WHEC Practice Bulletin and Clinical Management Guidelines for healthcare providers. Educational grant provided by Women's Health and Education Center (WHEC).
Worldwide, sterilization (tubal sterilization and vasectomy) is used by more people than any other method of contraception. Female surgical sterilization is the second most commonly used method of contraception among women in the United States. In 2002, 16.7% (10.3 million) of women in U.S. between 15 to 44 years old used female sterilization as their method of contraception, compared with 18.9% who used oral contraceptive pills and 11.1% who used condoms (1). All techniques of tubal sterilization in widespread use in the United States have low risks of surgical complications. Although tubal sterilization is highly effective, the risk of pregnancy varies by age and method of occlusion. The availability and use of contraception have contributed greatly to women's health. Despite the development of newer contraceptive technologies, tubal sterilization and vasectomy continue to be among the methods most widely used globally. For many practicing obstetricians-gynecologists, tubal-ligation was the gold standard by which female sterilization techniques were measured. Since the early 1970s, tubal-ligation -- both laparoscopic and postpartum -- has been performed safely and efficiently, and nearly all healthcare providers are well versed in the procedure.
The purpose of this document is to provide an overview of surgical sterilization, with a focus on tubal sterilization and the major clinical alternatives to this procedure -- vasectomy and long-acting contraceptives. The emphasis should be on the safety and effectiveness of tubal sterilization as compared with these alternatives. For women who no longer desire family, sterilization is a safe and highly effective option. With today's technology, transcervical sterilization can easily be performed both comfortably and cost-effectively in an office setting rather than operating room, making sterilization a convenient and private choice for non-reversible birth control.
The first reported tubal sterilization was performed at the time of cesarean delivery by Samuel Smith Lungren of Toledo, Ohio in 1880. The appropriateness of tubal sterilization for non-medical reasons remained controversial, throughout the late 19th and early 20th centuries. Further, tubal sterilization for non-medical reasons was not available in all states in the United States until 1972, when federal courts struck down the legal restrictions. Tubal sterilization became an increasingly available and acceptable contraceptive choice in the 1977, and the number of procedures performed in U.S. hospitals increased more than threefold -- from 201,000 to 702,000. That increase, in turn, was associated with the availability and use of laparoscopy as an alternative to laparotomy. This trend was also associated with a striking decrease in length of hospital stay, with the average length of stay for all procedures combined decreasing from 6.5 nights in 1970 to 4.0 nights in 1975-1978. Subsequently, laparoscopic sterilization required no hospital stay and the length of stay for postpartum sterilizations decreased with that for deliveries in general. Among women age 35 and older, tubal sterilization is the most commonly used method (2). Between 1982 and 2002, the proportion of women using contraception who had undergone tubal sterilization increased slightly (from 23.2% to 27%) and the corresponding proportion for women whose partners underwent vasectomy decreased slightly (from 10.9% to 9.2%). Worldwide, surgical sterilization is currently being used by more individuals than any other method of contraception, with an estimated 180 million women of reproductive age using tubal sterilization and 43 million women using their partner's vasectomy for preventing pregnancy. Approximately 75% of these people live in China and India.
Tubal sterilizations are performed in association with pregnancy (during postpartum period) or as an interval (not pregnancy-related) procedure. Approximately one half of tubal sterilizations (most recent data are for 1994-1996) are performed in postpartum during hospitalization for vaginal or cesarean delivery (58% and 42% of the total number of postpartum procedures, respectively). The vast majority (96%) of interval procedures are performed on an outpatient basis. The timing of the procedure with respect to pregnancy often, in turn, influences the surgical approach and the method of tubal occlusion (3). Most tubal sterilization after vaginal delivery is performed by mini-laparotomy using partial salpingectomy as the method of occlusion. Most procedures at the time of cesarean delivery are likewise usually performed by partial salpingectomy. Most interval procedures (89% of outpatient and 53% of inpatient interval procedures in 1994-1996) are performed by laparoscopy with use of coagulation, clip application, or band application as the method of occlusion. The focus is on surgical techniques commonly used in the United States.
