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After reading this publication, clinicians should be able to:
- Understand the options available for obstetric sterilization following vaginal or cesarean delivery
- Describe Filshie clip technology, its correct application, and proper procedure documentation
- Discuss failure rates for female sterilization
- Evaluate the findings of the Collaborative Review of Sterilization (CREST) study
Postpartum tubal sterilization is most often performed using the Pomeroy method, a technique that has remained unchanged since its introduction in 1930. Recently introduced clip technology provides an important alternative for clinicians. The Filshie clip—approved for both postpartum and interval use in 1996—offers efficacy rates similar to the Pomeroy method, with potential advantages for physicians and operating room (OR) personnel.
Tubal sterilization—the number one birth control method in the United States—is the choice of 11 million US women, approximately 28% of the women who use contraception1 (TABLE 1). Of this total, half of all tubal sterilization procedures are performed postpartum and are more likely to be performed among women aged 20 to 34 than are interval sterilization procedures.2
In this publication, 3 experts describe their clinical experiences with the Filshie clip and review the medical literature on its use in obstetric sterilization. They offer practical pearls for obstetricians who may want to consider using this technology in their practices. Additionally, they review the Filshie clip and other procedures and devices within the context of the evidence in the medical literature concerning efficacy, ease of use, surgeon time required, and the potential for complications.
TABLE 1
Tubal sterilization procedures in the United States, 1994-1996
| Timing/Setting | Mean Annual No. | Ratea | Standard Error | Distribution (%) | Standard Error |
|---|---|---|---|---|---|
| Total | 684,000 | 11.5 | 0.4 | 100 | na |
| Postpartum Inpatient (hospital) | 338,000 | 5.7 | 0.3 | 49.5 | 3.0 |
| Interval | 345,000 | 5.8 | 0.3 | 50.6 | na |
| Inpatient (hospital) | 15,000 | 0.2 | 0.03 | 2.1 | 0.3 |
| Outpatient Hospital ambulatory surgery centerb Freestanding outpatient surgery center | 331,000 288,000 43,000 | 5.6 4.9 0.7 | 0.3 0.3 0.1 | 48.5 42.2 6.3 | 3.2 0.9 |
| aTubal sterilizations per 1000 women of reproductive age (20-49 years) in the US civilian resident population. | |||||
| bIncludes procedures performed in hospitals as outpatient procedures. | |||||
| Reprinted with permission from MacKay AP, et al, Tubal sterilization in the United States, 1994-1996, Family Planning Perspectives, 2001;33(4):162. | |||||
Adding the Filshie clip to OR options
DR KAUNITZ: Most ob/gyns have been trained to perform obstetric postpartum sterilization using the Pomeroy method—perhaps that’s why it is often viewed as the only option in this setting. However, at my institution, Shands Jacksonville Medical Center, the Filshie clip is routinely used for postpartum tubal sterilization among the approximately 3000 teaching service deliveries we perform each year.
I became familiar with use of the Filshie clip for laparoscopic sterilization in the mid to late 1990s, following its approval for use in the United States. Once I learned that it was approved for use in C-sections and postpartum procedures and that a short applicator was available (FIGURE), I wanted to try it.
FIGURE The Filshie short applicator
Comparing the Filshie clip vs the Pomeroy method
DR KAUNITZ: As part of a resident research project, we performed a small randomized trial that compared perioperative outcomes with obstetric tubal sterilization using the Pomeroy method versus the Filshie clip.3 In this study, we were particularly interested in the procedure because it alleviates the need for the physician to perform incisions near the engorged broad ligament blood vessels present during pregnancy and delivery. The Filshie clip does not require tubal exteriorization, a potential advantage in obese patients and in those who have tubal adhesions.
Reducing operating time
DR KAUNITZ: Our findings revealed that the Filshie clip was faster and was preferred by the surgeons (TABLE 2). Since then, we’ve kept the short applicator in our labor and delivery OR. We use the Filshie clip not only as the dominant laparoscopic procedure but also increasingly for sterilization performed after childbirth (vaginal and cesarean). The Filshie clip is an appealing option that is becoming more important as the C-section rate continues to rise, and an increasing number of sterilizations may be done at the time of the C-section.
TABLE 2
Results of surgeon and operating room technician questionnaires
| Filshie Clip (n =14) | Pomeroy (n=15) | P Value | |
|---|---|---|---|
| Surgical technician questionnaire | |||
| Ease of applicator preparation (Filshie) vs ease of preparation for Pomeroy technique | 1.07±0.27 | 1.08±0.28 (n=12) | .98 |
| Ease of assisting in procedure | 1.29±0.61 | 1.85±1.46 (n=12) | .64 |
| Surgeon questionnaire | |||
| Ease of entry into peritoneal cavity | 1.71±0.83 | 2.5±1.97 | .51 |
| Ease of tubal identification | 1.57±0.85 | 2.19±2.19 | .63 |
| Ease of tubal exteriorization | 3.00±0.44 | 2.34±1.21 (n=10) | .97 |
| Ease of clip/suture application | 1.07±0.27 | 2.29±2.58 (n=14) | .08 |
| Ease of procedure, overall | 1.14±0.36 | 2.60±1.88 | .03 |
| Data are presented as mean±standard deviation. | |||
| Questionnaire scale from 1 to 5: 1=very easy, 5=very difficult. | |||
| Reprinted from Contraception, Vol. 69, Kohaut BA, Musselman BL, Sanchez-Ramos L, Kaunitz AM, Randomized trial to compare perioperative outcomes of Filshie clip vs Pomeroy technique for postpartum and intraoperative cesarean tubal sterilization: a pilot study, pages 267-270. Copyright 2004, with permission from Elsevier. | |||
Making the short applicator available
DR HARKINS: During my residency in 1996, the Filshie clip became popular as a laparoscopic technique. It was at the forefront of my training, although we did learn how to use the Falope ring, etc. I had seen the Filshie clip—with the short applicator—used in obstetric postpartum procedures. But we primarily used the Pomeroy method in that setting.
In 2000, when I was at Fort Hood, Texas, the Filshie clip, with its short applicator, was available in the labor and delivery OR. I believe that its availability in this setting is what encouraged me to use it. During their training, most ob/gyns see the Parkland or Pomeroy methods used for postpartum tubals. It doesn’t occur to them to use the Filshie clip in obstetric cases until they see the short-handle applicator, which is specifically made for obstetric use.
1880
First reported tubal sterilization at time of C-section performed by Samuel Smith Lungren of Toledo, Ohio
1896
Debate on whether a woman had the right to choose to undergo sterilization, held at the 21st annual meeting of the American Gynecological Society
1970
Number of tubal sterilizations performed in the United States: 201,000
1972
Federal courts strike down legal restrictions to tubal sterilization for nonmedical reasons
1977
Number of tubal sterilization procedures performed in the United States: 702,000
Reversing sterilization
DR SANFILIPPO: It’s important for the device to be readily accessible. For me, the question is “How do we get the short applicator into more surgeons’ hands and get them to think more about performing obstetric-related sterilization with this device?” I’ve always been a fan of the Filshie clip because it’s quick and effective.
As important, it’s a joy to reverse a sterilization that has been performed with this technique. We need to keep in mind that we can’t be certain that the patient—particularly a younger woman—will be happy in the long term with her decision to undergo sterilization. It’s comforting to know that with the Filshie clip, reversal of the sterilization procedure is generally easy to perform and carries a higher success rate compared with procedures that result in greater tubal destruction.
Choosing Filshie vs sutures
DR HARKINS: At our institution, the decision of which technique to use is based on the individual physician’s preference. I estimate that 1 in 4 sterilization procedures are done with the Filshie clip. Often, the staff base their decision on the tubal anatomy they find when performing a C-section.
