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Lecture 3

MIRENA
Its role in Menorrhagia
Dr. Jyoti Bhaskar

“Save
Uterus
Campaign”
Lecture Series
(1 to 4 )
MIRENA
Its role in Menorrhagia
Dr. Jyoti Bhaskar
Dr. Sharda Jain
Dr. Jyoti Agarwal
Mirena (LNG IUS)
is a

Magic Stick
What is Mirena - LNG IUS
• Progestin releasing
intrauterine system
• T shaped polyethylene
frame
• Contains 52 mg
levonorgestrel
• Releases 20 µg LNG daily
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
Mirena has an additional advantage
of providing reversible contraception.

Menorrhagia
Contraception
Efficacy of LNG IUS in
Idiopathic Menorrhagia
Bleeding pattern in the first 5-year period

Ammenorhea
26%
Infrequent
3.7%

Regular
70.3%

Rönnerdag M, Odlind V. Acta Obstet Gynecol Scand 1999;78:716–21
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
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

11
LNG IUS versus Hysterectomy
When patients were given the option of mirena
a significant percentage of women cancelled
their hysterectomy

Pekka Lähteenmäki et al. 1998 316: 1122 (6)

12
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
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
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
My Journey with LNG- IUS

Oman to Republic of Ireland to India
2001 -- 2010 --- 2013
My Journey with LNG IUS
• 2 – 4 cases of Hysterectomy/month
• 4-5 cases of Hysteroscopy/D&C/
Mirena Insertion per theatre
• 2-4 cases of Mirena Insertion / week
in OPD for contraception.
Cost of Mirena- 120 euros

Paid by patient
My Journey with LNG IUS

• Inserted in unmarried girls, morbidly
obese, DM , HT patients.
• Women with Fibroids, adenomyosis,
endometriosis, complex hyperplasia.
• Not used in HRT patients.
Lifecare Experience
with

MIRENA in
Heavy Bleeding
Used in 41 cases

INCLUDING FIBROIDS AND ENDOMETRIOSIS

• It can replace the need of hysterectomy in
50 % of cases.
• Especially useful when future fertility is
desired

Expulsion in 3
(UBT , hysterectomy , reinsertion )
Mirena

Positive Side
• Effective after 4 month
• Major Surgery is saved – Mortality
- Morbidity

Cost Effective
UBT v/s Mirena
Great
Great
Great

4th Month
Jaan Nikaal
Deta Hai

Really
troublesome

But one should TRY
Mirena its role in menorrhagia   dr. jyoti bhaskar,lecture -3

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Mirena its role in menorrhagia dr. jyoti bhaskar,lecture -3

  • 1. Lecture 3 MIRENA Its role in Menorrhagia Dr. Jyoti Bhaskar “Save Uterus Campaign” Lecture Series (1 to 4 )
  • 2. MIRENA Its role in Menorrhagia Dr. Jyoti Bhaskar Dr. Sharda Jain Dr. Jyoti Agarwal
  • 3. Mirena (LNG IUS) is a Magic Stick
  • 4. What is Mirena - LNG IUS • Progestin releasing intrauterine system • T shaped polyethylene frame • Contains 52 mg levonorgestrel • Releases 20 µg LNG daily
  • 5. Mirena : local mode of action Prevents endometrial proliferation • Thickens cervical mucus • Inhibits sperm motility Serum Levels are 4 times lower than after oral ingestion
  • 6. Benefits of local action No significant change in • • • • • • Blood pressure Lipid profile Coagulation factors Carbohydrate metabolism Liver function Bone mineral density
  • 7. Mirena has an additional advantage of providing reversible contraception. Menorrhagia Contraception
  • 8. Efficacy of LNG IUS in Idiopathic Menorrhagia
  • 9. Bleeding pattern in the first 5-year period Ammenorhea 26% Infrequent 3.7% Regular 70.3% Rönnerdag M, Odlind V. Acta Obstet Gynecol Scand 1999;78:716–21
  • 10. 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
  • 11. Effectiveness and Cost-Effectiveness of Levonorgestrel- Containing Intrauterine System in Primary Care against Standard Treatment for Menorrhagia (ECLIPSE) Trial 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 11
  • 12. LNG IUS versus Hysterectomy When patients were given the option of mirena a significant percentage of women cancelled their hysterectomy Pekka Lähteenmäki et al. 1998 316: 1122 (6) 12
  • 13. 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
  • 14. 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
  • 17. Mirena provides long term relief of chronic pelvic pain Obstet gynecol 2012;119:519-526
  • 18. FIBROIDS Significant reduction in both the uterine volume and
  • 19. 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
  • 20. 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
  • 21. 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
  • 23. 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?
  • 24. Counselling- Three problems !!! • Spotting after insertion • Amenorrhea in 25 % of women • Price
  • 25. 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
  • 26. 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
  • 27. 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
  • 29. My Journey with LNG- IUS Oman to Republic of Ireland to India 2001 -- 2010 --- 2013
  • 30. My Journey with LNG IUS • 2 – 4 cases of Hysterectomy/month • 4-5 cases of Hysteroscopy/D&C/ Mirena Insertion per theatre • 2-4 cases of Mirena Insertion / week in OPD for contraception. Cost of Mirena- 120 euros Paid by patient
  • 31. My Journey with LNG IUS • Inserted in unmarried girls, morbidly obese, DM , HT patients. • Women with Fibroids, adenomyosis, endometriosis, complex hyperplasia. • Not used in HRT patients.
  • 33. Used in 41 cases INCLUDING FIBROIDS AND ENDOMETRIOSIS • It can replace the need of hysterectomy in 50 % of cases. • Especially useful when future fertility is desired Expulsion in 3 (UBT , hysterectomy , reinsertion )
  • 34. Mirena Positive Side • Effective after 4 month • Major Surgery is saved – Mortality - Morbidity Cost Effective
  • 35. UBT v/s Mirena Great Great Great 4th Month Jaan Nikaal Deta Hai Really troublesome But one should TRY