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.
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.