DR KAUNITZ: Since both the Pomeroy method and the Filshie clip are used in your C-section rooms, what has been your experience with the speed or convenience of the Filshie clip compared with the Pomeroy method?
DR HARKINS: I find the outcomes identical to those that you reported in your article in Contraception (TABLE 2).3
The procedure is performed more quickly with the Filshie clip, and this device is easier to use. At our institution, the scrub technicians are the ones who often ask us to use the Filshie clip because they see that it’s fast and efficient.
DR SANFILIPPO: I’ve had the same experience, but I want to add that the Filshie clip features the least tubal damage—an important point in performing reconstructive surgery. Only 4 mm of tube is affected by clip application.4
Reducing risk of bleeding
DR KAUNITZ: We are all familiar with the risk of mesosalpingeal bleeding associated with the Pomeroy method, whether used postpartum via minilaparotomy or at the time of cesarean delivery. The knots or sutures may slip off the cut ends of the tube; this results in persistent postoperative bleeding, perhaps with hemoperitoneum, low hemoglobin, or hypovolemia, which requires relaparotomy.
DR HARKINS: That’s very important—we’ve all had a patient or know a colleague whose patient had to return to the OR because of a hemorrhage in the broad ligament vessel. Obviously, you remember those cases and want to avoid such occurrences. Certainly, using the Filshie clip is a way of eliminating the worry about this complication.
DR KAUNITZ: Although we have no clinical trial data to prove that the Filshie clip results in fewer complications, I feel it is prudent to use a method, such as the Filshie clip, in that it is as effective as others that are available but that it also enables us to minimize unusual negative occurrences.
Pomeroy method
Developed in 1930, the Pomeroy method is highly effective and relatively inexpensive, although additional costs are incurred for pathology. This technique is associated with a small risk of postoperative mesosalpingeal bleeding, which often requires reoperation.
In this procedure, the tubes are grasped with a clamp and formed into a loop. A suture is tied around the loop, and the portion of the tube within the loop is cut.1
Filshie clip
The Filshie clip consists of a titanium (nonferrous) clip, 14 mm long, 4 mm wide, and 0.36 g in weight. It is lined with a silicone cushion, which facilitates occlusion of swollen and fragile fallopian tubes characteristic of the immediate postpartum period. The clip construction creates minimal damage to the surrounding structures.2,3 Only 4 mm of tube is destroyed, thus facilitating reanastomosis.4,5 There is no risk from the magnetic effects of future MRI investigations.
The soft silicone lining is associated with substantial clip capacity and may reduce transection and fistula formation in the tubal stump. When applied over the tube, the clip immediately compresses and occludes the tube. As necrosis occurs, the lining expands and maintains blockage. Eventually, the tube divides and the closed stump heals.3 The large tubal capacity allows the procedure to be performed in women with thick fallopian tubes or whose tubes may be edematous, as may occur postpartum.
The procedure is associated with a low failure rate of approximately 2.7 per 1000 patients. It obviates the potential risk of bowel burn and does not require the use of instrumentation that may lacerate blood vessels.
Filshie clip application steps
The Filshie clip is applied across the entire diameter of the isthmic portion of the fallopian tube with the hooked end of the lower jaw visible through the mesosalpinx. Before closure, the applicator manipulates the structures to properly identify the tube(s) and confirm correct clip placement. The applicator is squeezed to compress and flatten the upper jaw, locking it under the hooked end of the lower jaw. The applicator is removed, leaving the locked Filshie clip compressing the entire diameter of the tube within its jaw. One Filshie clip per fallopian tube is required; clips are permanently implanted.
Hulka clip system
This device features a Lexan plastic jaw, attached with goldplated stainless steel spring “teeth” and a plastic tip. The length of the clip makes complete occlusion of some tubes challenging.
Hulka clip system steps
The clip is attached to the fallopian tube at the isthmus, with the tube placed on stretch. The clip must be applied exactly perpendicular to the long axis of the tube to fully enclose the tube, with the hinge jaw of the open clip adjacent to the tube and the clip jaws extending onto the mesosalpinx. After correct placement, the jaws of the clip are closed.6
As part of the procedure, 1 cm of tissue is destroyed. Sterilization can be reversed. The failure rate is substantially higher than other laparoscopic techniques.
Parkland method
In this procedure, the tube is identified and elevated. The proximal and distal portions of the tube (2 cm) are ligated and the remaining tube is excised to reduce the risk of natural reattachment.
The procedure is associated with low failure rates (7.5/1000). It is inexpensive (if no pathology is required). Although rare, complications include the risk of ectopic pregnancy, infection, and bleeding. The procedure requires more time to perform than do currently used methods.1
Irving technique
The results of sterilization with this method were published in 1924. It has been used with cesarean delivery. The procedure is moderately difficult to perform. Both the Pomeroy and Parkland methods are quicker and easier to perform. The reported failure rate of the Irving technique is 2.3 per 1000 patients.7
Uchida procedure
Introduced by Hajime Uchida in the 1940s, this procedure can be performed immediately postpartum. The procedure is moderately difficult to perform. The Pomeroy and Parkland methods are quicker to perform. Uchida personally performed more than 20,000 cases without a failure.8
References
1. Peterson HB. Sterilization. Obstet Gynecol. 2008;111:189-203.
2. Kohaut BA, Musselman BL, Sanchez-Ramos L, et al. Randomized trial to compare perioperative outcomes of Filshie clip vs Pomeroy technique for postpartum and intraoperative cesarean tubal sterilization: a pilot study. Contraception. 2004;69:267-270.
3. Yan J-S, Hsu J, Yin CS. Comparative study of Filshie clip and Pomeroy method for postpartum sterilization. Int J Gynecol Obstet. 1990;33:263-267.
4. Filshie clip [package insert]. Trumbull, CT: Cooper Surgical, Inc. 2005.
5. Penfield AJ. The Filshie clip for female sterilization: A review of world experience. Am J Obstet Gynecol. 2000;182:485-489.
6. Peterson HB, Xia Z, Hughes JM, et al. The risk of pregnancy after tubal sterilization: findings from one US Collaborative Review of Sterilization. Am J Obstet Gynecol. 1996;174:1161-1168.
7. Lopez-Zeno JA, Muallem NS, Anderson JB. The Irving sterilization technique: a report of a failure. Int J Fertil. 1990;35:23-25.
8. Sklar AJ. Tubal Sterilization. eMedicine. Nov 15, 2002. http://www.emedicine.com/med/topic3313.htm. Accessed Feb 7, 2008.
Training physicians and residents
DR KAUNITZ: In general, gynecologic surgery is moving away from the premise of “see one and then perform one,” but the short learning curve required with the Filshie clip is one of its appeals—it is quite easy to use. If you follow the rules and pay attention to technique, you can become adept at it very quickly.
DR HARKINS: I agree. The Filshie clip translates from the laparoscopic application to the open application very quickly.
DR SANFILIPPO: I would like to advocate for the use of the Filshie clip as part of resident training. Most centers now have a lab for teaching minimally invasive procedures. I’d like to see the Filshie clip incorporated into such training. Teaching this procedure to residents is a good investment for the future.
DR KAUNITZ: I agree—simulation training should feature the short applicator and obstetric-type simulation applications of Filshie clips in the obstetric setting.
DR HARKINS: Unfortunately, teaching the postpartum procedure has never been a priority of training. In thinking about different techniques, I don’t believe we give residents sufficient information about the issues and available techniques of postpartum tubal sterilization. Certainly, translating techniques from laparoscopic to open and having residents learn to use the short applicator is very useful. We should emphasize the obstetric use of the Filshie clip in training so that it becomes second nature for these physicians to consider it among their treatment options.
DR KAUNITZ: I think younger clinicians may not be aware that the Pomeroy method has not changed since the 1930s.
