MENSTRUAL PATTERNS AND WOMEN'S ATTITUDES FOLLOWING STERILIZATION BY FA LOPE RINGS*

FERTILITY AND STERILITY Copyright 1979 The American Fertility Society Vol. 31, No.6, June 1979 Printed in U.s.A. MENSTRUAL PATTERNS AND WOMEN'S ATTITUDES FOLLOWING STERILIZATION BY FA LOPE RINGS* LIDIA M. RUBINSTEIN, M.D., F.A.C.O.G.t LLOYD BENJAMIN, M.D., M.P.H. VICKI KLEINKOPF, M.D., M.P.H. Department of Obstetrics and Gynecology, University of California School of Medicine, Los Angeles, California 90024 Follow-up data on 147 women sterilized by laparoscopic Falope ring application were analyzed for changes in menstrual patterns, postoperative complications, patient feelings about surgery, and incidence of regret. Twelve to twenty-eight months after surgery, there were no consistent changes in interval, length, or amount of menstrual flow, and only 4% of women developed transient episodes of dysfunctional uterine bleeding. Analysis of feelings after sterilization showed that 90% of women were satisfied with the sterilization, 3% were unhappy, and 7% were ambivalent. Feelings of regret were not associated with postoperative complications and appeared to be related to the reasons for sterilization. Individual counseling not only helped to identify the population at risk for regret but also served to reduce the incidence of poststerilization ambivalent feelings. Fertil Steril31:641, 1979 In the past several years, sterilization by laparoscopy has become the method of choice for voluntary interval sterilization. However, few follow-up studies have evaluated the possible long-term physical and psychologic sequelae. More recently, reports on the incidence of subsequent gynecologic disease, changes in menstrual pattern, and patients' feelings about surgery have shown conflicting results.l-s In a previous follow-up study, 18 to 36 months after laparoscopic electrocoagulation, the incidence of abnormal menstrual flow was 5.4% when corrected for prior disturbances and contraceptive use. 2 Although most (77%) patients were content with their decisions about sterilization, 16% were uncertain and 5% expressed regret. In the present study, a group of patients exposed to structured counseling services was sterilized by Received September 18, 1978; revised December 7, 1978; accepted February 19, 1979. *Computing assistance was obtained from the Health Sciences Computing Facility, UCLA, supported by National Institutes of Health Special Resources Grant RR-3. t To whom reprint requests should be addressed. 641 means of a mechanical device, i.e., the Falope Ring. The aim of the follow-up was 2-fold: (1) to determine the incidence and types of changes in the menstrual cycle, and (2) to study patient feelings about surgery and possible reasons for regret. MATERIALS AND METHODS Women referred or self-referred to the sterilization clinic were counseled by specially trained personnel in individual sessions where a detailed menstrual, contraceptive, and gynecologic history was obtained. Questions pertaining to reasons for sterilization, surgical procedure, risks, complications, alternatives, and expectations were discussed during these interviews, including the possibility of regret. Psychiatric evaluation was requested when there was a concern about the patient's capabilities for informed consent. Because of limitations of operating schedules, there was a 2- to 3-month delay between counseling and surgery. The patients were interviewed 2 weeks after the procedure and contacted again 12 to 28

642 RUBINSTEIN ET AL. June 1979 months after surgery by means of a self-administered questionnaire. The questionnaire contained specific questions relating to demographic data, menstrual histories, changes since surgery, new gynecologic complaints, reasons for sterilization, patient's views regarding her decision for sterilization, and personal feelings about the outcome of the procedure and its effect on life situations. Different formats of questions were used, including open-ended, yes-no, and scales from 1 to 7 to tabulate the degree of personal feelings. Questionnaires were received from 147 women representing 73% of the surgical procedures. Additional information was obtained from review of operative records and subsequent hospital admissions and/or visits. Statistical Analysis. The information was organized for statistical comparisons both within and between the patients. For analysis of comparisons and correlations, Pearson's x: t-test analysis and McNemar test of symmetry were used when indicated. Procedure. All procedures were performed in the outpatient surgical unit under general anesthesia by the resident staff under direct supervision of a faculty member. A two-incision technique was used to allow for insertion of the Falope Ring. In 85% of cases, sterilization was not combined with any other surgery, in 6.8% it was associated with suction curettage, and in 5.4% with diagnostic dilatation and curettage. Intraoperative complications were not serious, although three patients required a laparotomy to complete the procedure (Table 1). In 10% of patients, postoperative pain was moderate to severe, requiring medication for 48 hours after the procedure. Three intrauterine pregnancies occurred during the follow-up period, none of which constituted a luteal phase failure. The lack of familiarity with the Falope Ring technique might have played a role, since all of the failures occurred early in the series. During the follow-up period, two patients underwent hysterectomies which were not directly related to complications of sterilization. One was for chronic pelvic inflammatory disease noted at the time of surgery and the other for persistent dysfunctional uterine bleeding which preceded sterilization. RESULTS Patient Profile. Age at the time of surgery ranged from 20 to 45 with a mean of 32.3 years. Parity ranged from 0 to 8 with a mean of 2.01 TABLE 1. Numbers of Women with Intraoperative and Postoperative Complications Complications