CHAPTER 39: Sterilization

Sterilization is a popular choice of contraception for millions of men and women. Among women using contraception, one third rely on either male or female sterilization (Daniels, 2015). This procedure is indicated in those requesting sterilization and who clearly understand its permanence and its difficult and often unsuccessful reversal. All persons considering sterilization should also be counseled regarding alternative contraceptive choices (American College of Obstetricians and Gynecologists, 2017a,c).

Female sterilization is usually accomplished by occlusion, excision, or division of the fallopian tubes. Puerperal sterilization procedures follow cesarean or vaginal delivery and approximately 7 percent of all live births in the United States (Moniz, 2017). Nonpuerperal tubal sterilization is done at a time unrelated to recent pregnancy and is also termed interval sterilization.

Timing

For several days postpartum, the uterine fundus lies at the level of the umbilicus, and fallopian tubes are accessible directly beneath the abdominal wall. Moreover, abdominal laxity allows easy repositioning of the incision over each uterine cornu.

On our service, puerperal tubal ligation is performed by a surgical team dedicated to this role the morning after delivery. This timing minimizes hospital stay but lowers the likelihood that postpartum hemorrhage would complicate recovery following surgery. In addition, the status of the newborn can be better ascertained before surgery. In contrast, some prefer to perform sterilization immediately following delivery and use neuraxial analgesia already placed for labor. In this model, barriers to sterilization can be lessened by designating these postpartum surgeries as urgent, especially in high-volume labor and delivery units, which usually prioritize limited operating-room availability for intrapartum procedures (American College of Obstetricians and Gynecologists, 2016; Potter, 2013).

Technique

Various techniques are now used to disrupt tubal patency. In general, a midtubal segment of fallopian tube is excised, and the severed ends seal by fibrosis and peritoneal regrowth. Commonly used methods of puerperal sterilization include the Parkland, Pomeroy, and modified Pomeroy techniques (American College of Obstetricians and Gynecologists, 2017a). Less often, Filshie clips are used (Madari, 2011). Irving and Uchida techniques or Kroener fimbriectomy are rarely used because of their increased required dissection or unfavorably high failure rates. Also, in the absence of uterine or other pelvic disease, hysterectomy solely for sterilization at the time of cesarean delivery, early in the puerperium, or even remote from pregnancy is difficult to justify. It carries significantly increased surgical morbidity compared with tubal sterilization.

Evidence suggests that the fallopian tube may be the origin of pelvic serous carcinomas, especially those of the ovary. With this knowledge, the Society of Gynecologic Oncologists (2013) and American College of Obstetricians and Gynecologists (2017b) recommend consideration of salpingectomy to lower cancer risks. Specifically, for women at average risk of ovarian cancer, risk-reducing salpingectomy should be discussed and considered with patients at the time of abdominal or pelvic surgery, at hysterectomy, or in lieu of tubal ligation.

Spinal analgesia is typically selected for cases scheduled for the first postpartum day. If done more proximate to delivery, the same epidural catheter used for labor analgesia can be used for sterilization analgesia. Notably, for those with preeclampsia, HELLP (hemolysis, elevated liver enzyme levels, low platelet count) syndrome, or gestational thrombocytopenia, platelet levels should be >100,000 for spinal blockade (Chap. 25, Contraindications). General anesthesia may be less desirable due to residual pregnancy-related airway vulnerabilities (Bucklin, 2003). The bladder is emptied before surgery to avoid its laceration. A full bladder can also push the fundus above the umbilicus.

A small infraumbilical incision is ideal for several reasons. As noted, the fundus in most cases lies near the umbilicus. Second, the umbilicus usually remains the thinnest portion of the anterior abdominal wall and requires less subcutaneous dissection to reach the linea alba fascia. Third, an infraumbilical incision offers fascia with sufficient integrity to provide a closure that has minimal risk for later incisional hernia. Last, incisions that follow the natural curve of the lower umbilical skin fold yield suitable cosmesis. A 2- to 4-cm transverse or vertical skin incision is usually sufficient for normal-weight women. For obese women, a 4- to 6-cm incision may be needed for adequate abdominal access.

