Ablation

The Hysterectomy Series: On Endometrial Ablation and Hyperplasia

More than 78% of hysterectomized women report a change in personality. More than 77% report a "loss of energy" and "pro-found fatigue." More than 66% report "short term memory loss." More than 64% say they're "unable to maintain home" and more than 48% say they're "unable to maintain previous level of employment." More than 58% of hysterectomized women report "insomnia" and 68% report "difficulty relating with and interacting with others." When a woman becomes permanently disabled, her friends and family may console her and support her for a while, but her family will soon need to go on with their lives, even if her problems won't go away. - The H Word

If they don’t cut, they burn.

Here, we are going to look at another one of their Safe & Effective™ interventions.

The burning of the insides of women.

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This is stack no. 6 of The Hysterectomy Series I am writing. The list so far:

• Hormones - Interview with Carol Petersen

• Hysterectomy

• Female Castration

• Anaphrodisia

• Beyond Surgery - Interview no.2 with Carol Petersen

This article is based on Chapter 22 of The H Word (strong book recommendation for all women).

The H Word: by Nora W. Coffey and Rick Schweikert – HERS Foundation

The main takeaways from this chapter are:

1. Ablation is a procedure that involves burning the endometrium to scar it permanently, which is meant to prevent menstrual bleeding. However, it can lead to severe, ongoing pain and other complications.

2. Despite the risks and potential complications, various ablation methods have been developed over time, such as electrocautery, rollerball, cryo-ablation, balloon ablation, and microwave ablation. Regardless of the method, the scarring of the uterus remains harmful.

3. Many women who undergo ablation end up requiring a hysterectomy within a few years due to the complications and pain caused by the procedure.

4. The medical industry continues to promote and perform these harmful procedures, often prioritizing financial gain over patient well-being. The FDA's approval process and lack of strict oversight contribute to this problem.

5. Ablation is often performed for endometrial hyperplasia, even though it is contraindicated and can mask the progression of the condition, potentially leading to cancer.

6. The text suggests that gynecologists often perform multiple procedures, such as D&C, ablation, and UAE, before ultimately resorting to the "gold standard" of hysterectomy, which is seen as a lucrative practice for the medical industry.

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The H Word by Coffey and Schweikert

Chapter 22 – Endometrial ablation and hyperplasia

Ablation involves burning the endometrium (the inside lining of the uterus) and permanently scarring it. The idea is to scar the endometrium so it can't proliferate. If it can't build-up, there’ll be nothing to shed as it naturally does during menstruation. The problem is, even though the endometrium is permanently scarred, the uterus still tries to perform its natural functions. The natural engorgement of blood still occurs, but the lining of the uterus can't build up after it's been burned. Because it can't build up, there's nothing to shed, so the uterus remains engorged with nowhere for the blood to go. That may initially only cause a feeling of fullness in the pelvis, but after a few months of this abnormally induced amenorrhea (suppression of menstruation), many women experience constant, debilitating pain.

In addition to the common occurrence of severe, ongoing pain, the risks of ablation include: possible perforation of the uterus, bowel, or bladder, infection, hemorrhage, thermal injuries to the uterus and other organs, fluid overload, and death.

A doctor begins an ablation by filling the woman's body with fluid intravenously. The amount of fluid must be closely monitored, and every woman is unique in terms of how much her body will tolerate. The surgeon then applies the heat to the endometrium, which causes some of the fluid to evaporate. Some of the fluid is also absorbed into the woman's body, but the amount of evaporation and absorption can't be measured precisely, and women have died from fluid overload of the heart and lungs.

The first method of ablation doctors used to burn and scar the endometrium was electrocautery. Later, rollerball ablation was developed, which involves heating a metal ball sufficiently to bum the endometrium. Rollerball was then replaced with cryo-ablation, which involves burning by freezing. And when cryoablation way finally recognized as just as damaging as all of the other methods, balloon ablation was invented, which involves filling a balloon with in extremely hot substance and inserting it into the uterus. The idea is that a heated balloon will burn the endometrial tissue more slowly, and thus be safer: And after balloon ablation came microwave ablation. But if a doctor said to a man that he was going to scar the inside of his genitals by burning them, it wouldn't make any difference what method was used. It would still damage his sex organs. It makes no difference if it's done slowly or quickly, by heating or freezing or microwave—it's still damaging.

Furthermore, there's no remedy for the problems caused by ablation, because you can't unscar the uterus. The symptoms often worsen with each menstrual cycle because of the unreleased engorgement of menstrual blood, so by the end of the first or second year following ablation, a lot of women are told that hysterectomy is the only option to get relief from the problems caused by it.

