Dr. Paul Indman: "I think we're very, very fortunate today to have with us both Dr. Brooks and Dr. Loffer, who bring a wealth of experience in alternatives to hysterectomy. I think it's one thing to develop a new technique, do it for a few weeks, promote it, and it's another to have been around long enough to have been involved in the development and to see what happens over a long period of time. Are these ideas good - many will be and some may not be so good. We've heard a lot about alternatives to hysterectomy over the past week at the AAGL. What are your thoughts about the different techniques that have been proposed?"
Dr. Phillip Brooks: "Clearly, Paul, we have to look at what patients need, what they want, and what they desire. There is a very strong trend towards conserving organs as much as possible, and a lot of women will choose - and have a right to - preserving the uterus if at all possible. What we're really talking about is obviously not cancer and not prolapse but we're talking about benign conditions that can be treated with either extensive surgery - like hysterectomy or with other procedures, such as hysteroscopic surgery, endometrial resection, or rollerball with electricity. We're talking about balloon therapy using heat to destroy the endometrium, and that's something that Dr. Loffer has been one of the great pioneers in this new modality. We're talking about embolization, a procedure that was mentioned on network television not too long ago. But without a full expanse of some of the pros and cons, we're talking about myomectomy or even myolysis which are transabdominal techniques to destroy the fibroids either surgically to remove them with a laparoscope or by open incision or by injecting needles and destroying the circulation. So those are the basic fields that we're looking at right now that are available to patients, and they should give them a choice and an option instead of hysterectomy."
Dr. Paul Indman: "Let's talk about fibroids for just a minute. Traditionally, if a woman has fibroids that are large enough to cause symptoms, she'll be offered either a hysterectomy or a myomectomy. Now there are choices of whether a myomectomy is done through an incision or through the laparoscope, and there are some newer procedures that are being proposed, such as myolysis and uterine artery embolization. Dr. Loffer, what is your feeling about this? I know I get phone calls from patients saying - do you do this procedure, I have a fibroid I want a uterine artery embolization. What would you tell your patients?"
Dr. Franklin Loffer: "I think the first question that needs to be asked is what type of symptoms are you experiencing? If it's a matter of bleeding or if it's a matter of pressure symptoms, you may want to approach it in a different fashion. Bleeding problems very frequently can be managed either by endometrial ablation or hysteroscopic resection of fibroids. The techniques that destroy the fibroid without actually removing it have gained a lot in recent popularity, specifically - arterial embolization. We know the short-term results and intermediate results but we still don't know the long term results."
Dr. Paul Indman: "Dr. Brooks, I know they've been doing uterine artery embolization in Los Angeles. What can you tell me about what you've seen or have heard about the procedure? Are all the women doing well, immediately getting up, and going home?"
Dr. Phillip Brooks: "I just heard a presentation by the interventional radiologist who does this at UCLA. Just briefly to describe it for your audience - it's basically a technique where they put little microspheres, tiny little spheres, into the blood vessels that block off the circulation to the fibroid. In essence, it would kill the fibroid or decrease it's oxygen supply, the fibroid would stop growing or, hopefully, even shrink. Number one, the procedure is highly investigational and should be considered investigational until we have more data and long term follow-ups to see about it's ultimate success. I have some concerns about the long-term effects on this type of procedure. Although there have been a hand full of patients throughout the world that have been reported to be able to conceive following embolization of fibroids and have a baby, there are not enough to know whether or not this is a real conservative operation for women who want to preserve their fertility. So I would never recommend it for somebody who is planning on having a baby after doing this procedure. Secondly, the most significant problem is that virtually all of these patients are admitted overnight with intense discomfort - severe pain - and on narcotics for at least overnight. So the amount of pain that is engendered by this operation seems to be exceedingly high and patients need to know that. Thirdly, they have a 10% hysterectomy rate, some of those patients are done immediately as an emergency. In a patient who wants to preserve her uterus to have that high hysterectomy rate and a 22% failure rate in not controlling the growth and development of those fibroids overall, and the patients who continue to bleed or have severe pain and need intervention - the point is, 22% is not very good. And I don't know about the long-term effects. There have been studies all over the world where those numbers have been reported as not quite so high but still it is not a benign and simple procedure. So until we have a long term efficacy, until we know that it's going to last for a while, I am hesitant to recommend it as a routine for my patients."
