Features

Will Abdominal Sterilization Become Obsolete?

J. Kell Williams, MD; Sheila Connery, MD

Feature article

Abdominal sterilization remains a popular choice for permanent contraception in the United States, despite the emergence of many attractive, reliable alternatives. Perhaps it is time for physicians to take a fresh look at the array of possibilities so that they can better counsel patients according to individual needs.

Today, it appears that abdominal sterilization may soon become obsolete. There are five reasons for this trend, four of which concern the original impetus for abdominal sterilization:

• The perception that hormonal contraception is unsafe for women over the age of 35, and that intrauterine devices (IUDs) are unsafe for women of any age
• Failure to recognize the noncontraceptive benefits of hormonal contraceptives
• Emergence of laparoscopy as a minimally invasive, low-risk, means of abdominal sterilization
• The belief that laparoscopic sterilization is the most effective form of contraception once childbearing is completed.

back to top

HORMONAL CONTRACEPTION

There is no question that women aged 35 years or older require effective contraception. Even though a woman’s fertility declines with increasing age, contraception remains a major concern for women past the age of 35. Regardless of previous desire for pregnancy, many of these women have reached a point in their lives when an unplanned pregnancy may be ill-advised for both personal and medical reasons. Not surprisingly, the rate of elective terminations of pregnancy is very high among women over the age of 40, exceeding that of all other age groups with the exception of preteens.1 Because the use of hormonal contraception in this population is lower than that in other age groups, the abdominal sterilization rate remains very high.

Traditionally, clinical practice dictated that the use of hormonal contraception be limited to women younger than age 35. This proscription evolved primarily because the FDA mandated labeling that included a reported association between adverse cardiovascular events and oral contraceptive (OC) use after that age based on retrospective epidemiologic trials from the 1960s. These studies involved OCs with estrogen doses ranging from 100 to 150 mcg, and despite implementation of lower estrogen doses this labeling was not changed for many years. This amounted to a prohibition of hormonal contraceptive use in women older than age 35, and stimulated the quest for effective nonhormonal contraception. This situation persisted until 1991, when the FDA re-evaluated the evidence. Realizing that the increased cardiovascular risk was confined to smokers, and that the age of the nonsmoking user was unrelated to the risk, the age-specific contraindication was removed.

While the higher estrogen doses in older OCs were implicated in increasing the risk of myocardial infarction and/or stroke, recent epidemiologic data demonstrate that the newer low-dose OC formulations (<50 mcg of estrogen) do not contribute to an increased risk for nonsmoking, nonhypertensive women.2,3 In addition, if hormonal contraceptives cause an increase in atherosclerosis, it is reasonable to expect an increase in related cardiovascular events among former OC users. However, no such association has been found.4

The most comprehensive studies estimating the risk of venous thromboembolism (VTE) among low-dose hormonal contraceptive users demonstrate a 3- to 4-fold increase over nonusers. Although never directly compared with OC users, VTE is the second leading cause of perioperative morbidity from gynecologic laparoscopy.5

Users of combination (estrogen-progestin) hormonal contraception are required to take a pill every day of a cycle, resulting in high nonadherence and user-failure rates. Consequently, abdominal sterilization seemed to be a more effective method. The introduction of nondaily, nonoral hormonal contraception has since been shown in prospective clinical trials to have significantly better adherence than daily OCs.6,7 In general, healthy women without contraindications should not be driven to choose sterilization over hormonal contraception because of fears about safety or compliance.

Clinical Pearls

Many women and their physicians have outdated perceptions about the risks of OCs and IUDs. The view that abdominal sterilization is "safer" than most alternatives (eg, OCs and other hormonal methods, IUDs) is invalid. The risk of cardiovascular events associated with OC use after age 35 is largely confined to women who smoke and/or those who are hypertensive. The noncontraceptive benefits of hormonal contraceptives address two major sources of disease and fear in women: cancer and osteoporosis. Laparoscopic sterilization has been found to be as effective as, but not more effective than, most nonpermanent forms of contraception. Younger women who choose permanent sterilization frequently regret their decision, and may benefit from trying a long-term contraceptive method while they continue to consider their choices. Hysteroscopic tubal occlusion offers another alternative for minimally invasive sterilization that has shown excellent efficacy and satisfaction to date.

