In the United States during survey years 2006 to 2010, sterilization was the most commonly reported form of contraception among women aged 15 to 44 years. Specifically, among women using contraception, 36 percent relied on either male or female sterilization (Jones, 2012). The yearly incidence of these procedures cannot be tracked accurately because most interval tubal sterilizations and vasectomies are performed in ambulatory surgical centers. However, according to the National Survey of Family Growth, approximately 643,000 female tubal sterilizations are performed annually in the United States (Chan, 2010).
Sterilization can be offered to women or men. In the United States, female sterilization is approximately three times more common than male sterilization (Guttmacher Institute, 2015). Of sterilization procedures, vasectomy is available to men. For women, options are greater and are presented in this chapter.
When female sterilization is performed at the time of a neonate’s birth, either at cesarean delivery or very soon after vaginal birth, such sterilization is called puerperal or postpartum sterilization. For procedures completed at a time unrelated to delivery, the term interval sterilization is used.
Unfortunately, access to puerperal sterilization is not universal. One barrier is a federal regulation that requires all women covered by government insurance to sign a surgical consent at least 30 days prior to the procedure (Borrero, 2013, 2014). Another barrier is seen in high-volume labor and delivery units, which typically prioritize limited operating-room availability for intrapartum procedures. Improvement may be achieved by designating postpartum sterilization surgeries as urgent (American College of Obstetricians and Gynecologists, 2014; Potter, 2013).
In women who are unable to achieve the sterilization they desire, effects can be profound. Thurman and colleagues (2010) found the rate of subsequent conception within a year of the delivery in such women doubled compared with women who were also within a year of delivery but had not requested sterilization.
Tubal sterilization can be performed concurrently with pregnancy termination that may be cesarean delivery, vaginal delivery, or pregnancy evacuation. Each of these influences options for surgical approach and tubal occlusion method. For example, after vaginal delivery, most procedures are partial salpingectomies completed through an umbilical incision and described later.
If puerperal sterilization cannot be performed, then most surgeons prefer to wait at least 4 to 6 weeks postpartum to ensure complete uterine involution and diminished blood flow to the fallopian tubes. These cases performed later are considered interval sterilization, described next.
Most interval procedures are performed laparoscopically, mainly because of minimally invasive surgery’s postoperative advantages. With laparoscopy, sterilization is most frequently achieved with tubal occlusion by mechanical clips, by Silastic bands, by electrosurgical coagulation, or by suture ligation (Pati, 2000). Alternatively, minilaparotomy is infrequently selected for interval partial salpingectomy for women in the United States who elect sterilization (Peterson, 1996). It is an option for situations in which laparoscopy may not be indicated. Examples include cases complicated by extensive adhesions, those in which other concurrent pelvic pathology dictates laparotomy, or those in which laparoscopic equipment or surgical skills are lacking. Last, hysteroscopic sterilization is a minimally invasive, transcervical method to perform surgical sterilization. Currently, only the Essure Permanent Birth Control system is Food and Drug Administration (FDA)-approved and manufactured. This method employs a coiled microinsert that is placed into the proximal section of each fallopian tube. Over time, synthetic fibers within the insert incite local tissue ingrowth from the surrounding tube to occlude the tubal lumen. Generally, interval sterilization is considered in the realm of general gynecologic practice. Thus, interested readers are referred to Williams Gynecology, 3rd edition.
As noted earlier, the surgical approach to puerperal sterilization is influenced by mode of delivery. With cesarean delivery and its attendant laparotomy, tubal sterilization typically follows hysterotomy closure. After vaginal delivery, sterilization usually is completed through a minilaparotomy incision at the level of the uterine fundus, that is, periumbilically. After a first- or second-trimester pregnancy loss or termination, the uterus is smaller and lies well below the umbilicus. In these cases, a low transverse or midline vertical minilaparotomy incision is chosen and is positioned to allow optimal access to the fallopian tubes. In each of these instances, sterilization is traditionally completed by partial midsegment salpingectomy. With this, a midportion of the fallopian tube length is tied with suture and excised. Less often, a clip may be applied across the tube instead. In contrast to these, a risk-reducing total salpingectomy may be preferred. The rationale for this choice is described later on this page.
