Dr. Parker's Fibroids Blog

Dr. Parker’s Discharge Instructions and Suggestions after Laparoscopic Surgery

February 23, 2015 – 8:28 am

UCLA Gyn Subspecialties Group
1450 Tenth Street, Suite 404
Santa Monica, CA, 90401
(310) 451 8144 (phone)

Disclaimer: it is important for you to follow your own doctor’s instructions.

ACTIVITY AFTER SURGERY:

No strenuous exercise or intercourse for 2 weeks
You may start walking for exercise on day 1
- Walking is the best activity following surgery. You can walk up and down stairs, outside, and on a treadmill. Walking will keep your circulation going and build back your stamina.
Fatigue – fatigue is extremely common after surgery and may last many weeks.
Iron – to help build back any blood lost during surgery. Either Fergon or SlowFe – 1-3 times a day along with 1,000mg of vitamin C (helps with the absorption of iron)
You may start driving when you are no longer taking narcotic pain medication and you feel it is SAFE for you to drive.
Showers only (no baths) for the first 2 weeks.

PAIN/DISCOMFORT MANAGEMENT

For pain, we will prescribe either Norco 5/320mg or Percocet 5/325mg for you to take once you get home.
- Days 2-3 may be worst, pain-wise
- Some cramping and shooting pains are normal, even in areas away from the incisions
- Do not drive under the influence of narcotic pain medication
Lowering, raising and turning yourself will hurt (try using your arms instead of abs)
Urination may burn/pinch initially, but will get easier (avoiding caffeine). Taking D-Mannose helps.
Shoulder Pain – In order to see the pelvic organs during laparoscopic surgery, we need to put carbon dioxide gas (CO2) into the abdomen which pushes the bowel out of the way. If the CO2 is left in the abdomen, it can irritate the nerve under the diaphragms. This nerve runs close to the nerves for your shoulder and the gas will cause shoulder and back pain. The pain can be sharp and can last for a day or two. Sometimes changing position can help, but over time the pain will go away.

INCISIONS

Depending on the type of laparoscopic surgery you have, you will have either 2, 3 or 4 small incisions. Usually the first 1/2 inch incision is made in the navel. For a laparoscopic myomectomy, a 1/3 inch incision is made a few inches to the left of the navel and another incision is made a few inches to the right side of the navel. The last incision is about 3/4 inch and is placed on the right side above the hip bone. For larger fibroids, the incisions will be higher. For laparoscopic hysterectomy the right side smaller incision is not necessary.

At the end of the surgery, I inject local anesthesia into the incisions which provides a few hours of some pain relief. You will likely have some pain in the recovery room and then nurses will give you pain medication as needed. When the local anesthesia wears off, you will have some incisional pain and, during your pre-op visit to the office, we will give you a prescription for pain medication to take at home. The larger incision on the right side tends to be uncomfortable for a few weeks since it is larger, gets more sutures and is close to a nerve.

It is OK to shower with steri-strips (do not scrub the wounds). You can remove the steri-strips after a week. After the steri-strips are removed, I suggest you buy Scar Away at the drug store. Scar away is a silicon bandage (like a large band-aid) that you can cut into small strips and put over the incisions for as many hours a day as you can. Over time, the Scar Away thins and lightens the incisions so that they heal more nicely.
Bruising: bruising around the incision(s) is very common, even beyond the surgery area, for a few weeks after surgery. Cold packs can keep the incision swelling down and the bruising will go away by itself.
Lumpy Incisions – the sutures dissolve by themselves and are replaced by collagen scar tissue. Initially, the collagen is thick and may be bumpy. Over the next few months the initial collagen is replaced by a softer type of collagen and the bumps will go away.

DIET AND BOWEL ISSUES

No dietary restrictions
- Avoid foods that cause gas such as broccoli, cauliflower and brussel sprouts
No alcohol if taking narcotic pain medications
Chewing gum helps with bowel function
Walking helps bowel function
Constipation is unusual after laparoscopic surgery. But, if you have constipation you may take Metamucil or Colace as needed (over-the-cunter).
Expect some gas discomfort/pain. Gas pain can be relieved by walking, taking medication (Mylicon, Gas-X) and chewing gum. Bending your legs while lying on your back may also help.
Bloating (“swelly belly”) is normal for up to 2-4 weeks and will go away by itself. Surgery irritates and slows down the intestines and they retain more gas and stool.

