FDA warns gynecologic device has spread cancer

[WhiteTara]

Source: USA Today

The US Food and Drug Administration Monday warned against a gynecologic device that has spread cancer in women who thought they had harmless fibroids.

In the last year, two-dozen women have reported that their cancer was made worse by the device, called a power morcellator, which turned a treatable condition into a life-threatening disease.

"We believe that in the vast majority of women, the procedure should not be performed," said Dr. William Maisel, deputy director for science and chief scientist of the FDA's Center for Devices and Radiological Health.

The device is used to pulverize fibroids before removing them through a tiny hole in the abdomen. If any growths are cancerous – which is impossible to determine before surgery – the power morcellation spreads cancer cells throughout the abdomen, virtually guaranteeing that the cancer will become more dangerous.

Opposition to the device has been led by a surgeon, Hooman Noorchashm. Noorchashm, who has repeatedly called for the FDA to institute an outright ban on morcellation, said Monday that he doesn't think the warning goes far enough to protect women like his wife. As long as the device is on the market, women will be vulnerable, he said.wife, Amy Reed, went in for a routine hysterectomy a year ago and came out with stage 4 cancer. Reed, then a doctor at Beth Israel Medical Center in Boston, is now in remission and getting ready to go back to work at the Hospital of the University of Pennsylvania. The two have six children ages 2 to 13.

Read more: http://www.usatoday.com/story/news/nation/2014/11/24/fda-warning-power-morcellator-fibroids-cancer/19491165/

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It's called practicing for a reason.

[Faux pas]

1. Kickin'

[woodsprite]

2. I've warned my friends against having a procedure done where

they do a slice/dice hysterectomy. I was diagnosed with IIB Endometrial cancer about 7 yrs back. They knew it was cancer (endometrial biopsy), but weren't sure of the stage and grade until surgery. The doctor said that the goal was to remove the uterus/tubes/ovaries much in one piece as possible. Doing that greatly cut down on the chance of the cancer spreading or of them not getting 'clean margins'.

Another procedure I would warn women about would be uterine ablation. It works fairly well to stop excessive bleeding (in about 75% of the women to opt for it), BUT if something goes wrong -- like you develop endo cancer a year or two after having the ablation -- you may not see signs of it until it's grown to a later stage. That was me, and it is in the reading material that you are supposed to read before you sign, but who ever thinks it's going to happen to them.

[840high]

3. Thanks.

[chowder66]

4. What procedures do you think are safe?

I just found out I have fibroids and right now they are not prescribing anything. I'm just keeping a diary.
My doc said BC pills could be prescribed either alone or along with other procedures if things change.

[RebelOne]

5. I had fibroids many years ago,

and the doctor performed a simple D&C and I have never had any problem since.

[chowder66]

8. Thanks! nt

[pnwmom]

6. Fibroids often shrink by themselves after menopause, so this might be a situation

where the doctors just wait and see.

[chowder66]

9. Thanks! nt

[Delphinus]

23. But they don't always ...

which is what I'm dealing with now. Yahoo has a pretty good chat list on fibroids - you might learn a lot.

[chowder66]

25. Thanks again! nt

[MoonchildCA]

10. About 40% of women get fibroids.

They vary greatly in what type (having to do with location--inside, outside, etc.), what size, how many, and whether or not they cause symptoms. You may have one or dozens, and they could be pea size to grapefruit size, and rarely, larger.

I'm sure many cases go undiagnosed, and never become an issue. Unless yours are causing some debilitating problem, I would leave them alone, and maybe just occasionally monitor them. If a "procedure" of some sort is recommended, get a second opinion. They are very rarely life-threatening, so time is usually on your side.

[chowder66]

11. Thank you.

My mother and Aunt had them but my Aunt's were serious and she had a full hysterectomy. My mother didn't need any treatment.
So far I'm having a few problems but not enough to warrant any treatment thus far. As my Doc said BC pills can help and she would discuss any other options or procedures if needed. Luckily I have a really great doctor and if I feel uncomfortable I will get a second opinion. Thank you for the advice.

