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Mirena
An alternatives to Hysterectomy
in
Heavy menstrual Bleeding
Dr. Jyoti Agarwal
Dr. Sharda Jain
DR. Jyoti Bhaskar
Mirena slide share
Heavy Periods
More than 1 in 5
30s & 40s suffer from
HEAVY PERIODS
(Unmanageable)
Heavy menstrual bleeding
An important cause of morbidity
• 30% of women in
reproductive age group
suffer with Menorrhagia
• 60% of these women
will ultimately undergo
hysterectomy
Hysterectomy
• Second most
frequent surgical
procedure in women of
reproductive age group
• 90% for benign reasons
• Promptly offered
following a diagnosis.
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
Mirena slide share
Mirena slide share
Dilemma!! of Treatment
Aim - Quality Personal life
- Family life
- Preserve the feminity of a women
- ↓ Frequent leave from office
Age
Severity
Fertility
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
Present Practice
TVS/D&C
Drugs
Another D&C
Hysterectomy
Options AvailableOptions Available
Mirena /
Endometrial Ablation
Drug therapyDrug therapy
Hysterectomy
Options available
Alternatives to Hysterectomy
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
MIRENAMIRENA
Its role in menorrhagiaIts role in menorrhagia
MIRENA
Inspired by : Prof.Osama Showki
Mirena (LNG IUS)
is a
Magic Stick
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
Mirena has an additional advantage
of providing reversible contraception.
Menorrhagia
Contraception
• Progestin releasing
intrauterine system
• T shaped polyethylene
frame
• Contains 52 mg
levonorgestrel
• Releases 20 µg LNG daily
What is Mirena - LNG IUS
Mirena : local mode of action
Prevents endometrial
proliferation
• Thickens cervical
mucus
• Inhibits sperm motility
serum levels are 4 times lower than
after oral ingestion
Benefits of local action
No significant change in
• Blood pressure
• Lipid profile
• Coagulation factors
• Carbohydrate metabolism
• Liver function
• Bone mineral density
Efficacy of LNG IUS in
Idiopathic Menorrhagia
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%
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
Effectiveness and Cost-Effectiveness of Levonorgestrel- Containing
Intrauterine System in Primary Care against Standard Treatment for
Menorrhagia (ECLIPSE) Trial
27
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
LNG IUS versus Hysterectomy
28
When patients were given the option of mirena
a significant percentage of women cancelled
their hysterectomy
Pekka Lähteenmäki et al. 1998 316: 1122 (6)
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
Emerging new
indications for use
of mirena
ENDOMETRIOSIS
ADENOMYOSIS
Mirena provides long term relief
of chronic pelvic pain
Obstet gynecol 2012;119:519-526
FIBROIDS
Significant reduction in
both the uterine volume and
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
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
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
PRACTICAL TIPS
TO SUCCESS
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?
Counselling- Three problems !!!
• Spotting after insertion
• Amenorrhea in 25 % of women
• Price
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
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
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
Sonographic Evaluation
Experience
with
MIRENA in
Heavy Bleeding
Used in 141 cases
INCLUDING FIBROIDS AND ENDOMETRIOSIS
Updated on 1/9/2013
Expulsion in 13
(UBT , hysterectomy , reinsertion )
• It can replace the need of hysterectomy in
50 % of cases.
• Especially useful when future fertility is
desired
UBT v/s Mirena
Great
Great
Great
4th
Month
Jaan Nikaal
Deta Hai
Really
troublesome
But one should TRY
Mirena
Positive Side
• Effective after 4 month
• Major Surgery is saved – Mortality
- Morbidity
Cost Effective
KJ Carlson, NEJM 328:856,
1993
HYSTERECTOMY
as Treatment
Should be last resort
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

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Mirena slide share

  • 1. Mirena An alternatives to Hysterectomy in Heavy menstrual Bleeding Dr. Jyoti Agarwal Dr. Sharda Jain DR. Jyoti Bhaskar
  • 4. More than 1 in 5 30s & 40s suffer from HEAVY PERIODS (Unmanageable)
  • 5. Heavy menstrual bleeding An important cause of morbidity • 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
  • 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
  • 13. Options AvailableOptions Available Mirena / Endometrial Ablation Drug therapyDrug therapy Hysterectomy
  • 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
  • 16. MIRENAMIRENA Its role in menorrhagiaIts role in menorrhagia
  • 17. MIRENA Inspired by : Prof.Osama Showki
  • 18. Mirena (LNG IUS) is a Magic Stick
  • 19. 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
  • 20. Mirena has an additional advantage of providing reversible contraception. Menorrhagia Contraception
  • 21. • Progestin releasing intrauterine system • T shaped polyethylene frame • Contains 52 mg levonorgestrel • Releases 20 µg LNG daily What is Mirena - LNG IUS
  • 22. Mirena : local mode of action Prevents endometrial proliferation • Thickens cervical mucus • Inhibits sperm motility serum levels are 4 times lower than after oral ingestion
  • 23. Benefits of local action No significant change in • Blood pressure • Lipid profile • Coagulation factors • Carbohydrate metabolism • Liver function • Bone mineral density
  • 24. Efficacy of LNG IUS in Idiopathic Menorrhagia
  • 25. 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%
  • 26. 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
  • 27. Effectiveness and Cost-Effectiveness of Levonorgestrel- Containing Intrauterine System in Primary Care against Standard Treatment for Menorrhagia (ECLIPSE) Trial 27 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
  • 28. LNG IUS versus Hysterectomy 28 When patients were given the option of mirena a significant percentage of women cancelled their hysterectomy Pekka Lähteenmäki et al. 1998 316: 1122 (6)
  • 29. 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
  • 32. Mirena provides long term relief of chronic pelvic pain Obstet gynecol 2012;119:519-526
  • 33. FIBROIDS Significant reduction in both the uterine volume and
  • 34. 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
  • 35. 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
  • 36. 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
  • 38. 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?
  • 39. Counselling- Three problems !!! • Spotting after insertion • Amenorrhea in 25 % of women • Price
  • 40. 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
  • 41. 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
  • 42. 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
  • 45. Used in 141 cases INCLUDING FIBROIDS AND ENDOMETRIOSIS Updated on 1/9/2013 Expulsion in 13 (UBT , hysterectomy , reinsertion ) • It can replace the need of hysterectomy in 50 % of cases. • Especially useful when future fertility is desired
  • 46. UBT v/s Mirena Great Great Great 4th Month Jaan Nikaal Deta Hai Really troublesome But one should TRY
  • 47. Mirena Positive Side • Effective after 4 month • Major Surgery is saved – Mortality - Morbidity Cost Effective
  • 48. KJ Carlson, NEJM 328:856, 1993 HYSTERECTOMY as Treatment Should be last resort
  • 49. 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

  • #4: The sinequa non of dub is heavy periods.
  • #14: Mirena
  • #49: 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