PERIODS

Some bleeding and/or clumpy discharge is normal for a few weeks.
Periods won’t be normal again for 3-4 cycles – they may be heavy, light, long, short – anything can happen while you are healing.

CALL US AT 310-451-8144 FOR:

Fever over 100.4 degrees F, bad pain unrelieved by pain medications, heavy bleeding, vomiting, dizziness, pus-like drainage from the wound or other concerns.

SUGGESTED TO WEAR/BRING TO THE HOSPITAL

Comfortable slip-on flat shoes
Pants or skirt with elastic or drawstring waistband
Pillow for the car ride home (leave in car to put between your stomach and seat belt)
Lip balm (your mouth may be parched)
Your ID
Advance directives (optional)

BEFORE SURGERY – SUGGESTED SHOPPING LIST

Throat lozenges: Sometimes the tube placed down your windpipe (trachea) can cause irritation which can feel like a sore throat. At times, this irritation can lead to a not very pleasant feeling cough. Lozenges can help soothe your throat and also help minimize the coughing.
Stool softener: Many types are available: Smooth Move tea, Colace, Peri-Colace (stool softener and mild laxative together). High-fiber foods.
Anti-gas pains: Mylicon, Maalox, Gas-X or peppermint tea
Three days of groceries/easy-prep foods, since you won’t feel like cooking. Consider broth/soup, fruits + veggies (avoid gassy ones like broccoli, cauliflower and Brussels sprouts), rice, crackers, juice, yogurt.

BEFORE MYOMECTOMY

We ask women to insert 2 tablets (Cytotec) vaginally about 2 hours before surgery. Cytotec has been shown to decrease blood loss during myomectomy surgery. However, it can also cause cramping, vaginal bleeding and, sometimes nausea. If you have any of these symptoms, they are normal (and we apologize), but the medication does help decrease surgical blood loss.

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An Association between Thyroid Disease and Fibroids

January 12, 2015 – 8:59 am

Overt hypothyroidism is associated with the presence of uterine leiomyoma: a retrospective analysis. Eur J Obstet Gynecol Reprod Biol. 2014 Jun;177:19-22.

Authors: Ott J, Kurz C, Braun R, Promberger R, Seemann R, Vytiska-Binstorfer E, Walch K.

Study from: Medical University of Vienna, Vienna, Austria.

Problem: Few studies have examined the relationship between low thyroid function and the presence of uterine fibroids.

Study: 215 infertile women who had gynecologic surgery between 2007 and 2011 were studied. All fibroids that were suspected on ultrasound were confirmed during surgery. The authors calculated whether the 51 women with fibroids were more likely to: have thyroid disease; be older; be of African heritage; be older at the time of their first menstrual period; have more children, :or, be overweight.

Results: Women of African heritage were more likely to have fibroids and women with underactive thyroid (hypothyroidism) were 3 times as likely to have fibroids as women without hypothyroidism. Larger fibroids were found in women with hypothyroidism than in those women without hypothyroidism.

Authors’ Conclusions: Women with an underactive thyroid were more likely to have fibroids than women with normal thyroid function.

Dr. Parker’s Comments:

A number of women have asked me about the association of fibroids and thyroid disease, but I had been unaware of any studies that had reported this. However, this study does show that women with underactive thyroids are at a higher risk of having fibroids. This is an association and does not mean that thyroid disease causes fibroids, nor would treating thyroid disease be expected to reduce the chances of getting fibroids. The current (unproven) theory is that something in the body, perhaps proteins associated with chronic inflammation, can lead to both thyroid disease and fibroids. Until more is known about this association, it might make sense for women with fibroids to have their thyroid hormone level checked with a blood test.

By webmaster | Posted in Recent Fibroid Research | Tagged African American, African heritage, fibroids, hypothyroidism, thyroid, thyroid disease, underactive thyroid, uterine leiomyoma | Comments (0)

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Safety and five-year re-intervention following magnetic resonance-guided focused ultrasound (MRgFUS) for uterine fibroids

January 7, 2015 – 10:56 pm

Authors: Quinn, S, Vedelago J, Gedroyc W, Regan L.

Journal: Europeam Journal of Obstetrics & Gynecology and Reproductive Biology

Study From: London, England

Problem: While MRgFUS (also called high intensity focused ultrasound or HIFU) is not new, the results of treatment over the long-term have not been reported in the medical literature.

Study: Following treatment with MRgFUS (HIFU), 280 women were evaluated for complications from the treatment. Five years after treatment, 162 of those women were evaluated to determine if another treatment had been needed to resolve fibroid symptoms.

