A new device for Mechanical Contraception and Uterine Septa; should we resect them?

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Dr. Hugo Verhoeven:  “My name is Hugo Verhoeven, and I am on the Editorial Board of OBGYN.net. I’m reporting from the 9th Annual Congress of the International Society for Gynecologic Endoscopy at the Gold Coast in Queensland, and it’s my honor to interview Rafael Valle. He is Professor at the Department of Obstetrics and Gynecology, Northwestern University Chicago and certainly one of the leading experts in the field of hysteroscopy and general endoscopy. Rafael, it’s a great honor for me to have the chance to talk to you. I selected two topics, the first one is a new device for mechanical contraception, and a second topic is uterine septa and whether we have to remove them or not. So let’s start with contraceptive devices - what was available until now, and what were the advantages and the disadvantages of those devices we put in the past into the uterus?”

Professor Valle: “First of all, thank you very much for inviting me to share with you my ideas and opinions about these topics. As you probably remember, in the early seventies there was a tremendous enthusiasm in introducing intratubal devices to occlude the fallopian tubes because it seemed from the logical and mechanical point of view that it was very simple. Using hysteroscopy, the tubes could be reached and then plugged, and that raised enormous interest from physicians, clinicians, and investigators to try different tubal plugs. Some of them were made of metal, some of Dacron tissue to promote tissue in-growth (promoting growth), and some of them were from polyethylene. However, the problem then was that technology was not advanced enough to manufacture those plugs appropriately and keep them anchored in the intramural portion, number one. Number two - there was a great enthusiasm to make these plugs reversible, like an IUD. That means place them and remove them if the patient decided to have more children, so reversibility was a main objective as well. Devices designed for this purpose could not occlude, in the majority of patients, the fallopian tube, on the other hand they could be removed to re-establish fertility.”

Dr. Hugo Verhoeven:  “So the failure rate was high?”

Professor Valle: “The failure rate was very high and the complication rate of those methods that approached more the concept of being permanent was too high because the tubal occlusion was by unipolar electrocoagulation. Therefore, within four or five years the interest declined and nothing else came into the investigation phase until maybe a year ago when we looked at new technology, and other devices were designed. Designs not having the problems those previous devices had. Number one - to be able to anchor acutely so they don’t dislodge once you put it in, and number two – to be sure that they completely occlude the fallopian tube, and the only way that this can be achieved is to combine the action of acute anchoring by the device at insertion and the tubal occlusion by forming a permanent scar. Like the one manufactured by Conceptus, which is a coil that has memory and while inserted in a delivery tube of 1 mm it keeps its memory of expansion, and once it’s deployed in the intramural portion, it expands and anchors mechanically. Furthermore, the plug also has tissue that is biocompatible and made of Dacron. Dacron is used in heart valves to protect and suture the valves when they rupture. Dacron is used for aneurisms; and in other types of vascular surgery so it’s biocompatible and can be used permanently in the human body without rejection or reaction problems. This tissue will promote tubal occlusion. So with this concept, the investigation really began to prove or disprove this was feasible. The company acted upon the idea of placing these devices in patients that eventually will have hysterectomy for medical reasons but they were willing to wait at least three months so we could see what would happen with the tissue at that level.”

Dr. Hugo Verhoeven:  “So, what happens to the tissue?”

Professor Valle: “What happened is that we observed in all women that were subjected to a hysterectomy two to three months after the placement of these devices, there was a local benign reaction of tissue with destruction of tubal epithelium and lamina propria and complete tubal occlusion. Tissue from the tubes grows into this mesh, and in all cases that we did a histological evaluation, there was complete occlusion. This was very good because we first of all demonstrated that not only there is acute anchoring but also chronic anchoring which is most important with total tubal occlusion. Furthermore, we were very interested to see that this reaction began at the tubal wall, it didn’t go through the wall, not to the serosa, and about 5 mm away from the distal portion of the device the tube was completely normal. Of course this is the first step and that’s what it has to be offered as permanent contraception because in order to, let’s assume, reverse this if the word is appropriate, you have to do segmental resection and anastomosis. So there is a warning, it’s better to use now the newer developed reproductive technologies in vitro fertilization and embryo transfer and avoid surgery. At this moment, based on those evaluations by histology, we are beginning clinical trials on patients with informed consent, approved by the ethical committee of each institution, and they’re being asked to volunteer for this type of sterilization and the response has been overwhelming. That means that we have many patients, some of them nurses that inquired about this and they volunteer to have this device implanted.”

