Complications of female sterilization: immediate and delayed

Transcription

1 FERTILITY AND STERILITY Copyright ~ 1984 The American Fertility Society Vol. 41, No.3, March 1984 Printed in U.SA. Complications of female sterilization: immediate and delayed George R. Huggins, M.D.. Steven J. Sondheimer, M.D. Division of Human Reproduction, Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania Surgical sterilization has undergone explosive worldwide growth over the past 30 years. From 1950 to 1980, the number of couples worldwide using sterilization for contraception grew from 3 million to more than 13 million. 1, 2 This growth can be attributed to improvements in technology, changes in public mores, and removal of restrictive legislation. This article will focus on the technologic changes that have reduced the rate of complications and have made sterilization widely available and acceptable to large numbers of women throughout the world. STERILIZATION GROWTH RATES The exponential growth in popularity of sterilization as a form of contraception in the United States parallels the worldwide statistics. The National Fertility Study, conducted in 1970 and repeated in 1975, demonstrates the increasing util- ization of sterilization by married couples in the United States. 3, 4 In 1975, the National Fertility Study included reinterview data on 2361 women who had been interviewed first in 1970 and data from 1042 women who were interviewed for the first time in 1975, a total of 3403 respondents. As shown in Table 1,7 there were striking increases in the numbers of sterilizations for the decade 1965 to Among women married 10 to 14 years, use of sterilization increased from 7.1 % to 20.6%; for those married 15 to 19 years, it increased from 9.1% to 27.8%; for marriage durations of 20 to 24 years, it increased from 8.3% to 30.2%. Despite the limitations inherent in any sampling study, the trends described in the National Fertility Study have been confirmed by others. Among couples who have achieved desired family size, sterilization is the single most popular method of contraception. Numbers of sterilizations in the United States have been reported by the Association for Voluntary Sterilization, which estimated that 1,325,000 female and 1,425,000 male sterilizations were performed in the United States before 1971 (Fig. 1).5 In 1971, there were 701,000 male and only 178,000 female sterilizations performed. This ratio changed dramatically after the introduction of laparoscopic sterilization. By 1973, the number of female sterilizations (445,000) was greater than the number of male sterilizations (432,000). Since 1973, the number of procedures in women has consistently been slightly higher than in men. 5 By 1981, the estimated cumulative total of male and female sterilizations performed in the United States was 13,761, Comparative Association for Voluntary Sterilization data from 1980 to 1981 show that most sterilizations are performed by physicians in private practice (Table 2).7 However, significant numbers also are performed in military service facilities and in clinics associated with family planning programs. CHANGING METHODOLOGIES By 1950, postpartum tubal sterilization had become the most widely used technique for female sterilization, but this method required open ab- Vol. 41, No.3, March 1984 Huggins and Sondheimer Complications of female sterilization 337

2 Table 1. Percent of Sterilization Among Continuously Married White Women in the United States by Marriage Duration 7 Years of marriage Partner sterilized % % <5 Husband Wife Husband Wife Husband Wife Husband Wife Husband Wife dominal surgery. The introduction of effective and relatively safe laparoscopic techniques by 1970 greatly influenced the number of procedures performed on women. However, concern about bowel bums from unipolar tubal cautery stimulated the development of bipolar cautery and nonelectrical methods which rapidly replaced unipolar cautery. A survey of trends in laparoscopic sterilization conducted in 1979 among 1452 members of the American Association of Gynecologic Laparoscopists reported that from 1976 to 1979 the use of unipolar cautery decreased from 63% to 30% of reported procedures, while the use of bipolar cautery increased from 20% to 43% (Fig. 2).8 During the same period, the use of the Falope ring increased from 16% to 24%. The spring clip accounted for only 1% ofthe procedures in 1976 and 3% in This trend toward use of noncautery rings and clips also is evident in Great Britain. In a review of 2243 female sterilization procedures between and 1981, Vessey et a1. 9 showed several changing patterns in laparoscopy techniques (Table 3). From 1968 to 1974, the use of laparoscopy increased from 34.5% to 52.8% of all procedures, while laparotomy (all procedures) decreased from 65.5% to 47.2%. Ring and clip use began in late 1974 and, from 1975 through 1981, the use of rings or clips rose from 10.3% to 39.0%. In this same period, the use of cautery decreased from 53.6% to 27.2% of all procedures, while the percentage oflaparotomy procedures remained about the same, decreasing only slightly from 36.1% to 33.8%. As in the United States, bipolar cautery is used for most of the cautery procedures done in Great Britain. COMPLICATIONS OF STERILIZATION STERILIZATION BY HYSTERECTOMY Several studies have indicated that routine use of hysterectomy for sterilization cannot be justified because of its unacceptable morbidity rates. In 1982, Dicker et al.lo analyzed data from the Collaborative Review of Sterilization (CREST), a prospective evaluation conducted by the Center for Disease Control (CDC) from 1978 to Part of the CREST study included data on 1851 nonpregnant women who were to undergo either vaginal or abdominal hysterectomy for benign disease. Overall complication rates were 42.8% for abdominal hysterectomy and 24.5% for the vaginal procedure (Table 4). Postoperative febrile morbidity was the most common complication; however, 0.8% of the abdominal hysterectomy patients and 1.6% of the vaginal hysterectomy patients required repeat exploratory operations. Even in a select group of parous women, who had had no abdominal operations or preexisting medical conditions before the hysterectomy and had had a postoperative diagnosis of dysplasia or bleeding, the overall complication rate was 46.7% for abdominal and 15.8% for vaginal hysterectomy. Laros and Work,ll in an earlier study, reviewed the experience with vaginal hysterectomy for sterilization at two university teaching hospitals from 1965 to Overall morbidity was 40.9%, most commonly due to unexplained fever, urinary tract infection, or pelvic cellulitis (Table 4). However, of greater concern was the fact that 11 patients (10%) required additional surgical procedures, including vaginal or abdominal drainage or bilateral salpingo-oophorectomy, in order to control infection. STERILIZATION BY LAPAROSCOPY Laparoscopy has become the most widely used technique for sterilization because of its many positive aspects. It is readily available and has few operative risks or postoperative complications, and the cost is relatively low, particularly when it is performed as an outpatient procedure. OVERALL COMPLICATIONS A review of several large-scale studies provides a composite picture of the complications of laparoscopic sterilization. 338 Huggins and Sondheimer Complications of female sterilization Fertility and Sterility