Balloon endometrial ablation was invented by Robert S. Neuwirth, who is affiliated with St. Luke's-Roosevelt Hospital at Columbia University in New York. His bio says he introduced techniques "to avoid hysterectomy." But FDA's Manufacturer And User Facility Device Experience Database (MAUDE) reveals that the end result of balloon ablation may be hysterectomy. In those instances, not only do balloons and the ablators fail “to avoid no hysterectomy” they actually lead to hysterectomy. More specifically, the following is from an article titled “Complications Associated With Global Endometrial Ablation: The Utility of the MAUDE Database":

RESULTS: ...A search of the US Food and Drug Administration MAUDE database yielded reports of 85 complications in 62 patients. These included major complications: eight cases of thermal bowel injury, 30 cases of uterine perforation, 12 cases in which emergent laparotomy was required, and three intensive care unit admissions. One patient developed necrotizing fasciitis and eventually underwent vulvectomy, ureterocutaneous ostomy, and bilateral below-the-knee amputations. One of the patients with thermal injury to the bowel died.

CONCLUSION: Use of the US Food and Drug Administration MAUDE database is helpful in identifying serious complications associated with global endometrial ablation not yet reported in the medical literature.

It's ironic that FDA provides MAUDE—a very helpful forum for the public to see just how damaging these devices and techniques are - while it's responsible for approval of these damaging devices and techniques in the first place. Unfortunately, the way we find out just how dangerous these medical practices are comes only after FDA approves them and millions of people are injured. Only after deaths and public outcry is something finally done. FDA has become an arm of industry and no longer puts public safety first.

One of the many examples of the interdependent relationship between FDA and the medical industry is what's known as "pre-emption.” Preemption is a legal doctrine that aims to protect the medical industry from product liability lawsuits when the dies vice or drug has been approved by FDA. A New York Times editorial explains the perverse problems with this situation:

The pharmaceutical industry...[is] working hard to prevent consumers from filing damage suits for injuries caused by federally approved drug products... If this perverse legal doctrine, known as federal pre-emption, continues to spread, the public will be deprived of a vital tool for policing companies and unearthing documents that reveal their machinations.

Another Times article by Gardiner Harris and Alex Beren-son, paints an even grimmer picture of FDA oversight:

A series of independent assessments have concluded that the agency is poorly organized, scientifically deficient and short of money. In February, its commissioner, Andrew C. von Eschenbach, acknowledged that the agency faces a crisis and may not be “adequate to regulate the foods and drugs of the 21^st century.” The F.D.A. does not test experimental medicines but relies on drug makers to report the results of their own tests completely and honestly. Even when companies fail to follow agency rules, officials rarely seek to penalize them.

It's sometimes difficult to discern accurate information from misinformation...or reliable sources from self-promotion. The website OBGYN.net, for example, may seem like an informative site. It lists a Herbert Goldfarb as Editorial Advisor for hysterectomy alternatives and infertility." It also publishes an essay from Goldfarb, where he tells us that the first endometrial ablation was performed in 1981 by "Goldrath and colleagues." Here's a quote from that page:

...A study by Unger and Meeks indicated that as many as 34% of women required a hysterectomy within 5 years of ablation, a number that increased with time. A recent report by Martyn and Allan on long-term follow-up of 301 patients having endometrial ablation revealed that after 5 years 27% had required further surgery because of bleeding, and 38% because of pain... Those authors also noted that because the uterine cavity may be scarred by the procedure and no longer patent with the vagina, any subsequent menstrual flow may be forced into the fallopian tubes, causing pain and endometriosis.

Goldfarb is the author of The No Hysterectomy Option, a book that tells women they almost never need a hysterectomy. As he says, no matter how you perform an ablation, scarring, menstrual problems, and subsequent surgeries are very common. Goldfarb is also a member of The One-Kilo Club, whose mission is spelled out on their website, onekiloclub.org:

The ONE-KILO CLUB is an association of pelvic surgeons who are committed to furthering the technical horizons of minimally invasive surgery and who have demonstrated that commitment by their accomplishments. Hence our motto, EX UNGUE LEONEM (By its claw one tells the lion.) The extirpation of a uterus that weighs one kilogram or more without a laparotomy has been chosen as the test of that commitment...

To "extirpate" is to cut out, kill, destroy. The One-Kilo Chub, then, is an association of surgeons who believe that cutting out a person's sex organs with a laparoscope is "minimally invasive, but minimally invasive compared to what? There's a poem on their website called "The One-Kilo Lion." One of the lines of that poem says of the uterus, "Please, weigh it accurately, it might be a kilo as good as gold and diamonds."