Assessing potential for complications
DR KAUNITZ: What about the possibility of clip migration or extrusion? I’m not aware of any such occurrences, despite our institution’s longstanding experience with Filshie clips; however, the medical literature contains a number of case reports on migration of Filshie clips into or around various visceral structures.5 Interestingly, these reports rarely show major morbidity.
In the original data submitted to the Food and Drug Administration (FDA) for premarket approval of the Filshie clip, 5454 cases were reviewed. Of these cases, 8 (0.1%) women reported clip migration, clip expulsion, or foreign body reaction.5
DR SANFILIPPO: I have not seen any migrations or complications.
DR HARKINS: I have had situations where a patient has had a prior tubal ligation with Filshie clips, and when she is seen at laparoscopy for an unrelated procedure, I have found Filshie clips free floating or in the lower pelvis. The tubal occlusion was still effective, but the clip was free floating because of necrosis and resorption of a small portion of the fallopian tube.
DR KAUNITZ: You have not run into situations involving migration of Filshie clips into the bladder or bowel, as has been described in rare case reports?
DR HARKINS: No.
Reimbursement issues
DR HARKINS: When I came to Hershey 4 years ago, I wanted to use the Filshie clip. We looked carefully at cost issues. If you compare the costs for the Filshie clip with the costs for the Pomeroy method—and include the pathology charges for handling and reading the tubal specimens—the Filshie clip has advantages: its use does not require pathology costs.
With the Filshie clip, there is the initial purchase of the applicator. The set of clips costs between $70 and $80.6 We found that the total pathology costs associated with the Pomeroy method were $185. This included the processing fee for both fallopian tubes and the professional interpretation fees. These costs made the Filshie clip appealing from a financial standpoint and countered the argument that the Pomeroy method is less expensive because it relies on “just cheap sutures.” In actuality, performing a procedure using Filshie clips may be the equivalent or significantly less than the cost of using the Pomeroy method.6
People don’t think about the other potential costs as well: if one additional laparotomy a year is required as a result of bleeding from a Pomeroy procedure, that cost also needs to be factored in.
DR KAUNITZ: Are pathology reports important in cases of failure? Is pathology needed even when performing a procedure with a Filshie clip? Or is it sufficient to do the Filshie clip procedure correctly and then document in your operative report that the appropriate anatomy was identified and the appropriate clip application technique was used?
DR HARKINS: Every patient signs a consent form, which contains information about risk of failure. We say that the failure rate is 1 in 300 to 1 in 500, and we emphasize that the procedure is always accompanied by a risk of failure.
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.
TABLE 3
Overall 10-year failure rates for interval procedures
| Method | Patients (n) | Failure Rate (%) |
|---|---|---|
| Bipolar coagulation | 2267 | 2.48 |
| Unipolar coagulation | 1432 | 0.75 |
| 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. | ||
TABLE 4
Long-term failure rates for Mark VI hinged Filshie Clip System sterilization (interval procedures)
| Investigator | Patients (n) | Follow-up (y) | Failures (n) | Failure Rate (%) |
|---|---|---|---|---|
| Filshie | 434 | 6-15 | 1 | .023 |
| Heslip | 467 | 10 | 1 | .21 |
| Yuzpe | 497 | 10 | 0 | 0 |
| Puraviappan | 796 | 7 | 3 | 0.4 |
| 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.
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
Conclusion
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.
Disclosures
- 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.
1. ACOG Committee on Practice Bulletins—Gynecology. ACOG Practice Bulletin No. 46. Benefits and risks of sterilization. Obstet Gynecol. 2003;102:647-658.
2. MacKay AP, Kieke BA, Jr, Koonin LM, et al. Tubal sterilization in the United States, 1994-1996. Fam Plann Perspect. 2001;33:161-165.
3. Kohaut BA, Musselman BL, Sanchez-Ramos L, et al. Randomized trial to compare perioperative outcomes of Filshie clip vs Pomeroy technique for postpartum and intraoperative cesarean tubal sterilization: a pilot study. Contraception. 2004;69:267-270.
4. Filshie clip [package insert]. Trumbull, CT: CooperSurgical, Inc. 2005.
5. US Department of Health and Human Services. Premarket Approval of Femcare Ltd. Filshie Clip System™. http://www.fda.gov/cdrh/pdf/p920046.pdf. Accessed Feb 7, 2008.
6. Data on file. CooperSurgical, Inc. Trumball, CT.
7. Hulka JF, Fishburne JI, Mercer JP, et al. Laparoscopic sterilization with a spring-clip: A report of the first fifty cases. Am J Obstet Gynecol. 1973;116:715-720.
8. Graf A-H, Staudach A, Steiner H, et al. An evaluation of the Filshie Clip for postpartum sterilization in Austria. Contraception. 1996;54:309-311.
9. Yan J-S, Hsu J, Yin CS. Comparative study of Filshie clip and Pomeroy method for postpartum sterilization. Int J Gynecol Obstet. 1990;33:263-267.
10. Peterson HB. Sterilization. Obstet Gynecol. 2008;111:189-203.
11. 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;28:34-35.
12. Grimes DA, Mishell DR, Jr. Intrauterine contraception as an alternative to interval tubal sterilization. Contraception. 2008;77:6-9.
13. Penfield AJ. The Filshie clip for female sterilization: A review of world experience. Am J Obstet Gynecol. 2000;182:485-489.
After reading this publication, clinicians should be able to:
- Understand the options available for obstetric sterilization following vaginal or cesarean delivery
- Describe Filshie clip technology, its correct application, and proper procedure documentation
- Discuss failure rates for female sterilization
- Evaluate the findings of the Collaborative Review of Sterilization (CREST) study
Postpartum tubal sterilization is most often performed using the Pomeroy method, a technique that has remained unchanged since its introduction in 1930. Recently introduced clip technology provides an important alternative for clinicians. The Filshie clip—approved for both postpartum and interval use in 1996—offers efficacy rates similar to the Pomeroy method, with potential advantages for physicians and operating room (OR) personnel.
Tubal sterilization—the number one birth control method in the United States—is the choice of 11 million US women, approximately 28% of the women who use contraception1 (TABLE 1). Of this total, half of all tubal sterilization procedures are performed postpartum and are more likely to be performed among women aged 20 to 34 than are interval sterilization procedures.2
In this publication, 3 experts describe their clinical experiences with the Filshie clip and review the medical literature on its use in obstetric sterilization. They offer practical pearls for obstetricians who may want to consider using this technology in their practices. Additionally, they review the Filshie clip and other procedures and devices within the context of the evidence in the medical literature concerning efficacy, ease of use, surgeon time required, and the potential for complications.
TABLE 1
Tubal sterilization procedures in the United States, 1994-1996
| Timing/Setting | Mean Annual No. | Ratea | Standard Error | Distribution (%) | Standard Error |
|---|---|---|---|---|---|
| Total | 684,000 | 11.5 | 0.4 | 100 | na |
| Postpartum Inpatient (hospital) | 338,000 | 5.7 | 0.3 | 49.5 | 3.0 |
| Interval | 345,000 | 5.8 | 0.3 | 50.6 | na |
| Inpatient (hospital) | 15,000 | 0.2 | 0.03 | 2.1 | 0.3 |
| Outpatient Hospital ambulatory surgery centerb Freestanding outpatient surgery center | 331,000 288,000 43,000 | 5.6 4.9 0.7 | 0.3 0.3 0.1 | 48.5 42.2 6.3 | 3.2 0.9 |
| aTubal sterilizations per 1000 women of reproductive age (20-49 years) in the US civilian resident population. | |||||
| bIncludes procedures performed in hospitals as outpatient procedures. | |||||
| Reprinted with permission from MacKay AP, et al, Tubal sterilization in the United States, 1994-1996, Family Planning Perspectives, 2001;33(4):162. | |||||
Adding the Filshie clip to OR options
DR KAUNITZ: Most ob/gyns have been trained to perform obstetric postpartum sterilization using the Pomeroy method—perhaps that’s why it is often viewed as the only option in this setting. However, at my institution, Shands Jacksonville Medical Center, the Filshie clip is routinely used for postpartum tubal sterilization among the approximately 3000 teaching service deliveries we perform each year.
