Hugo Verhoeven, MD: "Good afternoon, my name is Hugo Verhoeven from the Center for Reproductive Medicine in Dusseldorf, Germany. I'm on the Editorial Board for OBGYN.net, and I'm reporting from the 30th meeting of the AAGL in San Francisco, California. It is a great honor for me to talk this afternoon with one of the guru's in the field of clip contraception, Marcus Filshie from Nottingham, England. Professor Filshie, we've known each other for about fifteen to twenty years."
Marcus Filshie, DM, FRCOG, MFFP: "Certainly, Hugo."
Hugo Verhoeven, MD: "And that's also about the time that elapsed since you invented a clip that survived eighteen years and it's still the gold standard in clip sterilization. When you started thinking about developing a clip twenty years ago, what was the reason for that? What were your thoughts at that moment in your life?"
Marcus Filshie, DM, FRCOG, MFFP: "In Nottingham, two women died from having a sterilization using electrocautery and that was very sad. Of course, that's a very rare event but it can happen."
Hugo Verhoeven, MD: "What is electrocautery for our listeners?"
Marcus Filshie, DM, FRCOG, MFFP: "Electrocautery is when the fallopian tubes are grasped by some forceps and an electrical current goes down the forceps. It burns the fallopian tube so that it no longer functions. It's one of the common methods that used to be used and it's now very rarely used, it's called unipolar or bipolar coagulation."
Hugo Verhoeven, MD: "Twenty years ago we probably had just the unipolar coagulation or was bipolar already available?"
Marcus Filshie, DM, FRCOG, MFFP: "Bipolar was just coming out in 1973 so the bipolar was already there."
Hugo Verhoeven, MD: "We also had the Yoon-band?"
Marcus Filshie, DM, FRCOG, MFFP: "The Yoon-band was there, indeed, that was just emerging at the same time as we started our research on it."
Hugo Verhoeven, MD: "But most of the sterilizations were still performed probably by a minilaparotomy, doing a Pomeroy, or a segmental resection of the tube. Is that correct?"
Marcus Filshie, DM, FRCOG, MFFP: "No, we were doing laparoscopy in 1973 which was quite common at that stage but it was the electrocautery which was the dominant method. I must remind you that the laparoscopic approach was a revolution because it meant to say that women could have their tubes burned and if it was successful they could go home the same day with remarkably little problems, and it became very popular."
Hugo Verhoeven, MD: "What was the fantastic thing about your clip?"
Marcus Filshie, DM, FRCOG, MFFP: "It went totally away from electrocautery so there's no electricity involved at all so all electrical complications disappeared. Of course the other thing is the clip, which is only 3 mm wide, only destroys or compresses a very small amount of fallopian tube. This means to say that should a woman remarry and want to have another family, surgically, the clip can be removed with a little bit of tube and the tubes can be joined together with a reasonably high success rate."
Hugo Verhoeven, MD: "We'll talk about the reversibility of the clip later. In those twenty years, how many patients have been sterilized with your clip do you think?"
Marcus Filshie, DM, FRCOG, MFFP: "About three and quarter million women have been sterilized today."
Hugo Verhoeven, MD: "The clip is popular not only in Europe but I think all over the world, and especially in the third world."
Marcus Filshie, DM, FRCOG, MFFP: "I must say when the research was undertaken we desperately wanted it for the third world, particularly India. In fact, a lot of the early clinical trials were taking place in India, and although they loved it, they can't afford it because it's too expensive. In third world terms the clip is quite expensive."
Hugo Verhoeven, MD: "Is it expensive for the doctor performing the sterilization because the instruments are expensive or is the clip itself also expensive?"
Marcus Filshie, DM, FRCOG, MFFP: "The instrument is expensive but it is robust, and when well maintained it can last for a very long period of time. We have some applicators eighteen years old and still being used very well. The clip itself in the developed world is maybe $30-$40 which actually is prohibitive for a developing world situation."
Hugo Verhoeven, MD: "We are both very experienced laparoscopists but maybe you should explain for our readers and listeners what's happening exactly - what are you doing?"
Marcus Filshie, DM, FRCOG, MFFP: "At the moment we are very interested in the American market because it came to America in the beginning of 1997. Because we had to go through the FDA, they were very careful and very thorough and they looked all the work over for quite a number of years and so it was delayed. We are now experiencing in America what we experienced in Europe in the early eighties which is to introduce a new concept, and you must remember when a new concept is introduced to a new country and to a new set of doctors, there is always and quite rightly so a lot of resistance because we're a very conservative group. I think people should be conservative, they should look at all the pros and cons, and I think when people pay attention and do that they look on it very favorably."