3 700,_ '~I 701._ -.- 1\ n 500._, I/.~-~.-f-.~'j I I , L.-- I- \. /' \ \, \, \ \4.- \.,~H.OOO \, 510, ,,,, \,, ' \ \.,'" I- " \,/" 1\ \ 511_' \ ' / " \ \,,,,, 445,000 7,, 5 ~v. 43f.>.~ v~ ~::z. "'~: l1li' ~.43',/ 432,000 I _, 4,,,,, , 300._ 3,", 200._ Sterilizations Performed in the U.S , 17',000 Male and Female Compared by Year 100._ Pre 1971 estimates M F Cumulallve lotal, , Male slenhzahon Female stenllzatlon 73 7' ASSOClallon to, ~unl.., seet'~8bdn. Inc 122 EaSi.. 2nd St,eet. New 'bill. N. Y 101. e 1982 Figure 1 From Association for Volun tary Sterilization, Inc.,5 New York, NY. The CREST was initiated by the CDC in The purpose of this prospective study at nine hospitals associated with University Medical Centers was to assess the safety of female sterilization and determine ways in which sterilization could be made safer. The CREST study reports relatively recent experience, includes standardized reporting criteria, and has follow-up data on a large percentage of women. Different aspects of the CREST study have been reported by various investigators. Analysis of CREST data by De Stefano et al 12 includes information on 3500 women who underwent intervallaparoscopic sterilization by electrocoagulation or Silastic banding without other concurrent surgery from September 1978 to March The overall rate of intraoperative or postoperative complications was 1.8% (Tables 4 and 5). Unintended laparotomy, the most frequent complication, occurred in 37 patients (Tables 5 and 6). Thirty of these laparotomies were required in order to complete the procedure because of technical problems affecting visualization of the tubes, while 7 were required for operative complications, including bleeding. The choice of Silastic band versus electrocoagulation did not affect the occurrence of complications, nor was the risk of complications greater with unipolar electrocoagulation than with bipolar coagulation. The use of general anesthesia was more likely to be associated with complications than was the use of local anesthesia; however, DeStefano et alp suggest that possibly the surgeons who used local anesthesia had greater Table 2. Number and Distribution of Male and Female Sterilizations by Type of Provider: United States, a Provider Private practice Male 460 b 377 Female Total Clinics Male Female Total Military service Male Female Total Totals Male 511 (48%) 424 (48%) Female 558 (52%) 464 (52%) Total afrom Association for Voluntary Sterilization, Inc. bin thousands. Note: all figures subject to sampling error. Vol. 41, No.3, March 1984 Huggins and SondJteimer Complications of female sterilization 339

4 ~ 0 Clip %- - 16% Ring % % Bipolar Unipolar 24% 43% 30% Figure 2 Method oflaparoscopic sterilization used 1976 and From Phillips et a1. 8 skills or more experience with the procedure. Sixteen patients (0.5%) required rehospitalization before the follow-up interview, but none of these required additional surgery or transfusion. In another study, Cunanan et al. 13 reviewed the experience of 5018 women who were to undergo laparoscopic sterilization at a single institution from 1970 to Unipolar cautery, with or without resection of the tube, was used for sterilization. Simultaneous abortion was performed on 861 of the women (17.6%). Overall, 46 women had operative complications (0.92%); 23 required laparotomy (0.46%) (Tables 4 and 6). Bowel injuries occurred in five women (0.1%); three of these were bum injuries and two were related to trocar perforations. Two of the three thermal bowel injuries were not recognized until the patients were readmitted because of signs of peri toni tis. Bowel injuries secondary to unipolar electrical bums were reported first by Thompson and Wheeless,14 who found 11 burn cases (0.2%) in 3600 laparoscopic tubal sterilizations. The incidence of bowel injuries with unipolar cautery is similar to the incidence of bowel injuries with other laparoscopic sterilization techniques. However, injuries secondary to unipolar electrical burns are potentially more serious. Burns may not be recognized during the sterilization procedure and may require more extensive surgery for repair. If not detected until late, perforation and peritonitis develop. In a third major study, Baggish et al.15 also reviewed and compared experience in a single hospital from 1972 to Patients underwent sterilization with the Silastic ring or unipolar cautery with division of the tube. Of the 4500 patients sterilized by unipolar cautery, 13 sustained electrical burns (0.28%) and 3 required bowel resections (0.06%). In two of these three cases, the diagnosis was not made until 1 to 3 days after the operation. Mechanical trauma to the intraabdominal structures, requiring laparotomy, occurred in seven of the cautery patients (0.15%) and in two of the Silastic ring patients (0.23%) (Table 6). Bleeding from the mesosalpinx, requiring laparotomy, was relatively similar between the two groups, affecting 13 in the unipolar cautery group (0.28%) and 3 in the Silastic ring group (0.35%). Baggish et al. 15 also studied the incidence of intraoperative laparotomy required to control mesosalpinx bleeding, comparing a group who underwent sterilization without concurrent dilatation and evacuation (D&E) with another group who underwent sterilization with D&E. Of 4876 women who had either Silastic banding or cautery without D&E, 9 required subsequent laparotomy to control bleeding (0.18%). Of the 470 who had sterilization in addition to D&E, 6 required laparotomy to control bleeding (1.27%).. However, the incidence of laparotomy after first trimester abortion without sterilization is 0.07%.16 The additive risk of needing a laparotomy because of complications from sterilization and first trimester abortion procedures performed separately probably is less than the risk when Table 3. Procedures Used at Different Calendar Periods 9 Percentage of subjects Type of procedure i Laparoscopy, tubal di athermy Laparoscopy, rings, clips, etc. Laparotomy, all pro cedures Total Huggins and Sondheimer Complications of female sterilization Fertility and Sterility

5 Table 4. Complications of Sterilization in Selected Studies Procedure Investigator Cases Overall complica tion rate (%) Additional unintended major surgical procedures (%) Hysterectomy Abdominal (benign disease) Vaginal (benign disease) Vaginal (sterilization only) Dicker et al. lo Dicker et al.lo Laros and Work ll a 40.9 l Laparoscopic sterilization Cautery or Silastic band Unipolar cautery DeStefano et au2 Cunanan et al aprophylactic antibiotics used. blncludes laparotomies required to complete sterilization procedure. cdoes not include laparotomies required to complete sterilization procedure. 1.1 b; 0.2c 1.2 b ; 0.46 c they are performed concurrently, but this is not a substantial difference'. SPECIFIC COMPLICATIONS Bleeding Complications of bleeding resulting from laparoscopic sterilization usually occur only if there has been resection or transection of the burned segment of the tube as part of cautery ligation. Tears of the mesosalpinx or tube that occur during Silastic banding usually can be controlled with cautery or reapplication of the ring; thus, most do not require laparotomy. In the DeStefano et al. CREST series of 3500 women,12 4 underwent laparotomy to control bleeding (0.11 %). In the series of 5018 women studied by Cunanan et al.,13 23 women (0.45%) had bleeding complications during unipolar cautery; 15 of them (0.29%) required laparotomy. Of these 23 cases of bleeding, 18 had resulted from inadequate coagulation before resection of the tube, resection of too large a segment of tube, resection of the tube too close to the cornua, or resection of a structure other than the tube.. Seiler et al. 17 reviewed 232 bipolar laparoscopic sterilizations, most with tube resection in a single institution from 1976 to 1979, and reported only 1 (0.43%) bleeding complication requiring laparotomy (Table 6); this occurred during transection of the burned segment of the tube. In the 846 Silastic ring sterilizations reported by Baggish et al.,15 26 women (3.1%) had bleeding complications, but only 2 of these (0.23%) required laparotomy. In addition, there were 14 complications (1.6%) related to the ring technique, e.g., loss of the ring in the peritoneal cavity. None of the other complications required laparotomy. It is interesting to note that 9 of the 14 complications occurred during the first year the technique was used, suggesting that the rate of complications decreased as experience with the technique increased. Infection The high follow-up rate for the CREST study makes it a reliable indicator of early postoperative infection; DeStefano et al.12 reported that febrile morbidity judged by standard criteria occurred in seven of the patients (0.2%) (Table 5). Cunanan et al. 13 reported infections in 6 of the 5018 women within 2 weeks after the sterilization procedure (0.12%). There was one case of abdominal wall cellulitis and three cases of pelvic inflammatory disease (PID) within 2 weeks after the procedure; one patient required cul-de-sac Table 5. Complications of Laparoscopic Sterilization in the CREST Study 12 Complications n % Unintended major surgery Technical failures Operative complications Total 37 l.la Rehospitalization Febrile morbidity Bowel burns (not requiring hospitalization or surgery) Thrombophlebitis (lower ex tremities) Transfusion 0 0 Life-threatening event 0 0 Death 0 0 Totals arounded numbers add up to more than 1.8. Vol. 41, No.3, March 1984 Huggins and Sondheimer Complications of female sterilization 341