Sterilization timing also influences the choice of anesthesia, and regional or general anesthesia is typical. That used to accomplish cesarean delivery will suffice for concurrent sterilization. Similarly, epidural anesthesia placed prior to vaginal delivery is ideal for an immediate puerperal procedure. Others may prefer to delay obstetric surgery to the morning after vaginal delivery. This approach may be advantageous if there is concern for postpartum hemorrhage complicating recovery or if a delay would allow the status of the newborn to be better ascertained prior to surgery. If scheduled for the first postpartum day, spinal analgesia is preferable to general anesthesia, as postpartum women are at increased risk for aspiration due to delayed gastric emptying. If used, steps are taken to avoid aspiration. Last, in resource-limited areas, where general or regional anesthesia may not be available, local anesthesia can be used.
The conversation between a clinician and patient regarding sterilization ideally contains a discussion of contraceptive alternatives, procedure goals and limitations, efficacy, and short- and long-term surgical risks. Topics in that discussion are presented here.
The risk of death from puerperal tubal sterilization is remarkably low. In the United States, the case-fatality rate for all deaths attributed to all tubal sterilization procedures is 1 to 2 deaths per 100,000 procedures (Escobedo, 1989). Complications of general anesthesia are the leading cause of death from tubal sterilization in the United States. Others include sepsis and hemorrhage (Peterson, 1983).
Few studies have evaluated morbidity and mortality associated specifically with puerperal sterilization. The best estimates for puerperal sterilization after vaginal delivery may be taken from studies of minilaparotomy. One of these is the Collaborative Review of Sterilization (CREST), a multicenter cohort study that followed women for up to 14 years after tubal sterilization. These investigators found major complications in 1.7 percent of women undergoing interval laparoscopic sterilization and among 3.5 percent of women undergoing interval minilaparotomy procedures (incision length ≤4 cm) (DeStefano, 1983; Layde, 1983). Study participants were not randomized, and women undergoing interval laparotomy procedures likely had intrinsically greater surgical risk factors.
Incision length was also identified as an important determinant of complication rate. Women with an incision 7 cm or longer had a threefold greater complication rate than women with shorter incisions (Layde, 1983). In some of these women, incisions initially ≤4 cm may have been extended to manage complications. However, it is likely that incision length is an independent risk factor for complications, and longer incisions raise associated morbidity rates.
The Society of Gynecologic Oncology (2013) issued a statement regarding bilateral total salpingectomy as a prevention measure for ovarian cancer. This consideration of risk-reducing salpingectomy was later echoed by the American College of Obstetricians and Gynecologists (2015). Both organizations recommend consideration of bilateral total salpingectomy at the time of tubal sterilization or hysterectomy. This is especially true for women with the greatest ovarian cancer risk, specifically women with BRCA1 or BRCA2 mutation.
The rationale for this practice stems from the theory that most serous tumors of the ovary likely originate in the distal fallopian tube. Thus, total salpingectomy may confer a reduction in serous and endometrioid ovarian cancer rates (Erickson, 2013; Reade, 2014; Sieh, 2013).
In low-risk women, a procedure solely for risk-reducing salpingectomy is likely unwarranted based on current data. However, if hysterectomy or tubal sterilization is planned, all women should be counseled regarding the risks and benefits of bilateral total salpingectomy. Of benefits, in addition to proposed cancer prevention, total salpingectomy substantially lowers the need for subsequent tubal surgery, especially for tubal ectopic pregnancy. Of disadvantages, operating time may be increased by 10 minutes (Creinin, 2014). Also, the long-term effects on ovarian blood supply from total salpingectomy are unclear. One small pilot studied antimüllerian hormone (AMH) levels up to 3 months in women after hysterectomy with or without total salpingectomy. As a brief review, AMH levels correlate with ovarian follicular reserves and can be a marker for ovarian failure. Investigators found no differences in AMH levels between the two groups. However, the follow-up length in this study was short (Findley, 2013). Finally, data are incomplete regarding increased bleeding complications with total compared with partial puerperal salpingectomy.
With risk-reducing salpingectomy, pelvic washing collection is not required in women at low risk for ovarian cancer. Specimen processing in this group obtains representative sections of the tube, any suspicious lesions, and entire sectioning of the fimbriae. This contrasts with women carriers of BRCA1 and BRCA2 mutations undergoing salpingectomy, and this genetic information should be clearly stated on the pathology requisition form. This prompts more thorough tubal specimen sectioning to search for cancer and precancerous lesions, which may already be present in the tubes of BRCA mutation carriers.
Invariably, some women will later express regrets regarding sterilization. From the CREST study, Jamieson and coworkers (2002) reported that by 5 years, 7 percent of women undergoing tubal ligation had regrets. This is not limited to female sterilization, as 6 percent of women whose husbands had undergone vasectomy had similar remorse. The cumulative probability of regret within 14 years of sterilization was 20 percent for women aged 30 or younger at sterilization compared with only 6 percent for those older than 30 years (Hillis, 1999).
