Female sterilization is one of the most common

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1 A Clinical and Medico-Legal Review of Tubal Ligation in Canada Paul Martyn, FRCSC, FRCOG, FRANZCOG, 1 Valerie Prather, LLB 2 1 University of Calgary, Foothills Medical Centre, Calgary AB 2 Bennett Jones LLP, Calgary AB INTRODUCTION Female sterilization is one of the most common gynaecological procedures performed in Canada. In a 12-month period in there were tubal ligations performed in Canada (Dr Doug Bell, CMPA, personal communication, May 2012). Tubal ligation was the third most common gynaecological procedure to provoke litigation, involving 15% of cases and 12% of costs associated with gynaecology cases. Litigation most commonly arises from the inherent failure rate associated with the procedure itself, poor surgical performance, or inadequate preoperative counselling or consent. In the 10-year period from 1999 to 2008, 54 civil actions for failed tubal ligation were initiated in Canada. The frequency of reported cases declined during this period, with 34 reports in the first five years and 20 in the second five years. During the same 10-year period there was a downward trend in cases of general medical negligence and gynaecological negligence (Dr Doug Bell, CMPA, personal communication, May 2009). CLINICAL ISSUES Specific Risks of Laparoscopy Complications of laparoscopic surgery include injury to adjacent structures, hematomas, port site infections, C0 2 retention pain, and anaesthetic risks. Overall complication rates are from 0.4% to 1.0 % 1,2 For elective procedures, the list of all potential complications should be discussed with the patient. Key Words: Tubal ligation, laparoscopy, complications Competing Interests: None declared. Received on December 18, 2011 Accepted on March 14, 2012 Over 50% of laparoscopic complications occur during abdominal entry, and 25% are not recognized until the postoperative period. 3 Delayed diagnosis of intraoperative complications, especially bowel injuries, can have serious consequences for the patient and is a frequent cause of litigation. 3 Serious complications involving visceral or major vascular injury occur at a frequency of one in 1000 cases. 3 In Canada between 1990 and 1998, 15 of 40 bowel injuries and one of 13 major vessel injuries alleged by plaintiffs in laparoscopic cases occurred in association with tubal ligation (Dr Doug Bell, CMPA, personal communication, May 2009). Vascular injuries are reported at a frequency of 0.1 to 6.4 per 1000 laparoscopic procedures. Bleeding is often retroperitoneal and may go unnoticed intraoperatively. 3 According to the United States Collaborative Review of Sterilization, the odds ratio of complications from general or regional anaesthesia is approximately three times that from local anaesthesia. 4 The risk of having to perform laparotomy after a severe complication of laparoscopic sterilization was reported as 1.9 per 1000 cases in a large prospective study. 3 Laparoscopic tubal ligation should be performed only in a centre where immediate laparotomy is available. Overall complication rates for laparoscopic sterilization, excluding failure, are approximately 1%. 3 In the United States, mortality is quoted at one to four deaths per procedures, most of these resulting from complications of general anaesthesia. 3 The laparoscopic approach is generally considered contraindicated in patients with severe cardiopulmonary disease, in patients with morbid obesity, and in patients J Obstet Gynaecol Can 2012;34(7): JULY JOGC JUILLET

2 with a history of multiple abdominal procedures with potential for significant adhesion formation. The hysteroscopic insertion of micro inserts for tubal occlusion may be safely performed in a physician s office under local anaesthesia. As of December 2011, one case of litigation related to hysteroscopic sterilization had been reported in Canada (Dr Doug Bell, CMPA, personal communication, May 2012). Regret After Sterilization Patient ambivalence towards sterilization is an absolute contraindication to the procedure. Sterilization should be considered permanent and irreversible, and it should be clear that patients understand this before they make the decision to proceed. Regret has been reported by 2% to 26% of women who have undergone sterilization procedures. 5 In the CREST study the regret rate was 7%. 4 A further study of 1101 women undergoing Filshie clip sterilization reported regret in 4% when women were followed for five to 15 years. 5 The CREST study also reported a sterilization reversal rate of 0.2%. 4 In a large Quebec trial the sterilization reversal rate was 1.8%. Regret was three times more common in women under 30 years of age. Young women in this series who had been sterilized between 15 and 29 years of age had a sterilization reversal rate of 4.2%. 