6 Table 6. Laparotomy Required Because of OPerative Complications in Laparoscopic Sterilization Investigator Method D Laparotomy required DeStefano et al. 12 Cautery (unipolar or (0.2%) bipolar) or Silastic banding Cunanan et al. 13 Cautery (unipolar) (0.4%) Seiler et alp Cautery (bipolar) (0.4%) Baggish et au 5 Cautery (unipolar) (0.5%) Baggish et al. 15 Silastic banding (0.3%) drainage. One of the three patients with PID had an intrauterine device (IUD) removed at the time of sterilization. In the CREST data analyzed by DeStefano et ai.,12 the use of an IUD 1 month prior to sterilization did not alter the risk of complications. In the Cunanan et ai. series, women had IUDs removed at the time of sterilization and 1 developed PID. The number of anecdotal case reports of PID or tuboovarian abscesses after sterilization with simultaneous removal of an IUD has led to suggestions that these procedures not be performed concomitantly. However, data from recent studies do not support these concerns. It is clear that additional data are needed before more definite recommendations can be made. Technical Failures In the CREST report by DeStefano et al.12 on 3500 women, 30 (0.85%) underwent laparotomy because of technical difficulties (Le., not operative complications). In 1 case, there was equipment malfunction; in 19 cases, pelvic or abdominal adhesions interfered with proper visualization; in the other 10 cases, there were various other difficulties, including obesity. These data suggest that the risk of requiring laparotomy to complete the procedure is slightly greater if the woman has a history of previous abdominal or pelvic surgery or obesity> 120% of ideal body weight. However, this risk actually is quite small, and most patients with previous surgery or obesity underwent uneventful laparoscopic sterilization. Cunanan et al.13 reported that laparoscopic sterilization could not be completed in 26 (0.51%) of 5018 women. In ten women, this was due to intraoperative complications. In the remaining 16, the failure was due to adhesions, obesity, or pelvic mass requiring laparotomy. In this series, 20% of all the women had had previous abdominal or pelvic surgery. Of the 23 women who had complications requiring laparotomy, 4 (17%) had had previous surgery. In one of these four patients, bowel perforation could be attributed to adhesions secondary to the previous surgery. Therefore, previous surgery is not usually associated with an increased risk of laparoscopic complications. However, obesity increased the chances of technical failure but was not associated with increased risk of complication. Death Most individual series of sterilization procedures by laparoscopy report no deaths. In the 1979 American Association of Gynecologic Laparoscopists (AAGL) membership survey,8 2 deaths were reported out of 88,986 procedures, a death rate of 2 in 100,000. As part of CDC surveillance, Peterson et ai. 18 identified 29 deaths attributable to tubal sterilization. Sterilization was by laparoscopy in 17, laparotomy in 11, and colpotomy in 1. Eleven of these deaths were reported to have resulted from anesthesia complications with cardiorespiratory arrest. At least six of these deaths were due to hypoventilation, and none of these women had been intubated. Seven deaths were due to sepsis, four were due to hemorrhage, three were due to myocardial infarction, and four were related to other causes. Three deaths related to major vessel laceration after laparoscopy were reported, one due to the Verres needle, one due to the trocar, and one due to the scalpel at skin incision. One death after a myocardial infarction and one death after mesenteric vein thrombosis occurred in women who had used oral contraceptives until the day of the ligation. Three women died from unrecognized bowel burns with subsequent sepsis after unipolar cautery. The CDC group estimates that the death rate for tubal sterilization (all techniques) is 3.6 in 100,000 women. STERILIZATION BY MINILAPAROTOMY Minilaparotomy using local anesthesia has been advocated by several authors This approach seem particularly suited for areas of the world where general anesthesia and dependable electrical power are unavailable. Shepard21 described the surgical approach to the minilaparotomy incision. A 3- to 4-cm transverse incision is begun - 2 fingerbreadths above the pubic symphysis and carried down to the peritoneum. Surgical entry into the peritoneal cavity is made under direct vision. This approach de- 342 Huggins and Sondheimer Complications of female sterilization Fertility and Sterility

7 creases the danger of bowel or bladder injury that can result from the introduction of the needle and trocar in closed laparoscopy. After entering the peritoneum, several different instruments and approaches can be used to locate the tubes Tubal occlusion has been performed most often by the Pomeroy technique, but clips and bands have also been used. 25, 26 Lee and Boyd 20 reviewed the experience at three military hospitals from 1976 to 1978 with 208 outpatient minilaparotomy sterilizations under local anesthesia. Complications included three wound hematomas and two wound infections, for a minor complication rate of 2.5%; there were no major complications. In eight patients (3.8%), the procedure could not be completed because of adhesions, obesity, fibroids, or a retroverted uterus. THE POST-TUBAL LIGATION SYNDROME-DOES IT EXIST? The symptom complexes that make up the posttubal ligation syndrome (PTLS) discussed by many authors, are dissimilar, and there is no well-defined, widely accepted definition of the syndrome. In some studies, PTLS includes only "abnormal bleeding" and pain, while in others it includes subsequent gynecologic events such as hysterectomy. As mentioned previously, there is also a paucity of data concerning objective evaluation of blood loss. Meaningful analysis of data about PTLS also is hampered by the widely different periods of follow-up used and the use of differing control groups or no control groups. In addition, the patient's perception of poststerilization bleeding patterns and amount of flow can be influenced markedly by the prior use of oral contraceptives and IUDs. GYNECOLOGIC DISORDERS FOLLOWING STERILIZATION From the 1950s to the early 1970s, the advisability of performing simple hysterectomy versus tubal ligation was widely debated. Several authors 27, 28 strongly advocated the selective use of elective hysterectomy for surgical sterilization. This recommendation was based in part on experience that showed high incidences of gynecologic problems after tubal ligation, leading to subsequent surgery including hysterectomy. A frequently quoted study by Muldoon 28 reported lo-year follow-up data on 374 patients who had undergone tubal ligation. This study employed a retrospective review of records from 1955 to 1960 and a questionnaire administered in 1972 to patients who were sterilized during 1955 through Muldoon 28 reported that 43% of patients needed "further gynecologic treatment" and 25% needed "major gynecologic surgery." On the basis of these findings, he stated, "there seems a good cause for the selective use of hysterectomy as a method of sterilization." Muldoon's article refers to a study by Williams et a1. 29 that also demonstrated a high incidence of subsequent pelvic disease, usually disorders of menstruation, following sterilization by tuballigation. The study by Williams et a1. 29 involved an analysis of 200 patients who had been sterilized at Vanderbilt University Hospital from 1926 through Studies like those of Muldoon 28 and Williams et a1. 29 must be evaluated carefully. In general, the women sterilized during 1950 through 1970 make up different patient populations from those gathered after Women sterilized before 1970 were relatively older and more parous; and few, ifany, had been using oral contraceptives or IUDs prior to During the decade 1960 to 1970, the use of oral contraceptives and IUDs became increasingly more common. There was virtually no use in 1960, but by 1970, millions of American women were using oral contraceptives and IUDs.3o These changing contraceptive practices introduce major confounding variables into any analysis of subsequentgynecologic disorders. Prior gynecologic disorders may influence the choice of a specific contraceptive, and the choice of a particular contraceptive may modify the disease being studied. For example, patients who have irregular menses are more likely to have oral contraceptives prescribed than diaphragms. After discontinuing contraception, this history of irregular menses would predispose the group of oral contraceptive users to a higher incidence of menstrual abnormalities than the diaphragm users. Thus, the etiology may be related to the preexisting condition rather than to the method of contraception used. Therefore, any study of subsequent gynecologic problems among sterilized women must account for prior gynecologic disorders and prior contraceptive use. In addition, prior to 1970, many hospitals had restrictive sterilization regulations so that elective sterilization was difficult to obtain. Because many patients undergoing sterilization had med- Vol. 41, No.3, March 1984 Huggins and Sondheimer Complications of female sterilization 343

