Uterine Fibroid Embolization

New Advances in Women's Health Care

A National Conference Meeting Program
October 22 - 23, 1999
McLean, Virginia

On October 22 and 23, I attended the Uterine Fibroid Embolization conference put on by the Society of Cardiovascular and Interventional Radiology. It was a national conference that included both gynecologists and interventional radiologists. It was fascinating for me to attend this conference and a wonderful opportunity to meet a wide variety of physicians interested in the treatment of uterine fibroids.

Forgive my sarcastic commentary that appears from time to time in this report -- all in all, it truly was a well worthwhile experience for me and although certain elements struck a nerve it was still all good to experience.

Friday, October 22, 1999

On Friday, the plenary session was a major dog and pony show by gynecologists describing uterine fibroids and the diagnosis thereof. In addition, they detailed all of the procedures they utilize to treat fibroids. Oddly, their details regarding complications and post-op follow-up were sorely lacking any real content. Here's a breakdown of the presentations on Friday:

This was, by and large, a rather boring series of presentations on everything gynecologists know about fibroids and how THEY treat them. I think you could have put it all in a dixie cup and called it a day. Okay, okay -- in all fairness it was probably educational for the interventional radiologists that this is all new to...but hardly educational to just about any woman who has been diagnosed with uterine fibroids and had them for awhile.

There were a few surprising statistics presented, however. Know those "rapidly growing fibroids" we all have been warned about as being potentially cancerous? You know -- the ones that come with dire warnings of certain death if we don't have a hysterectomy? As it turns out, in 320 cases where "rapidly growing fibroids" were actually diagnosed, there was only a .25% incidence of malignancy.

• As many as 80% of women with fibroids may have adenomyosis. In the majority there are no symptoms.
• Leiomyosarcoma is most common in post-menopausal women in their 50's and 60's and occur around 1% of the time for that age bracket and older. For pre-menopausal women, the risk is around .1%.
• According to ACOG, laparoscopic myomectomy is also considered "investigational" as the "...benefit of laparoscopic removal of leiomyomata has not been established...".

I loved the documentation that was submitted by Dr. Coddington that discussed genetic relationships, hormonal relationships, cytokines and growth factors. Let me sum it up for you: fibroids seem to have a relationship to all of these items but we don't really know what the hell that relationship is yet (and that paper had 67 bibliographic citations). Never mind that gyns have known and written about fibroids for over 100 years now.

There was some info on Pain Mapping that was most interesting. I nearly choked listening to it. Great details on how to diagnose what the hell is going on when a woman presents with pelvic pain and how to determine where it initiates or radiates from so that it can potentially be treated appropriately. I presented with pain to a lot of doctors and the only thing they ever did was recommend hysterectomy. Pain Mapping? Yeah. Right.

Oh, and it was so special how one gyn stood up to say that 50% of the women who present with pelvic pain have been sexually abused. Brother. SHOW ME THE RESEARCH! (You won't find any because it doesn't exist.) Apparently this man sincerely does not understand what it's like to squish a 10 pound bowling ball inside your abdomen and then carry it around with you all day long.

Best presentation of the day was by Dr. Reena Jha as she detailed and demonstrated via slides the differences between ultrasound and MRI in diagnosing fibroids. Damn, I think I can read those things now.

For me, the two areas of discussion that peaked my interest were around the discussion of Lupron as a viable treatment option for fibroids (either as a pre-surgical option for shrinking fibroids for ease in surgery or stand alone treatment with addback therapy) and LACK of discussion or acknowledgement by the gyns of potential for sexual dysfunction post-hysterectomy.

Let's start with Lupron.

Major info around clinical trials and efficacy of this drug. No mention whatsoever of the fact that the doctor repeatedly cited as having led these clinical trials (Dr. Andrew Friedman) who led the way for FDA approval of Lupron for use with fibroids and endometriosis IS NO LONGER A DOCTOR! The man lost his license because he falsified over 80% of the records in his clinical trials. In addition, he was fined $10,000 and was found to have been heavily funded by Tap Pharmaceuticals. According to the Chicago Tribune, even the FBI were involved in this case.

