Surgical Sterilization

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Chapter 28 Surgical Sterilization

HISTORY

The first female sterilization in North America was performed in 1880 by S.S. Lungren of Toledo, Ohio and was done at the time of cesarean section. For the next few decades, all tubal sterilizations were performed at the time of laparotomy as a concurrent procedure or at the time of cesarean section because the risk of mortality was too high to perform this operation for sterilization alone. Sterilization became better accepted with the advent of the Pomeroy method of tubal occlusion, which could be accomplished through a small incision.

In the 1970s tubal sterilization became widespread due to the introduction of minilaparotomy and laparoscopy as methods. Anderson1 is credited with performing the first laparoscopic electrocoagulation procedure in the United States in 1937. Steptoe2 in 1967 reported the first large series of laparoscopic sterilizations, and Wheeless3 in 1973 reported the first single-puncture laparoscopic technique. These procedures allowed for interval surgery, surgery without hospital stay, reduced recovery time, less morbidity, and better cosmetic result.4 Sterilization is now the most commonly used method of family planning in the world.

PREOPERATIVE EVALUATION

Tubal sterilization should be available to any woman who desires permanent sterilization, assuming that she has proper informed consent (Table 28-1) and adequate knowledge regarding the procedure. The procedure should be considered purely elective. There are virtually no absolute contraindications to tubal sterilization except for gynecologic malignancy or gynecologic disease that requires hysterectomy or bilateral oophorectomy.

Table 28-1 Elements of Informed Consent for Sterilization

Review of alternative methods of permanent sterilization (e.g., vasectomy)
Indication that the procedure is considered permanent
Review of failure rate of procedure
Description of the planned operative technique
Discussion of potential surgical risks

Certain circumstances require specific mention. For example, if the patient has known extensive intra-abdominal adhesions, the potential for intraoperative morbidity may be so great as to consider another form of contraception. For the patient with a severe medical problem, it is probably advisable to consult with a specialist in the particular disease-related area or a maternal medicine specialist to determine exactly how pregnancy would affect the condition in question. Often, patients have been told by a well-meaning healthcare provider that pregnancy is contraindicated when in fact it is not. The family of a severely mentally retarded patient may request sterilization, but these are special circumstances that require discussion with the family and most often require a second opinion, an ethics committee recommendation, and, at times, a court order.

Informed Consent

Because most methods of sterilization are designed to be permanent, proper patient counseling and informed consent are important. The decision for sterilization should be made on an entirely voluntary basis after appropriate counseling on risk, benefits, and alternatives.

Various materials are available to assist the physician in counseling the patient. The American College of Obstetricians and Gynecologists (ACOG) distributes a pamphlet that discusses different techniques of sterilization as well as alternative methods for contraception. For couples desiring permanent sterilization, vasectomy should always be discussed because vasectomy is associated with fewer complications than tubal sterilization. When counseling the patient on the benefits of sterilization, it is important to include that all methods are extremely effective, are permanent, and have a low failure rate.5 Risks of the female sterilization procedure include risk of anesthesia, operative surgical risks, and the 1% to 3% risk of failure with an increased risk of ectopic pregnancy. It should be remembered that patients whose sterilization will be federally funded must sign a special consent document and must be at least 21 years old.

The patient’s husband is not required to give consent before the procedure is performed. Obviously, it is best if both partners have an understanding of the procedure as well as the benefits and potential risks of it. Thus, if a problem is encountered, the patient’s family is in a better position to deal with the problem.

Sterilization Regret

Anywhere from 3% to 25% of women have regret about sterilization, and 1% to 2% of these patients actually seek tubal reversal. Some reasons for regret (Table 28-2) include change in marital status, death of a child, and wanting another child after other children have gotten older. Studies have shown that there is an increased risk of regret with change in marital status, age less than 30 at the time of sterilization, psychiatric history, postpartum sterilization, poor outcome with previous delivery, and ongoing marital, financial, health, or personal problems at the time of sterilization.5

Table 28-2 Factors That Have and Have Not Been Associated with Regret After Sterilization