8 Table 7. Late Sequelae of Sterilization in Study and Control Groups31 Laparoscopic sterilization Interval laparotomy Vasectomy Number" Sequela Increased menstrual 39b loss (%) Increased pain. (%) 21b 14 6 anumber in group who completed follow-up questionnaire. bsignificant difference for female sterilization (combined) (P < 0.001). ical indications for the surgery, there is a significant potential for bias if a study includes a disproportionate group of patients with prior gynecologic pathology. The use of questionnaires that require patients to recall symptomatology many years in the past is subject to significant recall bias. There were almost no large early studies that used as controls women whose husbands had undergone vasectomy. For information more relevant to the sterilization techniques used today, it is helpful to consider studies done after 1971, which account for these confounding variables. In 1975, Neil et al.31 reported increases in menstrual blood loss and dysmenorrhea in 454 women sterilized by laparoscopy with diathermy or by abdominal tubal ligation when compared with a control group of 154 women whose husbands had undergone vasectomy (Table 7). The procedures were performed between January 1972 and July In this retrospective study, questionnaires were sent to 327 patients who had undergone interval laparoscopic sterilization by diathermy and division, 127 patients who had abdominal tubal ligation, and a control group of 198 patients whose husbands had undergone vasectomy, 75.6% returned the questionnaires. The authors state: "There was no significant difference at the 1 % level between the groups in symptomatology before the procedure or in the number who had been taking the contraceptive pill." No comparative data are given, but it is stated that in the control group', there were 10% fewer women on oral contraceptives. In the statistical analysis, Neil et al.31 appear to combine the laparoscopy and laparotomy groups, resulting in a case group of 350 versus a control group of 143, or a ratio of 2.5 cases to 1 control. Several facets of this study make it difficult to draw meaningful conclusions. First, there is a lack of data on prior contraceptive use and prior menstrual problems for both case and control groups. Second, the case group is larger than the control group. Some parts of the data analyses appear to combine data in the case groups, but other parts appear to separate the laparoscopy and laparotomy groups. Chamberlain and Foulkes32 found an increased incidence of dysmenorrhea in women who had undergone laparoscopic tubal sterilization. Their analysis determined that almost all of the women who reported increased dysmenorrhea after sterilization had used oral contraceptives prior to sterilization. When the group of oral contraceptive users was excluded from the analysis, there was no significant increase in dysmenorrhea after sterilization. Edgerton33 analyzed 517 patients wh9 underwent unipolar electrocoagulation and partial tubal resection between 1970 and Office records, questionnaires sent to referring physicians, or questionnaires sent to patients, were reviewed - 3 years after sterilization. By that time, 20 (3.9%) of the patients had undergone hysterectomy, 18 (3.5%) reported oligomenorrhea, 16 (3.0%) reported pelvic pain/dysmenorrhea, and 88 (17%) reported some type of "abnormal uterine bleeding." Analysis by prior contraceptive use showed abnormal uterine bleeding in 16 (22.9%) of the women who had used oral contraceptives for 5 or more years prior to sterilization. This contrasts with 29 patients (13.1%) reporting abnormal bleeding who had used other methods of contraception (excluding IUDs). This difference was barely significant: X2 = 5.37; P = slightly> Analysis by prior history of abnormal bleeding showed a 50% rate among patients with prior history versus 14.3% among patients with no prior history. This difference was highly significant: P < Stock,34 in a 1978 report, evaluated 226 patients who had undergone laparoscopic coagulation sterilization using different techniques: division, 55; division and resection of a segment, 102; and Falope ring, 69. An additional 42 patients underwent postpartum sterilization by the Pomeroy method. Evaluation was carried out by preoperative and postoperative questionnaires. Of the 268 postoperative questionnaires mailed, 233 (87%) were returned completed. Data obtained included information about prior oral contraceptive use, pelvic pain, and menorrhagia. Oral contraceptives had been used by 68% of the 344 Huggins and Sondheimer Complications of female sterilization Fertility and Sterility

9 Table 8. Altered Pathophysiologic Findings in 81 of 226 Patients Undergoing Laparoscopy14a Type of sterilization Divi Division Falope Total sion and ring removal Pelvic inflam matory disease Pelvic varicosities Leiomyomas Endometriosis Pelvic adhesions afrom Stock RJ: Evaluation of sequelae of tubal ligation. Fertil Steril29:169, Reproduced with permission of the publisher, The American Fertility Society. patients for an average of 6 years. Pelvic pathology was noted in 81 of the 226 patients. (36%) (Table 8). In Stock's study,34 the overall incidence of postoperative menorrhagia was 42%. However, among those who did not use oral contraceptives, the incidence was ~ 6%. This same disparity was noted in reports of pelvic pain: 31% overall versus 9% corrected. These data agree with those of Rubenstein et al. 35 ALTERATIONS IN MENSTRUA,})ION Although several studies seem to suggest an increase in adverse menstrual symptoms following Japaroscopic sterilization, data from these studies suffer from a lack of consistency. A retrospective study by Madrigal et al.36 analyzed menstrual changes occurring up to 31 months after sterilization in 635 women who underwent laparoscopy with fulguration and division. The parameters studied were intermenstrual bleeding, cycle regularity, and amount and duration of flow. There was a high incidence of change in amount and duration of flow: at 6 months, 27.1 % of patients reported an increase and 24.6% reported a decrease in the amount and duration of flow. Results at 2 years were similar. Because there were no data on prior contraceptive use and no control group, it was difficult to draw conclusions from these data. It is well known that estimates of cycle regularity and amount of menstrual blood flow among patients are parameters subject to significant recall bias. Patient perception of amount of flow at the time of menses often is quite inaccurate. Kasonde and Bonnar,37 however, conducted one of the few studies that analyzed menstrual blood loss objectively. In the Kasonde and Bonnar study,37 menstrual blood loss was measured 1 to 3 months before and 6 to 12 months after tubal ligation. All the women were multiparous, aged between 25 and 45 years, and menstruating regularly (cycle length, 21 to 35 days). Sixteen patients who had been using oral contraceptives stopped using them and had two spontaneous periods before entering the study. Lactating women, those reporting excessive bleeding, or those who had had delivery or abortion in the preceding 3 months, were excluded. Three patients were using IUDs; no mention is made about the time of the IUD removal. Blood was extracted from tampons and sanitary pads before and after tubal ligation and analyzed by the alkaline hematin method. In 22 patients sterilization was performed by the Oxford technique, which involves excision of a small portion of the middle third of the tube with separate ligation of each end. Two patients had laparoscopic fulguration, and one had a Pomeroy ligation. Kasonde and Bonnar37 found that the amount of menstrual blood loss varied widely, but there was no significant change in menstrual loss up to 12 cycles after operation. DISORDERED HORMONAL FUNCTION Explanations for the cause of PTLS include impaired ovarian blood supply, altered innervation to the tube or ovary, and intermittent torsion of the distal fallopian tube or ovary. If these explanations were correct, PTLS would parallel the amount of tissue destruction that occurs in each type of technique, producing accompanying disordered hormonal function. Data to support this theory, however, are confusing and conflicting. In a 1981 experiment, Riedel and Semm38 studied the extent of cautery tissue destruction in rabbits and found more extensive tissue destruction with unipolar current than with bipolar current (Fig. 3). Unipolar coagulation was performed at an output of 32 to 100 watts, at coagulation times from 10 to 50 seconds. Bipolar coagulation was performed at 2.2, 7.3, 10,23,30, and 50 watts, also at 10 to 50 seconds. Subsequent control laparoscopies were performed at 1, 2, 4, 8, and 12 weeks. Measured tissue destruction at 4 to 12 weeks demonstrated 3 to 5 cm of coagulated length of tube and a 2 to 4 cm depth of tissue destruction in the mesosalpinx. In contrast, bipolar high-frequency coagulation caused only 1.5 to 3 cm tubal destruction and 1.5 to 2 cm destruction in the Vol. 41, No.3, March 1984 Huggins and Sondheimer Complications of female sterilization 345