Results: Three women had serious complications (1.1%) including one woman with a skin burn that required surgical repair, one woman with a fibroid that passed through the vagina following treatment and one woman with a persistent nerve injury. Of the 162 women who had 5 years of follow-up, 59% needed another type of treatment to give them symptom relief. When more than half of the fibroid volume was able to be treated, 50% of women needed an additional treatment to deal with their symptoms.

Authors’ Conclusions: MRgFUS (HIFU) treatment of uterine fibroids is a safe treatment for uterine fibroids. The re-intervention rate at 5 years is high, but improvements in technique may further improve the long-term results.

Dr. Parker’s Comments:

High intensity focused ultrasound seems like an ideal treatment for fibroids; for most women it is painless, treatment requires no anesthesia and the recovery requires essentially no time off from work or family. However, the results of treatment have been disappointing. Early on, when the technology was new, the FDA only allowed small areas of the fibroids to be treated to make sure the technique was safe. Therefore, the symptom relief was understandably limited. More recent studies have treated more of the fibroid volume with seemingly better results.

But, even new MRgFUS (HIFU) techniques are not able to treat the entire fibroid volume raising the question: is this good enough? This study suggests that while MRgFUS (HIFU) appears to be safe, many women need other treatment to deal with persistent fibroid symptoms. Although I am rooting for this technique because of its non-invasive approach and quick recovery, I think it is still not effective enough for the majority of women with fibroids.

By webmaster | Posted in Recent Fibroid Research | Tagged complications, HIFU, high intensity focused ultrasound, long term, MRgFUS | Comments (0)

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Why not biopsy fibroids before surgery to make sure they are not cancer?

August 19, 2014 – 10:01 am

Some people have recently suggested that all women have biopsies of their fibroids before surgery to determine which women have typical fibroids and which women might have a leiomyosarcoma (LMS). There are many problems with this idea.

To start, I am going to use the word tumor throughout this post. When we hear” tumor”, most of us (doctors included) think “cancer”. However, “tumor” means a growth and a growth can be benign or it can be malignant. Fibroids are a very common benign tumor of the uterine muscle cells (75% of women have them by age 50). Leiomyosarcoma is a very rare malignant tumor (see previous post) that starts in the uterine muscle wall. No one knows the causes of either fibroids or LMS, but it is now fairly well established that fibroids do not turn into LMS.

Fibroids are made up of uterine muscle cells, but also contain collagen and other proteins called proteoglycans. When the pathologist looks at a fibroid under the microscope, they see muscle cells that are very similar to one another and the cells appear to be dividing very slowly (very few mitoses). The diagnosis of fibroids is very easy for a pathologist to make.

The diagnosis of LMS under the microscope, however, is very hard. In order to make the diagnosis of a leiomyosarcoma many changes in the muscles cells need to be present: abnormal appearing cell nuclei (atypia); many cells that are dividing (mitoses); invasion of the cells into the surrounding tissue; breakdown of the cells (necrosis) and other features. All of these features need to be seen by the pathologist in order to make the diagnosis of LMS .

Another characteristic of LMS is that it is a very uneven tumor (heterogeneous), meaning that the cells can look almost normal in one area but very abnormal and aggressive in another area. Often, many areas of the tumor need to be examined before a diagnosis of a benign fibroid, atypical fibroid (mild abnormality) or LMS ( malignant) can be made. Even good pathologists can have trouble making the diagnosis of LMS because they see so very few of these tumors in their lifetimes. In my practice, whenever we have had any question about the diagnosis of a unusual-looking fibroid, I have the tissue sent for a second opinion to the world’s expert LMS pathologists at Stanford, Drs. Kempson and Hendrickson.

The next issue is that biopsy of fibroids before surgery would involve finding the fibroids using ultrasound, placing a needle through the abdominal wall into the uterus and fibroid, applying suction to collect cells and then withdrawing the needle and placing the cells into a container for the pathologist. The problem with a needle biopsy of a “fibroid” is that the needle will get a sample of only one very small area of the fibroid and there will be very few cells for the pathologist to examine. If the cells in that particular area look uniform, then the diagnosis will be fibroid, even if another area that has not been biopsied looks very abnormal and is, in fact, a LMS. Furthermore, frozen section, where a piece of tissue is removed from the tumor during surgery, immediately frozen, prepared and then examined by the pathologist is also very inaccurate because the freezing process distorts the LMS cells, which are already hard to diagnose. Proper preparation of the slides takes many hours.

