This chapter deals primarily with APGO Educational Topic Areas:
TOPIC 32 OBSTETRICAL PROCEDURES
TOPIC 33 FAMILY PLANNING
TOPIC 41 GYNECOLOGIC PROCEDURES
Students should be able to compare and contrast common methods of permanent sterilization. They should be able to describe the risks and benefits.
Clinical Case
A couple in their mid-30s comes to you for contraceptive counseling. With their third of three planned pregnancies ending with the birth of twin sons, they are “quite certain that their family is complete” and wish to consider long-term contraception and sterilization procedures. Despite the high efficacy, they rapidly discard ideas of long-acting reversible contraception because the mother is only 34 years old and, thus, would need repeat insertion of implants or intrauterine devices until menopause. You then review the risks and benefits of transabdominal tubal ligation and hysteroscopic tubal blockage for her and vasectomy for him.
STERILIZATION AS A METHOD OF CONTRACEPTION
Sterilization offers highly effective birth control without continuing expense, effort, or motivation. It is the most frequently used method of controlling fertility in the United States. Approximately one in three married couples has chosen surgical sterilization as their method of contraception. Sterilization is the leading contraceptive method for couples in whom the wife is older than age 30 years and who have been married more than 10 years.
All available surgical methods of sterilization prevent the union of sperm and egg, either by preventing the passage of sperm into the ejaculate (male sterilization, vasectomy) or by permanently occluding the fallopian tube (female sterilization, tubal ligation and hysteroscopic sterilization). Although it is possible to reverse some forms of surgical sterilization, the difficulty of doing so combined with the generally poor rates of success and the financial expense demands that women or couples consider the decision for surgical sterilization to be permanent.
The physician should counsel couples who are considering surgical sterilization using empathic communication skills combined with the latest evidence-based information about the methods under consideration and assist them with counseling specific to their circumstances in determining the best method.
Changes in operative techniques; anesthesia methods; and attitudes of the public, insurance providers, and physicians have contributed to the rapid increase in the number of sterilization procedures performed each year. Modern methods of surgical sterilization are less invasive, less expensive, safer, and as effective—if not more effective—than those used in the past (Table 27.1).
STERILIZATION OF MEN
About one third of all surgical sterilization procedures are performed on men. The technique for vasectomy varies and includes excision and ligation, electrocautery, and mechanical or chemical occlusion of the vas deferens. Because vasectomy is performed outside the abdominal cavity, the procedure is safer, more easily performed in most cases, less expensive, and generally more effective than procedures done on women. Vasectomy is also more easily reversed than most female sterilization procedures (Fig. 27.1), although its reversal is still uncertain in outcome. The main benefit of tubal ligation (but not hysteroscopic sterilization) over vasectomy is immediate sterility.
Minor postoperative complications occur in 5% to 10% of cases and include bleeding, hematomas, acute and chronic pain, and local skin infections. Some authors report a greater incidence of depression and change in body image after vasectomy than after female sterilization. This risk may be minimized with preoperative counseling and education. Concern has been raised about the formation of sperm antibodies in approximately 50% of patients, but no adverse long-term effects of vasectomy have been identified. Likewise, concerns about an increased risk of prostate cancer following vasectomy are not supported in literature; indeed, in countries with the highest rates of vasectomy, there is no increase in the incidence of prostate cancer.
FIGURE 27.1. Vasectomy.
Pregnancy after vasectomy occurs in about 1% of cases. Many of these pregnancies result from intercourse too soon after the procedure, rather than from recanalization. Vasectomy is not immediately effective. Multiple ejaculations are required before the proximal collecting system is emptied of sperm. Couples should use another method of contraception until male sterility is reasonably assured or postoperative azoospermia is confirmed by semen analysis (50% at 8 weeks, 100% at 10 weeks postprocedure). Unlike occlusion of the fallopian tubes by tubal ligation, occlusion of the vas deferens is not immediately effective. Complete azoospermia is usually not obtained until 10 weeks after vasectomy.
STERILIZATION OF WOMEN
Surgical sterilization techniques for women can be performed by laparoscopy, minilaparotomy, or hysteroscopy. Sterilization can be performed as an interval procedure, after a spontaneous or elective abortion, or as a postpartum procedure at the time of cesarean delivery or following vaginal delivery. Some nonsurgical methods based on principles of immunization as well as sclerosing agents are under investigation, but remain experimental although promising. Regardless of the method chosen, patients should be counseled about the various components of the procedure, effectiveness rates, and possible complications. Because of the relative safety, low cost, and ease of most sterilization procedures, care must be taken to be certain that the patient understands that the procedure should be considered as a permanent decision. Patients should understand that reversal is sometimes possible, but at a high cost and usually with low success rates. Failure rates of tubal sterilization are roughly comparable with those of the intrauterine contraceptive. Pregnancy should also be ruled out prior to performing any sterilization procedure.
