How power morcellators inadvertently spread uterine cancer

imagesUntil a few weeks ago, I’d never even heard of a “power morcellator.” Nor was I aware of the controversy that has pitted defenders of a woman’s right to choose a minimally invasive laparoscopic procedure in removing fibroids—enabled by the power morcellator–and those who decry the danger it poses in spreading an undetected uterine cancer throughout a woman’s abdomen. The most outspoken member of the anti-morcellation group is surgeon Hooman Noorchashm. His wife, Dr. Amy Reed, had a laparoscopic hysterectomy that resulted in morcellating a hidden cancer, progressing it to Stage IV sarcoma. Below is their video (link is here), followed by a recent FDA warning. I may write this in stages or parts. (I will withhold my view for now, I’d like to know what you think.)

Morcellation: (The full Article is here.)

^^^^^^^^^^^^^^^^^^^

FDA Safety Communication:images-1

UPDATED Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm

The following information updates our April 17, 2014 communication.

Date Issued: Nov. 24, 2014

Product: 
Laparoscopic power morcellators are medical devices used during different types of laparoscopic (minimally invasive) surgeries. These can include certain procedures to treat uterine fibroids, such as removing the uterus (hysterectomy) or removing the uterine fibroids (myomectomy). Morcellation refers to the division of tissue into smaller pieces or fragments and is often used during laparoscopic surgeries to facilitate the removal of tissue through small incision sites.

Purpose: 
When used for hysterectomy or myomectomy in women with uterine fibroids, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus. The FDA is warning against using laparoscopic power morcellators in the majority of women undergoing hysterectomy or myomectomy for uterine fibroids. Health care providers and patients should carefully consider available alternative treatment options for the removal of symptomatic uterine fibroids.

Summary of Problem and Scope: 
Uterine fibroids are noncancerous growths that develop from the muscular tissue of the uterus. Most women will develop uterine fibroids (also called leiomyomas) at some point in their lives, although most cause no symptoms1. In some cases, however, fibroids can cause symptoms, including heavy or prolonged menstrual bleeding, pelvic pressure or pain, and/or frequent urination, requiring medical or surgical therapy.

Many women choose to undergo laparoscopic hysterectomy or myomectomy because these procedures are associated with benefits such as a shorter post-operative recovery time and a reduced risk of infection compared to abdominal hysterectomy and myomectomy2. Many of these laparoscopic procedures are performed using a power morcellator.

Based on an FDA analysis of currently available data, we estimate that approximately 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. At this time, there is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma.

If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s long-term survival. While the specific estimate of this risk may not be known with certainty, the FDA believes that the risk is higher than previously understood.

Because of this risk and the availability of alternative surgical options for most women, the FDA is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.

Limiting the patients for whom laparoscopic morcellators are indicated, the strong warning on the risk of spreading unsuspected cancer, and the recommendation that doctors share this information directly with their patients, are part of FDA guidance to manufacturers of morcellators. The guidance strongly urges these manufacturers to include this new information in their product labels.

Recommendations for Health Care Providers:

  • Be aware ofthefollowingnewcontraindications recommended by the FDA;
    1. Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal, or are candidates for en bloc tissue removal, for example through the vagina or mini-laparotomy incision. (Note: These groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy.)
    2. Laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
  • Be aware of the following new boxed warning recommended by the FDA:
The FDA warns that uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer, and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.
  • Carefully consider all the available treatment options for women with uterine fibroids.
  • Thoroughly discuss the benefits and risks of all treatments with patients. Be certain to inform the small group of patients for whom laparoscopic power morcellation may be an acceptable therapeutic option that their fibroid(s) may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis. This population might include some younger women who want to maintain their fertility or women not yet peri-menopausal who wish to keep their uterus after being informed of the risks.

Recommendations for Women:

  • Ask your health care provider to discuss all the options available to treat your condition. There are risks and benefits associated with all medical devices and procedures and you should be aware of them.
  • If your doctor recommends laparoscopic hysterectomy or myomectomy, ask him/her if power morcellation will be performed during your procedure, and to explain why he or she believes it is an appropriate treatment option for you.
  • If you have already undergone a hysterectomy or myomectomy for fibroids, tissue removed during the procedure is typically tested for the presence of cancer. If you were informed these tests were normal and you have no symptoms, routine follow-up with your physician is recommended. Patients with persistent or recurrent symptoms or questions should consult their health care provider.
  • A number of additional surgical treatment options are available for women with symptomatic uterine fibroids including traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, laparoscopic hysterectomy and myomectomy without morcellation, and laparotomy using a smaller incision (minilaparotomy). All treatments carry risk, and you should discuss them thoroughly with your health care provider.