10 MONOPOLAR HIGH FREQUENCY COAGULATION.tter u wwyh.h"'of~~n of blood _Is and _ Figure 3 From Reidel and Semm. 38 mesosalpinx. There are concerns that bums further out in the isthmic area of the tube might interfere more significantly with ovarian blood and nerve supply, thus contributing to ovarian dysfunction. Hargrove and Abraham 39 reported finding high serum estradiol and low serum progesterone (P) levels in 29 patients who had PTLS consisting of pain, bleeding, and premenstrual tension. However, this study did not control for prior contraceptive use or prior history of menstrual problems. In addition, the mean age of the 11 control patients (29.7 years) was 2.1 years less than that of the 29 patients (31.8 years). Donnez et a1. 40 studied midluteal P and endometrial biopsy levels among three groups of patients. Group 1 contained 35 women who had undergone laparoscopic sterilization using Hulka Clemens Spring Clip (Richard Wolf Medical Instruments Corporation, Rosemont, IL); group 2 contained 23 women who had undergone tubal ligation by either the Pomeroy method or laparoscopic electrocoagulation; group 3, the control group, contained 65 fertile women. The women in I all three groups were aged 37 years or less, had parity of 2 or more, and had regular menstrual cycles of 28 to 31 days without dysfunctional bleeding. The average P level (mean ± standard deviation [SDD in the control group (group 3) was 17.2 ± 4.8 ng/ml; in the clip group (group 1) it was ± 6.3 ng/m1. These differences were not statistically significant. However, in group 2, the Pomeroy or electrocoagulation group, average P levels measured 8.5 ± 6 ng/m1. The value was significantly lower (P < 0.001) than those of the clip or control groups. Analysis of endometrial histologic studies, showed that 9 of 35 biopsies in the clip group and 11 of 20 biopsies in the Pomeroy or electrocoagulation group had endometrial development retarded by 2 days or more. Donnez et a1. 40 hypothesized that the Pomeroy or electrocoagulation method alters the supplementary blood flow to the ovary by interrupting the uteroovarian artery, whereas the Hulka clip does not interfere with this blood supply when placed within 2 cm of the uterine cornua. Their proposed explanation is that the decreased blood supply might lead to deficient formation and function of the corpus luteum. If these researchers were accurate in concluding that laparoscopic sterilization results in the destruction of significant portions of the uterine blood supply to the ovary, there should be some disruption of ovarian steroidogenesis. A study by Doyle et a1. 41 demonstrated in 1971 that cyclic ovarian function persisted in patients who had undergone hysterectomy. In the patients studied, levels of plasma P measured were interpreted as normal for ovulating women. However, a reanalysis of these data by Radwanska et a1. 42 contends that mean P levels actually were decreased when compared with normal controls. In 1979, Radwanska et a1. 42 studied 40 women with normal menstrual cycles who had been sterilized by tubal ligation or electrocoagulation. P levels were determined in blood samples drawn 5 to 10 days prior to the expected onset of the next menses. Twenty-four normally menstruating women whose husbands were infertile served as control subjects. Mean midluteal serum P levels in the sterilized women were significantly lower than those among controls, 9.4 ± 5.7 ng/ml versus 17.4 ± 7.1 ng/m1. Levels measured < 10 ng/ ml in 25 of the study women (62%) and in only 4 of the control women (17%). 346 Huggins and Sondheimer Complications of female sterilization Fertility and Sterility

11 Table 9. Comparison of Serum Progesterone Levels 44 Sterilized Ring Electric Control Hysterectomy Mean SD Median Mean SD Median Mean SD Median Mean SD Median nglml nglml Cycle Cycle Combined n = 16 patients n = 13 patients 20 observations 26 observations nglml nglml n = 12 patients n = 7 patients 21 observations 10 observations In a second study, Radwanska et a1. 43 investigated serial follicle-stimulating hormone, luteinizing hormone, estradiol, and P levels in 23 previously sterilized women, 14 with menstrual disturbances (group I) and 9 with normal cycles (group II). The control group consisted of 28 parous women (group III). Four patients were found to be anovulatory, all from group I. Mean midluteal P values were lower in group I (8.5 ng/ml) than in group II (13.9 ng/ml) or in the control group (III) (16.5 ng/ml) (P < 0.01). Furthermore, 78% of those in group I, 44% in group II, and only 15% in group III had mean midluteal P levels < 10 ng/ml. Laparoscopy performed on seven patients in group I who complained of pelvic pain revealed endometriosis in four, suspected adenomyosis in one, and significant postoperative adhesions in two. Radwanska et a1. 43 concluded that anovulation or poor P production by the ovary may be responsible for menstrual disorders in some sterilized women and that these disorders may be related to altered blood supply caused by the sterilization procedure. It was mentioned that the endometriosis or adhesions could have contributed to the disordered ovarian function. Other studies, however, do not confirm these observations. Corson et al. 44 studied hormone profiles in asymptomatic patients sterilized by bipolar electrosurgical or the Falope ring laparoscopic technique, comparing them with women undergoing hysterectomy and with control patients. In all, 48 patients were studied for a total of 74 cycles. Menstrual cycles were monitored with the use of oral basal body temperature charts. P determinations were done on the eighth day (± 1) after the thermal nadir and subsequent rise. P levels reported are seen in Table 9. The authors conclude that there were no statistical differences in P levels among the four groups. Despite inherent methodologic problems and selection bias, these studies suggest that some women do experience ovarian dysfunction after sterilization, and that the severity may be related to the amount of disruption in blood or nerve supply to the ovary. Further studies with adequate case and control selection are needed to address this issue more definitely. FINDINGS OF LARGE SCALE STUDIES Several large-scale studies have provided information that is useful in discussing PTLS. These well-controlled studies have accounted for contraceptive use before sterilization and for prior history of menstrual disorders. Information about gynecologic and psychiatric sequelae to sterilization was gathered as part of the Oxford Family Planning Association (OFPA) study, a prospective study of health risks associated with the different forms of contraception. Vessey et a1. 9 reported data on sterilizations in The OFPA study group consists of 17,032 white married women who were recruited from 17 family planning clinics in England and Scotland from 1968 to Each had been a successful user of the diaphragm (25%), oral contraceptives (56%), or the IUD (19%) for 5 months prior to enrollment. The OFPA follow-up rate is> 96%. During follow-up, each patient provides an interval medical history, including details of pregnancies and their outcomes, changes in contraceptive practices and reasons for change, and particulars of any hospital referrals as an outpatient or an inpatient. Discharge diagnoses are confirmed by obtaining copies of discharge letters or summaries. Women who stopped attending the clinic are sent a postal questonnaire; if this is not returned, they are interviewed by telephone or in person. Vol. 41, No.3, March 1984 Huggins and Sondheimer Complications of female sterilization 347