Beneath this incision, the subcutaneous tissue is bluntly separated to reach the linea alba fascia. For this, an Allis clamp can be opened and closed as downward pressure is exerted. Similarly, the blades of two army-navy retractors both pulling in downward yet opposite directions can part the subcutaneous layer. Clearing this fatty tissue away from the fascia isolates the fascia for incision and for later closure without intervening fat, which may impede wound healing.

The fascial incision may be transverse or vertical and follows the same orientation of the skin incision. For this, once the linea alba is reached, it is grasped with two Allis clamps—one placed on either side of the planned fascial incision. The purchase of tissue with each clamp should be substantial and creates a small roll of fascia to be incised. Often, the peritoneum is incorporated simultaneously and entered. If not, the peritoneum is grasped with two hemostats and sharply cut. Others may prefer to bluntly enter with a single index finger. Notably, if the initial fascial incision is too small, it can be extended with curved Mayo scissors.

Adequate exposure is critical, and army-navy or appendiceal retractors are suitable. For obese women, a slightly larger incision and narrow deeper retractors may be required. If bowel or omentum is obstructing, Trendelenburg position can help displace these cephalad. Digitally packing with a single, moist, fanned-out piece of surgical gauze can also be used, but a hemostat should always be attached to the distal end to avert its retention. At times, tilting the entire table to the opposite side of the tube being exposed assists tube isolation.

The fallopian tube is identified and grasped at its midportion with a Babcock clamp, and the distal fimbria confirmed. This prevents confusing the round ligament with the midportion of the tube. A common reason for sterilization failure is ligation of the wrong structure, typically the round ligament. Therefore, identification and isolation of the distal tube prior to ligation is necessary. Whenever the tube is inadvertently dropped, it is mandatory to repeat this identification process. Surgical steps for ligation are outlined in Figures 39-1 and 39-2.

Steps of salpingectomy are shown in Figure 39-3. The umbilical incision generally will need to be larger to allow an adequate view of the tube and mesosalpinx and to place clamps. With total salpingectomy, the entire mesosalpinx must be divided to free the fallopian tube.In two small cohorts undergoing salpingectomy after vaginal birth, surgical times were longer than for tubal occlusion, and in one report, blood loss was increased (Danis, 2016; Powell, 2017). With salpingectomy and cesarean delivery, total blood loss rates were not statistically higher (Powell, 2017; Shinar, 2017).

After surgery, diet is given as tolerated. Ileus is infrequent and should prompt concern for bowel injury, albeit rare. Most women have an uncomplicated course and are discharged on the first postoperative day.

These techniques and other modifications basically consist of (1) ligation and resection at laparotomy as described earlier for puerperal sterilization; (2) application of permanent rings, clips, or inserts to the fallopian tubes by laparoscopy or hysteroscopy; or (3) electrocoagulation of a tubal segment, usually through a laparoscope. A detailed description and illustration of these can be found in Williams Gynecology, 3rd edition (Thompson, 2016).

In the United States, a laparoscopic approach to interval tubal sterilization is the most common. The procedure is frequently performed in an ambulatory surgical setting under general anesthesia. In almost all cases, the woman can be discharged within several hours. Minilaparotomy using a 3-cm suprapubic incision is also popular, especially in resource-poor countries. Major morbidity is rare with either minilaparotomy or laparoscopy. Although not often used, the peritoneal cavity can be entered through the posterior vaginal fornix via colpotomy to perform tubal interruption.

Contraceptive Failure

Pregnancy following sterilization is infrequent. The Collaborative Review of Sterilization (CREST) study followed 10,863 women who had undergone tubal sterilization from 1978 through 1986 (Peterson, 1996). The cumulative failure rate for the various tubal procedures was 18.5 per 1000 or approximately 0.5 percent. The study found puerperal sterilization to be highly effective. The 5-year failure rate was 5 per 1000, and for 12 years, it was 7 per 1000.

