Permanent Contraception for Women

Abstract

Permanent methods of contraception are used by an estimated 220 million couples worldwide, and are often selected due to convenience, ease of use and lack of side effects. A variety of tubal occlusion techniques are available for female permanent contraception, and procedures can be performed using a transcervical or transabdominal approach. This article reviews currently available techniques for female permanent contraception and discusses considerations when helping patients choose a contraceptive method and tubal occlusion technique.

Sterilization versus permanent contraception

According to the Merriam Webster dictionary, the word ‘sterilization’ means, “To make sterile: as a) to cause (land) to become unfruitful, b) (1) to deprive of the power of reproducing, (2) to make incapable of germination, c) to make powerless or useless by restraining from a normal function, relation, or participation, d) to free from living microorganisms.” The term is politically charged, and medically inaccurate, connoting historical practices such as forced sterilization, extreme procedures such as castration, and eugenics. Such connotations have led to unnecessary politically motivated impediments to women's access to effective contraception. While hysterectomy, another common gynecologic procedure, does completely preclude future reproductive capacity, this is not always the case for most modern permanent techniques, which do not affect the function of the uterus or ovaries. Sterilization procedures have failure rates that are comparable to those of other effective methods of contraception. Furthermore, pregnancy can occur in the presence of tubal occlusion with use of reproductive technologies.

The authors believe the term ‘sterilization’ should be replaced by the politically neutral and medically accurate term ‘permanent contraception’. While these methods are intended to be permanent, patients and physicians alike must understand they are no more effective than certain reversible methods and that they are part of the wide range of contraceptive options that differ in terms of reversibility, duration of use, efficacy and user dependence. The purpose of this article is to review currently available techniques for female permanent contraception and describe indications, risks, benefits and other important considerations in contraceptive counseling.

Globally, an estimated 220 million couples rely on permanent contraception [1]. In the USA, permanent contraception is used by approximately 23% of women and nearly half of all married couples, making it the most commonly used contraceptive method: more popular than oral contraception, condoms and intrauterine devices (IUDs) [2]. Between 600,000 and 700,000 tubal occlusion surgeries are performed annually in the USA [3]. Approximately half of these procedures are performed in the postpartum period [4].

Currently available forms of permanent contraception for women

Permanent contraceptive techniques can be performed using a variety of surgical approaches: transabdominal (via laparoscopy or laparotomy), transcervical (via hysteroscopy). Transvaginal approaches, via colpotomy, are not commonly used due to their higher rate of complications.

Transabdominal tubal occlusion procedures may be performed at any time in the menstrual cycle in non-pregnant women, and can also be performed in the immediate postpartum period, or after a spontaneous or induced abortion. Hysteroscopic surgery is generally performed during the early follicular phase of the menstrual cycle. Insurance coverage and legal restrictions specifying when a woman is capable of providing consent may also affect timing in relation to pregnancy as well as choice of method.

In general, surgical approach dictates the type of anesthesia selected for the procedure. The vast majority of laparoscopic procedures are performed under general anesthesia, whereas hysteroscopic procedures are commonly performed under local anesthesia (para-cervical block), with or without oral or intravenous sedation. Postpartum tubal ligations often utilize conduction anesthesia, used as part of standard obstetric care. Complications from general anesthesia have been found to be the leading cause of death associated with tubal ligation [5].

Transabdominal methods

The laparoscopic approach is used for interval (timing not related to a pregnancy) or postabortion tubal occlusion procedures and is performed as an outpatient procedure. Laparoscopic tubal occlusion can generally be performed using a single umbilical port, or with two ports (using a suprapubic operative port), unless additional procedures are planned. Laparoscopy requires specialized equipment and poses small risks of bowel, bladder or major vessel injury.

