Flesh-shredding hysterectomy tool leads to unnecessary cancer deaths

Alessandra Kelley

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http://well.blogs.nytimes.com/2014/...risks-unmentioned/?_php=true&_type=blogs&_r=0
http://articles.philly.com/2014-03-19/news/48334892_1_uterine-cancer-hysterectomy-leiomyosarcoma

(The original article about this was in today's "Wall Street Journal," but they have an online paywall.)

Apparently hysterectomies, the surgical removal of a woman's uterus, were made vastly simpler a couple or three decades ago by the invention of a tool called a morcellator, a sort of electric gun-vacuum with a grinding tip which could be inserted into a small incision to grind the uterus up a bit at a time and vacuum out the flesh in minimally invasive surgery.

Many surgeons prefer to encase the flesh in a protective bag before morcellating, but gynecologists performing hysterectomies usually do not bother, as the industry standard does not call for it and it can cause complications.

As it turns out, though, scattered bits of flesh can be left inside women's bodies, and if any of them are unsuspected cancers, things go very bad very fast.

One study found women who had had the procedure had a 9x higher rate of unexpected sarcomas than doctors had been led to believe -- and told their patients -- might happen.

The cancer risk seems to be between 1 in 400 and 1 in 1000. Almost half a million hysterectomies are performed in the US alone every year, which means hundreds, maybe up to a thousand rapidly-spreading cancers spawned by this procedure, many of them fatal, have hit women every year.

The story has come to light because the widower of a woman who died of suddenly appearing metastatic cancer after a morcellation hysterectomy has sued the hospital to find out who manufactured the morcellator and to have the devices banned.

The FDA does not require that medical devices, which are not tested as stringently as drugs, be further tested for safety or effectiveness once something like them has already been approved for market. The first morcellator was brought to market in the 1990s and was adjudged not different enough to need testing.
 
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Roxxsmom

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A friend of mine is living this nightmare now. She had larger fibroids and they were biopsied and thought to be benign. So she was considered to be a good candidate for this "morcellation" technique. Seemed like a no-brainer as it was presented--no abdominal incision and a shorter recovery time. Except she gets this phone call a week after her procedure. Turns out there was cancer in her uterus after all (in spite of their earlier biopsy that said there wasn't), and since they'd ground everything up, well, there were possibly cancer cells left behind in her.

So now she's getting to go through exploratory surgery and extra biopsies of her lymph nodes (clean so far, thank God) and radiation therapy as a preventative--which she likely wouldn't have needed for localized and early uterine cancer.
 
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Snowstorm

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Holy smokes. I've never heard of this. Thank you for posting this, Alessandra Kelley. What a nightmare. I hope your friend is able to get beyond this, Roxxsmom!
 

regdog

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Holy shit, what a nightmare.
 

Roxxsmom

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Holy smokes. I've never heard of this. Thank you for posting this, Alessandra Kelley. What a nightmare. I hope your friend is able to get beyond this, Roxxsmom!

I'm horrified by this. Roxxsmom, I hope your friend is okay!

The good thing in her case is that they realized what the situation was before there was any sign of the tumors existing outside the uterus. So hopefully, this extra treatment she's having to endure will be good for preventing the proliferation of any cells that might have escaped.

The crazy thing is, this happened to her right after there was a story in the media about these kinds of problems.
 

Alessandra Kelley

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The FDA announced yesterday that it officially discourages use of laparoscopic power morcellation for removal of uterus or uterine fibroids due to the increased risk of cancer.

This does not take morcellators off the market, nor does it ban their use. It is only a recommendation.

There are some clarifications, too.

Based on an analysis of currently available data, the FDA has determined that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.

1 in 350 cases is considerably more prevalent than the previous estimate gynecologists had been using to assess the risk. It had previously been believed that the incidence of unsuspected cancers was as little as 1 in 10,000.

According to Denise Grady of the New York Times, women were routinely not even warned of the risk, "in part because the threat was thought to be vanishingly small. Indeed, many women having hysterectomies were not even told that morcellation was being performed."