back to top

INTRAUTERINE DEVICES

While fears about the perceived risks of hormonal contraception discourage women from using OCs, the fear of infection due to the use of IUDs is even greater. This is primarily attributable to the infamous Dalkon Shield, a source of widespread litigation almost 30 years ago. In view of the lingering negative publicity, women need to be informed about the compelling evidence of IUD safety today. Intrauterine devices either copper-containing or progestin-containing have been shown to be a safe, effective method of long-term contraception in women of all ages, with minimal differences between method failure and user failure.8 These data should allay unfounded fears of IUD risks; indeed, a 1999 analysis concluded that IUD use should replace abdominal sterilization. 9

back to top

NONCONTRACEPTIVE BENEFITS

Sterilization does not provide women with access to the ever-expanding list of noncontraceptive benefits attributed to hormonal contraception. These include reductions in ovarian and endometrial cancers, functional ovarian cysts, ectopic pregnancy, pelvic inflammatory disease, benign breast disease, iron deficiency, menstrual disorders, dysmenorrhea, bone loss, and acne. Such evidence is strong enough to warrant a preoperative discussion with patients who are considering discontinuation of hormonal contraception in favor of sterilization. The best evidence is in the area of cancer prevention, acne vulgaris, and maintenance of bone mineral density; the protective effect on bone mineral density is especially apparent in women older than 35 years of age with declining ovarian function. With hormonal contraception use exceeding 5 years, protection increases with lengthening duration of use. There is also evidence that hormonal contraceptives suppress uterine fibroids, rheumatoid arthritis, and atherosclerosis.10.

back to top

LAPAROSCOPIC STERILIZATION

The advent of laparoscopy in the 1970s renewed interest in abdominal sterilization and the need for abdominal sterilization spurred the interest in the laparoscope, which became even more popular with the change from unipolar to safer bipolar cautery. Soon laparoscopic abdominal sterilization was the most common method of contraception for women in the United States, and at one time it was believed to be the most effective form of contraception. However, based on evidence from the Centers for Disease Control and Prevention (CDC), laparoscopic sterilization is as effective as, but not more effective than, many nonpermanent methods; the failure rate is method-dependent and ranges from 0.75% to 3.65%.11 The risks are directly related to surgical/anesthetic complications, which correlate more with body habitus and general health than with age.

Laparoscopic sterilization provides no inherent protection against sexually transmitted diseases. Also, although it is commonly believed that sterilization leads to less normal menstrual cycles, the best evidence is that there is no relation to menstrual cycle control, either negative or positive.12 This is in contrast to the proven positive impact on menstrual cycles from hormonal contraception. Laparoscopic sterilization may also reduce the risk of ovarian cancer secondary to sealing off the peritoneal cavity from the possibility of transmitting carcinogens through the fallopian tubes.13 However, this evidence is very tenuous compared with the 50% to 80% reduction in ovarian cancer risk in long-term hormonal contraceptive users.

Even with appropriate preoperative counseling, the CDC and other researchers have documented a higher-than-anticipated rate of sterilization regret.14 Regret has been associated with:

• Age younger than 30 years
• Intrapartum/postpartum sterilization (as opposed to within the year subsequent to a birth)
• Performance at the time of an unrelated intraabdominal procedure
• New partner or marriage
• Death of an infant or child
• Trivialization of the sterilization procedure by health care professionals.

back to top

HYSTEROSCOPIC STERILZATION

For women who still desire permanent sterilization, hysteroscopic tubal occlusion offers an alternative to standard abdominal methods.15 Hysteroscopic tubal occlusion requires no incisions or entry into the peritoneal cavity. The fallopian tubes are not subjected to burning, clipping, cutting, or suturing. The entire procedure consists of placing a microinsert into each of the fallopian tubes through a hysteroscope. Most hysteroscopic tubal occlusions can be performed in the office.16

The device uses a disposable delivery system for each fallopian tube. The system is comprised of a single-handed ergonomic handle containing a delivery wire, release catheter, delivery catheter, and microinsert. The microinsert contains an inner coil of stainless steel, a nitinol superelastic outer coil, and polyethylene fibers. The coil measures 4 cm in length and 0.8 mm in diameter and is flattened to permit entry into the fallopian tube. Approximately 5 to 10 mm of the microinsert remains in the uterine cavity, and the coil unwinds to a diameter of 1.5 to 2 mm as the device is withdrawn. This allows the microinsert to become firmly lodged within the fallopian tube while the larger diameter of the device remains in the uterus, preventing migration into the peritoneal cavity. The polyethylene fibers in the fallopian tube provide a “scaffold” where tissue grows and occludes the tube.

