Background
Laparoscopic tubal ligation is a surgical sterilization procedure in which a woman's fallopian tubes are either clamped and blocked or severed and sealed. Both methods prevent eggs from being fertilized. Tubal ligation is a permanent method of sterilization.
About 20% of women choose tubal ligation as their contraceptive method, making it the second most common form of female contraception in the United States. [1] The use of tubal ligation increases with parity: 59% of women who have had 3 children undergo sterilization versus 13% after 1 child. Of women who decide not to have more children, 44% choose sterilization over reversible contraceptive methods. [2]
The number of tubal ligation procedures performed in the United States has recently declined somewhat. This decline is thought to be attributable to the introduction of more options for long-acting reversible contraception, an aging baby-boomer population, and access-to-care issues.
Tubal ligation can be performed in the peripartum period or at any time remote from pregnancy (referred to as interval sterilization). Approximately half of female sterilizations are interval sterilizations, and the other half are performed at the time of cesarean delivery or immediately postpartum. Most interval sterilizations are performed laparoscopically.
Laparoscopic tubal ligation has many advantages that explain its use as the interval procedure of choice. It offers the opportunity to explore pelvic and abdominal anatomy, especially if the patient has complaints such as pelvic pain. The procedure is an outpatient surgery with a rapid recovery, allowing patients to return quickly to work or home. All laparoscopic methods are immediately effective. Laparoscopic tubal ligation is attractive to surgeons because many gynecologists are well trained in laparoscopic techniques and it involves a short operating time.
Disadvantages of laparoscopic tubal ligation include the need for anesthesia and cost of laparoscopic equipment. The procedure is usually performed under general anesthesia, which has its own risks. There is inherent risk with any surgery in which the peritoneal cavity is entered, including the rare risks of bowel injury, hemorrhage, transfusion, and, with some sterilization methods, thermal injury. All sterilization methods have risks of failure and regret.
Indications and Contraindications
Indications
Indications for laparoscopic tubal ligation include the following:
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Desire for permanent sterilization
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Completed childbearing
Contraindications
Contraindications to laparoscopic tubal ligation include the following:
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Any contraindication to laparoscopic surgery (see Gynecologic Laparoscopy)
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Concern that patient's decision for sterilization was not fully voluntary or that patient does not fully understand the intended permanence of the procedure
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Other condition requiring a hysterectomy or bilateral oophorectomy (eg, gynecologic malignancy)
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Concurrent desired pregnancy
Outcomes
Laparoscopic sterilization is a very effective permanent contraceptive procedure. The US Collaborative Review of Sterilization published data on 10,685 women monitored for 8-14 years. This study showed 143 sterilization failures with a resulting pregnancy. With all methods considered (unipolar, bipolar, Falope ring, spring clip, peripartum Pomeroy), there was a 5-year cumulative life-table probability of failure of 13 per 1,000 procedures and a 10-year cumulative life-table probability of failure of 18.5 per 1,000 procedures. The risk of failure continued and accumulated over time. [3]
In the US Collaborative Review of Sterilization study, bipolar cauterization had a 10-year cumulative life-table probability of failure of 24.8 per 1,000 procedures, Falope ring was 17.7 per 1,000 procedures, and the spring clip was 36.5 per 1,000 procedures. These were all performed laparoscopically. [3]
The probability of failure was directly affected by age: The younger the age at the time of sterilization, the higher the failure rate. When bipolar cauterization and Falope ring procedures were considered, women younger than 28 years at the time of their procedure had a statistically significant increase in failure compared to women 34 years or older. All methods, except for the spring clip, had failure rates equivocal to an intrauterine device. [3]
An internationally performed clinical trial followed women for 1 year after randomized placement of the Filshie clip or Falope ring. In the laparoscopic procedure group, there was a 1 year life-table pregnancy probability of 2.5 per 1,000 procedures for both the Falope ring and Filshie clip. [4] Another randomized trial followed Filshie clip and spring clip patients for 1 year to examine failure rates. The 1-year cumulative life-table pregnancy probability was 1.9 per 1,000 procedures in the Filshie group and 9.5 per 1,000 procedures in the spring clip group. [5]
The US Collaborative Review of Sterilization data included 2,267 women who underwent bipolar electrocautery as their sterilization method. Patients with 3 or more burn sites had a failure rate of 6.3 per 1,000 procedures. Patients with 2 or less burn sites had a failure rate of 12.9 per 1,000. These data demonstrated lower failure rates with increased physician experience and more burn sites. [6] Soon after the US Collaborative Review of Sterilization study was published, another study established the exact amount of electrical energy needed to cause complete desiccation and hopefully decrease failure rates further. [7]
Family Health International conducted 11 studies looking at failure and complication rates with Filshie clips. At 24 months, 0.7 failures occurred per 100 procedures. [8] Another retrospective review of 30,000 patients found 73 failures, or a failure rate of 2-3/1,000 patients. [9] Long-term failure rates are unknown at this time.
Limited information is available about failure rates with the laparoscopic Pomeroy method, probably because of its infrequent use as a sterilization technique. One study looking at this method in a teaching institution found 1 failure in the 99 procedures performed. [10] Another small study followed 28 woman undergoing laparoscopic Pomeroy and found no failures at 18 months. [11] More data is needed to determine failure rates with this method.