I became familiar with use of the Filshie clip for laparoscopic sterilization in the mid to late 1990s, following its approval for use in the United States. Once I learned that it was approved for use in C-sections and postpartum procedures and that a short applicator was available (FIGURE), I wanted to try it.
FIGURE The Filshie short applicator
Comparing the Filshie clip vs the Pomeroy method
DR KAUNITZ: As part of a resident research project, we performed a small randomized trial that compared perioperative outcomes with obstetric tubal sterilization using the Pomeroy method versus the Filshie clip.3 In this study, we were particularly interested in the procedure because it alleviates the need for the physician to perform incisions near the engorged broad ligament blood vessels present during pregnancy and delivery. The Filshie clip does not require tubal exteriorization, a potential advantage in obese patients and in those who have tubal adhesions.
Reducing operating time
DR KAUNITZ: Our findings revealed that the Filshie clip was faster and was preferred by the surgeons (TABLE 2). Since then, we’ve kept the short applicator in our labor and delivery OR. We use the Filshie clip not only as the dominant laparoscopic procedure but also increasingly for sterilization performed after childbirth (vaginal and cesarean). The Filshie clip is an appealing option that is becoming more important as the C-section rate continues to rise, and an increasing number of sterilizations may be done at the time of the C-section.
TABLE 2
Results of surgeon and operating room technician questionnaires
| Filshie Clip (n =14) | Pomeroy (n=15) | P Value | |
|---|---|---|---|
| Surgical technician questionnaire | |||
| Ease of applicator preparation (Filshie) vs ease of preparation for Pomeroy technique | 1.07±0.27 | 1.08±0.28 (n=12) | .98 |
| Ease of assisting in procedure | 1.29±0.61 | 1.85±1.46 (n=12) | .64 |
| Surgeon questionnaire | |||
| Ease of entry into peritoneal cavity | 1.71±0.83 | 2.5±1.97 | .51 |
| Ease of tubal identification | 1.57±0.85 | 2.19±2.19 | .63 |
| Ease of tubal exteriorization | 3.00±0.44 | 2.34±1.21 (n=10) | .97 |
| Ease of clip/suture application | 1.07±0.27 | 2.29±2.58 (n=14) | .08 |
| Ease of procedure, overall | 1.14±0.36 | 2.60±1.88 | .03 |
| Data are presented as mean±standard deviation. | |||
| Questionnaire scale from 1 to 5: 1=very easy, 5=very difficult. | |||
| Reprinted from Contraception, Vol. 69, Kohaut BA, Musselman BL, Sanchez-Ramos L, Kaunitz AM, Randomized trial to compare perioperative outcomes of Filshie clip vs Pomeroy technique for postpartum and intraoperative cesarean tubal sterilization: a pilot study, pages 267-270. Copyright 2004, with permission from Elsevier. | |||
Making the short applicator available
DR HARKINS: During my residency in 1996, the Filshie clip became popular as a laparoscopic technique. It was at the forefront of my training, although we did learn how to use the Falope ring, etc. I had seen the Filshie clip—with the short applicator—used in obstetric postpartum procedures. But we primarily used the Pomeroy method in that setting.
In 2000, when I was at Fort Hood, Texas, the Filshie clip, with its short applicator, was available in the labor and delivery OR. I believe that its availability in this setting is what encouraged me to use it. During their training, most ob/gyns see the Parkland or Pomeroy methods used for postpartum tubals. It doesn’t occur to them to use the Filshie clip in obstetric cases until they see the short-handle applicator, which is specifically made for obstetric use.
1880
First reported tubal sterilization at time of C-section performed by Samuel Smith Lungren of Toledo, Ohio
1896
Debate on whether a woman had the right to choose to undergo sterilization, held at the 21st annual meeting of the American Gynecological Society
1970
Number of tubal sterilizations performed in the United States: 201,000
1972
Federal courts strike down legal restrictions to tubal sterilization for nonmedical reasons
1977
Number of tubal sterilization procedures performed in the United States: 702,000
Reversing sterilization
DR SANFILIPPO: It’s important for the device to be readily accessible. For me, the question is “How do we get the short applicator into more surgeons’ hands and get them to think more about performing obstetric-related sterilization with this device?” I’ve always been a fan of the Filshie clip because it’s quick and effective.
As important, it’s a joy to reverse a sterilization that has been performed with this technique. We need to keep in mind that we can’t be certain that the patient—particularly a younger woman—will be happy in the long term with her decision to undergo sterilization. It’s comforting to know that with the Filshie clip, reversal of the sterilization procedure is generally easy to perform and carries a higher success rate compared with procedures that result in greater tubal destruction.
Choosing Filshie vs sutures
DR HARKINS: At our institution, the decision of which technique to use is based on the individual physician’s preference. I estimate that 1 in 4 sterilization procedures are done with the Filshie clip. Often, the staff base their decision on the tubal anatomy they find when performing a C-section.
DR KAUNITZ: Since both the Pomeroy method and the Filshie clip are used in your C-section rooms, what has been your experience with the speed or convenience of the Filshie clip compared with the Pomeroy method?
DR HARKINS: I find the outcomes identical to those that you reported in your article in Contraception (TABLE 2).3
The procedure is performed more quickly with the Filshie clip, and this device is easier to use. At our institution, the scrub technicians are the ones who often ask us to use the Filshie clip because they see that it’s fast and efficient.
DR SANFILIPPO: I’ve had the same experience, but I want to add that the Filshie clip features the least tubal damage—an important point in performing reconstructive surgery. Only 4 mm of tube is affected by clip application.4
Reducing risk of bleeding
DR KAUNITZ: We are all familiar with the risk of mesosalpingeal bleeding associated with the Pomeroy method, whether used postpartum via minilaparotomy or at the time of cesarean delivery. The knots or sutures may slip off the cut ends of the tube; this results in persistent postoperative bleeding, perhaps with hemoperitoneum, low hemoglobin, or hypovolemia, which requires relaparotomy.
DR HARKINS: That’s very important—we’ve all had a patient or know a colleague whose patient had to return to the OR because of a hemorrhage in the broad ligament vessel. Obviously, you remember those cases and want to avoid such occurrences. Certainly, using the Filshie clip is a way of eliminating the worry about this complication.
DR KAUNITZ: Although we have no clinical trial data to prove that the Filshie clip results in fewer complications, I feel it is prudent to use a method, such as the Filshie clip, in that it is as effective as others that are available but that it also enables us to minimize unusual negative occurrences.
Pomeroy method
Developed in 1930, the Pomeroy method is highly effective and relatively inexpensive, although additional costs are incurred for pathology. This technique is associated with a small risk of postoperative mesosalpingeal bleeding, which often requires reoperation.
In this procedure, the tubes are grasped with a clamp and formed into a loop. A suture is tied around the loop, and the portion of the tube within the loop is cut.1
Filshie clip
The Filshie clip consists of a titanium (nonferrous) clip, 14 mm long, 4 mm wide, and 0.36 g in weight. It is lined with a silicone cushion, which facilitates occlusion of swollen and fragile fallopian tubes characteristic of the immediate postpartum period. The clip construction creates minimal damage to the surrounding structures.2,3 Only 4 mm of tube is destroyed, thus facilitating reanastomosis.4,5 There is no risk from the magnetic effects of future MRI investigations.
The soft silicone lining is associated with substantial clip capacity and may reduce transection and fistula formation in the tubal stump. When applied over the tube, the clip immediately compresses and occludes the tube. As necrosis occurs, the lining expands and maintains blockage. Eventually, the tube divides and the closed stump heals.3 The large tubal capacity allows the procedure to be performed in women with thick fallopian tubes or whose tubes may be edematous, as may occur postpartum.
