Power Morcellation: a hazardous Practice

Cardiothoracic surgeon Hooman Noorchashm waged a national campaign to put an end to the practice of power morcellation

On Oct. 17, 2013, a surgical instrument called a power morcellator tore into the uterus of Amy Reed, an anesthesiologist at Beth Israel Deaconess Medical Center, pulverizing what were believed to be benign fibroids

More information
  • Reed’s “minimally invasivehysterectomy, a routine procedure, was performed at the Brigham and Women’s Hospital, a teaching hospital of Harvard Medical School.  Alas, Reed’s uterus contained an occult sarcoma, which the morcellator proceeded to spread through her abdominal pelvic cavity.  Over ensuing months, as Reed battled to stay alive, her husband, Hooman Noorchashm, a cardiothoracic surgeon and, at the time, a lecturer at Harvard, waged a national campaign to put an end to the practice of power morcellation.
  • Video published on 3 July 2014 by TheCancerLetter.
    Read the full story on The Cancer Letter, Jul 3, 2014.
Dr. Noorchashm campaign against hysterectomy using electric power morcellation
  • Public testimony gets heated at FDA panel meeting on morcellation, OBGYNNews,video, JULY 11, 2014.
  • Health Alert: Many Women Have Died Because Deadly Cancers of the Uterus Are Being Spread by Gynecologists. Stop Morcellation of the Uterus in Minimally Invasive Surgery,
    Change, SIGN the Petition by Hooman Noorchashm.

UterineFibroids : Questions to ask your Surgeon before Fibroid Surgery

What should you do if you need to have fibroids removed?

Here are three questions to ask your surgeon that may help you decide:

Many physicians are still using morcellators and may inadvertently spread undiagnosed cancer…
  • What exactly are you going to do?
  • What are the risks?
  • What do my imaging tests reveal?

Read 3 Questions to Ask Before Fibroid Surgery, NewsHealth, 2014/09/23.

Also checkout some related posts.

Deadly Medicine: Laparoscopic Power Morcellation

A Common Surgery for Women and the Cancer it Leaves Behind

Deadly Medicine ebook cover image
Download this free WSJ ebook.

Since the 1990s, thousands of women have undertaken a surgical procedure that may have risked their lives.

After Dr. Amy Reed had surgery to remove uterine fibroids, involving a procedure known as power morcellation, she learned that it had worsened her prognosis by spreading a cancer she and her doctors didn’t know she had.

Dr. Reed became a vocal critic of power morcellators and the doctors who used them, dividing the medical community. Now doctors and companies are waiting for more-permanent guidance from the FDA.

This story, drawn from ongoing coverage in The Wall Street Journal, is a gripping human-interest account of public trust and the fallibility of modern medicine. ”

Dr. Noorchashm campaign against hysterectomy using electric power morcellation
  • Public testimony gets heated at FDA panel meeting on morcellation, OBGYNNews, video, JULY 11, 2014.
  • Health Alert: Many Women Have Died Because Deadly Cancers of the Uterus Are Being Spread by Gynecologists. Stop Morcellation of the Uterus in Minimally Invasive Surgery,
    Change, SIGN the Petition by Hooman Noorchashm.

Uterine Morcellation – How was this allowed to happen?

Dr. Noorchashm MD – HealthWatchUSA Video, 2014

Dr Hooman Noorchashm presents his research and perspective leading to a plan of action to ban the procedure of morcellation and revising the 510K medical device approval process.
Health Watch USA meeting, Jun. 25, 2014. Part 3 of 3.

More about Dr. Noorchashm campaign against hysterectomy using electric power morcellation:
  • Public testimony gets heated at FDA panel meeting on morcellation, OBGYNNews, video, JULY 11, 2014.
  • Health Alert: Many Women Have Died Because Deadly Cancers of the Uterus Are Being Spread by Gynecologists. Stop Morcellation of the Uterus in Minimally Invasive Surgery,
    Change, SIGN the Petition by Hooman Noorchashm.

Uterine Cancers among Women undergoing a Minimally Invasive Hysterectomy using Electric Power Morcellation

Evaluating the Risks of Electric Uterine Morcellation

JAMA Network logo
Presence of uterine cancers at time of hysterectomy studied using morcellation.

Even though minimally invasive surgery has improved outcomes for hysterectomy, the procedure requires removal of the uterus through small incisions. Morcellation, or fragmentation of the uterus into smaller pieces, is one method to remove the uterus. Recently, concern has been raised that morcellation may result in the spread of undetected malignancies.

Despite the commercial availability of electric power morcellators for 2 decades, accurate estimates of the prevalence of malignancy at the time of electric power morcellation (herein referred to as morcellation) are lacking.

Among women undergoing a minimally invasive hysterectomy using electric power morcellation, uterine cancers were present in 27 per 10,000 women at the time of the procedure, according to a new study. There has been concern that this procedure, in which the uterus is fragmented into smaller pieces, may result in the spread of undetected malignancies.

