Endometrial Ablation - Center for Women's Health
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Transcript Endometrial Ablation - Center for Women's Health
Endometrial Ablation
for
Heavy bleeding
“A new treatment for an old problem”
Abnormal
Uterine
Bleeding:
Scope and Impact
Widespread Impact
In the United States,
AUB affects more than
40 of every 100 women
between the ages of 35
and 55
A Common Condition
Abnormal Uterine Bleeding
Affects 7.5 Million American Women
When asked:
Does heavy menstrual bleeding
disrupt your life?
20%
80%
Warner P. British Med J. 2001;323:24
1 woman in 5
says
“Yes”
Heavy Bleeding Disrupts Lives
“How often does your period cause you to miss
the following activities?”
60%
Sometimes
50%
Many times
40%
30%
20%
10%
0%
Sex
Work
Party/Fun
Event
Athletic Event Time with
Friends/Family
National Women's Health Resource Center. National survey of 653 women, 35-49 with
reported heavy periods and intact uterus; conducted Sept 29-Oct 12, 2005.
Other Symptoms
Accompany Bleeding
“Do you have the following problems often,
sometimes, rarely, never?” Often
Often/
(%)
Sometimes (%)
Fatigue or tiredness
45
85
Depression or moodiness
38
77
Really bad cramps
34
76
Headaches
32
69
Low blood count or anemia
13
38
Nausea
5
29
Other severe symptoms
9
30
National Women's Health Resource Center. National survey of 653 women, 35-49 with
reported heavy periods and intact uterus; conducted Sept 29-Oct 12, 2005.
Many Women Suffer in Silence
>5 Million
Silent Sufferers
2 Million Diagnosed,
Receiving Therapy
Silent Sufferers
Don’t recognize heavy bleeding as a problem
Fertility concerns
Past therapy ineffective
Unaware of alternatives
Problem not diagnosed
Few Women Mention Abnormal
Uterine Bleeding
Have you discussed this problem
with your doctor?
No
71%
Data on file. BioVid; January 2005
Yes
29%
Assess Abnormal Uterine Bleeding
With Four Questions
How are your periods?
How many days do they last?
Do you think they are heavy?
Do your periods bother you or disrupt your life?
Answers to these questions provide an
excellent gauge of how a woman perceives
her menstrual bleeding
Diagnostic Techniques in AUB
Careful history and PE *
Laboratory work-up *
Endometrial biopsy *
Transvaginal ultrasonography (TVS) *
Hysteroscopy
Saline infusion sonography (SIS) *
Magnetic resonance imaging (MRI)
Etiologies of
Abnormal Uterine Bleeding
Organic causes
– Reproductive tract
lesions
– Systemic disease
Iatrogenic causes
– Hormones
– Nonhormonal drugs
– Foreign bodies
Mishell D in Comprehensive Gynecology 4th Edition 2003
Dysfunctional causes
– Anovulatory
– Ovulatory
Current Management of AUB
(Among Women 35-55)
No Treatment
“Silent Sufferers”
Medical Management
< 2 MM
Hormonal
NSAIDs
< 1MM
Surgical Intervention
D&C
Hysterectomy
Endometrial Ablation
Cytyc Corporation, 2005, Data on file.
5 MM
Perspective on Management
Historically, Two Predominant Modalities:
Medical management for women wanting to
preserve their fertility
Hysterectomy for women not concerned about
fertility
Newer Treatment Modalities Have Expanded
The Options:
Drug-eluting IUDs
Endometrial ablation
Medical Management
<2 MM
Options Include
Dual-hormone contraceptives
Progestins
Levonorgestrel-releasing IUD
NSAIDs
Antifibrinolytics
Identifying
Candidates
for
Endometrial
Ablation
Endometrial Ablation History
Skill dependent: <10% gynecologists
able to perform
General anesthesia/O.R. setting
Risk of fluid overload and electrolyte
disturbances
1976 Laser
1987 Desiccation
Risk of thermal or mechanical
perforation of the uterus or adjacent
organs
1990s Vaporization
Risk of hemorrhage
1983 Resection
Late 1990s
Global Endometrial Ablation
Ablation vs. Hormone Therapy
Advantages of Ablation
More immediate relief from problem bleeding
Fewer contraindications
No additional medications to monitor or
remember
No drug interactions
If failure, other options remain for medical or
surgical intervention
Ablation vs. Hysterectomy
Advantages of Ablation
Fewer contraindications
Option for local anesthesia, or conscious
sedation
Minimal morbidity
Outpatient or office-based procedure
Diminished potential for post-op complications
If failure, other options remain for medical or
surgical intervention
Impact of Endometrial Ablation
Rate of Operations (000s)
Reduction in Hysterectomy Rates
4.2
4
3.8
3.6
3.4
3.2
3
1994
1995
1996
1997
Jacobson GF et al. Obstet Gynecol. 2006;107:1278
1998
1999
2000
2001
2002
2003
NovaSure® Contraindications*
Pregnant or the desire to be pregnant in the future
Known or suspected endometrial carcinoma or pre-malignancy
Any anatomic condition that could lead to weakening of the
myometrium:
– Classical C-section
– Transmural myomectomy
Uterine cavity length < 4 cm
Uterine cavity width < 2.5 cm as determined by the Disposable
Device Width Dial
Active pelvic inflammatory disease
Genital or urinary tract infection
IUD currently in place
*For complete descriptions of contraindications refer to the NovaSure® Instructions for Use
NovaSure® Success Rates
Success
100%
98%
97%
Amenorrhea
91%
80%
60%
41%
47%
44%
40%
20%
0%
1 Year
2 Years
3 Years
Fulop I. 2nd World Congress on Controversies in Obstetrics, Gynecology & Infertility.
September 6-9, 2001.
NovaSure® Avoids Additional Intervention
Long-term avoidance of hysterectomy
100%
97%
94%
92%
80%
60%
40%
Pivotal trial, 3 years
Gallinat, 5 Years
NovaSure® Instructions for Use
Gallinat A. J Reprod Med. 2007;52:467.
Fulop T et al. J Minim Invasiv Gynecol. 2007;14:85
Fulop, 7 Years
NovaSure® Improves Quality of Life
“During your last menstrual cycle did you
experience … ?”
Pre-treatment
100%
12-months follow-up
84%
80%
75%
66%
60%
57%
40%
20%
24%
16%
24%
10%
0%
Lack of
confidence
NovaSure® Instructions for Use
Less or no
enegry
Difficulty w/
work/activities
Anxiety
Many Women May Prefer In-Office
Scheduling
Increased patient acceptance of in-office
procedures
Preference for office vs. hospital setting
– More comfortable for some
– Perceived as more “confidential”
– Charges may be limited to office co-payment
Ease of access and scheduling
Given Options,
Women Prefer Ablation
% Ranking as
Top Choice
% Ranking as
Bottom Choice
Endometrial
Ablation
Hormone
Therapy
Hysterectomy
49%
37%
15%
8%
23%
69%
Data (rounded to the nearest whole number) on file. BioVid; January 2005
NovaSure® Procedure
Uterine Cavity, Hysteroscopic View,
After 85-Second Treatment
Before
After
Endometrium completely removed, leaving
only myometrium