Puerperal sterilization fails for two major reasons. First, surgical errors occur and include transection of the round ligament or only partial transection of the tube. For this reason, both tubal segments are submitted for pathological confirmation. Second, a fistulous tract or spontaneous reanastomosis may form between the severed tubal stumps.

Approximately 30 percent of pregnancies that follow a failed tubal sterilization procedure are ectopic. This rate is 20 percent for those following a postpartum procedure (Peterson, 1996, 1997). Thus, any symptoms of pregnancy in a woman after tubal sterilization must be investigated, and an ectopic pregnancy excluded.

Other Effects

Overall, risks for ovarian cancer decline and for breast cancer are unaffected following sterilization (Gaudet, 2013; Pearce, 2015). Women who have undergone tubal sterilization are highly unlikely to subsequently have salpingitis (Levgur, 2000). For menorrhagia and intermenstrual bleeding following tubal sterilization, most studies of the risk have found no association (DeStefano, 1985; Peterson, 2000; Shy, 1992).

Less objective but important psychological sequelae of sterilization have also been evaluated. In the CREST study, Costello (2002) found that tubal ligation did not change sexual interest or pleasure in 80 percent of women. In most of the 20 percent of women who did report a change, positive effects were 10 to 15 times more likely.

Invariably, a number of women express regrets regarding sterilization, and this is especially true if it is performed at a younger age (Curtis, 2006; Kelekçi, 2005). In the CREST study, Jamieson (2002) reported that 7 percent of women who had undergone tubal ligation had regrets by 5 years. This is not limited to their own sterilization, because 6.1 percent of women whose husbands had undergone vasectomy had similar regrets.

Tubal Sterilization Reversal

No woman should undergo tubal sterilization believing that subsequent fertility is guaranteed either by surgery or by assisted reproductive techniques. Both approaches are technically difficult, expensive, and not always successful. In general, pregnancy rates after tubal reversal favor women with age younger than 35 years, with 7 cm of remaining tube, with a short time from antecedent sterilization, and with isthmic–isthmic repairs. With reanastomosis via laparotomy, rates of live births range from 44 to 82 percent (Deffieux, 2011; Malacova, 2015). The rate of ectopic pregnancy is 2 to 10 percent after reanastomosis (American Society for Reproductive Medicine, 2015). With reanastomosis to reverse Essure sterilization, only 27 percent of women had subsequent live births (Monteith, 2014).

Devices can be inserted via hysteroscopy to occlude the proximal fallopian tubes. The Essure microinsert has a fine stainless-steel inner coil enclosed in polyester fibers and an expandable outer coil of Nitinol—a nickel and titanium alloy (Fig. 39-4). The outer coil expands after placement, allowing the inner fibers to expand. These synthetic fibers incite a chronic inflammatory response to prompt local tissue ingrowth that leads to complete tubal lumen occlusion. For hysteroscopic placement, sedation, paracervical block, or both may be used, and in-office insertion is often elected. Devices cannot be placed in all women, and some do not tolerate the procedure while awake (Duffy, 2005). Bilateral placement is achieved in 81 to 98 percent of cases on a first attempt (la Chapelle, 2015).

Since the introduction of Essure, cited adverse events include abnormal bleeding, perforation of the uterus or fallopian tubes from device migration, and allergy or hypersensitivity reactions, especially to the nickel component (Al-Safi, 2013; Mao, 2015). Some events resulted in device removal that requires abdominal surgery (Casey, 2016; Lazorwitz, 2017). To provide more information of the risks and benefits, the Food and Drug Administration (2016) has drafted a black box warning and patient-decision checklist to aid counseling.