Ms. Grady also points out that although half a million hysterectomies are performed in the US every year (which seems an enormous number to me), only a tenth of those, about 50,000 "involve power morcellation of tissue containing fibroid tumors," the cancer-risking surgery.

Using those numbers, it looks like the process leads to roughly 140 women with unnecessarily-spread cancer cells per year in the US.
 

Alessandra Kelley

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Update

Apparently after this story erupted last spring, doctors in the pay of morcellator manufacturers who did not disclose their ties helped shape medical policies across the country to favor morcellators.

(Once again, this is behind a Wall Street Journal paywall. The only other online sources I could find were personal liability lawsuit blogs. Make of that what you will.)

"Doctor Group Split Over Disfavored Surgical Device," by Joseph Walker and Jennifer Levitz. (Wall Street Journal, Tuesday, February 17, 2015, front page)

Barely a month after the FDA issued its warning (previous post) the AAGL ("formerly known as the American Association of Gynecologic Laparascopists") issued a widely-read report claiming that morcellation was safe and should continue to be done.

Doctors and hospitals across the country closely read the report to determine their policies.
What they didn't know: An AAGL executive officer who received consulting fees from a morcellator maker had weighed in before publication.

The officer, New York surgeon Arnold Advincula, joined the AAGL board's final discussions of the report, raising concerns among some in the group's leadership ...

That involvement violated conflict-of-interest policies, said Ceana Nezhat, the association's president at the time, in a May 7 email to its executive director and medical director.
He's not the only one:
In July, Andrew Brill, a former AAGL president, stepped down from an FDA panel evaluating the tool's risks after the Journal disclosed he had done paid consulting for a morcellator maker.
The WSJ cites at least one hospital group which changed from deciding to eliminate morcellation to going ahead with it after hearing this report.
 
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Maryn

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Oh, gawd. Everybody's dirty, all the time. At least it seems that way.

After three deaths related to this device, all the hospitals in my metro area stopped using power morcellation. Still, three women are not there to see their children grow up, or to be with their husbands through long and happy marriages, due to bad advice from people who had a finger in the pie.

Sheesh.
 

Reziac

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Uterine fibroids are 100% indicative of hypothyroidism: fibroids are thyroid receptor tissue (reproductive tract trying to collect enough thyroid hormone to function in a deficient system). This has been known to endocrinologists for over 30 years but somehow has never filtered into the gynecology field, let alone to GPs.

Anyone who suffers from uterine fibroids should get a full thyroid workup including tests for Hashimoto's antibodies and Free T3 (and maybe Reverse T3), NOT just the TSH/Free T4 test. Most doctors will only test TSH, which is at best a shotgun metric, but T3 level is what's critical to your body's function.

Fibroid sufferers may have NO other hypothyroid symptom (other than possibly a persistent headache).

Incidentally most doctors will not treat subclinical hypothyroidism, despite that research indicates early treatment can prevent it from progressing to fullblown Hashimoto's (which is a tissue-destructive autoimmune disorder).

[My mom nearly bled to death from fibroids, and I have Hashimoto's thyroiditis myself. I've had to become a pocket expert in sheer self-defense.]
 

MaryMumsy

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I find the connection between thyroid and fibroids fascinating. My Mom had her thyroid removed in 1957 due to cancerous nodules and was on replacement medication the rest of her life. She had a hysterectomy in 1967 due to bleeding/painful fibroids. I was diagnosed with Hashimoto's in 1981 and with fibroids in 1994. I take thyroid replacement, but never did anything about the fibroids. I only knew about the fibroids because of routine pelvic exams. No symptoms at all. I've been told that the fibroids shriveled up and disappeared on their own. Probably because of hormone replacement therapy.

Isn't the body a strange and wonderful thing?

MM
 

Reziac

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I find the connection between thyroid and fibroids fascinating.

The list of symptoms hypothyroidism can cause is over 300 strong, and that's not an exhaustive list. I've personally experienced about 50 different symptoms (some quite odd or very minor, like swelling in the tip of the nose!)