The Federal Register (May 1, 1996; Volume 61, Number 85; Page 19295-19296) reported the following:

"Between 1992 and 1995, Dr. Friedman altered and fabricated information in permanent patient medical records and notes by changing dates, changing and adding text, and fabricating notes for clinical visits that did not occur. Dr. Friedman admitted that he had falsified and fabricated approximately 80 percent of the data in research reports published in Fertility and Sterility (Friedman, A.J. and Hornstein, M.D. 'Gonadotrophin releasing hormone agonist plus estrogen-progestin 'add-back' therapy for endometriosis-related pelvic pain.' Fertility and Sterility 30: 236-41, 1993.), in Obstetrics and Gynecology (Friedman, A.J. and Thomas P.P. 'Does low-dose combination oral contraceptive use affect uterine size or menstrual flow in premenopausal women with leiomyomas?' (Obstetrics and Gynecology, pp. 631-635, 1995.), and in an unpublished manuscript."

So, the presentation on Lupron was pretty incredible in my book because an awful lot of time was spent on it as a treatment modality. THEN, Dr. Richard Falk had the absolute, unmitigated gall, to stand up and speak extensively on the validity of clinical trials and what makes up indisputable research. Boy. Had my mouth hanging in disbelief.

Question I wanted to stand up and ask but was too chicken: When does completely discredited, invalidated research get removed from the medical literature and when do doctors stop quoting from those documents to substantiate what they do today?

During the closing panel Q&A session, Dr. Scott Goodwin got up to ask about impact on sexual function with any of the gynecological procedures for fibroid treatment. It had not been brought up or discussed by the gynecological panel members at all. He asked about reduced or loss of blood flow to the pelvic region with removal of uterus and/or cervix and what and how much did they know about this affecting the sexual function of women undergoing these procedures. Dr. Louis Sanz talked about sex being a matter of "perception", Dr. Coddington talked about women with severe symptoms pre-procedure suddenly having a better sex life post-procedure, and Dr. Falk talked about the Finland studies that showed hysterectomy has no impact on sexual function whatsoever (he didn't, however, indicate "which" Finland studies -- since there are 2 different ones out these days that contradict each other).

Dr. Scott Goodwin was a bit frustrated with those answers and decided to direct his question more specifically towards potential impact of uterine fibroid embolization -- what might the impact of an ischemic injury sustained by the utervaginal plexus that innervates the pelvic organs have on sexual function? Also, would embolization of the uterine arteries possibly compromise the vascular circulation to the cervix, thereby altering its normal physiologic functions crucial to internal orgasms?

:)

Dead silence. Then all 3 men repeated what they had stated previously. Dr. Goodwin gave up and sat down.

Oh boy. Where to even begin. I know -- here's a segment from Dr. Luis Sanz' paper entitled "Different Surgical Approaches to Perform a Hysterectomy":

"...Sexual functioning is usually not affected by hysterectomy unless the patient has a preconceived fear before the surgery that it will change her sexual life. This tends to be less of a problem with a supracervical hysterectomy since the cervix is left in place and the support of the vagina remains intact."

Someone please help me understand this 'cuz I'm real confused as to what this man wrote. In the first sentence he indicates that sexual functioning is a matter of "preconceived fear" implying that sexual function is psychological. In the second sentence he indicates that retention of the cervix reduces sexual functioning problems. Okay Luis -- make up your mind -- is sexual functioning psychological or physiological? Sheesh. Pick a fence post and hang on it buddy. Besides, either way I'd like to nail you to it 'cuz you are clearly clueless.

Okay. That was harsh. My understanding is that Dr. Sanz is an excellent gynecological surgeon. (I still wouldn't trust him with my body.) Why not? Because he also stated this

"As long as the patient is the one making the decision, then they are usually happy with the hysterectomy. This is where the trick comes in."

I'm quite certain that this physician doesn't even understand why that statement was bothersome to me.