Laparoscopy
Performed as an outpatient interval procedure, laparoscopic techniques may be carried out under local, regional, or general anesthesia (see Chapter 34). Small incisions, a relatively low rate of complications, and a degree of flexibility in the procedures have led to high physician and patient acceptability.
Occlusion of the fallopian tubes may be accomplished through the use of electrocautery (unipolar or bipolar) or the application of a plastic and spring clip (Filshie clip) or silastic band (Yoon or Falope ring). The choice among laparoscopic methods and cautery or occlusive device is often based more on operator experience, training, and personal preference than on outcome data. It can also be based on patient characteristics, such as body habitus or condition of the fallopian tube. Tubal excision can also be done through laparoscopy.
Electrocautery-Based Methods
Electrocautery-based methods are fast, but they carry a risk of inadvertent electrical damage to other structures, poorer reversibility, and greater incidence of ectopic pregnancies when failure does occur. Most operators coagulate at the isthmus, taking care that the coagulation forceps is placed over the entire fallopian tube and onto the mesosalpinx so that the entire tube and its lumen are coagulated >3 cm in length. Bipolar cautery is safer than unipolar; it has less risk of spark injury to adjacent tissue, because the current passes directly between the blades of the coagulation forceps (Fig. 27.2). Unipolar cautery, however, has a lower failure rate than bipolar. The surgeon, therefore, needs to carefully weigh the risk of the individual procedure with its respective effectiveness.
FIGURE 27.2. Electrocautery. (A) Placement of electrocautery forceps. (B) Cauterization of the fallopian tube. (c) Tube coagulated to >3 cm in length.
Hulka Clip
The Hulka clip is the most readily reversible method because of its minimal tissue damage, but it also carries the greatest failure rate (>1%) for the same reason. As in coagulation, care must be taken to place the jaws of the Hulka clip over the entire breadth of the fallopian tube at a 90° angle. This can be especially difficult when performed immediately postpartum, due to the natural edematous dilation of the tubes.
FIGURE 27.3. (A) Falope ring. (B) Filshie clip.
Falope Ring
The Falope ring has intermediate reversibility and failure rates. Patients may, however, have a higher incidence of postoperative pain, requiring strong analgesics. Care must be taken to draw a sufficient “knuckle” of fallopian tube into the Falope ring applicator so that the band is placed below the outer and inner borders of the fallopian tube, thus occluding the lumen completely (Fig. 27.3A). Bleeding is a potential complication if too much pressure is placed on the mesosalpinx during the application of the ring.
Filshie Clip
The Filshie clip has a lower failure rate than the Hulka clip because of its larger diameter, ease of application, and atraumatic locking device (see Fig. 27.3B). To maximize effectiveness, this clip should be placed at the isthmic portion of the fallopian tube.
Minilaparotomy
Minilaparotomy is the most common surgical approach for tubal ligation throughout the world. Minilaparotomy can be accomplished with a small infraumbilical incision made in the postpartum period or a small lower abdominal suprapubic incision used as an interval procedure, both of which provide ready access to the fallopian tubes. Occlusion of the fallopian tubes may then be accomplished by excision of all or part of the fallopian tube or the use of clips, rings, or cautery.
A common method of tubal interruption utilized in mini-laparotomy is the Pomeroy tubal ligation (Fig. 27.4). In this procedure, a segment of tube from the midportion is elevated, and an absorbable ligature is placed across the base, forming a loop, or knuckle, of tube. This knuckle is then excised. Because of the similarity in appearance between the fallopian tube and the round ligament, this tissue is sent for histologic confirmation. When healing is complete, the ends of the tube will have sealed closed, with a 1- to 2-cm gap between the ends. Electrocoagulation or the application of clips or bands may also be accomplished through a minilaparotomy incision, although these are more widely used with laparoscopy.
FIGURE 27.4. Pomeroy technique. (A) A segment of the tube is elevated. (B) A suture is tied, forming a loop in the tube. (c) The loop is excised. (D) A 1- to 2-cm gap forms between the ends of the cut tube when healing is complete.