The procedure is associated with a low failure rate of approximately 2.7 per 1000 patients. It obviates the potential risk of bowel burn and does not require the use of instrumentation that may lacerate blood vessels.
Filshie clip application steps
The Filshie clip is applied across the entire diameter of the isthmic portion of the fallopian tube with the hooked end of the lower jaw visible through the mesosalpinx. Before closure, the applicator manipulates the structures to properly identify the tube(s) and confirm correct clip placement. The applicator is squeezed to compress and flatten the upper jaw, locking it under the hooked end of the lower jaw. The applicator is removed, leaving the locked Filshie clip compressing the entire diameter of the tube within its jaw. One Filshie clip per fallopian tube is required; clips are permanently implanted.
Hulka clip system
This device features a Lexan plastic jaw, attached with goldplated stainless steel spring “teeth” and a plastic tip. The length of the clip makes complete occlusion of some tubes challenging.
Hulka clip system steps
The clip is attached to the fallopian tube at the isthmus, with the tube placed on stretch. The clip must be applied exactly perpendicular to the long axis of the tube to fully enclose the tube, with the hinge jaw of the open clip adjacent to the tube and the clip jaws extending onto the mesosalpinx. After correct placement, the jaws of the clip are closed.6
As part of the procedure, 1 cm of tissue is destroyed. Sterilization can be reversed. The failure rate is substantially higher than other laparoscopic techniques.
Parkland method
In this procedure, the tube is identified and elevated. The proximal and distal portions of the tube (2 cm) are ligated and the remaining tube is excised to reduce the risk of natural reattachment.
The procedure is associated with low failure rates (7.5/1000). It is inexpensive (if no pathology is required). Although rare, complications include the risk of ectopic pregnancy, infection, and bleeding. The procedure requires more time to perform than do currently used methods.1
Irving technique
The results of sterilization with this method were published in 1924. It has been used with cesarean delivery. The procedure is moderately difficult to perform. Both the Pomeroy and Parkland methods are quicker and easier to perform. The reported failure rate of the Irving technique is 2.3 per 1000 patients.7
Uchida procedure
Introduced by Hajime Uchida in the 1940s, this procedure can be performed immediately postpartum. The procedure is moderately difficult to perform. The Pomeroy and Parkland methods are quicker to perform. Uchida personally performed more than 20,000 cases without a failure.8
References
1. Peterson HB. Sterilization. Obstet Gynecol. 2008;111:189-203.
2. Kohaut BA, Musselman BL, Sanchez-Ramos L, et al. Randomized trial to compare perioperative outcomes of Filshie clip vs Pomeroy technique for postpartum and intraoperative cesarean tubal sterilization: a pilot study. Contraception. 2004;69:267-270.
3. Yan J-S, Hsu J, Yin CS. Comparative study of Filshie clip and Pomeroy method for postpartum sterilization. Int J Gynecol Obstet. 1990;33:263-267.
4. Filshie clip [package insert]. Trumbull, CT: Cooper Surgical, Inc. 2005.
5. Penfield AJ. The Filshie clip for female sterilization: A review of world experience. Am J Obstet Gynecol. 2000;182:485-489.
6. Peterson HB, Xia Z, Hughes JM, et al. The risk of pregnancy after tubal sterilization: findings from one US Collaborative Review of Sterilization. Am J Obstet Gynecol. 1996;174:1161-1168.
7. Lopez-Zeno JA, Muallem NS, Anderson JB. The Irving sterilization technique: a report of a failure. Int J Fertil. 1990;35:23-25.
8. Sklar AJ. Tubal Sterilization. eMedicine. Nov 15, 2002. http://www.emedicine.com/med/topic3313.htm. Accessed Feb 7, 2008.
Training physicians and residents
DR KAUNITZ: In general, gynecologic surgery is moving away from the premise of “see one and then perform one,” but the short learning curve required with the Filshie clip is one of its appeals—it is quite easy to use. If you follow the rules and pay attention to technique, you can become adept at it very quickly.
DR HARKINS: I agree. The Filshie clip translates from the laparoscopic application to the open application very quickly.
DR SANFILIPPO: I would like to advocate for the use of the Filshie clip as part of resident training. Most centers now have a lab for teaching minimally invasive procedures. I’d like to see the Filshie clip incorporated into such training. Teaching this procedure to residents is a good investment for the future.
DR KAUNITZ: I agree—simulation training should feature the short applicator and obstetric-type simulation applications of Filshie clips in the obstetric setting.
DR HARKINS: Unfortunately, teaching the postpartum procedure has never been a priority of training. In thinking about different techniques, I don’t believe we give residents sufficient information about the issues and available techniques of postpartum tubal sterilization. Certainly, translating techniques from laparoscopic to open and having residents learn to use the short applicator is very useful. We should emphasize the obstetric use of the Filshie clip in training so that it becomes second nature for these physicians to consider it among their treatment options.
DR KAUNITZ: I think younger clinicians may not be aware that the Pomeroy method has not changed since the 1930s.
Assessing potential for complications
DR KAUNITZ: What about the possibility of clip migration or extrusion? I’m not aware of any such occurrences, despite our institution’s longstanding experience with Filshie clips; however, the medical literature contains a number of case reports on migration of Filshie clips into or around various visceral structures.5 Interestingly, these reports rarely show major morbidity.
In the original data submitted to the Food and Drug Administration (FDA) for premarket approval of the Filshie clip, 5454 cases were reviewed. Of these cases, 8 (0.1%) women reported clip migration, clip expulsion, or foreign body reaction.5
DR SANFILIPPO: I have not seen any migrations or complications.
DR HARKINS: I have had situations where a patient has had a prior tubal ligation with Filshie clips, and when she is seen at laparoscopy for an unrelated procedure, I have found Filshie clips free floating or in the lower pelvis. The tubal occlusion was still effective, but the clip was free floating because of necrosis and resorption of a small portion of the fallopian tube.
DR KAUNITZ: You have not run into situations involving migration of Filshie clips into the bladder or bowel, as has been described in rare case reports?
DR HARKINS: No.
Reimbursement issues
DR HARKINS: When I came to Hershey 4 years ago, I wanted to use the Filshie clip. We looked carefully at cost issues. If you compare the costs for the Filshie clip with the costs for the Pomeroy method—and include the pathology charges for handling and reading the tubal specimens—the Filshie clip has advantages: its use does not require pathology costs.
With the Filshie clip, there is the initial purchase of the applicator. The set of clips costs between $70 and $80.6 We found that the total pathology costs associated with the Pomeroy method were $185. This included the processing fee for both fallopian tubes and the professional interpretation fees. These costs made the Filshie clip appealing from a financial standpoint and countered the argument that the Pomeroy method is less expensive because it relies on “just cheap sutures.” In actuality, performing a procedure using Filshie clips may be the equivalent or significantly less than the cost of using the Pomeroy method.6
People don’t think about the other potential costs as well: if one additional laparotomy a year is required as a result of bleeding from a Pomeroy procedure, that cost also needs to be factored in.
DR KAUNITZ: Are pathology reports important in cases of failure? Is pathology needed even when performing a procedure with a Filshie clip? Or is it sufficient to do the Filshie clip procedure correctly and then document in your operative report that the appropriate anatomy was identified and the appropriate clip application technique was used?
DR HARKINS: Every patient signs a consent form, which contains information about risk of failure. We say that the failure rate is 1 in 300 to 1 in 500, and we emphasize that the procedure is always accompanied by a risk of failure.
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.