Sources and More Information:

  • Uterine Pathology in Women Undergoing Minimally Invasive Hysterectomy Using Morcellation, JAMA, articleid=1890400,  doi:10.1001/jama.2014.9005, July 22, 2014.
  • Presence of uterine cancers at time of hysterectomy studied using morcellation, ScienceDaily, 140722164353, July 22, 2014.
  • Patient safety must be a priority in all aspects of care, The Lancet Oncology, Volume 15, Issue 2, Page 123,  doi:10.1016/S1470-2045(14)70042-7, February 2014.
  • Evaluating the Risks of Electric Uterine Morcellation, JAMA. 2014;311(9):905-906. articleid=1828692, doi:10.1001/jama.2014.1093, March 5, 2014.
  • Peritoneal Dissemination Complicating Morcellation of Uterine Mesenchymal Neoplasms, PLOS one, DOI: 10.1371/journal.pone.0050058, November 26, 2012.
  • Risk of occult malignancy in morcellated hysterectomy: a case series, NCBI, PMID: 21804400, 30(5):476-83. doi: 10.1097/PGP.0b013e3182107ecf, 2011 Sep.
  • Robotically Assisted vs Laparoscopic Hysterectomy Among Women With Benign Gynecologic Disease, JAMA, articleid=1653522, 2013;309(7):689-698. doi:10.1001/jama.2013.186, February 20, 2013.
  • The value of re-exploration in patients with inadvertently morcellated uterine sarcoma, GynecologicOncology, Volume 132, Issue 2 , Pages 360-365, article/S0090-8258(13)01351-6, February 2014

Uterine Morcellation Disseminating Unexpected Malignancy with Associated High Increase in Mortality

Peritoneal dissemination complicating morcellation of uterine mesenchymal neoplasms

Abstract

PLoS logo
Uterine morcellation carries a risk of disseminating unexpected malignancy with apparent associated increase in mortality much higher than appreciated currently

Background:
Power morcellation has become a common technique for the minimally invasive resection of uterine leiomyomas. This technique is associated with dissemination of cellular material throughout the peritoneum. When morcellated uterine tumors are unexpectedly found to be leiomyosarcomas or tumors with atypical features (atypical leiomyoma, smooth muscle tumor of uncertain malignant potential), there may be significant clinical consequences. This study was undertaken to determine the frequency and clinical consequence of intraperitoneal dissemination of these neoplasms.

Methodology/Principal Findings:
From 2005-2010, 1091 instances of uterine morcellation were identified at BWH. Unexpected diagnoses of leiomyoma variants or atypical and malignant smooth muscle tumors occurred in 1.2% of cases using power morcellation for uterine masses clinically presumed to be “fibroids” over this period, including one endometrial stromal sarcoma (ESS), one cellular leiomyoma (CL), six atypical leiomyomas (AL), three smooth muscle tumor of uncertain malignant potential (STUMPs), and one leiomyosarcoma (LMS). The rate of unexpected sarcoma after the laparoscopic morcellation procedure was 0.09%, 9-fold higher than the rate currently quoted to patients during pre-procedure briefing, and this rate may increase over time as diagnostically challenging or under-sampled tumors manifest their biological potential. Furthermore, when examining follow-up laparoscopies, both from in-house and consultation cases, disseminated disease occurred in 64.3% of all tumors (zero of one ESS, one of one CL, zero of one AL, four of four STUMPs, and four of seven LMS). Only disseminated leiomyosarcoma, however, was associated with mortality. Procedures are proposed for pathologic evaluation of morcellation specimens and associated follow-up specimens.

Conclusions/Significance:
While additional study is warranted, these data suggest uterine morcellation carries a risk of disseminating unexpected malignancy with apparent associated increase in mortality much higher than appreciated currently.

Sources:
  • Peritoneal dissemination complicating morcellation of uterine mesenchymal neoplasms, NCBI, PMC3506532, doi: 10.1371/journal.pone.0050058, PLoS One. 2012; 7(11): e50058., Epub 2012 Nov 26.

Uterine Morcellation – Use of the Technique may be Too Risky under Any Circumstance

Some professional groups and medical institutions are stressing the importance of counseling patients about both the potential risks and benefits of morcellation of a fibroid or uterus

Evaluating the Risks of Electric Uterine Morcellation

Gynecologic surgeons, like many other surgical specialists, have embraced laparoscopic surgical techniques because they offer quicker recovery, less postoperative pain, and fewer wound complications than open procedures. The removal of large pieces of tissue through the small incisions of laparoscopy is difficult. However, this problem can be overcome by tissue morcellation, a technique of fragmenting tissue into smaller pieces that often prevents the need to enlarge established incisions. Surgeons have long used manual morcellation with a scalpel or scissors to remove masses abdominally and vaginally, but use of the technique has increased with wide adoption of laparoscopic approaches and with the introduction of laparoscopic electric morcellators in 1993.

Critics of Fibroid Removal Procedure Question Risks It May Pose for Women With Undetected Uterine Cancer

Jama Network logo
Uterine Morcellation – Use of the Technique may be Too Risky under Any Circumstance

Use of a surgical technique that involves cutting fibroid or uterine tissue into small pieces for extraction during minimally invasive surgery has come under scrutiny recently—scrutiny prompted by concerns that the process may disperse fragments of undetected malignant tumors throughout the abdominal cavity and upstage otherwise contained cancers.

