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ROLE OF MIRENA IN
HEAVY PERIODS
DR. JYOTI BHASKAR
MD MRCOG
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
Our Experience
• Over 300 cases Observed
• Inserted in 100 cases personally
• 70 for DUB, 30 for Contraception
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.
My Journey with LNG IUS
• Amenorrhea in 40% after 1 year
• Reduction of bleeding in 90%
• 1 patient – absolute failure – removed
within 1 month.
• Irregular spotting was the main cause for
removal ( 20%)
• Significant Pain relief in post surgery
endometriosis
WHY MIRENA?
• Patient satisfaction
• Comparison with other techniques
• Emerging New Indications
• Cost Effective
• Ease of insertion and Removal
Patient Satisfaction
•8
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%
Mirena in the treatment of menstrual disorders:
a survey of UK patients' experience.
1056 patients – 1995-2003
• The majority 73% of women continued to use the Mirena.
• Women ranked their satisfaction with a mean score of
7.07/10.
• The commonest side-effect experienced was spotting
(19%).
• Less than 5% of the women required subsequent operative
treatment
J Obstet Gynaecol. 2008; 28(7):728-31
Comparison of Rx Modalities
LNG IUS
First-line treatment for menorrhagia
. Hormonal Method is acceptable
• Ongoing Treatment for more than 1 year is
anticipated
NICE GUIDELINES- CG44 Heavy menstrual bleeding:
2January 2007
Progesterones or LNG IUS
LNG IUS reduces menstrual blood
loss more effectively and has a
higher likelihood of treatment
success than oral
medroxyprogesterone acetate.
Levonorgestrel-releasing intrauterine system or medroxyprogesterone
for heavy bleeding Obstet Gynecol. 2010
Progesterone or progestogen-releasing
intrauterine systems for heavy menstrual
bleeding
• LNG IUS is more effective than cyclical
norethisterone (for 21 days) as a treatment
for heavy menstrual bleeding.
• Women with an LNG IUS are more
satisfied and willing to continue with
treatment but experience more side
effects, such as intermenstrual bleeding
and breast tenderness
Cochrane summaries ;November 10, 2010
Effectiveness and Cost-Effectiveness of
Levonorgestrel- Containing Intrauterine System in
Primary Care against Standard Treatment for
Menorrhagia (ECLIPSE) Trial
•14
LNG-IUS lead to greater improvement in women’s assessments of the effect of
heavy menstrual bleeding on their daily routine, including work, social and family
life, and psychological and physical well-being
NEJM
2013
LNG IUS vs Surgical Approach
SOURCES
• Surgery versus medical therapy for heavy menstrual
bleeding. Cochrane Database Syst Rev. 2006
• Levonorgestrel-releasing intrauterine system and
endometrial ablation in heavy Obstet Gynecol. 2009
• Hysterectomy, endometrial destruction, and levonorgestrel
releasing intrauterine BMJ. 2010
• The effect of hysterectomy or levonorgestrel-releasing
intrauterine system on sexual functioning among women
with menorrhagia: a 5-year randomised controlled trial.
BJOG. 2007
• The effect of hysterectomy or levonorgestrel-releasing
intrauterine system on BJOG. 2010
Surgery versus long term hormone treatment for‐
heavy menstrual bleeding
LNG IUS‐
• Improves the quality of life as
effectively as surgical treatment at 1
year
• It is more cost effective than
hysterectomy in the short term
This version published: 2010;
LNG vs Surgical Approach
• Surgical treatment is more effective
at reducing menstrual blood loss at 1
year
• Therapeutic results are comparable
at two years for endometrial ablation
LNG vs Surgical Approach
• Sexual function is better post-
hysterectomy although the risk of
urinary tract infections and stress
incontinence is higher
• Hysterectomy stopped all bleeding
but caused serious complications for
some women
Time to think again !!
• Hysterectomy:
• 40% morbidity rate
• 10 per 10,000 surgeries mortality rate
• In a recent survey of the outcomes of
37,000 hysterectomies, the overall
operative and postoperative
complication rates were 3.5% and 9%,
respectively
Reference: Dicker et al., 1982; Lilford R, 1997
LNG IUS versus Hysterectomy
•20
Percentage of women who cancelled their Hysterectomy when given the
option of LNG IUS in management of Menorrhagia
Pekka Lähteenmäki et al. 1998 316: 1122 (6)
EMERGING INDICATIONS
ENDOMETRIOSIS
ADENOMYOSIS
Endometriosis
• Mirena after operative laparascopy for
endometriosis was more effective compared to
the group that was only treated surgically.