Saturday, October 23, 1999

Author disclosure: If you've read My Journal on this website, then you are well aware that I have undergone uterine fibroid embolization. I do have, therefore, some bias towards this procedure as a treatment option for uterine fibroids. I do NOT, however, believe this procedure is for every woman with fibroids and have painstakingly detailed my own journey and both positive and negative side effects from this procedure in My Journal. This procedure has both helped me and hurt me. Nonetheless, I was never given the option of anything other than a hysterectomy until this procedure came along. At this point, I readily accept the bad with the good as it helped me to retain my uterus and avoid major surgery. Had any gynecologist in my history ever acted proactively on my behalf in the diagnosis and treatment of either symptoms or the actual fibroids, I would probably not be writing this report today. Over a dozen gyns for me and, judging from my email, hundreds upon hundreds of additional gyns who are not doing their work in the best interests of the women they serve. Obviously, I have bias. Take it with a grain of salt, read and judge for yourselves based on your own experiences.

On Saturday, the shoe was on the other foot. Time for the interventional radiologists to get up and share what they know and teach each other all about fibroids, patients, and this procedure. Boy did they. I know interventional radiologists don't want to create or perpetuate an adversarial role with gynecologists -- they are trying hard to develop a partnership for all of our sakes -- but the way these guys put the Friday presenters to shame was almost unbearable. Even when the presentations were bad, they were brutally honest and ultimately served a higher purpose toward good. Many complications from cases were detailed and there was even an Informed Consent list of benefits and risks provided in the handout. Whoa. You guys don't seem to understand that this is not information typically presented to patients by gynecologists. At any rate, here's a breakdown of the presentations that occurred on Saturday:

To begin with, I'd have to say that the organization of information that was presented by the interventional radiologists was obviously well thought out and, well, downright anal retentive in nature. Hey, it's a GOOD thing to write this. Trust me. :) The flow of presentations from a) overview of the history of embolotherapy to b) patient evaluation to c) technique for performing the procedure to d) dealing with anatomic variants to e) pain management to f) post-procedural complications was an excellent information map for this procedure from start to finish. There was so much logic involved in what and how the information was presented that I knew, without a doubt, these were not gynecologists.

Ouch. Sorry about that slam. No, actually I'm not. Let me explain why.

In Dr. Sterling's paper Patient Evaluation and Preparation, he opens with the following Learning Objectives:

1. To understand the important clinical criteria used to evaluate patients who are being considered to undergo uterine artery embolization for treatment of their fibroids,
2. To identify the appropriate pre-procedure work-up necessary for patients to have prior to uterine artery embolization,
3. To review the components of the clinical consultation that patients should have prior to uterine artery embolization.

This paper, along with Dr. Sterling's presentation, was a simple and straightforward directive of patient management. Step by step. I'd like to copy this paper and send it to every gynecologist I know. Why? It addresses the patient who presents with fibroids from square one and makes no assumptions about hysterectomy as the primary default procedure. It details symptoms and appropriate diagnostic procedures for patient evaluation and does so in a rational, logistical manner.

My biggest complaint? The lack of recognition that patients who make it all the way to an IR with submucosal fibroids or a pedunculated subserosal fibroid have probably NOT been given the option of myomectomy by their gynecologist. Nope. Nice thought though. Ain't happening guys. Do you honestly think a woman with only a submucosal fibroid would be sitting in your office if a gynecologist had told her that it could be easily resected? Puh-lease. You turn these patients away without asking if their gyn has offered myomectomy and the next thing they do is turn to me online and whine about how NO ONE gives a hoot about them wanting to retain their uterus. You folks included. You turn them away and the next thing the gyn says is "...now don't you think it's time you had that hysterectomy...".

If you are going to carte blanche turn away patients with submucosal or pedunculated subserosal fibroids (yeah -- that was the directive I heard), do us all a favor and give them a referral to a gyn who is amenable to performing a myomectomy. Regardless of the age or fertility desires of the patient. Women need to know they've been honestly presented with all of their true options. Not simply directed back to only a hysterectomy.

But I digress. Dr. Scott Goodwin did a terrific dog and pony with all new slides (I'm told mine was in the pile -- don't think I recognized them though when they popped up -- can't imagine why not). Loved the Informed Consent document in the conference handout. Actually saw and overheard several IRs say they were going to have to update theirs when they got back home. Major audience whispering over items on the RISKS portion of the consent document -- including sexual dysfunction. Interesting. Most interesting. I don't recall seeing any informed consent documents in the literature provided by the gynecologists. Hmm. Don't recall a discussion about it either.

