmed menometrorrhagia and with the desire for or the medical need for permanent tubal sterilization. Patients underwent combined hysteroscopic placement of Essure® and hysteroscopic endometrial resection procedures: ThermaChoice® (n=14), NovaSure® (n=4), Hydrothermablator® (n=2) and endometrial resection using monopolar energy (n=1), or bipolar energy (n=2). RESULTS: Fallopian tubes were successfully cannulated bilaterally in 87% of the cases (20/23). No adverse event was reported. Adequate bilateral occlusion was confirmed for all patients (20/20) by 3D ultrasound and pelvic X-ray at a 3-month follow-up. Furthermore, 85% of these patients were
satisfied with the results of the procedure, all experiencing a significant reduction in menstrual blood loss (Higham blood loss score). CONCLUSION: Combining EA and hysteroscopic sterilization seems to be feasible and effient in patients with menometrorrhagia.
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Tissue encapsulation of the proximal Essure
micro-insert from the uterine cavity following
hysteroscopic sterilization.
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J Minim Invasive Gynecol. 2007 Mar-Apr;14(2):202-4.
Kerin JF, Munday D, Ritossa M, Rosen D.
STUDY OBJECTIVE: To assess the interaction between the trailing ends of a sterilization micro-insert extending into the uterine cavity and the surrounding uterine tissue environment over time. DESIGN: Multicenter, retrospective observational study (Canadian Task Force classification II-1). SETTING: Hospital-based clinical research centers. PATIENTS: A subset of a study population of 545 women who had undergone a hysteroscopic sterilization procedure. INTERVENTION: A second-look hysteroscopy was performed in 22 (20 with uterine bleeding, 2 pre IVF) of these 545 women between 4 and 43 months from the sterilization procedure. MEASUREMENTS AND MAIN RESULTS: Over a mean time period of 19.73 months, the trailing coils of the micro-inserts into the uterine cavity shortened from a mean of 5.7 mm to 2.0 mm and from 5.4 mm to 1.8 mm on the right and left sides, respectively. In cases observed within 12 months or fewer post-procedure, the complete tissue encapsulation of both micro-inserts had already occurred in 17% of the observations. Among cases evaluated from 13 to 43 months post-procedure, 25% evidenced complete encapsulation. CONCLUSION: Two mechanisms appear to be responsible for this process. First, there is an initial mechanical "winding-in" of the micro-insert of approximately 1 rotation of its outer coil, accounting for 1 mm of its length, after release from its delivery system. Second, the tissue around the ostium appears to use the trailing coils of the micro-insert as a scaffolding structure, gradually encapsulating and excluding them from the uterine cavity. The gradual tissue exclusion of the micro-insert from the uterine cavity may make it pregnancy-compatible after in vitro fertilization and embryo transfer procedures.
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Successful pregnancy outcome with the use
of in vitro fertilization after Essure®
hysteroscopic sterilization.
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Fertil Steril. 2007 Mar 6; [Epub ahead of print]
Kerin JF, Cattanach S. Flinders Reproductive Medicine Unit, Flinders University, Adelaide, South Australia, Australia.
THIS PUBLICATION DOES NOT REFLECT CURRENT U.S. ESSURE PROCEDURE LABELING. THIS INFORMATION IS PROVIDED AS A COURTESY ONLY.