An added problem is that most women have more than one fibroid. I have removed 150 fibroids from one woman (very unusual) and often need to remove more than 20. It would be technically impossible to biopsy every fibroid, and no woman would be able to tolerate the discomfort from multiple biopsies unless they were put to sleep with general anesthesia.

Because of all of these limitations, biopsying of “fibroids” is neither reasonable nor would it be accurate. That’s why we don’t do it.

By webmaster | Posted in Recent Fibroid Research | Tagged biopsy, fibroids, leiomyosarcoma, LMS, power morcellation, power morcellator | Comments (0)

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How Often Does Morcellation Involve Cancers other than LMS?

August 7, 2014 – 9:39 am

A recent article in the Journal of the American Medical Association (JAMA) reported that the rate of uterine cancer among women having surgical procedures using morcellation was 1 woman out of 368. Since the recent FDA hearing was about morcellation and the risk of finding uterine leiomyosarcoma (LMS), some of the media have misinterpreted this number to mean that 1 out of 368 women who had a morcellation procedure were found to have a LMS.

The authors reviewed 6 years of data from an insurance company’s database of 500 hospitals and found 36,470 women who had procedures with morcellation during that time. Then they determined how many of these women had a final diagnosis of any type of uterine cancer. Over the 6 years, 99 of the 36,470 women were found to have any kind of uterine cancer. However, the authors did not determine how many of these women had leiomyosarcomas and how many had the more common (and usually less dangerous) types of uterine cancers such as uterine lining cell cancer.

The US Center for Disease Control (CDC) states that uterine lining cell cancers make up 97% of all uterine cancers, and uterine leiomyosarcomas (LMS) make up about 2-3% of all uterine cancers (other uterine sarcomas are even more rare). If we apply these percentages to the JAMA study, and we do the math, then 3% of the 99 cancers found in the JAMA study means 3 women with LMS were found among the 36,470 women who had morcellation. That means 1 woman with LMS for every 12,279 women (0.008%) who had morcellation. This number is even lower than the rate calculated in Dr. Pritts’ study (see earlier post) and is much lower than the rate calculated in the sub-optimal analysis done by the FDA, which calculated a risk 27 times higher.

Nevertheless, gynecologists and women who are considering hysterectomies with morcellation may have something important to learn from the JAMA study. If 96 cancers of the uterine lining (endometrial cancer) were not detected or suspected prior to surgery, then gynecologists may not be doing the best job of evaluating women with this disease, or our current testing methods are not working very well. While we currently do not have a way of detecting LMS before surgery, we do have ways to detect uterine lining cell cancers before surgery. Many women with fibroids have heavy vaginal bleeding with their periods. Many women with uterine lining cell cancer have irregular bleeding before menopause or have bleeding after menopause when bleeding is supposed to have stopped. If women have irregular bleeding, we have ways to detect uterine lining cancer in the office.

Trans-vaginal pelvic ultrasound can measure the thickness of the uterine lining fairly accurately and MRI, while more expensive, is also very accurate to measure the lining cell thickness. If the lining is normal thickness (“normal” will depend on whether you are pre-menopausal or post-menopausal), then the risk of having uterine lining cancer is very, very small. If the lining measures thicker than normal, the causes may be benign polyps, a fibroid inside the uterine cavity, benign overgrowth of the lining cells (benign hyperplasia), pre-cancer of the uterine lining cells (atypical hyperplasia) or uterine cancer.

If the lining is thick, then the next step is either an endometrial biopsy in the office or a full D&C, often in an outpatient surgery center. Both of these procedures remove lining cells for analysis by the pathologist, and both are very accurate, although not quite 100%. The unanswered question raised by the JAMA article is whether gynecologists are not appropriately evaluating women for uterine lining cancers before hysterectomies or whether ultrasound, MRI, endometrial biopsy and D&C do not detect these cancers as well as we thought.

We obviously need more research to find a way to diagnose leiomyosarcomas before surgery – this should be one critical outcome of the current FDA hearing. We also need to heed this study as a call for gynecologists to consider the diagnosis of uterine lining cell cancer more often and make sure we do the proper testing before surgery, and certainly before morcellation. If you have questions about whether you should have testing for uterine cancer before surgery, ask your doctor to discuss this with you.

Next post: Why not biopsy fibroids to make sure they are not cancer?