Several prospective observational studies have noted a reduction in ovarian cancer risk after a sterilization procedure. Furthermore, no relationship between breast cancer and sterilization has been found. [12] While pelvic inflammatory disease and tubo-ovarian abscesses occur in sterilized patients, fewer sterilized patients require hospitalization. This is possibly from the physical blockage of organisms from the lower genital tract. [13]
A French nationwide cohort study by Bouillon et al that included 105,357 women reported that risks of medical outcomes were not significantly increased with hysteroscopic sterilization compared with laparoscopic sterilization. Hysteroscopic sterilization was associated with higher risk of gynecological complications over 1 year and over 3 years compared to laparoscopic sterilization in women undergoing first sterilization. [14]
Complications
Immediate complications
Immediate complications of laparoscopic tubal ligation include the following:
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Incorrect anatomical site of sterilization
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Bowel, bladder, or blood vessel injury or perforation
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Conversion to laparotomy
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Electrocautery complications
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Transection of the fallopian tube
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Uterine perforation or cervical laceration
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Mortality
It is important to identify the fallopian tube and document this in the dictation. Performing procedures on the round ligament will result in a procedure failure. Taking a picture after the procedure will help document correct surgical site in the event of a failure.
Laparoscopic surgery has certain inherent associated complications, including bowel, bladder, or blood vessel injury or perforation by the trocar, scalpel, or Veress needle. These complications are very rare but can be life threatening. [15]
Conversion to laparotomy occurs upon unexpected injury or technical difficulty. Conversion may be caused by abnormal anatomical findings, such as extensive adhesions, distorted pelvic anatomy, or pelvic masses. A patient's comorbidities, such as obesity or previous abdominal surgery, can increase this risk. The US Collaborative Review of Sterilization found that conversion to laparotomy was the most common complication with laparoscopic tubal ligation. It occurred in 0.9% of laparoscopic sterilization procedures because of difficulty with the fallopian tube, failed pneumoperitoneum or entry, incidental disease, or laparoscopic complication. [16]
Thermal injury is associated with any procedure that involves electrocautery. Most thermal injuries from the sterilization procedure itself occur with unipolar cauterization sterilization. Bipolar cauterization is safer as a sterilization technique because the electric current is localized to the tissue in the paddles. However, unsuspected or accidental injuries can occur by unintentional contact of the paddles to other tissue. In the US Collaborative Review of Sterilization, the one thermal injury that occurred with laparoscopic tubal ligation was associated with cauterization during a Falope ring procedure. [16] These injuries typically present with acute abdomen, peritoneal signs, fever, or sepsis about 5-7 days after the procedure. [15, 17]
Transection of the tube occurred in 1%-5% of Falope ring cases in the original trials. [18] In a series of 846 Falope ring sterilizations, 3.1% had bleeding complications, but only 2 of these cases required laparotomy. [19] The US Collaborative Review of Sterilization found a 0.79% complication rate associated with this technique, which is much lower than previously found. However, all fallopian tube transections occurred in Falope ring procedures. [16]
It is possible that the complication rate with Falope ring procedures is decreasing owing to increasing surgeon experience. If a fallopian tube laceration occurs, it can be addressed by cauterizing the fallopian tube or placing a ring over each transected end. There is differing information about the possibility of increased postoperative pain with this procedure compared to others. A Cochrane review reported more pain in the Falope ring group than in the bipolar cauterization group. [20]
Placement of the uterine manipulator can result in uterine perforation or cervical laceration. Uterine perforation can be assessed laparoscopically and usually requires no intervention, as the bleeding typically stops on its own. If uterine bleeding is seen, it can be addressed by pressure and time, cauterization, or suture ligation. The cervix should be inspected upon removal of the uterine manipulator. Cervical bleeding can be addressed with pressure, silver nitrate, Monsel solution, or suture if heavy bleeding is seen.
Deaths associated with tubal ligation are very rare. [21, 22] Most of the deaths result from hypoventilation and cardiopulmonary arrest during the administration of general anesthesia. [1] Many studies include all types of sterilization procedures and do not look exclusively at laparoscopic procedures. The US Collaborative Review of Sterilization, which included 9,475 patients, and a randomized study conducted by the World Health Organization showed no deaths attributable to laparoscopic tubal sterilization. [16, 23]
Delayed complications
Delayed complications of laparoscopic tubal ligation include the following:
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Failure
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Filshie clip complications
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Regret
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Ectopic pregnancy
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Menstrual changes
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Hysterectomy
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Sexual function
Laparoscopic sterilization is a very effective permanent contraceptive procedure. Failure rates are described in more detail in Outcomes.