OBJECTIVE: To assess the compatibility of pregnancy after IVF and ET procedures with the presence of the Essure® microinsert. DESIGN: Prospective,single-arm, clinical study (Canadian Task Force classification III). SETTING:Clinical research center. PATIENT(S): Two women requesting IVF and ET procedures after Essure® microinsert sterilization. INTERVENTION(S): Hysteroscopic sterilization, followed by IVF and ET procedures. MAIN OUTCOME MEASURE(S):Successful implantation and pregnancy outcomes after IVF procedures. RESULT(S):Both patients underwent a second-look hysteroscopy within 3 months of an IVF procedure. Device encapsulation by tissue ingrowth reduced the average number of coils trailing into the uterine cavity from four to one, with no evidence of inflammation or any other abnormality. One woman conceived in her second IVF cycle after the transfer of two embryos, and the second woman conceived in her first cycle after the transfer of 1 embryo. Ultrasound showed that the proximal echogenic segments of the microinserts remained >/=10 mm distant from the pregnancy sac. Both women had spontaneous vaginal deliveries of healthy female infants. Postpartum ultrasound demonstrated that the microinserts maintained their prepregnancy utero-tubal locations. CONCLUSION(S): The Essure microinsert used for hysteroscopic sterilization may be compatible with implantation and successful pregnancy outcomes after IVF.
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Retrospective cost analysis comparing Essure hysteroscopic sterilization and laparoscopic bilateral tubal coagulation.
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J Minim Invasive Gynecol. 2007 Jan-Feb;14(1):97-102.
Hopkins, MR, Creedon DJ, Wagie AE, Williams AR, Famuyide AO. Department of Obstetrics and Gynecology, Mayo Clinic, Rochester, Minnesota
55905, USA.
STUDY OBJECTIVE: To compare the institutional cost of permanent female
sterilization by Essure hysteroscopic sterilization and laparoscopic bilateral
coagulation. DESIGN: Retrospective cohort study (Canadian Task Force
classification II-2). SETTING: Midwestern academic medical center. PATIENTS:
Women of reproductive age who elected for permanent contraception by the Essure
method (n = 43) or by laparoscopic tubal coagulation (n = 44) during the time
frame studied. INTERVENTIONS: Placement of the Essure inserts according to the
manufacturer's instructions or laparoscopic tubal sterilization using bipolar
forceps according to standard techniques of open or closed laparoscopy.
MEASUREMENTS AND MAIN RESULTS: Cost-center data for the institutional cost of
the procedure was abstracted for each patient included in the study. In
addition, demographic data and procedural information were obtained and compared
for the patient populations. The Essure system of hysteroscopic sterilization
had a significantly decreased cost compared with laparoscopic tubal
sterilization when both procedures were performed in an operating room setting.
The decrease per patient in institutional cost was 180 dollars (p = .038). This
included the cost of the confirmatory hysterosalpingogram 3 months after Essure
placement and the cost of laparoscopic tubal occlusion by Filshie clip if the
Essure micro-inserts could not be placed. The majority of the cost was related
to hospital costs as opposed to physician costs. The Essure procedure had higher
costs for disposable equipment (p <.0001), but this was offset by higher charges
for operating room costs, which included the recovery room (p <.0001) and
pharmacy costs (p <.0001) in the patients in the laparoscopy group. CONCLUSION:
In our setting, the Essure hysteroscopic sterilization had significant cost
savings compared with laparoscopic tubal sterilization (p = .038). We believe
that our data represent the minimum of potential savings using this approach,
and future developments will only increase the cost difference found in our
study.
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2006
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Concomitant Essure tubal sterilization and Thermachoice endometrial ablation: feasibility and safety.
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Valle RF, Valdez J, Wright TC, Kenney M. Northwestern University Medical School, Chicago, Illinois 60611, USA.