Dr. Hugo Verhoeven:  “So let’s now go back to the technique. You insert those plugs hysteroscopically, is it under general anesthesia or local anesthesia?”

Professor Valle: “One of the good things is that the catheter that deploys the plug is only 1 mm so it can be passed through a 5-French operating channel. Today we have hysteroscopes that we didn’t have in the early seventies that are 4-mm and 5-mm in diameter and have this type of channel. Therefore, we don’t have to dilate the cervix, so this permits us to insert those plugs under local anesthetic. Some very selective patients can have it done with no anesthesia; maybe a steroid anti-inflammatory agent fifteen minutes before and they tolerate it well. Of course selection is very important.”

Dr. Hugo Verhoeven:  “What about pain after the procedure?”

Professor Valle: “They end up after the procedure amazingly with practically no pain. We subjected these patients who were having the plugs inserted three months before the hysterectomy, to rigorous follow-up, and the pain in some patients was very minimal like a menstrual cramp on the first or second day but within a week more than 90% did not have any pain.”

Dr. Hugo Verhoeven:  “So to conclude, we have a new way of permanent contraception. It’s an easy technique, and it’s an outpatient technique. I think it may also be a cheap technique. What is the cost for the patients?”

Professor Valle: “Today, we don’t yet have those values to tell you, but I assume that it will be inexpensive due to the fact that it’s going to be performed under local anesthesia in an ambulatory setting and perhaps in an office setting. Furthermore, let me answer regarding my vision for the future. Not only for this device but I am almost positive that within 3, 4, or 5 years, other companies are going to come up with similar devices. Although the hysteroscopic placement is now emphasized, I don’t think this is very unique to hysteroscopy. Because ultrasound technology has advanced tremendously even if you don’t use 3-D ultrasound, because the device is echogenic it can be placed under ultrasound. It can also be placed under fluoroscopy, so the radiologist will have a field for insertion as well in case somebody doesn’t have a hysteroscope so there are going to be three approaches, it will depend on the imaging technique but I have a hunch that these devices may be placed very fast just with plain sonography.”

Dr. Hugo Verhoeven:  “So that means that the time that we were doing permanent contraception by laparoscopy, using clips or coagulation, could be over soon.”

Professor Valle: “I would not go as far as to predict that but certainly this is going to be a good alternative because all women fear an incision and general anesthesia. That’s why we see a resurgence of laparoscopy under local anesthesia but still it’s not as simple and maybe the possibility of serious morbidity, the patients have to recover, they have to use some type of analgesics thereafter, and the little incision is still evident there, and women prefer not to have incisions.”

Dr. Hugo Verhoeven:  “This new plug is still experimental?

ProfessorValle: “In the way that it still needs to complete the clinical trials to be used in the routine clinical setting, yes, I would say it’s experimental. It’s not experimental in the sense that the phase 1 which was the placement of these devices in women who require a hysterectomy is over but still we had to put a significant number of patients to the test and the test is to see what’s going to happen. It will be very difficult to predict that all fallopian tubes will occlude. There is absolutely no method of contraception today that is 100% but we have to see what happens if a woman gets pregnant in the uterus perhaps even in the tube or something similar is going to happen, as it happens when any other method of tubal sterilization, fails. But I have a hunch that the failure rate is not going to be any higher.”

Dr. Hugo Verhoeven: “Thank you very much for this first part of the interview. Now we’re coming to the second part as I stated before, the significance of septa and the indications for hysteroscopic removal. Let me ask you about your thoughts on this topic?”

