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Best practices for female sterilization in 2012 and beyond.

HISTORICAL PERSPECTIVE

Female sterilization remains the leading contraceptive choice for women in the United States who do not plan future childbearing, with over 40% choosing this option) While different techniques for obtaining tubal occlusion have been developed over the years, including using monopolar or bipolar electrosurgery, rings, or clips, these procedures all require entry into the peritoneal cavity using a transabdominal approach. Data from the US Collaborative Review of Sterilization, also known as the CREST study have examined both the failure and complication rates related to various sterilization techniques. Surprisingly, the cumulative 5-year failure rate for all techniques was much higher than previously reported (1.31%), and with the most popular technique, using bipolar current, the failure rate was 1.65%. These rates were found to increase over time, with the 10-year failure rate for laparoscopic bipolar tubal sterilization approaching 2.5%. (2) A subgroup of patients from the CREST study, who had undergone interval laparoscopic tubal ligation, had an overall complication rate of 1.6%. Of note, 0.9% of those scheduled to undergo a laparoscopic approach required conversion to laparotomy. The reasons identified for conversion to laparotomy included true laparoscopic complications, difficulty with the fallopian tube, failed entry, and detection of incidental disease. (3) The FIGURE examines failure rates for different methods of sterilization based on clinical data. (2,4,5)

Transcervical hysteroscopic sterilization

Over the past 10 years the transcervical hysteroscopic approach to tubal occlusion has proven to be an excellent option for women seeking permanent contraception. This technique takes advantage of recent innovations, such as miniaturization of endoscopes, continuous flow systems, and advanced cardiovascular technology, to facilitate access and improve the ability to accurately catheterize the fallopian tubes.The greatest advantage of the transcervical hysteroscopic approach is that it avoids entry into the peritoneal cavity and the associated complications. These procedures can be performed without general anesthesia and often in an office setting with minimal analgesia.

Until recently there were 2 options for performing hysteroscopic sterilization: the Essure device (Conceptus, Inc) and the Adiana device (Hologic, Inc). (NOTE: In May 2012, Hologic, Inc withdrew the Adiana device from the market.) The Essure device has been approved by the US Food and Drug Administration (FDA) since November 2002; the Adiana method was approved by the FDA in July 2009. The Essure insert traverses the uterotubal junction and is anchored in place using a nitinol coil. (6) Within this outer nitinol coil is an inner coil with polyethylene fibers. There is a 3-fold explanation for the Essure device's mechanism of action: first, the expandable outer coil is responsible for acute device anchoring; second, the device provides both space filling and mechanical blockage of the tubal lumen; and finally, occlusion is achieved as a result of a tissue in-growth from the tubal mucosa into and around the insert. Complete occlusion is currently confirmed with a hysterosalpingogram (HSG) 12 weeks after the procedure. The devices are radiopaque, which make them easily identifiable. Correct placement is established based on appropriate position of the inserts as well as tubal occlusion. Data from a pivotal trial show no pregnancies being reported from that cohort for the past 5 years. (6) Product labeling calculates the effectiveness of this technique to be 99.83% at 5-year follow-up. Bilateral placement rates in large cohort studies range from 92% to 99%. (7,8) In a recent publication examining the currently-marketed purple handle 305 Essure device, the average placement rate among 76 physicians, involving 576 patients, was 97%. (9) In comparison with the 5-year CREST data, which include nonhysteroscopic approaches, Essure appears to be the most effective form of sterilization. Unlike the techniques evaluated in the CREST study, there does not appear to be any significant drop off in effectiveness for Essure going out to 10 years.

The Adiana procedure worked by causing an electrosurgical insult to the intimal portion of the proximal fallopian tube using bipolar energy. A silicone matrix was placed in the area of the thermal injury. Data from the pivotal trial for the Adiana technique in 2008 showed similar bilateral placement rates to the Essure procedure. (9,10) The Adiana labeling gave an effectiveness rate of 98.41% at 4 years.