By webmaster | Posted in Recent Fibroid Research | Tagged endometrial cancer, FDA, LMS, Morcellation, morcellation risks, power morcellation, risk of Uterine Leiomyosarcoma, uterine leiomyosarcoma, uterine lining cell cancer | Comments (0)

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How Common is Uterine Leiomyosarcoma? (LMS)?

August 4, 2014 – 8:51 am

There is a lot of confusing information circulating about morcellation and uterine leiomyosarcoma in the media since the FDA hearing on this issue a few weeks ago. I plan to post my analysis of the information, in segments, over the next week or two. This first post provides commentary about the numbers used in research articles about the risk of having leiomyosarcoma and the numbers cited in the FDA hearings.

Some gynecologists and major medical centers had been quoting the risk of a woman having surgery for what are thought to be “fibroids” and being found to, in fact, have a leiomyosarcoma (LMS) as 1 woman out of 10,000. However, this number is incorrect. The rate of 1 in 10,000 is the incidence of LMS in the entire population of women, meaning that for every 10,000 women in the US (or elsewhere) 1 will have LMS. This is a very different number than will concern women with fibroids. Although many women will have some fibroids in their lifetime (77% of women by age 50), only a small minority (20%) will ever need treatment. For these women who have symptoms bothersome enough to need treatment for fibroids (medication, surgery, UAE, HIFU), the risk of having LMS had been previously been stated as 1 in 1,332, based on a study we published in 1994. So, that’s the first difference: 1 in 10,000 women in the entire population versus 1 in 1332 women who actually have fibroids and need surgery because of fibroids.

However, the FDA recently calculated the risk of LMS to be 1 in 482 women having surgery for fibroids and presented this data to the FDA hearing a few weeks ago. (I will discuss other uterine cancers in a future post) At the same FDA hearing, Dr. Elizabeth Pritts, a reproductive endocrinologist from Wisconsin, presented another analysis showing that the incidence of LMS in women having surgery for fibroids was 1 in 7,450. (disclosure: I am one of the co-authors on this paper that Dr. Pritts will soon be submitting for publication) Why are these numbers so different, and which number is accurate? Below is a comparison of how the two numbers were determined.

In order to calculate 1 in 482, the FDA researchers drastically limited their search of the medical literature. The FDA required that any studies showing up in their computer search have the words “uterine cancer” included in the terms used by journals to categorize articles in Pub Med or other medical search engines. Therefore, all studies of women who had surgery for fibroids, but where no one was found to have cancer were excluded from the FDA analysis. Let me say this clearly: any study of surgery for fibroids where no LMS was found was excluded from the FDA calculation! This is a very large number of studies since LMS is a very rare disease and is infrequently found.

Dr. Pritts looked at ALL articles where surgery was performed for fibroids and the pathology of all the removed tissue was both analyzed and reported in the paper. So, studies where the incidence of LMS was “0” were included, as they should be.

The FDA limited their search to articles only written in English. This may have been acceptable 20 years ago, but now the rest of the world actively publishes quite good medical research, and free computer translators can generate an understandable version of an article quickly. Many articles pertinent to this issue but published in languages other than English were readily available, but not included in the FDA analysis.

Dr. Pritts reviewed hundreds of articles in other languages and translated them to see if they met the criteria for analysis.

There are two major types of research studies for the data we need in order to figure out the risk of LMS: retrospective and prospective. A retrospective study often begins with this scenario: someone operates on a woman thought to have a fibroid and the pathology later shows the tissue to be a LMS. The doctor then decides to go back through their hospital’s records to see if other similar cases have occurred. But, on day one the incidence of LMS is 100%. Depending on how many years the authors go back in the records, the 100% incidence will be diluted by the many cases without LMS. But, the incidence will never be 0% because they started counting when they had the first case.

A prospective study follows this scenario: the authors decide to study women who are going to have surgery for fibroids in the future, and among other things they will study whether any women had a LMS. So, on day 1 the incidence of LMS is 0% and the research data starts with a clean slate. This is the gold standard of this type of research.

The FDA literature search yielded 18 studies of which 9 were used for their analysis. One was a prospective study, and 7 were retrospective studies. The last “study” was a letter to the editor, which is not subject to peer review of data by outside experts. The 9 studies included 9,160 women and 19 were found to have a LMS (1 in 482 or 0.2%).

Dr. Pritts’ much more complete search yielded 1,020 papers, of which 365 were peer reviewed and felt to be of good enough quality to be included in the data analysis. In the 67 prospective studies (best quality), 5,951 women had surgery for fibroids and 2 women were found to have leiomyosarcomas (1 in 2,975 or 0.03%). Dr. Pritts also found 66 retrospective studies, where the first case may have prompted the study, and of the 23,926 women having surgery for fibroids, 22 were found to have LMS (1 in 1087 or 0.09%).