Oh yes. Rob. Dear sweet Rob. He's performed more UFEs than any other interventional radiologist in the world. Dr. Robert Worthington-Kirsch took the podium next. I want to be kind. I want to be kind. I want to be kind. Sat down to a nice lunch with Dr. Kirsch at the table on Friday. Was civil and all -- considering our past email to one another. I'm trying to be kind. Damn. I can't. Will somebody please sidle up to this man and explain to him the definition of INFORMED CONSENT? Please. His presentation on anatomic variants was actually quite interesting...up until the point where he described how he gets patient permission to proceed with partial ovarian artery embolization...oh dear. Ladies, here's the lesson: When you are undergoing a procedure and sedated in any way, shape or form and in the middle of that procedure the physician asks permission to do something that was NOT discussed OR approved PRIOR to your sedation, any decision you make and communicate to that physician is NOT considered informed consent. 'Nuff said.

That was hard. Sorry Rob. I didn't give the gynecologists any slack -- can't go around making exceptions for interventional radiologists when they say incredulous things. Discuss and gain approval for what you might have to embolize during a procedure while the woman is sitting in your office in the pre-procedure consult. Not during the procedure.

Pain management presented by Dr. John Lipman and complications presented by Dr. Woodruff Walker netted some rather interesting descriptions of patient situations. In John's case, he discussed a patient that continued to have persistent pain after embolization with no shrinkage of the fibroids. Turned out to be uterine sarcoma. She subsequently underwent hysterectomy.

Dr. Woodruff Walker talked about a patient he considers "...a walking timebomb...". Her fibroid uterus at embolization was 30 weeks in size. At 18 months post UFE, she began having pain but still refuses to undergo hysterectomy. I cringed at hearing this story as it reminded me of my own journal entry awhile back on the topic of Flowers for Algernon. Until more time has passed and more is known about patient selection / patient outcome from this procedure, all of us who have chosen this procedure are subject to a potentially "as-of-yet unknown" complication. Thanks to meetings like this conference, IRs can share notes and eliminate patient selections that are fraught with potential for poor patient outcome.

On the subject of death. There have been two. The first was a 65 year old patient in Milan who had two, rather small, fibroids. She died of pulmonary embolus within 24 hours of the procedure. Not a lot of details are available on this case but it was most certainly an odd set of circumstances under which this woman was embolized.

The second death is the one reported on the Death Update webpage for UFE.

While the rest of the presentations were interesting, they dealt more with the business of getting patients, putting together clinical trials, working more closely with gynecologists, talking to the media, and getting payment out of the insurance companies. Not nearly as interesting as procedural information -- in my book, that is.

Dr. James Spies announced that a protocol to study UAE with patients who have pure adenomyosis and NO fibroids was recently approved. No details were given but it is interesting to note that they want to differentiate this disease and try to determine if blocking the blood flow through the uterine artery has any impact. If it proves successful, this would be a definite breakthrough for women suffering from symptoms of adenomyosis.

Dorothy Pirovano gave a rather interesting presentation on giving interviews to the media. I'm not sure, but I think the bottom line of her message was: what gets published or broadcast isn't really within your control...but isn't it terrific that you're getting coverage? Oy. In reading her materials in the conference handouts, I learned that I should never criticize the media. Oh dear. Guess I better take that Good Morning America slam off my UFE and Fertility webpage.

On a final note: insurance. Who's paying. Who's not. Why not. How many hoops do we have to jump through to get paid around here? Basically, I didn't hear that the status quo has changed much. Michael Mabry did indicate that Blue Cross Blue Shield is looking for the completion of a randomized controlled trial -- the highest level of proof in a clinical trial -- for efficacy of this procedure. Gee. One hasn't even been started yet. So far, only case series (and quite a few of them) have been done. Good enough for the little guys (like Aetna or United Healthcare) but not good enough for the big boys -- like Blue Cross.

All in all, a most informative two days well spent.

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