Hugo Verhoeven, MD: "So you're putting a clip on the medial part of the tube, what is the failure rate and what could be the reason for those failures?"
Marcus Filshie, DM, FRCOG, MFFP: "There's a failure rate of any method of contraception including sterilization, as you know, and just to remind everybody, there are 23 cases of pregnancy following hysterectomy so you can't get a zero failure rate. If you look at all the studies that have been published, either in reference journals or in ordinary articles, and you look at all the figures that are available, the overall failure rate including the best which have got no failures or the worst which have got some failures, the overall failure rate is 2.7 per 1,000 patients during their lifetime. We call it a lifetime risk, it's not an annual risk - it's a lifetime risk."
Hugo Verhoeven, MD: "What about the learning curve? Is it difficult for doctors to learn to insert or to use a clip like that or is it easy?"
Marcus Filshie, DM, FRCOG, MFFP: "One of the advantageous of it, particularly compared to any other method, it's actually a very, very simple apparatus. It's a simple operation to do and that's one of the attractions."
Hugo Verhoeven, MD: "You mentioned before that if you're using electricity, especially if you're using unipolar, most of the time more of the tube is destroyed as you would like it to be. That's the advantage of the clip: if the clip is inserted correctly, only a small part of the isthmus will be destroyed."
Marcus Filshie, DM, FRCOG, MFFP: "That's correct."
Hugo Verhoeven, MD: "So a microsurgical reanastomosis even laparoscopically must be quite easy. Do you have any information on what the rate of pregnancy is after reversal?"
Marcus Filshie, DM, FRCOG, MFFP: "After microsurgery when you do a small little laparotomy, in other words - an open operation, fertility can be restored to about 80% or 90% of the existing fertility. In other words, if you are in the fertile age group up to, should we say, 35 you would expect an 80%-90% success rate. Obviously, if you're in the forties it would be considerably less because of natural fertility."
Hugo Verhoeven, MD: "The age of the patient and probably also the distance between sterilization and reversal would be important."
Marcus Filshie, DM, FRCOG, MFFP: "That's actually right."
Hugo Verhoeven, MD: "Marcus, what is your biggest competition?"
Marcus Filshie, DM, FRCOG, MFFP: "In America it is certainly the bipolar cautery, and if we look at the failure rates of the bipolar cautery versus the Filshie Clip System one of the most staggering differences between the two is, if there's a pregnancy following a cautery it can often be ectopic. In fact, we're probably talking about two-thirds would be an ectopic pregnancy, whereas with the clip with over twenty years experience it's around about 4%. So that life threatening ectopic pregnancy is very much reduced and I believe that's a consideration."
Hugo Verhoeven, MD: "So despite the fact that your clip is twenty years old, it is still a very reliable and cheap method of contraception. Let's say cheap in our countries and the reversibility rate is quite high so it's still the gold standard together with bipolar coagulation for sterilization, is that correct?"
Marcus Filshie, DM, FRCOG, MFFP: "It is correct, and one thing which has come out in examinations is the failure rate of a correctly applied clip is actually quite rare. It's quite a rare event so if the clip is not totally and completely and correctly placed on the right part of the tube, the tube may not be fully closed and so we've got to look at that situation. But when I talk about the overall failure rate, I'm talking about even correctly applied as well as incorrectly applied, it's 2.7 per 1,000 which I think we would say is pretty acceptable."
Hugo Verhoeven, MD: "May I ask your opinion on the insertion of plugs into the intramural part of the tube?"
Marcus Filshie, DM, FRCOG, MFFP: "You certainly can, in fact, when we started using our clip research in 1974 there was already books published about transcervical hysteroscopic plugs. There have been a lot of plugs that have been invented and developed and suddenly they've all been tried and they haven't really had a good success rate in the market. There are now at least two or three new plug systems, which have been developed and, again, they're very exciting. I think they're very interesting but the bottom line is it seems that only 90%-92% of patients can actually have the operation completed because of the technical problems of looking at the fallopian tube where it comes into the uterus. Now I can't remember ever failing to do an operation whereas if you're going to choose this the doctor will have to tell the patient that he can only do it in 9 out of 10 cases, and if she accepts that that's fine. That's quite a high difficulty rate."
Hugo Verhoeven, MD: "So we are going to use your clip maybe not for a decade but certainly for the next five years, still being the gold standard."
Marcus Filshie, DM, FRCOG, MFFP: "I think it's still going to be a popular decision."
Hugo Verhoeven, MD: "Marcus, thank you very much. It was a pleasure talking to you."
Marcus Filshie, DM, FRCOG, MFFP: "Thank you, Hugo."
Hugo Verhoeven, MD: "Thank you."