Because it’s not possible to reliably detect the presence of uterine sarcomas before surgery, some experts say that use of the technique—known as intracorporeal uterine morcellation, which can be performed with an electric morcellator or by hand with a knife—may be too risky under any circumstance. Others say more research on risks associated with the procedure is needed before banning it outright. In the meantime, some professional groups and medical institutions are stressing the importance of counseling patients about both the potential risks and benefits of morcellation of a fibroid or uterus.

Sources and Full Text
  • Evaluating the Risks of Electric Uterine Morcellation, The Journal of the American Medical Association, 1828692, 2014;311(9):905-906. doi:10.1001/jama.2014.1093.
  • Critics of Fibroid Removal Procedure Question Risks It May Pose for Women With Undetected Uterine Cancer, JAMA Network, 1828691, 2014;311(9):891-893. doi:10.1001/jama.2014.27.

Stop Morcellating the Uterus in Minimally Invasive and Robot Assisted Hysterectomy and Myomectomy

Women’s Health Alert: Deadly Cancers of the Uterus Spread by Gynecologists

change logo
Stop Morcellating the Uterus in Minimally Invasive and Robot Assisted Hysterectomy and Myomectomy!

More than 600,000 hysterectomies are done in the US every year. By the age of 70, one out of every three American women will have had a hysterectomy. About 90% of these surgeries are done for what is presumed to be a benign condition called fibroids. More and more of these surgeries are done with minimally invasive techniques. Usually, to get the uterus out of the body using the “minimally invasive” technique, it is cut into small pieces with a machine called a morcellator. However, a devastating problem happens if in fact the woman did NOT have fibroids – but if she actually had cancer. Unfortunately, the tests that are done before a hysterectomy do not identify these cancers well. Many gynecologists don’t even bother getting any tests. In fact, morcellating cancer spreads the cancer inside the woman’s body.

This is called ‘up staging’ the cancer. It is important to understand:

  1. The average life span following accidental morcellation of sarcoma is only 24-36 months.
  2.  Only 15% of woman who have leiomyosarcoma (LMS) that has spread (stage 4) will be alive after 5 years.
  3. Women with sarcoma who are morcellated are about 4 times more likely to die from sarcoma than if they had not been morcellated.

This is an avoidable disaster..

Read on Change.org Women’s Health Alert: Deadly Cancers of the Uterus Spread by Gynecologists. Stop Morcellating the Uterus in Minimally Invasive and Robot Assisted Hysterectomy and Myomectomy
and SIGN the petition.

Uterine Morcellation – when a Hysterectomy can spread Cancer to a Death Sentence

The procedure spread Amy Reed cancer

USA TODAY Health logo
Uterine morcellation carries a risk of disseminating unexpected malignancy with apparent associated increase in mortality much higher than appreciated currently.

Uterine morcellation carries a risk of disseminating unexpected malignancy with apparent associated increase in mortality much higher than appreciated currently.

  • Morcellation is done in at least 11% of the nearly 500,000 U.S. hysterectomies a year.
  • The process pulverizes the uterus for easier removal, and quicker recovery.
  • But in cases where undiagnosed cancer may be present, the process spreads it.

Read When a hysterectomy can be a death sentence, USA Today, /5347093/, February 18, 2014

FDA discourages Use of Laparoscopic Power Morcellation for Hysterectomy, Uterine Fibroids Removal

Hysterectomy and procedures to remove uterine fibroids should avoid use of laparoscopic power morcellation, according to a safety advisory from the Food and Drug Administration

DES Action USA communication:
fda logo
Hysterectomy: the FDA discourages Use of Laparoscopic Power Morcellation for Removal of Uterus or Uterine Fibroids.

DES Daughters, with their increased risk for uterine fibroids – pay attention! Find out what your doctor plans to do when surgically treating them. A tool called a power morcellator, that looks and works like the immersion blender found in your kitchen, may inadvertently spread cancer cells while breaking up the fibroid. You may want to be firm with your doctor about options. Sources: here.

Abstract:

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.

A number of additional 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, laparotomy using a smaller incision (minilaparotomy), deliberate blocking of the uterine artery (catheter-based uterine artery embolization), high-intensity focused ultrasound, and drug therapy. Evidence demonstrates that, when feasible, vaginal hysterectomy is associated with comparable or better results and fewer complications than laparoscopic or abdominal hysterectomy3.

Importantly, based on an FDA analysis of currently available data, it is estimated that 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. 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 likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.

Sources:
  • FDA discourages use of laparoscopic power morcellation for removal of uterus or uterine fibroids, FDA, Press Announcements, ucm393689, April 17, 2014
  • Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication, FDA, Safety Communications, ucm393576, April 17, 2014
  • Uterine Fibroids, NIH Fact Sheets, csid=50, March 29, 2013
  • FDA Warns of Cancer Risk With Laparoscopic Device, MedPage Today, 45309, Apr 17, 2014