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LNG – IUS (Mirena) In
HMB
Dr. Sharda Jain
Dr. Jyoti Agarwal
Dr. Jyoti Bhaskar
Heavy Periods
More than 1 in 5
30s & 40s suffer from
HEAVY PERIODS
(Unmanageable)
Causes of HMB
FIGO Classification
Munro MG, Critchley H, Broder MS, Fraser IS; for the FIGO Working Group on Menstrual Disorders. International Journal of Gynecology and
Obstetrics 113 (2011) 3–13
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
Non surgical methods of management of
HMB
• Pharmacological
– Levonorgesterol -Intrauterine System (LNG-IUS)
– Antifibrinolytics
– NSAIDS
– GnRH analogues
– Oral contraceptives
– Cyclic progestins
Marret H, Fauconnier A, Chabbert-Buffet N, et al. Eur J Obstet Gynecol Reprod Biol. 2010 Oct;152(2):133-7.
Medical therapy is usually considered a first-line treatment for
idiopathic HMB
GnRH – Gonadotrophin Releasing Hormone
Surgical methods of management of HMB
• Endometrial ablation (EMA)
– Considered appropriate only for patients who have completed their
family.
– It is also not suitable for women with a large uterus
• Hysterectomy
– Remains the definitive treatment for HMB
– Should not be used as first-line treatment in cases with primary
HMB unless all other treatments are contraindicated or refused by
the patient.
• Uterine fibroid embolization
– New and still experimental
In patients where pharmacological treatment is ineffective or inappropriate,
or the patient does not want drugs, and in patients with certain histological
abnormalities of endometrium, non pharmacological treatment is more
suitable
National Collaborating Centre for Women’s and Children’s Health. Heavy Menstrual Bleeding Clinical Guideline. London: RCOG Press for NICE; 2007.
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
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
30
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: Efficacy
97% Reduction in
Menstrual Blood Loss over
1 year of therapy
Significant increase in
Hemoglobin and Serum
Ferritin level
LNG IUS versus TXA/MFA and MPA: MBL
Reduction
Significant reduction in MBL as compared to TXA/ MFA as well as MPA, with higher
likelihood of treatment success with LNG IUS
MFA = Mefenamic acid: Medroxy progesterone acetate
LNG-IUS vs. thermal balloon ablation (TBA)
prospective randomized controlled trial
5 year follow up results across various parameters with use of LNG-IUS vs. TBA
Five-year follow-up of HMB treatment with LNG-IUS was associated with
higher efficacy and satisfaction ratings compared to TBA.
Patient acceptability, perceived clinical improvement and overall
satisfaction rates were significantly higher in women using LNG-IUS.
Silva-Filho AL, Pereira Fde A, de Souza SS, et al. Contraception. 2013;87:409-15.
LNG IUS versus Hysterectomy
34
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 235 cases
INCLUDING FIBROIDS AND ENDOMETRIOSIS
Updated on 26/6/2014
Expulsion in 3
(UBT , hysterectomy , reinsertion )
• It can replace the need of hysterectomy in
2/3rd
of cases.
• Especially useful when future fertility is
desired
• Moderate Size
• Multiple
• With Heavy bleeding
• Young (wanted child - 2)
FIBROIDS
16 cases
Effective
Size ↓ - 25 – 30 %
• Grade IV with cyst
• Sever Dysmenorrhoea
&
• Bleeding Problem
Endometriosis
15 Cases
Effective – Except 1st
4 month
DUB / adenomyosis
Few Keen for future childbearing
Rest Causes
EFFECTIVE – Except 1st
4 month
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
Mirena
Trouble shooting
1st
4th
Month
OCP GnRh Agonist
?
As Teacher we Trying
• POSITIVE ATTITUDE which is
contagious
• Improve Knowledge / Share Exp.
• Motivate you to try
Give A Lot - Expect a Lot
If you want to Become one !!
ALL
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
Thank You

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Mirena ppt for 2 july 14

  • 1. LNG – IUS (Mirena) In HMB Dr. Sharda Jain Dr. Jyoti Agarwal Dr. Jyoti Bhaskar
  • 2.