• Comparing use of GNRH analog to Mirena:
equally effective in reducing chronic pelvic pain.
The analogue was superior in reducing the
amount of blood flow.
Human Reproduction 2005
Use of LNG IUS for recurrence of symptoms in
women who have surgery for endometriosis
There is limited but consistent
evidence showing that postoperative
LNG-IUD use reduces the recurrence
of painful periods in women with
endometriosis
Cochrane summaries :Published Online:
January 31, 2013
FIBROIDS
FIBROIDS
• Use of the LNG-IUS appears to lead to a
significant reduction in the uterine
volume of women with menorrhagia
• Reduces the MBL in women with uterine
leiomyomas.
Efficacy of the levonorgestrel-releasing intrauterine system in
uterine leiomyoma.
Int J Gynaecol Obstet. 2012 Jan Kriplani A, Awasthi D, Kulshrestha V, Agarwal N.
Endometrial Hyperplasia
• Beneficial effects are observed by
the majority within 1 year.
• Treatment can be reliably monitored
through regular 6-montly outpatient
endometrial Pipelle surveillance
The effectiveness of a levonorgestrel-releasing intrauterine system (LNG-IUS) in the
treatment of endometrial hyperplasia--a long-term follow-up study
Eur J Obstet Gynecol Reprod Biol. 2008
Early-stage Endometrial
Carcinoma
• Combined Operative HSC and LNG IUS for 12
months
• May have a role of safe and conservative
management of early EC
• In selected patients willing to preserve fertility
Conservative treatment of early endometrial cancer: preliminary
results of a pilot study.
Gynecol Oncol. 2011; 120(1):43-6
OTHER INDICATIONS
• In protection of endometrium from
endometrial hyperplasia during CCHRT
• Endometrial protection for women on
tamoxifen
• Women With Clotting Disorders Or Under
Anti Thrombotic Treatment
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 (explain)
• Amenorrhea in 25 % of women
• Price
Irregular Bleeding
• May last for 4-6 months
• Acceptance depends on good pre
insertion counselling
• Use COC or Progesterone to tide
over this period
• GnRHa too has a role
COST EFFECTIVENESS
LNG IUS
• Cost- Rs 8205/-
• Insertion cost – Rs.
2000/ Rs.5000
Covered by
Insurance
ORAL
PROGESTERONE
1 mnth – Rs. 3000
6 months Rs. 18000
1 Yr Rs. 36000
No insurance
SIDE EFFECTS
• Altered patterns of menstrual bleeding
• Hormonal symptoms
• Ectopic pregnancy – 1 in 20
• Uterine expulsion ( 1 in 20)
• Perforation ( 1-2/1000)
• Ovarian cysts
• Pelvic Infection
Insertion tips
• Screening for STI, Cervical
Screening
• Antibiotic Coverage( Optional)
• Insertion Tip – tighten and then
LOCK
DURATION
Menorrhagia:
It can be removed at mid 50s as long
as it controls the bleeding
HRT
Change it after 4 years “licenced”
Mirena after five years
• Contraception:
-<45years…..5 years
->45 years ….7 years
NICE GUIDELINES : “if inserted >45 and has
complete amenorrhea may continue to use it until
menopause”
Sonographic Evaluation
EXTRA TIPS
• Not be used as Emergency
Contraception
• Can be used with ATT
• No effect on BMD
PROMISING NEW LNG IUSPROMISING NEW LNG IUS
• LNG-IUS12 and LNG-IUS16
• For Nulliparous and Postmenopausal
• Phase III trial results are now being analyzed and
"hopefully they will be ready soon."
Fertil Steril 2012.
•42
Effective alternative to
Surgery
Preserves Fertility
Convenient
Highly effective in reducing blood loss
Well Tolerated
High User Satisfaction
LNG IUS In
Menorrhagia
Take Home Messages!!!!
New
Indications
Mirena is a new horizonMirena is a new horizon
to your patient and yourselfto your patient and yourself
BE BOLD, WALK ALONG NEW PATHS
EXPERIENCE IT YOURSELF
ADDRESS
35 , Defence Enclave, Opp. Preet Vihar
Petrol Pump, Metro pillar no. 88, Vikas
Marg , Delhi – 110092
CONTACT US
011-22414049, 42401339
WEBSITE :
www.lifecarecentre.in
www.drshardajain.com
www.lifecareivf.com
E-MAIL ID
Sharda.lifecare@gmail.com
Lifecarecentre21@gmail.com
info@lifecareivf.com
&

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Role of mirena in heavy periods

  • 1. ROLE OF MIRENA IN HEAVY PERIODS DR. JYOTI BHASKAR MD MRCOG
  • 2. My Journey with LNG- IUS Oman to Republic of Ireland to India 2001 -- 2010 --- 2013
  • 3. 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
  • 4. Our Experience • Over 300 cases Observed • Inserted in 100 cases personally • 70 for DUB, 30 for Contraception
  • 5. 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.