I am shocked, embarrassed and disgusted by the FDA’s lazy and irresponsible analysis of the “literature”. I don’t know how long it took the FDA to do their analysis, but Dr. Pritts spent months collecting and then analyzing the papers. For me, there is no question as to which analysis is more complete and representative of how rare this disease is. It is a terrible, aggressive cancer, but it is rare.

Some women may feel that any risk of LMS is more than they want to take. Other women may find Dr. Pritts’ analysis of the available data reassuring, since the risk of LMS is so low. But I absolutely believe that it is your right to decide. All medical treatments are associated with some risk. It is the doctor’s job to inform you of the risks (informed consent), but it is your job to decide what risks you are willing or not willing to take.

The next post will deal with how often morcellation involves cancers other than LMS.

By webmaster | Posted in Recent Fibroid Research | Tagged FDA, fibroids, laparoscopic myomectomy, laparoscopy, LMS, Morcellation, morcellation risks, myomectomy, power morcellation, risk of LMS, risk of Uterine Leiomyosarcoma, robotic myomectomy, uterine leiomyosarcoma | Comments (0)

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Morcellation – Write Congress

July 6, 2014 – 1:06 pm

Joan, San Diego

I’ve been feeling frustrated and concerned about the upcoming FDA meeting later this week on the power morcellator. My fear is that the FDA panel will get a very slanted view of the situation because not enough woman who have benefited from minimally invasive gyn surgery using a morcellator can take the time away from work and family much less afford to be present for the meeting. I’m sure many women who’ve benefited from minimally invasive gyn surgery aren’t even aware of what is going on and that women are under threat of possibly losing some if not a lot of the uterus saving alternatives woman have been seeking for so many years.

Dr. Noorchasm group is well-funded and well organized and I’m sure will be there in force. My heart goes out to Dr. Reed and her family as well as others suffering from LMS but it’s also very important that the FDA panel and the other elected officials hearing from Noorchashm’s group also hear the other side of the story — that many, many women HAVE benefited from minimally invasive gyn surgery and that women WANT these minimally invasive options!

While I can’t be in DC next week …. my Congressman does have staff in D.C. …… so ….. I’ve decided to contact both my Congressman and my two Senator’s offices to express my concern about the FDA meeting and the importance that the panel fully consider that many, many woman have benefited from these procedures and want them. I will share my letter to the FDA with them and also let them know about NUFF”s petition on Informed Consent and my petition calling on the FDA not to ban a woman’s fibroid treatment options. (Thank you to those of you who have signed the petition — I see names I recognize from the group on the petition site. 🙂 There is a growing list of comments on the petitio! n site too which is great but I’d sure like to have some m! ore sign atures and comments before I contact my Congressional Reps tomorrow.

If anyone else would like to contact their Congressperson and/or Senators about this issue (the more the better!!!) but you don’t know who they are, here are two links to help you find their names and contact info:

http://www.senate.gov/general/contact_information/senators_cfm.cfm

http://www.house.gov/representatives/find/

If those links don’t get you what you need, private message me and I will help you.

Joan

By Bill Parker, MD | Posted in Recent Fibroid Research | Tagged abdominal myomectomy, FDA, fibroids, focused ultrasound, Gynecologic Surgery, HIFU, hysteroscopic myomectomy, laparoscopic hysterectomy, laparoscopic myomectomy, minimally invasive surgery, Morcellation, morcellator, supra-cervial hysterectomy, UAE, uterine artery embolization | Comments (0)

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The FDA and the Warning About Uterine and Fibroid Morcellation

April 21, 2014 – 8:40 pm

As many of you probably know by now, the FDA recently issued a warning saying that morcellation of fibroids during laparoscopic myomectomy (or during laparoscopic hysterectomy) should be avoided because of the risk of uterine leiomyosarcoma (uterine muscle wall cancer).

I disagree with this decision (see reasons below) and ask that women who have benefitted from minimally invasive myomectomy or hysterectomy e-mail the FDA and tell them about the benefits these procedures provided with quicker recovery, less pain, faster return to family or work, etc.