  • 4. More than 1 in 5 30s & 40s suffer from HEAVY PERIODS (Unmanageable)
  • 5. Causes of HMB FIGO Classification Munro MG, Critchley H, Broder MS, Fraser IS; for the FIGO Working Group on Menstrual Disorders. International Journal of Gynecology and Obstetrics 113 (2011) 3–13
  • 6. 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
  • 7. Non surgical methods of management of HMB • Pharmacological – Levonorgesterol -Intrauterine System (LNG-IUS) – Antifibrinolytics – NSAIDS – GnRH analogues – Oral contraceptives – Cyclic progestins Marret H, Fauconnier A, Chabbert-Buffet N, et al. Eur J Obstet Gynecol Reprod Biol. 2010 Oct;152(2):133-7. Medical therapy is usually considered a first-line treatment for idiopathic HMB GnRH – Gonadotrophin Releasing Hormone
  • 8. Surgical methods of management of HMB • Endometrial ablation (EMA) – Considered appropriate only for patients who have completed their family. – It is also not suitable for women with a large uterus • Hysterectomy – Remains the definitive treatment for HMB – Should not be used as first-line treatment in cases with primary HMB unless all other treatments are contraindicated or refused by the patient. • Uterine fibroid embolization – New and still experimental In patients where pharmacological treatment is ineffective or inappropriate, or the patient does not want drugs, and in patients with certain histological abnormalities of endometrium, non pharmacological treatment is more suitable National Collaborating Centre for Women’s and Children’s Health. Heavy Menstrual Bleeding Clinical Guideline. London: RCOG Press for NICE; 2007.
  • 9. Hysterectomy • Second most frequent surgical procedure in women of reproductive age group • 90% for benign reasons • Promptly offered following a diagnosis.
  • 10. 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
  • 11.
  • 12.
  • 13. Dilemma!! of Treatment Aim - Quality Personal life - Family life - Preserve the feminity of a women - ↓ Frequent leave from office Age Severity Fertility
  • 14. 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
  • 16. Options AvailableOptions Available Mirena / Endometrial Ablation Drug therapyDrug therapy Hysterectomy
  • 18. 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
  • 19. MIRENAMIRENA Its role in menorrhagiaIts role in menorrhagia
  • 20. MIRENA Inspired by : Prof.Osama Showki
  • 21. Mirena (LNG IUS) is a Magic Stick
  • 22. 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
  • 23. Mirena has an additional advantage of providing reversible contraception. Menorrhagia Contraception
  • 24. • Progestin releasing intrauterine system • T shaped polyethylene frame • Contains 52 mg levonorgestrel • Releases 20 µg LNG daily What is Mirena - LNG IUS
  • 25. Mirena : local mode of action Prevents endometrial proliferation • Thickens cervical mucus • Inhibits sperm motility serum levels are 4 times lower than after oral ingestion
  • 26. Benefits of local action No significant change in • Blood pressure • Lipid profile • Coagulation factors • Carbohydrate metabolism • Liver function • Bone mineral density
  • 27. Efficacy of LNG IUS in Idiopathic Menorrhagia
  • 28. 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%
  • 29. 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
  • 30. Effectiveness and Cost-Effectiveness of Levonorgestrel- Containing Intrauterine System in Primary Care against Standard Treatment for Menorrhagia (ECLIPSE) Trial 30 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
  • 31. LNG IUS: Efficacy 97% Reduction in Menstrual Blood Loss over 1 year of therapy Significant increase in Hemoglobin and Serum Ferritin level
  • 32. LNG IUS versus TXA/MFA and MPA: MBL Reduction Significant reduction in MBL as compared to TXA/ MFA as well as MPA, with higher likelihood of treatment success with LNG IUS MFA = Mefenamic acid: Medroxy progesterone acetate
  • 33. LNG-IUS vs. thermal balloon ablation (TBA) prospective randomized controlled trial 5 year follow up results across various parameters with use of LNG-IUS vs. TBA Five-year follow-up of HMB treatment with LNG-IUS was associated with higher efficacy and satisfaction ratings compared to TBA. Patient acceptability, perceived clinical improvement and overall satisfaction rates were significantly higher in women using LNG-IUS. Silva-Filho AL, Pereira Fde A, de Souza SS, et al. Contraception. 2013;87:409-15.