Preoperative Assessment and Pre-Sterilization Counseling:
Preparation before the procedure will include detailed counseling regarding the intended performance of sterilization as well as information regarding contraceptive alternatives and risks and benefits of the contraceptive alternatives and risks and benefits of procedure -- including the risks of intrauterine and ectopic pregnancy. For postpartum sterilization, counseling should be performed and consent obtained before labor and delivery (3). The potential for luteal phase pregnancy with interval procedures also should be considered. This risk will depend, in part, on the effectiveness of the method of contraception currently used and can be reduced by using a highly effective method, by timing the sterilization during the follicular phase of the menstrual cycle, and by pregnancy testing as indicated. A gynecologic history and physical are needed before the procedure. A review of deaths attributable to tubal sterilization in the United States found that complications of general anesthesia were the leading cause of death (4). The safe use of general anesthesia during pregnancy and postpartum as well as during laparoscopy requires special considerations. The use of general anesthesia increases the risk of the laparoscopic sterilizations employ this technique. Postpartum procedures are often performed with conduction anesthesia. Hysteroscopy to place the newly available microinsert can be performed using a paracervical block with or without intravenous sedation and/or analgesia (4).
Components of pre-sterilization counseling are: permanent nature of the procedure; alternative methods available, including male sterilization; reasons for choosing sterilization; screening for risk indictors for regret; details of the procedure, including risks and benefits of anesthesia; the possibility of failure, including ectopic pregnancy; the need to use condoms for protection against sexually transmitted diseases, including human immunodeficiency virus (HIV) infection; completion of informed consent process; and local regulations regarding interval from time of consent to procedure. Ambivalence should be addressed directly. In particular, ambivalence displayed in the postpartum period just before sterilization should be seriously weighed against any advantage and should be considered an indication for interval sterilization.
Sterilization via Laparoscopy / Minilaparotomy:
A key to success that is common to all methods of tubal occlusion is correct identification of the fallopian tubes, which is best accomplished during laparotomy or laparoscopy by following the tubes out to the fimbriae when possible. All procedures should be considered as permanent methods of contraception. Transvaginal approach, although performed infrequently, sterilization by the vaginal route remains an option. Fimbriectomy, Pomeroy, and other tubal occlusion methods traditionally used with laparoscopic techniques can be performed via posterior colpotomy.
As a group, partial salpingectomy techniques are used in most postpartum sterilizations and thus comprise the most common methods of tubal occlusion (approximately 50% of all U.S. procedures). One of the most common methods of tubal sterilization is the Pomeroy or "Modified" Pomeroy procedure. The original Pomeroy procedure included grasping mid portion of the tube and then creating a loop of tube that was ligated and resected. The authors highlighted the importance of using absorbable suture (they used a double strand of 1 chromic catgut, but plain catgut is used most commonly today) to assure that the resected ends separate (5). Numerous modifications of this technique have been employed.
Another common method of partial salpingectomy is the Parkland procedure. With this approach, an avasular portion of the mesosalpinx is entered, and the tube is separated from the mesosalpinx. A 2-cm segment of the mid portion of the tube is ligated proximally and distally with 0 chromic sutures. The intervening segment is then excised.
Two far less common procedures that are somewhat more difficult to perform but highly effective are the Irving procedure and the Uchida procedure. Both seek to reduce the risk of sterilization failures through fistula formation. In the Irving procedure, an avasular portion of the mesosalpinx is entered about 4 cm from the uterotubal junction and the tube is ligated proximately and distally. The intervening segment is then excised, and the proximal portion of the tube is buried into the myometrium through and incision in the posterior uterine wall near the uterotubal junction. The distal portion can be left as is or buried in the mesosalpinx (6).
In the Uchida procedure, the mid portion of the tube is grasped and after the subserosa is infiltrated, is incised. The muscular portion of the tube is then identified and divided. The serosa over the proximal segment is then dissected bluntly, and the exposed muscular portion is ligated and resected. The proximal portion is then buried within the mesosalpinx and the distal stump is exteriorized and left open to the peritoneal cavity (6).
