DR SANFILIPPO: At laparoscopy, many physicians will document bipolar cautery with a photograph. This may also be applicable for Filshie clip sterilization procedures. I believe that a well-documented operative report is ample protection for postpartum placement.
Other techniques and devices
DR KAUNITZ: Let’s look at the medical literature. Certainly, the pivotal findings on sterilization techniques were reported in the Collaborative Review of Sterilization (CREST) study; however, the Filshie clip was not yet available. The Hulka was used in that trial. From a historical perspective, the Hulka clip was an important new technology, but in CREST, it had the highest 10-year failure rate. The data in TABLE 3 refer to interval procedures but also provide important information about failure rates.
Clearly, the data regarding the Filshie clip are much more favorable than those shown by Hulka in the CREST study.7 In addition to the findings from our study, we have good literature from other countries: Graf et al reported 209 obstetric procedures with the Filshie clip, with 0 failures at 24 months.8 Yan et al performed 100 Filshie clip procedures postpartum; at 24 months, there were 0 pregnancies.9
We should also note that much larger laparoscopic studies underscore the high long-term efficacy obtained with the Filshie clip. The efficacy is comparable to that of the Pomeroy method, as evidenced in the CREST study. Possibly, the long-term results shown with the Filshie clip even surpass those of the Pomeroy method (TABLE 4).
DR HARKINS: The ACOG practice bulletin on sterilization provides 5- and 10-year numbers from CREST and also places them within the context of long-term reversible contraceptive options:
- 5-year cumulative life-table probability of failure of aggregated sterilization was 13/1000 procedures. By comparison, 5-year failure rates for the Copper T 380-A IUD (Paragard) were 14/1000 procedures and 5 to 11/1000 for the levonorgestrel-releasing intrauterine system (Mirena).
- Postpartum partial salpingectomy (Pomeroy or Parkland methods) had the lowest 5- and 10-year cumulative pregnancy rates: 6.3 per 1000 and 7.5 per 1000, respectively.
- Bipolar coagulation 5- and 10-year failure rates were 16.5/1000 and 24.8/1000 procedures, respectively.
- Silicone band or Yoon band (Falope ring) method 5- and 10-year failure rates were 10/1000 and 17.7/1000 procedures, respectively.
- The spring clip (Hulka) 5- and 10-year failure rates were 31.7/1000 and 36.5/1000 procedures, respectively.1
DR SANFILIPPO: I wonder if we could compare these data to other procedures, such as the Irving technique?
DR KAUNITZ: I worry that older data may be suspect. Certainly, they were not created prospectively, as was the case with CREST, which was a large, prospective, multicenter observational study of 1685 women.
DR KAUNITZ: In terms of obstetric sterilization, are the other techniques, such as Uchida or Irving, relevant?
DR HARKINS: I don’t believe they’re performed on any regular basis.
DR SANFILIPPO: It is useful, from a historical perspective, to be familiar with these techniques. Whereas the Irving technique has a history of postpartum use, the Uchida technique has been more commonly performed as an interval method.
DR HARKINS: Both require more surgery of the fallopian tube than does the Filshie clip or the Pomeroy method. They require more time and involve a larger section of fallopian tube.
DR KAUNITZ: Yes, although they are effective, they may be more difficult to perform and are rarely used.
Overall 10-year failure rates for interval procedures
|Method||Patients (n)||Failure Rate (%)|
|Yoon band application||3329||1.77|
|Hulka clip application||1595||3.65|
|Interval partial salpingectomy||425||2.01|
|Adapted from Am J Obstet Gynecol, Vol. 174, Peterson HB, et al, The risk of pregnancy after tubal sterilization: Findings from the US Collaborative Review of Sterilization, pages 1161-1168. Copyright 1996, with permission from Elsevier.|
Long-term failure rates for Mark VI hinged Filshie Clip System sterilization (interval procedures)
|Investigator||Patients (n)||Follow-up (y)||Failures (n)||Failure Rate (%)|
|Reprinted from Am J Obstet Gynecol, Vol. 182, Penfield AJ, The Filshie clip for female sterilization: A review of world experience, pages 485-489. Copyright 2000, with permission from Elsevier.|
Summary of the medical literature
In addition to the trials previously discussed by the roundtable participants, various studies and literature searches have reviewed sterilization in general and provide specific additional documentation about the Filshie clip, as follows.
Peterson (2008). This recent overview summarized the literature on sterilization to date, noting that overall sterilization-attributed mortality rates are 1 to 2 procedures per 100,000 performed.10 For women who undergo a sterilization procedure at the time of C-section delivery, the risk of major morbidity is defined primarily by the risks associated with delivery. Likewise, after vaginal delivery, the risk of major morbidity from sterilization is potentially related to complications of pregnancy or delivery.