The Morcellation Debate
Marisa Adelman, MD
Assistant Professor, Dept. Obstetrics & Gynecology
The Morcellation Debate
(at least we’re not talking about vaginal mesh)
Marisa Adelman, MD
Assistant Professor, Dept. Obstetrics & Gynecology
Talking points:
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Why now?
The respondents: FDA, SGO, ACOG, AAGL
The disease and it’s prognosis
The affects of morcellation
The alternatives
Risks vs. Benefits: how does it all shake out?
One woman’s opinion…
“Always and never are two words you should
always remember to never use”
- Wendell Johnson
We learn through experience…and we get better.
The case that started the debate
The case that started the debate
The SGO weighs in
December, 2013
“…the Society of Gynecologic Oncology (SGO) asserts that
it is generally contraindicated in the presence of
documented or highly suspected malignancy”
“The SGO recognizes that currently there is no reliable
method to differentiate benign from malignant
leiomyomas…Furthermore, these diseases offer an
extremely poor prognosis, even when specimens are
removed intact.”
Nobody likes being called soft
“It is difficult to understand why the SGO has taken such a soft line”
The Lancet Oncology, February 2014
…especially Barbara Goff
(President of the SGO)
“In the vast majority of cases, hysterectomy is done because of the presence
of benign uterine fibroids. In these circumstances, intracorporial morcellation
has benefited hundreds of thousands of women. It is especially beneficial for
obese women. It would be a disservice to deny these women this option.”
The Lancet Oncology, April 2014
The FDA responds to requests for recall
April, 2014
Laparoscopic Uterine Power Morcellation in Hysterectomy
and Myomectomy: FDA Safety Communication.
The FDA responds…
“Based on an FDA analysis of currently available
data, it is estimated that a 1 in 350 women
undergoing hysterectomy or myomectomy for the
treatment of fibroids is found to have an
unsuspected uterine sarcoma”
“…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.”
Why perform minimally invasively?
ACOG weighs in…
May, 2014
• Approximately 600,000 hysterectomies
performed annually in the U.S.
• 40% are for the indication of uterine leiomyomas
ACOG weighs in…
• Preoperative considerations:
– Age:
• Lowest incidence with age <35
• Highest incidence with age >65
– Menopausal status:
• Increased risk of occult malignancy
– Uterine size:
• Not predictive, but large or rapidly growing leiomyomas
may raise concern
ACOG weighs in…
• Patient counseling and informed consent:
– Potential risk of undiagnosed gynecologic cancers
• Approximately 2:1000 in women undergoing hysterectomy
for uterine fibroids.
– If present, power morcellation will increase the risk of
intraperitoneal dissemination.
• May result in the need for additional surgery and/or medical
management.
– There is a risk of disseminating and seeding viable
ectopic benign tissue.
ACOG weighs in…
• “There should be a continual focus on training,
including techniques for morcellation…”
• “There is no sufficiently large population-based series to
provide an accurate rate of preoperatively undiagnosed
uterine sarcoma in patients undergoing hysterectomy.”
• “…a national prospective morcellation surgery registry is
needed to acquire an adequate volume of consistent and
reliable data.”
• “ACOG encourages the FDA to call for the establishment of
such a registry.
…oh yeah, don’t forget about the AAGL
May, 2014
AAGL
• “…despite our incomplete understanding of these
issues, MIS employing morcellation remains safe
when performed by experienced, high-volume
surgeons in select patients who have undergone
an appropriate preoperative evaluation.”
• Studies analyzed by the FDA:
– Not stratified by risk factors for sarcoma (esp. age)
• Need to consider implications of alternatives
AAGL
Statement to the FDA on Power
Morcellation
4 cautions against discontinuing morcellation
1)
2)
3)
4)
“The AAGL cautions against eliminating beneficial technology on
the basis of such imprecise data”.
“… at this time there exist insufficient data to discontinue power
morcellation in appropriately screened patients at low risk”.
“The AAGL does not believe that such limited evidence warrants
removal of the option of power morcellation”.
“… the available data do not warrant discontinuing power
morcellation”.
Leiomyosarcoma
• No reliable preoperative diagnostic tests
– Not ultrasound, CT, PET, MRI
• 1 in 400 to 1 in 1000 of hysterectomy specimens
for presumed benign uterine leiomyoma.
– Estimate of 1 in 350 based on 9 studies
• All referral-center, single-institution, retrospective studies,
with 104-1429 cases.
• Spans several decades, with various histopathologic criteria
• Includes postmenopausal women, and women diagnosed
preoperatively.
Prevalence: what are we counting?
All-payer database, including more than 500 hospitals.
232,882 MIS
hysterectomies
(2006-2012)
36,470
morcellations
99 cases of
uterine cancer.