OBJECTIVE: To evaluate the feasibility and safety of combining endometrial ablation (EA) with a thermal balloon endometrial ablation system (Gynecare Thermachoice IIIC Uterine Balloon Therapy System; Ethicon Inc., Somerville, NJ) and transcervical sterilization by intratubal insert (Essure Permanent Birth Control System; Conceptus, San Carlos, CA). DESIGN: Feasibility and safety studies. SETTING: University hospital in Chihuahua, Mexico. PATIENT(S): There were 40 volunteers in the feasibility study and 9 in the safety study, all requiring hysterectomies for benign uterine bleeding. INTERVENTION(S): In the feasibility study, both procedures were performed just before hysterectomy; in the safety study, thermocouples were inserted under the tubal serosa to assess heat transmission from the intratubal insert devices to the tubes and surrounding organs during EA. MAIN OUTCOME MEASURE(S): Completeness of EA and possible device dislodgement in the feasibility study; temperature readings in the safety study. RESULT(S): No disturbance of the intratubal insert devices was noted, and EA by the thermal balloon endometrial ablation system was complete visually and histologically, although small areas near the tubal ostia exhibited less endometrial destruction. Mean tubal temperatures ranged from 37.1 degrees C to 37.5 degrees C and did not reach the critical temperature of 45 degrees C. No damage to the tubes was noted. CONCLUSION(S): Performance of EA and sterilization with these two systems in a one-step approach is safe for women who require EA and permanent contraception.
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Sonography, CT, and MRI appearance of the Essure microinsert permanent birth control device.
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Wittmer MH, Brown DL, Hartman RP, Famuyide AO, Kawashima A, King BF. Department of Radiology, Mayo Clinic, 200 First St. SW, Rochester, MN 55905, USA. wittmer.michael@mayo.edu
THIS PUBLICATION DOES NOT REFLECT CURRENT U.S. ESSURE PROCEDURE LABELING. THIS INFORMATION IS PROVIDED AS A COURTESY ONLY.
OBJECTIVE: The purpose of this article is to describe the appearance and location of the Essure permanent birth control device on sonography, CT, and MRI. CONCLUSION: The Essure device has a distinct appearance and typical location that allow it to be accurately identified on sonography, CT, and MRI scans.
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Hysterosalpingography for assessing efficacy of Essure microinsert permanent birth control device.
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Wittmer MH, Famuyide AO, Creedon DJ, Hartman RP. Department of Radiology, Mayo Clinic, 200 1st St., SW, Rochester, MN 55902, USA.
OBJECTIVE: The Essure microinsert is a new U.S. Food and Drug Administration-approved method of birth control. The objective of this study is to report our initial experience using hysterosalpingography (HSG) to assess its efficacy for permanent tubal occlusion. CONCLUSION: The Essure microinsert produced tubal blockage in all patients. As this device may become more widely used, radiologists should be aware of the device's appearance and be able to assess device position and presence of tubal occlusion on HSG.
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A comparative study of hysteroscopic sterilization performed in-office versus a hospital operating room.
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Nichols M, Carter JF, Fylstra DL, Childers M; Essure System U.S. Post-Approval Study Group. Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, Oregon.
STUDY OBJECTIVE: To compare hysteroscopic female sterilization procedures performed in-office versus a hospital operating room (OR) among newly trained physicians. DESIGN: Multisite hospital operating rooms and physician offices. PATIENTS: Women desiring permanent hysteroscopic sterilization. INTERVENTION: Hysteroscopic female sterilization with the Essure system. MEASUREMENTS AND MAIN RESULTS: 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% vs 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%). CONCLUSION: There is no clear advantage to performing hysteroscopic sterilization in a hospital OR. Hysteroscopic sterilization can be performed safely and efficiently in an office setting.
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2005
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Female sterilization: a cohort controlled comparative study of ESSURE versus laparoscopic sterilization.
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| S Duffy, F Marsh, L Rogerson et al. BJOG: an International Journal of Obstetrics and Gynaecology. 2005; Volume 112; pp 1522-1528.
OBJECTIVE: To compare patient satisfaction, discomfort, procedure time, success rate and adverse events of hysteroscopic (ESSURE, Conceptus Inc, San Carlos, USA) versus laparoscopic sterilisation. DESIGN: Cohort controlled comparative study. SETTING: The day surgery and outpatient unit of three large UK hospitals. POPULATION: Eighty-nine women requesting sterilisation were enrolled into the study. METHODS: 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. MAIN OUTCOME MEASURES: 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. RESULTS: 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%). CONCLUSIONS: 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.
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Follow-up of successful bilateral placement of Essure micro-inserts with ultrasound.