I was an author of a study published in 1994 that showed that the risk of leiomyosarcoma among women operated on for “fibroids” was 1 out of 1,332. This study has been widely used to show the low risk of sarcoma. Our study was conducted at two community hospitals in Santa Monica and represents the incidence of leiomyosarcoma in a population of women in a community having symptoms bothersome enough to warrant surgery. Many of the studies used by the FDA to come to their conclusion were conducted at referral or University hospitals, where women are referred BECAUSE they have sarcoma or have severe symptoms that require the expertise of a specialized physician. These studies are not reliable indicators of how common a disease might be.

Those of you who are interested should look at the actual studies used by the FDA to come to their conclusion. The most obvious flaw with the data is that the article with the largest numbers (by Park), and cited by the FDA, states in the summary that 49 of 22,825 women who underwent surgery for presumed uterine fibroids had leiomyosarcoma.

In fact, as described in the body of the article and confirmed by Dr Nam (the senior author) in an e-mail to me, 26 of the 49 women were referred to Asan Medical Center for further surgery and treatment following a diagnosis of leiomyosarcoma already made elsewhere. Since the denominator of the outside population of women who had surgery for fibroids is unknown (but presumably very large since this is a major referral hospital in Korea), those 26 women must be excluded from the incidence calculation.

Therefore, the incidence of leiomyosarcoma among women operated on for fibroids at Asan Medical Center and who were then discovered to have leiomyosarcoma was 22/22,285 or 1/1000 and Dr. Nam has also confirmed this number in an e-mail to me.

The Cleveland Clinic, which has a very busy gynecologic surgery service, reviewed their records for the past three years and did not find even one woman who had morcellation of a leiomyosarcoma. In my 35 years of practice, operating on 2-4 women with fibroids every week, I have operated on one woman with a leiomyosarcoma. It is a terrible cancer, but is very rare. I am aware of the very unfortunate circumstances regarding Dr. Amy Reed and the morcellation of her uterine leiomyosarcoma in Boston. I cannot imagine how hard this must be for her, her husband and their children. However, banning other women from access to the benefits of minimally invasive surgery seems unwarranted.

Many of the studies quoted by the FDA included other types of surgery where the uterus or fibroids are cut into to remove them from the body. If we are to avoid all forms of morcellation, women with suspected fibroids will have total abdominal hysterectomy as their only surgical option. Laparoscopic hysterectomy for large fibroids that require vaginal or power morcellation, laparoscopic myomectomy, hysteroscopic myomectomy and even abdominal myomectomy would be considered “below the standard of care”. In addition, watchful waiting, medications, uterine artery embolization and focused ultrasound would be improper treatment since a woman “might have a leiomyosarcoma”” and have a delay in diagnosis.

This paradigm shift would eliminate all of the alternatives to hysterectomy developed over the past 20 years, which greatly benefit the vast majority of women who choose them. Furthermore, total abdominal hysterectomy has a higher risk of complications and death than most of these other alternatives. The risk of dying from a hysterectomy approaches 1/1000, no different than the approximate risk of inadvertently morcellating a LMS.

In 2002, a protocol was developed in Japan (Goto protocol) to help make the diagnosis of leiomyosarcoma prior to surgery using MRI with contrast dye and blood tests for the enzyme LDH and its iso-enzymes. I have used this protocol for women who might be suspected of having leiomyosarcoma with excellent results. No woman with normal results has had a leiomyosarcoma. However, because leiomyosarcoma is so rare, it would take a very large study to confirm the excellent results shown in the Goto study. I have recently recommended that the laparoscopy organizations conduct such a study so that we can make the diagnosis of leiomyosarcoma before surgery.

Each medical decision involves weighing potential benefits against possible risks. I think women should be advised of these risks and be allowed to make up their own minds as to what treatment they wish to receive. As it stands, the FDA wants to make this decision for women. The FDA will hold a hearing (open to the public) in a few months to determine their final recommendation. Please make your own thoughts known to the FDA: dsmica@fda.hhs.gov

Sincerely,

Bill Parker, MD

Disclosure: I am a salaried Clinical Professor at UCLA and I do not own any stock or interest in any medical device company. I have nothing to gain or lose financially based on the outcome of the FDA’s final ruling.

By webmaster | Posted in Recent Fibroid Research | Tagged FDA, fibroid removal, hysterectomy, laparoscopy, Morcellation, morcellation and cancer, morcellation risks, morcellator, total abdominal hysterectomy, uterine leiomyosarcoma | Comments (0)

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Fibroids and Thyroid Disease

April 7, 2014 – 1:14 pm

Overt hypothyroidism is associated with the presence of uterine leiomyoma: a retrospective analysis.