Factors Associated with Regret Factors Not Associated with Regret
Marital status change Religion
Family stress (e.g., death of a child) Socioeconomic level
Desire for additional children as the “baby” grows up Education level
Post-tubal ligation syndrome symptoms Low parity
Postpartum procedure Decision made with husband’s approval
Sterilization before age 30 Interval procedure

TIMING

Postpartum Sterilization

Sterilization after delivery, during the patient’s postpartum hospital stay, is a convenient, effective, and efficient way to prevent future pregnancy. In the immediate postpartum period the uterus is enlarged to the level of the umbilicus, making it convenient to perform sterilization with a small 1- to 2-cm infraumbilical incision. Any of several techniques could be used. The longest period that the patient may wait before undergoing sterilization is controversial. In some circumstances, a delay of 12 to 24 hours may be needed to assess the infant’s condition, or delays secondary to staffing patterns or availability of anesthesia may be encountered. Studies done show no increased risk of morbidity if the sterilization is delayed for the first postpartum day.6,7 If it is not feasible during this time period to perform the sterilization, the patient should probably wait at least 6 weeks so that the uterine architecture will be back to normal. Before this time, the uterus may be enlarged, making laparoscopy more difficult, and there may be an increased risk of infection during the postpartum period. The patient who has a postpartum endometritis or has had premature rupture of the membranes, intrapartum fever, or manual placental removal is probably at risk of a postsurgical infection. Therefore, it may be prudent for this patient to wait and undergo interval sterilization.

If cesarean section is required and the patient desires sterilization, the two procedures should be performed concurrently. The addition of sterilization to cesarean section adds little to the operative risk of the procedure or to the postoperative morbidity. Also, performance of the sterilization procedure at the time of cesarean section or shortly after vaginal delivery allows the patient to recover from the two procedures simultaneously and therefore does not add to the patient’s hospitalization or convalescence period.

STERILIZATION METHODS

More than 100 sterilization techniques have been described in the gynecologic literature. A discussion of the risks, benefits, technical aspects, and failure rates of each of these procedures is beyond the scope of this chapter. Therefore, only those techniques that are currently popular or are widely used are discussed. For the most part, interval sterilizations are performed by laparoscopy and postpartum sterilizations are done by minilaparotomy.

Madlener Technique

The Madlener technique involves forming a loop of tube, of which a portion is crushed at the base of the loop and ligated with a nonabsorbable suture. Occlusion but not division of the lumen is achieved (Fig. 28-1). The end result is similar to the laparoscopic placement of a Silastic band for occlusion, as described in the section on the Falope ring in this chapter. Failures are often attributed to fistula formation at the ligature site. This technique is generally of historic interest only.

Irving Procedure

The Irving procedure was introduced as a technique for ligation and division of the oviduct at the time of cesarean section. At the ampullary–isthmic junction, the proximal stump is buried within the myometrium and the distal stump is buried between the leaves of the broad ligament (Fig. 28-2). As the uterus undergoes involution postpartum, the buried proximal and distal ends of the tubes become compressed and eventually obliterated. This procedure takes longer and there is often more blood loss; however, the chances of tubal recanalization or pregnancy in the proximal stump are remote.

Pomeroy Method

The Pomeroy method (Fig. 28-3) or its modifications are probably the most commonly used sterilization procedures today. A knuckle of tube is grasped at the midportion using a Babcock clamp. This segment of tube, approximately 2cm in length, is then ligated at the base with an absorbable suture, preferably plain gut. This segment of tube is then excised and sent to the pathology laboratory for confirmation. The use of absorbable sutures allows the proximal and distal segments of the tube to separate, thus decreasing the risk of recanalization of the tube. The advantages to the Pomeroy method are that it is easy and quick to perform and highly effective. Its acceptance for both postpartum and interval sterilization is quite high.

Fimbriectomy

The technique of fimbriectomy described by Kroener employs the ligation of the distal ampulla with two permanent sutures and division and removal of the tubal infundibulum (Fig. 28-5). The simplicity of this procedure accounted for its popularity, but fimbriectomy does not seem to have many advocates due to the availability of easier and much more effective procedures.

