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.
Evaluating the Risks of Electric Uterine Morcellation
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
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
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.
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!
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:
The average life span following accidental morcellation of sarcoma is only 24-36 months.
Only 15% of woman who have leiomyosarcoma (LMS) that has spread (stage 4) will be alive after 5 years.
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.orgWomen’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 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
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:
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
Pregnancy after New Womb, the @UniOfGothenburg Live-Donor Uterus Transplant Project, 2014
Nine women in Sweden have received uterus transplants from living relatives in an experimental fertility project. The patients in this trial headed by Mats Brannstrom of the University of Gothenburg are mostly women in their 30s who had lost their uterus to cancer or were born without one. The series of transplants took off in September 2012, with donors including the mothers and relatives of the recipients. These women will soon try to get pregnant, Brannstrom said in a CBS report. Video by TomoNews US, Published on 13 Feb 2014.
In this procedure, a radical hysterectomy is performed on the donor to remove the uterus, cervix and surrounding blood vessels, which will then be implanted to ensure adequate blood flow needed to sustain the uterus. Since the transplanted womb is not connected to the recipient’s fallopian tubes through which eggs are released, natural fertilisation cannot occur in the uterus. Instead, mature eggs will be extracted from the recipient and implanted to the uterus after performing in vitro fertilisation. When the uterus recipient has carried the fetus to full term, the baby is delivered by Caesarian section. The uterus recipient needs to remain on an extensive anti-rejection drug regimen, and the uterus is expected to be removed after a maximum of two pregnancies so the women can be taken off the anti-rejection drugs.
“Mats has done something amazing and we understand completely why he has taken this route, but we are wary of that approach,” said Dr. Richard Smith, head of the U.K. charity Womb Transplant UK. Smith is trying to raise 500,000 pounds ($823,000) to carry out five operations in Great Britain.
Two uterus transplants in Turkey and Saudi Arabia had failed to produce successful pregnancies. Similar procedures are currently under development in Hungary and the UK..
Possble risk of cervical or vaginal cancer higher in women previously treated for pre-cancerous cells on cervix
” Possble risk of cervical or vaginal cancer higher in women previously treated for pre-cancerous cells on cervix ” @DrAlisonHill
British Medical Journal aims to lead the debate on health, and to engage doctors, researchers and health professionals to improve outcomes for patients. @bmj_latest
Although the risk of cervical cancer after treatment for screen detected cervical precancer is low compared with non-treated women, the incidence of invasive cervical cancer is still significantly higher than in the general population. These findings are confirmed by Strander and colleagues in a trend analysis that linked data from pathology, cancer, and cause of death registries that have covered the whole Swedish population for more than half a century. The authors report that the risk of developing or dying from cervical or vaginal cancer in women with a history of treatment for CIN3 (cervical intraepithelial neoplasia grade 3) is two to three times higher than in the general population. Furthermore the increase in risk among women treated for CIN3 rises significantly with older age and more recent year of treatment.
These results agree with previous data suggesting that the rates of residual or recurrent high grade CIN after treatment are higher for older than for younger women. Endocervical precancerous lesions, a predisposing factor for recurrence, are more common in older women than in younger ones. The lower recurrence rates in younger women that are independent of the completeness of excision suggest that age specific immunity may also contribute to the ultimate cure of cervical precancer.
It is worrying that Strander and colleagues found that women who received local treatment more recently were at greater risk of developing cervical and vaginal cancer. The authors suggest that the use of less aggressive treatments in the two most recent decades may have adversely affected oncological outcomes. The trend in treatment was driven by an increasing awareness that extensive procedures are associated with poor reproductive outcomes. Recent meta-analyses of reports published since the end of the 1970s and registry based cohort studies have shown that pregnant women with a history of excisional treatment of CIN have a greater risk of premature delivery, particularly if the excised cones were large. Researchers from Norway have also described a parallel trend between less aggressive treatment for cervical precancer and a lower risk of preterm delivery.
The study population comprising more than three million women years of follow-up after treatment gave the current trend analysis enough power to identify significant differences between different subgroups of women. (Nevertheless, an age-period interaction term was not included in the log-linear model and this could have informed readers about the age specificity of the period effect.) Further analysis of the Swedish data on compliance with follow-up could provide important information on the possible reasons for treatment failure. The suggestion of reduced therapeutic effectiveness over time might also be partly explained by the decreased use of hysterectomy over the past two decades. A separate analysis of cervical and vaginal cancer rates, adjusted for rates of hysterectomy and for trends in the dimensions of excised cones, would help interpret the observed period effect.
Research is needed to identify accurate biomarkers that predict a woman’s future risk of cancer. A recent review concluded that testing for DNA from human papilloma virus helps to identify early treatment failure (recurrence within two years of treatment for cervical precancer), with higher sensitivity and similar specificity to follow-up cytology or histological assessment of the section margins. However, longer term data are limited. A cohort study from the Netherlands assessed the predictive value of combined cytological and virological follow-up for 10 years after treatment for cervical precancer. The overall cumulative incidence of recurrent CIN2 or worse was 17%, and that for CIN3 or worse was 9%. In women with two negative tests (cytology and high risk human papillomavirus DNA) at six and 24 months post-treatment, the risk of these outcomes was similar to that in women who tested negative for cervical precancer at baseline screening. Further cohort studies with long term follow-up are needed to confirm these results and to generate more evidence on the safety of different follow-up protocols for women treated for cervical precancer.
Currently, colposcopists who treat women with high grade CIN lesions must choose between complete excision to obtain free margins or a more prudent approach, especially if a further pregnancy is desired. Published and aggregated data still leave considerable room for doubt about the magnitude of the association between the extent of treatment and risk of later preterm delivery. Divergent findings may be explained by variability in therapeutic practices, particularly the size of the cone excised. The COSPCC study—a meta-analysis of individual patient data—should allow more precise measurement of the obstetric and oncological safety associated with different treatment options, while accounting for patient and lesion characteristics. The study should also provide more detailed evidence on how to balance treatment decisions.
However, Strander and colleagues’ study makes it clear that women who have been treated for a high grade intraepithelial cervical lesion, particularly those aged 50 years or more, require careful surveillance, and that measures should be taken to assure full compliance with follow-up. The data also underline the need for better standardisation and quality assurance in colposcopic practice to achieve an optimal balance between risk of cancer and obstetric safety.
Daughters of women prescribed DES have also been prone to cancer. Anne Needham, who as a young woman had a hysterectomy for cancer, sued White Laboratories, makers of a DES drug.
Lawrence S. Charfoos – an attorney in the litigation – and Stephen Fenichell detail the case and provide a history of DES development, research linking it early to cancer, the FDA’s approval, the pharmaceutical company promotion, and the medical community’s involvement.
Relay of Life Heroes of Hope Lisa Krugman and John D. Thompson – David Knopf/Richmond News Photo
Lisa Krugman, 58, has been a cancer survivor since 1979, when at 23 she was diagnosed with cervical and ovarian cancer and underwent a complete hysterectomy. Her doctors speculated her cancer was associated with her mother having taken DES (Diethylstilbestrol, a synthetic form of estrogen) while pregnant with her daughter. Five years ago, Lisa was diagnosed with jaw cancer, which could also have its roots in DES.
Relay For Life is an inspirational fundraising event that honours cancer survivors and celebrates life. Each Relay is a community-led, non-athletic event where teams fundraise and then join together in the Relay event.