Laparoscopic tubal ligation is usually performed using bipolar electrocoagulation or mechanical occlusive devices. To maximize the effectiveness of bipolar tubal ligation, at least 3 cm of the isthmic portion of the fallopian tube must be completely fulgurated using sufficient energy delivered in a cutting waveform. Use of a current meter, rather than a visual end point or a defined period, more accurately indicates complete coagulation [6]. Bipolar electrocoagulation poses a risk of thermal injury and has been shown in some studies to be less effective than other occlusion techniques [6].

Mechanical tubal occlusion devices include the silicone band (Falope ring) and the titanium clip lined with silicone rubber (Filshie clip). The Hulka–Clemens clip was a first-generation device associated with a high failure rate and is no longer available [7]. These devices must be used with specialized applicators. In the case of the titanium clip, the applicator necessitates an accessory laparoscopic port that is at least 7.5 mm in diameter. Tubal clips and rings are designed for normal fallopian tubes; tubal pathology that increases the diameter of the tube or adhesions may increase the risk of misapplication and contraceptive failure. Compared to electrocoagulation, less of the fallopian tube is destroyed with mechanical methods (∼5 mm for clips and 2 cm for rings) making microsurgical reversal more likely to succeed [8,9].

Laparotomy, referred to as minilaparotomy if the incision is less than 6 cm, is used most commonly for postpartum procedures or in those who are considered at high risk for laparoscopic procedures. Tubal ligation is also performed as a concomitant procedure to cesarean section and, less commonly, in women undergoing laparotomy for unrelated reasons. Minilaparotomy is performed using a 2–3 cm incision placed at approximately the level of the uterine fundus; peri-umbilical in the immediate postpartum period, or suprapubic for interval procedures. Obese patients often require a larger incision [10].

In contrast with laparoscopy, minilaparotomy requires only basic surgical instruments and can be used in low resource settings. This is the preferred interval technique in regions where laparoscopy is not available. Interval minilaparotomy is performed as an outpatient procedure, under local anesthesia with a low midline incision. A specialized uterine manipulator (such as the Ramathibodi uterine manipulator) is used to elevate the uterus and facilitate rapid identification of the fallopian tubes [11].

During laparotomy, partial salpingectomy is the most common technique, though tubal occlusive devices described above may also be used. A variety of techniques for resecting a portion of both fallopian tubes have been developed, including the Pomeroy, modified Pomeroy, Parkland, Uchida and Irving methods [12].

Postpartum procedures are performed at the time of cesarean delivery or after a vaginal delivery and typically do not extend hospital stay. After a vaginal delivery, infraumbilical minilaparotomy is ideally performed within 1–2 days postpartum, prior to significant uterine involution. After a first- or second-trimester abortion, tubal occlusion can be performed via either laparoscopy or minilaparotomy.

Efficacy of transabdominal methods

The best data on the efficacy and safety of permanent contraception comes from the US Collaborative Review of Sterilization, or CREST study, a large, prospective, multicenter observational study of 10,685 women conducted by the US Centers for Disease Control and Prevention (CDC) from 1978 to 1986. This study found a 5-year cumulative failure rate for permanent contraceptive methods of 13 per 1000 procedures, and 10 year cumulative failure rate of 18 per 1,000 procedures [7]. An unexpected finding of the CREST study was that the risk of pregnancy persists for many years after the procedure, 10 years or more for women whose procedures are done earlier in their reproductive lifespan. Risk of failure also was found to vary according to tubal occlusion method and many patient characteristics including age, race and ethnicity. As expected, women who underwent tubal occlusion at a younger age had a higher risk of failure. Although pregnancy after a permanent contraception procedure is uncommon, there is substantial risk that any subsequent pregnancy will be ectopic. Analysis of CREST data found that one third of pregnancies after tubal ligation were ectopic [13].

More recent data of the efficacy of tubal ligation is comparable to that demonstrated in the CREST study. Using data from the 1999 and 2002 National Survey of Family Growth, Trussell et al. reported that the failure rate for female permanent contraception was 0.5% per year [14].