The process of tubal occlusion requires approximately 12 weeks postprocedure for completion. The patient must use alternative contraception until occlusion is confirmed. Such confirmation requires hysterosalpingography performed no sooner than 12 weeks after the procedure. Hysteroscopic tubal occlusion has a success rate of up to 99.8%.17 One report has estimated a significant cost savings compared with laparoscopic sterilization (P = 0.038).18 Patient satisfaction is reported to be very high; although 15% of subjects experienced difficult insertions according to the physician, 100% of the women rated the method as highly satisfactory.19 Contraindications to hysteroscopic tubal occlusion include:

• Uncertainty regarding future fertility
• Ability to place only one microinsert on inspection of the tubal ostia at hysteroscopy
• Pregnancy delivery or termination of a pregnancy less than 6 weeks previously, active or recent pelvic inflammatory disease, and
• Known allergy to nickel.

back to top

CONCLUSION

It is difficult today to rationalize the continued popularity of abdominal sterilization. For those who desire permanent sterilization, hysteroscopic tubal occlusion represents an excellent option. For women who want long-term, effective, nonhormonal contraception, IUDs are a good choice. Most other women can rely on long-term hormonal methods to provide both effective contraception and noncontraceptive benefits. Even for those who cannot comply with a daily regimen, there are very effective nondaily, nonoral contraceptives.

back to top

J. Kell Williams, MD, is professor and director, Division of Gynecology; and Sheila Connery, MD, is assistant professor, Division of General Obstetrics and Gynecology, both in the Department of Obstetrics and Gynecology, University of South Florida College of Medicine, Tampa, FL.

References

1. Henshaw SK. Unintended pregnancy in the United States. Fam Plann Perspect. 1998;30(1):24-32.
2. Lewis MA, Heinemann LA, Spitzer WO, MacRae KD, Bruppacher R. The use of oral contraceptives and the occurrence of acute myocardial infarction in young women. Results from the Transnational Study on Oral Contraceptives and the Health of Young Women. Contraception. 1997;56(3):129-140.
3. Petitti DB, Sidney S, Bernstein A, Wolf S, Quesenberry C, Ziel HK. Stroke in users of low-dose contraceptives. N Engl J Med. 1996;335(1):8-15.
4. Carr BR, Ory H. Estrogen and progestin components of oral contraceptives: relationship to vascular disease. Contraception. 1997;55(5):267-272.
5. Johnston K, Rosen D, Cario G, et al. Major complications arising from 1265 operative laparoscopic cases: a prospective review from a single center. J Minim Invasive Gynecol. 2007;14(3):339-344.
6. Archer DF, Cullins V, Creasy GW, Fisher AC. The impact of improved compliance with a weekly contraceptive transdermal system (Ortho Evra) on contraceptive efficacy. Contraception. 2004; 69(3):189-195.
7. Oddsson K, Leifels-Fischer B, de Melo NR, et al. Efficacy and safety of a contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive: a 1-year randomized trial. Contraception. 2005;71(3):176-182.
8. Grimes DA, Lopez LM, Manion C, Schulz KF. Cochrane systematic reviews of IUD trials: lessons learned. Contraception. 2007;75(6 Suppl):S55-S59.
9. Fortney JA, Feldblum PJ, Raymond EG. Intrauterine devices. The optimal long-term contraceptive method? J Reprod Med. 1999;44(3):269-274.
10. Williams JK. Noncontraceptive benefits of oral contraceptive use: an evidence-based approach. Int J Fertil Womens Med. 2000;45(3):241-247.
11. Peterson HB, Xia Z, Hughes JM, Wilcox LS, Tylor LR, Trussell J. The risk of pregnancy after tubal sterilization: findings from the US Collaborative Review of Sterilization. Am J Obstet Gynecol. 1996;174(4):1161-1170.
12. Peterson HB, Jeng G, Folger SG, et al. The risk of menstrual abnormalities after tubal sterilization: findings from the US Collaborative Review of Sterilization. N Engl J Med. 2000;343(23):1681-1687.
13. Hankinson SE, Hunter DJ, Colditz GA, et al Tubal ligation, hysterectomy, and the risk of ovarian cancer: a prospective study JAMA. 1993;270(23): 2813-2819.
14. Hillis SD, Marchbanks PA, Tylor LR, Peterson HB. Poststerilization regret: findings from the United States Collaborative Review of Sterilization. Obstet Gynecol. 1999;93(6):889-895.
15. Kerin JF, Carignan CS, Cher D. The safety and effectiveness of a new hysteroscopic method for permanent birth control: results of the first Essure pbc clinical study. Aust N Z Obstet Gynaecol. 2001;41(4):364-370.
16. Ubeda A, Labastida R, Dexeus S. Essure: a new device for hysteroscopic tubal sterilization in an outpatient setting. Fertil Steril. 2004;82(1): 196-199.
17. Duffy S, Marsh F, Rogerson L, et al. Female sterilisation: a cohort controlled comparative study of ESSURE versus laparoscopic sterilisation. BJOG. 2005;112(11):1522-1528.
18. Hopkins MR, Creedon DJ, Wagie AE, Williams AR, Famuyide AO. Retrospective cost analysis comparing Essure hysteroscopic sterilization and laparoscopic bilateral tubal coagulation. J Minim Invasive Gynecol. 2007;14(1):97-102.
19. 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.

back to top