Dr. Paul Indman: "Now in an interview we did with Dr. Hutchinson, who has been doing a lot of these procedures, he argues that the fibroid is dead, we've killed the fibroid, it can't grow back. What is your reaction to that, Dr. Loffer?"
Dr. Franklin Loffer: "I don't think that they can say for sure that they've killed the fibroid. They have certainly severely damaged it, that's why some of these problems develop. They also don't destroy every potential fibroid that exists in the uterus. We know fibroids are more often than not a multiple problem, multiple areas of fibroids and they don't solve the problems of fibroids forever. They may kill off a single fibroid, they may severely damage it, but their potential still exists."
Dr. Paul Indman: "Another technology that's also been advocated is something called "myolysis" where essentially we're cooking the fibroid, either with laser or electricity going in through the laparoscope. Do you think that's a good idea?"
Dr. Franklin Loffer: "I think one of one defects in any destructive procedure is that you don't know the histology. If you don't know for sure exactly what you're destroying, you may have attempted to destroy a cancer - a sarcoma. I think that's a defect in both of these methods."
Dr. Phillip Brooks: "Let me just add one thing, I think before we get too deep into this discussion, I think it's really important to understand that just because a woman has a fibroid doesn't mean that something needs to be done about it. Fibroids occur in probably one out of three women over the age of thirty. They're incredibly common, they're multiple, and what you may get rid of today, she'll grow new ones five years from today. But the point is that if the fibroids don't bother her, they really don't need to be removed. Just because you have them doesn't mean that they need to be surgically removed. You need to understand that a asymptomatic woman with fibroids - unless they are huge and causing pressure symptoms or rapid growth or suspicious problems with configuration unless they cause excessive bleeding - I think, they can be very successfully watched. They mostly stop growing at the onset of menopause anyhow, and many patients can be carried into that with just observation. So unless they're symptomatic and something needs to be done, I'm not so sure that any of these techniques are necessary."
Dr. Paul Indman: "I think that's a very important point Dr. Brooks, because I have many women coming to ask me about the latest treatment for their fibroids that don't need treatment at all. Just because they're there, that doesn't mean we have to do anything about them. In getting back to some of new technologies, let's say that a woman comes in - she has large fibroids, they're up to her bellybutton, and they've been growing somewhat slowly. She's now forty-two years old, her periods are pretty heavy, and she feels like she's carrying a bowling ball around in her stomach. She says, "Doctor, what should I do?" What would you tell her, Dr. Loffer?"
Dr. Franklin Loffer: "I would try to access what her feelings were about a hysterectomy. There's still a place for hysterectomy in the management of fibroids. Describing fibroids at the umbilicus, probably in an older patient where fertility is not an issue, you could do a lot of piece meal things - you can try to embolize them, or necrose them, or you can try to just remove the fibroid and leave the uterus. But I think an option that needs to be on the table and the patient needs to understand is the definitive treatment is a hysterectomy."
Dr. Paul Indman: "Why would that be better than a myomectomy?"
Dr. Franklin Loffer: "A myomectomy can be a major procedure. There's frequently blood loss associated with it, there's a potential of scarring and causing that pelvic pain and dyspareunia or pain with intercourse, and many times it's technically more difficult than a hysterectomy to do. And doing a hysterectomy, you don't necessarily need to remove the ovaries. I think patients frequently forget that fact."
Dr. Paul Indman: "Dr. Brooks, you do a lot of laparoscopy, as well as hysteroscopy, and I think it's important to point out that Dr. Loffer does too. What would your thoughts be about doing a laparoscopic myomectomy in this woman?"