Partial salpingectomy appears to be more effective than other tubal occlusion techniques. In the CREST study, postpartum partial salpingectomy had the lowest 5-year cumulative pregnancy rates: 6.3 per 1000 procedures [7]. Though the CREST study was carried out several decades ago and does not provide efficacy data for many modern occlusive techniques, recent studies are consistent with these results [15]. However, since most centers perform histology on the removed tubal segments, the observed lower failure rate may reflect active identification and treatment of a subset of women most at risk for failure.

In the postpartum period in particular, tubal resection is probably more effective than placement of tubal occlusive devices such as the titanium clip [15]. However, the greater efficacy of partial salpingectomy must be weighed against potential risks, particularly for procedures complicated by adhesions that limit visualization or access to a sufficient length of the tube, such as seen with repeat cesarean section, or in other patients who have had multiple abdominal procedures. A Cochrane review found that the modified Pomeroy technique had higher morbidity than the electrocoagulation, and was associated with greater frequency of postoperative pain [16].

Transcervical approach

Transcervical approaches to tubal occlusion involve gaining access to the fallopian tubes through the cervix. The currently available technique requires the use of hysteroscopy with visualization and cannulation of each fallopian tube. Two transcervical methods are approved by the US FDA. Essure®, approved in 2002, utilizes a 4 cm long implant, with a stainless steel inner coil and nitinol outer coil, inserted into each tube via a disposable delivery catheter; tubal occlusion occurs by an inflammatory reaction and tissue growth in response to polyethylene terephthalate (PET) fibers. The Adiana® procedure, approved in 2009, is performed with a disposable catheter that delivers 60 seconds of radiofrequency energy to the proximal tube, followed by placement of a 3.5 mm silicone matrix. Essure is generally performed with normal saline as the distension medium; however, Adiana requires a nonionic solution such as glycine or sorbitol. Adiana was withdrawn from the market by the manufacturer and is no longer available. Current transcervical techniques are indicated for interval procedures only. Essure is approved for use in women who are at least 6 weeks postpartum.

Hysteroscopic tubal occlusion is not immediately effective, as the process of fibrosis and obliteration of the tubal lumina occurs over several weeks. As per the FDA approved labeling for both hysteroscopic methods, an alternative method of contraception must be used for at least 3 months, until a hysterosalpingogram (HSG) confirms successful tubal occlusion. HSG is routinely performed 3 months after the procedure. If the 3-month HSG confirms proper placement of the inserts but tubal patency is noted, alternative contraception is continued and the HSG is repeated after three more months. Improper position of the inserts and persistent tubal patency are indications for laparoscopic tubal ligation. In 2015, the FDA approved transvaginal ultrasound as an alternative to HSG for confirming proper placement of the Essure inserts. Ultrasound is particularly useful in clinical settings where x-ray is not readily available or in patients with allergy to contrast dye [17,18].

Complications of hysteroscopic tubal occlusion include uterine perforation and expulsion of the occlusion devices. A tubal perforation risk of up to 3% and expulsion risk of 2.2% have been observed in clinical studies of the Essure device, though more recent analyses suggest a lower risk of serious complications [19,20]. Intraabdominal injury secondary to tubal or uterine perforation is a theoretical risk but has not been reported.

Transcervical procedures that do not require hysteroscopic guidance are currently under investigation. Chemical sclerosing agents, such as quinacrine, have been studied for many years as potential permanent contraceptive methods. Although some have shown promise, none are currently approved for use in the USA or Europe [21]. Polidocanol is a sclerosing agent that is FDA-approved for the treatment of small reticular veins. A foam preparation of polidocanol is being tested in nonhuman primates for potential as a nonsurgical method of tubal occlusion [22].

Efficacy of transcervical methods

In Phase II and III clinical trials of the Essure device, successful bilateral placement rate was 90.5% [20,23]. Among women in these studies with successful insert placement who had appropriate follow-up, 3.5% had tubal patency on HSG at 3 months and 0% at 6 months. No pregnancies have been reported among the 643 women in these clinical trials with confirmed tubal occlusion on HSG after bilateral placement of the inserts.