TABLE 3
Overall 10-year failure rates for interval procedures
| Method | Patients (n) | Failure Rate (%) |
|---|---|---|
| Bipolar coagulation | 2267 | 2.48 |
| Unipolar coagulation | 1432 | 0.75 |
| 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. | ||
TABLE 4
Long-term failure rates for Mark VI hinged Filshie Clip System sterilization (interval procedures)
| Investigator | Patients (n) | Follow-up (y) | Failures (n) | Failure Rate (%) |
|---|---|---|---|---|
| Filshie | 434 | 6-15 | 1 | .023 |
| Heslip | 467 | 10 | 1 | .21 |
| Yuzpe | 497 | 10 | 0 | 0 |
| Puraviappan | 796 | 7 | 3 | 0.4 |
| 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.
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
Conclusion
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.
Disclosures
- 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.
After reading this publication, clinicians should be able to:
- Understand the options available for obstetric sterilization following vaginal or cesarean delivery
- Describe Filshie clip technology, its correct application, and proper procedure documentation
- Discuss failure rates for female sterilization
- Evaluate the findings of the Collaborative Review of Sterilization (CREST) study
Postpartum tubal sterilization is most often performed using the Pomeroy method, a technique that has remained unchanged since its introduction in 1930. Recently introduced clip technology provides an important alternative for clinicians. The Filshie clip—approved for both postpartum and interval use in 1996—offers efficacy rates similar to the Pomeroy method, with potential advantages for physicians and operating room (OR) personnel.
Tubal sterilization—the number one birth control method in the United States—is the choice of 11 million US women, approximately 28% of the women who use contraception1 (TABLE 1). Of this total, half of all tubal sterilization procedures are performed postpartum and are more likely to be performed among women aged 20 to 34 than are interval sterilization procedures.2
In this publication, 3 experts describe their clinical experiences with the Filshie clip and review the medical literature on its use in obstetric sterilization. They offer practical pearls for obstetricians who may want to consider using this technology in their practices. Additionally, they review the Filshie clip and other procedures and devices within the context of the evidence in the medical literature concerning efficacy, ease of use, surgeon time required, and the potential for complications.
TABLE 1
Tubal sterilization procedures in the United States, 1994-1996
| Timing/Setting | Mean Annual No. | Ratea | Standard Error | Distribution (%) | Standard Error |
|---|---|---|---|---|---|
| Total | 684,000 | 11.5 | 0.4 | 100 | na |
| Postpartum Inpatient (hospital) | 338,000 | 5.7 | 0.3 | 49.5 | 3.0 |
| Interval | 345,000 | 5.8 | 0.3 | 50.6 | na |
| Inpatient (hospital) | 15,000 | 0.2 | 0.03 | 2.1 | 0.3 |
| Outpatient Hospital ambulatory surgery centerb Freestanding outpatient surgery center | 331,000 288,000 43,000 | 5.6 4.9 0.7 | 0.3 0.3 0.1 | 48.5 42.2 6.3 | 3.2 0.9 |
| aTubal sterilizations per 1000 women of reproductive age (20-49 years) in the US civilian resident population. | |||||
| bIncludes procedures performed in hospitals as outpatient procedures. | |||||
| Reprinted with permission from MacKay AP, et al, Tubal sterilization in the United States, 1994-1996, Family Planning Perspectives, 2001;33(4):162. | |||||
Adding the Filshie clip to OR options
DR KAUNITZ: Most ob/gyns have been trained to perform obstetric postpartum sterilization using the Pomeroy method—perhaps that’s why it is often viewed as the only option in this setting. However, at my institution, Shands Jacksonville Medical Center, the Filshie clip is routinely used for postpartum tubal sterilization among the approximately 3000 teaching service deliveries we perform each year.
I became familiar with use of the Filshie clip for laparoscopic sterilization in the mid to late 1990s, following its approval for use in the United States. Once I learned that it was approved for use in C-sections and postpartum procedures and that a short applicator was available (FIGURE), I wanted to try it.
FIGURE The Filshie short applicator
Comparing the Filshie clip vs the Pomeroy method
DR KAUNITZ: As part of a resident research project, we performed a small randomized trial that compared perioperative outcomes with obstetric tubal sterilization using the Pomeroy method versus the Filshie clip.3 In this study, we were particularly interested in the procedure because it alleviates the need for the physician to perform incisions near the engorged broad ligament blood vessels present during pregnancy and delivery. The Filshie clip does not require tubal exteriorization, a potential advantage in obese patients and in those who have tubal adhesions.
Reducing operating time
DR KAUNITZ: Our findings revealed that the Filshie clip was faster and was preferred by the surgeons (TABLE 2). Since then, we’ve kept the short applicator in our labor and delivery OR. We use the Filshie clip not only as the dominant laparoscopic procedure but also increasingly for sterilization performed after childbirth (vaginal and cesarean). The Filshie clip is an appealing option that is becoming more important as the C-section rate continues to rise, and an increasing number of sterilizations may be done at the time of the C-section.
TABLE 2
Results of surgeon and operating room technician questionnaires
| Filshie Clip (n =14) | Pomeroy (n=15) | P Value | |
|---|---|---|---|
| Surgical technician questionnaire | |||
| Ease of applicator preparation (Filshie) vs ease of preparation for Pomeroy technique | 1.07±0.27 | 1.08±0.28 (n=12) | .98 |
| Ease of assisting in procedure | 1.29±0.61 | 1.85±1.46 (n=12) | .64 |
| Surgeon questionnaire | |||
| Ease of entry into peritoneal cavity | 1.71±0.83 | 2.5±1.97 | .51 |
| Ease of tubal identification | 1.57±0.85 | 2.19±2.19 | .63 |
| Ease of tubal exteriorization | 3.00±0.44 | 2.34±1.21 (n=10) | .97 |
| Ease of clip/suture application | 1.07±0.27 | 2.29±2.58 (n=14) | .08 |
| Ease of procedure, overall | 1.14±0.36 | 2.60±1.88 | .03 |
| Data are presented as mean±standard deviation. | |||
| Questionnaire scale from 1 to 5: 1=very easy, 5=very difficult. | |||
| Reprinted from Contraception, Vol. 69, Kohaut BA, Musselman BL, Sanchez-Ramos L, Kaunitz AM, Randomized trial to compare perioperative outcomes of Filshie clip vs Pomeroy technique for postpartum and intraoperative cesarean tubal sterilization: a pilot study, pages 267-270. Copyright 2004, with permission from Elsevier. | |||
Making the short applicator available
DR HARKINS: During my residency in 1996, the Filshie clip became popular as a laparoscopic technique. It was at the forefront of my training, although we did learn how to use the Falope ring, etc. I had seen the Filshie clip—with the short applicator—used in obstetric postpartum procedures. But we primarily used the Pomeroy method in that setting.
In 2000, when I was at Fort Hood, Texas, the Filshie clip, with its short applicator, was available in the labor and delivery OR. I believe that its availability in this setting is what encouraged me to use it. During their training, most ob/gyns see the Parkland or Pomeroy methods used for postpartum tubals. It doesn’t occur to them to use the Filshie clip in obstetric cases until they see the short-handle applicator, which is specifically made for obstetric use.
1880
First reported tubal sterilization at time of C-section performed by Samuel Smith Lungren of Toledo, Ohio
1896
Debate on whether a woman had the right to choose to undergo sterilization, held at the 21st annual meeting of the American Gynecological Society
1970
Number of tubal sterilizations performed in the United States: 201,000
1972
Federal courts strike down legal restrictions to tubal sterilization for nonmedical reasons
1977
Number of tubal sterilization procedures performed in the United States: 702,000
Reversing sterilization
DR SANFILIPPO: It’s important for the device to be readily accessible. For me, the question is “How do we get the short applicator into more surgeons’ hands and get them to think more about performing obstetric-related sterilization with this device?” I’ve always been a fan of the Filshie clip because it’s quick and effective.