  • 6. My Journey with LNG IUS • Amenorrhea in 40% after 1 year • Reduction of bleeding in 90% • 1 patient – absolute failure – removed within 1 month. • Irregular spotting was the main cause for removal ( 20%) • Significant Pain relief in post surgery endometriosis
  • 7. WHY MIRENA? • Patient satisfaction • Comparison with other techniques • Emerging New Indications • Cost Effective • Ease of insertion and Removal
  • 9. 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%
  • 10. Mirena in the treatment of menstrual disorders: a survey of UK patients' experience. 1056 patients – 1995-2003 • The majority 73% of women continued to use the Mirena. • Women ranked their satisfaction with a mean score of 7.07/10. • The commonest side-effect experienced was spotting (19%). • Less than 5% of the women required subsequent operative treatment J Obstet Gynaecol. 2008; 28(7):728-31
  • 11. Comparison of Rx Modalities LNG IUS First-line treatment for menorrhagia . Hormonal Method is acceptable • Ongoing Treatment for more than 1 year is anticipated NICE GUIDELINES- CG44 Heavy menstrual bleeding: 2January 2007
  • 12. Progesterones or LNG IUS LNG IUS reduces menstrual blood loss more effectively and has a higher likelihood of treatment success than oral medroxyprogesterone acetate. Levonorgestrel-releasing intrauterine system or medroxyprogesterone for heavy bleeding Obstet Gynecol. 2010
  • 13. Progesterone or progestogen-releasing intrauterine systems for heavy menstrual bleeding • LNG IUS is more effective than cyclical norethisterone (for 21 days) as a treatment for heavy menstrual bleeding. • Women with an LNG IUS are more satisfied and willing to continue with treatment but experience more side effects, such as intermenstrual bleeding and breast tenderness Cochrane summaries ;November 10, 2010
  • 14. Effectiveness and Cost-Effectiveness of Levonorgestrel- Containing Intrauterine System in Primary Care against Standard Treatment for Menorrhagia (ECLIPSE) Trial •14 LNG-IUS lead to greater improvement in women’s assessments of the effect of heavy menstrual bleeding on their daily routine, including work, social and family life, and psychological and physical well-being NEJM 2013
  • 15. LNG IUS vs Surgical Approach SOURCES • Surgery versus medical therapy for heavy menstrual bleeding. Cochrane Database Syst Rev. 2006 • Levonorgestrel-releasing intrauterine system and endometrial ablation in heavy Obstet Gynecol. 2009 • Hysterectomy, endometrial destruction, and levonorgestrel releasing intrauterine BMJ. 2010 • The effect of hysterectomy or levonorgestrel-releasing intrauterine system on sexual functioning among women with menorrhagia: a 5-year randomised controlled trial. BJOG. 2007 • The effect of hysterectomy or levonorgestrel-releasing intrauterine system on BJOG. 2010
  • 16. Surgery versus long term hormone treatment for‐ heavy menstrual bleeding LNG IUS‐ • Improves the quality of life as effectively as surgical treatment at 1 year • It is more cost effective than hysterectomy in the short term This version published: 2010;
  • 17. LNG vs Surgical Approach • Surgical treatment is more effective at reducing menstrual blood loss at 1 year • Therapeutic results are comparable at two years for endometrial ablation
  • 18. LNG vs Surgical Approach • Sexual function is better post- hysterectomy although the risk of urinary tract infections and stress incontinence is higher • Hysterectomy stopped all bleeding but caused serious complications for some women
  • 19. Time to think again !! • Hysterectomy: • 40% morbidity rate • 10 per 10,000 surgeries mortality rate • In a recent survey of the outcomes of 37,000 hysterectomies, the overall operative and postoperative complication rates were 3.5% and 9%, respectively Reference: Dicker et al., 1982; Lilford R, 1997
  • 20. LNG IUS versus Hysterectomy •20 Percentage of women who cancelled their Hysterectomy when given the option of LNG IUS in management of Menorrhagia Pekka Lähteenmäki et al. 1998 316: 1122 (6)
  • 23. Endometriosis • Mirena after operative laparascopy for endometriosis was more effective compared to the group that was only treated surgically. • Comparing use of GNRH analog to Mirena: equally effective in reducing chronic pelvic pain. The analogue was superior in reducing the amount of blood flow. Human Reproduction 2005
  • 24. Use of LNG IUS for recurrence of symptoms in women who have surgery for endometriosis There is limited but consistent evidence showing that postoperative LNG-IUD use reduces the recurrence of painful periods in women with endometriosis Cochrane summaries :Published Online: January 31, 2013
  • 26. FIBROIDS • Use of the LNG-IUS appears to lead to a significant reduction in the uterine volume of women with menorrhagia • Reduces the MBL in women with uterine leiomyomas. Efficacy of the levonorgestrel-releasing intrauterine system in uterine leiomyoma. Int J Gynaecol Obstet. 2012 Jan Kriplani A, Awasthi D, Kulshrestha V, Agarwal N.