In more recent studies using the current Essure delivery catheter, successful bilateral placement rate is over 96% [24]. A postmarketing study of 229 women who underwent Essure between 2009 and 2011 reported higher tubal patency rates than initially reported: 16.1% at 3 months and 5.8% after 6 months, despite proper placement of the inserts on HSG noted in all study participants [25]. Between 1997 and 2005, 64 unintended pregnancies were reported to the Essure manufacturer among over 50,000 procedures, with most due to inappropriate follow up, leading to an observed failure rate of less than 0.15% [26].

A recent systematic review that included 24 studies of Essure confirmed a failure rate that is lower than that of transabdominal methods. Among a total of more than 60,000 procedures described in the included studies, 102 pregnancies were reported, with just 15 of these occurring in women who had documented bilateral tubal occlusion on HSG [27].

Helping patients choose a laparoscopic or hysteroscopic procedure

Transcervical techniques avoid entry into the peritoneal cavity, and may decrease the risk of serious complications such as injury to abdominal organs. The hysteroscopic tubal occlusion procedure is ideal for patients at greatest surgical risk, such as those with multiple prior abdominal surgeries, suspected dense adhesions or morbid obesity. Another important advantage of this technique is avoidance of general anesthesia. Hysteroscopic tubal occlusion can be performed in the office setting, with or without oral or intravenous sedation. For patients with serious medical problems, such as cardiac disease, this may be the best option in order to prevent significant anesthesia-related risks.

For most women, both laparoscopic and hysteroscopic techniques are reasonable options. Choice of surgical approach depends on a patient's specific situation and her personal preferences and values. For women who desire a method that is immediately effective and requires no further follow up, the laparoscopic approach is preferable. However, for those who would like to avoid abdominal incisions and general anesthesia, hysteroscopic tubal occlusion may be the best choice. Gynecologists should take each woman's individual circumstances into account and provide directed counseling in order to help patients with the decision-making process.

While at first look, the low failure rate of the hysteroscopic technique is compelling, effective counseling should include a discussion of the multiple steps and patient compliance essential for maximal efficacy. The procedure can fail for many different reasons: inadequate hysteroscopic visualization, inability to cannulate both tubes, perforation or malposition of an insert or patency of one or both tubes on HSG despite successful placement. Women with a failed procedure or complication require a laparoscopic procedure for tubal ligation and/or removal of the inserts, and this possibility must be included in the informed consent process. Hysteroscopic tubal occlusion requires continued use of another contraceptive method for at least 3 months, at which time an HSG is performed to confirm tubal occlusion. However, up to 87% of patients do not comply with recommended HSG follow-up [29]. A decision analysis comparing hysteroscopic tubal occlusion to laparoscopic tubal ligation found that women choosing laparoscopy were significantly more likely to have successful permanent contraception after 1 year (99 vs 95%) [28]. This analysis also concluded that the chance of successful tubal occlusion after the first attempt was 99% for laparoscopic tubal ligation and just 87–88% for hysteroscopic procedures (Figure 1). On the other hand, for a motivated patient, the option of verification of tubal occlusion provides additional reassurance of long-term effectiveness.

Figure 1.

Segment of Markov model used in decision analysis comparing hysteroscopic and laparoscopic tubal occlusion procedures.