FDA Actions:

The FDA has taken the following actions in light of scientific information that suggests that the use of laparoscopic power morcellators may contribute to the spread and upstaging of unsuspected uterine cancer in women undergoing hysterectomy and myomectomy for fibroids:

  • The FDA conducted a review of published and unpublished scientific literature, including patients operated on from 1980 to 2011 to estimate the prevalence of unsuspected uterine sarcoma and uterine leiomyosarcoma in patients undergoing hysterectomy or myomectomy for presumed benign fibroids (leiomyoma). This analysis led us to believe that the prevalence of unsuspected uterine sarcoma in patients undergoing hysterectomy or myomectomy for presumed benign leiomyoma is 1 in 352 and the prevalence of unsuspected uterine leiomyosarcoma is 1 in 498. Both of these estimates are higher than the clinical community previously understood.
  • Convened a meeting of the Obstetrics and Gynecological Medical Device Advisory Panel in July 2014. The panel discussed patient populations in which laparoscopic power morcellators should not be used, mentioning specifically patients with known or suspected malignancy. The panel also discussed mitigation strategies such as labeling, and suggested that a boxed warning related to the risk of disseminating unsuspected malignancy would be useful.
  • Issued an Immediately In Effect (IIE) guidance that asks manufacturers of new and existing laparoscopic power morcellators to include two contraindications and a boxed warning in their product labeling. This information warns against using laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy and recommends doctors share this information with their patients.
  • Published safety information related to these devices and alternative treatment options for the treatment of fibroids available on its website to help people better understand the risks of laparoscopic power morcellators.

In addition to the most recent contraindications and boxed warning, the FDA continues to consider other steps that may further reduce such risk—such as encouraging innovative ways to better detect uterine cancer and containment systems designed specifically for gynecological surgery.

The FDA will continue to review adverse event reports, peer-reviewed scientific literature, and information from patients, health care providers, gynecologic and surgical professional societies, and medical device manufacturers.

 

.

Categories: morcellation: FDA warning, Statistics | Tags: | 7 Comments

Post navigation

7 thoughts on “How power morcellators inadvertently spread uterine cancer

  1. I think what’s most disturbing about these cases is that women were not told they would be morcellated, and what the consequences would be if they happened to have an undetected “occult” cancer lying around.

  2. Mark

    It’s called iatrogenics! Surgical hubris on a foundation of severe lack of knowledge. They can’t “know” whether a cancer (or maybe just a small mass of abnormal cells that would eventually be taken care of by the body itself or might never be a problem in the woman’s lifetime were it to not be disturbed) is present or not. They can’t actually “know” the prevalence (even the FDA’s assumption (or “belief”) of 1/350 is contrived). And it’s logically and statistically impossible to prove or “demonstrate” anything, any drug or surgical procedure, to be safe (in the sense of proving it to be equivalent to a placebo or sham procedure). Absence of evidence is not evidence of absence.

    I think what’s most disturbing about these cases is that the surgeons really believe that they know the extent of risk (full disclosure, I work with some surgeons who perform this procedure).

    I feel very bad for Dr.s Reed and Noorchashm, and very much agree with what they say in this interview.

    • The 1/350-1/500 del frequency of occult uterine cancer among women with sufficient fibroid problems to seek surgery is fairly well known from the >50,000 women who have morcellation yearly.

      • Mark

        This is only based on those cancers that were detected following the operation. This is why the FDA guidance says “This analysis led us to believe that the prevalence…” Further, at best, this is a description of what had happened previously, not necessarily a general statement of what is to come, and it certainly does not apply to any individual woman in any case.

        • Prevalence estimates never do refer to a particular person. If they found around the same incidence year to year, it would be pretty informative don’t you think? Of course practice will change now.

  3. Steven McKinney

    I agree that all too often medical practitioners believe this or that about a procedure, instead of reasoning this or that based upon sound science and measurement.

    But I disagree that it is logically and statistically impossible to prove or demonstrate anything. This is a statistical blog after all. If it is impossible to demonstrate anything, we may as well go back to snake oil and witch doctoring. Plenty of procedures have been shown to be safe with sound statistical evaluation. We’ve just been through another round of showing that vaccines purported to cause autism do no such thing, and the vaccine is safer than a placebo or sham in the sense that vaccinated populations show many fewer medical/health complications or death after receiving the vaccine than populations that do not receive the vaccine.

    The problem here is that reasonable evidence to assess the medical complications and death rates associated with morcellation versus those associated with surgery to remove fibroids intact have not been done fully and adequately. Only a randomized trial on a large population will allow reasonable assessment of patient outcome associated with these differing techniques, and there’s plenty of evaluation of current data and assessment of moral and ethical issues that needs to happen before any such trial could be undertaken. Assessments of surgical complications and deaths from infections occurring with whole fibroid removal versus other adverse outcomes from morcellation have not yet been adequately performed. The moral implications of patients dying from infection versus dying from cancer are clearly difficult, as we are currently seeing.

    At this point there’s clearly a case for review of this technique, and at a minimum clear discussion with indicated patients of the now known possible side effects of both options, whole fibroid removal or morcellation. I agree with those who think a moratorium on morcellation is warranted while these issues are reviewed, but I need more severe testing of evidence before being willing to advocate one methodology over the other. Thankfully the FDA has issued a statement discouraging use of morcellation for fibroid or uterine removal, while this issue gets the reasoned review it needs.

  4. Jan. 29, 2015 update: new dangers beyond spreading hidden cancer: creating other uterine conditions.
    http://newyork.legalexaminer.com/defective-dangerous-products/new-study-shows-power-morcellator-complications-apparently-extend-beyond-cancer/

I welcome constructive comments for 14-21 days. If you wish to have a comment of yours removed during that time, send me an e-mail.

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

Blog at WordPress.com.