Intraoperative Lacerated cervix Lacerated tube Transectedtube Impaired visualization due to adhesions Postoperative Severe pain over 48 hours Wound infection Failureb Wound hematoma Salpingitis arequired laparotomy. bintrauterine pregnancy. No. of women children. Four per cent of patients were grand multiparous, 9.2% had no history of pregnancy, and 15.6% were nulliparous women. Only 24% of the women defined themselves as housewife, the remainder listed an outside home occupation. Few changes occurred in marital status within 2 years following sterilization. None of the single women (12%) had married, and 5% of the married women had been divorced or separated at the time of follow-up. The majority of women had used more than one contraceptive method prior to electing sterilization. At the time of surgery, 40% of women were using hormonal contraceptives, 25.9% barrier methods, 18.4% intrauterine devices, and 15.6% none. The contraceptive profile was important not only to analyze the changes in the menstrual patterns following surgery but also as the factor prompting 34% of the women to seek sterilization (Table 2). Very few patients (4.7%) indicated a financial reason as the motivation to seek sterilization. The medical indications, e.g., heart disease, RH isoimmunization, and juvenile diabetes, accounted for 8.1% of the patients. Menstrual Pattern. Four menstrual cycle parameters were determined before sterilization and at the time of follow-up: days of bleeding, days of interval between menses, amount offlow, and episodes of intermenstrual bleeding. TABLE 2. Reasons for Sterilization Reason 14 3 3 1 1 Total group No. % Medical 12 8.1 Multiparity 6 4.0 Desired family size attained 72 48.9 Desire to stop present contracep- 50 34.0 tive method Financial 7 4.7

Vol. 31, No.6 STERILIZATION BY FALOPE RINGS 643 Menstrual pattern" TABLE 3. Menstrual Pattern before Sterilization and at Time of Follow-up Presterilization P08tsterilization Range Mean± SE Range Mean± SE Menses (days) 1-10 4.8± 0.1 2-12 5.0 ± 0.1 Interval (days) 19-90 30.3 ± 0.7 19-60 29.1 ± 0.5 Amount of fl.owb S M H S M H % of patients 16 69 15 18 60 22 ano significant difference in duration of menses or length of interval (paired t-test analysis). bs, Slight; M, moderate; H, heavy. The amount of flow for each woman was defined as slight, moderate, or heavy according to the number of pads/tampons used and the presence of clots. Slight indicated one or two pads daily; moderate, three or four pads daily; and heavy, five or more pads and/or clots. Intermenstrual bleeding was defined as none, rare, occasional, or heavy. Rare indicated one or two episodes of spotting per year, occasional indicated three or four episodes of spotting per year, and heavy indicated either more than four episodes of spotting and/or any episode of prolonged bleeding. There were no significant differences in the duration of menses or the length of interval after sterilization as compared either by the means of the groups or by paired t-test analysis (Table 3). There was a slight increase in the number of women reporting heavy menstrual flow after surgery, particularly among prior users of hormonal and barrier methods. However, comparisons between the amount of flow pre- and poststerilization for each woman revealed no demonstrable pattern of increased or decreased flow. Very few of the changes in menstrual flow were of more than one magnitude difference (Table 4). Statistical analysis applying the McNemar test for symmetry showed no significant over-all changes in menstrual flow. Intermenstrual bleeding was not a frequent complaint before or after surgery (Table 5). In one woman a pre-existent problem of dysfunctional uterine bleeding worsened and in five women with TABLE 4. Change in Amount of Menstrual Flow after Sterilization a Menstrual flow presterilization Menstrual flow poststerilization None Slight Moderate Heavy None 0 0 0 0 Slight 0 12 10 1 Moderate 0 11 71 16 Heavy 1 2 4 14 adata for the total group (IV = 142). There were no significant differences according to McNemar's test for symmetry. prior intermenstrual bleeding episodes there was frank improvement after sterilization. Thirteen women reported the onset of intermenstrual bleeding within 1 year following surgery. Further analysis of this group indicated that seven women developed rare to occasional episodes of spotting following discontinuation of oral contraceptives. In the remaining six patients (4%), the diagnosis of dysfunctional uterine bleeding was established. Following sterilization, 15.9% of women reported dysmenorrhea; however, in half of them, dysmenorrhea pre-existed surgery. No correlations were found between complaints of dysmenorrhea and menorrhagia following sterilization. Personal Feelings. In response to questions regarding the effect of sterilization on life situations, the majority of women indicated a lack of influence in their sex life and relationships with partner and/or family (Table 6). Comments on the positive influence of sterilization, particularly on improvement of sex life, outnumbered those about negative effects. About 35% of women reported increased sexual activity and satisfaction following sterilization, and 19% noted improvement in the relationships with the partner. Very few women (1%) considered that sterilization contributed to negative effects in the relationship with the partner, and only 5% expressed worsening of the sexual or family life. At the time of follow-up, women were requested to rate and separate into two scales their feelings about sterility from those about surgery. In addition, they were asked whether or not they would TABLE 5. Change in Intermenstrual Bleeding ([MB) after Sterilization a 1MB presterilization 1MB Poststerilization None Rare Occasional Heavy None 116 6 6 1 Rare 2 3 0 1 Occasional 1 1 3 0 Heavy 1 0 0 1 adata for the total group (IV = 142). There were no significant differences according to McNemar's test for symmetry.