There have been case reports of migration and spontaneous extrusion of the Filshie clip from various locations, including the vagina, urethra, and the abdominal wall. [24, 25, 26] Furthermore, case reports have reported Filshie clips involved in abscesses. [27] There is a case report of torsion involving a Filshie clip. [28] These complications are rare because the clip is peritonealized over after fibrosis of the tube occurs. [15]
Regretting the decision for sterilization is a common complication of sterilization. However, most women do not regret their decision. [12] The US Collaborative Review of Sterilization looked at 11,232 women in a prospective cohort study over 14 years, in which 12.7% of the sterilized woman experienced regret. Regret occurred in 20.3% of women who were younger than 30 years at the time of sterilization compared to 5.9% among women older than 30 years. Regret was the same for peripartum and interval sterilizations. The most common reasons for regret were the desire for more children or a divorce or remarriage. [29]
Another review showed that women aged 30 years or younger were twice as likely to express regret, up to 8 times more likely to request information about reversal procedures, and 8 times more likely to undergo these procedures. [30] Therefore, it is imperative to have thorough presterilization counseling discussion with all women, as well as to focus on the high risk of regret in young women. Some studies show that women who experience regret report feeling they had not received enough counseling regarding the risks and alternatives. [12]
The different surgical techniques also have different likelihoods of successful surgical reversal. Bipolar cautery causes damage to a large area of the fallopian tube and is difficult to reverse. The Filshie clip and spring clip affect a small width of the fallopian tube and have minimal lateral damage. The Falope ring has a relatively higher rate of successful reanastomosis compared to bipolar cautery, but not as high as the Filshie clip. Pregnancy was successful in 72% of cases for Falope ring and 90% for Filshie clip after successful reanastomosis. [17]
All of the tubal techniques depend on complete occlusion of the fallopian tube to be successful. Most failures in a properly performed procedure involve tuboperitoneal fistula formation. This is thought to be the mechanism for a large proportion of poststerilization pregnancies being ectopic in nature. The absolute risk is very low at 7.3 per 1,000 procedures, but it should be a top concern if a patient has a positive pregnancy test after a sterilization procedure. [13]
The US Collaborative Review of Sterilization found a 32.9% ectopic rate among failed tubal ligations. The ectopic risk increased the longer time from surgery. About 20% of ectopic pregnancies occurred in the first 3 years, and 61% occurred 4-10 years after sterilization. Patients younger than 30 years at the time of sterilization had twice the ectopic rate as women aged 30 years or older at the time of sterilization. This is possibly because of their greater fecundity. [31]
The risk of ectopic pregnancy was highest among the bipolar coagulation group (65% of pregnancies were ectopic), Falope ring group (29%), and spring clip group (15%). The high bipolar cauterization ectopic rate is thought to result from inadequate cauterization. These cases were done prior to the routine use of a power meter to monitor tissue desiccation. The Filshie clip was not included in this study. [31]
Many studies have investigated posttubal sterilization syndrome or posttubal ligation syndrome. There is no consensus definition of this syndrome, but a general description includes an increase in dysmenorrhea, heavy menstrual bleeding, and premenstrual syndrome. Original studies examining this syndrome had a significant amount of recall bias and failed to evaluate for confounders, such as birth control use prior to sterilization or recent pregnancy.
The US Collaborative Review of Sterilization found a decrease in the number of days and amount of bleeding and menstrual pain in the female sterilization group. However, they did notice a slight increase in menstrual irregularity. There were no differences in these results among bipolar cauterization, the Falope ring, the spring clip, and partial salpingectomy. This study included peripartum and laparoscopic surgical sterilization procedures. [32]
Several other cohort studies with nonsterilized controls have found no association with pelvic pain, dysmenorrhea, cycle irregularity, or premenstrual syndrome. [33, 34, 35] Furthermore, a study comparing estrogen and progesterone levels between sterilized and nonsterilized patients showed no differences in hormone levels over 2 years. [36] According to the American Congress of Obstetricians and Gynecologists and a sterilization review, the evidence does not support the existence of a posttubal ligation syndrome. [12, 13]
There is an increased rate of hysterectomy in patients who have undergone a tubal ligation procedure. In the US Collaborative Review of Sterilization study, sterilized women had an 8% hysterectomy rate compared to 2% in the control group, or were 4–5 times more likely to undergo hysterectomy. This was regardless of the age of the patient at the time of sterilization or the type of sterilization procedure performed. [37]
Another US Collaborative Review of Sterilization analysis followed 10,698 women over 14 years and showed a hysterectomy rate of 17%. Patients with a presterilization gynecologic diagnosis had the highest risk. For example, women with leiomyomata at the time of sterilization had a 27% hysterectomy rate versus a 14% hysterectomy rate in the women without leiomyomata. [38] Older studies suggested that the hysterectomy rates increased as the patient age at the time of sterilization decreased, but more recent evidence suggests all ages are at risk. Again, these studies did not look specifically at laparoscopic sterilization techniques. [12, 13]
The US Collaborative Review of Sterilization followed 4,576 women over 5 years and surveyed patients about sexual interest and pleasure. Eighty percent of the women reported no change in sexual interest or pleasure. Several women had fluctuating levels of sexual interest and pleasure. Women with consistent scores were 10 times more likely to have more sexual interest and 15 times more likely to have more sexual pleasure. This was true regardless of age at the time of procedure or time from sterilization. There was a decrease in sexual interest or pleasure if regret was present. Overall, there was no change to a women’s sexuality attributed to sterilization. [39]