Dr. Phillip Brooks: "When they're up to the umbilicus or larger, it's very difficult to maneuver, you can't get back far enough to appropriately approach it. I think what Dr. Loffer did mention is that many a times when a uterus is enlarged by fibroids up to the umbilicus or higher, those are usually and very often multiple fibroids. I've taken as much as fifty-two fibroids out of one uterus with the intent of preserving it. But I will tell you - it's a longer surgery, it's tedious, there's much more breakdown of tissue and fever afterward but this is a young woman wanted very desperately to save her uterus, and it's her right to have that done. It was a difficult procedure, and we did salvage and save a pretty good-looking uterus when we were done but it's not an easy surgery. Most fibroids are multiple so that when you have lots of fibroids, myomectomy is more risky, it's more fraught with postoperative complications than a hysterectomy would be in that case. So there still is a place for hysterectomy in some patients. But I think, as Dr. Loffer said, you need to sit down, discuss the desires, the needs, the wants, and some of the cultural aspects of hysterectomy with the patients. We can't ignore a patient's needs and wants, as well as the medical problems. We have to talk about all of it as a total picture and include what the impact of that hysterectomy will be on this woman's life and social involvement."
Dr. Paul Indman: "I think that's a very important point because this isn't a political issue, this is what's best for an individual patient - Dr. Loffer."
Dr. Franklin Loffer: "Given the situation where a hysterectomy is not acceptable to the patient for whatever reason, cultural, age, whatever, and she has large fibroids, one of the things that needs to be considered is the use of an agent to suppress and decrease their size. GnRH analogues are appropriately used to make surgery easier in the patient who has large fibroids."
Dr. Paul Indman: "Now, do they offer any long term benefit instead of surgery?"
Dr. Franklin Loffer: "They don't replace surgery, they work as long as you take them. There are problems in long term usage, specifically, the fact that it creates an artificial menopause has the bone loss issue."
Dr. Paul Indman: "While we still have just a few more minutes, I would like to explore one subject and that's balloon ablation. Will the balloon ablation replace standard endometrial ablation, Dr. Loffer?"
Dr. Franklin Loffer: "I think what balloon ablation will do is allow more physicians to feel comfortable in doing endometrial ablation, and therefore, more patients will have it as an option. Endometrial ablation technically requires a great deal of skill. It requires a long learning curve, and for that reason, it has not become a popular method of managing women with menorrhagia. A lot of our colleagues simply haven't learned or developed the skills in them. The newer balloon ablation methods allow an individual to ablate a patient without the necessity of developing hysteroscopic skills. So I think its primary benefit is it's going to allow more physicians to offer this alternative to their patients."
Dr. Paul Indman: "Dr. Brooks, could you commit on the difference between the two balloons?"
Dr. Phillip Brooks: "Basically, the difference is the ThermaChoice balloon is a distension balloon, like a plastic polymer-type of thing. It uses the technology of hot water to heat the uterine lining, denature the protein, and seal the blood vessels. Whereas the Vesta balloon is a similar polymer but it has electrical plates on the outer surface, it uses electricity to generate the heat and the Thermal damage to the cells instead of hot water. The exciting thing is as we look at the data, and you know we need a longer time period to see how it will hold up but for both of them, the data submitted to FDA are fairly similar -both offer a substantial benefit to patients. They're certainly not as effective as a hysterectomy but they offer a safe alternative without the risks of the resectoscopic or hysteroscopic surgery, especially in the hands of people without vast experience and technical skills. So I think it does offer an opportunity for patients to have some benefits."
Dr. Franklin Loffer: "I think it's very important to point out that the procedure is designed for women of menstruating age who have menorrhagia that's not related to a malignant or pre-malignant condition. Their use in patients who have fibroids is severely limited - submucosal fibroids. This is not a problem that solves all bleeding issues for women. There are some special indications in post-menopausal women but, by and large, the burden is on the physician and the post-menopausal patient with abnormal bleeding to determine what the cause is. More often than not - a balloon ablation is not an appropriate procedure."
Dr. Paul Indman: "Dr. Brooks."
Dr. Phillip Brooks: "I think it's important to emphasis that we're not saying that you don't need to know how to use a hysteroscope and be able to do this. Patients must be very thoroughly and very carefully worked up in order to be adequately managed by these techniques. I think hysteroscopy is essential, and you're hearing this from a hysteroscopist so, of course, I would say that all the time. But I think hysteroscopy is essential in evaluating the uterine cavity in patients who have abnormal bleeding, particularly, menorrhagia patterns and to sample or adequately assess the uterine lining to make sure no hyperplasia or significant atypia exists before you destroy the uterine lining."