6 This emphasizes the need for discussion of reversible methods of contraception in younger women. Discussion of Tubal Ligation Failure The CREST study, the first study addressing longterm follow-up of women after sterilization, reported a 10-year cumulative probability of pregnancy of 18.5/1000 in a longitudinal trial involving patients who had surgery between 1978 and Failure rates varied by technique and were greatest for Hulka clip procedures (36.5/1000) and lowest after unipolar coagulation and postpartum partial salpingectomy, each having a failure rate of 7.5/1000 procedures. Women who had undergone application of Filshie clips were not included in this study. Women sterilized at a young age by bipolar coagulation or Hulka clip application had a cumulative risk of pregnancy of 54.3/1000 and 52.1/1000 respectively. These rates are higher than pregnancy rates associated with reversible methods of contraception. Counselling regarding rates of tubal ligation failure has been influenced by the results of ABBREVIATIONS CMPA Canadian Medical Protective Association CREST Collaborative Review of Sterilization the CREST study. A study of bipolar coagulation for tubal sterilization by Peterson et al. showed a reduced failure rate when three or more sites per fallopian tube were coagulated. 7 This study reported only five years of followup, whereas the CREST study showed high failure rates five to 10 years after bipolar tubal coagulation. 4 Coagulation of three or more sites would effectively destroy most of the tube and make tubal reanastomosis very difficult. In a retrospective study involving patients in Quebec, Trussel et al. reported failure rates after tubal sterilization of 8/1000. Although the sterilization methods were not specifically reported, most procedures were performed using Filshie clips. 6 In a retrospective multicentre trial Kovacs and Krins reported the largest series of Filshie clip sterilizations, involving approximately cases between 1994 and They reported 73 documented failures, giving a failure rate of 2.4/ Failure rates are increased from 2.7/1000 for interval procedures to 9/1000 for postpartum procedures when Filshie clips are used. 9,10 Factors Affecting Tubal Ligation Failure In all studies, age less than 30 years is a risk factor for failure because of greater fecundability and subsequent years of exposure to pregnancy. Distorted anatomy affecting access to tubes has been a factor in many cases resulting in litigation, especially when the patient was not informed of the situation. Postoperative hysterosalpingography should be performed if is not certain that both tubes are occluded. Neither occlusion of the wrong structure nor incomplete occlusion of the tube is defensible, as these surgical errors fall below the standard of care. Incompletely closed Filshie clips were a factor in a large number of litigation cases brought in Australia in These cases arose because of failure of the applicator to close down the clips properly. 11,12 In one geographic area, 10% of women who had Filshie clip sterilization subsequently became pregnant (40 times the reported failure rate). It was not known prior to these cases that the clip applicator required calibration, and this has since led the manufacturer to produce disposable applicators. In a study of 131 sterilization failures, Varma and Gupta analyzed whether time to failure was predictive of negligence. 13 The cause of failure was established by direct pelvic visualization or histology of the fallopian tubes or a combination of both. Filshie clips were used in 47% of the cases analyzed. Most failures (72.5%) occurred in the first 12 months after application. 684 JULY JOGC JUILLET 2012

3 A Clinical and Medico-Legal Review of Tubal Ligation in Canada Negligent failures occurred at a median interval of seven months after application, and non-negligent failures at a median interval of 12 months. Tubal non-occlusion and occlusion of the wrong structure were considered negligent actions, whereas spontaneous tubal recanalization or fistula formation was considered non-negligent. It is possible that many of the cases established by direct visualization were incorrectly diagnosed. 13 Tubal recanalization, transection, and reanastamosis (or fistula formation) have been reported in various studies depending on the tubal ligation technique employed LEGAL CONSIDERATIONS IN CASES LEADING TO JUDGEMENT In the five years from January 2004 to December 2008, the CMPA closed 27 legal actions involving failed tubal ligation. The results of these 27 cases are shown in Table 1. In the only case that was successful for the plaintiff over this period, the Court concluded that the gynaecologist breached the standard of care by failing to close the Filshie clip properly and by not inspecting the clip site after application. The CMPA also reported on the central issue in tubal ligation cases closed between 1990 and 1997 (Table 2). In an analysis of 500 medico-legal claims in the United Kingdom, 19% were related to failed sterilization. 17 The most common complaint in these claims was inadequate communication and charting, resulting in findings that informed consent was not obtained. This was closely followed by incompetent surgery with occlusion of the wrong structure or incomplete occlusion of the tube. 17 Ward reported on 500 obstetric or gynaecological malpractice claims in the United States. 