It should be noted that the risk of complications has been reported to be significantly higher among women who have diabetes, are obese, have had prior abdominal or pelvic surgery, or receive general anesthesia. Further, data suggest that sterilization has a negligible impact on changes in menstrual patterns. Studies have shown that women who have tubal sterilizations are 4 to 5 times more likely to have subsequent hysterectomies than are women whose partners have had vasectomies. The risk is most significant among women who have gynecologic disorders (menstrual abnormalities, endometriosis, uterine leiomyomata, pelvic inflammatory disease, and ovarian cysts) at the time of sterilization. However, most women with gynecologic disorders at sterilization did not undergo hysterectomy during follow-up. No biological explanation for this increased risk has been identified, and it is unlikely to reflect a biological impact of sterilization. A possible explanation for this association is in the setting of abnormal bleeding, regardless of cause. Women who have been sterilized may be more likely to consider themselves appropriate candidates for hysterectomy than do other women.
Compared with sexually active women using no contraception, women who have been sterilized have a lower overall risk of ectopic pregnancy. However, when pregnancy occurs in a sterilized woman, the risk that the pregnancy is ectopic is high. Following bipolar coagulation, for example, 65% of pregnancies are ectopic. Following use of the Pomeroy or Parkland sterilization methods postpartum, 20% of pregnancies are ectopic, whereas 15% of pregnancies after clip sterilization are ectopic.10 These observations underscore the importance of ruling out ectopic pregnancy when a woman who has been sterilized is found to be pregnant.
These practice guidelines note that tubal sterilization may be recommended as a safe and effective method for women who want permanent contraception.1 The procedure is not intended to be reversible and does not protect against sexually transmitted diseases.
Morbidity and mortality rates with tubal ligation are low, although they are higher than those of vasectomy. Efficacy rates are similar. Tubal sterilization is more effective than short-term, user-dependent contraception methods.1 Failure rates of tubal sterilization are comparable to those of intrauterine contraceptive devices.10,12
Kovacs (2002). In this retrospective Australian trial, questionnaires assessed the failure rate of the Filshie clip. Of the 30,000 laparoscopic Filshie clip procedures performed, 276 of 277 gynecologists responded (99.6%). A total of 73 failures were reported, providing an estimated failure rate of 2 to 3 per 1000.11 It is worth noting that Kovacs reported no ectopic sterilizations in a review of 30,000 procedures performed with the Filshie clip.11
Penfield (2001). This overview evaluates the literature on the Filshie clip since its initial use in 1981 and reveals a high level of acceptance worldwide because of its effective design and ease of application. It also notes the usefulness of mechanical devices that avoid the risk of accidental electrical burns and reduce the risk of ectopic pregnancy. This review notes that the Filshie clip also features minimal tubal destruction, thereby allowing maximum potential for reversibility. It includes these practical tips for clinicians:
- To prevent dropping the open clip into the abdomen, open the end of the applicator slowly, because the jaw of the applicator opens quicker than the clip can open spontaneously.
- Tubal transection is a rare event that is usually associated with a large fallopian tube that has been clipped too quickly. Close the clip slowly to “milk away” edema. If transection occurs, place a clip on both ends of the transected tube.
- Use of the double-puncture technique for all laparoscopic sterilization procedures is strongly recommended.13
The Filshie clip provides an important option for clinicians who perform postpartum sterilization. The medical literature highlights both the safety and efficacy of the device, and also demonstrates that it is easy to use and that procedures performed with this device can be done quickly.
- Dr Harkins is a consultant and surgical instructor for Ethicon Endo-Surgery, Inc.
- Dr Kaunitz is a consultant to Barr Pharmaceuticals, Inc, Bayer HealthCare Pharmaceuticals Inc, Johnson & Johnson, Organon USA Inc, and Warner Chilcott, and has participated in clinical trials supported by Barr Pharmaceuticals, Inc, Bayer HealthCare Pharmaceuticals Inc, Organon USA Inc, and Warner Chilcott.
- Dr Sanfilippo receives grant/research support from Barr Pharmaceuticals, Inc, and is on the speaker’s bureau for Merck & Co., Inc., and Bayer HealthCare Pharmaceuticals Inc.