[Ms. Toad]

14. Make sure to check your family history for breast cancer -

and thrombosis, and birth control ingredients to make sure they make sense general.

Personally, I would not take birth control pills for fibroids. I think it is a waste of money (they don't generally work) and - with my personal and family history - downright dangerous.

[chowder66]

16. Thanks again! nt

[MoonchildCA]

15. I had a full hysterectomy too,

but mine was not a typical case...

[chowder66]

17. I'm hoping I don't have to but my Aunt

didn't have any problems after hers which did ease my mind in case I do have to go down that road. Fingers crossed I don't!

[MoonchildCA]

21. I had no problems either, after recovery.

It is a last resort though, I wouldn't worry too much about it.

There is a great website though, hystersisters.com. They have a lot of information, not just on hysterectomies, but on different diagnoses, alternative treatments, etc., and great forums to read and ask questions.

It was invaluable to me when I was going through my ordeal.

[chowder66]

22. I'm not nearly as worried as I was

now that I've got a better overview from the women here. Thank you for the link! I've bookmarked it and will browse through it this weekend.

[Ms. Toad]

13. If there is a single submucosal fibroid,

hysteroscopic myomectomy. Outpatient surgery - resolves the problem and you're back to work in 24 hours.

If not - none of the options are fantastic. I was headed for uterine artery embolization (although the thought of gazillion tiny pellets implanted did not thrill me).

If the issue is just bulk and discomfort - you don't really need to do anything and they will shrink after menopause. If the issues is really excessive bleeding, they are both more likely to be submucosal fibroids - and likely to be more easily removed.

[chowder66]

18. That's really good to know.

Since my mom had a partial when I was really young and my Aunt had her full hysterectomy when she was young they can't remember a whole lot about them, plus medicine has changed since they went through this. I had one massively heavy period that scared the bejeezus out of me but they found that I was not anemic. I felt like a kid who didn't know anything about menstruation or biology. I've been reading about peri-menopause but haven't gotten around to fibroids probably since my doctor said all is well to date.

Everyone is providing really good information. Thank you all so much!

My fears are lessoning for sure.

[Ms. Toad]

19. My great grandmother had a radium pellet

implanted in her uterus to cure bleeding - and died of cancer caused by the implant.

I had to fight two doctors to avoid a hysterectomy, Had I not found a doctor who was more innovative, I would have needed one to keep me from hemorrhaging to death (the extreme anemia convinced separate doctors my bone marrow was no longer producing red blood cells). But once I found the right doctor it was such a trivial procedure (15 years ago with no recurrence) it is a crime that an office hysteroscopy (look around) isn't standard first step to determine if a hysteroscopic myomectomy (removal through the cervix) is an viable option. Unfortunately, way too many doctors just figure the uterus is a useless piece of equipment once you are done with childbearing - and it is easier, and more lucrative, to do a hysterectomy.

Feel free to PM me if you have questions - although it has been a long time since I've done research on this particular issue.

[chowder66]

20. That's terrible about your Great Grandmother

I'm sorry that she went through that but I'm glad you found the right doctor. If I have to go down this road and your still here I will most definitely pm you. Thank you so much for the offer.

[noiretextatique]

24. get a hysterectomy

Is my advice to women who do not plan to have a child. I had breast cancer and had to take Tamoxifen, which can cause uterine cancer. So when I developed fibroids, I eagerly had a complete hysterectomy...a laparascopic one. The recovery time was about two weeks. Since my breast cancer was estrogen-positive, the loss of estrogen is OK for me.

[chowder66]

26. I appreciate the advice

Right now, this is new so I'm not eager to do anything but what my doctor tells me at the moment. There are no serious issues occurring at the moment and there is no history of breast cancer in my family. But I didn't realize there are so many different treatments, some sounding down right deadly so I appreciate all of the advice.

Thank you!

[noiretextatique]

28. please do some research

i learned that the hard way when my idiot doctor sent me to a general surgeon, instead of a breast surgeon. the general surgeon tried to get me to do a type of radiation that i later learned was not fully accepted by most reputable radiologists. and i still need to have a breast reduction because the general surgeon did not know to do it with the lumpectomy.
here's some of my story:
http://www.nytimes.com/2008/10/27/health/policy/27device.html?_r=0

find out all your options...and best wishes.