Vaginal Approach

Theoretically the vaginal approach (Fig. 28-6) seems ideal for safe and rapid tubal sterilization and has the advantage of avoiding an abdominal incision. However, the potential complications and complexity of the procedure prevent its widespread popularity. The possible complications from this procedure are cellulitis, hemorrhage, infection, cuff abscess, and bowel and bladder damage. Deep dyspareunia may also be a complication with some patients.

The vaginal approach is particularly helpful in very obese patients or patients who have an umbilical hernia or previous umbilical hernia repair. Relative contraindications include multiple pelvic surgical procedures, endometriosis, known extensive pelvic adhesive disease, or uterine immobility on examination.

The patient is placed in the dorsal lithotomy or knee-chest position. A right-angle or Dever retractor is used to expose the cervix, which is grasped on its posterior lip with a single-toothed tenaculum. The posterior cul-de-sac is exposed, and a colpotomy incision is performed using Mayo scissors. The tips of the scissors are placed in the peritoneal opening and spread to enlarge the incision. The anterior retractor is placed posterior to the cervix just inside the incision and is elevated. This maneuver results in retroflexion of the uterus. The fallopian tube is grasped with a Babcock clamp and brought into the operative field. The sterilization can be accomplished using tubal bands, electrocautery, or clips.9 However, the most common method described is the use of the Pomeroy technique.10 Once completed, the colpotomy incision is closed using interrupted figure-of-eight sutures or a single running suture of an absorbable suture material.

Intraoperatively, the most common problem encountered is difficulty in exposing the fallopian tube. Placing the anterior retractor too deeply into the incision will antevert the uterus rather than cause uterine retroflexion. Suprapubic pressure can be used to facilitate uterine retroversion. Postoperatively, pelvic infection is the most serious potential complication after vaginal sterilization. Therefore, a single dose of prophylactic antibiotic should be administered approximately 30 minutes before the procedure.

Laparoscopic Sterilization

Laparoscopic sterilization has become quite popular over the past few decades. This procedure provides superb visualization not only of the pelvic organs, but also of the entire abdominal cavity. Since the introduction of laparoscopy, women have had access to a safe, effective, and dependable method of sterilization.

Clips

Hulka first reported the use of a spring clip for tubal sterilization in 1973. The Hulka clip, made of Lexan plastic, is maintained in its closed position by a gold-plated spring that diminishes peritoneal reaction. The interlocking plastic teeth compress the tube and obliterate the lumen of the tube. Placement is crucial with this clip. The clip is applied to the isthmic portion of the tube about 2cm from the uterus and exactly at right angles to the tube. The jaws should be pressed against the tube with the tip of the clip extending onto the mesosalpinx, forming the characteristic envelope sign (Fig. 28-9). Like the Falope ring, this method works by necrosis; therefore, local anesthetic on the tube is preferable. This clip is most successful when placed on a normal tube because thickening of the tube, distortion, and adhesions may make application difficult and increase failure rates. One advantage to this method is that only a small portion of tube is damaged, which makes reanastomosis procedures more successful.

A few years after the development of the Hulka clip, Filshie developed a clip with jaws of titanium and an inner cushion of silicone rubber. When the jaws close, the silicone rubber expands as tube necrosis occurs, causing complete occlusion of the tube and lumen. The Filshie clip is the easiest to apply due to the grasping effect from the curve on the upper jaw. This clip, like the Hulka, is placed at a right angle on the isthmic portion of the tube 2 to 2.5cm distal to the uterotubal junction, after application of local anesthetic on the portion of the tube to be obliterated. Because of its length, the Filshie clip can be placed on any type and shape of tube, including postpartum.12,13 Several randomized clinical trials compared the Hulka clip to the Filshie clip and showed that the failure rate with the Hulka is slightly higher (1.0 per 1000 for Filshie vs. 7.0 per 1000 for Hulka). This method also only destroys a small segment of tube, making tubal reversals easier.

Tubal Ligation Under Local Anesthesia

With the popularity of tubal sterilization, finding ways to shorten operative time, hospital stay, and the cost of the procedure has become significant. One option to accomplish this goal is the introduction of tubal ligation under local anesthesia.