Prevalence of
27/10,000
(~ 1/368)
Prevalence: what are we counting?
• There was no distinction made between uterine cancers.
• The population was older.
Leiomyosarcoma: staging
Leiomyosarcoma: staging
Leiomyosarcoma: prognosis
SEER report, 2007
Stage
Location
5-year
survival
Stage I
Confined to the uterus
60%
Stage II
Confined to the pelvis
35%
Stage III
Abdominal spread, local nodes
28%
Stage IV
Bladder, rectum, or distant metastases
15%
Leiomyosarcoma: prognosis
• Retrospective
• Single institution: Asian Medical Center, Seoul, Korea.
TAH
(31)
77 patients with LMS
(1989-2010)
56 w/ early disease
(confined to the uterus)
Abdominal, vaginal, or
laparoscopic morcellation
(25)
Leiomyosarcoma: prognosis
65%
40%
5-year DFS 53% (all patients)
73%
46%
5-year OS 60% (all patients)
Leiomyosarcoma: prognosis
• Identified all cases of LMS and STUMP’s from 2005-2012 at Brigham and
Women’s, Dana Farber Cancer Institute, and Mass. General Hospital.
– 15 with LMS
– 5 with STUMP
• Assigned a FIGO stage after the initial surgery and restaging surgery.
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–
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3 LMS upstaged
5 LMS not-upstaged
3 LMS not re-staged
3 LMS unstaged initially
1 LMS was already stage IV initially
Leiomyosarcoma: prognosis
• Three patients with LMS were upstaged
– One stage III  stage IV
– Two stage I  stage III
• 2 out of 3 upstaged patients are deceased,
and the 3rd is alive with evidence of disease.
• 5 of 5 who were not upstaged were alive
without evidence of disease at follow-up.
Leiomyosarcoma: prognosis
• 58 patients with LMS from 2007 to 2012
– 39 patients underwent TAH without morcellation
– 19 patients underwent morcellation
Leiomyosarcoma: prognosis
10.8
39.6
73%
64%
* The mean age was 53.4 years
Leiomyosarcoma: prognosis
• 1091 cases of uterine morcellation from 2005-2010 for
presumed fibroids at BWH.
– 10 cases of leiomyoma variants
– 2 cases of malignancy
(1 endometrial stromal sarcoma, 1 leiomyosarcoma)
• 14 cases of follow-up laparoscopy
– 7 “in-house” (5 leiomyoma variants, 1 ESS, 1 LMS)
– 7 “consults” (1 leiomyoma variant, 6 LMS)
Leiomyosarcoma: prognosis
• 64.3% occurrence of morcellator-based dissemination.
• No definite infiltration or invasion of adjacent tissue.
Leiomyosarcoma: prognosis
• 4 out of 7 (57.1%) LMS with peritoneal dissemination.
– 3 out of 4 with dissemination are deceased (average survival of 24.3 months)
– 3 out of 3 without dissemination were alive (average follow-up of 29.7 months)
• 4 out of 7 were alive at 24 months (57.1%)
Park et al
George et al
~90 %
~60%
Leiomyosarcoma: prognosis
~60%
~ 25%
Assuming early stage disease:
• Non-morcellated patients
≈ expected 5 year OS.
• Morcellated patients =
worse survival (but not
quite Stage IV disease)
Leiomyosarcoma: prognosis
(big picture)
• 60% of patients present with disease confined to the
uterus.
• Local and distant failure rates 45-80%.
– 50% recurrence risk after TAH
• Long-term survival rates 20-60%, with an overall
survival of 40% at 5 years.
• Median overall survival of 1-2 years in patients with
metastatic disease.
Hysterectomy: Complications
• Per Cochrane Review:
– Decreased rate of abdominal wall or wound infection
– Significantly lower EBL
– No difference in vaginal cuff cellulitis, hematoma,
abscess formation, or GU injury.
Hysterectomy: mortality
• Retrospective cohort from 2002-2008.
– LH patients experienced lower rates of DVT, PE,
blood transfusion, MI.
– LH patients experienced lower mortality rates
(0.01% versus 0.03%, OR 0.48).
Informed consent
• Per AAGL:
– Dissemination of malignant tissue
– Dissemination of benign tissue
– Difficult or incomplete pathologic evaluation
– Injury to adjacent organs
Where have all the morcellators gone?
• Johnson & Johnson withdrew their morcellators
from the market in late July.
• Highmark Inc. stopped covering L/S power
morcellation on September 1st.
Alternatives to morcellation:
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Contained morcellation
Vaginal morcellation
Colpotomy
Minilaparotomy
Abdominal hysterectomy
Let’s do the numbers
(a quick run down)
• >600,000 hysterectomies per year
• 0.1% mortality rate for LH versus 0.3% for TAH:
– 600 deaths if all hysts were laparoscopic
– 1,800 deaths if all hysts were abdominal
– Excess of 1,200 deaths if all done abdominally.