Advantages of hysteroscopic sterilization

The major advantage of hysteroscopic sterilization is the avoidance of entry into the peritoneal cavity, which has its inherent risks and morbidity. In addition, the lack of an incision, quick recovery, and ability to be performed in an office setting make this an excellent option for most patients. Hysteroscopy has a lower complication rate when compared to laparoscopy and even when a complication does occur it is most often not major.

The hysteroscopic approach to sterilization also yields many tangible and intangible advantages to patients, physicians, and the larger health care system. Women are afforded the benefits of an effective procedure that can be executed in an office setting, with minimal or no anesthesia. The placement rates are not affected by the site of performance (ie, office, ambulatory surgery center, or hospital), with multiple studies showing extremely high satisfaction rates for this procedure. (8,11) In fact, most cases can be performed in an office setting with just a nonsteroidal anti-inflammatory drug prior to starting. Many procedures are now performed vaginoscopically, avoiding the discomfort of placement of a speculum (see videos of the Essure procedure at www.obgmanage ment.com/Essure/Essure1.html and www.obgmanage ment.com/Essure/Essure2.html). Given the lack of an incision and anesthesia, as well as the rapidity with which this procedure can be executed (typically 10 minutes of hysteroscopy time), patients are able to return to normal activity almost immediately without any major loss of time from work or family life.

This procedure has been shown to be cost-effective, especially when performed in an office setting. (12,13) These savings are multifold and include the pure savings of moving a procedure out of the operating room (OR), an expensive and limited commodity that is better used for high-acuity procedures. This move also allows many women to pay just a small copay for an office visit rather than a higher sum until their deductible is met. Lastly, the physician benefits by being able to remain in the office, where several of these procedures could be performed, while seeing other patients. In the office, the physician and staff are responsible for the equipment and take pride and care to make sure that things run efficiently. Furthermore, having a hysteroscope in the office opens the possibilities of in-office diagnostic and operative hysteroscopy for abnormal uterine bleeding, polypectomy, retained intrauterine device (IUD) removal, and selective endometrial sampling, all of which are beneficial to patients.

Confirmatory hysterosalpingogram

Currently in the United States, patients are counseled to have a 3-month postoperative HSG in order to confirm location and tubal occlusion after placement of the Essure device. When patients have bilateral placement with proper positioning and bilateral occlusion demonstrated on HSG, the risk of pregnancy is negligible. In commercial use, as can be expected, there have been pregnancies. (14) As of 2010 there have been approximately 500,000 Essure kits sold with 748 pregnancies reported to the company. This number is far less than the 0.26% failure rate expected by the initial data for Essure and is very reassuring. Outside of the United States (in Europe and Australia), HSG is no longer used as the standard confirmatory test; it has been replaced with either flat plate x-ray or transvaginal ultrasound localization. A study is now ongoing within the United States to evaluate whether transvaginal ultrasound is an adequate technique to confirm device positioning.

Patient counseling and choices

Counseling patients prior to any permanent sterilization procedure is essential. Data from the CREST study show that most women express no regret after tubal sterilization; however, women aged 30 years or younger at the time of sterilization have an increased probability of expressing regret. (15) Therefore, consideration of all other reversible options must be discussed with patients prior to deciding on a permanent technique. Long-acting reversible contraception (LARC) is the most effective reversible form of contraception, as its effectiveness is not user dependent.

While LARC may be an excellent option for women who desire, or are not sure of their desire for, future fertility, data from the LARC Guideline Development Group show that female sterilization is overall more effective than all LARC methods. (16) Female sterilization was also found to be more cost-effective for patients seeking contraception that lasted longer than 6 years. Furthermore, LARC method use is associated with side effects, predominantly menstrual disturbances, which are among the major causes of discontinuation. Up to 43% of women discontinue IUD use at 4 years, with close to one-third stopping due to method-related reasons. (17)

Summary

Whereas sterilization has been available to women for more than 200 years, our oath to minimize risk and maximize outcomes and reliability should shift the paradigm from laparoscopic and laparotomic toward hysteroscopic sterilization. The benefits to society as a whole are convincing. The applicability for almost all women seeking sterilization, the high effectiveness rates, and the overall satisfaction make this approach very appealing to patients and their physicians. Hysteroscopic sterilization should be considered a best practice for physicians and their patients as we care for women in the 21st Century.