Electrocoagulation and division of peritoneal structures via the laparoscope are facilitated if the surgeon achieves adequate displacement of the intestine out of the pelvis, maintains a clear pneumoperitoneum free of smoke, and ensures that the installation of the electro-coagulating instrument is advanced sufficiently to prevent contact between the instrument and the tip of the laparoscope. These principles are valid whether performing sterilization, fulguration of endometrial implants, biopsy of the ovary, or lysis of adhesions. The purpose of operation is to provide a simple method of female sterilization by electrocoagulation of the fallopian tube via the laparoscopic technique. After the electrofulgrated tubes heal, migrating spermatozoa should not be transported through fallopian tubes. Oocytes entering the distal end of the tubes should not pass the point of obstruction. Point of caution: there is the additional risk with electrocoagulation of inadvertently burning the intestine (6). Even with utmost care and attention to detail, the surgeon cannot always prevent some electrocoagulation burns of the bowel. Care should be taken, however, to ensure that insulation on the grasping forceps is well beyond the point of the metal trocar or laparoscope. In addition, the structure being electrocoagulated should be moved well away from the adjacent bowel or bladder.
Technique: Unipolar coagulation was the first method of occlusion to be performed by laparoscopy and although highly effective, was associated with early reports of electrical injuries -- including thermal bowel injuries and deaths. These concerns led to the development of bipolar coagulation instruments and mechanical occlusion techniques, which are now in common use. Sterilization by electrocoagulation can be achieved by either extensive electrocoagulation of fallopian tubes alone or electrocoagulation and division. Experience has shown a lower failure rate when the tubes are coagulated and divided. The uterus is markedly anteflexed and deviated to one side, placing the tube on a slight stretch. The tube is grasped in the ischemial portion approximately 3 cm from the cornua of the uterus. The tube is elevated and placed in a position that is free from contact with bowel or bladder. The electrocoagulation forceps is checked to be sure that insulation is clearly visible and that the metal grasping jaws of the coagulation forceps are not in contact with laparoscope or trocar sleeve of the second-incision instrument. The current is turned on, and the tubes one at a time, are thoroughly electrocoagulated for at least 5 full seconds. Frequently, the tube will swell and make a popping noise, indicating that fluid within the lumen of the tube and tubal cells has reached the boiling point. The burn will spread over a finite area, usually 3-4 cm along the tube and 2 cm into the mesosalpinx. The burn will not spread farther because burned tissue has a greater resistance to the flow of electrical current than does normal tissue. When the tube has collapsed from its swollen state, it has been coagulated sufficiently. At this point, the tube is avulsed off the mesosalpinx and from its connection to the proximal and distal tube. This is facilitated by shearing the tube against the operative port of the laparoscope. The reduced tensile strength of the burned tube has little resistance to the tearing motion of the grasping forceps.
Silicone Rubber Band (Falope Ring) Application:
The purpose of the silicone band applied by laparoscopy is to obstruct the fallopian tubes to achieve female sterilization. Care must be taken not to bring an excessively large knuckle of fallopian tube into the housing of the banding scope. If a large mass of fallopian tube, with associated mesosalpinx, is brought into the housing of the laparoscope, the grasping tongs will lacerate the tube. The uterus is anteflexed by manipulating and the fallopian tubes are visualized. They are grasped with the tongs of the silastic band instrument, which has been previously loaded with a Falope ring. The fallopian tube is drawn into silastic band applicator, and the Falope ring is pushed off the applicator onto a knuckle of tube. The knuckle of tube is released from the grasping tongs. Care is taken to avoid excessive traction on the tube during retraction to reduce the risk of mesosalpingeal hemorrhage. When the loop of the tube (about 1.5-2 cm) is fully retracted into the applicator, the band is applied to the base of loop. This technique, as with the other mechanical occlusion technique (clips), is most effective when applied to normal tubes (8).