ExAblate is yet another device currently being tested on women in American hospitals with FDA's blessing. Like ablation, it brings gold and diamonds to gynecologists, but a lifetime of grief for the women who are damaged by it. It involves burning the fibroid itself, not the entire endometrium. But it's been shown to burn other tissue as well, causing pain and injury that can radiate throughout the pelvis, buttocks, and lower extremities. A report on FDA'S MAUDE makes the point very clearly:

Treatment was stopped when the pt [patient] complained of pain radiating to the left leg and catheter tip. In recovery the lady complained of a sensation of numbness in the left buttock. On closer exam she was found to have decreased sensation throughout the peri-anal and perineal region as well as the posterior left thigh. She had leaked some faecal matter....

ExAblate involves using high intensity focused ultrasound (HIFU) waves to burn fibroids. HERS recently received an email from a woman who said she underwent ExAblate, but the bleeding returned. She's searching for a doctor who has the skill to perform a myomectomy, but none of the doctors in her area will do it. The reason they’re reluctant is that ExAblate creates adhesions that are thicker and larger than the kind of scar made by cutting, so the ExAblate treatment may have made it more difficult, if not impossible, to now perform a myomectomy.

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Ablation is often performed for heavy or continuous bleeding. That kind of bleeding is sometimes caused by endometrial hyperplasia, an abnormal build-up of the endometrium. Hyperplasia progresses slowly through the early, simple, cystic, and then on up the ladder to complex adenomatous hyperplasia with atypia, before becoming a frank endometrial cancer. The two most common factors that can speed up that timeline are hormones and weight. Excess estrogens are stored in fatty tissue. Excess androgens are converted to estrogens in the fatty tissue and stored, which accelerates the hyperplasia's growth.

The first step in determining if you have hyperplasia is a pelvic and transvaginal ultrasound, which evaluates the thickness of the endometrium. The endometrium is thickest before menstruation and thinnest after, so ultrasound should be performed within a day or two after menstruation stops-when the thickness of the endometrium should be between about 4mm and 7mm. It's common for low level hyperplasia to develop in perimenopausal women the beginning of menopause), but it usually spontaneously reverts to normal after menopause.

Most doctors want to first perform an endometrial biopsy (the removal of a small sample of endometrial tissue with a thin, glass, straw-like pipelle), an extremely painful procedure that is inadequate to evaluate the endometrium. It only tells you what's going on in the spot where the tiny endometrial sample was removed.

If an ultrasound reveals that the endometrium is abnormally thickened, it should be confirmed the following month with a repeat ultrasound that's performed not more than a week after menstruation ends to make sure the first one was accurate.

If the endometrium remains thickened or if bleeding continues after menstruation for two months in a row, then a D&C (dilation of the cervix and scraping of the lining of the uterus) will both diagnose hyperplasia (it allows a pathologist to determine if it exists, and if so what level) and treat it (because the build up of endometrial tissue is removed during the D&C). Whether or not further treatment is advisable will be determined by the level of hyperplasia.

Although ablation is contraindicated for endometrial hyperplasia, it's commonly performed to stop the heavy bleeding associated with it. Ablation isn't advisable for hyperplasia because it makes it impossible to monitor the endometrium and may mask hyperplasia. The thickness of the endometrium can be monitored with pelvic and transvaginal ultrasound. But after ablation, the lining is scarred and doesn't proliferate as it normally would, so the endometrium can't then be evaluated to see if it's reverting to normal or if the hyperplasia is progressing Seat the hyperplane continues to progress because it's not being treated, it can invade the myometrium (the middle layer of the body of the uterus). What starts out as a low-level, treatable hyperplasia may develop to a higher level. And if not treated appropriately, it may progress to cancer.

Many women continue to have bleeding after ablation because some areas of the endometrium may have been burned unevenly, inadvertently leaving some of the endometrium to grow. But because of the scarring there's no way of knowing it the bleeding is caused by the ablation or by continuing hyperplasia. At that point women are likely to be told they need a hysterectomy. The women who contact HERS say they would not have consented to ablation in the first place if they had been told about the risks and the appropriate conservative treatment for hyperplasia.

The Spring 2004 edition of New Growth Opportunities in Medical Technology is telling:

The primary motivation behind this report is... a breakout in the growth of the UroGynecology market... While the current market sizes remain fairly modest, investor awareness of these expanding market opportunities is expanding, boosted by items such as American Medical's eye-opening announcement of 80% growth in its women's health business in the fourth quarter of 2003.

One of the subtopics under "TREATMENTS FOR ABNORMAL UTERINE BLEEDING (AUB)" is "Surgery...Hysterectomy Remains the Gold Standard." It's the gold standard, all right, and the goldmine. But gynecologists first expand their markets by selling women a D&C, an ablation, and maybe a UAE too before they remove the female organs. It's like leaving money on the table to not perform other treatments before turning to the "gold standard" of unnecessary and damaging surgeries— hysterectomy.

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