VIII. Possible Complications/ Risks/ Adverse Events

Unsuccessful Attempts

A variety of technical and or procedural issues may arise when performing the Essure procedure, a trouble shooting guide provided by Conceptus, Inc. has categorized these into the following major steps: 1) introducing the hysteroscope, 2) achieving uterine distention, 3) achieving ostial visualization, 4) advancing the micro-insert into the fallopian tube, 5) deploying the micro-insert. In the advent of unilateral or bilateral micro-insert placement failure the patient should be informed that she has not achieved permanent contraception, and should be counseled about the opportunity to undergo a second attempt. If the second procedure fails the patient is unlikely to have success at subsequent attempts. If the patient chooses laparoscopic sterilization both fallopian tubes should be clipped or coagulated in the ampullary portion of the fallopian tube and not at a portion of the tube containing a micro-insert.

Possible Adverse Events and Complications

In the coil catheter study, the patient who did not demonstrate bilateral occlusion at HSG had experienced a tubal perforation. Other possible adverse events are vaso-vagal response, device expulsion or migration, device proximal band detachment, broken device tip. None of these has clinical sequelae.

Possible Minor Side Effects

• Post-procedure pain: In the coil catheter study post-procedure pain was reported by 68 of 98 (69%) respondents. Thirty women (31%) experienced some pain during the first week; 16 reported it as mild, 10 as moderate, and four as severe. In recent publication there was a comparison between Essure versus laparoscopic sterilization which concluded pain was less following the Essure procedure versus laparoscopic sterilization (31% vs. 63% respectively, P=0.008). 21 Data of Radha Syed and Sultana Khimani presented at the 2005 American College of Obstetrics and Gynecology annual clinical meeting, comparing laparoscopic sterilization and Essure, where the primary end point was post-procedure pain, concluded that patient report of pain was higher in the laparoscopic group than the Essure group. The mean pain score being 5.7 on the analog pain score in the laparoscopic group versus 1.3 in the Essure group. Additionally patients requiring pain medications post-procedure was 75% in laparoscopic group versus 5% in Essure group. 22

• Post-procedural bleeding: At one-week follow-up during the coil catheter study, light vaginal bleeding or spotting was experienced by 56 of the 98 (57%) women for up to one week following the procedure.

• Nausea/ Vomiting: In the same study post-procedure recovery was reported as uneventful by 99 (97%) of the women, and 3 (3%) experienced some nausea and vomiting on the day of the procedure.

• Over absorption of infusion fluid: This is a rare occurrence which is manifested when routine protocol for hysteroscopic procedures is not followed. Intake and output of infusion fluid must be appropriately accounted for and procedure completion is ideally performed within twenty minutes to reduce this risk. If this complication is recognized by patient complaining of shortness of breath or noted by anesthesiologist appropriate action must be taken by administering intravenous diuretics and terminating the procedure.
• Undiagnosed pregnancy at time of device placement: A pregnancy test prior to the Essure procedure or scheduling this procedure in the first half of the menstrual cycle will obviate this complication. On rare occasions if the procedure is performed in the second half of the cycle women can be unknowingly pregnant at the time of the procedure. The effects of micro-inserts on a developing fetus are unknown.
• Pregnancy and ectopic pregnancy: No method of birth control is one hundred percent effective. Essure has been shown in clinical studies to be 99.74% effective at five years. Ectopic pregnancies have not been reported so far in any clinical study, but the clinical possibility exists and therefore the patient must be instructed that if she suspects that she may be pregnant or has delayed menses she must report it to her physician immediately for further investigation.
• Changes in menstrual cycle: In clinical studies there were temporary changes in the menses either heavier or more prolonged or inter-menstrual spotting. However, none of these changes were reported as permanent.
• Pelvic/Back/Abdominal Pain: There were rare episodes of pelvic, back, and abdominal pain following the Essure procedure, but very few women reported persistent pain.
• Anesthesia risk: The risk of general anesthesia or local anesthesia when used during the Essure procedure are similar to that of any procedure and treatment should be customized to particular situations.
• Infection: Infection is rare and may include fever, vaginal discharge or odor. Severe pelvic pain may dictate investigation and intravenous antibiotics.
• Risk of hysterosalpingogram (HSG): Those patients who have known allergies to intravenous contrast dye should avoid the Essure procedure as this is an integral part of the follow-up required by the FDA. Also, there is mild risk of pelvic infection with the use of HSG.
• Risk of future medical procedures: If the patient requires dilatation and curettage, endometrial biopsy it is possible that the portion of the micro-insert that is trailing within the uterine cavity maybe be snagged during these procedures. If a tubal procedure is required, especially electrocautery, the proximal segment of the fallopian tube must be avoided. An invitro fertilization (IVF) procedure may face interference with the trailing portions of the outer coils and therefore impair successful implantation of the fertilized eggs. Only one publication has thus far reported successful IVF resulting in the live birth of healthy twins post-Essure. 23
• MRI and micro-inserts: Micro-inserts have been found to be safe at the standard MRI field strength. No substantial temperature increases were observed, presenting no heat-related risk to tissue. And, the micro-insert did not pose an impediment to diagnostic accuracy. An exception may be if the area of interest to be imaged is in exactly the same position as the insert. 24