As important, it’s a joy to reverse a sterilization that has been performed with this technique. We need to keep in mind that we can’t be certain that the patient—particularly a younger woman—will be happy in the long term with her decision to undergo sterilization. It’s comforting to know that with the Filshie clip, reversal of the sterilization procedure is generally easy to perform and carries a higher success rate compared with procedures that result in greater tubal destruction.
Choosing Filshie vs sutures
DR HARKINS: At our institution, the decision of which technique to use is based on the individual physician’s preference. I estimate that 1 in 4 sterilization procedures are done with the Filshie clip. Often, the staff base their decision on the tubal anatomy they find when performing a C-section.
DR KAUNITZ: Since both the Pomeroy method and the Filshie clip are used in your C-section rooms, what has been your experience with the speed or convenience of the Filshie clip compared with the Pomeroy method?
DR HARKINS: I find the outcomes identical to those that you reported in your article in Contraception (TABLE 2).3
The procedure is performed more quickly with the Filshie clip, and this device is easier to use. At our institution, the scrub technicians are the ones who often ask us to use the Filshie clip because they see that it’s fast and efficient.
DR SANFILIPPO: I’ve had the same experience, but I want to add that the Filshie clip features the least tubal damage—an important point in performing reconstructive surgery. Only 4 mm of tube is affected by clip application.4
Reducing risk of bleeding
DR KAUNITZ: We are all familiar with the risk of mesosalpingeal bleeding associated with the Pomeroy method, whether used postpartum via minilaparotomy or at the time of cesarean delivery. The knots or sutures may slip off the cut ends of the tube; this results in persistent postoperative bleeding, perhaps with hemoperitoneum, low hemoglobin, or hypovolemia, which requires relaparotomy.
DR HARKINS: That’s very important—we’ve all had a patient or know a colleague whose patient had to return to the OR because of a hemorrhage in the broad ligament vessel. Obviously, you remember those cases and want to avoid such occurrences. Certainly, using the Filshie clip is a way of eliminating the worry about this complication.
DR KAUNITZ: Although we have no clinical trial data to prove that the Filshie clip results in fewer complications, I feel it is prudent to use a method, such as the Filshie clip, in that it is as effective as others that are available but that it also enables us to minimize unusual negative occurrences.
Pomeroy method
Developed in 1930, the Pomeroy method is highly effective and relatively inexpensive, although additional costs are incurred for pathology. This technique is associated with a small risk of postoperative mesosalpingeal bleeding, which often requires reoperation.
In this procedure, the tubes are grasped with a clamp and formed into a loop. A suture is tied around the loop, and the portion of the tube within the loop is cut.1
Filshie clip
The Filshie clip consists of a titanium (nonferrous) clip, 14 mm long, 4 mm wide, and 0.36 g in weight. It is lined with a silicone cushion, which facilitates occlusion of swollen and fragile fallopian tubes characteristic of the immediate postpartum period. The clip construction creates minimal damage to the surrounding structures.2,3 Only 4 mm of tube is destroyed, thus facilitating reanastomosis.4,5 There is no risk from the magnetic effects of future MRI investigations.
The soft silicone lining is associated with substantial clip capacity and may reduce transection and fistula formation in the tubal stump. When applied over the tube, the clip immediately compresses and occludes the tube. As necrosis occurs, the lining expands and maintains blockage. Eventually, the tube divides and the closed stump heals.3 The large tubal capacity allows the procedure to be performed in women with thick fallopian tubes or whose tubes may be edematous, as may occur postpartum.
The procedure is associated with a low failure rate of approximately 2.7 per 1000 patients. It obviates the potential risk of bowel burn and does not require the use of instrumentation that may lacerate blood vessels.
Filshie clip application steps
The Filshie clip is applied across the entire diameter of the isthmic portion of the fallopian tube with the hooked end of the lower jaw visible through the mesosalpinx. Before closure, the applicator manipulates the structures to properly identify the tube(s) and confirm correct clip placement. The applicator is squeezed to compress and flatten the upper jaw, locking it under the hooked end of the lower jaw. The applicator is removed, leaving the locked Filshie clip compressing the entire diameter of the tube within its jaw. One Filshie clip per fallopian tube is required; clips are permanently implanted.
Hulka clip system
This device features a Lexan plastic jaw, attached with goldplated stainless steel spring “teeth” and a plastic tip. The length of the clip makes complete occlusion of some tubes challenging.
Hulka clip system steps
The clip is attached to the fallopian tube at the isthmus, with the tube placed on stretch. The clip must be applied exactly perpendicular to the long axis of the tube to fully enclose the tube, with the hinge jaw of the open clip adjacent to the tube and the clip jaws extending onto the mesosalpinx. After correct placement, the jaws of the clip are closed.6
As part of the procedure, 1 cm of tissue is destroyed. Sterilization can be reversed. The failure rate is substantially higher than other laparoscopic techniques.
Parkland method
In this procedure, the tube is identified and elevated. The proximal and distal portions of the tube (2 cm) are ligated and the remaining tube is excised to reduce the risk of natural reattachment.
The procedure is associated with low failure rates (7.5/1000). It is inexpensive (if no pathology is required). Although rare, complications include the risk of ectopic pregnancy, infection, and bleeding. The procedure requires more time to perform than do currently used methods.1
Irving technique
The results of sterilization with this method were published in 1924. It has been used with cesarean delivery. The procedure is moderately difficult to perform. Both the Pomeroy and Parkland methods are quicker and easier to perform. The reported failure rate of the Irving technique is 2.3 per 1000 patients.7
Uchida procedure
Introduced by Hajime Uchida in the 1940s, this procedure can be performed immediately postpartum. The procedure is moderately difficult to perform. The Pomeroy and Parkland methods are quicker to perform. Uchida personally performed more than 20,000 cases without a failure.8
References
1. Peterson HB. Sterilization. Obstet Gynecol. 2008;111:189-203.
2. Kohaut BA, Musselman BL, Sanchez-Ramos L, et al. Randomized trial to compare perioperative outcomes of Filshie clip vs Pomeroy technique for postpartum and intraoperative cesarean tubal sterilization: a pilot study. Contraception. 2004;69:267-270.
3. Yan J-S, Hsu J, Yin CS. Comparative study of Filshie clip and Pomeroy method for postpartum sterilization. Int J Gynecol Obstet. 1990;33:263-267.
4. Filshie clip [package insert]. Trumbull, CT: Cooper Surgical, Inc. 2005.
5. Penfield AJ. The Filshie clip for female sterilization: A review of world experience. Am J Obstet Gynecol. 2000;182:485-489.
6. Peterson HB, Xia Z, Hughes JM, et al. The risk of pregnancy after tubal sterilization: findings from one US Collaborative Review of Sterilization. Am J Obstet Gynecol. 1996;174:1161-1168.
7. Lopez-Zeno JA, Muallem NS, Anderson JB. The Irving sterilization technique: a report of a failure. Int J Fertil. 1990;35:23-25.
8. Sklar AJ. Tubal Sterilization. eMedicine. Nov 15, 2002. http://www.emedicine.com/med/topic3313.htm. Accessed Feb 7, 2008.
Training physicians and residents
DR KAUNITZ: In general, gynecologic surgery is moving away from the premise of “see one and then perform one,” but the short learning curve required with the Filshie clip is one of its appeals—it is quite easy to use. If you follow the rules and pay attention to technique, you can become adept at it very quickly.
DR HARKINS: I agree. The Filshie clip translates from the laparoscopic application to the open application very quickly.
DR SANFILIPPO: I would like to advocate for the use of the Filshie clip as part of resident training. Most centers now have a lab for teaching minimally invasive procedures. I’d like to see the Filshie clip incorporated into such training. Teaching this procedure to residents is a good investment for the future.
DR KAUNITZ: I agree—simulation training should feature the short applicator and obstetric-type simulation applications of Filshie clips in the obstetric setting.