  • 34. LNG IUS versus Hysterectomy 34 When patients were given the option of mirena a significant percentage of women cancelled their hysterectomy Pekka Lähteenmäki et al. 1998 316: 1122 (6)
  • 35. 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
  • 38. Mirena provides long term relief of chronic pelvic pain Obstet gynecol 2012;119:519-526
  • 39. FIBROIDS Significant reduction in both the uterine volume and
  • 40. 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
  • 41. 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
  • 42. 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
  • 44. 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?
  • 45. Counselling- Three problems !!! • Spotting after insertion • Amenorrhea in 25 % of women • Price
  • 46. 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
  • 47. 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
  • 48. 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
  • 51. Used in 235 cases INCLUDING FIBROIDS AND ENDOMETRIOSIS Updated on 26/6/2014 Expulsion in 3 (UBT , hysterectomy , reinsertion ) • It can replace the need of hysterectomy in 2/3rd of cases. • Especially useful when future fertility is desired
  • 52. • Moderate Size • Multiple • With Heavy bleeding • Young (wanted child - 2) FIBROIDS 16 cases Effective Size ↓ - 25 – 30 %
  • 53. • Grade IV with cyst • Sever Dysmenorrhoea & • Bleeding Problem Endometriosis 15 Cases Effective – Except 1st 4 month
  • 54. DUB / adenomyosis Few Keen for future childbearing Rest Causes EFFECTIVE – Except 1st 4 month
  • 55. UBT v/s Mirena Great Great Great 4th Month Jaan Nikaal Deta Hai Really troublesome But one should TRY
  • 56. Mirena Positive Side • Effective after 4 month • Major Surgery is saved – Mortality - Morbidity Cost Effective
  • 58. As Teacher we Trying • POSITIVE ATTITUDE which is contagious • Improve Knowledge / Share Exp. • Motivate you to try Give A Lot - Expect a Lot
  • 59. If you want to Become one !! ALL
  • 60. KJ Carlson, NEJM 328:856, 1993 HYSTERECTOMY as Treatment Should be last resort
  • 61. 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

  1. The sinequa non of dub is heavy periods.
  2. FIGO classification: Munro MG, Critchley H, Broder MS, Fraser IS; for the FIGO Working Group on Menstrual Disorders. International Journal of Gynecology and Obstetrics 113 (2011) 3–13
  3. Medical therapy is usually considered a first-line treatment for idiopathic HMB Marret H, Fauconnier A, Chabbert-Buffet N, et al. Clinical practice guidelines on menorrhagia: management of abnormal uterine bleeding before menopause. Eur J Obstet Gynecol Reprod Biol. 2010 Oct;152(2):133-7. doi: 10.1016/j.ejogrb.2010.07.016. Epub 2010 Aug 4.
  4. Endometrial ablation (EMA) Can be offered to patients as initial treatment for HMB but is considered appropriate only for patients who have completed their family. The patients, however, will require reliable contraception afterwards. It is also not suitable for women with a large uterus Hysterectomy Remains the definitive treatment for HMB with high satisfaction rates, Should not be used as first-line treatment in cases with primary HMB unless all other treatments are contraindicated or refused by the patient. Uterine fibroid embolization This technique is new and still experimental, and requires a body of work before being implemented in clinical practice.
  5. Mirena
  6. Silva-Filho AL, Pereira Fde A, de Souza SS, et al. Contraception. 2013;87:409-15. A prospective, randomized controlled trial was conducted to compare 5-year follow-up of LNG-IUS or thermal balloon ablation (TBA) for the treatment of HMB. Hysterectomy rates, hemoglobin level, bleeding pattern, well-being status and satisfaction rates were assessed. Results After 5 years of follow-up the results were as follows (Table 5): „„ Women treated with a TBA had higher rates of hysterectomy (24%) compared to the LNGIUS group (3.7%) due to treatment failure (p=0.039). „„ Use of LNG-IUS resulted in higher mean hemoglobin (±SD) levels in comparison to the TBA group (14.1±0.3 vs. 12.7±0.4 g/dl, p=0.009). „„ Menstrual blood loss was significantly higher in the TBA when compared to the LNG-IUS group (45.5% vs. 0.0% p&amp;lt;0.001) . „„ The psychological general well-being index scores were similar. Patient acceptability, perceived clinical improvement and overall satisfaction rates were significantly higher in women using LNG-IUS. Five-year follow-up of HMB treatment with LNG-IUS was associated with higher efficacy and satisfaction ratings compared to TBA.
  7. 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