Spring Clip (Hulka) and Titanium Clip Applications:
The spring clip technique, described by Hulka and colleagues (8), is applied to the mid isthmic portion of a tube that has been placed on stretch. The clip must be applied exactly perpendicular to the long axis of the tube and must fully enclose the tube, with the hinge of the open clip being adjacent to the tube and the jaws of the clip extending onto the mesosalpinx before it is closed. With a loaded clip applier next to the fallopian tube, 2-3 ml of 1% xylocaine solution are pushed through the clip applier and sprayed on the fallopian tube for local anesthesia. The surgeon opens the clip by activating the shaft retractor at the end of the clip applier. The same mechanism is used to close the clip and lock it into position with its metallic spring. The clip has been applied to the fallopian tube. It is released from the clip applier when the surgeon withdraws the shaft to the extreme position. The same procedure is performed on the opposite tube. The titanium clip is like the spring clip, and it is applied to the mid isthmus. It must include the entire circumference of the tube. The lower jaw of the clip should be visible through the mesosalpinx before the clip is applied to make certain that the entire tube is closed.
Unlike most temporary methods, the effectiveness of sterilization does not require ongoing effort to assure consistent and correct use. Pregnancies can and do occur even many years after sterilization was documented by the U.S. Collaborative Review of Sterilization (CREST), in which pregnancies occurred in the 10th year after each of the four methods of laparoscopic sterilization studied (unipolar coagulation, bipolar coagulation, silicone rubber band application, and spring clip application). An analysis of the experience of 10,685 women followed prospectively for up to 8 years to 14 years in the U.S. Collaborative Review of Sterilization identified 143 sterilization failures (pregnancies other than luteal phase pregnancies) and found that the risk of pregnancy after sterilization varied by age at sterilization and method of tubal occlusion (9). The 10-year cumulative probability of pregnancy was low for most women aged 34-44 years at sterilization but was as high as 5% for women aged 18-27 years with two methods (bipolar coagulation and spring clip application). Another noteworthy finding from this analysis is that the risk of pregnancy accumulated over time after each method of occlusion. The timing of sterilization failures varied by method; for example, a high proportion of pregnancies after clip application occurred in the first 3 years after the procedure, whereas pregnancies after bipolar coagulation occurred at approximately the same rate year after year. The titanium clip was not available in the United States during the enrollment period for the CREST and comparable U.S. multicenter long-term failure rates for this clip have not been reported. However, published data suggest that the titanium clip is, like the other methods of tubal occlusion, highly effective in both long and short term.
The CREST data reported that the 10-year cumulative probability for sterilization failure varied by sterilization method and ranged from 7.5 per 1,000 to 36 per 1,000 procedures. Postpartum partial salpingectomy had the lowest 5-year and 10-year cumulative pregnancy rates: 6.3 per 1,000 and 7.5 per 1,000 procedures, respectively. The 5-year and 10-year pregnancy rates, respectively for other occlusion are as follows (3)(9):
Although pregnancy after sterilization is uncommon, there is substantial risk that any post-sterilization pregnancy will be ectopic. Analysis of CREST data found that one third of post-sterilization pregnancies were ectopic (9). For all methods of sterilization except postpartum partial salpingectomy, women younger than 30 years were more likely to experience ectopic pregnancy than women older than 30 years (a reflection of the greater overall fecundity of younger women). Non-Hispanic black had 4 times the relative risk of ectopic pregnancy than non-Hispanic whites. Women with a history of pelvic inflammatory disease had 2.7 times the relative risk of women without a history of pelvic inflammatory disease.