Incidentally there is a case on record of Elephantiasis that was at least partly caused by uncontrolled Hashimoto's antibodies (basically the psoriasis symptom got completely out of hand).

I've been told that the fibroids shriveled up and disappeared on their own. Probably because of hormone replacement therapy.

That would do it, all right. They're a symptom, not a separate disease process.

Isn't the body a strange and wonderful thing?

"Dear God; I wish to file a bug report..."
-- old BBS tagline
 

heza

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Incidentally most doctors will not treat subclinical hypothyroidism, despite that research indicates early treatment can prevent it from progressing to fullblown Hashimoto's (which is a tissue-destructive autoimmune disorder).

*General PSA*

Yeah. It's really crucial, if you think you have hypothyroidism, to just keep seeking out doctors until you find one who will do the right tests and treat you. I saw four doctors who refused to do anything but the basic tests and all kept saying, "your numbers are 'in range'." I finally found a reproductive endocrinologist/gynecologist who did a whole battery of tests and immediately put me on low doses of thyroid medication. He also diagnosed me as severely insulin resistant (which 2 of my previous doctors claimed wasn't an actual thing) and is treating that with Metformin before I develop diabetes. The change it has made in my life...

Don't let a doctor intimidate you with "in range" and "you're just making this up" or any of the number of things they say so they don't have to actually deal with you.

Listen to your body. If you're pretty sure something's wrong, just keep seeing different doctors until you find one who agrees. No every doctor knows what they're doing and they don't actually feel what you feel.
 
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MaryMumsy

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Pretty much verbatim report on my last bloodwork:

Well, your cholesterol is XXX, which is fine. Your sugars are XXX, which is fine. Your thyroid is running a little high, but it always is, so we won't worry about it.

When we adjust my thyroid medication to the point the labs are "normal", I feel like crap.

And Heza's ordeal is similar to what I went through when I first started menopause. I had to go to 4 (count them, 4) Ob-Gyns before one would listen to me. Because I was "too young" at 44 to be starting menopause. I riposted that I was "too young" at 11 to start having periods, but I did.

I've been on HRT for over 20 years (with occasional breaks to see if I could stop), and feel fine. No more hellish mood swings, no more hot flashes.

MM
 

Gretad08

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Pretty much verbatim report on my last bloodwork:

Well, your cholesterol is XXX, which is fine. Your sugars are XXX, which is fine. Your thyroid is running a little high, but it always is, so we won't worry about it.

When we adjust my thyroid medication to the point the labs are "normal", I feel like crap.

And Heza's ordeal is similar to what I went through when I first started menopause. I had to go to 4 (count them, 4) Ob-Gyns before one would listen to me. Because I was "too young" at 44 to be starting menopause. I riposted that I was "too young" at 11 to start having periods, but I did.

I've been on HRT for over 20 years (with occasional breaks to see if I could stop), and feel fine. No more hellish mood swings, no more hot flashes.

MM

Too young at 44? I have a friend who went through it in her thirties, as did her mom and sisters. That's really odd that they would say that. So sorry you had to deal with dummies!
 

Gretad08

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In regard to hypothyroidism, I had to have mine removed a few years ago. When your levels are out of whack, at least for me, the symptoms are distinct.

I was having thyroid symptoms, and was already headed to my GP for a checkup so I just had her run my levels. She said they were normal. I didn't agree, so I went to my endocrinologist, who ran my levels again, and agreed they were low. A mild dosage increase, and I was back to symptom free. If you don't agree, get a second opinion. I didn't even waste my time arguing with the GP. She doesn't know what she doesn't know, and although I like her I wasn't going to get in to a battle of egos with a doctor.

Heza, I've never heard of a reproductive endo/gyno. Interesting. I'll have to check in to that.
 

heza

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Heza, I've never heard of a reproductive endo/gyno. Interesting. I'll have to check in to that.

He deals mostly with thyroid issues, insulin resistance, and polycystic ovarian syndrome because these things are frequently related and affect fertility.