  • 27. Endometrial Hyperplasia • Beneficial effects are observed by the majority within 1 year. • Treatment can be reliably monitored through regular 6-montly outpatient endometrial Pipelle surveillance The effectiveness of a levonorgestrel-releasing intrauterine system (LNG-IUS) in the treatment of endometrial hyperplasia--a long-term follow-up study Eur J Obstet Gynecol Reprod Biol. 2008
  • 28. Early-stage Endometrial Carcinoma • Combined Operative HSC and LNG IUS for 12 months • May have a role of safe and conservative management of early EC • In selected patients willing to preserve fertility Conservative treatment of early endometrial cancer: preliminary results of a pilot study. Gynecol Oncol. 2011; 120(1):43-6
  • 29. OTHER INDICATIONS • In protection of endometrium from endometrial hyperplasia during CCHRT • Endometrial protection for women on tamoxifen • Women With Clotting Disorders Or Under Anti Thrombotic Treatment
  • 30. PRACTICAL TIPS TO SUCCESS
  • 31. 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?
  • 32. Counselling- Three problems !!! • Spotting after insertion (explain) • Amenorrhea in 25 % of women • Price
  • 33. Irregular Bleeding • May last for 4-6 months • Acceptance depends on good pre insertion counselling • Use COC or Progesterone to tide over this period • GnRHa too has a role
  • 34. COST EFFECTIVENESS LNG IUS • Cost- Rs 8205/- • Insertion cost – Rs. 2000/ Rs.5000 Covered by Insurance ORAL PROGESTERONE 1 mnth – Rs. 3000 6 months Rs. 18000 1 Yr Rs. 36000 No insurance
  • 35. SIDE EFFECTS • Altered patterns of menstrual bleeding • Hormonal symptoms • Ectopic pregnancy – 1 in 20 • Uterine expulsion ( 1 in 20) • Perforation ( 1-2/1000) • Ovarian cysts • Pelvic Infection
  • 36. Insertion tips • Screening for STI, Cervical Screening • Antibiotic Coverage( Optional) • Insertion Tip – tighten and then LOCK
  • 37. DURATION Menorrhagia: It can be removed at mid 50s as long as it controls the bleeding HRT Change it after 4 years “licenced”
  • 38. Mirena after five years • Contraception: -<45years…..5 years ->45 years ….7 years NICE GUIDELINES : “if inserted >45 and has complete amenorrhea may continue to use it until menopause”
  • 40. EXTRA TIPS • Not be used as Emergency Contraception • Can be used with ATT • No effect on BMD
  • 41. PROMISING NEW LNG IUSPROMISING NEW LNG IUS • LNG-IUS12 and LNG-IUS16 • For Nulliparous and Postmenopausal • Phase III trial results are now being analyzed and "hopefully they will be ready soon." Fertil Steril 2012.
  • 42. •42 Effective alternative to Surgery Preserves Fertility Convenient Highly effective in reducing blood loss Well Tolerated High User Satisfaction LNG IUS In Menorrhagia Take Home Messages!!!! New Indications
  • 43. Mirena is a new horizonMirena is a new horizon to your patient and yourselfto your patient and yourself BE BOLD, WALK ALONG NEW PATHS EXPERIENCE IT YOURSELF
  • 44. ADDRESS 35 , Defence Enclave, Opp. Preet Vihar Petrol Pump, Metro pillar no. 88, Vikas Marg , Delhi – 110092 CONTACT US 011-22414049, 42401339 WEBSITE : www.lifecarecentre.in www.drshardajain.com www.lifecareivf.com E-MAIL ID Sharda.lifecare@gmail.com Lifecarecentre21@gmail.com info@lifecareivf.com &