IX. Future Strategies

Hysteroscopic sterilization has revolutionized women’s health care delivery. This technique is an office based procedure which can be performed in any standard examination room because it’s non-incisional and non-invasive. In most instances intravenous sedation is not required, and is relatively comfortable for the patient. In this respect, the Essure procedure exemplifies the benefits of hysteroscopic sterilization. There are other companies examining transcervical sterilization techniques which have yet to be FDA approved. Amongst them is the Adiana procedure, manufactured in Australia. 4 The Adiana procedure, like the Essure procedure involves hysteroscopic placement of devices that rely on both mechanical occlusion and stimulation of tissue in-growth to effect tubal occlusion.

The Adiana sterilization method is a combination of controlled thermal damage of the endosalpinx and insertion of a biocompatible matrix within the tubal lumen hysteroscopically. The thermal injury to the endosalpinx is aimed at removing the epithelium. Healing brings fibroblast into direct contact with the matrix which soon becomes colonized with the fibroblast. Then tissue in-growth effects occlusion of the lumen, and simultaneously anchors the matrix in place. The procedure is performed under hysteroscopic control and on an average takes fifteen minutes. It is performed under local anesthesia, with occasional intravenous sedation. The histology of the tube demonstrates the incorporation of tissue in-growth into the matrix at twelve weeks post-procedure.

The device is currently being investigated in an FDA study in the United States, and in Australia, and Mexico. 25 It can delivered to more than ninety percent of the tubes, has a high success rate of pregnancy prevention (over 99% in studies to date), and has a high patient satisfaction rate. 376 women have had the procedure performed, with 353 bilateral placements. 273 women have had a three-month HSG demonstrating tubal occlusion. There have been a total of 2445 women months of device wearing and one pregnancy which occurred in a woman who had both devices placed in the same tube. The Adiana study is expected to be completed in 2006. The Essure procedure is the only FDA approved hysteroscopic sterilization technique currently in the United States.

X.Conclusion

Hysteroscopic sterilization is a technique whose time has come. In this era of minimally invasive female surgery hysteroscopic procedures offer not only a premium experience but also are devoid of serious complications of laparoscopy. The Essure device’s effectiveness as a permanent form of contraception has been established to be equal or superior to the existing standard sterilization technique of laparoscopic tubal ligation. This non-incisional method of permanent contraception is associated with rapid recovery, high patient satisfaction, and effective permanent contraception. Following placement there have been no serious side effects, nor the need for hospitalization. No pregnancies have occurred in a five year follow-up in those with proper bilateral placement of the micro-inserts.

The advantage of the hysteroscopic approach is that it offers a less invasive and taxing procedure that will appeal to all requesting interval tubal sterilization. Patient satisfaction approaches 96% and a great majority of women tolerated this procedure with either intravenous sedation or no sedation at all. 19 Most women are able to walk from the procedure room to the recovery room and can be discharged in forty-five minutes of the procedure. The most powerful predictor of return to normal activity is the total amount of pain experienced. With the Essure procedure the return to normal activity has been reported to be within 24 hours.