Another important finding from the CREST study was the relationship between regret and the timing of sterilization relative to pregnancy (Hillis, 1999). Overall, the cumulative probability of regret decreased as time from the birth of the youngest child increased. This was particularly true for women 30 years or younger at the time of sterilization. Specifically, among these women the 14-year cumulative probability of regret was 16.2 percent for those who underwent sterilization between 2 and 3 years after the birth of their youngest child. The probability was 11.3 percent if sterilized 4 to 7 years after the birth, 8.3 percent at 8 or more years, and 6.3 percent among women with no previous births.
In sum, regret after sterilization is not rare. It is often triggered by life changes, such as divorce and remarriage, which are difficult to predict before sterilization. The fact that young age at sterilization is a strong and consistent predictor of later regret is likely a reflection of this association with life changes. On the other hand, some portion of women who do not choose sterilization may also experience regret. This can stem from subsequent unintended pregnancies or side effects of reversible contraceptive methods.
Although most women do not regret their choice of tubal sterilization, counseling, especially for young women, should emphasize the permanency of tubal sterilization. Also, alternative, highly effective methods of contraception should each be described. Intrauterine devices (IUDs) and implantable hormonal forms are termed long-acting reversible contraception (LARC) and are considered very effective, first-tier choices. Oral and injectable hormonal contraceptives are other effective options.
Reasons for interval tubal sterilization failure are not always apparent, but some have been identified. First, surgical error may occur and likely accounts for 30 to 50 percent of cases. Second, tubal fistula may later develop. This is especially true with electrocoagulation procedures, but these are rarely used for puerperal sterilization. In some cases, sterilization failure may follow spontaneous reanastomosis of the tubal segments. With faulty clips, occlusion can be incomplete.
The overall failure rate reported from the CREST studies was 1.3 percent of 10,685 tubal sterilization surgeries. As shown in Figure 33-1, these rates vary for different procedures. The lifetime increased cumulative failure rates over time support that failures after 1 year are not likely due to technical errors. Indeed, Soderstrom (1985) found that most sterilization failures were not preventable.
FIGURE 33-1
Data from the U.S. Collaborative Review of Sterilization (CREST) shows the cumulative probability of pregnancy per 1000 procedures by five methods of tubal sterilization. (Data from Peterson, 1996; reproduced with permission from Stuart GS: Contraception. In Hoffman BL, Schorge JO, Bradshaw KD, et al: Williams Gynecology, 3rd ed. New York, McGraw-Hill Education, 2016.)
The 10-year cumulative life table probability of failure varied considerably by method and age at sterilization (Table 33-1). But of methods, puerperal partial salpingectomy and laparoscopic unipolar coagulation were the most effective. They each had a 10-year cumulative probability of failure of 1.5 pregnancies per 1000 procedures. The cumulative probability of pregnancy was greater for women sterilized at ages younger than 28 years compared with women sterilized at ages 34 years and older. This trend held for all methods, except interval partial salpingectomy.
Age at Sterilization | No.b | Years since Sterilization | |||
---|---|---|---|---|---|
1 | 2 | 5 | 10 | ||
18–27 yr | |||||
Bipolar coagulation | 693 | 3.0 (0.0–7.1) | 10.8 (2.9–18.8) | 26.4 (12.5–40.4) | 54.3 (28.3–80.4) |
Unipolar coagulation | 280 | 3.7 (0.0–11.1) | 3.7 (0.0–11.1) | 3.7 (0.0–11.1) | 3.7 (0.0–11.1) |
Silicone rubber band application | 994 | 9.5 (3.3–15.7) | 10.7 (4.1–17.3) | 18.2 (8.9–27.5) | 33.2 (10.6–55.9) |
Spring clip application | 694 | 24.1 (12.5–35.8) | 32.4 (18.8–46.1) | 45.3 (28.8–61.8) | 52.1 (31.0–73.3) |
Interval partial salpingectomy | 120 | 0.0 (0.0–0.0) | 9.7 (0.0–28.6) | 9.7 (0.0–28.6) | 9.7 (0.0–28.6) |
