5. Heavy menstrual bleeding
An important cause of morbidity
• It affects 1 in 5
women.
• 30% of women in
reproductive age group
suffer with Menorrhagia
• 60% of these women
will ultimately undergo
hysterectomy
6. Hysterectomy
• Second most
frequent surgical
procedure in women of
reproductive age group
• 90% for benign reasons
• Promptly offered
following a diagnosis.
7. Value Study(BJOG - 2004)
survey of outcomes of 37,000 hysterectomies
• Operative and
postoperative
complication rate of
3.5% and 9 %
respectively were reported
• Postoperative
mortality of 0.38 /
1000.
• Psychological
implications 35-45%
•
Hysterectomy should not be taken up
8.
9.
10. Dilemma!! of Treatment
Aim - Quality Personal life
- Family life
- Preserve the feminity of a women
- ↓ Frequent leave from office
Age
Severity
Fertility
11. Treatment of Heavy Periods
Individualized
• age
• need for contraception
• desire to retain uterus
• Nature and severity of complaints
• presence of any pelvic pathology
• outcome of previous treatment
• cost of treatment
• time away from work
15. NICE guideline (Jan 2007)
management of heavy menstrual bleeding
• If future childbearing is desired
LNG – IUS is the first line intervention
• If future child bearing is not
desired
Endometrial ablation
18. Day Care Procedure
• Definitive solution for patients
• Minimally Invasive
• High safety profile
• Requires minimal training
• Clinically proven (90-97%)
• Can be performed under LA
• Cost Effective
See to Believe it
19. • Long learning curveLong learning curve
•Succes rate 85%Succes rate 85%
• Re-surgery up to 30%Re-surgery up to 30% ..
•LO
FEAT
FIRST GENERATION ENDOMETRIAL ABLATIONFIRST GENERATION ENDOMETRIAL ABLATION
TECHNIQUESTECHNIQUES
(Hysteroscopic Techniques)(Hysteroscopic Techniques)
Given up by most expertsGiven up by most experts
22. UTERINE BALLOON THERAPYUTERINE BALLOON THERAPY
SYSTEMSYSTEM
““UBT”UBT”
(GynecareThermachoice(GynecareThermachoiceRR
))
First global ablation technology to
receive FDA approval 1997
19971997
23. Therma choice
• A balloon tipped
catheter is positioned
into the uterine cavity
and filled with fluid
that is heated to 87
degrees centigrade
• Ablation cycle takes
8 minutes.
24. Uterine Balloon Therapy
• 95 % success rate
• 50 % amenorrhic at 1
year
• Affects fertility
Pre-Ablation Post Ablation
Use of effective contraception
following procedure is must
26. Patient Selection
• Unresponsive to medical therapy
• Completed family
• Normal pap smear
• Negative endometrial biopsy
• Cavity depth 6-12 cm
27. Not fully Evaluated
• Large uterus (> 30 cc, >12 cm)
• Previously failed TCRE
• Repeat Endometrial Ablation
28. INTERNATIONAL MULTI-CENTER STUDY
PATIENTS WITH AT LEAST 24 MONTH FOLLOW-UP
INTERNATIONAL MULTI-CENTER STUDY
PATIENTS WITH AT LEAST 24 MONTH FOLLOW-UP
8 min treatment; >150 mmHg Start Pressure
Hypomenorrhea
38%
Amenorrhea /spotting
36%
Minimal or no
reduction in
menses 4.0%
22%
NormalperiodsNormalperiods
35. Mirena is as effective as
endometrial ablation in reducing
heavy menstrual bleeding
• In sept 2009 , the US FDA approved
mirena as a treatment for heavy menstrual
bleeding
Obstet gynecol 2009;1104-1116
36. Mirena has an additional advantage
of providing reversible contraception.
Menorrhagia
Contraception
37. • Progestin releasing
intrauterine system
• T shaped polyethylene
frame
• Contains 52 mg
levonorgestrel
• Releases 20 µg LNG daily
What is Mirena - LNG IUS
38. Mirena : local mode of action
Prevents endometrial
proliferation
• Thickens cervical
mucus
• Inhibits sperm motility
serum levels are 4 times lower than
after oral ingestion
39. Benefits of local action
No significant change in
• Blood pressure
• Lipid profile
• Coagulation factors
• Carbohydrate metabolism
• Liver function
• Bone mineral density
41. Bleeding pattern in the first 5-year period
Rönnerdag M, Odlind V. Acta Obstet Gynecol Scand 1999;78:716–21
Infrequent
3.7% Regular
70.3%
Ammenorhea
26%
42. Comparison of Rx Modalities
Progesterone or LNG IUS
LNG IUS reduces menstrual blood loss more
effectively and has a higher likelihood of
treatment success than oral medroxyprogesterone
acetate.