644 RUBINSTEIN ET AL. June 1979 TABLE 6. Changes in Relationships following Sterilization Type of change Sex life Relationship Family (%) with partner (%) (%) None 60 63 72 Better 35 19 9 Worse 5 1 5 Not applicable 17 14 repeat the operation (Table 7). The majority of women (90%) were pleased with the outcome and willing to repeat the operation. Although 4.8% would not repeat and 5.4% were unsure, none of the women was extremely unhappy with the outcome and only 2.9% expressed dissatisfaction. There were 6.8% of women who indicated ambivalence about their sterility; this percentage correlated well with 5.4% who were unsure about repeating the operation. The few patients unhappy with their decisions had chosen sterilization for financial reasons or because of the desire to discontinue the present method of contraception (Table 8). None of the patients sterilized for medical reasons regretted their decisions, but this was the group which showed the highest proportion of ambivalent individuals (33.3%). On the other hand, of those women who elected sterilization after having reached their ideal family size, less than 3% were ambivalent. With regard to feelings about surgery, the responses were similar to those about sterility except for a higher number of women (5.5%) who expressed dissatisfaction with the procedure. The regret or ambivalence about sterility was not correlated with postoperative complications. However, there was an over-all statistically significant correlation (P < 0.05) between negative feelings about surgery and the presence of postoperative complications (Table 9). DISCUSSION The incidence of subsequent menstrual disor- TABLE 7. Feelings at Time of Follow-up Feelings Sterilization Surgery No. % No. % Very unhappy 0 0 5 3.4 Unhappy 4 2.7 3 2.1 Ambivalent 10 6.8 8 5.5 Happy 13 8.9 14 9.6 Very happy 120 81.6 115 79.4 Repeat operation Yes 132 89.8 No 7 4.8 Unsure 8 5.4 ders and gynecologic disease in women sterilized by traditional tubal ligation has been extensively reviewed. 6 The most common complaint has been a high incidence of menometrorrhagia, ranging from 25% to 51%.7,8 In recent years, several studies have evaluated the possibility of similar problems after laparoscopic sterilization.2, 5, 9 Follow-up studies 10 to 36 months after laparoscopic electrocoagulation have reported 33% to 39% incidences of menorrhagia.!. 4 However, these high incidences have not been confirmed by other studies with similar intervals of follow-up.2, 5 When follow-up studies have used careful presterilization menstrual histories rather than matched women as controls, the reported incidence of subsequent menstrual disorders has been very low. Using each patient as her own control, we reported2 a 5.4% incidence of menorrhagia, which was corrected for prior histories of dysfunctional uterine bleeding and the use of oral contraceptives. These results were recently confirmed by Stock, 5 who found approximately 6% of women with menorrhagia following sterilization by three laparoscopic methods, including the use of Falope Rings. The results of the present study indicate that there are no significant changes in interval, duration, or menstrual flow 12 to 28 months following sterilization with Falope Rings. Furthermore, none of the hysterectomies carried out during the TABLE 8. Feelings about Sterilization: Comparison of Reasons for Operation Reason for operation Feelings medical (%) Multiparity (%) Family size (%) Financial (%) Discontinue contraceptive method (%) Very unhappy 0 0 0 0 0 Unhappy 0 0 0 14.3 6.0 Ambivalent 33.3 16.7 2.8 14.3 8.0 Happy 33.3 16.7 8.5 0 4.0 Very happy 33.3 66.6 88.7 71.4 82.0 Total N = 12 N = 6 N=71 N = 7 N = 50

Vol. 31, No.6 STERILIZATION BY FALOPE RINGS 645 TABLE 9. Feelings about Surgery and Sterility Related to Postoperative Complications in 147 Women a Feelings Surgery" Sterility No(%) Yes(%) No(%) Yes(%) Very unhappy 1.6 12.5 0 0 Unhappy 1.6 4.2 2.5 4.2 Ambivalent 4.9 8.3 7.4 4.2 Happy 7.4 20.8 9.0 8.3 Very happy 84.5 54.2 81.1 83.3 apostoperative complications occurred in 25 women, including three who required laparotomies. bp < 0.05. follow-up period were performed as a result of gynecologic problems resulting from the previous sterilization. The lack of consistent changes in menstrual patterns agrees with the data reported in a collaborative study of 8500 sterilized women. 9 In our follow-up, the occurrence of transient episodes of dysfunctional uterine bleeding was reported by only 4% of women, a figure similar to that found after sterilization by electrocoagulation.2, 5 The present study does not confirm the hypothesis that sterilization by mechanical means may result in fewer disturbances of the menstrual pattern than does use of electrocoagulation techniques.1,4 The rate of failure found in this study is higher than that which has been reported in the literature. 