12 Table 10. Hospital Referrals for Gynecologic Disorders After Sterilization 9 Type of referral Uterine prolapse Any hospital referral Menstrual disorder Hospital admission Any hospital referral Pelvic inflammatory disease Hospital admission Cervicitis or erosion Hospital admission Referral leading to hysterectomy Referral leading tod&c "Tubal sterilization. bhusband vasectomy. Sterilization procedure Tsa Vb TS V TS V TS V TS V TS V TS V No. of women referred 3 years Life-table estimate (referral rate per 100 women) 6 years Table 3 demonstrates that in the OFPA study, open sterilization procedures were more common than laparoscopic sterilization in the interval 1968 to 1971, but that the reverse has become true since Only a small part of this trend can be attributed to the fact that delivery-associated sterilization was relatively more frequent during the early years of the study. Table 3 also shows the recent displacement of laparoscopic tubal diathermy by the application of rings or clips via the laparoscope. Using the OFPA data, Vessey et a1. 9 compared 2243 women who had undergone sterilization and 3551 women whose husbands had undergone vasectomy. Possible late complications of sterilization were analyzed by comparing rates of referral to specialists for gynecologic and/or psychiatric disorders. Factors compared included age, social class, parity, method of contraception prior to sterilization, and prior gynecologic problems. Vessey et a1. 9 reported that women who underwent sterilization in association with delivery were younger and of much higher parity and had used oral contraceptives much less frequently than the women who had undergone interval sterilization or whose husbands had had vasectomies. Women in the interval group were quite similar to those in the vasectomy group, although 30% of those in the interval group and only 20% of those in the vasectomy group had histories of previous gynecologic disorder. For this reason, the analysis was restricted to women who had had no prior gynecologic disorders and who had undergone interval sterilizations. Thus, the final study group comprised 1274 women who had undergone interval sterilization and 2823 women whose husbands had undergone vasectomy. Table 10 9 lists results of hospital referrals for gynecolgic disorders after sterilization. For this analysis, each woman has been counted only once in each row of the table, i.e., the analysis considers only first referrals for a particular disorder. Rates are given on both a simple woman-years basis and on a cumulative basis estimated by lifetable procedures. There is no evidence of any important difference between the two groups of women with respect to the occurrence of uterine prolapse, cervicitis, or erosion (dilatation and curettage [D&C]), or hysterectomy. Hospital admission for PID was uncommon among the women whose husbands had undergone vasectomy and did not occur at all among those who had had tubal sterilization. Menstrual problems, however, were responsible for hospital referral slightly more frequently in the tubal sterilization group, with a suggestion that referral rates were higher among those who had had laparoscopic tubal diathermy (23.0/1000 woman-years) than among those who had been sterilized at laparotomy (19.8/1000 woman-years); this difference was not statistically significant. OFPA data concerning hospital referrals for psychiatric disorders are summarized in Table Table 11. Hospital Referrals for Psychiatric Disorders After Sterilization 9 Type of referral Psychiatric disorder Hospital admission Any hospital referral Suicide attempt "Tubal sterilization. bhusband vasectomy. Sterilization procedure Tsa Vb TS V TS V Life-table estimate (referral rate per No. of 100 women) women referred 3 years 6 years Huggins and Sondheimer Complications of female sterilization Fertility and Sterility

13 ~:::C::::::::;=::L::::::;::::::;=:::;::~~~~~ ~~~~~~=L:::::::;::::::::i::::::::;:::::::i:~ '- I I I De",... ed D Unchanged line'... Tubal ring (/01""1691 nj,fj- Electrocoagulation (N= Prototype spring Chp IUS,. Europel IN=315 '2721 Prototype spring clip I Developing world) (N= Rocket Clip IN= Tubal ring (N= , E lectrocoagulat Ion IN"" Prototype spring clip (US 81 Europel fn=314221) Prototype spring clip IDeveloplng worldl (N= Rocket chp fn=281227, Tubal rlog (N; Electrocoagulation fn= Prototype spring clip (US 81 Europel (N=77260, Prototype spring clip (Developing worldl (N=14' "1151 Rocket chp fn;88661 ~ Percent ot Women with Change trom 6 month Follow up ~ to 12 month Follow up Figure 4 Percentage of women with change in amount of menstrual flow from admission to 6-month follow-up (n = 10,004) compared to change from 6-month follow-up to 12-month followup (n = 6191). From Bhiwandiwala et al ; there is no indication of any important difference between the two groups of women. Vessey et a1. 9 concluded that there was little or no evidence of any adverse long-term sequelae of tubal sterilization. The strengths of this study lie in its prospective design. Data on prior contraceptive use and prior gynecologic problems were available, so this information was not subject to patient recall. Excluding from comparison the dissimilar groups of women who had delivery-associated sterilizations and those women who had prior gynecologic problems ensures that the study and control groups were more similar, removing a major confounding variable. Because the authors were unable to determine rates of visits to general practitioners for menstrual abnormalities or other gynecologic disorders, it is conceivable that these incidence rates could be altered slightly. However, because the British health care system requires that all D&Cs and hysterectomies be done in hospitals, it is unlikely that the study missed any significant gynecologic disease. Another large-scale study, reported by Bhiwandiwala et al.,45 is an ongoing multinational multicenter collaborative study on sterilization, involving 64 institutions in 27 countries. The latest analysis of this study compared menstrual pattern changes reported by 10,004 women who had been sterilized by one of four methods: laparoscopy with tubal ring, laparoscopy with unipolar cautery, laparoscopy with a prototype spring clip, and laparoscopy with an improved spring clip (Hulka-Clemens). A menstrual history was obtained at the time of admission and at 6-, 12-, and 24-month follow-up. All 10,004 women were seen at the 6-month follow-up; 62% (6152) returned at 12 months; and 20% (2043) returned at 24 months. Six menstrual parameters were examined: cycle length, cycle regularity, menstrual flow duration, amount of flow, dysmenorrhea, and intermenstrual bleeding. Patients were stratified by contraceptive method used in the 3 months prior to sterilization as follows: no contraceptive or barrier method and/or withdrawal method (combined in one group), oral contraceptives, and IUDs. Figure 445 illustrates the proportion of women who reported changes in the amount of menstrual flow during the time period from admission to 6 and 12 months after sterilization. This figure demonstrates the effect of prior contraception on the perception by the patient of changes in her menstrual habits. Of the patients in the nonelbarrier/withdrawal group, the majority experienced no change. Of those who did report changes, about half changed in one direction and about half in the other. The prior oral contraceptive users were more likely to report changes in regularity, increased cycle length, flow duration, and amount offlow. The IUD users were more likely to report more regular periods, decreased amount and duration of flow, and decreased dysmenorrhea. From 6 to 12 months, there was no evidence that prior contraceptive use had any significant effect on menstrual patterns. Upon further analysis, there was no evidence that the more destructive technique of unipolar coagulation carried a greater risk of subsequent menstrual abnormalities. Vol. 41, No.3, March 1984 Huggins and Sondheimer Complications of female sterilization 349