Choosing permanent or reversible contraception

Female permanent contraception is much more effective than reversible user-dependent contraceptive methods. Contraceptive failure occurs in the first year of typical use in 9% of women using oral contraception, the contraceptive patch or contraceptive vaginal ring, 18% using the male condom and 24% using fertility awareness-based methods [14]. However, the effectiveness of permanent contraception appears to be comparable to that of the long acting reversible methods (LARC), the IUD and contraceptive implants. The copper T380 IUD has a failure rate of 0.8% for the first year of use, and a 5-year cumulative failure rate of 14 per 1000 insertion procedures [14,30]. For the levonorgestrel-releasing IUD, the first year failure rate is reported to be 0.2%, and the 5-year cumulative failure rate between 5 and 11 per 1000 [31]. The etonogestrel contraceptive implant has the lowest reported failure rate of any female contraceptive method, 0.05% in the first year [14]. The LARC methods are also safe, and have few contraindications. These methods can safely be used in most women who cannot take estrogen due to various medical conditions, such as hypertension and history of blood clots [32].

The primary factor that women should consider prior to considering permanent contraception is whether or not they desire future childbearing. Occasionally, a woman will request a tubal ligation procedure who has not fully considered the implications of this choice; gynecologists must not assume that patients have fully explored their future reproductive plans. Some women may have concerns, legitimate or unfounded, regarding risk of poor pregnancy outcomes or worsening health status with pregnancy due to an underlying medical condition. Women who express uncertainty regarding pregnancy plans or who appear to have been coerced by a partner or healthcare provider should be steered towards effective LARC methods.

Women who do not desire future pregnancies must be counseled about all contraceptive options, particularly the IUD and contraceptive implant, as these methods are equally effective but do not require a surgical procedure. However, for a variety of reasons, these reversible methods do not meet the needs of all women. The hormonal IUD and contraceptive implant have important noncontraceptive benefits, including potentially decreased or absent menstrual blood loss, and decreased dysmenorrhea. However, they also cause unpredictable or prolonged bleeding in a significant proportion of users. Other women may report symptoms, such as acne and weight gain, which they perceive to be related to the contraceptive hormone. Discontinuation of the levonorgestrel IUD due to side effects has been reported to be as high as 60% within 5 years [33]. The only nonhormonal long-acting reversible method is the copper IUD, which increases menstrual blood loss in most women, particularly in the first year of use [34,35]. Many women feel that heavier bleeding is unacceptable, and some have heavy menses at baseline that would make this method suboptimal or possibly unsafe.

In considering a LARC method of contraception, women must also weigh the need for device removal and replacement every 3 to 12 years, depending on the method. This may present a serious barrier for young women or those who risk losing insurance coverage. In low resource settings, providers offering the IUD or contraceptive implant must consider the need for a skilled care provider for removal. In our experience, most women who pick permanent contraception are motivated in part by the ease of use of use of the method.

In addition to the reversible female methods, all women considering permanent contraception should be counseled about vasectomy. In the USA, vasectomy procedures are performed in an outpatient setting under local anesthesia, using a no-scalpel or incisional technique. Vasectomy is not immediately effective, and semen analysis must be performed after 3 months and at least 20 ejaculations. A couple can rely on this method of contraception only after azoospermia is confirmed on semen analysis. Approximately 0.4% of men will have persistent motile spermatozoa on semen analysis 6 months after vasectomy [36]. After azoospermia is confirmed, the failure rate of vasectomy is estimated to be 0.15% in the first year [14].

When compared with female permanent contraception methods, vasectomy is safer, less expensive and more effective [37]. Laparoscopic tubal ligation is associated with a risk of major complications that is 20-times greater than vasectomy, and at a cost that is three-times greater than vasectomy [38].

Noncontraceptive benefits of permanent contraception for women

According to several large observational studies, tubal occlusion significantly decreases the risk of ovarian cancer (RR: 0.29–0.69) [10]. It is hypothesized that salpingectomy may provide even greater protection against ovarian cancer, as pathologic studies indicate that many cancers originate in the tubal fimbriae [39]. While some gynecologists and professional organizations advocate for bilateral salpingectomy as the method of choice for female permanent contraception, the authors have not adopted this approach given the potential for increased operative time and morbidity.

Tubal occlusion has also been shown to provide some protection against pelvic inflammatory disease, by reducing the spread of organisms from the lower genital tract to the peritoneal cavity [40]. Permanent contraceptive methods do not protect against the transmission of sexually transmitted diseases.