Hysteroscopy
Transcervical approaches to sterilization include hysteros-copy and involve gaining access to the fallopian tubes through the cervix. Until 2012, there were two hysteroscopic sterilization methods on the market, both of which involve the placement of inserts to stimulate a tissue reaction that ultimately leads to tubal occlusion. The Essure system involves the introduction of a 3.6-cm stainless steel inner coil and a nickel titanium outer coil into each fallopian tube. The Adiana system involves placing a 0.4-cm flexible silicon insert into the fallopian tube after priming the tube with low radiofrequency energy (Fig. 27.5). Patients are instructed to use an additional form of contraception for 3 months after the procedure, until the efficacy of the device can be proven with hysterosalpingography. Contraindications include nickel or contrast allergies for the Essure system, active pelvic infection, and suspected pregnancy. These procedures can be used for obese patients who may otherwise not be suitable candidates for laparoscopic tubal ligation due to their body habitus. The efficacy for this procedure has been reported to be as great as 99.8%. Essure is still available, but the Adiana system was taken off the market in 2012. Both methods are included because current physicians may still be called upon to treat patients with either insert in place.
Side Effects and Complications
No surgically based technology is free of the possibility of complications or side effects. Infection, bleeding, injury to surrounding structures, or anesthetic complications may occur with any of the techniques discussed in this chapter. The overall fatality rate attributed to sterilization is about 1–4 per 100,000 procedures, significantly lower than that for childbearing in the United States, estimated at about 10 per 100,000 births.
Although pregnancy after sterilization is uncommon, there is substantial risk that any poststerilization pregnancy will be ectopic. The risk varies with the type of procedure and the age of the patient. Ectopic pregnancy occurs after tubal ligation more commonly after cautery than after mechanical tubal occlusion, probably because of microscopic fistulae in the coagulated segment connecting to the peritoneal cavity. Overall, the 10-year cumulative probability of ectopic pregnancy after tubal ligation is 7.3 per 1,000 procedures.
FIGURE 27.5. Hysteroscopic sterilization.
Noncontraceptive Benefits
Patients who undergo a tubal ligation not only gain effective contraception but also benefit from a decreased lifetime risk of ovarian cancer. The mechanism for this risk reduction is unknown at this time. Although tubal sterilization has not been shown to protect against sexually transmitted diseases (STDs), it may offer some protection against pelvic inflammatory disease.
REVERSAL OF TUBAL LIGATION
Reversal of tubal ligation by microsurgical techniques is most successful when minimal damage is done to the smallest length of the fallopian tube (e.g., Hulka clip, Filshie clip, and Falope ring)—in some series approaching 50% to 75%. In most cases, however, rates of 25% to 50% are more reasonable expectations, so that many specialists in infertility recommend the use of assisted reproductive technology (e.g., in vitro fertilization) rather than attempts at tubal ligation reversal with the attendant low success rates and increased risk of tubal ectopic pregnancy. A patient who has undergone tubal reversal and becomes pregnant is presumed to have an ectopic pregnancy until intrauterine pregnancy is established.
THE DECISION FOR STERILIZATION
The decision for sterilization is an important one, and the risks, effectiveness, and long-term implications (Box 27.1).
Components of presterilization counseling should include the following:
• Permanent nature of the procedure
• Alternative methods available, including male sterilization
• Reasons for choosing sterilization
• Screening for risk indicators for regret
• Details of the procedure, including risks and benefits
• The possibility of failure, including ectopic pregnancy
• The need to use condoms for protection against STDs, including human immunodeficiency virus
BOX 27.1 Risk Indicators for Regret about Decision for Sterilization
Age < 25 years at the time of sterilization
Sterilization at the time of cesarean section
Low parity
Minority status
Change in marital status
Less access to, information about, or support for other contraceptive method use
Incomplete or inadequate information about the procedure
Making the decision under pressure from a spouse or because of medical indications
• Completion of informed consent process
• Local regulations regarding interval from time of consent to procedure
Despite careful counseling, up to 26% of patients who undergo sterilization subsequently report regret, although only 1% actually request reversal of the procedure.
Clinical Follow-Up
The idea of having to get a confirmation hysterosalpingogram 3 months after hysteroscopic tubal procedures makes them unattractive to the couple. They feel that from their perspective, the risks of both surgical procedures are similar enough to be inconsequential. However, learning that the 10-year failure rate per 1,000 procedures is 2.5 times greater for tubal ligation when compared with vasectomy, they choose vasectomy, and a urologic appointment is arranged. After learning about the 10-week “waiting period” after vasectomy they choose an estrogen–progestin combined hormonal formulation for interval contraception until his procedure.
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