Safety and Surgical Complications:
Tubal sterilization is a safe method of contraception. Death from tubal sterilization is a rare event, and overall complication rates are low. Mortality rate in the United States have been estimated at 1-4 deaths per 100,000 procedures (10). Most deaths in the United States have been attributed to hypoventilation and cardiopulmonary arrest during general anesthesia. In an early U.S. study, 11 of 29 sterilization-related deaths occurred in women with underlying medical conditions. A more recent study found no mortality among 9,475 women who underwent interval laparoscopic tubal ligation. Major complications from tubal sterilization are uncommon and vary by study definition, occurring at levels that range from 1% to 3.5% (3)(9)(10). Using a standard definition of complications, including intraoperative and postoperative events, overall complication rates for tubal sterilization are estimated to be 0.9-1.6 per 100 procedures; unintended major surgery (laparotomy) represented 0.9 per 100 cases. This complication rate did not vary significantly according to the method of occlusion used. Intraoperative complications include unintended, unplanned major surgery needed because of a problem related to tubal surgery, transfusion, a life-threatening event, or death. Postoperative complications include unintended major surgery, transfusion, febrile morbidity, a life-threatening event, re-hospitalization, or death caused by a complication within 42 days of surgery.
When sterilization is performed concurrent with cesarean delivery, any higher associated morbidity has been attributed to the indications for which the cesarean delivery was performed (3). The risk of complications was similarly low for women undergoing tubal sterilization after abortion when compared with the risks of sterilization alone. The risk of ectopic pregnancy varies substantially with the method and timing of sterilization. Based on CREST study data (9), the 10-year cumulative probability of ectopic pregnancy after tubal sterilization by any method was 7.3 per 1,000 procedures. Bipolar coagulation had the highest cumulative probability of ectopic pregnancy (17.1/1,000 procedures), and postpartum partial salpingectomy had the lowest cumulative probability (1.5/1,000 procedures). For all methods of occlusion, the risk of ectopic pregnancy did not diminish with the length of time since the tubal sterilization.
Long-Term Health Effects of Female Sterilization:
The long-term protective effect of tubal sterilization on ovarian cancer incidence has been confirmed by multiple observational studies. This protective effect persists after adjusting for age, use of oral contraceptives, and parity. In addition, a case control study of 4,742 women found no association between tubal sterilization and breast cancer (3). Most prospective studies have shown either no consistent change or no improvement in sexual interest or pleasure after sterilization (11). Although tubal sterilization does not protect against sexually transmitted disease, including HIV, it has been shown to reduce the spread of organisms from the lower genital tract to the peritoneal cavity and thus protect against pelvic inflammatory disease (PID). This protection is incomplete, however, as suggested by rare case reports of pelvic inflammatory disease and tuboovarian abscess in women who have undergone sterilization.
Menstrual Disorders: The long-term health effects of tubal sterilization on menstrual pattern disturbance (post-tubal ligation syndrome) appear to be negligible. Early studies of menstrual disturbances after sterilization failed to account for confounding variables, such as post-sterilization use of hormonal contraceptives, that generally mask underlying menstrual dysfunction, and in particular heavy bleeding and inter-menstrual bleeding. A recent analysis of the CREST data prospectively examined menstrual patterns of 9,514 women for 5 years after interval tubal sterilization and compared them with those of women whose partners underwent vasectomy (12). The study found that women who underwent sterilization were no more likely than the control group to report persistent changes in their menstrual cycle length or inter-menstrual bleeding. However, they were more likely to have beneficial changes in their menstrual cycle, including decreased amount of bleeding, number of days of bleeding, and menstrual pain. Although an increase in "cycle irregularity" was reported in one study subset, this was considered likely to be caused by chance. The method of tubal occlusion did not have a significant impact on the findings.
Hysterectomy: Women who undergo tubal sterilization appear to be 4-5 times more likely to undergo hysterectomy than those whose partners underwent vasectomy. In one analysis of CREST data (3)(11), this increased risk was found to persist across all ages and methods for a 14-year follow-up period. A history of endometriosis or uterine leiomyomata was associated with the highest long-term probability of hysterectomy at 14 years post-sterilization. These findings are consistent with the results from previous studies. There is no known biologic mechanism to support a causal relationship between tubal sterilization and subsequent hysterectomy. Non-biologic mechanisms are speculative. Women who choose one surgical procedure may be more likely to undergo another for the management of gynecologic conditions. Women who have had tubal sterilization may be more likely to perceive themselves or be perceived as appropriate candidates for hysterectomy, given that fertility preservation is no longer a factor in decision making.