9, 10 This difference may be attributable to the number of physicians in training involved in performing the procedures rather than a reflection of true failure of the method. At least one failure was due to misplacement of the ring in the round ligament, whereas in another the ring may not have been slipped deeply enough around a complete knuckle of fallopian tube. Few studies have addressed the question of women's personal feelings following sterilization. Furthermore, little is known about the elements in the patient profile, indications for surgery, or subsequent complications that may help to identify the woman at risk for regret. In our follow-up survey, the majority of women indicated that sterilization had vey little influence in their sex life and relationship with partner or family. However, when changes were reported, comments on improvement of sex life and relations far outnumbered the negative comments about sterilization. A similarly low incidence of dissatisfaction was elicited by the questions regarding sterility. Ninety per cent of women would have made the same decision again, which confirms the results of other surveys.!' 2, 5 Although 5% of women would not repeat the operation, this group included not only women regretting their inability to reproduce, but also those unhappy with the surgery. The association between feelings of regret and subsequent gynecologic complaints reported elsewhere10 was not found in the present study. Recent reports on women requesting reversal of sterilization have suggested a correlation between the incidence of regret and the reasons for sterilization. 12, 13 In the series of Winston, 12 75% of women asking for reversal chose sterilization because of bad marital relations. This association was not found in the present study, perhaps because very few changes occurred in marital status within 2 years following surgery. However, of the 2.7% of women unhappy with sterilization, none indicated a worsening of relations with her partner. This group of cases was composed equally of parous and nulliparous women who chose sterilization either for financial reasons or the desire or need to discontinue their present methods of contraception. The survey indicates that reaching an ideal family size was the motivation for sterilization associated with the highest incidence of satisfaction and lowest incidence of regret or ambivalent feelings. Less than 7% of women expressed ambivalence after the procedure. This is much lower than the incidence we found in a previous study,2 reflecting perhaps the benefits of individual counseling. Although adequate counseling had provided women with information regarding risks, advantages, complications, and alternatives to permanent contraception, the emphasis has been to stress the permanent results of the procedure. Of equal importance, however, should be the identification during counseling of women most likely to be ambivalent about or to regret sterilization. In the future this information may influence the choice of technique for sterilization. REFERENCES 1. Neil JR, Noble AD, Hammond GT, Rushton L: Late complications of sterilization by laparoscopy and tubal ligation. Lancet 2:699, 1975 2. Rubinstein L, Lebherz TB, KleinkopfV: Laparoscopic tubal sterilization: long-term post-operative follow-up. Contraception 13:631, 1976 3. Noble AD: Sterilisation: laparoscopy or laparotomy? Br Med J 4:227, 1975 4. Chamberlain G, Foulkes J: Late complication of sterilisation by laparoscopy. Lancet 2:878, 1975 5. Stock RJ: Evaluation of sequelae of tubal ligation. Ferlil Steril 29:169, 1978 6. Shepard MK: Female contraceptive sterilization. Obstet Gynecol Survey 29:739,1974 7. Lu T, Chun D: A long-term follow-up study ofl,055 cases of post-partum tubal ligation. J Obstet Gynaecol Br Commonw 74:874, 1967

646 RUBINSTEIN ET AL. June 1979 8. Muldoon MJ: Gynecologic illness after sterilization. Br Med J 1:84, 1972 9. McCann MF, Kessel E: International experience with laparoscopic sterilization: follow-up of 8500 women. Adv Planned Parent 12:199, 1978 10. Yoon IB, King TM: A preliminary and intermediate report on a new laparoscopic tubal ring procedure. J Reprod Med 15:54,1976 11. Cox MD, Crozier JM: Female sterilization: long-term follow-up with particular reference to regret (abstr). J Reprod Fertil 35:624, 1973 12. Winston RML: Why 103 women asked for reversal ofsterilisation. Br Med J 2:305, 1977 13. Thompson P, Templeton A: Characteristics of patients requesting reversal of sterilization. Br J Obstet Gynaecol 85:161, 1978