14 The researchers conducting these large-scale studies on tens of thousands of women have concluded that PTLS may occur in individual women as a result of sterilization, but there is no evidence that PTLS is a sequela of sterilization in any large numbers of women. PREGNANCY FOLLOWING STERILIZATION Although rare, unintentional pregnancy following sterilization does occur. Approximately 50% result from undetected luteal phase pregnancies that were present at the time of sterilization. A D&C may not always remove an early pregnancy, and a pregnancy test in the luteal phase may be negative. Other reasons for unintended pregnancy after tubal ligation included (1) mistaking the round ligament or infundibulopelvic ligament for the fallopian tube; (2) spontaneous rejoining of the tube, especially if there had been little tubal tissue damage; (3) development of a fistula at the cauterized or occluded end of the tube; and (4) slippage of a mechanical seal such as the clip or band. The CDC CREST study on sterilization by Silastic band and coagulation with 95% follow-up between 2 and 15 weeks after operation and an 85% follow-up at 2 years yields the most reliable recent data on pregnancies. A report of these data 46 showed that the overall pregnancy rate after tubal sterilization was 1.8 in 1000 women after 12 months and 3.0 in 1000 after 24 months. The 24-month rate after Silastic band sterilization (7.1 in 1000) was considerably greater than that after coagulation (1.7 in 1000), but the difference in failure rate between these methods was not significant and may be a result of chance or confounding variables. Table 12. Pregnancy Rates After Sterilization Technique Laparoscopic tubal coagulation 50 Nonlaparoscopic tuballigation 5o Laparoscopy48 Coagulation Silas tic band Spring-loaded clip Spring-loaded clip (prototype) Laparoscopy47 Coagulation and cutting Spring-loaded clip Silastic band anot available. Sterilizations 23,238 13, Although most tubal ligation pregnancies occur in the first year after sterilization, they can occur years after the procedures; therefore, proper follow-up is important. 47 The CDC's ongoing CREST study should continue to provide useful follow-up information. Many studies have no follow-up or inconsistent follow-up or do not report their follow-up data. Chi et a1. 48 evaluated data on 14,700 female sterilizations collected by the International Fertility Research Program from 1972 to This demonstrates a marked improvement in efficacy, with the improved Hulka-Clemens spring clip (6.5 in 1000) failure rate, compared with that of the prototype clip (43.5 in 1000). Data from the OFPA study reported by Vessey et a1. 9 indicate that there were 16 poststerilization pregnancies in 2243 women who underwent tubal sterilization. The adjusted pregnancy rate during the first 12 months is 0.37/100 womanyears; after 13 months the rate drops to 0.10/100 woman-years. Laparoscopic procedures were slightly more likely to fail than were laparotomy procedures. However, McCausland's review of the literature 49 found failures more frequent in the nonlaparoscopic tubal ligations (Table 12). ECTOPIC PREGNANCY Tubal sterilization is an important cause of ectopic pregnancy. Wolf and Thompson 5o conducted a retrospective study covering 86,809 live births and 721 ectopic pregnancies. Over the 8-year study period, 33 of the ectopic pregnancies (4.5%) had been preceded by tubal sterilization, but the rate over the last 4 years of the study rose to 7.4% (29 of 393). This seems to indicate the increasing influence of tubal sterilization as an etiologic agent in ectopic pregnancy. Failures Intrauterine Ectopic 45 (0.19%) 22 (49.0%) 23 (51.0%) 106 (0.76%) 93 (87.7%) 13 (12.3%) 14 (0.32%) NAa NA 19 (0.53%) NA NA 3 (0.65%) NA NA 66 (4.35%) NA NA 5 (0.80%) NA NA 22 (2.3%) NA NA 8 (0.78%) NA NA 350 Huggins and Sondheimer Complications of female sterilization Fertility and Sterility

15 McCausland49 reviewed ectopic pregnancy following laparoscopic tubal coagulation failures, noting that 12.3% of pregnancies that occurred after nonlaparoscopic tubal ligation were ectopic, compared with 51% of pregnancies that occurred after tubal electrocoagulation. These are shown in Table 12. McCausland49 theorized that more proximal coagulation, i.e., closer to the cornua, leads to a greater likelihood of fistula formation. Tatum and Schmidt51 found a 70% incidence of ectopic pregnancies when pregnancies occurred after failure of laparoscopic coagulation. There was no difference in ectopic pregnancy ratios after coagulation with or without transection. In a group of 54 women, Grunert52 found that when hysterosalpingography was performed prior to reversal of tubal sterilization, 16.7% of patients had tubal patency. Even with the increase in the numbers of ectopic pregnancies after tubal sterilization, the yearly risk of an ectopic pregnancy after sterilization still is lower than no method of contraception or the IUD. For most women, then, tubal ligation decreases the lifetime risk of an ectopic pregnancy.53 REVERSAL OF TUBAL STERILIZATION With liberalized indications for sterilization, many women are choosing sterilization at younger ages. Changing life-styles, especially divorce and remarriage, are leading to later desires for further childbearing. In addition, improved microsurgical techniques have made the reversal procedure more successful. For these reasons, the percentage of women who request reversal of tubal sterilization appears to be increasing. In general, women who request reversal of sterilization are relatively younger at the time of sterilization. Because these women have more years ahead in which to experience changes in life-style, they are more likely than older women to decide that they want more children. Several studies have confirmed these impressions. The prospective study by Stock34 included data from questionnaires mailed in 1977 to women who had been sterilized from 1973 to 1977 in a private suburban practice with an apparently well-structured informed consent and education process. Of the 268 women who underwent tubal ligation, follow-up questionnaires were received on 87%. Six patients (3%) were dissatisfied with their decision to have a tubal ligation, but five of these six expressed dissatisfaction because they perceived later gynecologic problems to be related to the procedure. Although 5% of the women considered reversal, for most it was only a passing thought; two women, or 1 %, pursued reversal. Seven women (3%) felt they had not received adequate counseling before their procedure; four of these seven women were postpartum procedures, and two of the postpartum women had infants later found to have congenital problems. It should be noted that although patients may complain that they are dissatisfied with the sterilization decision, this does not necessarily imply that they would seek reversal. In interviewing 103 women in England, Winston54 found that the most common reason for requesting reversal of sterilization was remarriage (81 of 103) (78.5%). Interestingly, 75% of those sterilized said they made the decision because their marriages had been so unhappy that they decided to end their childbearing. However, 25% said that they had been reasonably happily married at the time of the sterilization. Two thirds of those who requested reversal had been sterilized immediately postpartum. Other reasons for requesting reversal are listed in Table 13. Gomel in Canada,55 Murray in Australia,56 Cantor and Riggall in Florida,57 and Jackson and Lander in New Zealand58 reported similar experiences. For example, Jackson and Lander's 5-year follow-up in New Zealand,58 with approximately a 50% response, found that 1% of sterilized women (8 of 831) requested reversal. All of the women who requested reversal had been 30 years of age or younger at the time of sterilization. The main reason for requesting reversal was a change in partner. Women who request reversal ofsterilization generally are younger at s terilization and of lower parity than the overall sterilization population. Forty-six of 64 women in Murray's study in Australia56 and similar numbers in England54 and the United States4 had their initial sterilization to limit family size, hoping to prevent financial hardship and resulting increased marital discord. In Murray's study, of the 64 women who requested reversal had had an unwanted or unplanned pregnancy just before sterilization. These women seeking reversal were more likely to have had a postpartum procedure than the general sterilized population. Other, less common, reasons for reversal were death of a child, Vol. 41, No.3, March 1984 Huggins and Sondheimer Complications of female sterilization 351