References

(1.) CDC. Female sterilization: summary of surgical sterilization in the United States: prevalence and characteristics, 1965-1995. http://www .cdc.gov/reproductivehealth/unintendedpregnancy/Sterilization Summary.htm. Published June 1998. Accessed August 8, 2012.

(2.) Peterson HB, Xia Z, Hughes JM, Wilcox LS, Tylor LR, Trussell J. The risk of pregnancy after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization. Am J Obstet Gynecol. 1996;174(4):1161-1168.

(3.) Jamieson DJ, Hillis SD, Duerr A, Marchbanks PA, Costello C, Peterson HB. Complications of interval laparoscopic tubal sterilization: findings from the United States Collaborative Review of Sterilization. Obstet Gynecol. 2000;96(6):997-1002.

(4.) Data on file. Conceptus, Inc.

(5.) Jamieson DJ, Costello C, Trussell J, Hills SD, Marchbanks PA, Peterson HB; US Collaborative Review of Sterilization Working Group. The risk of pregnancy after vasectomy [published correction appears in Obstet Gynecol. 2004;104(1):200]. Obstet Gynecol. 2004;103(5 Pt 1):848-850.

(6.) Essure[R] Permanent Birth Control System [instructions for use]. Mountain View, CA: Conceptus, Inc; 2012.

(7.) Connor VF. Essure: a review six years later. J Minim Invasive Gynecol. 2009;16(3):282-290.

(8.) Palmer SN, Greenberg JA. Transcervical sterilization: a comparison of Essure[R] permanent birth control system and Adiana[R] permanent contraception system. Rev Obstet Gynecol. 2009;2(2):84-92.

(9.) Levie M, Chudnoff SG. A comparison of novice and experienced physicians performing hysteroscopic sterilization: an analysis of an FDA-mandated trial. Fertil Steril. 2011;96(3):643-648, e1.

(10.) Vancaillie TG, Harrington DC, Anderson JM. Mechanism of action of the Adiana[R] device: a histologic perspective. Contraception. 2011;84(3): 299-301.

(11.) Mino M, Arjona JE, Cordon J, Pelegrin B, Povedano B, Chacon E. Success rate and patient satisfaction with the Essure sterilisation in an outpatient setting: a prospective study of 857 women. BJOG. 2007;114(6):763-766.

(12.) Levie MD, Chudnoff SG. Office hysteroscopic sterilization compared with laparoscopic sterilization: a critical cost analysis. J Minim Invasive Gynecol. 2005;12(4):318-322.

(13.) Kraemer DF, Yen PY, Nichols M. An economic comparison of female sterilization of hysteroscopic tubal occlusion with laparoscopic bilateral tubal ligation. Contraception. 2009;80(3):254-260.

(14.) Levy B, Levie MD, Childers ME. A summary of reported pregnancies after hysteroscopic sterilization. J Minim Invasive Gynecol. 2007;14(3):271-274.

(15.) Jamieson D J, Kaufman SC, Costello C, Hillis SD, Marchbanks PA, Peterson HB; US Collaborative Review of Sterilization Working Group. A comparison of women's regret after vasectomy versus tubal sterilization. Obstet Gynecol. 2002;99(6):1073-1079.

(16.) Mavranezouli I, Wilkinson C. Long-acting reversible contraceptives: not only effective, but also a cost-effective option for the National Health Service. J Fam Plann Reprod Health Care. 2006;32(1):3-5.

(17.) Moreau C, Bouyer J, Bajos N, Rodriguez G, Trussell J. Frequency of discontinuation of contraceptive use: results from a French population-based cohort. Hum Reprod. 2009;24(6):1387-1392.
FIGURE Failure rates per 1000 women at 5 years (a)

Essure (4)                  1.7

Postpartum partial
 salpingectomy (2)          6.3

Vasectomy (5)              11.3

All tubal ligation
 methods (2)               13.1

* Based on 5 years of clinical data;
no direct comparative data exist.

Note: Table made from bar graph.
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Publication:OBG Management
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Date:Oct 1, 2012
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