As more physicians are trained in this technique and the patient population educated as to the advantages and availability of hysteroscopic sterilization, the request for this modality is bound to exponentially increase. Healthcare expenses are constantly being evaluated in both developed and developing nations. Hysteroscopic sterilization has been shown to be more cost-effective than laparoscopic sterilization. 26 The cost of the Essure device is currently prohibitive for use in developing nations, but is likely to come down in the future so that there may be a world-wide application of this minimally invasive form of female sterilization. This technology most importantly offers a choice to the patient, and a safer alternative to transabdominal sterilization.

References

• WHO Part 1d
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• Corson SL, Derman RJ, Tyrer LB, eds. Fertility Control, 2 nd. London, Ontario, Canada: Goldin Publishers, 1995: 363-377.
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• Peterson HB, Xia Z, Hughes JM, Wilcox LS, Tylor LP, Trussell J, for the U.S. Collaborative Review of Sterilization Working Group, The risk of pregnancy after tubal sterilization: finding from the U.S. Collaborative Review of Sterilization, Am J Obstet Gynecol 174:1161, 1996.
• Kerin JF. Hysteroscopic sterilization: Long-term safety and efficacy (98). JMIG. September/October Supplement, 2005; 12(5).
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• William D. Mosher, Ph.D.; Gladys M. Martinez, Ph.D.; Anjani Chandra, Ph.D.; Joyce C. Abma, Ph.D.; and Stephanie J. Willson, Ph.D., Division of Vital Statistics: Use of Contraception and Use of Family Planning Services in the United States: 1982–2002.
• Jamieson DJ. Complications of Interval Laparoscopic Tubal Sterilization: Findings from the United States Collaborative Review of Sterilization. Obstet Gynecol 2000; 96:997-1002.
• Layde PM. Risk factors for Complication of Interval tubal Sterilization by Laparotomy. Obstet Gynecol ; 62: 180, 1983.
• Destefano F. Complications of Interval Laparoscopic Tubal Sterilization. Obstet Gynecol; 61: 153, 1983.
• Essure Permanent Birth Control: Physician Training Manual, by Conceptus, Inc. (CC-0386 11.04.02, TR2467-06 03/18/03)
• Kerin JF, Cooper JM, Price T, Van Herendael BJ, Cayuela-Font E, Cher D, Carignan CS. Hsyteroscopic sterilization using a micro-insert device: results of a multicentre Phase II study. Human Reproduction; Vol 18: 1223-1230, June 2003.
• Kerin J, Munday D, Ritossa M, Pesce A, and Rosen D. Essure hysteroscopic sterilization; Results based on utilizing a new coil catheter delivery system. J Am Assoc Gynecol Laparosc. August 2004, Volume 11(3); pp 388-393.
• Duffy S, Marsh F, Rogerson L, Hudson H, Cooper K, Jack S, Hunter D, Philips G. Female sterilisation: a cohort controlled comparative study of ESSURE versus laparoscopic sterilisation. BJOG. 2005 Nov;112(11):1522-8.
• Khimani S & Syed R. Comparative study between laparoscopic tubal sterilization and fallopian tube occlusion. Obstetrics and Gynecology. April 2005 Vol.105 (4), Supplement.
• Rosenfied R, Stones, R, Coates A, et al. Proximal occlusion of hydrosalpinx by hysteroscopic placement of microinsert before in vitro fertilization–embryo transfer. Fertility and Sterility. 2005; 83, No. 5; pp 1547-1550.
• Shellock F. New metallic implant used for permanent contraception in women: Evaluation of MR safety. American Journal of Roentgenology. June 2002; Volume 178; pp 1513-1516.
• Vancailie T. Adiana hysteroscopic sterilization: interim results of the EASE clinical trial. The American Association of Gynecological Laparoscopy Global Meeting, San Francisco, California USA, 2004.
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October 2006

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