16 Table 13. Reasons for Requesting Reversal of Sterilization Reason Remarriage Death of a child Desire for more children Psychological reasons Medical reasons Improved sexual relationship Total n % desire for more children, and adverse psychologic reaction to sterilization. Vessey et al. 9 reported request for reversal in only 2 women among 2243 (0.09%) who had undergone sterilization. All these women had been married, and their ages were 25 to 39 years at the time of sterilization. In developing countries, death of a child from disease or natural disaster is a common cause for reversal request. In addition, dissatisfaction is high among those who were sterilized with financial incentives_ 59 Gomel55 reviewed his personal experience with reversal of sterilization procedures in 118 patients over a 10-year period_ Not surprisingly, 25% of all couples who initially were interested in the reversal procedure decided not to pursue the surgery after education about what reversal entails and the chances of success; another 20% were excluded following preoperative investigationbecause of another absolute cause of infertility, because the condition of the tubes or pelvis made reversal impossible, or because the patients changed their desires_ Dissatisfaction with sterilization does not appear to be related to age since most dissatisfaction is not due to desire for more children, but rather the perception that medical or emotional problems were caused by the tubal ligation. Retrospective studies of those requesting reversal show common characteristics: many patients were relatively young at the time of sterilization and then later changed partners, had made the decision for socioeconomic reasons or in association with marital problems, or had the procedure at the time of an abortion or immediately postpartum. Unfortunately, there are no studies that allow the physician or counselor to predict who will regret the decision to undergo sterilization. Therefore, the best course we can recommend is to be sure the patient and her partner know in what setting regret is likely to occur, explain in detail that this is not a reversible procedure, and allow the woman to make her own decision. TECHNIQUES FOR SUCCESSFUL REVERSAL Several researchers have reported good results with attempts at reversal of sterilization. Winston,60 in particular, after considerable operative laboratory experience, published his clinical results using the operating microscope and microscopic technique with fine suture_ After 126 anastomosis procedures, overall pregnancy rate was 58%, and only 2.5% of women experienced ectopic pregnancies. Factors that seem to increase the chances,of success include preservation of long segments of tube, isthmic-isthmic anastomosis (i.e., previous destruction of only short segments of isthmic tubal portion), time since sterilization < 5 years, and use of microsurgical technique. However, pregnancies still have been reported after anastomosis with conventional techniques, after anastomosis of short tubes,and even after second attempts at anastomosis after failed first attempts_ In a study by Winston,60 only 37% of women sterilized by unipolar cautery had enough tube remaining to allow anastomosis; the pregnancy rate for this group was 55%. Of the ten patients who had been sterilized by spring clip, all conceived after the reanastomosis. Cantor and Rigga1l 57 published experience with reversal over 2 years from 1976 through Of 27 women evaluated for reversal, 14 decided not to have the procedure for a variety of reasons and 6 were rejected after laparoscopy because of either lack of fimbria or total length of remaining tube < 3 cm. These latter six patients, who had very short remaining tubes, had undergone interval sterilization by coagulation with a t~o- or three-burn technique. Of the seven pabents who had sufficient tube and underwent subsequent anastomosis, five had Pomeroy-type ligations and two had had single-burn coagulations. Anastomosis in these eight patients resulted in intrauterine pregnancies in three (38%). Laparoscopic sterilization by the spring clip, ~ilastic band, bipolar cautery of the isthmic porbon, or laparotomy Pomeroy ligation all give relatively good chances of reversal. SUMMARY Surgical sterilization in women has changed dramatically over the past 20 years. The devel- 352 Huggins and Sondheimer Complications of female sterilization Fertility and Sterility

17 opment of laparoscopy and minilaparotomy have made the procedure readily available even in developing countries. In the United States, changing social values and changes in hospital regulations have done as much as technology to account for the tremendous increases in the number of women undergoing sterilization. Improved sterilization procedures have resuited in lower costs for sterilization and lowered morbidity and mortality rates. Hysterectomy for sterilization alone carries unacceptable morbidity and mortality rates. Originally, laparoscopic techniques utilized unipolar cautery. However, bowel burns, a rare but serious complication, were reported, and this led to newer techniques. These techniques, using bands, clips, and bipolar cautery, have gained increasing popularity and have eliminated many of the serious complications of female sterilization. Historically, there has been concern that tubal sterilization by any method produces, in significant numbers of patients, the subsequent gynecologic and psychologic problems called "post-tubal ligation syndrome." A review of earlier literature indicates that many of these studies have serious methodologic problems, including recall bias, inappropriate control groups, failure to elicit prior history of gynecologic or psychologic problems, and failure to account for the use of oral contraceptives or IUDs. More recent large prospective epidemiologic studies that have controlled for prior gynecologic problems and contraceptive usage have failed to show increased incidence of gynecologic sequelae in large numbers of women. However, there are some data to support the concept that in certain individuals, sterilization may result in disruption of ovarian blood or nerve supply, producing gynecologic sequelae. Additional data from these ongoing large-scale studies and others should help to elucidate this problem in the future. Pregnancy after sterilization (even excluding pregnancies present at the time of the procedure) is more common the first year after the procedure with the risk decreasing in subsequent years. First-year failures are to 0.37/100 womanyears and then fall off to 0.10 to 0.12/100 womanyears in subsequent years. The ratio of ectopic pregnancy among these pregnancies is higher after laparoscopic cautery techniques. Band and clips may be slightly less effective than the use of electrocoagulation or the Pomeroy technique. Failure rates are not improved by resection of the fallopian tube after cautery, and resection is associated with a slightly higher risk of mesosalpingeal bleeding. Patients should be informed that the sterilization procedure.may not be 100% effective in preventing pregnancy. There is a small number of patients who request reversal of sterilization, usually younger women who remarry after sterilization and decide that they want more children. There is no formula or accurate way to predict individually who will later request reversal of sterilization. The best the physician can hope to do is describe to the patient the circumstances under which most requests for reversal are made and let the patient make her own decision about the procedure. Reversal rates have been shown to be most successful if the sterilization has produced minimal tubal damage in the midisthmic portion. Ackrwwledgments. We are grateful for the excellent technical assistance provided by Ms. Diana Wheeler and Ms. Margaret Casey. We also thank Ms. Joby Jackson for typing the manuscript. REFERENCES 1. Green CP: Voluntary sterilization: world's leading contraceptive method. Popul Rep [M] 2:1, Stepan J, Kellogg EH, Piotrow PT: Legal trends and issues in voluntary sterilization. Popul Rep [E] 6:1, Westoff CF, Jones EF: Contraception and sterilization in the United States, Fam Plann Perspect 9:135, Westoff CF, McCarthy J: Sterilization in the United States. Fam Plann Perspect 11:147, Sterilizations performed in the U.S., , male and female compared by year. Association for Voluntary Sterilization, Inc., New York, NY, 1982, chart, p 1 6. Cumulative totals of estimated voluntary sterilizations, Association for Voluntary Sterilization, Inc., New York, NY, 1982, p 2 7. U.S. sterilizations near 14 million. AVS News 20:1, Phillips JM, Hulka JF, Hulka B, Corson SL: 1979 AAGL membership survey. J Reprod Med 26:529, Vessey M, Huggins G, Lawless M, Yeates D, McPherson K: Tubal sterilization: findings in a large prospective study. Br J Obstet Gynaecol 90:203, Dicker RC, Greenspan JR, Strauss LT, Cowart MR, Scally JM, Peterson HB, DeStefano F, Rubin GL, Ory HW: Complications of abdominal and vaginal hysterectomy among women of reproductive age in the United States. Am J Obstet Gynecol 144:841, Laros RK, Work BA: Female sterilization. III. Vaginal hysterectomy. Am J Obstet GynecoI122:693, 1975 Vol. 41, No.3, March 1984 Huggins and Sondheimer Complications of femflle sterilization 353

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