Obstet Gynecol. 2010
43. Effectiveness and Cost-Effectiveness of Levonorgestrel- Containing
Intrauterine System in Primary Care against Standard Treatment for
Menorrhagia (ECLIPSE) Trial
43
Improvements in MMAS scores were significantly greater
(lesser score= more severity)
Gupta J, Kai J, Middleton L, Pattison H, Gray R, Daniels J for the ECLIPSE Trial Collaborative Group N Engl J Med 2013;368:128-37
Daily routine work, social and family life, and psychological and physical well-being
44. LNG IUS versus Hysterectomy
44
When patients were given the option of mirena
a significant percentage of women cancelled
their hysterectomy
Pekka Lähteenmäki et al. 1998 316: 1122 (6)
45. Finnish trial
(multicentric RCT 236 pts)
• Mirena improves the quality of life as
effectively as surgical treatment at 1 year.
• Women ranked their satisfaction with a
mean score of 7 / 10.
• Less than 5% of women required subsequent
operative treatment
• Mirena is more cost effective than
hysterectomy in the short term
50. Endometrial Hyperplasia
• Beneficial effects are observed by1
year.
• Treatment should be reliably
monitored through regular 6-montly
outpatient follow up
Eur J Obstet Gynecol Reprod Biol. 2008
51. Early-stage Endometrial Carcinoma
May have a role in selected patients
willing to preserve fertility
• Endometrial protection for women on tamoxifen
• Women With Clotting Disorders Or Under Anti
Thrombotic Treatment
Conservative treatment of early endometrial
cancer: preliminary results of a pilot study.
Gynecol Oncol. 2011; 120(1):43-6
52. Are there any drugs that interact with
mirena ?
• Women using mirena
may be reassured that
• No drugs are known
to interact with
mirena
• Can be used safely
with ATT
• No effect on BMD
Not to be used as Emergency Contraceptive
54. COUNSELLING
Is it not very costly as
compared to oral
medication?
Doctor, I am spotting
daily? What do I do?
I have not had periods
since 6 months? Am I
in menopause?
56. Irregular Bleeding or spotting
• May last for 4-6 months
COC or Progesterone is used to tide over
this period
• GnRHa can also be used
Acceptance depends on good
pre insertion counselling
57. COST EFFECTIVENESS
LNG IUS
• Cost- Rs 8205/-
• Insertion cost – Rs.
2000 - 5000
Covered by Insurance
ORAL
PROGESTERONE
1 mnth – Rs. 3000
6 months Rs. 18000
1 Yr Rs. 36000
No insurance
58. How long ?
NICE GUIDELINES : If inserted > 45 yrs of
age and has complete amenorrhea may
continue to use it until menopause.
It can be removed at mid 50s as long as it controls the
bleeding
HRT
Change it after 4 years “licenced”
Contraception
< 45years…..5 years
> 45 years ….7 years
61. Used in 41 cases
INCLUDING FIBROIDS AND ENDOMETRIOSIS
Expulsion in 3
(UBT , hysterectomy , reinsertion )
• It can replace the need of hysterectomy in
50 % of cases.
• Especially useful when future fertility is
desired
64. KJ Carlson, NEJM 328:856,
1993
HYSTERECTOMY
as Treatment
Should be last resort
65. Mirena and uterine balloon therapy isMirena and uterine balloon therapy is
thus a new horizon to your patient andthus a new horizon to your patient and
yourselfyourself
BE BOLD, WALK ALONG NEW
PATHS
EXPERIENCE IT YOURSELF
Editor's Notes
Mirena
Benefits of hysterectomy. There are women out there who want amenorrhea and will be satisfied with nothing less. After understanding and accepting the balanced risks, benefits, and alternatives, those patients may be more appropriate candidates for hysterectomy than for any type of endometrial ablation, since no type of ablation can guarantee amenorrhea.
WHY SHOULD’NT A HYSTERECTOMY BE AVOIDED IF THE BENEFIT CAN BE PROVIDED TO A GOOD NO, OF PATIENTS BY A SAFER ALTERNATIVE TT MODALITY COZ HYSTERECTOMY DOES CARRY RISKS OF ANAESTHESIA ETC