Sexual Function: Most studies find that tubal sterilization has no consistent effect on sexual interest or pleasure. In an analysis of data regarding interval tubal sterilization from the U.S. Collaborative Review of Sterilization, about 80% of women reported no consistent change in sexual interest (80.0%) or pleasure (81.7%) within 2 years after sterilization. Of those reporting a consistent change, positive effect were much more likely to be reported than negative one for both sexual interest and pleasure (approximately 10 times and 15 times as likely) respectively (11).
More than 5 million men in the United States have undergone vasectomy; approximately 500,000 vasectomies were performed in the most recent year for which national data are available (1)(2). Vasectomy is usually performed on an outpatient basis using local anesthesia. Two surgical approaches are commonly employed; One -- a "no-scalpel" technique in which a small puncture is performed, and the other -- in which a small incision is made with a scalpel. A variety of methods of vas occlusion are performed. These include ligation and excision and use of coagulation -- either of which can be performed with fascial interposition between the resected ends (13).
Effectiveness of Vasectomy:
Vasectomy is not immediately effective. The risk of pregnancy is decreased by avoiding unprotected intercourse until semen analysis at 3 months or more after vasectomy demonstrates effectiveness. The long-term effectiveness of vasectomy has not been studied as well as that for tubal sterilization. Most reports are based on case series from individual surgeons. It seems likely, however, that vasectomy is at least as effective as tubal sterilization. Most studies report failures rates of less than 1%. In the U.S. Collaborative Review of Sterilization, the cumulative probability of failure was 7.4 per 1,000 procedures at one year after vasectomy and 11.3 per 1,000 procedures at year 5 (14). It seems that the effectiveness of vasectomy, like tubal sterilization, may vary by method of occlusion.
Surgical Complications and Long-Term Health Effects of Vasectomy:
The risk of serious complications from vasectomy is exceedingly low, and deaths in the United States are very rare. Minor complications are not uncommon: hematoma formation, wound infection, acute epididymitis, and painful sperm granulomas are the most common of these, each usually reported to occur in less than 5% of vasectomies (13)(14). Vasectomy is considered by many academic societies as a safer procedure than tubal sterilization, because it is less invasive and is performed with local anesthesia.
Questions about the long-term safety of vasectomy were raised in 1980 with a report of an increase in atherosclerosis among monkeys who had undergone the procedure. At least nine human studies were performed subsequently, and none found the increased risk; the investigators who initially identified the findings in monkeys later reported that they could not reproduce them (13). A recent large population-based study in New Zealand supported by National Institutes of Health (NIH) and the World Health Organization (WHO) adds strong weight to the evidence against prostate cancer risk (15). Available evidence also argues against an increased risk of either testicular cancer or overall mortality after vasectomy. Whether there is post-vasectomy pain syndrome remains controversial. The syndrome is variably defined to include chronic epididymal pain, scrotal pain, or testicular pain, and surveys have reported complaints of such pain in as many as 2-15% of men after vasectomy. These surveys had substantial methodological shortcomings, however, and a large retrospective cohort study supported by NIH would suggest much lower rate. The Health Status of American Men study identified a rate of epididymitis-orchitis of 24.7 per 10,000 person-years among men at more than 12 months after vasectomy, which was about twice that (13.6 per 10,000 person-years) among men who had not undergone vasectomy (13).