Because complete tubal blockage is not 100 percent, it must be confirmed by hysterosalpingography (HSG) 3 months following surgery (Bayer Healthcare, 2002). With such confirmation, efficacy rates for these devices reach 98 to 99 percent (Chudnoff, 2015; Munro, 2014). In real-world settings, pregnancies following transcervical sterilization are most frequently attributed to conception before insertion or HSG and to noncompliance with HSG or its misinterpretation. Although data are limited to small case series, pregnancies conceived with Essure in place do not appear to be at increased risk from the device (Arora, 2014; Veersema, 2014).

Another insert, Adiana, also stimulates tissue ingrowth for tubal occlusion using a cylindrical, nonabsorbent silicone elastomer matrix. However, for financial reasons, production of this device has now been discontinued by the manufacturer (Hologic, 2012). That said, patients with these inserts may be encountered and can consider their device effective.

Although not currently available in the United States, quinacrine pellets cause sclerosis at the tubal ostia. Placement at the uterine fundus with an IUD-type inserter method allows pellet migration into the tubal ostia. Of drawbacks, prior cancer associations have been disproved (Sokal, 2010a,b). Efficacy appears enhanced by technique modification. In one early cohort of 1335 treated women, pregnancy rates at 10 years were 12 percent (Sokal, 2008). Following insertion technique improvement, a 2-year failure rate of 1.2 percent was calculated by Lippes (2015).

Currently, up to a half million men in the United States undergo vasectomy each year (Barone, 2006; Eisenberg, 2010). And 5 percent of women rely on this method for contraception (Daniels, 2015). For sterilization, the vas deferens lumen is disrupted to block the passage of sperm from the testes. Most commonly, a no-scalpel vasectomy (NSV) accomplishes this with one specialized instrument that grasps the vas deferens and surrounding skin together. A second dissector tool punctures the skin and then isolates the vas (Rogers, 2013). As clarified by the American Urological Association, minimally invasive vasectomy includes any vas isolation procedure, including the no-scalpel technique, which uses a skin incision measuring ≤1 cm and requires minimal vas dissection (Fig. 39-5) (Sharlip, 2012). Compared with conventional vasectomy that employs incisions >1 cm and greater dissection, the no-scalpel technique is associated with fewer minor surgical complications, but each is equally effective (Cook, 2014).

Vasectomy is safer than tubal sterilization because it is less invasive and is performed with local analgesia (American College of Obstetricians and Gynecologists, 2017a). In a review to compare the two, Hendrix and associates (1999) found that, compared with vasectomy, female tubal sterilization has a 20-fold increased complication rate, a 10- to 37-fold failure rate, and costs three times as much.

One disadvantage is that sterilization following vasectomy is not immediate. Complete release of sperm stored in the reproductive tract beyond the interrupted vas deferens takes approximately 3 months or 20 ejaculations. The American Urological Association recommends a postprocedural semen analysis at 8 to 16 weeks to document sterility (Sharlip, 2012). During the period before azoospermia is documented, another form of contraception should be used.

The failure rate for vasectomy during the first year is 9.4 per 1000 procedures and 11.4 per 1000 at 2, 3, and 5 years (Jamieson, 2004). Failures result from unprotected intercourse too soon after ligation, incomplete occlusion of the vas deferens, or recanalization (Awsare, 2005; Deneux-Tharaux, 2004).

Other than regrets, long-term consequences are rare. One is troublesome chronic scrotal pain, which develops in up to 15 percent of men (Leslie, 2007; Manikandan, 2004). Previous concerns for atherogenesis, immune-complex mediated disease, testicular cancer, and prostate cancer have been allayed by a number of investigators (Bernal-Delgado, 1998; Giovannucci, 1992; Goldacre, 1983; Møller, 1994).

Reanastomosis of the vas deferens can be completed most effectively using microsurgical techniques. In general, conception rates following reversal are adversely affected by longer duration from vasectomy, poor sperm quality found at reversal, and type of reversal procedure required (American Society for Reproductive Medicine, 2008).