This type of tubal ligation is ideal for patients without contraindications for local anesthesia, opportune for a nonoperating room setting, and ideal for patients who have a great fear of general anesthesia or have cardiac or pulmonary disorders preventing the use of general anesthesia. This approach is contraindicated in the anxious patient or obese patient who might require greater manipulation of abdominal organs. Local anesthesia should not be used by inexperienced surgeons due to its complexity.

Advantages of this are that it avoids the risks associated with general anesthesia and decreases the cost of anesthesia. This is due to the fact that anesthesia time is decreased and recovery time is shortened with less postoperative nausea and vomiting with local anesthesia compared to general anesthesia.

Disadvantages to local anesthesia are that the technique requires precise and gentle surgical manipulation with mild to moderate discomfort to the patient. Local anesthesia can also make the procedure more difficult for the surgeon because of the increased risk of patient movement during surgery and an increased need for close verbal contact between the surgeon and the patient during the procedure.

Hysteroscopic Sterilization

Hysteroscopy is another method by which permanent sterilization can be achieved and is the newest method used for sterilization. One advantage of hysteroscopic sterilization is that it can be performed in the office setting under local anesthesia. Three approaches are being investigated at this time, and one procedure has received FDA approval. These include coagulation of the ostia, chemical sclerosis of the endosalpinx, and use of a plug to obstruct the tubal lumen.

Plugs

Three plugtype devices have reached human clinical trials, and the Essure device has been approved by the U.S. FDA (Fig. 28-10). The Essure procedure is a nonincisional surgical procedure that involves placing a small, flexible device called a micro-insert into each of the fallopian tubes. The micro-inserts are made from polyester fibers and metals (nickel–titanium and stainless steel).15 Once the micro-inserts are in place, tissue ingrowth occurs into the micro-inserts, blocking the fallopian tubes. Nickel allergy, recent pelvic infection, and possibly hydrosalpinx are contraindications to the procedure. A hysterosalpingogram must be done 3 months after the procedure to ensure and document tubal occlusion.

Two separate studies of the safety and effectiveness of the Essure method have been conducted in women from the United States, Australia, and Europe. In the first study, 192 women relied on Essure for contraception for 1 year, 177 relied on Essure for contraception for 2 years, and 172 relied on Essure for contraception for 3 years. In the second study, 434 women relied on Essure for contraception for 1 year, 403 relied on Essure for contraception for 2 years and 21 for 3 years. None of the women who relied on Essure for contraception during the clinical trials became pregnant over the 1 to 3 years of follow-up.16

COMPLICATIONS

Sterilization Failure

Sterilization, although a reliable method of birth control, does have a failure rate that should be related to patients in counseling. Historically, the laparoscopic failure rate has been 0.1% to 0.4% compared to the Pomeroy method failure rate of 0.17% to 5%. These values are flawed by small study groups, methodology problems, and short follow-up (generally 1 to 2 years). This led to the U.S. Collaborative Review of Sterilization (CREST) study, which showed that sterilization has a higher failure rate than once thought.

U.S. Collaborative Review of Sterilization (CREST) Study

This study was a multicenter, prospective study involving 10,685 women who had been sterilized who were then followed for 8 to 14 years to determine their probability of pregnancy.1719 The techniques studied were silicone rubber rings, bipolar electrocoagulation, postpartum partial salpingectomy, spring clip application, unipolar coagulation, and interval partial salpingectomy. Among these women, 143 sterilization failures occurred, with 32.9% being ectopic pregnancies. The cumulative 10-year probability of pregnancy was lowest after unipolar coagulation and postpartum partial salpingectomy, and highest with spring clip application. Results with the Filshie clip were not reported.

In this study the sterilization failure rate after 10 years was 2%. The two most important variables were age at the time of sterilization and the technique used. The failure rate after 10 years for bipolar electrocoagulation in young women age 18 to 27 is 5.4%; in those age 28 to 33, it is 2.1%; in those age 34 to 44, it is 0.6%. Postpartum salpingectomy had a 10-year failure rate of 1.1% in those age 18 to 27, 0.6% in those age 28 to 33, and 0.4% in those age 34 to 44.

The higher failure rate than expected seen in this study has been accounted for in part by the fact that the centers used for these studies were teaching hospitals, and failure may be from poor technique and lack of experience. Therefore, to decrease the failure rate of tubal sterilization, proper technique should be used.