Professor Valle: “The uterine septum is a uterine anomaly that in the majority of women who have them do not cause any problems in reproduction but 20%-25% may suffer from repetitive abortions, and that is very difficult for any woman to bear. I remember what a very famous infertility doctor in the United States, John Rock, used to say, “infertility is a sad affliction but not being able to carry a pregnancy despite conception that’s worse.” So when it happens, the only treatment that was available until the late seventies was to do a laparotomy - open the abdomen, divide the uterus – hysterotomy, and then divide the septum and reconstruct the uterus. Not a difficult operation but tremendously taxing because it requires a laparotomy and a hysterotomy, and the woman requires a mandatory caesarian section. She cannot get pregnant for 4, 5, or 6 months and some of them end up with secondary infertility due to pelvic adhesions. So despite that only 20%-25% of these women may have problems with reproduction, when they do, they require treatment and the only treatment available is surgical. Now with the introduction of hysteroscopic techniques, you can bypass all the drawbacks of the classical abdominal metroplasty operation and then divide the septum hysteroscopically very elegantly, very simply, and with very low morbidity in all these women.”

Dr. Hugo Verhoeven: “The question is, of course: it’s not because a technique is available that we should treat every septum that we see during hysteroscopy.”

Professor Valle: “Absolutely, you are absolutely correct. So we treat primarily those that have problems of early abortions and first, we eliminate other risks for spontaneous abortions” 

Dr. Hugo Verhoeven: “Waiting until the patient has two or more abortions?

Professor Valle: “That’s a very good question because you see originally when you have to do these operations by laparotomy, there was a classical definition of repetitive abortions that was used, and the woman had to abort at least three times. Those definitions are gone. Today, if a woman aborts once, particularly if it carries through the first trimester, I think it’s not appropriate to see if she’s going to abort a second time. Why? Because if you eliminate the most frequent reasons for abortions; chromosomal abnormalities or some type of endocrinopathy and you find her evaluation normal, but you find the septum, it’s better to treat it because the simplicity is greater than the laparotomy done before. Now the question arises; what are we doing with septa found in infertile patients, infertile for other reasons like tubal occlusion, and these septa are found during routine hysteroscopy. Should we remove these septa? I think the tendency, although the data is not available, is to treat these patients because the majority certainly will need expensive treatments, be it ovulation induction or be it one of the new reproductive technologies particularly in vitro fertilization and embryo transfer. I think it’s an error, and you as a specialist in that field will agree with me, to subject the patient to in vitro fertilization and embryo transfer without treating the septum. Of course you are going to have implantation, but with 25% chance of failure; you should avoid this rate of abortion.”

Dr. Hugo Verhoeven: “So the conclusion would be: technology is available and easy. Why not treating every septum we see in the infertile patient, even if we cannot say it’s absolutely necessary to do it? We don’t lose anything, and it’s not an invasive procedure for the patient.”

Professor Valle: “I think that’s a crucial point and although I cannot offer you any data, I have the tendency to do that.” 

Dr. Hugo Verhoeven: “So, hysteroscopy to look actively for septa should be part of the screening of all infertile patients?”

Professor Valle: “Exactly.”

Dr. Hugo Verhoeven: “My final question is the following, I’m doing quite a lot of hysteroscopies, it’s seldom that I find real pathology at all and it is seldom that I see real septa. In your experience, what is the percentage of infertile patients presenting a septum? Is it more than 1%-2%?”

Professor Valle: “Less than that, at maximum 1%-2%, but remember the population I see is more selected, as physicians screen their patients and if somebody finds an anomaly, some are sent to me for treatment, but in routine screening, you are correct, I don’t think you will reach more than 2%.”

Dr. Hugo Verhoeven: “Rafael, thank you very for this interview.”

Professor Valle: “Anytime.”

Dr. Hugo Verhoeven: “Thank you.”