Minimizing regret among women choosing permanent contraception

Most women who choose permanent contraception do not regret their decision [41,42]. Regret after tubal occlusion is typically measured by self-report or by request for information on tubal ligation reversal surgery or in vitro fertilization. However, proxy measures for regret may overestimate its true prevalence. Many women who are unable or unwilling to use other effective forms of contraception may not regret having received a permanent contraceptive procedure, despite seeking pregnancy in the future. A woman's ability to control her fertility may contribute to an improvement in her economic or interpersonal situation, which may in turn lead to her reconsider her wish to avoid future pregnancies. It is also important to frame the significance of regret in the overall context of fertility. Half of all pregnancies in the USA are unintended, and about half of unintended pregnancies end in abortion [43]. Arguably, many more women are at risk for harm due to excess fertility than by infertility due to permanent contraception.

The overall risk of regret among women in the CREST study was 12.7%, over 14 years of follow-up [44]. However, this number varied widely by age: risk of regret was 20.3% for women aged 30 years or younger, compared with 5.9% for women older than 30 years at the time of the procedure. Younger women are at greater risk for regret, likely because they have more time in their reproductive lifespan for their circumstances or partner to change. In the CREST study, the 14-year cumulative probability of requesting reversal information was almost four-times greater for women aged 18–24 at the time of the procedure, compared with those over 30 years. Other risk factors for regret include receiving less information about other contraceptive methods, and making the decision under pressure from a spouse or because of medical indications [45].

Patients must be thoroughly counseled about the risk of regret, and must be given detailed information about reversible contraceptive options. However, patients should not be denied the choice of permanent contraceptive methods due to risk factors such as young age and nulliparity. Physicians must trust women to choose a contraceptive method that is best for their individual circumstances – including medical conditions, experiences with prior pregnancies and future family and career plans.

Conclusion & future perspective

Gynecologists should be confident offering permanent methods to all women who do not desire future pregnancies. A woman's individual circumstances should always be the primary consideration. Barriers to permanent contraception procedures, such as mandatory waiting periods for consent and restrictions on timing in relation to pregnancy, decrease women's ability to choose these highly effective methods and increase risk for unintended pregnancy and poorer educational and economic outcomes that result.

Reversible contraceptive methods, particularly the IUD and contraceptive implant, are highly effective but do not meet the needs of all women. Since these methods, along with vasectomy, are at least as effective as permanent contraception for women, a thorough discussion of these options is a critical component of informed consent prior to any tubal occlusion procedure. Hormonal methods may also provide significant noncontraceptive benefits. Nonetheless, a large percentage of women will continue to choose permanent options due to their convenience and lack of menstrual cycle changes and other side effects. Further research must be devoted to novel methods of permanent contraception that decrease surgical risks and improve access in low resource settings. Over the coming years, we expect to see new options for nonsurgical female permanent contraception that can be performed with a single in-office procedure with no or minimal follow up.

Executive summary

• In the USA, permanent contraception is used by approximately 23% of women and nearly half of all married couples, making it the most commonly used contraceptive method.

• Permanent contraceptive options include transabdominal tubal ligation (via laparoscopy or minilaparotomy), hysteroscopic tubal occlusion and vasectomy.

• Postpartum tubal ligation is usually performed within 1–2 days of vaginal delivery, or at the time of cesarean section.

• The failure rate of tubal ligation is 0.5% in the first year.

• Hysteroscopic tubal occlusion is not immediately effective. Successful tubal blockage must be confirmed with hysterosalpingogram 3 months after the procedure.

• Vasectomy is safer, more effective and less expensive than tubal ligation.

• Some reversible methods of contraception, such as the intrauterine device and contraceptive implant, are as effective as permanent methods.

• Most women do not regret their decision to undergo permanent contraception. Young age is the strongest risk factor for regret.