Delayed Complications

SUMMARY

With the desire for convenient methods of contraception, tubal ligation continues to be the most popular form of permanent sterilization in the United States. As seen in this discussion, there are many options for tubal ligation; the type of procedure used should be tailored to each individual patient’s needs. Female sterilization has progressed considerably and will continue to progress as easier, more efficient, and reversible methods are developed.

REFERENCES

1 Anderson ET. Peritoneoscopy. Am J Surg. 1937;35:136-138.

2 Steptoe PC. Laparoscopy in Gynaecology. Edinburgh: E. and S. Livingston Ltd., 1967.

3 Wheeless CRJr. Elimination of second incision in laparoscopic sterilization. Obstet Gynecol. 1972;39:134-136.

4 Soderstrom: Food and Drug Administration advisory panel on sterilization: Randomized, controlled trials of Filshie clip (1996).

5 Penney GC, Souter V, Glasier A, Templeton AA. Laparoscopic sterilization: Opinion and practice among gynacologists in Scotland. BJOG. 1997;104:71-77.

6 Black WP, Sclare AB. Sterilization by tubal ligation—a follow-up study. J Obstet Gynaecol Br Commonw. 1968;75:219-224.

7 Green LR, Laros RK. Postpartum sterilization. Clin Obstet Gynecol. 1980;23:647-659.

8 Lipscomb GH, Spellman JR, Ling FW. The effect of same-day pregnancy testing on the incidence of luteal phase pregnancy. Obstet Gynecol. 1993;82:411-413.

9 Hartfield VJ. Female sterilization by the vaginal route: A positive reassessment and comparison of four tubal occlusion methods. Austral NZ J Obstet Gynaecol. 1993;33:408-412.

10 Hartfield VJ. Day care Pomeroy sterilization by the vaginal route. NZ Med J. 1977;85:223-225.

11 Ezeh UO, Shoulder V, Martin JL, et al. Local anesthetic on Filshie clips for pain relief after tubal sterilization: A randomized double-blinded control trial. Lancet. 1995;34:82-85.

12 Filshie GM, Casey D, Pogmore JR, et al. The titanium/silicone rubber clip for female sterilization. BJOG. 1981;88:655-662.

13 Graf AH, Staudach A, Steiner H, et al. An evaluation of the Filshie clip for postpartum sterilization in Austria. Contraception. 1996;54:309-311.

14 MacKenzie IZ, Turner E, O’Sullivan GM, Guillebaud J. Two hundred out-patient laparoscopic clip sterilizations using local anesthesia. BJOG. 1987;94:449-453.

15 Valle RF, Carignan CS, Wright TC, the STOP Preshysterectomy Investigation Group. Tissue response to the STOP microcoil transcervical permanent contraceptive device: Results from a prehysterectomy study. Fertil Steril. 2001;76:974-980.

16 Cooper JM, Canignan CS, Chen D, et al. Microinsert nonincisional hysteroscopic sterilization. Obstet Gynecol. 2003;102:59-61.

17 Hillis SD, Marchbanks PA, Tylor LR, Peterson HB, for the U.S. Collaborative Review of Sterilization Working Group. Higher hysterectomy risk for sterilized than nonsterilized women: Findings from the U.S. Collaborative Review of Sterilization. Obstet Gynecol. 1998;91:241-246.

18 Hillis SD, Marchbanks PA, Tylor LR, Peterson HB, for the U.S. Collaborative Review of Sterilization Working Group. Poststerilization regret: Findings from the U.S. Collaborative Review of Sterilization. Obstet Gynecol. 1999;93:889-895.

19 Hillis SD, Marchbanks PA, Tylor LR, Peterson HB, for the U.S. Collaborative Review of Sterilization Working Group. Tubal sterilization and long-term risk of hysterectomy: Findings from the U.S. Collaborative Review of Sterilization. Obstet Gynecol. 1997;89:609-614.

20 Peterson HB, Jeng G, Folger SG, Hillis SA, et alfor the U.S. Collaborative Review of Sterilization Working Group. The risk of menstrual abnormalities after tubal sterilization. NEJM. 2000;343:1681-1687.