18 Twenty-two percent of gynaecological claims were indefensible. Of these, 62% breached the standard of care, 24% involved inadequate documentation with respect to informed consent, and 13% involved both performance and consent. Sterilization failure accounted for the largest number of gynaecological claims, but only four of 30 cases were not defensible. Of these four cases, three were not defensible because of poor documentation of the consent discussion, and the fourth was not defensible because of a combination of substandard surgical technique and poor documentation. 18 These outcomes again demonstrate the critical importance of documenting preoperative counselling and consent and intraoperative details. A review of Canadian legal cases of tubal ligation failure identifies the need for: Table 1. Summary of 27 failed tubal ligations in Canada between 2004 and 2008 Legal outcome Dismissed pre-trial 14 Won at trial 01 Lost at trial 01 Settlement 11 Reason for settlement No documentation of discussion of the risk of 02 failure Failure to inform that only one tube was found 02 and ligated Various application issues that fell below the 07 standard of care Table 2. Litigation arising from tubal ligations in Canada 1990 to 1997 Failure of procedure 43% Intraoperative injury 23% Deficient consent 14% Retained foreign body (sponge in vagina) 10% Undiagnosed pregnancy 06% IUD not removed 05% 1. Adequate discussion and documentation of the informed consent process. Best practice involves discussion of the risks, benefits, and alternatives, and provision of a handout outlining these. In addition, the patient should sign a document confirming that a discussion has occurred and that she has received the handout. The discussion regarding tubal ligation should include the following: description of the procedure and the rationale for the planned procedure (prevention of pregnancy); review of the risks and complications of laparoscopy (or other method), the permanence of the procedure, and the failure rate of the technique; review of the risk of injury to adjacent structures, including the possible need for laparotomy; review of alternative methods of contraception, including reversible methods and vasectomy (patients should be informed that vasectomy is associated with a lower failure rate [1:2000] and carries less surgical risk than tubal ligation); and JULY JOGC JUILLET

4 review of the sequelae of surgery, including the risk of subsequent pregnancy, the possibility of ectopic pregnancy, and the need for urgent management should symptoms of pregnancy occur. Over 30% of pregnancies arising from sterilization failure are ectopic. 19 A study in the United Kingdom suggested use of a standardized pro forma in order to improve documentation of preoperative counselling for female sterilization Detailed notes of the operative procedure performed. In particular, the operative note should make reference to the following: the identification of the fallopian tubes by tracing them laterally to the fimbriae prior to occlusion; the clip positions, which should be on the isthmic portion of the tube, 2 to 2.5 cm from the cornu; the fact that total occlusion of the lumen was confirmed by visualizing the locking tip of the clip through the transparent mesosalpinx; and a final check of the appropriate location and application of the clips prior to closing, as well as a check for any injury to adjacent structures. There is a need to standardize operative reports and chart documentation. The best possible medical care cannot be defended in a court action if it is not documented in the chart. The physician s recollection of events is usually unclear after several years, and reliance is often placed on the physician s standard practice. Standardized operative reports have been shown to provide more complete reproducible information than dictated reports in gynaecologic, general surgery, and oncology publications Patients should be informed postoperatively of the method of tubal ligation used if it differed from the preoperative plan, and they should also be informed of any surgical complications and any change in the anticipated failure rate. 3. Documentation of the cause of failure. In the event of failure of a tubal ligation, clinicians should be cautious in making comments to the patient about how the failure occurred in the absence of objective evidence. Litigation is often commenced because of the statements of the subsequent treating physician, who may provide inaccurate or incomplete information to the patient. When a subsequent surgical procedure is undertaken, an attempt should be made to determine the cause of tubal ligation failure. This entails careful inspection and documentation of the appearance of the tubes with images being taken where possible. Tubal insufflation should be performed to determine the site of failure. 24 Tubal segments encompassing the ligated area should be submitted for pathological examination, with specific instructions to the pathologist to check for fistula, scarring, or evidence of reanastomosis. 24 If bipolar coagulation was used for sterilization, pathological examination should document the extent of tubal coagulation. It is prudent not to criticize the performance of the primary surgery unless there is clear evidence of negligence such as ligation of the round ligament. Speculation about the cause of the failure, when this is not known, should be avoided. Migration of tubal clips is common. 