Dr. Paul Indman: "Dr. Loffer, do you find that most women coming into your practice who have abnormal bleeding understand what hysteroscopy is and how this does fit into their evaluation?"
Dr. Franklin Loffer: "No, actually I've been amazed with the increasing interest women have in their bodies and what's available to them but this is one subject that they haven't explored in a great depth. Certainly some women understand the issues, they've surfed the web, they know what's out there but the vast majority of my patients are really educated for the first time about hysteroscopy in my office."
Dr. Phillip Brooks: "Let me add that I really want to congratulate OBGYN.net because of their educating patients and educating the public about such things as hysteroscopy. I've been very impressed that it's been one of the early aspects of your presentations. I'm really pleased to see that your coverage in educating patients about hysteroscopy has been so good."
Dr. Paul Indman: "Just to help put this in perspective, if we're evaluating someone with abnormal bleeding and she comes in, her uterus is enlarged to about twice the normal size, she's tried birth control pills - she gets migraine headaches. She's tried anti-inflammatories - she has an ulcer and can't take them. She says, "Doc, I just need to do something - what would be best?" How would you explain her options to her, Dr. Loffer, and help her make that decision?"
Dr. Franklin Loffer: "Every patient I talk to about abnormal bleeding, I like to put out on the table at the very beginning what I see are the four options that are available to her. I tell her ahead of time these are not necessarily going to apply to you, and you've already described a patient where several of them don't apply. But I point out to them - unless the bleeding is causing a problem, it doesn't have to be managed. Secondly, we frequently can use medications to manage it. Your hypothetical patient, both of those don't apply to her, and then I usually say the third option. And I use hysterectomy as a third option because they all know about that, and then I tell them that there are some potential options of operating within the uterus that may avoid a hysterectomy."
Dr. Paul Indman: "Dr. Brooks, when we talk about the surgical options, and in particular, the alternatives to hysterectomy - how would you explain to her or help her choose between the newer options? Let's say she has small fibroids - a uterine artery embolization vs. balloon ablation vs. resection of the myoma with a resectoscope, what we've been doing for years."
Dr. Phillip Brooks: "I think I would try and discuss the pros and cons of all of those issues. This is really the bottom line of informed consent that I respect my patient's right to understand these things, to make those choices, and even for things that I possibly don't have access to. If there is a new research project or a new technology that's being studied somewhere and I think it might be appropriate, I would suggest to the patient that they could try and get on one of the studies that are going on in something new that's being evaluated. But the bottom line is - you need to give them the pros and cons - you need to tell them. There is nothing that is a 100%, and there is nothing that is ideal and optimum for every patient. So you give them the options, you give them the pros and cons, and you have them participate in the decision. There are a lot of patients who come and say - Doctor, what would you do or what would you do if I was your wife - and certainly that is putting the responsibility of me making a decision as what might be best for this patient. And I do that sometimes but I don't do that without thoroughly telling them the pros and cons of the other options that Dr. Loffer has just put on the table to spell out. I wouldn't choose one without telling the patient what else exists. If they concur with my choice, then that is their choice based upon the fact that together we made that decision."
Dr. Paul Indman: "I think that's very important, and I think this is an excellent discussion with Dr. Brooks and Dr. Loffer. I think we all agree that a woman needs to understand her options available, and women today are capable of understanding the options available. They are able to understand what the problems are that's causing their bleeding, what we do to find out, and women are able to understand the advantages and disadvantages of treatments that are available. Many of the answers that are requested are questions we're all asking - are these new procedures good, the studies haven't been done. They've been done a year or two, there have been some side effects, most patients have done okay and some haven't. Should I have that - I don't know, ask in ten years. I think every woman needs to decide whether she wants to try a new procedure and be on the leading edge of something that may be a good idea or may not be such a good idea or whether she would like to try something that is tried and true. Thank you very much."