DR HARKINS: Unfortunately, teaching the postpartum procedure has never been a priority of training. In thinking about different techniques, I don’t believe we give residents sufficient information about the issues and available techniques of postpartum tubal sterilization. Certainly, translating techniques from laparoscopic to open and having residents learn to use the short applicator is very useful. We should emphasize the obstetric use of the Filshie clip in training so that it becomes second nature for these physicians to consider it among their treatment options.
DR KAUNITZ: I think younger clinicians may not be aware that the Pomeroy method has not changed since the 1930s.
Assessing potential for complications
DR KAUNITZ: What about the possibility of clip migration or extrusion? I’m not aware of any such occurrences, despite our institution’s longstanding experience with Filshie clips; however, the medical literature contains a number of case reports on migration of Filshie clips into or around various visceral structures.5 Interestingly, these reports rarely show major morbidity.
In the original data submitted to the Food and Drug Administration (FDA) for premarket approval of the Filshie clip, 5454 cases were reviewed. Of these cases, 8 (0.1%) women reported clip migration, clip expulsion, or foreign body reaction.5
DR SANFILIPPO: I have not seen any migrations or complications.
DR HARKINS: I have had situations where a patient has had a prior tubal ligation with Filshie clips, and when she is seen at laparoscopy for an unrelated procedure, I have found Filshie clips free floating or in the lower pelvis. The tubal occlusion was still effective, but the clip was free floating because of necrosis and resorption of a small portion of the fallopian tube.
DR KAUNITZ: You have not run into situations involving migration of Filshie clips into the bladder or bowel, as has been described in rare case reports?
DR HARKINS: No.
Reimbursement issues
DR HARKINS: When I came to Hershey 4 years ago, I wanted to use the Filshie clip. We looked carefully at cost issues. If you compare the costs for the Filshie clip with the costs for the Pomeroy method—and include the pathology charges for handling and reading the tubal specimens—the Filshie clip has advantages: its use does not require pathology costs.
With the Filshie clip, there is the initial purchase of the applicator. The set of clips costs between $70 and $80.6 We found that the total pathology costs associated with the Pomeroy method were $185. This included the processing fee for both fallopian tubes and the professional interpretation fees. These costs made the Filshie clip appealing from a financial standpoint and countered the argument that the Pomeroy method is less expensive because it relies on “just cheap sutures.” In actuality, performing a procedure using Filshie clips may be the equivalent or significantly less than the cost of using the Pomeroy method.6
People don’t think about the other potential costs as well: if one additional laparotomy a year is required as a result of bleeding from a Pomeroy procedure, that cost also needs to be factored in.
DR KAUNITZ: Are pathology reports important in cases of failure? Is pathology needed even when performing a procedure with a Filshie clip? Or is it sufficient to do the Filshie clip procedure correctly and then document in your operative report that the appropriate anatomy was identified and the appropriate clip application technique was used?
DR HARKINS: Every patient signs a consent form, which contains information about risk of failure. We say that the failure rate is 1 in 300 to 1 in 500, and we emphasize that the procedure is always accompanied by a risk of failure.
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.
TABLE 3
Overall 10-year failure rates for interval procedures
| Method | Patients (n) | Failure Rate (%) |
|---|---|---|
| Bipolar coagulation | 2267 | 2.48 |
| Unipolar coagulation | 1432 | 0.75 |
| 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. | ||
TABLE 4
Long-term failure rates for Mark VI hinged Filshie Clip System sterilization (interval procedures)
| Investigator | Patients (n) | Follow-up (y) | Failures (n) | Failure Rate (%) |
|---|---|---|---|---|
| Filshie | 434 | 6-15 | 1 | .023 |
| Heslip | 467 | 10 | 1 | .21 |
| Yuzpe | 497 | 10 | 0 | 0 |
| Puraviappan | 796 | 7 | 3 | 0.4 |
| 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.
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
Conclusion
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.
Disclosures
- 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.
1. ACOG Committee on Practice Bulletins—Gynecology. ACOG Practice Bulletin No. 46. Benefits and risks of sterilization. Obstet Gynecol. 2003;102:647-658.
2. MacKay AP, Kieke BA, Jr, Koonin LM, et al. Tubal sterilization in the United States, 1994-1996. Fam Plann Perspect. 2001;33:161-165.
3. Kohaut BA, Musselman BL, Sanchez-Ramos L, et al. Randomized trial to compare perioperative outcomes of Filshie clip vs Pomeroy technique for postpartum and intraoperative cesarean tubal sterilization: a pilot study. Contraception. 2004;69:267-270.
4. Filshie clip [package insert]. Trumbull, CT: CooperSurgical, Inc. 2005.
5. US Department of Health and Human Services. Premarket Approval of Femcare Ltd. Filshie Clip System™. http://www.fda.gov/cdrh/pdf/p920046.pdf. Accessed Feb 7, 2008.
6. Data on file. CooperSurgical, Inc. Trumball, CT.
7. Hulka JF, Fishburne JI, Mercer JP, et al. Laparoscopic sterilization with a spring-clip: A report of the first fifty cases. Am J Obstet Gynecol. 1973;116:715-720.
8. Graf A-H, Staudach A, Steiner H, et al. An evaluation of the Filshie Clip for postpartum sterilization in Austria. Contraception. 1996;54:309-311.
9. Yan J-S, Hsu J, Yin CS. Comparative study of Filshie clip and Pomeroy method for postpartum sterilization. Int J Gynecol Obstet. 1990;33:263-267.
10. Peterson HB. Sterilization. Obstet Gynecol. 2008;111:189-203.
11. 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;28:34-35.
12. Grimes DA, Mishell DR, Jr. Intrauterine contraception as an alternative to interval tubal sterilization. Contraception. 2008;77:6-9.
13. Penfield AJ. The Filshie clip for female sterilization: A review of world experience. Am J Obstet Gynecol. 2000;182:485-489.
1. ACOG Committee on Practice Bulletins—Gynecology. ACOG Practice Bulletin No. 46. Benefits and risks of sterilization. Obstet Gynecol. 2003;102:647-658.
2. MacKay AP, Kieke BA, Jr, Koonin LM, et al. Tubal sterilization in the United States, 1994-1996. Fam Plann Perspect. 2001;33:161-165.
3. Kohaut BA, Musselman BL, Sanchez-Ramos L, et al. Randomized trial to compare perioperative outcomes of Filshie clip vs Pomeroy technique for postpartum and intraoperative cesarean tubal sterilization: a pilot study. Contraception. 2004;69:267-270.
4. Filshie clip [package insert]. Trumbull, CT: CooperSurgical, Inc. 2005.
5. US Department of Health and Human Services. Premarket Approval of Femcare Ltd. Filshie Clip System™. http://www.fda.gov/cdrh/pdf/p920046.pdf. Accessed Feb 7, 2008.
6. Data on file. CooperSurgical, Inc. Trumball, CT.
7. Hulka JF, Fishburne JI, Mercer JP, et al. Laparoscopic sterilization with a spring-clip: A report of the first fifty cases. Am J Obstet Gynecol. 1973;116:715-720.
8. Graf A-H, Staudach A, Steiner H, et al. An evaluation of the Filshie Clip for postpartum sterilization in Austria. Contraception. 1996;54:309-311.
9. Yan J-S, Hsu J, Yin CS. Comparative study of Filshie clip and Pomeroy method for postpartum sterilization. Int J Gynecol Obstet. 1990;33:263-267.
10. Peterson HB. Sterilization. Obstet Gynecol. 2008;111:189-203.
11. 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;28:34-35.
12. Grimes DA, Mishell DR, Jr. Intrauterine contraception as an alternative to interval tubal sterilization. Contraception. 2008;77:6-9.
13. Penfield AJ. The Filshie clip for female sterilization: A review of world experience. Am J Obstet Gynecol. 2000;182:485-489.