Postpartum partial salpingectomy | 707 | 1.5 (0.0–4.3) | 7.8 (1.0–14.6) | 7.8 (1.0–14.6) | 11.4 (1.6–21.1) |
28–33 yr | |||||
Bipolar coagulation | 786 | 2.6 (0.0–6.2) | 2.6 (0.0–6.2) | 18.7 (8.1–29.3) | 21.3 (9.6–33.0) |
Unipolar coagulation | 549 | 0.0 (0.0–0.0) | 2.0 (0.0–5.8) | 2.0 (0.0–5.8) | 15.6 (0.0–31.4) |
Silicone rubber band application | 1199 | 4.3 (0.5–8.1) | 7.9 (2.8–13.1) | 9.0 (3.4–14.6) | 21.1 (6.4–35.9) |
Spring clip application | 487 | 21.2 (8.2–34.3) | 25.7 (11.4–40.1) | 31.3 (15.1–47.5) | 31.3 (15.1–47.5) |
Interval partial salpingectomy | 137 | 7.5 (0.0–22.0) | 15.4 (0.0–36.6) | 15.4 (0.0–36.6) | 33.5 (0.0–74.3) |
Postpartum partial salpingectomy | 625 | 0.0 (0.0–0.0) | 1.7 (0.0–5.0) | 5.6 (0.0–11.9) | 5.6 (0.0–11.9) |
34–44 yr | |||||
Bipolar coagulation | 788 | 1.3 (0.0–3.8) | 1.3 (0.0–3.8) | 6.3 (0.1–12.5) | 6.3 (0.1–12.5) |
Unipolar coagulation | 603 | 0.0 (0.0–0.0) | 1.8 (0.0–5.3) | 1.8 (0.0–5.3) | 1.8 (0.0–5.3) |
Silicone rubber band application | 1136 | 4.5 (0.6–8.4) | 4.5 (0.6–8.4) | 4.5 (0.6–8.4) | 4.5 (0.6–8.4) |
Spring clip application | 414 | 5.0 (0.0–11.9) | 7.6 (0.0–16.2) | 10.4 (0.2–20.5) | 18.2 (0.0–36.4) |
Interval partial salpingectomy | 168 | 12.3 (0.0–29.2) | 18.7 (0.0–39.6) | 18.7 (0.0–39.6) | 18.7 (0.0–39.6) |
Postpartum partial salpingectomy | 305 | 0.0 (0.0–0.0) | 0.0 (0.0–0.0) | 3.8 (0.0–11.4) | 3.8 (0.0–11.4) |
Failures occurred throughout the follow-up period. Specifically, the cumulative probabilities of pregnancy between years 5 and 10 after sterilization varied from 1.2 per 1000 procedures with puerperal partial salpingectomy to 8.3 per 1000 procedures for bipolar coagulation. Thus, it is clear from this information that a small risk of failure continues for many years after sterilization. Patients are so counseled and instructed to seek evaluation for amenorrhea, abnormal uterine bleeding, or pelvic pain, which all may herald ectopic pregnancy.
To help lower failure rates, tubal segments from puerperal partial salpingectomy are sent for histologic evaluation to confirm complete tubal transection bilaterally. If transection is deemed incomplete, then postoperative HSG can be scheduled to evaluate tubal occlusion. In the interim, other contraception should be used. In rare instances, the round ligament or a mesosalpingeal vein was erroneously ligated. For these women, laparoscopic or hysteroscopic sterilization, vasectomy for their partner, or other LARC can be offered.
Pregnancies following tubal sterilization have a high incidence of being ectopically implanted compared with the rate in a general gynecologic population (Bhiwandiwala, 1982; Chi, 1980; McCausland, 1980). These rates are especially high following electrocoagulation procedures, in which up to 65 percent of subsequent pregnancies are ectopic. With failures following other methods—Silastic ring, clip, tubal resection—this percentage is only 10 percent (Hendrix, 1999; Peterson, 1999). In the CREST study, the 10-year cumulative probability of ectopic pregnancy for all methods of tubal sterilization was 7.3 per 1000 procedures.
The risk of ectopic pregnancy also continues long after the sterilization procedure. Again, in the CREST study, the annual rate of ectopic pregnancies was the same across the first 10 years following sterilization (Peterson, 1997).
The absolute risk of ectopic pregnancy for a woman after sterilization reflects both the relative likelihood of ectopic pregnancy when pregnancy occurs after sterilization and the overall likelihood of sterilization failure. Thus, if sterilization failures were rare, an increased relative risk of ectopic pregnancy might have little practical consequence for the individual. However, sterilization fails often enough that some women may be at an overall increased risk of ectopic pregnancy relative to the risk they had with their prior contraceptive method before sterilization.
In comparison with other contraceptive methods, interval sterilization has an ectopic pregnancy risk equal to the risk associated with IUD use. In contrast, puerperal sterilization had a lower ectopic pregnancy risk than IUD use (Holt, 1991; Peterson, 1997).