Authors: Ott J, Kurz C, Braun R, Promberger R, Seemann R, Vytiska-Binstorfer E, Walch K.

Journal: Eur J Obstet Gynecol Reprod Biol. 2014 Mar 13 [Epub ahead of print]

Study From: Medical University of Vienna, Austria

Problem: A possible correlation between uterine fibroids and thyroid disease was initially reported in 1989. More recent reports on this topic are scarce. The authors intended to investigate the possible association between uterine fibroids and thyroid function, including thyroid antibodies, in a population of infertile women.

Study: 215 infertile women who underwent reproductive surgery were examined with ultrasound for the presence of uterine fibroids. They also had blood tests to determine if they were hypothyroid (under-active thyroid).

Results: Uterine fibroids were found in 51 of the 215 women (24%). After multivariate analysis, hypothyroidism was found to increase the risk of having fibroids by three times. Also, larger fibroids were found in women with hypothyroidism than in those without overt hypothyroidism, (average of 7 cm in women with hypothyroid disease versus 3 cm in women without hypothyroid disease).

Authors’ Conclusions: Overt hypothyroidism, but not auto-antibodies against the thyroid gland, was associated with the presence of uterine fibroids in our study.

Dr. Parker’s Comments: Over the years, there have been many posts on the fibroid message boards about the relationship of fibroids and thyroid disease. Unfortunately, there have been very few studies that examined this relationship. While this study suggests there is a real relationship, it should be noted that this study only included a small group of women (51) and all of the women were infertile. Therefore, the results may not apply to the general population of women. In any case, these findings are interesting and the relationship deserves more study.

By webmaster | Posted in Recent Fibroid Research | Tagged fibroids, hypothyroidism, thyroid disease, thyroid gland | Comments (0)

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Embolization has Better Long-term Results than High-Intensity Focused Ultrasound

October 7, 2013 – 8:40 am

Study: Outcome of uterine artery embolization versus MR-guided high-intensity focused ultrasound treatment for uterine fibroids: Long-term results.

Journal: European Journal of Radiology, 2013 (not printed yet)

Authors: Froeling V, Meckelburg K, Schreiter NF, Scheurig-Muenkler C, Kamp J, Maurer MH, Beck A, Hamm B, Kroencke TJ.

Study from: Medical University of Berlin, Germany

Problem: The first non-invasive, uterine sparing treatment of uterine fibroids, developed in 1995, was uterine artery embolization (UAE). UAE uses very small particles, injected through a thin tube placed in the groin and then into the uterine artery, to slow down the blood supply to the uterus. Without adequate blood flow fibroids die and shrink while normal uterine muscle stays relatively healthy. High intensity focused ultrasound (HIFU), approved by the FDA in 2004, focuses high frequency sound waves through a woman’s body and onto the fibroid, heating the tissue which causes fibroid cell death in the area. (see more about UAE and HIFU treatments for fibroids here )

The long-term success of UAE has been well-studied and HIFU less well-studied, but this paper reports patient satisfaction results 5 years after each treatment and compares them.

Study: UAE was performed for 41 women and HIFU performed for 36 women at the same university hospital in Berlin. Before and 5 years after treatment, women filled out questionnaires that measured how much their fibroid symptoms bothered them and how the fibroids affected their quality-of-life. The researchers also counted how many women in each group requested to have another treatment for fibroids because UAE or HIFU did not work.

Results: After 5 years, women who were treated with UAE had significantly greater improvement of symptoms and quality-of-life than women who were treated with HIFU. In addition, 66% of women who had HIFU requested other fibroid treatment during the 5 years, while only 12% of women who had UAE requested other treatment.

Authors’ Conclusions: Improvement of women’s symptoms and quality-of-life was significantly better after UAE, resulting in much less need for other treatments later on.

Dr. Parker’s Comments: Very good patient satisfaction and reduction of symptoms following UAE has been shown in many studies. HIFU has been less well-studied and results following treatment have not been as good. This study confirms that for most women UAE is a more effective treatment than HIFU. I do not have much personal experience with seeing women after either of these treatments since they are seen by the interventional radiologist who treated them. However, this information will be useful when I talk to women about non-surgical treatment options for bothersome fibroids.

By webmaster | Posted in Recent Fibroid Research | Tagged fibroid treatment, HIFU, long term, MR-guided high-intensity focused ultrasound, treatment for fibroids, UAE, uterine artery embolization | Comments (0)

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