• Using conservative 1/400 risk of leiomyosarcoma:
– 1,500 cases
• This is an over exaggeration, but you get the
point…
Let’s do the numbers
(a little more scientific)
• Decision analysis: treatment of symptomatic fibroids.
– Laparoscopic morcellation vs. TAH
(not amenable to vaginal removal).
• 100,000 subject hypothetical cohort.
• 5-year time-line
• Outcomes:
– Morbidity (transfusion, wound infection, cuff
dehiscence, VTE, and hernia)
– Death from leiomyosarcoma
– Death from TAH.
M. Siedhoff, D. Clarke-Pearson. Presented at 2014 AAGL Global Conference.
Decision analysis
(continued)
• Used an estimate of 0.0012 for occult
leiomyosarcoma incidence (~1/850).
• Estimated death from leiomyosarcoma by
laparoscopic and abdominal route.
– Assumed occult LMS cases would be FIGO stage III (59% death in 5 years).
– Assumed morcellation would escalate staging to
FIGO stage III (72% death in 5 years)
M. Siedhoff, D. Clarke-Pearson. Presented at 2014 AAGL Global Conference.
Decision analysis
(continued)
Outcome
LH
AH
Leiomyosarcoma cases
120
120
Leiomyosarcoma deaths
86
71
Hysterectomy-related deaths
12
32
98/100,000
103/100,000
Total deaths
• 5 additional deaths per 100,000 with AH.
• Lower mortality and higher QOL with LH.
M. Siedhoff, D. Clarke-Pearson. Presented at 2014 AAGL Global Conference.
Conclusions
The debate is not:
• Is morcellation of a leiomyosarcoma
associated with a worse outcome?
What we should be asking:
• What do we stand to loose by abandoning
morcellation?
• How do we make it more safe?
Parting words
(I guess it is kind of like vaginal mesh)
References
• SGO (Society of Gynecologic Oncology) position statement:
morcellation. Available at:
https://www.sgo.org/newsroom/position-statements2/morcellation/
• The Lancet Oncology. Patient safety must be a priority in all aspects
of care. Lancet Oncol 2014; 15:123.
• Goff BA. SGO not soft on morcellation: risks and benefits must be
weighed. Lancet Oncol 2014; 15:e148.
• Laparoscopic uterine power morcellation in hysterectomy and
myomectomy: FDA safety communication. Available at:
http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm3
93576.htm.
References
• American College of Obstetricians and Gynecologists. Power
morcellation and occult malignancy in gynecologic surgery.
Washington, DC: American College of Obstetricians and
Gynecologists; 2014.
• Hodgson B. AAGL Practice Report: Morcellation During Uterine
Tissue Extraction. J Minim Invasive Gynecol 2014; 21:517-30.
• Wright JD et al. Uterine pathology in women undergoing minimally
invasive hysterectomy using morcellation. JAMA 2014; 312:1253-55.
• Zivanovic O et al. Stage-specific outcomes of patients with uterine
leiomyosarcoma: A comparison of the International Federation of
Gynecology and Obstetrics and American Joint Committee on
Cancer Staging Systems. J Clin Oncol 2009; 27:2066-72.
References
• Park JY et al. The impact of tumor morcellation during surgery on
the prognosis of patients with apparently early stage uterine
leiomyosarcoma. Gynecol Oncol 2011; 122:255-9.
• Oduyebo T et al. The value of re-exploration in patients with
inadvertently morcellated uterine sarcoma. Gynecol Oncol 2014;
132:360-5.
• George S et al. Retrospective cohort study evaluating the impact of
intraperitoneal morcellation on outcomes of localized uterine
leiomyosarcoma. Cancer 2014; 120:3154-8.
• Seidman MA et al. Peritoneal dissemination complicating
morcellation of uterine mesenchymal neoplasms. PLOS
2012;7:e50058.
References
• Clark-Pearson DL, Geller EJ. Complications of hysterectomy. Obstet
Gynecol 2013; 121:654-73.
• Wiser A et al. Abdominal versus laparoscopic hysterectomies for
benign diseases: evaluation of morbidity and mortality among
465,798 cases. Gynecol Surg 2013; 10:117-22.
• Kho KA, Nezhat CH. Evaluating the risks of electric uterine
morcellation. JAMA 2014; 311:905-6.
• Johnson & Johnson suspends sale of device used in fibroid surgery:
Wall Street Journal. Available
at:http://onlinewsj.com/news/articles.
References
• Cortez, Michelle F. “Device recall means tougher surgeries.” The
Philadelphia Inquirer [Philadelphia] 11 Aug. 2014: A2. Print.