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THIS PUBLICATION DOES NOT REFLECT CURRENT U.S. ESSURE PROCEDURE LABELING. THIS INFORMATION IS PROVIDED AS A COURTESY ONLY.
S. Veersema, M. Vleugels, A. Timmermans, et al. Fertility and Sterility. 2005; Volume 84 (6); pp 1733-1736.
OBJECTIVE: To evaluate the reliability of pelvic X-ray and transvaginal ultrasound to localize Essure microinserts (Conceptus, San Carlos, California) after successful placement in both fallopian tubes 3 months after placement. DESIGN: Prospective, observational study. SETTING: Gynecology departments at two teaching hospitals. PATIENT(S): One hundred eighty-two patients who underwent hysteroscopic sterilization by placement of Essure microinserts between August 2002 and August 2004. INTERVENTION(S): Transvaginal ultrasound, pelvic X-ray, and hysterosalpingography (HSG) 3 months after sterilization with Essure. MAIN OUTCOME MEASURE(S): Transvaginal ultrasound confirmation of correct localization of microinserts after a 3-month follow-up. RESULT(S): In 150 of 182 patients, confirmation of successful bilateral placement of two microinserts (300 devices) was possible. In 9 patients it was not possible to identify both devices with ultrasound, or there was doubt about the extension of the device through the uterotubal junction. The other 291 devices were identified as being in a good position. CONCLUSION(S): Hysterosalpingography at the 3-month follow-up after successful placement of Essure microinserts can be replaced by transvaginal ultrasonography. A 3-month follow-up with HSG after the Essure procedure is only required after unsatisfactory placements. In those patients in whom transvaginal ultrasonography cannot confirm satisfactory localization, a complementary pelvic X-ray should be performed.
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Hysteroscopic permanent tubal sterilization using a nitinol-dacron intratubal device without anaesthesia in the outpatient setting: procedure feasibility and effectiveness.
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P Litta, E Cosmi, G Sacco, et al. Human Reproduction. December 2005; Volume 20 (12); 3419-3422.
BACKGROUND: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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 anesthesia. |
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Ultrasound: An effective method of localization of the echogenic Essure sterilization micro-insert: Correlation with radiologic evaluations.
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THIS PUBLICATION DOES NOT REFLECT CURRENT U.S. ESSURE PROCEDURE LABELING. THIS INFORMATION IS PROVIDED AS A COURTESY ONLY.
JF Kerin and BS Levy. Journal of Minimally Invasive Gynecology. 2005 Jan-Feb;12(1):50-4.
STUDY OBJECTIVE: 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. DESIGN: Prospective single-center, single-arm, clinical study (Canadian Task Force classification xx). SETTING: Hospital-based clinical research center. PATIENTS: One hundred forty-five women of reproductive age and proven fertility. INTERVENTION: 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. MEASUREMENTS AND MAIN RESULTS: 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. CONCLUSION: 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.
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2004
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Essure: A new device for hysteroscopic tubal sterilization in an outpatient setting.
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A Ubeda, S Labastida, and S Dexeus. Fertility and Sterility. 2004 Jul;82(1):196-9.
OBJECTIVE: To evaluate the results of hysteroscopic placement of an intratubal device for permanent birth control in 85 women in an outpatient setting. DESIGN: Prospective, observational study. SETTING: Private university hospital. PATIENT(S): Eighty-five premenopausal women who asked for tubal sterilization by hysteroscopy between July 2002 and July 2003. INTERVENTION(S): Hysteroscopic placement of titanium-dacron intratubal devices in an outpatient setting. MAIN OUTCOME MEASURE(S): Procedure feasibility without anesthesia, success rate of device implantation, patient satisfaction, and confirmation of correct placement. RESULT(S): Successful placement was achieved in 81 patients (95%). Mean time elapsed between the start of hysteroscopy, placement of devices, and removal of optics was 9 minutes (range, 1-35 minutes). No intraoperative or postoperative complications were detected. Of 81 patients, 75 (93%) had abdominal x-ray performed at the third month; bilateral correct placement was confirmed in all of them. CONCLUSION(S): Essure is a safe, effective, and minimally aggressive procedure with satisfactory patient acceptance that does not require anesthesia or hospitalization. It seems to be a good alternative to laparoscopic tubal sterilization.