Safety and Effectiveness of Tubal Sterilization Compared with Vasectomy:
Vasectomy is safer than tubal sterilization because it is a less invasive surgical procedure and because it is performed using local anesthesia. Tubal sterilization involves entry into the peritoneal cavity and usually is performed under general or regional anesthesia. Short-term effectiveness of vasectomy -- with reported failures of less than 1% - is comparable with that of tubal sterilization. Tubal sterilization provides immediate contraceptive protection, whereas men remain fertile for several months and require semen analysis to fully determine the success of the procedure. Neither female nor male sexual function appears to be affected after tubal sterilization or vasectomy. Assuming that vasectomy and tubal sterilization provide similar protection against pregnancy, women who have had tubal sterilization are at increased risk of ectopic pregnancy in the case of failures, with estimated absolute incidence of ectopic pregnancy of 0.32 per 1,000 women-years in women whose partners had vasectomy (3). By comparison, the estimated absolute incidence of ectopic pregnancy in women using no contraception is 2.6 per 1,000 women-years.
Many women who choose sterilization as a contraceptive method do not regret their decision; however, information and counseling about sterilization should be provided with the intent to minimize regret among individual women. Although there are certain key indicators for future regret -- such as young age at the time of sterilization -- many indicators of regret is part of individual social circumstances, which should be explored with the patient before a decision is made. Post-sterilization regret measured by self-report or by request for information on reversal ranges from 0.9% to 26%. Prospective CREST study data analysis found that the cumulative probability of regret over 14 years of follow up was 12.7%. However, the probability was 20.3% for women aged 30 years or younger at the time of sterilization, compared with 5.9% for women older than 30 years at the time of sterilization. Regarding the timing of sterilization, previous reports have identified postpartum sterilization as a risk factor for increased regret. Analysis of CREST data found similar levels of regret for interval sterilization within 1 year of delivery (22.3%) as for postpartum sterilization after vaginal delivery (23.7%) and cesarean delivery (20.7%). The cumulative probability of regret diminished steadily with the interval between delivery and sterilization (16). Post-abortion sterilization was not associated with increased regret when compared with interval sterilization.
The most common reason for regret is the desire for more children. Younger women who choose sterilization have more time to change their minds and life circumstances. Women sterilized before 25 years were 18 times more likely to request reversal over the course of follow-up than women older than 30 years at the time of sterilization. Because tubal sterilization is common and regret is not uncommon, it is important to attempt to reduce regret with thorough and effective counseling that takes into account the risk factors. Both the patient and her partner, when appropriate should be counseled. Because young age at the time of sterilization, regardless of parity or marital status, is associated with significant levels of regret, individualized counseling of younger women is critical. The Medicaid Title XIX consent form must be signed 30-180 days prior to sterilization (17). This process was developed to give women receiving publicly funded sterilizations ample time for informed consent, to avoid making this decision under the duress of labor and to prevent coerced sterilizations, which occurred in minority populations in the past.
In a large study authors performed Filshie clip sterilization in 1,101 women, from 1983 to 2002 (18). Five or more years later, they were able to contact 735 of the women to send follow-up questionnaires. One pregnancy occurred at 10 months in this series and one woman had the procedure repeated when unilateral tubal patency was identified with hysterosalpingogram (HSG) three weeks after surgery. Regret about having the operation was expressed by 24 women (4%) and seven women (1.2%) had a reversal operation with subsequent conception. The more careful the preoperative counseling; the lower the expected regret rate among patient. Certainly, the counseling should be performed very carefully, particularly for women younger than 30 years or with less than two deliveries.
Tubal sterilization may be recommended as a safe and effective method for women who desire permanent contraception. Women should be counseled that tubal ligation is not intended to be reversible; those who do not want permanent contraception should be counseled to consider other methods of contraception. Patient should be advised that neither tubal sterilization nor vasectomy provides may protection against sexually transmitted diseases, including HIV infection. Patients should be advised that the morbidity and mortality of tubal ligation, although low, is higher than that of vasectomy, and the efficacy rates of the two procedures are similar. Patients should be counseled that tubal sterilization is more effective than short-term, user-dependent reversible methods. Patients should be counseled that failure rates of tubal sterilization are comparable with those of intrauterine devices. If a patient has a positive pregnancy test result after a tubal ligation, ectopic pregnancy should be ruled out. Indications for hysterectomy in women with previous tubal sterilization should be the same as for women who have not had tubal sterilization.