24 Many legal actions have arisen from patients being told that the clips were not on the tubes and that therefore the initial procedure must have been negligently performed. SUMMARY 1. Tubal ligation is an effective form of permanent contraception, with failure rates averaging 2 to 3 per 1000 procedures with use of Filshie clips. 2. Older techniques such as use of bipolar coagulation or Hulka clips have higher than expected failure rates. 3. Laparoscopic surgery carries an overall complication rate of approximately 1%. 4. Vasectomy has a lower failure rate and a lower complication rate than tubal ligation. 5. Failure to document the consent process and poor recording of operative details are common reasons for litigation. 6. Use of templates is recommended for recording consent and for the operative report. 7. Image capture and recording is recommended to document proper surgical technique but is not a medico-legal requirement. 8. An attempt should be made to determine the cause of sterilization failure if further surgery is performed. 686 JULY JOGC JUILLET 2012

5 A Clinical and Medico-Legal Review of Tubal Ligation in Canada ACKNOWLEDGEMENTS The authors would like to thank Dr Doug Bell, Dr John Jarrell, and Laurel Lui for their assistance with the preparation of this review. REFERENCES 1. Jansen FW, Kapiteyn K, Trimbos-Kemper T, Hermans J, Trimbos JB. Complications of laparoscopy: a prospective multicentre observational study. Br J Obstet Gynaecol 1997;104: Pollack A; ACOG Committee on Practice Bulletins Gynecology. ACOG practice bulletin. Clinical management guidelines for obstetriciangynecologists. No 46, September (Replaces technical bulletin number 222, April 1996). Obstet Gynecol 2003;102: Magrina JF. Complications of laparoscopic surgery. Clin Obstet Gynecol 2002;45: Peterson HB, Xia Z, Hughes JM, Wilcox LS, Tylor LR, Trussell J. The risk of pregnancy after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization. Am J Obstet Gynecol 1996;174:1161 8; discussion MacKenzie IZ, Thompson W, Roseman F, Turner E, Guillebaud J. Failure and regret after laparoscopic Filshie clip sterilization under local anesthetic. Obstet Gynecol 2009;113: Trussell J, Guilbert E, Hedley A. Sterilization failure, sterilization reversal, and pregnancy after sterilization reversal in Quebec. Obstet Gynecol 2003;101: Peterson HB, Zhisen X, Wilcox LS, Ratliff Tylor L, Trussell J. Pregnancy after tubal sterilization with bipolar electrocoagulation. Obstet Gynecol 1999;94: Kovacs GT, Krins AJ. Female sterilisations with Filshie clips: what is the risk failure? A retrospective survey of 30,000 applications. J Fam Plann Reprod Health Care 2002;28: Rioux JE, Yuzpe AA. Modern approaches to female sterilization. Contemp Ob Gyn 1997;42: de Villiers VP. Postpartum sterilisation with the Filshie titanium siliconerubber clip and subsequent pregnancy. S Afr Med J 1987;71: Lyneham R. A review of the Filshie system in Australia and New Zealand. O & G 2003;5: Woodhouse D. Filshie clips safety alert update. O & G 1999;1: Varma R, Gupta JK. Predicting negligence in female sterilization failure using time interval to sterilization failure: analysis of 131 cases. Hum Reprod 2007;22: Soderstrom RM. Sterilization failures and their causes. Am J Obstet Gynecol 1985;152: Filshie GM, Robinson G. The consequences of surgical tubal occlusion. In: Grudzinskas JG, Chapman MG, Chard T, Djahahbakhch D, eds. The fallopian tube: clinical and surgical aspects. London: Springer-Verlag; 1994: Belot F, Louboutin A, Fauconnier A. Failure of sterilization after clip placement. Obstet Gynecol 2008;111(2 Pt 2): B-Lynch C, Coker A, Dua JA. A clinical analysis of 500 medico-legal claims evaluating the causes and assessing the potential benefit of alternative dispute resolution. Br J Obstet Gynaecol 1996;103: Ward CJ. Analysis of 500 obstetric and gynecologic malpractice claims: causes and prevention. Am J Obstet Gynecol 1991;165: ; discussion Jamieson DJ, Hillis SD, Duerr A, Marchbanks PA, Costello C, Peterson HB. Complications of interval laparoscopic tubal sterilization: findings from the United States Collaborative Review of Sterilization. Obstet Gynecol 2000;96: Yunus D, Sarkar PK. Compliance with the RCOG s guidelines on medical record keeping in female sterilisation: a complete audit cycle. J Obstet Gynaecol 2007;27: Harvey A, Zhang H, Nixon J, Brown CJ. Comparison of data extraction from standardized versus traditional narrative operative reports for database-related research and quality control. Surgery 2007;141: Laflamme MR, Dexter PR, Graham MF, Hui SL, McDonald CJ. Efficiency, comprehensiveness and cost-effectiveness when comparing dictation and electronic templates for operative reports. AMIA Annu Symp Proc 2005: Edhemovic I, Temple WJ, de Gara CJ, Stuart GC. The computer synoptic operative report a leap forward in the science of surgery. Ann Surg Oncol 2004;11: Thompson BH, Wheeless CR. Failures of laparoscopy sterilization. Obstet Gynecol 1975;45: JULY JOGC JUILLET