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2003
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Hysteroscopic sterilization using a micro-insert device: results of a multicentre Phase II study.
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JF Kerin, JM Cooper, T Price, et al. Human Reproduction. 2003 Jun;18(6):1223-30.
BACKGROUND: Unlike laparoscopic surgery for interval tubal sterilization, a hysteroscopic approach obviates surgical incision and requires only local anaesthesia or intravenous sedation. The safety, tolerability and efficacy of an hysteroscopically placed micro-insert device was evaluated. METHODS: A cohort of 227 previously fertile women participated in this prospective international multicentre trial. Micro-inserts were placed bilaterally into the proximal Fallopian tube lumens under hysteroscopic visualization in outpatient procedures. RESULTS: Successful bilateral micro-insert placement was achieved in 88% of women. The majority of women reported that intraprocedural pain was less than or equal to that expected, and 90% rated tolerance of the device placement procedure as good to excellent. Most women could be discharged in an ambulatory state within 1-2 h. Adverse events occurred in 7% of the women, but none was serious. Correct device placement was confirmed in 97% of cases at 3 months. Over 24 months follow-up, 98% of study participants rated their tolerance of the micro-insert as very good to excellent. After 6015 woman-months of exposure to intercourse, no pregnancies have been recorded. CONCLUSIONS: Hysteroscopic sterilization resulted in rapid patient recovery without unacceptable post-procedure pain, as well as high long-term patient tolerability, satisfaction and effective permanent contraception.
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Microinsert Nonincisional Hysteroscopic Sterilization.
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JM Cooper, CS Carignan, D Cher, et al. Journal of Obstetrics and Gynecology. 2003 Jul;102(1):59-67.
OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
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2001
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Tissue response to the STOP microcoil transcervical permanent contraceptive device: Results from a prehysterectomy study.
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R Valle, C Carignan, T Wright and the STOP Prehysterectomy Investigation Group. Fertility and Sterility. 2001 Nov;76(5):974-80.
OBJECTIVE: The present study examines the safety, effectiveness, and local tissue response for a new transcervical fallopian tube permanent contraceptive device, the STOP device (Conceptus, Inc., San Carlos, CA). DESIGN: Nonrandomized prospective evaluation of tubal occlusion and histologic response. SETTING: Inpatient, university and university-affiliated medical centers in the United States and Mexico. PATIENT(S): Premenopausal and perimenopausal women with benign indications for hysterectomy who were able to defer their hysterectomy for 1 to 13 weeks. INTERVENTION(S): A transcervically placed microcoil (STOP device) was inserted into the fallopian tubes of women who were scheduled for hysterectomy, and the device was worn for 1 to 12 weeks. At hysterectomy, hysterosalpingography was done to determine tubal occlusion; subsequently, the tubes containing the STOP devices were processed, sectioned, and evaluated to determine the histologic response. MAIN OUTCOME MEASURE(S): Ability to place a device and evaluate tubal occlusion and tissue response. RESULT(S): Devices were placed in 33 women, representing 57 tubes; the women wore the devices from 1 day to 30 weeks. Histology on 27 women (47 tubes) showed an acute inflammatory and fibrotic response in the short term that, over time, became a chronic inflammatory response with extensive fibrosis. CONCLUSION(S): The localized tissue response and notable absence of any normal tubal architecture in the segment of the fallopian tube containing the STOP device supports the postulated mechanisms of action of the device. Prehysterectomy study findings suggest the usefulness of the STOP device for pregnancy prevention, this is being evaluated in long-term safety and effectiveness studies.
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