[chowder66]

30. Thank you.

I read the article and it reinforces the decision to get a second opinion if a procedure is recommended. Since my Aunt had a successful hysterectomy I'm partial to that if it comes to that.
There are so many methods of treatment, I'm glad to read about them so if my doctor does suggest one of these that is not fully studied then I will know there's potentially a problem with my doctor's advice which could be invaluable.

I'm sorry that they didn't take care of the reduction when they should have. How maddening this all must have been for you.

All of the good advice I'm getting here helps lessen the worry if this turns out to be something that needs some sort of treatment.

[noiretextatique]

31. one of the best resources: women who've been through it

i used breastcancer.org, and i see others have given you some sties to check out. second opinion: YES. claiming the best outcome for you.

[chowder66]

32. : ) agreed. nt

[elleng]

7. OMG!

[BlancheSplanchnik]

12. some questions I'm wondering about...

What other procedures use morcellation? What's the history? I mean, what other diseases is it prescribed for?

Is it used in any other type of cancer situation? If so, what have been the outcomes?

[WinkyDink]

27. All part of the current medical fixation on surgery-through-anywhere-but-a-major-incision.

An abdominal operation for this problem in the 70's would not have this result.

[eissa]

29. Thanks for sharing this

I was told I had fibroids and my OB recommended a hysterectomy. I prefer to keep all my parts for as long as I can and don't want to remove anything unless absolutely necessary. I went in for a second opinion and was told they are not actually fibroids, but small, circular muscles that have formed inside the uterine glands. ALWAYS get a second opinion. Even if they were fibroids, like a poster said above, they do tend to dissolve with age, and I'm happy to wait and monitor them rather than undergo any drastic procedure, especially using new, relatively untested methods.

[HeiressofBickworth]

33. A friend of mine

had fibroids for many years with heavy bleeding and cramping as a result. I first met her when she was a Temp at the office I worked at. We became friends, she told me about her fibroids and said that she had no insurance and couldn't do anything about them but take acupuncture for the pain. She subsequently was given a full-time permanent job complete with health insurance. I talked with her again about having a hysterectomy now that she had insurance. She didn't want to because of the down-time and this was a new job and she couldn't take the time off. She also had issues with "western medicine" and preferred other treatments. She was there a couple of years and then moved on. Later, when the bleeding and pain became debilitating, she finally went to a doctor only to learn that she had Stage 4 uterine cancer. The fibroids had been masking the cancerous tumors. She died five months later.

So, when I had some problems and learned that it was fibroids, I INSISTED that I have a complete hysterectomy, just on the chance that fibroids might be masking cancerous tumors, like my friend. I had the hysterectomy and was fortunate enough not to have cancer. Now my daughter has fibroids. She knows about my friend's cancer and death. She has been pushing her doctor to do a hysterectomy but the doctor is one of those "let's wait and see" types. I told her that she should just go to the surgeon I went to and do it before something goes wrong. Taking the uterus out as whole as possible will contain any tumors that might exist. This slice n'dice method spreads cancer if it is present so there's no sense in taking chances.

[ecstatic]

34. I had that surgery - Davinci robot

14 years ago. Going into my surgery, I didn't fully understand the risks; however, my surgeon (very skilled, the best in the Southeast) required his patients to get a full MRI prior to moving forward. I assume that is meant to remove most of the risk. My recovery was super fast and I was pregnant less than 4 months later and carried to term without rupture. My fibroid(s) have remained tiny / non problematic ever since.

I don't think the surgery should be banned - just take extreme caution before proceeding. For example, in addition to the MRI, perhaps patients could take cancer screenings, risk assessments and incorporate family history into the equation. Also, don't go to just anybody. Make sure you go to someone who knows what the fuck s/he is doing.

The bottom line is every surgery carries risk. The alternative to the robot, I assume, is to have full abdominal surgery. Or the mysterious embolization treatments. Does anyone think that's without risk?